U.S. patent application number 15/891604 was filed with the patent office on 2018-09-06 for smart mirror.
The applicant listed for this patent is Bao Tran. Invention is credited to Bao Tran.
Application Number | 20180253840 15/891604 |
Document ID | / |
Family ID | 63144669 |
Filed Date | 2018-09-06 |
United States Patent
Application |
20180253840 |
Kind Code |
A1 |
Tran; Bao |
September 6, 2018 |
SMART MIRROR
Abstract
A mirror system includes a visual display disposed to convey
information and images during an active period; and the visual
display disposed to provide a reflected image during an inactive
period; a learning machine receiving data from one or more cameras;
and a processor coupled to the visual display, the learning
machine, and the camera.
Inventors: |
Tran; Bao; (Saratoga,
CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Tran; Bao |
Saratoga |
CA |
US |
|
|
Family ID: |
63144669 |
Appl. No.: |
15/891604 |
Filed: |
February 8, 2018 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15451321 |
Mar 6, 2017 |
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15891604 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 5/14532 20130101;
A61B 5/02444 20130101; G16H 40/63 20180101; A61B 5/4815 20130101;
H04N 13/204 20180501; A61B 5/0077 20130101; A61B 5/015 20130101;
G16H 20/70 20180101; H04N 13/275 20180501; G06T 2207/10016
20130101; G06T 2219/2021 20130101; G16H 50/30 20180101; A61B
5/02055 20130101; H01J 49/26 20130101; H04N 13/25 20180501; G06T
7/0012 20130101; G06T 2210/16 20130101; A61B 5/145 20130101; G16H
30/40 20180101; A61B 5/7267 20130101; A61B 5/742 20130101; G06T
11/60 20130101; A61B 5/0022 20130101; G06T 19/20 20130101; G01N
33/48 20130101; G01N 2570/00 20130101; G06K 9/00671 20130101; A61B
5/441 20130101; G06K 9/00228 20130101; G06T 15/20 20130101; G06F
16/90328 20190101; A61B 5/021 20130101; A61B 5/165 20130101; G06K
9/00369 20130101; A61B 5/0075 20130101; G06T 2207/30088
20130101 |
International
Class: |
G06T 7/00 20060101
G06T007/00; G06T 15/20 20060101 G06T015/20; G06T 19/00 20060101
G06T019/00; G06T 19/20 20060101 G06T019/20; A61B 5/01 20060101
A61B005/01; A61B 5/0205 20060101 A61B005/0205; A61B 5/00 20060101
A61B005/00; A61B 5/16 20060101 A61B005/16 |
Claims
1. A mirror system, comprising: a visual display disposed to convey
information and images during an active period, wherein the visual
display is disposed to provide a reflected image during an inactive
period; a high definition video camera and capturing images of the
user and one or more items worn or in contact with the user; a
second camera to capture a temperature and a heart rate; a learning
machine receiving data from the cameras; and a processor coupled to
the visual display, the learning machine, and the cameras, wherein
the processor determines weight, dimensions, temperature and heart
rate of the user, wherein the processor makes a recommendation
based on learning machine determination.
2. The system of claim 1, comprising code to separate a head or
body portion from a background scenery and replace the background
with a user selected virtual background.
3. The system of claim 1, wherein the visual device includes a
transparent front plate having an internal and an external surface,
and a metal layer formed on the internal surface of the front
plate, the metal layer having a thickness selected to reflect a
majority of incident external light during a time period when the
visual device is in an off state, while transmitting a majority of
internally generated light during a time period when the visual
device is in an on state.
4. The system of claim 1, comprising code to: identify the user's
current fashion style selected from a group consisting of hair
style, clothing, tattoo, shoe, bra, dental indicia, toe nail
indicia, fingernail indicia; determine matching style sets based on
one or matching attributes, current fashion style, fashion experts,
or celebrity styles; present matching style sets and get user
selection; identify a vendor of the user selected style; render a
3D augmented reality imposed over the user 3D model for preview;
accept user customization requests and re-render the 3D augmented
reality view.
5. The system of claim 1, comprising code to: identify a hair style
from a preferred person; receive a new 3D model of the hair style;
remove an existing hair from the 3D model of the user; and
superimpose and rendering a 3D view of the user with the new 3D
model of the hair style.
6. The system of claim 1, comprising code to display calorie count,
vital signs, fitness level and sleep quality from sensors.
7. The system of claim 1, comprising code to analyze a health trend
and project the health into a future facial or body shape for the
user.
8. The system of claim 1, comprising code to determine stress,
mental or emotional health of the user based on facial or body
changes.
9. The system of claim 8, comprising code to analyze mobile phone
usage pattern and social network communications to detect stress,
mental or emotional health of the user.
10. The system of claim 1, comprising code for remote examination
by a physician.
11. The system of claim 1, wherein the camera captures skin
condition.
12. The system of claim 1, wherein the camera includes an extension
to view throat structure, ear structure or nose structure.
13. The system of claim 1, comprising a thermometer, a scale and a
blood pressure measurement device coupled to the processor.
14. The system of claim 1, comprising a genetic sequencer or mass
spectrometer coupled to the processor to analyze DNA materials from
the user.
15. The system of claim 1, wherein the genetic sequencer or mass
spectrometer analyzes omic data from urine, stool, sweat, saliva,
tear, or bodily fluid.
16. The system of claim 1, wherein the genetic sequencer or mass
spectrometer analyzes cell-free DNA for cancer or pregnancy
issues.
17. The system of claim 1, comprising code to: change a shape or
size a body region, a breast region, or a butt region; model the
shape and size of the region due to an implant or removal of mass
therefrom; morph or project the shape or size of body change onto
the 3D model of the user; and allow user to iterative change shape
or size.
18. A mirror system, comprising: a visual display disposed to
convey information and images during an active period; and the
visual display disposed to provide a reflected image during an
inactive period; a multi-spectral 3D camera including a high
definition video camera and an infrared camera; and a processor
coupled to the visual display and the multi-spectral 3D camera, the
processor executing computer code to detect a trendy fashion style
based on one or matching attributes, current fashion style, fashion
experts, or celebrity styles, wherein the fashion style is selected
from a group consisting of hair style, clothing, tattoo, shoe, bra,
dental indicia, toe nail indicia, fingernail indicia and code to
morph the trendy fashion style to the 3D model of the user.
19. A mirror system, comprising: a visual display disposed to
convey information and images during an active period and the
visual display disposed to provide a reflected image during an
inactive period; a multi-spectral 3D camera including a high
definition video camera and an infrared camera; a processor coupled
to the visual display and the multi-spectral 3D camera and code to
analyze a user's health condition over a period of time by
examining images of the user's body or face.
20. The system of claim 1, comprising one or more medical sensors
including a genetic sequencer or mass spectrometer to analyze omic
data from urine, stool, sweat, saliva, tear, or bodily fluid;
wherein the processor executes code to predict a health condition
for the user and to schedule appointments for the user.
Description
BACKGROUND
[0001] The present invention relates to image analysis and pattern
recognition with a mirror.
[0002] A study from AOL and the Today show found that women spend
an average of 55 minutes in front of the mirror every day, whereas
men spend 39 minutes every day. The mirror is thus an integral part
of life that has not yet joined the digital age.
SUMMARY
[0003] In one aspect, a smart mirror provides relevant information
to a user to prepare him/her for daily tasks.
[0004] In another aspect, a mirror system includes a visual display
disposed to convey information and images during an active period;
and the visual display disposed to provide a reflected image during
an inactive period; a learning machine receiving data from one or
more cameras; and a processor coupled to the visual display, the
learning machine, and the camera.
[0005] In implementations, the smart mirror overlays a graphical
user interface over a partially reflective glass. The user
interface can provide news, traffic and weather information,
emails, social network communications. The smart mirror can act on
the user's verbal requests or gestures. A mirror gesture control
system includes a plurality of cameras mounted proximal to the
mirror to detect edges of an object; and a processor to translate
the edges as mouse movement and mouse clicks to control the vehicle
by moving hands.
[0006] In another aspect, a camera tracks movements and a 3-D
scanner analyzes the viewer's physique. Body recognition software
analyzes the body shape to determine weight loss or gain. The smart
mirror can provide clothing/jewelry/hair styling suggestions along
with augmented reality view of the suggestions so that the user can
visualize the impact of the clothing or jewelry or styling. Facial
recognition software inspects the face shape to determine health.
The smart mirror can provide make-up suggestions along with
augmented reality view of the applied suggestions so that the user
can visualize the impact of the makeup. The smart mirror can
provide non-surgical body augmentation suggestions such as
breast/buttock augmentations along with augmented reality view of
the body enlargements or size reduction so that the user can
visualize the impact of the body enhancement, along with clothing
or jewelry or hair styling changes.
[0007] In yet another aspect, built-in sensors in combination with
mobile phone usage pattern and social network communications can
detect signs of stress and other mental/emotional health states of
the user. The mirrors could also be combined with other
health-related apps to keep track of your calorie count, vital
signs, fitness level and sleep quality. By extrapolating from the
user's current behaviors, vitals and bone and muscle structure, the
augmented-reality mirror can forecast the user's future health. The
camera can measure breathing activity and/or heart rate of the user
in front of the mirror or alternatively the system can bounce WiFi
off the chest to detect breathing activity. The mirror highlights
hard-to-see changes in the body, such as increased fatigue, minute
metabolic imbalances and more. A DNA analyzer can receive swipes
from tongue, ear, and saliva, bodily fluids to capture genetic data
at a high frequency and such data can be correlated with the
fitness wearable devices for signs of health problems.
Additionally, the data can be analyzed at a metropolitan level for
public health purposes.
[0008] Advantages may include one or more of the following. The
mirror provides convenience and time efficiency when a user is in
front of a mirror. As today's habits shape future health, the smart
mirror can encourage users to take healthy actions. The time spent
in front of the mirror can be used to continually monitor health
and proactively report any changes before they get serious. The
smart mirror converts an everyday object that's already in the
homes into a communication portal, and provides people with more
"granular" health data that may otherwise be undetected until their
yearly checkups. The system turns time spent in the bathroom into
fun or productive periods. When these effects are considered in
aggregate, one or more of the methodologies described herein may
obviate a need for certain efforts or resources that otherwise
would be involved in convenience to the user. Efforts expended by
user or provider of fashion products may be reduced by one or more
of the methodologies described herein. Computing resources used by
one or more machines, databases, or devices may similarly be
reduced. Examples of such computing resources include processor
cycles, network traffic, memory usage, data storage capacity, power
consumption, and cooling capacity.
BRIEF DESCRIPTION OF THE DRAWINGS
[0009] FIG. 1 shows an exemplary smart mirror.
[0010] FIGS. 2A-2B show exemplary hardware supporting the smart
mirror.
[0011] FIG. 3A shows an exemplary process for suggesting styles for
the user with the mirror.
[0012] FIG. 3B shows an exemplary process for producing custom
fashion clothing based on images or videos of a model or a
celebrity that the user likes.
[0013] FIG. 3C shows a mass-customized clothing fabrication network
that is driven by current fashion and hot celebrity trends.
[0014] FIG. 4 shows an exemplary hair style suggestion process with
the mirror.
[0015] FIG. 5 shows an exemplary medical cosmetic suggestion
process with the mirror.
[0016] FIG. 6 shows an exemplary system for receiving health
information from the mirrors and for mining health data as part of
precision medicine.
DESCRIPTION
[0017] FIG. 1 shows an exemplary smart mirror 10 that provides
relevant information such as weather 14 and traffic 16 to a user to
prepare him/her for daily tasks. The smart mirror 10 overlays a
graphics user interface 13-16 over a reflective glass 12. The user
interface can provide videoconferencing, news, traffic and weather
information, emails, social network communications, among others.
The smart mirror can act on the user's verbal requests or
gestures.
[0018] FIGS. 2A-2B show exemplary hardware supporting the smart
mirror. As shown in FIG. 2A, a processor communicates with a mirror
display and receives 3D information from a 3D camera. The processor
can also communicate with fitness sensors that detect physical
activity, sleep quality, heart rate, among others. The process can
also capture medical information such as blood pressure,
temperature, weight scale, among others. In certain embodiments, a
portable genetic analyzer or mass spectrometer can communicate DNA
information captured from hair, skin flakes, saliva, stool, urine,
and sweat, among others, to the processor. In one embodiment shown
in FIG. 2B, a display disposed to convey information and images
during an active period; and the visual display disposed to provide
a reflected image during an inactive period. The display device
includes a transparent front plate having an internal and an
external surface, and a metal layer formed on the internal surface
of the front plate, the metal layer having a thickness selected to
reflect a majority of incident external light during a time period
when the visual device is in an off state, while transmitting a
majority of internally generated light during a time period when
the visual device is in an on state. In another embodiment, a solar
panel can be positioned above the metal layer to capture light and
generate electricity therefrom. In one embodiment shown in FIG. 2,
a high resolution display can be converted into an efficient mirror
during time periods when the visual display is not needed for
active data and image transmission. The elements of the
illustrative embodiment of a electroluminescent device 200 pixel
differ from a conventional display in the addition of a mirror
layer 222 placed between the ELE 214 and the ITO 216. The mirror
layer 222 may be what is known as a one way mirror, or a half
coated mirror, and comprise a very thin layer of a reflective
material. For example, the reflecting layer may be formed of
aluminum, with a thickness that is less than what may be known as
the skin depth of the material. Such a thin layer may be adjusted
to allow a desired percentage of the incident light to pass
through. When the cathode 204 is emitting electrons to strike the
ELE 214, there will be a substantial number of photons of light 220
produced, and with a thin enough half mirror layer 222, the great
majority of the photons will pass through the ITO 216 layer and the
front plate layer 218 to form part of the image. On the other hand,
during time periods when the cathode 204 is not emitting electrons,
the region between the anode 210 and the front plate 218 will be
dark and there will be few photons of light 220 produced. In this
situation, the majority of the light from the external area beyond
the top surface of the front plate will either reflect back from
the top surface of the front plate 218 (as occurs with the
situation of a lighted room reflected in the window looking out
over a dark night) or from the ITO layer, but the great majority of
the light will reflect from the half mirror layer 222, as occurs
with what are known as one way mirrors. Thus, the visual display
200 becomes an improved mirror when there is no image projected.
The mirror layer 222 should have a thickness determined by the
specific allowable loss of display intensity due to photons of
light 220 lost in the mirror layer 222, as compared to the desired
improvement in the front plate 218 mirror properties. The mirror
layer may be formed from a conductive material, and so may be used
as the electron attracting positive electrode, or as an addition to
the existing ITO 216 electrode. Thus, the high resolution display
can be converted into an efficient mirror during time periods when
the visual display is not needed for active data and image
transmission. When the display is active, to simulate a mirror, the
display can capture the user's 3D model and superimpose the room's
background with the user's movement and thus an electronic mirror
is presented. The mirror has voice recognition with search
capabilities such as those done by Apple's Siri, Microsoft's
Cortana, or Amazon Alexa speech response units.
[0019] A mirror gesture control system includes a plurality of
cameras 18 (FIG. 1) mounted proximal to the mirror to detect edges
of an object, among others. In one embodiment the Microsoft
Kinect.RTM. camera can be used, while in another embodiment, a 3D
camera such as the Intel RealSense.RTM. uses three components: a
conventional camera, a near infrared image sensor and an infrared
laser projector. Infrared parts are used to calculate the distance
between objects, but also to separate objects on different planes.
In one embodiment, a processor to translate the edges as mouse
movement and mouse clicks to control the vehicle by moving hands.
They serve for facial recognition as well as gestures tracking. The
Intel 3D camera can scan the environment from 0.2 m to 1.2 m. Its
lens has a built in IR cut filter. The video camera has a frame
rate up to 60 fps with a 90.degree. FOV, moreover its lens has an
IR Band Pass filter. The IR laser integrates an infrared laser
diode, low power class 1, and a resonant micro-mirror. The 3D
camera can provide skeletal and depth tracking and may gather
spatial data that describes objects located in the physical
environment external to the depth sensor (e.g., the user's bath
room). The skeletal and depth tracking technology may be
implemented in a depth sensor (e.g., the Kinect, the Intel
Realsense), stereo cameras, mobile devices, and any other device
that may capture depth data. In some example embodiments, the
skeletal and depth tracking technology is implemented on a server
using algorithms that utilize the RGB and depth channels. In some
example embodiments, depth sensing technologies use structured
light or time of flight based sensing. For example, an infrared
(hereinafter, also "IR") emitter that is part of the preference
analysis machine 310 and that is located in the user's living room,
may project (e.g., emit or spray out) beams of infrared light into
surrounding space. The projected beams of IR light may hit and
reflect off objects that are located in their path (e.g., the user
or a physical object in the user's living room). A depth sensor
(e.g., located in the user's living room) may capture (e.g.,
receive) spatial data about the surroundings of the depth sensor
based on the reflected beams of IR light. In some example
embodiments, the captured spatial data may be used to create (e.g.,
represent, model, or define) a 3D field of view that may be
displayed on a screen (e.g., of a TV set, computer, or mobile
device). Examples of such spatial data include the location and
shape of the objects within the room where the spatial sensor is
located. In some example embodiments, based on measuring how long
it takes the beams of IR light to reflect off objects they
encounter in their path and be captured by the depth sensor, the
preference analysis machine 310 may determine the location (e.g.,
the distance from the depth sensor) of the objects off which the
beams of IR light reflected (e.g., the user, a furniture piece, or
a wall). In various example embodiments, based on the received
spatial data, the system may determine details of the objects in
the room, such as spatial measurements of the objects in the room
(e.g., the dimensions of the user's body). The camera determines
one or more measurements (e.g., dimensions) of the body of the user
as part of the analysis of the image and the model. The processor
with 3D model information from the user may also determine, based
on the measurements of the user's body, one or more sizes of
fashion items from different brands (e.g., manufacturers or sellers
of fashion items) that may fit the user's body.
[0020] Video Conferencing with Virtual Background
[0021] For video conferencing, the camera can extract just the head
of the user from background scenery and replace the background with
a user selected background. For example, the background might show
a logo or a business scene. The user can simply incorporate a
virtual, not physical, background when video conferencing with
customers, suppliers, co-brokers, logistics providers, bankers,
etc., from the privacy of a bathroom or home.
[0022] Calendaring
[0023] The mirror can show the user's calendar and suggested
activities for free time and busy time, or activities to be
performed based on upcoming events. For example, if user's schedule
includes a date (e.g., user entered, company entered, etc.) in the
future for the completion of a report, suggestions can be made
earlier in time (e.g., during open time slots, blocked time slots)
to the user to begin preparing the report, or begin researching
data for preparing the report, for example. If the report
completion is an important deadline, as tagged by the user or the
entity that inserted the scheduled task, the suggestions for
preparation and completion can be given higher priority over other
suitable suggestions returned by the architecture. The suggested
activities can be obtained from web-based sources (e.g., social
networks), enterprise sources, client machines, other accessible
information sources, or any combination thereof. For example, in
one implementation, the user can select or prioritize the sources
of suggested activities such that a suggestion from a first source
will be given higher priority over a suggestion related to a second
source. This can be changed on a time basis, as well. For example,
if the first source is of the user's employer and the second source
is an entertainment source, suggestions from the employer source
can be given higher priority with one month of project completion,
while entertainment suggestions will be given higher priority
immediately after the project completion date, or one week before
project completion (to begin preparing for vacation or a short
relaxing break). In another example, the user places a parent
birthday on the calendar. The system then suggests time for the
user to shop for a gift for the parent two weeks before the
birthday. In yet another example, the user indicates on a to-do
list a dinner engagement with another couple two weeks hence, but
the location is yet to be determined. Five days before the
approximate time the system suggests that the user block out time
to choose a restaurant, generates a candidate list of suggestions,
and provides links to the candidates for booking. If the calendar
indicates an event such as a concert, the system can also suggest
fashion styles to stand out.
[0024] Clothing Recommendation
[0025] One embodiment includes obtaining a 3D model of a user
standing in front of the display and rendering one or more articles
or products on the 3D model. Images such as photographs or videos
can be made of the user (also referred to as customer or client)
when trying on different articles. These images can be seen on the
display and can simply be ordered/edited/deleted by the user by
"dragging" them across the screen. In this example, the display is
designed as a touch screen. In this manner, the articles tried on
can be compared more realistically and more easily by the user.
[0026] A user can be a consumer of fashion items. Further, a user
may include an expert such as a fashion professional, where this
fashion professional includes a fashion designer, a personal
shopper, a personal stylist, a journalist who reports on fashion,
or some other suitable person. Matching is based, in part, upon an
attribute of a fashion item. Attributes include color, fabric, cut,
designer, size, time of creation, and other suitable attributes
used in denoting a fashion. In one example embodiment, matching
includes receiving input in the form of a particular fashion item,
and based upon this fashion item suggesting an additional fashion
item based upon matching attributes. Matching is facilitated
through the use of a learning machine. In one example embodiment,
the learning machine can determine the user's favorite actress or
model and build a related association. Thus, the fashion style from
trendy stars, models, and musicians followed by the user in social
media (facebook, twitter) can be analyzed and similar items can be
added to the virtual digital closet of the user. Similar clothing
items worn by the actress or model can be retrieved and the
clothing data can be superimposed on the 3D model of the user to
show the user the expected appearance. In addition, experts such as
magazine editors/writers can provide outfit ideas and the user can
apply the outfit ideas to his/her wardrobe and hairstyling, among
others. The user can adjust color or size or any other attributes
of the clothing, and place an order. The order is sent to the
fashion maker, who customizes the item accordingly and ships the
product to the user.
[0027] One exemplary process is as follows: [0028] Identify user's
current fashion style. The fashion item can be hair styles,
clothing, shoes, bras, dental wear (braces/aligners) [0029]
Determine matching style sets based on one or matching attributes,
current fashion style, fashion experts, or celebrity styles [0030]
Present matching style sets and get user selection [0031] Identify
vendor of the user selected style [0032] Render a 3D augmented
reality imposed over the user 3D model for preview [0033] Accept
user customization requests and re-render the 3D augmented reality
view [0034] Send data to the vendor to ship fashion product to the
user
[0035] FIG. 3 shows an exemplary process to provide mass-customized
clothing [0036] Capture 3D model of body (310) [0037] Digitally
remove current dress (312) [0038] Select new fashion styles from
new trends (314) [0039] Morph or project clothing onto the 3D model
of body (316) [0040] Allow user to iterative change fashion color,
length until satisfied with new clothing (318) [0041] Allow user to
select from a library of jewelry and shoes to provide realistic
simulation (320) [0042] Order desired clothing with custom
measurements (322)
[0043] In one embodiment, trendy clothing identified based on news
or Internet buzz can be located. In this embodiment, the system
performs a search of an inventory of fashion items based on the
identified fashion preference of the user and then performs a
similarity search of the fashion inventory and generates similarity
search results (e.g., fashion items that are similar to an item
previously worn by the user).
[0044] In some example embodiments, the similarity search is based
on an image search of the style or the identification of similar
clothing. In some instances, the similarity search is also based on
one or more measurements of the user's body. For example, to
perform a similarity search, the search module compares one or more
visual features extracted from the fashion image and one or more
visual features identified in an image depicting a fashion item
included in the fashion inventory being searched. In some example
embodiments, the similarity search is based on an attribute-value
pair that characterizes a fashion item previously worn by a
celebrity, model, star, user's friend, user's social network or
even by the user. In some instances, the similarity search is also
based on one or more measurements of the user's body. The
performing of the similarity search may include selecting an
attribute-value pair to be used as a query attribute-value pair and
identifying one or more items in the fashion inventory that are
characterized by the attribute-value pair. In some instances, the
coordination search is also based on one or more measurements of
the user's body. The performing of the coordination search may
include identifying, based on a coordination rule, one or more
items in the fashion inventory that can be worn together with the
fashion item that corresponds to the query image. Similarly, the
search module may perform a similarity search based on the first
image and then may generate one or more similarity search results.
The search module may perform a coordination search based on the
second image and further generate one or more coordination search
results.
[0045] As still yet another embodiment, a feature to perform
similarity searching is a user's geographical location used as a
criterion to match the user to other users as style may vary from
one location to another location. To illustrate this type of
feature by way of example only is the case where a user A is a
business executive woman living in Country A1. She is travelling on
a business trip to country B1. Country A1 could be a conservative
country, where ethnic attire is normally worn even in business
meetings. Country B1 could be a fashion conscious country. User A
may want to wear fashionable clothing, that would look smart on her
and be appropriate for business meetings in B1." In yet another
example of using this type of feature of engine 110 is illustrated
as follows, a user is a graduating 22 year old female, 5'3'', 145
lbs, having a hourglass body shape, starting a new job as a project
manager in New York. She does not know what kind of attire is
appropriate and what style of clothing would look good on her. She
creates an account on the system of the present invention, creates
her profile, enter her attributes, instantly gets matched to other
users of similar attributes and gets recommendation on what style
of attire would look good on her. In another preferred embodiment,
the system may her to purchase the item in her size.
[0046] Clothing Fabrication
[0047] Based on the above fashion recommendation, the system can
fabricate mass-customized clothing for the user that is trendy. The
process has a training phase and a run-time phase as follows:
[0048] Training [0049] Collect library of fashion designs
(Pinterest, Google image, facebook images) [0050] Normalize the
fashion designs to standard size [0051] Break up the designs into
sections and extract features of sections [0052] Clusterize the
features into a codebook of clothing design sections/elements
[0053] Train library and create probabilistic model (HMM) to
represent a fashion design as a collection of sections
[0054] Run-Time [0055] Generate 3D model of user [0056] Receive
images of target fashion worn by celebrity or model for the user
[0057] Normalize target fashion images to a standard size [0058]
Extract features from the target fashion images [0059] Apply
probabilistic model to features and create a 3D model of the target
fashion model [0060] Do virtual fit to the user 3D model and
optimize the 3D clothing model for crotch fitting and movement
stress [0061] Flatten the 3D clothing model into 2D pattern [0062]
Present to laser cutter to cut pattern [0063] Move cut pattern to
computerized sewing system [0064] Perform QA as needed and ship
mass-customized clothing to user
[0065] In one embodiment, the system receives images of trendy
clothing or clothing style from a celebrity that the user wishes to
match. The images can be extracted from various news outlet or
celebrity sites, for example from google images with search
"celebrity fashion" or "tom cruise fashion", for example. For both
training and run-time, the system generates features associated
with portions of the fashion clothing. In one embodiment, a
L-C--S-H process can be used, for
low-level-characteristics-selection mask-high level. Low-level
refers to the features that are calculated from the images of each
article (e.g., 2D shape, 2D color, 2D texture, 2D edges, and 3D
shape). Characteristics refer to the attributes that are found on
generic articles of clothing (e.g., pockets, collars, hems).
Selection mask refers to a vector that describes what
characteristics are most useful for each category (e.g., collars
and buttons are most useful for classifying shirts), used as a
filter. High level refers to the categories to be classify (e.g.,
shirts, socks, dresses). In one embodiment, the unique
characteristics to differentiate categories of clothing can be:
Collar, Top brackets, Dark colored, Denim, Ankle hem, Front
pockets, Graphic pictures, Colored, Plaid, Thigh hem, Back pockets,
Graphic texts, White colored, Patterns, Inseam, Side pockets, Belt
loops, V-neck, Round neck, Elastic band, Top buttons, Striped,
Bicep hem, Front zipper, Shoulder hem, Wrist hem, or Shin hem,
among others.
[0066] The L component of the approach uses the low-level features
to estimate if the article does or does not have a particular
characteristic. The low-level features that were used in this
approach consist of color histogram (CH), histogram of line lengths
(HLL), table point feature histogram (TPFH), boundary,
scale-invariant feature transform (SIFT), and fast point feature
histogram (FPFH). To combine the low-level features of all five
instances into a single value or histogram, each value is
determined by averaging each individual value along with its
neighbors, in the case of the histogram.
[0067] For the part of the algorithm that converts from low-level
to characteristics, low-level features are compared to the various
characteristics. Since the characteristics were binary values,
libSVM is used to solve the two-class problem. Each low-level
feature determines if the characteristic is in class 1 or 2. Class
1 contains positive instances and class 2 contains negative
instances.
[0068] For an article of clothing, a high definition RGB image and
a raw depth map and background subtraction is done on the RGB image
to yield an image of only the object. The background subtraction is
performed using graph-based segmentation. Once the object is
isolated within the image, multiple features are calculated from
the RGB image and the 3D point cloud. These features capture 2D
shape, 2D color, 2D texture, 2D edges, and 3D shape for both global
and local regions of the object. One implementation uses
Felzenswalb and Huttenlocher's graph-based segmentation algorithm
which uses a variation of Kruskal's minimum spanning tree algorithm
to iteratively cluster pixels in decreasing order of their
similarity in appearance. An adaptive estimate of the internal
similarity of the clusters is used to determine whether to continue
clustering.
[0069] A color histogram CH is a representation of the distribution
of the colors in a region of an image, derived by counting the
number of pixels with a given set of color values. CH are chosen in
this work because they are invariant to translation and rotation
about the viewing axis, and for most objects they remain stable
despite changes in viewing direction, scale, and 3D rotation. CH is
used to distinguish, for example, between lights and darks, as well
as denim.
[0070] A Table Point Feature Histogram (TPFH) feature consists of a
263-dimension array of float values that result from three 45-value
subdivisions, that are calculated from extended fast point feature
histograms (eFPFH), and 128-value subdivision for table angle
information. This feature is a variant on the viewpoint feature
histogram. The eFPFH values are calculated by taking the difference
of the estimated normals of each point and the estimated normal of
the objects centerpoint. The estimated normals of each point and
the centerpoint are calculated by projecting them on the XY, YZ and
XZ plane.
[0071] A boundary feature captures 2D shape information by storing
the Euclidean distances from the centroid of each article to the
boundary. First, the centroid of each binary image is calculated
containing the object (after background subtraction). Then,
starting at the angle of the major axis found by principle
components analysis, 16 angles that range from 0 to 360 (i.e., 0 to
337.5) are calculated around the object. For each angle, the
process measures the distance from the centroid to the furthest
boundary pixel
[0072] Other feature includes histogram of line lengths (HLL) to
help distinguish between stripes, patterns, plaid, and so forth.
For this, we use the object image as before (after background
subtraction) and compute the Canny edges, then erode with a
structuring element of ones to remove effects of the object
boundary.
[0073] Next, local features can be computed. The SIFT, scale
invariant feature transform, descriptor is used to gather useful 2D
local texture information. The SIFT descriptor locates points on
the article (after background subtraction) that provide local
extremum when convolved with a Gaussian function. These points are
then used to calculate a histogram of gradients (HoG) from the
neighboring pixels. The descriptor consists of a 128-value feature
vector that is scale and rotation invariant.
[0074] A FPFH, fast point feature histogram descriptor can be used
to gather local 3D shape information. The FPFH descriptor utilizes
the 3D point cloud and background subtraction for each article and
segments the article from the background of the point cloud. For
each 3D point, a simple point feature histogram (SPFH) is
calculated by taking the difference of the normals between the
current point and its neighboring points with a radius. Once all of
the SPFHs are computed, the FPFH descriptor of each point is found
by adding the SPFH of that point along with a weighted sum of the
neighbors. Other features and descriptors can be used.
[0075] Once the features are computed, the global features are
concatenated to create a histogram of values. For local features,
SIFT and FPFH are calculated separately through bag-of-words to get
two element histograms of codewords. Being concatenated, this
yields predetermined values for the local features. Then being
concatenated with global features yields additional values, which
are then fed to the multiple one-versus-all SVMs.
[0076] With the codebook, one embodiment can train a probabilistic
learning system such as Hidden Markov Model (HMM) to represent a
fashion design as a constrained combination of various esthetic
components or sections. HMM is a statistical Markov model in which
the system being modeled is assumed to be a Markov process with
unobserved (hidden) states. A HMM can be presented as the simplest
dynamic Bayesian network. In simpler Markov models (like a Markov
chain), the state is directly visible to the observer, and
therefore the state transition probabilities are the only
parameters. In a hidden Markov model, the state is not directly
visible, but the output, dependent on the state, is visible. Each
state has a probability distribution over the possible output
tokens. Therefore the sequence of tokens generated by an HMM gives
some information about the sequence of states. The adjective
`hidden` refers to the state sequence through which the model
passes, not to the parameters of the model; the model is still
referred to as a `hidden` Markov model even if these parameters are
known exactly. A hidden Markov model can be considered a
generalization of a mixture model where the hidden variables (or
latent variables), which control the mixture component to be
selected for each observation, are related through a Markov process
rather than independent of each other. Recently, hidden Markov
models have been generalized to pairwise Markov models and triplet
Markov models which allow consideration of more complex data
structures and the modelling of nonstationary data. Other machine
learning/classifiers can be used, as detailed below.
[0077] Once the system is set up, it can recognize and recreate
clothing given an input image. For example, if a celebrity wears a
fashionable clothing to attend a highly publicized event, images of
the celebrity are publicized and the user may want to replicate the
look. In this case, the system retrieves a 3D model of the user and
receives images of target fashion worn by celebrity or model liked
by the user. The system normalizes the target fashion images to a
standard size and extracts features from the target fashion images
as detailed above. The system applies the probabilistic model to
features and creates a 3D model of the target fashion model using
the HMM recognizer using the components/sections model. The system
can then apply a virtual fit to the user 3D model and optimize the
3D clothing model for crotch fitting and movement stress.
[0078] In one embodiment, since the optimization problem is
combinatorial and the number of combination items can vary (e.g., a
pockets can be added or removed), it is difficult to define a
closed-form solution. In fact, as in the real world, it is
desirable to obtain multiple optimal solutions (outfits) from the
various components instead of a single global optimum. The process
generates candidate solutions by sampling a density function
defined over the space of possible outfits. The density function is
defined using idealized analytical formulations. Sampling is
preferably performed using a Markov Chain Monte Carlo sampler,
During the optimization dimensionality may change; i.e., the number
of clothing components/sections may be altered during the
optimization process, and a Reversible Jump MCMC (RJMCMC) framework
supplements parameter-changing diffusion moves of
Metropolis-Hastings (MH) with an additional set of
dimension-altering jump moves, which allow the chain to move
between subspaces of different dimension. To efficiently explore
the solution space, a simulated annealing technique is applied in
the optimization process with a Boltzmann-like objective function.
A dimension matching strategy is adopted to allow reversible jumps
across subspaces of different dimension or within the same
subspace. The RJMCMC can be used to define the jump moves as
adding/removing a clothing item to/from the outfit, which induce a
dimension change, and diffusion moves as swapping items or
modifying an item's colour, which involve no dimension change.
[0079] Various fitness criteria can be applied to evaluate how well
the new design fits the user, such as comparing lengths and areas,
analysis of space between clothing and the body, among others.
[0080] The final clothing model is flattened into 2D pattern. In
one embodiment, each mesh element is deformed during the flattening
from 3D to 2D plane. A pattern projection can be used that takes
into consideration elastic and shear properties of the fabric.
[0081] One embodiment uses Design Concept Tex Tech (DCTT) software.
The flattening operation involves two steps: first, the selection
of the region part to be flattened, and second, the selection of
flattening options appears in the "Flattening parameters" dialog
box. The flattening tool provided by DCTT considers the geometric
constraint of the shape, but no material properties. The process is
comparable to the flattening of a network of springs whose
stability is obtained through an even distribution of its internal
energy. It is an iterative process which proceeds layer by layer
beginning from the flattening start point. To control the
flattening process, DCTT offers both automatic and numerical
options, as can be seen in FIG. 3-6. The automatic control allows
the flattening algorithm to run until balance is reached. This
option is always selected for pattern flattening throughout this
research work. To prepare the flattened pattern pieces for
meaningful use in clothing manufacturing, an appropriate seam
allowance is added around them. This is done in a "2D product"
document using the "design parts" tool with the "create seamline
part" option, which is available under the "parts" menu. Rendering
of the virtual clothing items developed on the 3D templates is
performed by keeping both the "3D Design" document (containing the
3D template and virtual clothing design) and the "2D pattern"
document (containing the flattened pattern pieces open). On the
active "2D Pattern" document, the "create rendering" tool with a
"create virtual marker" option available under the "Pattern" menu
is used to apply different graphical images of a particular pattern
piece. After doing that, when the "realistic rendering" option in
the "rendering" tab is activated, the graphic image applied on the
pattern pieces is visualized in 3D.
[0082] In another embodiment, from the 3D model of the user, 2D
non-contact anthropometric and automatic pattern generation system
of men's shirts and pants can be done. The system needs the users
to provide front and side photos of the target celebrity or model,
and carry interaction design of shirts or pants' styles. Then the
patterns can be automatically generated based on the user's
physical measurement, the celeb photos and the style design. The
two-dimensional anthropometric system is integrated with automatic
pattern generation system. In one example, for men's trousers, an
automatic pattern generation can apply predetermined rules on the
3D model of the user such as those by Hong Xu in Pattern Automatic
Generation for Men's Trousers, ISSN: 2005-4297 IJCA 2014 SERSC.
[0083] The 2D pattern can be sent to a cutter such as a CNC or a
laser cutter to cut patterns from a fabric that is selected by the
user, and the system can move the fabric with the cut pattern on a
conveyor to a computerized sewing system, where a robot can pick up
the pattern and the sewing system can assemble the pieces into mass
customized clothing. The machine fabrication can extend into
computer controlled weaving, dying to create a highly
mass-customized fashion wear for users, as shown in FIG. 3C.
[0084] In some embodiments, the user's purchase history, retained
as part of their account information, may be used as training data
for a Bayesian network component associated with the outfit
suggestion component. For example, if the user has previously
purchased high heel shoes and a jacket in the same purchase, the
Bayesian network component may recognize that sports shoes and
vests should both belong to the outfit.
[0085] The present 3D clothing design systems offer a number of
benefits over 2D clothing design systems in use. Virtual
prototyping using computer-based 3D clothing product-development
techniques results in fewer physical prototypes and a shorter
product-development phase. For decision-making on product selection
and prior to the commencement of production, it is usual for at
least two up to ten physical prototypes to be made when using
existing traditional product-development systems and this incurs a
high cost involvement and time consumption. Virtual prototyping and
virtual try-on processes can significantly reduce the
product-development time and cost. Virtual review and evaluation of
fit with realistically simulated fabric behaviour can enable faster
detection of errors and earlier corrections to design elements,
material selection and assembly. At the same time, the virtual
prototypes can be used as a marketing aid for online product
presentation and internet-based retailing. The application of
flattening technology provides the opportunity to combine clothing
design and pattern creation in to a single step. Automatic flat
pattern extraction from 3D designs offers a considerable reduction
of the time and manpower involvement in the pattern cutting
process. The instant 3D CAD system will form the nerve centre of at
the centre of a textile information network.
[0086] Hairstyling Recommendation
[0087] In another embodiment, the system can analyze fashion trends
based on the user's social network profile, the twitter follow
profile, celebrity likes and followings, or expert advice from
his/her fashion advisor or hairdresser or experts from magazines
and a number of sources. As another alternative or addition,
another feature that may be used by mirror to perform similarity
searching may correspond to a user's height range to height range;
weight-weight, body shape-body shape; age group appropriate as
explained above; profession range-profession range; job
position-job position; geographic location to geographic location
and user profile attributes to celebrity profile attributes. For
instance, the height and the width of a user's body figure, as well
as a generalization or quantitative description of an overall
head-shape (elongated or round shape) may provide another basis for
identifying results. Additionally, a user may perform some actions
on other user's images. For example: If the user likes the way
clothing fits on another user, ii) likes the style of clothing,
iii) likes clothing by brand, iv) type of clothing or for any other
reason, the user can "like" the image, leave a "comment" on the
image, or save the image in his/her digital closet.
[0088] The system first captures the user's head 3D model. For
style recommendation, the hair color information, the apparel
pattern information, the season information, the weather
information, the indoor/outdoor information, and the time
information may be included in the style characteristics. The
recommendation unit may receive a style preference from the user or
celebrity or experts as discussed above and search the
recommendation style information matched with the received style
preference, the face and the style characteristics. In addition,
the style recognizer extracts style feature information from the
images of the model/celebrity/favorite people that the user
indicates directly or indirectly through social network likes and
twitter-follow profiles, and recognizes style characteristics using
the extracted style feature information. Next, the recommender may
search recommendation style information matched with the face and
style characteristics recognized in the face recognizer and the
style recognizer in the recommendation style table in which the
recommendation style information is templated according to face and
style characteristics stored in the memory to provide the searched
recommendation style information to the user.
[0089] The method includes selecting a suitable hair-style wherein
the most suitable hair-style can be decided based on consideration
of personality and facial features of each selector, along with
adopting her preference and request, and at the same time to
provide an image map for a hair-style where it can be easily
defined what kind of an image the selected hair-style has. The
system can analyze a contour of the selector's face and its image
are defined for the hair-style brought by an inner line which
constitutes a boundary line between a face and a hairline and an
outer line which constitutes an outside of the hair style, and
wherein it is analyzed whether the selected hair-style is suitable
or not with respect to form and balance features and also analyzed
whether the selected hair-style is suitable to the image. Analysis
for the form and the balance of the hair-style is performed based
on five elements; 1. balance between upper and lower parts of the
face, 2. Silhouette, 3. Face line, 4. Balancing between head and
face, and 5. Total balancing.
[0090] Further, analysis for an image of the hair-style is
performed based on two elements; 1. An impression on the hair-style
and 2. An image gap between face features and a hair-style.
Further, with regard to the analysis for a form of the hair-style
and its balance, the analysis is performed based on a comparison of
a standard proportion between the hair and the face. Further, the
system can apply predetermined standards such as those in U.S. Pat.
No. 6,333,985 where the standard proportion between the hair and
the face is devised as follows: [0091] 1. The placement of the eyes
is in the center of the whole construction. [0092] 2. The
proportion ratio between distance from the eyes to the top end of a
hair style and distance from the eyes to a bottom end of a jaw is
1:1. [0093] 3. The proportion ratio between length of a forehead,
distance from the bottom of the forehead to a nose tip and distance
from the nose tip to the bottom end of the jaw is 1:1:1. [0094] 4.
The proportion ratio between the length of the forehead and
distance from the top of the forehead at the hairline to the top
end of the hair style is 1:0.5. [0095] 5. The proportion ratio
between length and breadth of the face including the head and hair
is, 1.5:1.
[0096] Further, an image for "light" and "heavy" is prepared on a
perpendicular axis up and down, while the image for "curve line"
and "straight line" is prepared on a horizontal axis, and thus
representative hair-styles in accordance with these expressed
images are arranged.
[0097] Further, the image for "light" has some features considered
to be youthful such as fluffy loose hair ends, bright in color,
having hairs on the forehead, to appear dry, and short to medium
size.
[0098] On the other hand, the image for "heavy" has features
associated with to be calm and an adult image such as stable in the
hair-ends, dark in color, no hair on the forehead, to appear wet,
and medium to long hair length.
[0099] The "curve line" depicts a warm and sweet image, with some
features of the hair style waved and curled, a rounded line, and
abundant soft hair at the sides.
[0100] The "straight line" depicts a cool and clean image, with
some features of the style straight, an angular line, and having a
long and hard silhouette.
[0101] For the face recognizing process and the style recognizing
process, the recommendation device detects a face region from a
user image transmitted and extracts face feature information from
the detected face region. Next, the recommendation device may
recognize gender and age from the extracted face feature
information or from the user's social network profile. In addition,
the recommendation device may extract style feature information
from a region of the user image except for the face region and
recognize the user style characteristics from the extracted style
feature information. The hair style information matched with the
face characteristics is used to superimpose the hair onto the
user's 3D head model.
[0102] Then, the recommendation unit searches the recommendation
style information for the characteristics matched with the face and
style characteristics recognized in the face recognition unit and
the style recognition unit in the recommendation style table
according to the characteristics. Here, at least one of the hair
style information, makeup style information, and recommendation
product information is included in the recommendation style
information. The recommendation unit may receive a style preference
from the user and search the recommendation style information
matched with the received style preference and the characteristics.
Further, in the case in which a plurality of recommendation style
information is searched, the recommendation unit may prioritize the
plurality of searched recommendation style information according to
a matched ratio with the characteristics.
[0103] FIG. 4 shows an exemplary process to provide trendy new hair
recommendations [0104] Capture 3D model of head (350) [0105] Remove
current hair (352) [0106] Select hair styles from new trends (354)
[0107] Morph or project hair onto the 3D model of head (356) [0108]
Allow user to iterative change hair styling until satisfied with
new hairdo (358) [0109] Allow user to select from a library of
wardrobes to provide realistic simulation (360) [0110] Share
desired hair style with professional to achieve desired hairdo
(362)
[0111] Health
[0112] The 3D camera tracks movements and a 3-D scanner analyzes
the viewer's physique. Body recognition software analyzes the body
shape to determine weight loss or gain. The smart mirror can
provide clothing/jewelry/hair styling suggestions along with
augmented reality view of the suggestions so that the user can
visualize the impact of the clothing or jewelry or styling. Facial
recognition software inspects the face shape to determine health.
The smart mirror can provide make-up suggestions along with
augmented reality view of the applied suggestions so that the user
can visualize the impact of the makeup. The smart mirror can
provide non-surgical body augmentation suggestions such as
breast/buttock augmentations along with augmented reality view of
the body enlargements or size reduction so that the user can
visualize the impact of the body enhancement, along with clothing
or jewelry or hair styling changes.
[0113] Built-in sensors in combination with mobile phone usage
pattern and social network communications can detect signs of
stress and other mental/emotional health states of the user. The
mirrors could also be combined with other health-related apps to
keep track of your calorie count, vital signs, fitness level and
sleep quality. By extrapolating from the user's current behaviors,
vitals and bone and muscle structure, the augmented-reality mirror
can forecast the user's future health. The camera can measure
breathing activity and/or heart rate of the user in front of the
mirror or alternatively the system can bounce WiFi off the chest to
detect breathing activity. The mirror highlights hard-to-see
changes in the body, such as increased fatigue, minute metabolic
imbalances and more. A DNA analyzer can receive swipes from tongue,
ear, and saliva, bodily fluids to capture genetic data at a high
frequency and such data can be correlated with the fitness wearable
devices for signs of health problems. Additionally, the data can be
analyzed at a metropolitan level for public health purposes.
[0114] FIG. 5 shows an exemplary process to recommend cosmetic
enhancements for women, and the process can be applied to men to
improve muscular physique appearance [0115] Capture 3D model of
user (370) [0116] Isolate breast or butt region (372) [0117] Model
shape and size of breast or butt increase due to implant (374)
[0118] Morph or project the shape/size of breast or butt increase
onto the 3D model of user (376) [0119] Allow user to iterative
change breast/butt shapes/sizes until satisfied with new shape
(378) [0120] Allow user to select from a library of wardrobes to
provide realistic simulation (380) [0121] Send desired shape and
provide feedback to plastic surgeon to implement desired shape and
size (382)
[0122] The mirror becomes a personalized medical kiosk supporting
method for using the mirror/personal medical kiosk advance
healthcare delivery wherein users and physicians can engage in
real-time interactive consultations, providing convenient and
affordable healthcare services. The mirror/personal medical kiosk
includes the latest technologies in medical devices, video
conferencing, and VoIP telephony so that the mirror/personal
medical kiosk can extend traditional healthcare to convenient
retail pharmacy locations or other locations in a user's
neighborhood, therein enabling a user to see a medical provider and
obtain a prescription, if required, in a fast and convenient
manner.
[0123] Some advantageous aspect of the mirror/personal medical
kiosk and medical method are: [0124] User Portal (Cloud Based).
[0125] Provider Portal (Cloud Based). [0126] Integrated Care
Station. [0127] Facilitates Efficient Delivery of Basic Healthcare
Delivery. [0128] Automates All Aspects of a Check Up. [0129] Easy
Check-In. [0130] Vital Signs Capture. [0131] Prescription
Generation. [0132] Post Care and Outcomes. [0133] Convenient
Locations Where Consumers Want To Be. [0134] Video playback of the
recorded session between the user and medical provider.
[0135] The mirror/personal medical kiosk and medical method can be
used to provide primary and/or urgent care services in four (4)
simple steps: [0136] Step 1--User begins/completes check-in process
via web portal or at the mirror/personal medical kiosk. The user
can optionally begin the check-in via web portal and then later
complete check-in process at the mirror/personal medical kiosk;
however, this is not required. A medical provider can send a
reminder to user regarding an appointment and/or begin the check-in
process for a user (e.g., follow-up appointment, etc.); however,
this is not required. [0137] Step 2--Medical provider receives
eligible request and accepts and/or is assigned to user. [0138]
Step 3--User visits the mirror/personal medical kiosk and has a
private appointment with a doctor via the User Screen. [0139] Step
4--Visit is completed.
[0140] The mirror/personal medical kiosk and/or medical provider
can then provide additional care/services that include:
prescription, billing information, education, referrals, follow up
and/or EMR/PHR entry. The medical provider can cause the
mirror/personal medical kiosk to printout a prescription and/or
directly send the prescription request to a pharmacy. The
mirror/personal medical kiosk can print out a bill after the
medical services are provided and/or accept payment prior to or
after medical services are provided. The mirror/personal medical
kiosk can be designed to accept and/or process medical insurance
information provided by the user. The mirror/personal medical kiosk
can print out and/or display education materials/information
relevant to/requested by the user and/or provided by the medical
provider. The mirror/personal medical kiosk and/or medical provider
and/or attendant can schedule a follow-up visit for the user.
Email, twitter, Facebook, test, and/or mail reminders can be sent
to the user regarding scheduled and/or follow-up visits. The
medical provider and/or attendant can schedule a visit with another
medical provider and/or admit the user to the hospital, contact an
ambulance, etc. during or after the visit to the mirror/personal
medical kiosk. A visit summary can be printed out and/or sent to
the user. As can be appreciated, the mirror/personal medical kiosk
and method for using the mirror/personal medical kiosk can have
other or additional features.
[0141] Advantageous portal features of the mirror/personal medical
kiosk and associated medical method are: [0142] Practice Management
Engine. [0143] Appointments Scheduling Engine. [0144] Online
Eligibility, Claims, and Billing Engine. [0145] ePrescribing with
Alerts and Reminder Engine. [0146] Medical Records Interface and
Access. [0147] Personal Health Record (PHR). [0148] Electronic
Medical Record (EMR). [0149] Rules-Based Care Plans. [0150]
Rules-Based Education. [0151] Check In Pathway to Care Engine.
[0152] Secure Video Conferencing Engine. [0153] Documentation
Module. [0154] Appointment Storage and Analysis. [0155] Education
and Post Care.
[0156] Some non-limiting advantages to users by use of the
mirror/personal medical kiosk and medical method include
Convenient, Closer to home, Saves time, Language and culture
friendly, Better Access, Personal doctor available while traveling,
Larger selection of doctors, Not limited by doctor's visitation
schedule, More Accurate, Review record of appointment, Automatic
data entry into PHR, Less Exposure to Illness.
[0157] Some non-limiting advantages to medical providers by use of
the mirror/personal medical kiosk and medical method are: Higher
Revenues. More appointments/day. Less traveling. More Accurate.
Review record of appointment. Automatic data entry into EMR/HER.
Integrated Care. Referral and transfer. Load Balancing. Appointment
load can be shared with other doctors regardless of location.
[0158] The mirror/personal medical kiosk of the present invention
is an Integrated Care Terminal that is a highly equipped doctor's
office that is built and designed to deliver urgent and mirror
medical care in the field utilizing a centralized team of doctors
for the evaluation and treatment of users. The mirror/personal
medical kiosk can be fitted with the latest FDA approved medical
devices used by doctors today. Employing the latest technology that
is used in physician offices and emergency rooms, the
mirror/personal medical kiosk is able to allow users to obtain
appropriate care in locations that are convenient, accessible, and
more affordable.
[0159] The interior of the mirror/personal medical kiosk can
contain one or more of the following integrated medical devices:
[0160] Thermometer (e.g., temperature taken via ear, temperature
taken via ear, IR thermometer to scan head or other area of body,
etc.). [0161] Scale built into the user seat or floor for measuring
the user's weight. [0162] Otoscope--for examining the middle ear,
exterior ear, nasal passages, mouth and throat. [0163] Oximeter
which measures the blood oxygen saturation. [0164] Stethoscope for
evaluation of heart, lung and bowel sounds. [0165] Blood Pressure
Cuff to measure blood pressure. [0166] EKG which provides a
snapshot of the heart rhythm and data regarding stress or injury to
the heart muscle. [0167] Spirometer and transducer for measuring
lung function. [0168] Blood glucose measuring device or monitor.
[0169] Retinal scan device (e.g., Itronix retinal scan device,
etc.). [0170] Dermascope, or Derma-Camera.
[0171] A medical attendant (e.g., medical assistant, nurse
assistant, nurse, nurse practitioner, physician, etc.) who resides
outside the mirror/personal medical kiosk can be responsible for
answering user questions, assisting with user registration/payment,
thoroughly clean the mirror/personal medical kiosk after each use,
and restock and/or reset the mirror/personal medical kiosk after
each use. The cleaning of the mirror/personal medical kiosk can
include sanitizing the seat, touch screen, floor, walls, seat, and
all instruments as well as ensuring the mirror/personal medical
kiosk is free of debris and any user belongings. The
mirror/personal medical kiosk can also be designed to be
automatically sterilized after one or more users use the
mirror/personal medical kiosk by utilizing a chemical mist
sterilization technology and/or UV sterilization technology. The
medical attendant can also ensure that any insurance forms required
by the user/user for reimbursement are provided via a printer or
some other means contained in the exterior and/or interior of the
mirror/personal medical kiosk.
[0172] The mirror/personal medical kiosk can also contain one or
more computers, which are connected to the internet and powers the
one or more monitors and/or other type of equipment in the
mirror/personal medical kiosk; however, this is not required. The
exterior monitor on the mirror/personal medical kiosk can be used
for user registration and appointment selection that can be
conducted in a touch screen format.
[0173] The method for providing medical services via a
mirror/personal medical kiosk regarding protocols for scheduling,
diagnosing, delivering and documenting tele-medicine primary care
can include:
[0174] a. Medical Provider Application--this application is used by
the medical provider to provide clinical services. The application
contains all that the medical provider requires to diagnose,
deliver care and document the clinical episode. It runs on the
physician's computer and can be integrated with the leading EMR
applications.
[0175] b. User Application--this application is used by the user to
register with a mirror/personal medical kiosk and also captures the
user's medical history and/or vitals. It includes all the
information required to administer clinical services to the user.
This includes financial/billing information and a Healthspot
Electronic Medical Record (EMR), which can be accessed by the user
and the medical providers.
[0176] c. Integrated videoconferencing software--this application
supports the live user-clinician interaction required for delivery
of the clinical services. It uses a secure connection to the
servers and the provider via an internet connection. The software
shares the information from the following devices:
[0177] Thermometer--(e.g., temperature taken via ear, temperature
taken via ear, IR thermometer to scan head or other area of body,
etc.
[0178] Scale built into the user seat or floor for measuring the
user's weight.
[0179] Otoscope--for examining the middle ear, exterior ear, nasal
passages, mouth and throat.
[0180] Oximeter which measures the blood oxygen saturation.
[0181] Stethoscope for evaluation of heart, lung and bowel
sounds.
[0182] Blood Pressure Cuff to measure blood pressure.
[0183] EKG which provides a snapshot of the heart rhythm and data
regarding stress or injury to the heart muscle.
[0184] Spirometer and transducer for measuring lung function.
[0185] Blood Glucose measurement device and/or monitor to measure
blood glucose levels.
[0186] Retinal scan device to view structures in the eye.
[0187] Dermascope, or Derma-Camera to view the skin and/or
throat.
[0188] Blood analyzer to measure different chemicals in the blood
(e.g., glucose, serum albumin, creatinine, etc.) and/or other
characteristics of the blood (e.g., blood cell count, enzyme
levels, ion levels, measure ability of blood to clot, etc.).
[0189] DNA Sequencer/Mass Spectrometer
[0190] Because of the many germs and other contaminants that will
be inside the mirror/personal medical kiosk, a sterilization
technology can be used in the mirror/personal medical kiosk. One
type of sterilization system that can be used is a built-in
sanitizing misting system that dispenses from a series of misters
between every appointment. Another or additional sterilization
system that can be used is a UV lighting system that can be blasted
between appointments. The one or more cleaning/sanitizing systems
can be used to clean the air in the mirror/personal medical kiosk,
clean one or more surfaces of the mirror/personal medical kiosk
(e.g., floor, bench, display screen, cabinet surfaces, chair, etc.)
and/or a portion of all of the surfaces of a medical device. Other
techniques and technologies can also or alternatively be used. The
attendant can have the ability to activate one or more
sterilization systems (e.g., via button, computer, etc.). The
attendant can be required to keep track of records about the
sanitization process and can ensure that the doors to the
mirror/personal medical kiosk are closed/locked during the
sterilization process.
[0191] Video/Audio Conferencing--The user will communicate with the
medical provider via video and audio conferencing technology. This
environment can make the user feel as close to the medical provider
as actually being present as possible. A two-way glass can be used
to place the camera in the center of the monitor to keep the user
looking head on, versus the Skype and current video conferencing
solutions that keep users looking at the camera and back to the
monitor.
[0192] Video Playback--The recorded medical session can be
partially or fully reviewed by the user to enable the user to again
listen to information, instructions and/or advise from the medical
provider. As can be appreciated, the video playback feature can
also or alternatively be used for auditing purposes, compliance
purposes, security purposes, quality control purposes, etc.
[0193] Mirror Learning Machine
[0194] The mirror can identify new fashion styles by learning from
the user's preferences and/or social network information. For
example the system can learn that the user prefers certain
celebrities or friends' style and apply this style to the user's
fashion style. In some example embodiments, a system and method is
shown for fashion matching that interprets a user's style or
fashion and finds a match given a set of fashion items. A fashion
is a style of dress, while a fashion item includes an article of
clothing, jewelry, or anything that is used to denote a style of
dress. In addition to the user's existing style and wardrobe, the
mirror can add potentially interesting items or styles to the
digital closet for the user by automatically retrieving style
information from other social networking sites such as Facebook,
Twitter, Pinterest, LinkedIn, Instagram and other such social sites
for the purpose of more meaningful fashion and style match. Some
examples are, the system may retrieve and store user habits, i.e.,
TV shows, radio programs, songs, record albums, particular artists
and actors and movies the user likes as well as user preferences,
geographical location, school, other network affiliation, age,
likes, recent activity, images viewed, searches etc. and much more
variety of information via social network APIs. To incentivize the
user to upload more images of themselves thereby building a large
database, the system may assign points to the user each time the
user interacts with the system. Some examples of system interaction
are: a user uploads their own image with a new outfit, the user
uploads another user's image and labels it and links it with that
user's profile name.
[0195] The mirror can be assisted with a number of learning
machines, including neural networks, case-based reasoning, Bayesian
networks (including hidden Markov models), or fuzzy systems. The
Bayesian networks may include: machine learning algorithms
including--supervised learning, unsupervised learning,
semi-supervised learning, reinforcement learning, transduction,
learning to learn algorithms, or some other suitable Bayesian
network. The neural networks may include: Kohonen self-organizing
network, recurrent networks, simple recurrent networks, Hopfield
networks, stochastic neural networks, Boltzmann machines, modular
neural networks, committee of machines, Associative Neural Network
(ASNN), holographic associative memory, instantaneously trained
networks, spiking neural networks, dynamic neural networks,
cascading neural networks, neuro-fuzzy networks, or some other
suitable neural network. Further, the neural networks may include:
machine learning algorithms including--supervised learning,
unsupervised learning, semi-supervised learning, reinforcement
learning, transduction, learning to learn algorithms, or some other
suitable learning methods.
[0196] The system may use knowledge-based components such as a
knowledge-based repository (KB). The repository may include
clinical information. For example, it may include that "eating
salt-rich food causes blood pressure to increase." The information
may be stored in a variety of formats based on the type of
inference employing them. The knowledge-based repository may act as
a repository for some or all of the referenced knowledge. For
example, it can include reference values for certain consents and
variables used for inference. Accordingly, one or more layers (e.g.
a hierarchical pattern processing layer or Pattern Engine) may
subscribe to information from the knowledge-based repository. For
example, one or more of the services may query the knowledge-based
repository when making an inference.
[0197] In one embodiment, the knowledge-based repository may
aggregate relevant clinical and/or behavioral knowledge from one or
more sources. In an embodiment, one or more clinical and/or
behavioral experts may manually specify the required knowledge. In
another embodiment, an ontology-based approach may be used. For
example, the knowledge-based repository may leverage the semantic
web using techniques, such as statistical relational learning
(SRL). SRL may expand probabilistic reasoning to complex relational
domains, such as the semantic web. The SRL may achieve this using a
combination of representational formalisms (e.g., logic and/or
frame based systems with probabilistic models). For example, the
SRL may employ Bayesian logic or Markov logic. For example, if
there are two objects--`Asian male` and `smartness`, they may be
connected using the relationship `asian males are smart`. This
relationship may be given a weight (e.g., 0.3). This relationship
may vary from time to time (populations trend over years/decades).
By leveraging the knowledge in the semantic web (e.g., all
references and discussions on the web where `asian male` and
`smartness` are used and associated) the degree of relationship may
be interpreted from the sentiment of such references (e.g.,
positive sentiment: TRUE; negative sentiment: FALSE). Such
sentiments and the volume of discussions may then be transformed
into weights. Accordingly, although the system originally assigned
a weight of 0.3, based on information from semantic web about Asian
males and smartness, may be revised to 0.9.
[0198] In an embodiment, Markov logic may be applied to the
semantic web using two objects: first-order formulae and their
weights. The formulae may be acquired based on the semantics of the
semantic web languages. In one embodiment, the SRL may acquire the
weights based on probability values specified in ontologies. In
another embodiment, where the ontologies contain individuals, the
individuals can be used to learn weights by generative learning. In
some embodiments, the SRL may learn the weights by matching and
analyzing a predefined corpora of relevant objects and/or textual
resources. These techniques may be used to not only to obtain
first-order waited formulae for clinical parameters, but also
general information. This information may then be used when making
inferences.
[0199] For example, if the first order logic is `obesity causes
hypertension, there are two objects involved: obesity and
hypertension. If data on users with obesity and as to whether they
were diagnosed with diabetes or not is available, then the weights
for this relationship may be learnt from the data. This may be
extended to non-clinical examples such as person's mood, beliefs
etc.
[0200] The pattern recognizer may use the temporal dimension of
data to learn representations. The pattern recognizer may include a
pattern storage system that exploits hierarchy and analytical
abilities using a hierarchical network of nodes. The nodes may
operate on the input patterns one at a time. For every input
pattern, the node may provide one of three operations: 1. Storing
patterns, 2. Learning transition probabilities, and 3. Context
specific grouping.
[0201] A node may have a memory that stores patterns within the
field of view. This memory may permanently store patterns and give
each pattern a distinct label (e.g. a pattern number). Patterns
that occur in the input field of view of the node may be compared
with patterns that are already stored in the memory. If an
identical pattern is not in the memory, then the input pattern may
be added to the memory and given a distinct pattern number. The
pattern number may be arbitrarily assigned and may not reflect any
properties of the pattern. In one embodiment, the pattern number
may be encoded with one or more properties of the pattern.
[0202] In one embodiment, patterns may be stored in a node as rows
of a matrix. In such an embodiment, C may represent a pattern
memory matrix. In the pattern memory matrix, each row of C may be a
different pattern. These different patterns may be referred to as
C-1, C-2, etc., depending on the row in which the pattern is
stored.
[0203] The nodes may construct and maintain a Markov graph. The
Markov graph may include vertices that correspond to the store
patterns. Each vertex may include a label of the pattern that it
represents. As new patterns are added to the memory contents, the
system may add new vertices to the Markov graph. The system may
also create a link between to vertices to represent the number of
transition events between the patterns corresponding to the
vertices. For example, when an input pattern is followed by another
input pattern j for the first time, a link may be introduced
between the vertices i and j and the number of transition events on
that link may be set to 1. System may then increment the number of
transition counts on the link from i and j whenever a pattern from
i to pattern j is observed. The system may normalize the Markov
graph such that the links estimate the probability of a
transaction. Normalization may be achieved by dividing the number
of transition events on the outgoing links of each vertex by the
total number of transition events from the vertex. This may be done
for all vertices to obtain a normalized Markov graph. When
normalization is completed, the sum of the transition probabilities
for each node should add to 1. The system may update the Markov
graph continuously to reflect new probability estimates.
[0204] The system may also perform context-specific grouping. To
achieve this, the system may partition a set of vertices of the
Markov graph into a set of temporal groups. Each temporal group may
be a subset of that set of vertices of the Markov graph. The
partitioning may be performed such that the vertices of the same
temporal group are highly likely to follow one another.
[0205] The node may use Hierarchical Clustering (HC) to for the
temporal groups. The HC algorithm may take a set of pattern labels
and their pair-wise similarity measurements as inputs to produce
clusters of pattern labels. The system may cluster the pattern
labels such that patterns in the same cluster are similar to each
other.
[0206] In one embodiment, the probability of a transition between
two patterns may be used as the similarity between those patterns
for the HC algorithm. The similarity metric may be used to cluster
medical patterns that are likely to follow one another into the
same cluster. The HC algorithm may be configured such that patterns
that are unlikely to follow each other fall into different
clusters. A cluster of a set of patterns that are likely to follow
each other in time may be referred to as a temporal group. The HC
algorithm may start with all store patterns and separate clusters
and then recursively merge clusters with the greatest similarity.
This may be used to obtain a treelike structure (e.g. a dendrogram)
with a single cluster (which may contain all patterns) at the top
of the tree and the individual patterns at the bottom (e.g. each
pattern in its own cluster). The system may achieve the desired
clustering for temporal grouping (e.g. somewhere between the bottom
and a top of the dendrogram) by defining a suitable criteria. For
example, one criterion could be to cut the tree at a level where
the size of the largest cluster does not exceed a particular value.
The node may have a design perimeter that sets the maximum number
of clusters or temporal groups of the node. The desired temporal
groups may be achieved by selecting a level of the dendrogram that
gives the number of temporal groups closest to and less than the
configured maximum number of temporal groups. These temporal groups
may be updated as the Markov transition probabilities are updated.
These steps may be performed periodically during the learning
process. The learning process may be stopped once the temporal
groups have sufficiently stabilized.
[0207] Once a node has completed its learning process, it may be
used for sensing and/or inference. The characteristics of the input
to the node in sensing may be identical to those used during
learning. For example, objects may move under the field of view of
the node and the node may see portions of those objects. The
resulting patterns may be used as inputs to the node.
[0208] A node used for sensing and/or inference may produce an
output for every input pattern. A node may also use a sequence of
patents to produce an output. In one embodiment, it can be assumed
that the outputs are produced based on instantaneous inputs. Under
this assumption, the Markov graph may not be used during the
sensing phase. For example, it may be discarded once the temporal
groups within the node are completed.
[0209] For every input pattern, the node may produce an output
factor that indicates the degree of membership of the input pattern
and each of its temporal groups. However, the current input pattern
may not perfectly match any of the patterns stored in memory.
Accordingly, in one embodiment, the closeness of the input pattern
to every pattern stored in memory will be determined. For example,
let di be the distance of the ith stored pattern from the input
pattern. The larger this distance is, the smaller the match between
the input pattern and the stored pattern becomes. Assuming that the
probability that an input pattern matches a stored pattern falls
off as a Gaussian function of the Euclidean distance, the
probability that the input pattern matches the ith stored pattern
can be calculated as being proportional to e-d2i/.alpha., where a
is a parameter of the node. Calculating this for every stored
pattern may give the closeness of the current input pattern to all
the vertices of the Markov graph.
[0210] Degree of membership of the input pattern in each temporal
group may be determined by the maximum of its closeness to each of
the vertices within the temporal group. This results in a length
equal to the number of temporal groups, with each component of the
factor indicating the degree of membership of the input pattern in
the corresponding temporal group. This factor may then be used
normalize the sum to unity. These normalized memberships may be
used as estimates of probability of membership in each temporal
group. This normalized degree of membership may also be used as an
output of the node. The output may be a histogram giving estimates
of probability of membership of the current input pattern and each
of the temporal groups of the node.
[0211] As data is fed into the pattern recognizer, the transition
probabilities for each pattern and pattern-of-patterns may be
updated based on the Markov graph. This may be achieved by updating
the constructed transition probability matrix. This may be done for
each pattern in every category of patterns. Those with higher
probabilities may be chosen and placed in a separate column in the
database called a prediction list.
[0212] Logical relationships among the patterns may be manually
defined based on the clinical relevance. This relationship is
specified as first-order logic predicates along with probabilities.
These probabilities may be called beliefs. In one embodiment, a
Bayesian Belief Network (BBN) may be used to make predictions using
these beliefs. The BBN may be used to obtain the probability of
each occurrence. These logical relationships may also be based on
predicates stored the knowledge base.
[0213] The pattern recognizer may also perform optimization for the
predictions. In one embodiment, this may be accomplished by
comparing the predicted probability for a relationship with its
actual occurrence. Then, the difference between the two may be
calculated. This may be done for p occurrences of the logic and fed
into a K-means clustering algorithm to plot the Euclidean distance
between the points. A centroid may be obtained by the algorithm,
forming the optimal increment to the difference. This increment may
then be added to the (p+1)th occurrence. Then, the process may be
repeated. This may be done until the pattern recognizer predicts
logical relationships up to a specified accuracy threshold. Then,
the results may be considered optimal.
[0214] When a node is at the first level of the hierarchy, its
input may come directly from the data source, or after some
preprocessing. The input to a node at a higher-level may be the
concatenation of the outputs of the nodes that are directly
connected to it from a lower level. Patterns in higher-level nodes
may represent particular coincidences of their groups of children.
This input may be obtained as a probability distribution function
(PDF). From this PDF, the probability that a particular group is
active may be calculated as the probability of the pattern that has
the maximum likelihood among all the patterns belonging to that
group.
[0215] The system can use an expert system that can assess
hypertension in according with the guidelines. In addition, the
expert system can use diagnostic information and apply the
following rules to assess hypertension: [0216]
Hemoglobin/hematocrit: Assesses relationship of cells to fluid
volume (viscosity) and may indicate risk factors such as
hypercoagulability, anemia. [0217] Blood urea nitrogen
(BUN)/creatinine: Provides information about renal
perfusion/function. [0218] Glucose: Hyperglycemia (diabetes
mellitus is a precipitator of hypertension) may result from
elevated catecholamine levels (increases hypertension). [0219]
Serum potassium: Hypokalemia may indicate the presence of primary
aldosteronism (cause) or be a side effect of diuretic-therapy.
[0220] Serum calcium: Imbalance may contribute to hypertension.
[0221] Lipid panel (total lipids, high-density lipoprotein [HDL],
low-density lipoprotein [LDL], cholesterol, triglycerides,
phospholipids): Elevated level may indicate predisposition
for/presence of atheromatous plaques. [0222] Thyroid studies:
Hyperthyroidism may lead or contribute to vasoconstriction and
hypertension. [0223] Serum/urine aldosterone level: May be done to
assess for primary aldosteronism (cause). [0224] Urinalysis: May
show blood, protein, or white blood cells; or glucose suggests
renal dysfunction and/or presence of diabetes. [0225] Creatinine
clearance: May be reduced, reflecting renal damage. [0226] Urine
vanillylmandelic acid (VMA) (catecholamine metabolite): Elevation
may indicate presence of pheochromocytoma (cause); 24-hour urine
VMA may be done for assessment of pheochromocytoma if hypertension
is intermittent. [0227] Uric acid: Hyperuricemia has been
implicated as a risk factor for the development of hypertension.
[0228] Renin: Elevated in renovascular and malignant hypertension,
salt-wasting disorders. [0229] Urine steroids: Elevation may
indicate hyperadrenalism, pheochromocytoma, pituitary dysfunction,
Cushing's syndrome. [0230] Intravenous pyelogram (IVP): May
identify cause of secondary hypertension, e.g., renal parenchymal
disease, renal/ureteral-calculi. [0231] Kidney and renography
nuclear scan: Evaluates renal status (TOD). [0232] Excretory
urography: May reveal renal atrophy, indicating chronic renal
disease. [0233] Chest x-ray: May demonstrate obstructing
calcification in valve areas; deposits in and/or notching of aorta;
cardiac enlargement. [0234] Computed tomography (CT) scan: Assesses
for cerebral tumor, CVA, or encephalopathy or to rule out
pheochromocytoma. [0235] Electrocardiogram (ECG): May demonstrate
enlarged heart, strain patterns, conduction disturbances. Broad,
notched P wave is one of the earliest signs of hypertensive heart
disease.
[0236] The system may also be adaptive. In one embodiment, every
level has a capability to obtain feedback information from higher
levels. This feedback may inform about certain characteristics of
information transmitted bottom-up through the network. Such a
closed loop may be used to optimize each level's accuracy of
inference as well as transmit more relevant information from the
next instance.
[0237] The system may learn and correct its operational efficiency
over time. This process is known as the maturity process of the
system. The maturity process may include one or more of the
following flow of steps:
[0238] a. Tracking patterns of input data and identifying
predefined patterns (e.g. if the same pattern was observed several
times earlier, the pattern would have already taken certain paths
in the hierarchical node structure).
[0239] b. Scanning the possible data, other patterns (collectively
called Input Sets (IS)) required for those paths. It also may check
for any feedback that has come from higher levels of hierarchy.
This feedback may be either positive or negative (e.g., the
relevance of the information transmitted to the inferences at
higher levels). Accordingly, the system may decide whether to send
this pattern higher up the levels or not, and if so whether it
should it send through a different path.
[0240] c. Checking for frequently required ISs and pick the top `F`
percentile of them.
[0241] d. Ensuring it keeps this data ready.
[0242] In one embodiment, information used at every node may act as
agents reporting on the status of a hierarchical network. These
agents are referred to as Information Entities (In En). In En may
provide insight about the respective inference operation, the
input, and the result which collectively is called knowledge.
[0243] This knowledge may be different from the KB. For example,
the above described knowledge may include the dynamic creation of
insights by the system based on its inference, whereas the KB may
act as a reference for inference and/or analysis operations. The
latter being an input to inference while the former is a product of
inference. When this knowledge is subscribed to by a consumer (e.g.
administering system or another node in a different layer) it is
called "Knowledge-as-a-Service (KaaS)"
[0244] One embodiment processes behavior models are classified into
four categories as follows: [0245] a. Outcome-based; [0246] b.
Behavior-based; [0247] c. Determinant-based; and [0248] d.
Intervention-based. [0249] One or more of the following rules of
thumb may be applied during behavioral modeling: [0250] One or more
interventions affect determinants; [0251] One or more determinants
affect behavior; and [0252] One or more behaviors affect
outcome.
[0253] A behavior is defined to be a characteristic of an
individual or a group towards certain aspects of their life such as
health, social interactions, etc. These characteristics are
displayed as their attitude towards such aspects. In analytical
terms, a behavior can be considered similar to a habit. Hence, a
behavior may be observed for a given data from a user. An example
of a behavior is dietary habits.
[0254] Determinants may include causal factors for behaviors. They
either cause someone to exhibit the same behavior or cause behavior
change. Certain determinants are quantitative but most are
qualitative. Examples include one's perception about a food, their
beliefs, their confidence levels, etc.
[0255] Interventions are actions that affect determinants.
Indirectly they influence behaviors and hence outcomes. System may
get both primary and secondary sources of data. Primary sources may
be directly reported by the end-user and AU. Secondary data may be
collected from sensors such as their mobile phones, cameras,
microphone, as well as those collected from general sources such as
the semantic web.
[0256] These data sources may inform the system about the
respective interventions. For example, to influence a determinant
called forgetfulness which relates to a behavior called medication,
the system sends a reminder at an appropriate time, as the
intervention. Then, feedback is obtained whether the user took the
medication or not. This helps the system in confirming if the
intervention was effective.
[0257] The system may track a user's interactions and request
feedback about their experience through assessments. The system may
use this information as part of behavioral modeling to determine if
the user interface and the content delivery mechanism have a
significant effect on behavior change with the user. The system may
use this information to optimize its user interface to make it more
personalized over time to best suit the users, as well as to best
suit the desired outcome.
[0258] The system also may accommodate data obtained directly from
the end-user, such as assessments, surveys, etc. This enables users
to share their views on interventions, their effectiveness,
possible causes, etc. The system's understanding of the same
aspects is obtained by way of analysis and service by the pattern
recognizer.
[0259] Both system-perceived and end user-perceived measures of
behavioral factors may be used in a process called Perception
Scoring (PS). In this process, hybrid scores may be designed to
accommodate both above mentioned aspects of behavioral factors.
Belief is the measure of confidence the system has, when
communicating or inferring on information. Initially higher beliefs
may be set for user-perceived measures.
[0260] Over time, as the system finds increasing patterns as well
as obtains feedback in pattern recognizer, the system may evaluate
the effectiveness of intervention(s). If the system triggers an
intervention based on user-perceived measures and it doesn't have
significant effect on the behavior change, the system may then
start reducing its belief for user-perceived measures and instead
will increase its belief for system-perceived ones. In other words,
the system starts believing less in the user and starts believing
more in itself. Eventually this reaches a stage where system can
understand end-users and their behavioral health better than
end-users themselves. When perception scoring is done for each
intervention, it may result in a score called Intervention
Effectiveness Score (IES).
[0261] Perception scoring may be done for both end-users as well as
AU. Such scores may be included as part of behavior models during
cause-effect analysis.
[0262] Causes may be mapped with interventions, determinants, and
behavior respectively in order of the relevance. Mapping causes
with interventions helps in back-tracking the respective AU for
that cause. In simple terms, it may help in identifying whose
actions have had a pronounced effect on the end-user's outcome, by
how much and using which intervention. This is very useful in
identifying AUs who are very effective with specific interventions
as well as during certain event context. Accordingly, they may be
provided a score called Associated User Influence Score. This
encompasses information for a given end-user, considering all
interventions and possible contexts relevant to the user's
case.
[0263] The system may construct one or plans including one or more
interventions based on analysis performed, and may be implemented.
For example, the system may analyze eligibility of an intervention
for a given scenario, evaluating eligibility of two or more
interventions based on combinatorial effect, prioritizing
interventions to be applied, based on occurrence of patterns (from
pattern recognizer), and/or submitting an intervention plan to the
user or doctor in a format readily usable for execution.
[0264] This system may rely on the cause-effect analysis for its
planning operations. A plan consists of interventions and a
respective implementation schedule. Every plan may have several
versions based on the users involved in it. For example, the system
may have a separate version for the physician as compared to a
user. They will in turn do the task and report back to the system.
This can be done either directly or the system may indirectly find
it based on whether a desired outcome with the end user was
observed or not.
[0265] The methodology may be predefined by an analyst. For every
cause, which can be an intervention(s), determinant(s), behavior(s)
or combinations of the same, the analyst may specify one or more
remedial actions. This may be specified from the causal perspective
and not the contextual perspective.
[0266] This approach uses the idea of situation-aware metadata
description framework meaning that context specific information for
all possible contexts specified in the meta data during system
design. This process may be done for every cause, thereby
specifying what remedial actions are more appropriate for it and
for what context.
[0267] Accordingly, a set of remedial actions may be confirmed by
determining which users should participate in the intervention plan
and how. For example, if a physician had a high score for improving
confidence of a user, the intervention plan may consider that fact
and include one of the interventions to be motivational
interviewing of the user by that physician, provided the
cause-effect analysis confirms it with a closely associated
cause.
[0268] The system may optimize its plan to ensure that it reflects
a smooth transition between plans (current versus new) and hence
interventions to the end user. The rules for such optimizations may
be manually specified by the analyst during the design.
[0269] The system may include selecting appropriate presentation
mode (e.g. web or mobile) as well as device (e.g. phone or tablet)
based on the intervention specified, mapping rules to each
intervention based on plan, operating both proactively (based on
predefined plan) and reactively (feedback-based inference engine),
obtaining feedback about the end-user from system usage and
self-reporting, facilitating data to the pattern recognizer and
hence made the overall end-to-end system a reflexive feedback
system, and/or calling the pattern recognizer on-demand. In the use
case, the user may be presented with articles related to the
consumption of carbohydrates, given one or more
carbohydrate-counting goals, and/or receive one or more
notifications to perform a task, such as instructions to reduce
salt in the diet, pick up medication or exercise.
[0270] There may be a communication component within every
presentation channel that accepts its version of the plan through a
secured communication protocol. There may also be an execution
component within every presentation layer that will take care of
starting the new plan at a calculated period before the completion
of the current plan. This ensures that the transition between plans
is smooth enough for the users to not experience a drastic change
in interventions. Also, the execution component may also suppress
certain flows of delivering content in the inference engine based
on the new plan. This ensures that the users are not sent contents
from two plans which may look confusing. Considering the context,
either the new plan or the current plan may be preferred over the
other. This component also may manage between both plans
simultaneously, if necessary.
[0271] Every presentation channel may be associated with a
presentation device. The capabilities and various sensory data
input options of the device may be used by inference engine. The
device-specific version of the plan is meant to address this issue.
In certain cases, such as mobile phones, handheld devices, etc.,
where camera and microphone is available, a specific pattern
recognition engine takes specific samples of pictorial, video and
auditory data, using camera and microphone, and then compare it
with predefined categories of emotions. Hence, it may perform a
pattern classification operation. The engine may be pre-trained
with example data in these formats for those respective categories.
The pattern recognition mechanism may be similar to the one
performed by pattern recognizer. But in this engine, the focus may
be on only sensory inputs and basic classification. Thus, it may
not have any hierarchical layers of computation making it much
simpler and more specific. After classification, it may compare the
classification between the three sensory data sources and confirm
the emotional state of the end user using suitable algorithms. This
feature becomes a valuable source of information that may be used
by different services for making psychological and behavioral
inferences.
[0272] Accordingly, the system may send a variety of data and
information to pattern recognizer and other services, as feedback,
for these services to understand about the users. This
understanding may affect their next set of plans which in turn
becomes an infinite cyclic system where system affects the users
while getting affected by them at the same time. Such a system is
called a reflexive-feedback enabled system. The system may user
both positive and negative reflexive-feedback, though the negative
feedback aspect may predominantly be used for identifying gaps that
the system needs to address.
[0273] The system may provide information, such as one or more
newly identified patterns, to an analyst (e.g., clinical analyst or
doctor). In the use case, the doctor may be presented with one or
more notifications to address the relationship between
carbohydrates and the medication that the user is taking.
[0274] One embodiment of the system operation includes receiving
feedback relating to the plan, and revising the plan based on the
feedback; the feedback being one or more user behaviors that occur
after the plan; the revised plan including one or more additional
interventions selected based on the feedback; the one or more user
behaviors that occur after the plan include a behavior transition;
determining one or more persons to associate with the identified
intervention; automatically revising probabilities from the
collected information; storing the revised probabilities, wherein
the revised probabilities are used to determine the plan; and/or
automatically make one or more inferences based on machine learning
using one or more of the clinical information, behavior
information, or personal information.
[0275] Hypertension metrics may be one type of metrics utilized
within the principles of the present disclosure. A hypertension
score can be based on any type of alpha-numeric or visual analog
scale. Hypertension scales may or may not be clinically validated
and may use any scale (e.g. 1-100, 1-10, 1-4), picture, symbol,
color, character, number, sound, letter, or written description of
hypertension to facilitate the communication of a user's
hypertension level. The type of hypertension scale used may be
determined according to a user's and/or healthcare provider's
preferences, and may also be determined based on the needs of a
user including, for example, the user's age and/or communication
capability. In further embodiments, the selected hypertension
scale(s) may be determined by a service provider, such as, e.g., an
organization implementing the principles of the present disclosure
via a suitable software program or application.
[0276] Another metric may include a functionality score. A
functionality score can be based on any type of alpha-numeric or
visual analog scale. Non-limiting examples include the American
Chronic Pain Association Quality of Life (ACPA QoL) Scale, Global
Assessment of Functioning (GAF) Scale, and Short Form SF-36 Health
Survey. Functionality scales may or may not be clinically validated
and may use any picture, symbol, color, character, number, sound,
letter, written description of quality of life, or physical
functioning to facilitate communication of a user's functionality
level. The functionality score may be, e.g., based on an assessment
of a user's ability to exercise as well as perform daily tasks
and/or perform routine tasks such as, e.g., getting dressed,
grocery shopping, cooking, cleaning, climbing stairs, etc. In some
embodiments, the selected functionality scale(s) may be determined
by a service provider, such as, e.g., an organization implementing
the principles of the present disclosure via a suitable software
program or application.
[0277] A further metric may include a user's medication usage.
Medication use encompasses pharmacologic and therapeutic agents
used to treat, control, and/or alleviate hypertension, including
prescription drugs as well as over-the-counter medications,
therapeutic agents, and other non-prescription agents. Medication
use may include different classes of pharmacologic agents.
Medication use can be reported in any appropriate units, such as
number of doses taken, percentage of treatment plan completed,
frequency of doses, and/or dose strength; and may also specify
additional information such as the type of formulation taken and
the route of administration (oral, enteral, topical, transdermal,
parenteral, sublingual etc.). Molecular alternatives (e.g., acid,
salt, solvate, complex, and pro-drug forms, etc.) and formulations
(e.g., solid, liquid, powder, gel, and suspensions, etc.) are
further contemplated. Reported medication use may, for example,
include the number of doses and types of medication taken since a
previous reported medication use, and may also indicate the number
of closes and types of medication taken within a period of time,
such as within, the previous 2 hours, 4 hours, 6 hours, 12 hours,
18 hours, 24 hours, 36 hours, or 48 hours. In some embodiments, for
example, medication use may be reported in terms of dosage units
recommended by a manufacturer or healthcare provider for a given
medication (e.g., minimum, maximum, or range of appropriate unit
dosage per unit time).
[0278] Reported medication use may allow for tracking compliance
with a treatment regime. For example, a record of reported
medication use may assist a healthcare provider in evaluating
medication efficacy, adjusting dosage, and/or adding other
medications as necessary.
[0279] In some embodiments of the present disclosure, a user or
healthcare provider may create a user profile comprising, e.g.,
identifying, characterizing, and/or medical information, including
information about a user's medical history, profession, and/or
lifestyle. Further examples of information that may be stored in a
user profile includes diagnostic information such as family medical
history, medical symptoms, duration of hypertension, localized vs.
general hypertension, etc. Further contemplated as part of a user
profile are non-pharmacologic treatment(s) (e.g., chiropractic,
radiation, holistic, psychological, acupuncture, etc.), lifestyle
characteristics (e.g., diet, alcohol intake, smoking habits),
cognitive condition, behavioral health, and social well-being.
[0280] A user profile may, for example, be stored in a database and
accessible for analysis of the user's reported hypertension
metrics. In some embodiments, a user profile may be created before
collecting and/or transmitting a set of hypertension metrics to be
received by a server and/or database In other embodiments, a user
profile may be created concurrently with, or even after
transmitting/receiving one or more hypertension metrics. In some
embodiments a user profile may be used to establish one or more
hypertension metric e and/or reference values. A user profile may,
for example, allow for setting threshold values or ranges, wherein
reported hypertension metrics that fall outside of those limits
trigger an alert to be sent to the user or a healthcare provider.
Threshold values, limits, or ranges may also be set without
reference to a user profile. In some embodiments, one or more
target value(s) (e.g., hypertension metric value(s)) may be set to
determine how the reported hypertension metrics compare with the
target value(s).
[0281] The methods and systems disclosed herein may rely on one or
more algorithm(s) to analyze one or more of the described metrics.
The algorithm(s) may comprise analysis of data reported in
real-time, and may also analyze data reported in real-time in
conjunction with auxiliary data stored in a hypertension management
database. Such auxiliary data may comprise, for example, historical
user data such as previously-reported hypertension metrics (e.g.,
hypertension scores, functionality scores, medication use),
personal medical history, and/or family medical history. In some
embodiments, for example, the auxiliary data includes at least one
set of hypertension metrics previously reported and stored for a
user. In some embodiments, the auxiliary data includes a user
profile such as, e.g., the user profile described above. Auxiliary
data may also include statistical data, such as hypertension
metrics pooled for a plurality of users within a similar group or
subgroup. Further, auxiliary data may include clinical guidelines
such as guidelines relating to hypertension management, including
evidence-based clinical practice guidelines on the management of
acute and/or chronic hypertension or other chronic conditions.
[0282] Analysis of a set of hypertension metrics according to the
present disclosure may allow for calibration of the level, degree,
and/or quality of hypertension experienced by providing greater
context to user-reported data. For example, associating a
hypertension score of 7 out of 10 with high functionality for a
first user, and the same score with low functionality for a second
user may indicate a relatively greater debilitating effect of
hypertension on the second user than the first user. Further, a
high hypertension score reported by a user taking a particular
medication such as opioid analgesics may indicate a need to adjust
the user's treatment plan. Further, the methods and systems
disclosed herein may provide a means of assessing relative changes
in a user's distress due to hypertension over time. For example, a
hypertension score of 5 out of 10 for a user who previously
reported consistently lower hypertension scores, e.g., 1 out of 10,
may indicate a serious issue requiring immediate medical
attention.
[0283] Any combination(s) of hypertension metrics may be used for
analysis in the systems and methods disclosed. In some embodiments,
for example, the set of hypertension metrics comprises at least one
hypertension score and at least one functionality score. In other
embodiments, the set of hypertension metrics may comprise at least
one hypertension score, at least one functionality score, and
medication use. More than one set of hypertension metrics may be
reported and analyzed at a given time. For example, a first set of
hypertension metrics recording a user's current status and a second
set of hypertension metrics recording the user's status at an
earlier time may both be analyzed and may also be used to generate
one or more recommended actions.
[0284] Each hypertension metric may be given equal weight in the
analysis, or may also be given greater or less weight than other
hypertension metrics included in the analysis. For example, a
functionality score may be given greater or less weight with
respect to a hypertension score and/or medication use. Whether
and/or how to weigh a given hypertension metric may be determined
according to the characteristics or needs of a particular user. As
an example, User A reports a hypertension score of 8 (on a scale of
1 to 10 where 10 is the most severe hypertension) and a
functionality score of 9 (on a scale of 1 to 10 where 10 is highest
functioning), while User B reports a hypertension score of 8 but a
functionality score of 4. The present disclosure provides for the
collection, analysis, and reporting of this information, taking
into account the differential impact of one hypertension score on a
user's functionality versus that same hypertension score's impact
on the functionality of a different user.
[0285] Hypertension metrics may undergo a pre-analysis before
inclusion in a set of hypertension metrics and subsequent
application of one or more algorithms. For example, a raw score may
be converted or scaled according to one or more algorithm(s)
developed for a particular user. In some embodiments, for example,
a non-numerical raw score may be converted to a numerical score or
otherwise quantified prior to the application of one or more
algorithms. Users and healthcare providers may retain access to raw
data (e.g., hypertension metric data prior to any analysis)
[0286] Algorithm(s) according, to the present disclosure may
analyze the set of hypertension metrics according to any suitable
methods known in the art. Analysis may comprise, for example,
calculation of statistical averages, pattern recognition,
application of mathematical models, factor analysis, correlation,
and/or regression analysis. Examples of analyses that may be used
herein include, but are not limited to, those disclosed in U.S.
Patent Application Publication No. 2012/0246102 A1 the entirety of
which is incorporated herein by reference.
[0287] The present disclosure further provides for the
determination of an aggregated hypertension assessment score. In
some embodiments, for example, a set of pairs metrics may be
analyzed to generate a comprehensive and/or individualized
assessment of hypertension by generating a composite or aggregated
score. In such embodiments, the aggregated score may include a
combination of at least one hypertension score, at least one
functionality score, and medication use. Additional metrics may
also be included in the aggregated score. Such metrics may include,
but are not limited to, exercise habits, mental well-being,
depression, cognitive functioning, medication side effects, etc.
Any of the aforementioned types of analyses may be used in
determining an aggregated score.
[0288] The algorithm(s) may include a software program that may be
available for download to an input device in various versions. In
some embodiments, for example, the algorithm(s) may be directly
downloaded through the Internet or other suitable communications
means to provide the capability to troubleshoot a health issue in
real-time. The algorithm(s) may also be periodically updated, e.g.,
provided content changes, and may also be made available for
download to an input device.
[0289] The methods presently disclosed may provide a healthcare
provider with a more complete record of a user's day-to-day status.
By having access to a consistent data stream of hypertension
metrics for a user, a healthcare provider may be able to provide
the user with timely advice and real-time coaching on hypertension
management options and solutions. A user may, for example, seek
and/or receive feedback on hypertension management without waiting
for an upcoming appointment with a healthcare provider or
scheduling a new appointment. Such real-time communication
capability may be especially beneficial to provide users with
guidance and treatment options during intervals between
appointments with a healthcare provider. Healthcare providers may
also be able to monitor a user's status between appointments to
timely initiate, modify, or terminate a treatment plan as
necessary. For example, a user's reported medication use may convey
whether the user is taking too little or too much medication. In
some embodiments, an alert may be triggered to notify the user
and/or a healthcare provider of the amount of medication taken,
e.g., in comparison to a prescribed treatment plan. The healthcare
provider could, for example, contact the user to discuss the
treatment plan. The methods disclosed herein may also provide a
healthcare provider with a longitudinal review of how a user
responds to hypertension over time. For example, a healthcare
provider may be able to determine whether a given treatment plan
adequately addresses a user's needs based on review of the user's
reported hypertension metrics and analysis thereof according to the
present disclosure.
[0290] Analysis of user data according to the methods presently
disclosed may generate one or more recommended actions that may be
transmitted and displayed on an output device. In some embodiments,
the analysis recommends that a user make no changes to his/her
treatment plan or routine. In other embodiments, the analysis
generates a recommendation that the user seek further consultation
with a healthcare provider and/or establish compliance with a
prescribed treatment plan. In other embodiments, the analysis may
encourage a user to seek immediate medical attention. For example,
the analysis may generate an alert to be transmitted to one or more
output devices, e.g., a first output device belonging to the user
and a second output device belonging to a healthcare provider,
indicating that the user is in need of immediate medical treatment.
In some embodiments, the analysis may not generate a recommended
action. Other recommended actions consistent with the present
disclosure may be contemplated and suitable according to the
treatment plans, needs, and/or preferences for a given user.
[0291] The present disclosure further provides a means for
monitoring a user's medication use to determine when his/her
prescription will run out and require a refill. For example, a user
profile may be created that indicates a prescribed dosage and
frequency of administration, as well as total number of dosages
provided in a single prescription. As the user reports medication
use, those hypertension metrics may be transmitted to a server and
stored in a database in connection with the user profile. The user
profile stored on the database may thus continually update with
each added metric and generate a notification to indicate when the
prescription will run out based on the reported medication use. The
notification may be transmitted and displayed on one or more output
devices, e.g., to a user and/or one or more healthcare providers.
In some embodiments, the one or more healthcare providers may
include a pharmacist. For example, a pharmacist may receive
notification of the anticipated date a prescription will run out in
order to ensure that the prescription may be timely refilled.
[0292] User data can be input for analysis according to the systems
disclosed herein through any data-enabled device including, but not
limited to, portable/mobile and stationary communication devices,
and portable/mobile and stationary computing devices. Non-limiting
examples of input devices suitable for the systems disclosed herein
include smart phones, cell phones, laptop computers, netbooks,
personal computers (PCs), tablet PCs, fax machines, personal
digital assistants, and/or personal medical devices. The user
interface of the input device may be web-based, such as a web page,
or may also be a stand-alone application. Input devices may provide
access to software applications via mobile and wireless platforms,
and may also include web-based applications.
[0293] The input device may receive data by having a user,
including, but not limited to, a user, family member, friend,
guardian, representative, healthcare provider, and/or caregiver,
enter particular information via a user interface, such as by
typing and/or speaking. In some embodiments, a server may send a
request for particular information to be entered by the user via an
input device. For example, an input device may prompt a user to
enter sequentially a set of hypertension metrics, e.g., a
hypertension score, a functionality score, and information
regarding use of one or more medications (e.g., type of medication,
dosage taken, time of day, route of administration, etc.). In other
embodiments, the user may enter data into the input device without
first receiving a prompt. For example, the user may initiate an
application or web-based software program and select an option to
enter one or more hypertension metrics. In some embodiments, one or
more hypertension scales and/or functionality scales may be
preselected by the application or software program. For example, a
user may have the option of selecting the type of hypertension
scale and/or functionality scale for reporting hypertension metrics
within the application or software program. In other embodiments,
an application or software program may not include preselected
hypertension scales or functionality scales such that a user can
employ any hypertension scale and/or functionality scale of
choice.
[0294] The user interface of an input device may allow a user to
associate hypertension metrics with a particular date and/or time
of day. For example, a user may report one or more hypertension
metrics to reflect a user's present status. A user may also report
one or more hypertension metrics to reflect a user's status at an
earlier time.
[0295] User data may be electronically transmitted from an input
device over a wired or wireless medium to a server, e.g., a remote
server. The server may provide access to a database for performing
an analysis of the data transmitted, e.g., set of hypertension
metrics. The database may comprise auxiliary data for use in the
analysis as described above. In some embodiments, the analysis may
be automated, and may also be capable of providing real-time
feedback to users and/or healthcare providers.
[0296] The analysis may generate one or more recommended actions,
and may transmit the recommended action(s) over at wired or
wireless medium for display on at least one output device. The at
least one output device may include, e.g., portable/mobile and
stationary communication devices, and portable/mobile and
stationary computing devices. Non-limiting examples of output
devices suitable for the systems disclosed herein include smart
phones, cell phones, laptop computers, netbooks, personal computers
(PCs), tablet PCs, fax machines, personal digital assistants,
and/or personal medical devices. In some embodiments, the input
device is the at least one output device. In other embodiments, the
input device is one of multiple output devices. In some embodiments
of the present disclosure, the one or more recommended actions are
transmitted and displayed on each of two output devices. In such an
example, one output device may belong to a user and the other
device may belong to a healthcare provider.
[0297] The present disclosure also contemplates methods and systems
in a language suitable for communicating with the user and/or
healthcare provider, including languages other than English.
[0298] A user's medical data may be subject to confidentiality
regulations and protection. Transmitting, analyzing, and/or storing
information according to the methods and systems disclosed herein
may be accomplished through secure means, including HIPPA-compliant
procedures and use of password-protected devices, servers, and
databases.
[0299] One embodiment shares data with different health portals
such as Apple's Healthkit, Samsung's Health database, and the US
Government Blue Button, which is a nationally recognized symbol
indicating to consumers that they can get their own health records
electronically from doctors, hospitals, and other health care
providers, such as pharmacies and health insurance plans. With
electronic access to their health records, consumers can check them
for accuracy and completeness, share them with people they
trust--in case of emergency or to coordinate care among different
providers--and reference them as needed. Health records may include
clinical information from doctors and hospitals, health insurance
claims, prescription histories, and lab/diagnostic test results.
BlueButton.js parses and generates complex health data formats like
C-CDA to allow the BP devices to empower users with access to their
health records. Blue-button software interface is detailed at
https://github.com/blue-button/bluebutton.js the content of which
is incorporated by reference.
[0300] The systems and methods presently disclosed may be
especially beneficial in outuser, home, and/or on-the-go settings.
The systems and methods disclosed herein may also be used as an
inuser tool and/or in controlled medication administration such as
developing a personalized treatment plan.
[0301] In addition to monitoring health parameters, the system can
include interventional devices such as a defibrillator. The
defibrillator function is enabled by providing electrical energy of
a selected energy/power level/voltage/current level or intensity
delivered for a selected duration upon sensing certain patterns of
undesirable heart activity wherein said undesirable heart activity
necessitates an external delivery of a controlled electrical energy
pulse for stimulating a selected heart activity. The defibrillator
function is enabled by an intelligent defibrillator appliance that
operates in a manner similar to the functions of an intelligent ECG
appliance with the additional capability of providing external
electrical stimuli via for example a wireless contact system pasted
on various locations of the torso. The electrical stimuli are
delivered in conjunction with the intelligent defibrillator device
or the mobile device performing the additional functions of an
intelligent defibrillator appliance. The control actions for
providing real time stimuli to the heart of electrical pulses, is
enabled by the intelligent defibrillator appliance by itself or in
conjunction with an external server/intelligent appliance where the
protocols appropriate for the specific individual are resident. The
defibrillation actions are controlled in conjunction with the real
time ECG data for providing a comprehensive real time solution to
the individual suffering from abnormal or life threatening heart
activity/myocardial infraction. Additionally, by continuously
wearing the paste on wireless contacts that can provide the
electrical impulse needed, the individual is instantaneously able
to get real time attention/action using a specifically designed
wearable intelligent defibrillator appliance or a combination of an
intelligent ECG plus defibrillator appliance. Further the mobile
device such as a cellular telephone or other wearable mobile
devices can be configured with the appropriate power sources and
the software for performing the additional functions of an
intelligent defibrillator appliance specifically tailored to the
individual.
[0302] The cellular telephone/mobile device can receive signals
from the ECG machine/appliance or as an intermediary device that
transmits/receives the ECG data and results from a stationary or
portable ECG appliance. The ability of the individual to obtain an
ECG profile of the heart at a selected time and in a selected
location is critical to getting timely attention and for survival.
Getting attention within 10 to 20 minutes of a heart attack is
crucial beyond that the chances for survival diminish
significantly. The smart phone helps the user to quickly
communicate his/her location and or discover the location of the
nearest health care facility that has the requisite cardiac care
facilities and other facilities. The mobile device that the
individual is carrying on the person is enabled to provide the
exact location of the individual in conjunction with the global
positioning system. In addition the system is enabled to provide
the directions and estimated travel time to/from the health care
facility to the specific mobile device/individual.
[0303] Yet other intervention can include music, image, or video.
The music can be synchronized with respect to a blood pulse rate in
one embodiment, and in other embodiments to biorhythmic
signal--either to match the biorhythmic signal, or, if the signal
is too fast or too slow, to go slightly slower or faster than the
signal, respectively. In order to entrain the user's breathing, a
basic melody is preferably played which can be easily identified by
almost all users as corresponding to a particular phase of
respiration. On top of the basic melody, additional layers are
typically added to make the music more interesting, to the extent
required by the current breathing rate, as described hereinabove.
Typically, the basic melody corresponding to this breathing
includes musical cords, played continuously by the appropriate
instrument during each phase. For some applications, it is
desirable to elongate slightly the length of one of the respiratory
phases, typically, the expiration phase. For example, to achieve
respiration which is 70% expiration and 30% inspiration, a musical
composition written for an E:I ratio of 2:1 may be played, but the
expiration phase is extended by a substantially-unnoticed 16%, so
as to produce the desired respiration timing. The expiration phase
is typically extended either by slowing down the tempo of the notes
therein, or by extending the durations of some or all of the
notes.
[0304] Although music for entraining breathing is described
hereinabove as including two phases, it will be appreciated by
persons skilled in the art that the music may similarly include
other numbers of phases, as appropriate. For example, user may be
guided towards breathing according to a 1:2:1:3 pattern,
corresponding to inspiration, breath holding (widely used in Yoga),
expiration, and post-expiratory pause (rest state).
[0305] In one embodiment, the volume of one or more of the layers
is modulated responsive to a respiration characteristic (e.g.,
inhalation depth, or force), so as to direct the user to change the
characteristic, or simply to enhance the user's connection to the
music by reflecting therein the respiration characteristic. The 3D
camera can detect breathing activity from chest movement and can
provide instructions to reduce stress as detected by the facial
expression or body slouching or low energy voice. The system can
instruct the user to practice a yoga-like breathing and relaxation
to reduce stress. Alternatively or additionally, parameters of the
sound by each of the musical instruments may be varied to increase
the user's enjoyment. For example, during slow breathing, people
tend to prefer to hear sound patterns that have smoother structures
than during fast breathing and/or aerobic exercise.
[0306] Further alternatively or additionally, random musical
patterns and/or digitized natural sounds (e.g., sounds of the
ocean, rain, or wind) are added as a decoration layer, especially
for applications which direct the user into very slow breathing
patterns. The inventor has found that during very slow breathing,
it is desirable to remove the user's focus from temporal
structures, particularly during expiration.
[0307] Still further alternatively or additionally, the server
maintains a musical library, to enable the user to download
appropriate music and/or music-generating patterns from the
Internet into device. Often, as a user's health improves, the music
protocols which were initially stored in the device are no longer
optimal, so the user downloads the new protocols, by means of which
music is generated that is more suitable for his new breathing
training.
[0308] In one embodiment, the DNA sequencer can analyze a
polynucleotide comprising nucleotides by making electrical
measurements during translocation through a nanopore. Nanopores can
determine the identity of the polynucleotide or to estimate the
identity of individual nucleotides in the polynucleotide for
sequencing purposes. This is because the method is label-free,
provides measurements dependent on small numbers or even single
molecules, and generates an electric signal that is highly
scalable. In a measurement system utilizing a nanopore, some
property of the system depends on the nucleotides in the nanopore,
and electrical measurements of that property are taken. For
example, a measurement system can be created by placing a nanopore
in an insulating membrane and measuring voltage-driven ion flow
through the nanopore in the presence of nucleotides of the
polynucleotide. Depending on the nature of the nanopore,
information about the nucleotides may be revealed by distinctive
ion current signatures, such as the duration and extent of current
block and the variance of current levels. Such types of measurement
system using a nanopore has considerable promise, particularly in
the field of sequencing a polynucleotide such as DNA or RNA, and
has been the subject of much recent development. In one exemplary
setup, a lipid membrane separates two aqueous chambers, containing
an electrolyte such as KCl. Electrodes are placed in each aqueous
reservoir, a potential was applied across the membrane and the
ionic current between the two chambers was monitored. A 10.times.
concentration stock solution containing the DNA analyte and the
Phi29 DNAP is added to the solution. Enzyme-DNA binding events with
multiple current states occur as the DNA unzipped through the pore.
Runs are obtained at constant applied potential, occasionally
reversing the potential to unblock the pore. Multiple DNA molecules
can be moved through the nanopore over the duration of the run.
Typical run conditions were: MS-(B1)8, 400 mM KCl, 10 mM Hepes, pH
8.0, 1 mM EDTA, 1 mM DTT, +180 mV. The final concentration of DNA
analyte was run at 100 nM with 200 nM of Phi29 DNAP. Current levels
were extracted from the raw data to generate an event trace. The
levels from multiple molecules were aligned together to form a
consensus plot of that molecule. Once the changes in current level
have been detected, and the data is thus reduced to a sequence of
discrete states, alignment of the states found for each DNA capture
sequence can be performed to produce a single consensus sequence
for the strand. A number of alignment methods exist that can be
used for this purpose, including the Needleman-Wunsch and the
Smith-Waterman algorithms, both based on the principles of Dynamic
Programming. In cases where the number of possible states is small
and each state is constrained to allow only a small subset of
permitted subsequent states, more highly optimized heuristic or
probabilistic methods can used.
[0309] FIG. 6 shows an exemplary system for mining health data for
precision medicine. In this system, medical grade data from the
mirror system of FIG. 1, and lab test equipment data are stored in
a database. Omic test equipment also generates data that is stored
in another database. EHR data from primary care physician (PHP),
emergency room physicians (ER), and in-patient care data is also
stored in a database. These databases form a clinical data
repository that contains medical diagnosis and treatment
information. The clinical data is high grade medical information
that is secured by patient privacy laws such as HIPPA. One
exemplary process for improving healthcare using precision medicine
includes: [0310] obtain clinical data from mirror and 3d party
laboratory test equipment [0311] obtain clinical data from one or
more omic test equipment [0312] obtain clinical data from a primary
care physician database [0313] obtain clinical data from a
specialist physician database [0314] obtain clinical data from an
emergency room database [0315] obtain clinical data from an
in-patient care database [0316] save the clinical data into a
clinical data repository [0317] obtain health data from fitness
devices and from mobile phones [0318] obtain behavioral data from
social network communications and mobile device usage patterns
[0319] save the health data and behavioral data into a health data
repository separate from the clinical data repository [0320] mine
the clinical data repository and health data repository for
patients sharing similarity with the subject, including one or more
similar biomarkers associated with health conditions [0321]
identify at least one similar health conditions and identifying one
or more corrective actions recorded in the repository and the
result of each action for the one or more health conditions; [0322]
present the corrective action and result to the subject and
recommending an action to reduce risk from the predicted health
condition [0323] monitor the health condition using updates in the
clinical data repository and health data repository
[0324] In another embodiment for cost effective health maintenance,
the system includes a method of insuring a subject for cancer, by:
[0325] enrolling the subject into a cost-saving program; [0326]
receiving a body sample during routine periodic examinations and
characterizing the subject's omic information with a DNA sequencer;
and [0327] using historical omic information to detect an
occurrence of a disease such as cancer before the subject is
suspected of having the disease; and [0328] proactively
recommending early treatments based on the omic information
received at each time interval to cost-effectively control
disease.
[0329] Another exemplary process for applying the agents of FIG. 1A
to a weight loss treatment scenario. The general goals of weight
loss and management are: (1) at a minimum, to prevent further
weight gain; (2) to reduce body weight; and (3) to maintain a lower
body weight over the long term. The initial goal of weight loss
therapy is to reduce body weight by approximately 10 percent from
baseline. If this goal is achieved, further weight loss can be
attempted, if indicated through further evaluation. A reasonable
time line for a 10 percent reduction in body weight is 6 months of
therapy. For overweight patients with BMIs in the typical range of
27 to 35, a decrease of 300 to 500 kcal/day will result in weight
losses of about 1/2 to 1 lb/week and a 10 percent loss in 6 months.
For more severely obese patients with BMIs>35, deficits of up to
500 to 1,000 kcal/day will lead to weight losses of about 1 to 2
lb/week and a 10 percent weight loss in 6 months. Weight loss at
the rate of 1 to 2 lb/week (calorie deficit of 500 to 1,000
kcal/day) commonly occurs for up to 6 months. After 6 months, the
rate of weight loss usually declines and weight plateaus because of
a lesser energy expenditure at the lower weight.
[0330] After 6 months of weight loss treatment, efforts to maintain
weight loss should be put in place. If more weight loss is needed,
another attempt at weight reduction can be made. This will require
further adjustment of the diet and physical activity
prescriptions.
[0331] Dietary Therapy: A diet that is individually planned and
takes into account the patient's overweight status in order to help
create a deficit of 500 to 1,000 kcal/day should be an integral
part of any weight loss program. Depending on the patient's risk
status, the low-calorie diet (LCD) recommended should be consistent
with the NCEP's Step I or Step II Diet. Besides decreasing
saturated fat, total fats should be 30 percent or less of total
calories. Reducing the percentage of dietary fat alone will not
produce weight loss unless total calories are also reduced.
Isocaloric replacement of fat with carbohydrates will reduce the
percentage of calories from fat but will not cause weight loss.
Reducing dietary fat, along with reducing dietary carbohydrates,
usually will be needed to produce the caloric deficit needed for an
acceptable weight loss. When fat intake is reduced, priority should
be given to reducing saturated fat to enhance lowering of
LDL-cholesterol levels. Frequent contacts with the practitioner
during dietary therapy help to promote weight loss and weight
maintenance at a lower weight.
[0332] An increase in physical activity is an important component
of weight loss therapy, although it will not lead to substantially
greater weight loss over 6 months. Most weight loss occurs because
of decreased caloric intake. Sustained physical activity is most
helpful in the prevention of weight regain. In addition, it has a
benefit in reducing cardiovascular and diabetes risks beyond that
produced by weight reduction alone. For most obese patients,
exercise should be initiated slowly, and the intensity should be
increased gradually. The exercise can be done all at one time or
intermittently over the day. Initial activities may be walking or
swimming at a slow pace. The patient can start by walking 30
minutes for 3 days a week and can build to 45 minutes of more
intense walking at least 5 days a week. With this regimen, an
additional expenditure of 100 to 200 calories per day can be
achieved. All adults should set a long-term goal to accumulate at
least 30 minutes or more of moderate-intensity physical activity on
most, and preferably all, days of the week. This regimen can be
adapted to other forms of physical activity, but walking is
particularly attractive because of its safety and accessibility.
Patients should be encouraged to increase "every day" activities
such as taking the stairs instead of the elevator. With time,
depending on progress and functional capacity, the patient may
engage in more strenuous activities. Competitive sports, such as
tennis and volleyball, can provide an enjoyable form of exercise
for many, but care must be taken to avoid injury. Reducing
sedentary time is another strategy to increase activity by
undertaking frequent, less strenuous activities.
[0333] The communication system is used to provide Behavior
Therapy. The system automatically sends messages using rule-based
agents to communicate with patients. The agents can use learning
principles such as reinforcement provide tools for overcoming
barriers to compliance with dietary therapy and/or increased
physical activity to help patient in achieving weight loss and
weight maintenance. Specific communication message include
self-monitoring of both eating habits and physical activity, stress
management, stimulus control, problem solving, contingency
management, cognitive restructuring, and social support through the
social network system.
[0334] Pharmacotherapy can be used if behavior therapy does not
work. In carefully selected patients, appropriate drugs can augment
LCDs, physical activity, and behavior therapy in weight loss. Drugs
such as sibutramine and orlistat can be used as long as potential
side effects with drugs are considered. With sibutramine, increases
in blood pressure and heart rate may occur. Sibutramine should not
be used in patients with a history of hypertension, CHD, congestive
heart failure, arrhythmias, or history of stroke. With orlistat,
fat soluble vitamins may require replacement because of partial
malabsorption. Weight loss surgery is one option for weight
reduction in a limited number of patients with clinically severe
obesity, i.e., BMIs>=40 or >=35 with comorbid conditions.
Weight loss surgery should be reserved for patients in whom efforts
at medical therapy have failed and who are suffering from the
complications of extreme obesity. Gastrointestinal surgery (gastric
restriction [vertical gastric banding] or gastric bypass is an
intervention weight loss option for motivated subjects with
acceptable operative risks. An integrated program must be in place
to provide guidance on diet, physical activity, and behavioral and
social support both prior to and after the surgery.
[0335] The agents are adaptive to the patient and allow for program
modifications based on patient responses and preferences. For
example, the agent can be modified for weight reduction after age
65 to address risks associated with obesity treatment that are
unique to older adults or those who smoke.
[0336] The event handler can be coded to: [0337] Receive message
from patient or doctor (20) [0338] Determine user treatment
modality (22) [0339] For each modality [0340] Determine relevant
rules (26) [0341] For each rule [0342] Determine responsive
agent(s) (30) [0343] For each agent [0344] Execute agent program
(34) [0345] Get input from service provider if needed (36) [0346]
Format & send the message for the patient's mobile device
(38)
[0347] The system processes a communication from a patient
according to one or more treatment scenarios. Each treatment
scenario is composed of one or more rules to be processed in a
sequence that can be altered when invoking certain agents.
[0348] The if then rules can be described to the system using a
graphical user interface that runs on a web site, a computer, or a
mobile device, and the resulting rules are then processed by a
rules engine. In one embodiment, the if then rules are entered as a
series of dropdown selectors whose possible values are
automatically determined and populated for user selection to assist
user in accurately specifying the rules.
[0349] In one embodiment, the rules engine is Jess, which is a rule
engine and scripting environment written entirely in Sun's Java
language by Ernest Friedman-Hill at Sandia National Laboratories in
Livermore, Calif. With Jess, the system can "reason" using
knowledge supplied in the form of declarative rules. Jess is small,
light, and one of the fastest rule engines available. Jess uses an
enhanced version of the Rete algorithm to process rules. Rete is a
very efficient mechanism for solving the difficult many-to-many
matching problem (see for example "Rete: A Fast Algorithm for the
Many Pattern/Many Object Pattern Match Problem", Charles L. Forgy,
Artificial Intelligence 19 (1982), 17-37.) Jess has many unique
features including backwards chaining and working memory queries,
and of course Jess can directly manipulate and reason about Java
objects. Jess is also a powerful Java scripting environment, from
which you can create Java objects, call Java methods, and implement
Java interfaces without compiling any Java code.
[0350] The user can dynamically create an if/then/else statement. A
dropdown selector can be used to select a column, then a dropdown
to select the conditional operator (=, >, <, !=, among
others) and then a text box in which to enter a column, text or
number value. The system can add multiple conditions. The rules can
be saved as serialized object in a database. After entering
parameter values, a new set of rules can be generated and inserted
within the current active scenario. The corresponding rules can
then be modified directly by accessing the individual agents within
the rules.
[0351] In one embodiment, the agent can be self-modifying. The
agent receives parameters from its callers. The agent in turn
executes one or more functions. It can include an adaptive
self-modifying function, and the third-party extension interfaces.
The adaptive self-modifying function is capable of modifying the
agent parameters and/or the agent function at run time, thereby
changing the behavior of the agent.
[0352] An exemplary modality of the rules engine can be used to
serve obese patients that the doctor can review and approve. In
this scenario, the engine executes 3 master agents: blood pressure
master agent (50), diabetic master agent (52), and weight loss
agent (54). The blood pressure master agent in turn invokes the
following agents: [0353] If blood pressure is between 130-139/85-89
mm Hg then run agent high_blood_pressure [0354] If blood pressure
is between 140-159/90-99 mm Hg then run agent stage1_blood_pressure
[0355] If blood pressure is above 159/99 mm Hg then run agent
drug_treatment_for_blood_pressure
[0356] For the above example, high normal blood pressure of between
130-139/85-89 mm Hg is included in the risk stratification. In
patients with high normal blood pressure with no or only one
concurrent risk factor that does not include diabetes, target
organ, or clinical cardiac disease, the agent high_blood_pressure
suggests to the patient to use lifestyle modification to lower
blood pressure. Lifestyle modification includes changes to the
patient's dieting and exercising habits. With a risk factor of
target organ or clinical cardiac disease, diabetes and/or other
risk factors, the agent can recommend drug therapy, no matter what
the patient's blood pressure is. The agent for patients with stage
1 blood pressures of between 140-159/90-99 mm Hg who have no other
risk factors will suggest the patient try lifestyle modifications
for a year before drug therapy is used. But if these patients have
one risk factor other than diabetes, target organ, or clinical
cardiac disease, their lifestyle modification should be tried for
only 6 months before initiation therapy. For patients with blood
pressure above 150/100 mm Hg, the agent reminds the patient to have
drug therapy in addition to lifestyle modifications.
[0357] The diabetic master agent in turn invokes the following
agents: [0358] Monitoring agent: Make sure doctor orders the key
tests at the right times. [0359] Dieting planning agent: Work with
a dietitian to develop a great eating plan. [0360] Glucose Testing
Agent: Check blood glucose at correct intervals. [0361] Exercise
agent: Monitor exercise to help heart. [0362] Medication compliance
agent: check that insulin is taken at correct time. [0363] Foot
care agent: Check your feet with your eyes daily. [0364] Eye care
agent: remind patient to get periodic eye exam.
[0365] The weight loss agent considers the patient's BMI, waist
circumference, and overall risk status including the patient's
motivation to lose weight. The weight loss agent in turn call the
following agents:
[0366] Body Mass Index agent: The BMI, which describes relative
weight for height, is significantly correlated with total body fat
content. The BMI should be used to assess overweight and obesity
and to monitor changes in body weight. In addition, measurements of
body weight alone can be used to determine efficacy of weight loss
therapy. BMI is calculated as weight (kg)/height squared (m2). To
estimate BMI using pounds and inches, use: [weight (pounds)/height
(inches)2].times.703. Weight classifications by BMI, selected for
use in this report, are shown below:
TABLE-US-00001 CLASSIFICATION OF OVERWEIGHT AND OBESITY BY BMI
Obesity Class BMI (kg/m.sup.2) Underweight <18.5 Normal
18.5-24.9 Overweight 25.0-29.9 Obesity I 30.0-34.9 II 35.0-39.9
Extreme Obesity III .gtoreq.40
[0367] A conversion table of heights and weights resulting in
selected BMI units is
TABLE-US-00002 SELECTED BMI UNITS CATEGORIZED BY INCHES (CM) AND
POUNDS (KG). Height in BMI 25 kg/m.sup.2 BMI 27 kg/m.sup.2 BMI 30
kg/m.sup.2 inches (cm) Body weight in pounds (kg) 58 (147.32) 119
(53.98) 129 (58.51) 143 (64.86) 59 (149.86) 124 (56.25) 133 (60.33)
148 (67.13) 60 (152.40) 128 (58.06) 138 (62.60) 153 (69.40) 61
(154.94) 132 (59.87) 143 (64.86) 158 (71.67) 62 (157.48) 136
(61.69) 147 (66.68) 164 (74.39) 63 (160.02) 141 (63.96) 152 (68.95)
169 (76.66) 64 (162.56) 145 (65.77) 157 (71.22) 174 (78.93) 65
(165.10) 150 (68.04) 162 (73.48) 180 (81.65) 66 (167.64) 155
(70.31) 167 (75.75) 186 (84.37) 67 (170.18) 159 (72.12) 172 (78.02)
191 (86.64) 68 (172.72) 164 (74.39) 177 (80.29) 197 (89.36) 69
(175.26) 169 (76.66) 182 (82.56) 203 (92.08) 70 (177.80) 174
(78.93) 188 (85.28) 207 (93.90) 71 (180.34) 179 (81.19) 193 (87.54)
215 (97.52) 72 (182.88) 184 (83.46) 199 (90.27) 221 (100.25) 73
(185.42) 189 (85.73) 204 (92.53) 227 (102.97) 74 (187.96) 194
(88.00) 210 (95.26) 233 (105.69) 75 (190.50) 200 (90.72) 216
(97.98) 240 (108.86) 76 (193.04) 205 (92.99) 221 (100.25) 246
(111.59) Non-metric conversion formula = Metric conversion formula
= [weight (pounds)/height (inches).sup.2] .times. weight
(kg)/height (m).sup.2 704.5 Example of BMI calculation: Example of
BMI calculation: A person who weight 78.93 A person who weighs 164
pounds and kilograms and is 177 centimeters is 68 inches (or 5'
8'') tall has tall has a BMI of 25: a SMI of 25: weight (78.93 kg)/
[weight (164 pounds) height height (1.77 m).sup.2 = 25 (68
inches).sup.2] .times. 704.5 = 25
[0368] Waist Circumference agent: The presence of excess fat in the
abdomen out of proportion to total body fat is an independent
predictor of risk factors and morbidity. Waist circumference is
positively correlated with abdominal fat content. It provides a
clinically acceptable measurement for assessing a patient's
abdominal fat content before and during weight loss treatment. The
sex-specific cutoffs noted on the next page can be used to identify
increased relative risk for the development of obesity-associated
risk factors in most adults with a BMI of 25 to 34.9 kg/m2: These
waist circumference cutpoints lose their incremental predictive
power in patients with a BMI>=35 kg/m2 because these patients
will exceed the cutpoints noted above. The disease risk of
increased abdominal fat to the disease risk of BMI is as
follows:
TABLE-US-00003 CLASSIFICATION OF OVERWEIGHT AND OBESITY BY BMI,
WAIST CIRCUMFERENCE AND ASSOCIATED DISEASE RISKS Disease Risk.sup.a
Relative to Normal Weight and Waist Circumference Men .ltoreq.102
cm (.ltoreq.40 in) BMI Obesity Women .ltoreq.88 cm >102 cm
(>40 in) (kg/m.sup.2) Class (.ltoreq.35 in) >88 cm (>35
in) Underweight <18.5 -- -- Normal.sup.a 18.5-24.9 -- --
Overweight 25.0-29.9 Increased High Obesity 30.0-34.9 I High Very
High 35.0-39.9 II Very High Very High Extreme .gtoreq.40 III
Extremely High Extremely High Obesity
[0369] These categories denote relative risk, not absolute risk;
that is, relative to risk at normal weight. They should not be
equated with absolute risk, which is determined by a summation of
risk factors. They relate to the need to institute weight loss
therapy and do not directly define the required intensity of
modification of risk factors associated with obesity.
[0370] Risk Status agent is used for assessment of a patient's
absolute risk status and in turn uses the following agents:
[0371] Disease condition agent: determine existence of coronary
heart disease (CHD), other atherosclerotic diseases, type 2
diabetes, and sleep apnea.
[0372] Obesity-associated disease agent: determines gynecological
abnormalities, osteoarthritis, gallstones and their complications,
and stress incontinence.
[0373] Cardiovascular risk factors agent: cigarette smoking,
hypertension (systolic blood pressure>=140 mm Hg or diastolic
blood pressure>=90 mm Hg, or the patient is taking
antihypertensive agents), high-risk LDL-cholesterol (>=160
mg/dL), low HDL-cholesterol (<35 mg/dL), impaired fasting
glucose (fasting plasma glucose of 110 to 125 mg/dL), family
history of premature CHD (definite myocardial infarction or sudden
death at or before 55 years of age in father or other male
first-degree relative, or at or before 65 years of age in mother or
other female first-degree relative), and age (men>=45 years and
women>=55 years or postmenopausal). Patients can be classified
as being at high absolute risk if they have three of the
aforementioned risk factors. Patients at high absolute risk usually
require clinical management of risk factors to reduce risk.
Patients who are overweight or obese often have other
cardiovascular risk factors. Methods for estimating absolute risk
status for developing cardiovascular disease based on these risk
factors are described in detail in the National Cholesterol
Education Program's Second Report of the Expert Panel on the
Detection, Evaluation, and Treatment of High Blood Cholesterol in
Adults (NCEP's ATP II) and the Sixth Report of the Joint National
Committee on Prevention, Detection, Evaluation, and Treatment of
High Blood Pressure (JNC VI). The intensity of intervention for
cholesterol disorders or hypertension is adjusted according to the
absolute risk status estimated from multiple risk correlates. These
include both the risk factors listed above and evidence of
end-organ damage present in hypertensive patients. Approaches to
therapy for cholesterol disorders and hypertension are described in
ATP II and JNC VI, respectively. In overweight patients, control of
cardiovascular risk factors deserves equal emphasis as weight
reduction therapy. Reduction of risk factors will reduce the risk
for cardiovascular disease whether or not efforts at weight loss
are successful.
[0374] Other risk factors can be considered as rules by the agent,
including physical inactivity and high serum triglycerides (>200
mg/dL). When these factors are present, patients can be considered
to have incremental absolute risk above that estimated from the
preceding risk factors. Quantitative risk contribution is not
available for these risk factors, but their presence heightens the
need for weight reduction in obese persons.
[0375] One embodiment determines high interest disease- and
drug-related variants in the patient's genome and identifies top
diseases with the highest probabilities. For each disease, the
system determines the pretest probability according to the patient
age, gender, and ethnicity. The system then determines the
independent disease-associated SNVs used to calculate the subject's
disease probability. For each disease, for example type 2 diabetes,
the system determines probability using independent SNVs, a
likelihood ratio (LR), number of studies, cohort sizes, and the
posttest probability. Blood pressure and blood glucose trend
measurements are also determined.
[0376] A patient motivation agent evaluates the following factors:
reasons and motivation for weight reduction; previous history of
successful and unsuccessful weight loss attempts; family, friends,
and work-site support; the patient's understanding of the causes of
obesity and how obesity contributes to several diseases; attitude
toward physical activity; capacity to engage in physical activity;
time availability for weight loss intervention; and financial
considerations. In addition to considering these issues, the system
can heighten a patient's motivation for weight loss and prepare the
patient for treatment through normative messaging and warnings.
This can be done by enumerating the dangers accompanying persistent
obesity and by describing the strategy for clinically assisted
weight reduction. Reviewing the patients' past attempts at weight
loss and explaining how the new treatment plan will be different
can encourage patients and provide hope for successful weight
loss.
[0377] In an exemplary system for providing precision medicine,
historical data from a large population is received and provided to
a learning engine. The learning engine clusters the population into
groups of similar characteristics and then creates a social network
of patients who share enough health/medical similarity that they
are apt to share many medical issues. Thus a user's likelihood of
contracting a disease might be evaluated by knowing the disease
status of other users in the same influence cluster or
neighborhood, whether they are closely connected to that user or
not.
[0378] The system, generally denoted by reference numeral 100,
comprises one or more central processing units CP1 . . . CPn,
generally denoted by reference numeral 110. Embodiments comprising
multiple processing units 110 are preferably provided with a load
balancing unit 115 that balances processing load among the multiple
processing units 110. The multiple processing units 110 may be
implemented as separate processor components or as physical
processor cores or virtual processors within a single component
case. In a typical implementation the computer architecture 100
comprises a network interface 120 for communicating with various
data networks, which are generally denoted by reference sign DN.
The data networks DN may include local-area networks, such as an
Ethernet network, and/or wide-area networks, such as the internet.
In some implementations the computer architecture may comprise a
wireless network interface, generally denoted by reference numeral
125. By means of the wireless network interface, the computer 100
may communicate with various access networks AN, such as cellular
networks or Wireless Local-Area Networks (WLAN). Other forms of
wireless communications include short-range wireless techniques,
such as Bluetooth and various "Bee" interfaces, such as XBee,
ZigBee or one of their proprietary implementations. Depending on
implementation, a user interface 140 may comprise local
input-output circuitry for a local user interface, such as a
keyboard, mouse and display (not shown). The computer architecture
also comprises memory 150 for storing program instructions,
operating parameters and variables. Reference numeral 160 denotes a
program suite for the server computer 100. Reference number 115-135
denotes an optional interface by which the computer obtains data
from external sensors, analysis equipment or the like.
[0379] In some embodiments the data processing system is coupled
with equipment that determines an organism's genotype from an
in-vitro sample obtained from the organism. In other embodiments
the genotypes are determined elsewhere and the data processing
system may obtain data representative of the genotype via any of
its data interfaces.
[0380] One exemplary sensor communicating with one of the
interfaces 115-135 receives a biologic sample from an individual
such as a bodily fluid (such as urine, saliva, plasma, or serum) or
feces or a tissue sample (such as a buccal tissue sample or buccal
cell). The biologic sample can then be used to perform a genome
scan. For example, DNA arrays can be used to analyze at least a
portion of the genomic sequence of the individual. Exemplary DNA
arrays include GeneChip.RTM. Arrays, GenFlex.RTM. Tag arrays, and
Genome-Wide Human SNP Array 6.0 (available from Affymetrix, Santa
Clara, Calif.). In other examples, DNA sequencing with commercially
available next generation sequencing (NGS) platforms is generally
conducted: DNA sequencing libraries are generated by clonal
amplification by PCR in vitro; then the DNA is sequenced by
synthesis, such that the DNA sequence is determined by the addition
of nucleotides to the complementary strand rather through
chain-termination chemistry; next, the spatially segregated,
amplified DNA templates are sequenced simultaneously in a massively
parallel fashion without the requirement for a physical separation
step. For microbiome analysis, cotton swabs are applied to
forehead, behind ears, nose, among others, and fecal samples are
analyzed using DNA sequencing machines. In certain embodiments,
whole or partial genome sequence information is used to perform the
genome scans. Such sequences can be determined using standard
sequencing methods including chain-termination (Sanger
dideoxynucleotide), dye-terminator sequencing, and SOLiD.TM.
sequencing (Applied Biosystems). Whole genome sequences can be cut
by restriction enzymes or sheared (mechanically) into shorter
fragments for sequencing. DNA sequences can also be amplified using
known methods such as PCR and vector-based cloning methods (e.g.,
Escherichia coli).
[0381] In some embodiments, at least a portion of an individual's
genetic material (e.g., DNA, RNA, mRNA, cDNA, other nucleotide
bases or derivative thereof) is scanned or sequenced using, e.g.,
conventional DNA sequencers or chip-based technologies, to identify
the presence or absence of one or more SNPs or CNPs or copy number
polymorphisms ("CNPs") and their corresponding alleles.
[0382] One embodiment performs exome sequencing (also known as
Whole Exome Sequencing or WES), which is a technique for sequencing
all the protein-coding genes in a genome (known as the exome). It
consists of first selecting only the subset of DNA that encodes
proteins (known as exons), and then sequencing that DNA using any
high throughput DNA sequencing technology. There are 180,000 exons,
which constitute about 1% of the human genome, or approximately 30
million base pairs. Exome data relates with genetic variation that
is responsible for both Mendelian and common diseases such as
Miller syndrome and Alzheimer's disease without the high costs
associated with whole-genome sequencing.
[0383] The sensors connecting to interfaces 115-135 can also
include fitness sensors such as wearable watches/clothing/shoes
that monitor activity, heart rate, ECG, blood pressure, blood
oxygen level, among others. The sensors 115-135 can also detect
purchase activities and on-line activities that reflect the user's
health habits. For example, the sensors can be a data feed that
picks up data relating to grocery purchases, food expenses,
restaurant spending.
[0384] In yet other examples, the sensors connecting to interfaces
115-135 can be sensors in a phone. For example, in depression
sensor, the phone can detect a person's activity and correlate to
depression: people who stuck to a regular pattern of movement
tended to be less depressed as people with mental health problems
in general have disrupted circadian rhythms and a depressed mood
may pull a user off her routine. Depressed people also spends more
time on their phones or browsing aimlessly, as depressed people
tend to start avoiding tasks or things they have to do,
particularly when they're uncertain.
[0385] In addition to sensor captured healthcare data, healthcare
data refers to any data related or relevant to a patient.
Healthcare data may include, but is not limited to, fitness data
and healthcare-related financial data. Clinical data, as used
herein, refers to any healthcare or medical data particular to a
patient. In embodiments, clinical data can be medical care or
healthcare data resulting from or associated with a health or
medical service performed in association with a clinician in a
healthcare environment (e.g., lab test, diagnostic test, clinical
encounter, ecare, evisit, etc.). Clinical data may include, but is
not limited to, a health history of a patient, a diagnosis, a
clinician assessment, clinician narrative, a treatment, a family
history (including family health history and/or family genetics),
an immunization record, a medication, age, gender, date of birth,
laboratory values, diagnostics, a test result, an allergy, a
reaction, a procedure performed, a social history, an advanced
directive, frequency and/or history of healthcare facility visits,
current healthcare providers and/or current healthcare provider
location, preferred pharmacy, prescription benefit management data,
an alert, claims data, a vital, data traditionally captured at the
point of care or during the care process, a combination thereof,
and the like. In the same or alternative embodiments, the clinical
data may include medical compliance information. In certain
embodiments, medical compliance information refers to a level of
compliance of a particular patient with one or more prescribed
medical treatments, such as medications, diet, physical therapy,
follow up healthcare visits, and the like. In one or more
embodiments, the clinical data may include data obtained from the
natural language processing of one or more clinical assessments
and/or clinical narratives.
[0386] In certain embodiments, healthcare-related financial data
can refer to any financial information relevant to a patient, such
as insurance data, claims data, payer data, etc. Such healthcare
data (e.g., clinical data and healthcare-related financial data)
may be submitted by a patient, a care provider, a payer, etc. In
certain embodiments where the healthcare data is being submitted by
anyone other than the patient, the patient may be required to
approve of such submission and/or may opt-in to or opt-out of
having such healthcare data being submitted.
[0387] One embodiment uses local storage on the mobile phone of
data collected by other devices and an app is provided to interpret
sensor data. The phones have fingerprint sensor security, and the
mobile app is the point of aggregation for all the user's different
health data. The health data is captured by the footwear and also
by third party sensors (Nike+, Withings Scale, Fitbit Flex.RTM.
etc) and tie data from all fitness hardware into a cohesive
whole.
[0388] In one embodiment, sensors in the clothing or shoes or worn
by the user can communicate with a mobile phone and transmit user
activity or inactivity to networks that allow information access
and provide support on the back end. Having a network or backbone
that a much broader population base can seamlessly connect to will
fuel more meaningful data comparisons and analysis and distill
useful information. The network can then aggregate data from the
footwear with other health information--data from across a certain
geography or specific diagnosis, for example--to create a more
complete picture of group health.
[0389] Creating healthcare communities from which to collect data
is a way to crowd source valuable healthcare information. By
bringing together people with a common interest such as weight
loss, the footwear devices serve as a mechanism to build engagement
and at the same time compile information. In one embodiment, the
information is used by health payors or insurers to prompt patients
to change their lifestyles. The more employers, insurance
companies, or healthcare payors know about a population's health,
the more steps they can take to keep them healthy. For instance,
patient data entered into electronic health records at practices
and hospitals could reveal allergies, health histories, and
medication use. Combined with information collected through the
footwear, providers will have more complete and essentially
real-time data to treat and manage the health of individual
patients, as well as patient populations. The cumulative sum of
data captured from many individuals about a health condition or
population can be used to move the population to healthier
conditions. In one embodiment, health plans can offer incentives to
members willing to sign up for designated footwear health programs
and join in a "game" to be fit.
[0390] The system reduces healthcare costs by identifying trends
and commonalities among certain populations--thereby enabling
better preventive care. In addition to engaging patients and aiding
personal wellness, they can move healthcare beyond individual
monitoring and treatment toward more effective population health
management.
[0391] By engaging and empowering patients to take an active role
in data collection, the footwear applies inconspicuous foot data
with analytics to improve health. One embodiment uses Google Maps
to display health activity traffic; showing healthcare patterns
based on real time reporting of anonymous data from healthcare
footware devices. Healthcare organizations can tap the power of
that data to engage patients and develop more effective and more
personalized approaches to care, thereby lowering the overall cost
of care.
[0392] The system identifies pre-detectable characteristics of a
health condition, such that future incidents of the health
condition may be predicted, i.e., before the health condition
occurs for disease prevention. One implementation includes
capturing data from mobile fitness devices and establishing a
plurality of health related characteristics associated with the
population including walking status, weight, calorie burn. The
characteristics include a plurality of pre-detectable
characteristics with a relationship between the health related
characteristics and at least one health condition, and analyzing at
least a portion of said population in response to the
relationship.
[0393] Another embodiment includes establishing at least one
pre-detectable characteristic associated with a health condition,
applying an intervention in response to the characteristic,
monitoring a success characteristic of the intervention, and
determining a cause of the success characteristic.
[0394] Another embodiment builds a repository of health related
characteristics associated with the population, the characteristics
including a plurality of pre-detectable characteristics; and a
processor configured to receive the health related characteristics,
establish a relationship between the health related characteristics
and at least one health condition, and analyzing at least a portion
of the population in response to said relationship.
[0395] A population, as used herein, is any group of members. The
population may include a high level of members, for example a group
including one or more of the five kingdoms of living things, or a
subgroup, for example a group including humans of a certain age
range. The population may include living and/or dead members. The
analysis may include predicting a likelihood of a member developing
the health condition, in response to the relationship. The health
condition may be any type of physical or mental health condition,
disease, and/or ailment. In addition, the analysis may include
predicting the incidence of the health condition. The analysis may
also include performing a simple yes/no prediction regarding
whether a member will likely develop the health condition. The
analysis may be used to enable the management of a health care
program, such as a program associated with a corporation, or a
program offered to the public by a health care consultant or
provider. If the analysis is associated with a corporation's
healthcare program, the population may include some or all of the
employees and retirees of the corporation, and associated spouses
and dependents. The population may include other associated groups
of the corporation, such as consultants, contractors, suppliers
and/or dealers. The population may include participants from
multiple corporations and/or the general public. If the health care
program is offered to the public, the population may include
members of the public, organizations, and/or corporations.
[0396] The health related characteristics may include a plurality
of health characteristics, lifestyle characteristics and/or family
health characteristics associated with the members of the
population. Health characteristics may include characteristics
indicative of a specific member's health. For example, lifestyle
characteristic may include weight, heart rate, walking gait,
sitting gait, running gait, exercise or activity as detected by
accelerometers, diet, and other factors detectable by fitness
devices such as watches, phones, or foot sensors detailed above.
For other example, health characteristic may include medical
characteristics (e.g., what medical visits, processes, procedures,
or test have been performed associated with the member, the number
of days the member has spent in a medical facility (e.g., a
hospital), the number of visits the person has made to a doctor,
etc.), drug characteristics (e.g., what type and amount of drugs
are being consumed), a death characteristic (e.g., information
associated with a death certificate), an absenteeism
characteristic, disability characteristics, characteristics
associated with existing health conditions, etc. Family health
characteristics associated with the member may include information
associated with the family medical history of a specific member.
For example, a history of a particular health risk within the
family, e.g., heart failure, cancer, high blood pressure, diabetes,
anxiety, stress, etc. Lifestyle characteristic may include a
specific member's behavior characteristic(s), of which some or all
may be modifiable lifestyle characteristics. A modifiable lifestyle
characteristic may include an exercise characteristic (e.g., does
the member exercise, how often, what is the exercise, etc.) and/or
a nutrition characteristic (e.g., what types of food does the
member eat, and how often). Nutrition characteristics may also
include the amount of salt consumed during a designated period
(e.g., a day), and the amount of fat and/or saturated fat consumed
during a designated period. In addition, modifiable lifestyle
characteristics may include whether the member drinks alcohol (and
if so how much), a drug intake characteristic, (i.e., does the
member take drugs, and if so how often, what kind, and how much), a
weight characteristic (e.g., what does the member weigh, what is
the member's desired weight, is the member on a diet, what is the
member's weight indicator e.g., obese, slightly overweight,
underweight, normal, etc.), a smoking characteristic (does the
member smoke and if so how much), a safety characteristic (what are
the member's driving characteristics e.g., does the member where
seat belts, have one or more infractions associated with driving
under the influence, or speeding tickets, etc.). In addition,
modifiable lifestyle characteristics may include a hypertension
characteristic, a stress characteristic, a self-care
characteristic, a self-efficacy characteristic, a readiness to
change characteristics, and a prophylactic aspirin therapy
characteristic.
[0397] In one embodiment, the health related characteristics may
also include one or more of the following: demographic
characteristics, the member's location or geography, age, gender,
employment status, employment type, and/or work characteristics of
the member. The health-related characteristics may be obtained
through one or more of several sources, such as medical claims,
drug claims, and/or self-reported characteristics (or data). In one
embodiment, self-reported characteristics may be collected from the
population. The amount and type of self-reported characteristics
collected associated with the population is implementation
dependent and may vary based upon the participation of the
population, the relevance of the information to the different
members of the population, and the analysis to be performed.
Therefore the self-reported characteristics established may be
associated with a subset, or portion, of the established
population, or the entire population. The self-reported
characteristics may include one or more health characteristics,
family health characteristics, and lifestyle characteristics
associated with a member of the population. The self-reported
characteristics, also referred to as self-assessments, may be
obtained through the use of one or more health related
questionnaires submitted to the member. Examples of questionnaires
include physical questionnaires, electronic questionnaires (e.g.,
located on a health related web-site), questionnaires filled out
during a phone or personal interview, etc. The responses to the
questionnaires may include a member's self assessed health related
characteristics. The characteristics may include a self-efficacy
characteristic and/or a readiness to change characteristic. A
readiness to change characteristic is a characteristic indicative
of a members readiness to change one or more behaviors, activities,
or characteristics. A self-efficacy characteristic, as will be
discussed, includes an indication of a member's belief in their
ability to succeed in changing a lifestyle characteristic. For
example the self-assessment questionnaire may specifically ask the
member: does the member believe they can change their lifestyle or
a specific aspect of their lifestyle, is the member willing to
attempt to change an aspect of their lifestyle and if so, how
successful do they think they will be, how important do they think
it is to change one or more specified lifestyles, etc.
Alternatively, one or more questions may be asked of which the
answers may provide indirect indicators of whether the person
actually does believe they can change aspects of their lifestyle,
and also whether the member is actually ready to change a
particular aspect of their lifestyle.
[0398] In one embodiment, the health related characteristics of the
population are associated with self-reported biometric
characteristics. For example, the sources of the health related
characteristics may be self-reported biometric sources. That is,
the sources of the health related characteristics are sources other
than the direct physical examination of a member (e.g., where
members provide a biological sample etc). The distinction is based
on the issue that due to the size of the population, it may not be
possible to analyze all of the members by having detailed
examinations (e.g., blood samples, urine samples, etc.) of all, or
even a substantial portion of the population. Therefore, in one
embodiment, the health analysis is based on information that is
obtained second-hand, without having physically examined a specific
member to directly obtain the desired health related
characteristics. Of course, if the described analysis indicates a
particular member needs to be physically examined based on
likelihood of occurrence of a health condition, which examination
may occur. In one embodiment, the health related characteristics
may relate to non-intrusive characteristics, i.e., characteristics
that do not directly involve the physical examination or taking of
biological samples of a member by a physician. For example, a blood
sample may be considered intrusive data because it involves the
taking of a sample from a member.
[0399] The collected health related characteristics may be stored
in a repository. The duration of storage is implementation
dependent, but in general the more information available for
analysis, the more accurate the results will be. Therefore, a
historical repository of five to ten years may be established. In
some embodiments, characteristics may be available throughout the
working career of the members, e.g., if their employer collects
self-reported information, medical and/or drug claims. The
historical repository aids analysis in several ways, including
reducing the impact of recall bias. Recall bias is what may happen
when a member acquires a particular health condition, and then
attempts to recall what factors may have contributed to the
condition. The members recollection may be biased by any number of
issues including their ability to accurately remember all the
desired information. Therefore a historical repository aids in
providing accurate information for analysis.
[0400] The established health related characteristics may be used
to analyze the health of the population. In one embodiment, as
illustrated in a second control block 104, a prevalence of a health
condition within the population may be established. The prevalence
of a condition may be described as the current existence of a
condition. The prevalence of a health condition among a population
may be described as the number or percentage of members that have a
specific health condition. Establishing the prevalence of a
condition in a population may include determining which members
currently have a specific health condition. The prevalence of a
health condition may be established by analyzing the health related
characteristics associated with one or more members of the
population and responsively establishing whether one or more
members has the condition. For example, the prevalence may be
established by analyzing information associated with medical claims
and/or drug claims associated with the population.
[0401] Medical claims may include any type of health related
correspondence between a health analyst or provider (e.g., doctor,
physician, medical laboratory, hospital, medical support group such
as x-ray providers, etc.), and a member of the population and/or a
health care insurer, provider, or manager, for the member (e.g.,
corporation (employer) or third party insurer/manager, etc.). In
one embodiment, the healthrelated correspondence may include health
codes such as E/M (Evaluation and Management) codes, Current
Procedural Terminology (CPT) codes, and International
Classification of Diseases (ICD) codes. ICD codes provide coded
information associated with the treatment, health, and/or a
condition of a member. These codes may include information
associated with the professional services performed, the specific
procedure(s) performed, and why the procedure(s) was performed.
Therefore, analysis of ICD, CPT, and/or E/M codes may be used to
establish whether a member has a particular health condition.
[0402] A drug claim may include any type of medication related
correspondence between a medication provider (e.g., doctor,
pharmacist, etc.), and a member of the population and/or a health
care insurer, provider, or manager for the member (e.g.,
corporation (employer) or third party insurer/manager, etc.). In
one embodiment, the correspondence may include codes or
identification systems such as Group Product Index (GPI). The GPI
provides a numbering system associated with the medication a member
receives, and/or medication prescribed for a member. The GPI
enables the identification of the type of drug, manufacturer,
strength, associated dosage, and associated medication form (e.g.,
pill, tablet, liquid, etc.).
[0403] In one embodiment, information associated with at least one
medical and/or drug claim may be used to determine the prevalence
of a condition, e.g., whether a member has one or more specific
health conditions. For example, if a medical claim indicates a
particular procedure has been performed, then that procedure may be
correlated to one or more potential health conditions associated
with that procedure. Analogously, if a drug claim indicates that a
member is being prescribed and/or receiving a particular
medication, then that medication may be correlated to one or more
potential health conditions associated with that medication. In
this manner, the information associated with the medical and/or
drug claims may be analyzed to establish a prevalence of a
condition. The analysis may be performed on each member of the
population, or a subset thereof.
[0404] In one embodiment, information associated with multiple
medical and/or drug claims may be analyzed based on established
criteria, to establish the prevalence of a health condition. For
example, multiple medical and/or drug claims may be cross checked
with each other to establish the prevalence of a health condition.
An individual medical or drug claim may contain erroneous or
misleading information. For example, there may be instances where a
medical procedure is performed to test for a health condition,
without definitively establishing the condition exists in the
member. Analysis of the resulting medical claim may lead someone to
erroneously believe the person had the health condition (e.g.,
based on the types of procedures being performed). Therefore, using
one medical or drug claim may not provide an accurate indication of
the presence of a health condition. Additional medical claims
and/or drug claims may be analyzed to establish one or more
healthrelated characteristics of a member, such as the prevalence
of a health condition. In one embodiment, multiple medical and/or
drug claims, separated by a time period (e.g., a minimum duration)
may be analyzed. The separation in time increases the confidence
level regarding the determination that a particular health claim,
or health related characteristic, exists. For example, two claims
of the same type (e.g., two medical claims or two drug claims),
separated in time by at least three months, may be analyzed to
determine if a member has a health condition. If the first claim
indicates a condition exists, and a second claim indicates the same
condition exists, then the member may be assumed to have the
condition associated with the medical claims. The two claims may
sequentially occur, or be separated by one or more other medical
and/or drug claims. In addition, a claim of one type (e.g., medical
claim) may be cross checked with a claim of another type (e.g.,
drug claim) If the two claims correlate, then the member may be
considered to have the particular condition. The two different
types of claims may also be separated by a designated time period,
e.g., three months, to further establish that the condition
actually exists. In one embodiment, the time separation is
established such that the two claims represent independent
indicators, as opposed to two claims associated with the same
medical event (medical checkup or medication collection).
Additional criteria may include that the claims being correlated
should occur within a particular time period of each other. For
example, if two claims indicating a particular health condition are
separated by five years in time, there is a chance that the claims
were inaccurate anomalies as opposed to indications of the
existence of the health condition. Therefore, a maximum duration
between claims being cross checked may be established (e.g., one
year). In one embodiment, the maximum duration between cross
checked claims may be dependent upon the condition at issue. For
example, some health conditions may be more likely to have multiple
claims occur within a specific time duration. While other health
conditions may not manifest themselves in multiple medical claims
in that same specified time duration. Therefore, the duration
between claims may be implementation and health condition
dependent.
[0405] When claims are received, they may be manually or
automatically analyzed. For example, when a claim is received, it
may be analyzed to establish associated health characteristics. The
health characteristics may then be cross checked with information
from other claims in an attempt to verify one or more of the health
characteristics. The analysis may include correlating the claim
with a table of potential health characteristics associated with
claim information. The information may be compared with previous
claim information to determine if prior claims indicated the same,
or similar health related characteristics. If the cross check
indicates one or more prior claims indicated the same health
related characteristic, then the member may be assumed to have the
health related characteristic (e.g., the health condition). If no
prior claim information correlates with the current claim
information, then the current claim information, and the correlated
health related characteristics may be store to be compared with
future claims that are to be receive. In one embodiment, if a
strong correlation exists between the health related
characteristics associated with multiple claims, and a sufficient
time period exists between the claims, then the member may be
determined to have the characteristics. Alternatively, machine
learning such as classical, Bayesian, and/or statistical analysis
techniques may be used to correlate and cross check one or more
medical and/or drug claims with one or more health related
characteristics and/or health conditions. For example, neural
networks may be trained to associate information associated with
medical and/or drug claims with particular health related
characteristics and/or health condition. Then when a claim is
received, it may be analyzed to establish potential health related
characteristics and/or health conditions. The neural network may be
able to provide a weighted analysis such that the results have an
associated confidence factor. If multiple claims separated in time
indicate the same or similar health related characteristics, the
resulting neural network analysis may provide a higher confidence
indicator than if just one claim indicated the characteristics.
Therefore, as prevalent health conditions are established based on
medical and/or drug claims, the claims may be further analyzed to
establish a relationship capable of automatically detecting a
prevalence based on the available medical and/or drug claims.
[0406] In one embodiment, the medical and/or drug claims may be
analyzed as they are received. Alternatively, there may be a
repository of one or more previous medical and/or drug claims
associated with the member(s). For example, repositories may be
created that include a members historical health related
characteristics over a time period (e.g., the last five-ten years).
These repositories may be maintained by the health care provider,
insurer, analyzer, and/or manager. These repositories may be
analyzed to establish a prevalence of a condition among the
population.
[0407] In one embodiment, self-reported characteristics may be
analyzed to establish the prevalence of a condition, e.g., among
one or more members of a population and/or the population as a
whole. For example, a member may specifically indicate that they
have a particular condition such as high blood pressure, diabetes,
smoking, overweight, among others. Alternatively the analysis of
one or more of the family history, lifestyle, or health
characteristics indicated through the self assessments may indicate
that the member likely has a particular condition. In this case
additional follow-up may be performed with the member to determine
if they actually have the condition, or know that they have the
condition. In one embodiment, a relationship may be established to
determine the existence of a condition among a particular member
and/or among the population.
[0408] In one embodiment, medical claims, drug claims, and
self-reported characteristics may be used to establish the
prevalence of a particular condition among the population.
Alternatively, as indicated above, the prevalence of a condition
may be established based on one or more of the sources of
information (e.g., medical claims, drug claims, and/or
self-reported characteristics). The prevalence may be established
manually or through an automated process such as the use of
statistical analysis techniques as mentioned above. The decision of
what information (or sources of information) to use may be based on
what information is available for the population, or for a
particular portion of the population. For example, some portions of
the population may not have a historical data base of information
available for analysis. In addition, some portions of the
population may not have associated medical claims, drug claims
and/or self-reported characteristics. Therefore the type and amount
of information to be analyzed to establish the prevalence of a
disease is implementation dependent and may be based in part on the
type of information available for a particular population, or
portion thereof.
[0409] A relationship may be established between the health related
characteristics and one or more health conditions. In one
embodiment, the relationship is established in response to the
prevalence of the health condition. The relationship may then be
modified based on future occurrences, or rates of occurrences of
the condition. Alternatively, the relationship may be established
by analyzing future occurrences or rates of occurrence of the
condition without accounting for an initial prevalence of the
condition. In one embodiment, as described below, the relationship
may be used to predict an incident or occurrence of a disease,
e.g., an occurrence of a disease among a particular member or among
a population in general. Information gained from establishing the
prevalence of the condition may be used to establish the
relationship. For example, the health related characteristics
associated with the members determined to have a particular
condition may be analyzed to establish a relationship associated
with a likelihood of developing the condition. In one embodiment,
the predictive relationship is different than the analysis to
determine the prevalence of a condition because the prevalence
analysis may be used to establish who has the condition. However,
the occurrence predictor may be used to establish the health
related characteristics that are needed to predict the likelihood
of developing the health condition. In one embodiment, all of the
health related information associated with a member having a
condition, or all of the health related information believed to be
potentially relevant to a health condition that a member has, may
be analyzed to establish the relationship. The health related
information to be analyzed may be historical data that pre-dates
the incidence of the health condition.
[0410] The analysis and associated relationship may indicate the
pre-detectable characteristics associated with a health condition.
Pre-detectable characteristics are characteristics that impact the
chance of acquiring risk factors associated with a condition. A
pre-detectable characteristic may be associated with more than one
risk factor and/or more than one health condition. A heart attack
is an example of a health condition. Risk factors associated with a
heart attack may include obesity, age, and gender. A risk factor
may be described as one form of a heath related characteristic that
is a known, believed, or hypothesized to be an indicator of
acquiring a health condition, or increasing the risk of acquiring
the health condition. Risk factors usually have one or more
pre-detectable characteristics associated with them. Pre-detectable
characteristics associated with obesity, or being overweight,
include dietary characteristics, such as the amount of saturated
fat, fiber, and calories consumed during a time period. By reducing
the amount of saturated fat consumed (a pre-detectable
characteristic), the chances of acquiring the associated risk
factor may be reduced (e.g., reduced chance of being overweight).
If the chances of acquiring a risk factor is reduced or eliminated,
then the chances of acquiring an associated health condition (e.g.,
the heart attack) are also reduced or possibly eliminated. As will
be discussed, one embodiment of the present disclosure is
associated with identifying pre-detectable characteristics
associated with a health condition, and then predicting an incident
of the condition associated with a particular member based on the
particular health related characteristics associated with that
member. Intervention recommendations may then be tailored to the
particular pre-detectable characteristics exhibited by the
particular member. In one embodiment, the collected health related
characteristics may be detailed and extensive in order to acquire
the desired information that may be associated with possible
pre-detectable characteristics. By the nature of the analysis being
performed, the pre-detectable characteristics may not be initially
known. Therefore, monitoring of future occurrences of the
condition, and analysis of the associated health-related
characteristics enables the predictive relationship to evolve as
new information is available.
[0411] The details of the establishment of the relationship will be
described below. However, in general, the health related
information associated with the population will be analyzed to
establish the relationship. The analysis may include the use of
statistical analysis techniques such as classical, Bayesian, and/or
machine learning analysis techniques to analyze the health related
information. For example, neural networks may be trained using all
the health related characteristics of the members having a
particular condition. Then, the health-related characteristics of a
member of the population may be delivered to the neural network for
analysis. The resulting analysis may provide a weighted answer
indicative of the likelihood the person will acquire the condition.
In addition, review of the neural network may provide insight into
which health characteristics are more relevant to acquiring the
condition. These characteristics may then be reviewed to establish
the pre-detectable characteristics associated with the condition.
For example, the relevant health related characteristic may be a
pre-detectable characteristic, or may have associated
pre-detectable characteristics. Therefore, depending on the
specific implementation used, the analysis may be able to indicate
the health related characteristics that are most relevant to the
prediction of a particular health condition.
[0412] The relationship may be used to analyze the population with
respect to the health condition. For example, the relationship may
be used to predict the likelihood of developing a condition
associated with the population, or a portion thereof. As such, the
relationship may be used to predict a future incident or occurrence
of the health condition. In one embodiment, the health related
information associated with one of the members of the population
may be analyzed using the established relationship. The analysis
may indicate, or predict, whether the member will develop a
particular disease, which may include the likelihood the member
will develop the particular disease. The analysis may be used to
predict the occurrence of the disease based upon the established
pre-detectable characteristics. In addition, this analysis, or
information resulting from the analysis may be used to predict an
incidence of the health condition, e.g., over a specified period of
time, how many members will develop the disease, or what is the
likelihood of a particular portion of the population developing the
disease over a specified time period.
[0413] In one embodiment, depending on the health condition
associated with the analysis, the analysis may also establish a
predicted time period in which the incident may occur (e.g, the
next year, next five years, next ten years, etc.). In addition, the
analysis may establish a stage of the condition associated with a
particular member. For example, some conditions may have definable
stages of the onset of the disease.
[0414] In one embodiment, a likelihood of developing the condition
may be established based upon the analysis. For example, some
analytic techniques produce information associated with the
likelihood of having the incidence, e.g, a confidence level.
Therefore, the analysis may include classifying all or a portion of
the population with respect to one or more conditions, based on the
likelihood of the particular members having an incidence of the
disease, based on the particular stages of the condition the
population members fall within, and/or based on the predicted time
period associated with the incidence. In this manner the population
may be classified, or ranked, with respect to the likelihood of
developing a condition, the time period in which the development
may occur, and/or the stage of the condition the member is in. As
described below, this classification, or ranking of the population,
or a portion thereof, with respect to one or more conditions
enables, specific interventions to be applied to specific members
based on predicted risk, and also enables the management of the
population as a whole, and the intervention and associated cost,
etc. Therefore, the population may be analyzed to establish a
likelihood of developing of one or more conditions, among one or
more members of the population.
[0415] An intervention may be recommended in response to the
likelihood of developing the health condition. Factors that may be
used to select the appropriate intervention include the predicted
likelihood the member will develop the health condition and the
pre-detectable characteristics the member exhibits that are
associated with the condition. For example, the more likely the
person is to acquire a particular condition, the more aggressive
the intervention recommendation may be. Other health related
characteristics may also be used to determine the appropriate
intervention, such as the self-efficacy characteristic and/or
readiness to change characteristic associated with the member, and
the likelihood of success of the intervention. The cost of the
intervention may also be a factor in intervention selection. The
role of intervention cost may be based on the premise that there is
a finite amount of money available to administer health care
interventions to the population. Therefore, one use of the analysis
may be to determine how the interventions may be applied in a cost
effective manner, while providing the best benefit for the
population. For example, given the choice between recommending an
intervention that is 60% effective and an intervention that cost
twice as much, but is only 62% effective, the decision may be to
apply the less expensive, yet effective intervention, and use the
"savings" in other areas of the health care program.
[0416] One implementation may include the step of establishing a
success characteristic associated with the intervention. The
success characteristic may include a characteristic associated with
the success of the intervention, e.g., did the intervention succeed
(or assist in succeeding) the prevention or delay of the incidence
of the health condition. The success characteristic may include
characteristics associated with whether the intervention was used,
to what degree the intervention was used, why the intervention was,
or was not used, and how effective was the intervention in light of
how much it was used. Some of these success characteristics may be
established shortly after recommending the intervention (e.g., was
the intervention used and why or why not, to what degree the
intervention was used, if not used what would it take to motivate
the member to use, etc.), while other success characteristics may
not be established for a period of time (e.g., if used, how
successful was the intervention).
[0417] Success characteristics may be collected in several ways.
Fitness sensors on the phone, watch, or foot can detect changes
leading to/from success and provide appropriate warnings to the
user or an assigned health coach. The characteristics may also be
collected through medical and/or drug related information. For
example, an intervention may include a recommendation that the
member visit a medical provider (e.g., doctor), have a medical test
performed, and/or be prescribed a particular drug. The members
medical and/or drug claims may be monitored to determine if the
recommendation was followed. For example, if over a particular time
period, e.g., three months, there is no indication from reviewing
medical claims, that the member visited a medical provider, then
the assumption may be made that the member did not follow the
recommendation. In light of this, a health care counselor or
provider may be notified, and the member contacted to verify they
did not follow the recommendation, and determine why the
recommendation was not followed (if indeed it wasn't). This may be
done by monitoring claims either manually or in an automated
fashion, e.g., through the use of a computer program. For example,
once an intervention is recommended, a computer related program may
be configured to automatically review medical, drug claims, and/or
self assessment characteristics to monitor characteristics of
whether the recommended intervention was performed. In addition to
fitness device reporting or through claims reporting, the success
characteristics may be collected through self-reported data (e.g.,
targeted questionnaires, interviews, one on one phone calls such as
counseling phone calls, etc.). For example, if a particular
intervention recommended a medical visit, the targeted
questionnaire or counseling call may specifically inquire as to
whether the medical visit was made, and why or why wasn't the visit
made.
[0418] In one example, the success characteristics may include
information indicative of a persons self-efficacy, and/or readiness
to change. For example, if the established predictive relationship
indicates that a particular member is at risk for a heart attack,
and part of the pre-detectable characteristics associated with a
heart attack is that the member is eating too much saturated fat,
an intervention recommendation may include recommending a change in
lifestyle, e.g., increased exercise such as running, walking, or
swimming. The success characteristics may indicate that the person
did not engage in any exercise (e.g., on a subsequent self
assessment). Upon further follow up (e.g., within the same
questionnaire or counseling session, or in a later one), the member
may indicate that they don't enjoy exercising and/or they don't
perceive the need to do so. Alternatively, the member may indicate
that they tried running, but their knees hurt, so they stopped,
and/or they did not have access to a swimming pool. That is, while
they are willing to engage in a recommended intervention, the
specific intervention recommended did not work for them.
Alternatively, the member may indicate that while they enjoy
working out, they do not have time outside of their work and family
activities to engage in the recommended intervention. The measured
characteristics may also indicate that the recommended intervention
was followed. In this case, information may be obtained regarding
why the recommendation was followed.
[0419] The success characteristics may be used in several ways. In
one embodiment, analysis may be performed with the success
characteristics to establish a relationship capable of indicating
or predicting a members engagement of an intervention, or
willingness to engage in a particular intervention, or in any
intervention. For example, the health related information,
including the success characteristics, associated with members who
have been recommended a particular intervention, may be analyzed.
The analysis may result in a relationship that is able to establish
the likelihood a particular member will follow a particular
recommendation, based upon the specific health related information
associated with the member. In one embodiment, the success
characteristics may be used to establish a relationship capable of
indicating or predicting a particular member's engagement of any
recommendation, or willingness to engage in any intervention. In
one embodiment, the analysis may include establishing a
relationship capable of predicting a member's readiness to change
stage. That is, in one embodiment, readiness to change categories
may include a pre-contemplation, preparation, and action stages. If
a member is in a pre-contemplation stage, they may not be willing
to engage in any intervention. In the preparation stage, a member
may be willing to pursue a particular intervention, but not just
any intervention, or they may be willing to pursue interventions,
but have not started. In the action stage, the member may be ready
to take action in the appropriate intervention. By classifying a
member into a readiness to change category, interventions may be
further tailored for the individual member. For example, if a
member is in the pre-contemplation stage, then the selected
intervention may include additional counseling and/or educational
literature associated with the seriousness of the potential
condition, and the risk associated with this particular member of
acquiring the condition if no action is taken. In addition, the
intervention associated with the preparation category may include
customizing the proposed intervention to the interventions the
member is more likely to pursue. In this manner, self-efficacy and
readiness to change characteristics associated with a particular
intervention, may be analyzed with other self-efficacy and
readiness to change characteristics associated with other
interventions, and applied to the population as a whole where
appropriate. That is, some established self-efficacy and readiness
to change characteristics may be generalized (e.g., by creating a
predictive relationship) and applied to the whole population to
predict a particular members likelihood to engage in a particular
intervention, or an any intervention. The analysis may include
using statistical analysis (e.g., neural networks, regression
analysis, etc.) to establish a relationship that is able to predict
a members willingness or ability to pursue a particular
intervention. In this manner a relationship may be developed and
used in future instances such that when a member is predicted to
have an incidence of a condition, the recommended intervention may
be based upon indirect indicators of a members self-efficacy or
readiness to change, as well as direct indicators (e.g., specific
questions such as: are you willing to reduce your smoking).
[0420] For example, potential interventions may include an exercise
regimen, a dietary regimen or a medication, to reduce the risk of a
condition. The exercise regimen may indicate the highest success
rate if followed, the medication the lowest success rate if
followed. In addition, the member may provide strong direct
indications of self-efficacy and readiness to change
characteristics. However, the established participation predictive
relationship may indicate that members with similar health
characteristics (e.g., job requiring long hours, area of the
country not conducive to exercise during the winter, and number of
dependents in the family), that the member is not likely to follow
through on an exercise regiment (e.g., due to time constraints from
the job and family and inclement weather). However, based on the
other members, it may be predicted that this member is most likely
to follow through a dietary change. Therefore, the intervention may
be targeted to either changing the dietary habits of the
individual.
[0421] In addition, the analysis of the success characteristics and
associated health related characteristics may include establishing
a relationship able to indicate a potential success of a particular
intervention. For example, the success of an intervention may be
established by monitoring/analyzing the health related information
for an extended period of time. The health related information,
including characteristics indicative of the incidence of the health
condition may be monitored after the intervention is applied, and
compared to health related characteristics expected if the
intervention had not been applied (e.g., whether an incidence of
the health condition would occur, when it would occur, when the
stages of the incidence (if any) would occur. In addition, the
health related characteristics may be analyzed to determine if any
immediate changes in health care characteristics occurred. For
example, if the health condition is a heart attack, and one of the
pre-detectable characteristics associated with heart attacks is a
members consumption of high saturated fats, then one intervention
recommendation may be a dietary program. The health care
characteristics may be monitored to determine if the dietary
program was successful in reducing the members saturated fat
consumption, and/or whether the dietary program was successful in
eliminating or delaying the incidence of the health condition.
Therefore the success of the intervention may be monitored with
respect to eliminating or delaying the health condition, and/or
eliminating or reducing a cause associated with the health
condition. The results of the intervention monitoring and
associated health related characteristics may be used to further
refine the decision process regarding which intervention to
recommend.
[0422] The health related characteristics, including the success
characteristics, may be used to select one or more interventions
for a particular member at risk of a particular condition. In
addition, the health related characteristics may be used to
establish a relationship that associates one or more interventions
with particular health related characteristics and a health
condition. The success characteristics may indicate that
interventions have varying degrees of success based upon the health
related characteristics such as the physical characteristics of the
individual engaged in the intervention, the thoroughness of the use
of the intervention, the willingness of the person to pursue, etc.
For example, assume there are two potential interventions for a
health condition. Assume intervention 1, if followed 100%, is 90%
effective, and if followed 50% is 30% effective. In addition,
assume intervention 2, if followed 100% is 60% effective, and if
followed 50% is 45% effective. Depending on the health related
characteristics of a particular member, the best chance of
preventing or delaying the condition (or eliminating a cause of the
condition) may lie with pursuing intervention 2. For example, if
the self-efficacy characteristic, or readiness to change
characteristic is low, this may be an indication that the member
won't follow through completely with the recommendation. Therefore,
the second intervention may be pursued that may have a better
impact than the first intervention given that neither intervention
is used completely. Therefore, a relationship may be developed that
is able to predict the effectiveness of a particular intervention
in general, e.g., if the intervention is used X %, then it will be
Y % effective. This information may be used to make an intervention
recommendation to a member or, to engage in further correspondence
(interviews, follow-up questionnaires, etc.) with the member. For
example, the member may be notified of the preferred intervention,
but of the concerns that they are not going to fully engage the
intervention. If they don't fully engage the intervention then
there is an alternative intervention that is preferred. In
addition, a relationship may be established to predict the usage of
an intervention by a particular member, based upon the health
related characteristics of the member. The relationship may also be
able to predict the success of a particular intervention based on
the predicted use of a member (e.g., based on the members
self-efficacy, readiness to change, and or other health related
characteristics). In addition, interventions may have varying
success among different members, even if pursued to the same
degree. Therefore, the recommendations may be modified based on any
previous engagement by the member in an activity related to an
intervention. For example, health related characteristics
associated with the member and the activity the member engaged in
may be used to tailor the specific recommendation provided.
[0423] In one embodiment, the success characteristics associated
with a particular member may be used to further refine, or
establish, a recommended intervention for the member. In addition,
the success characteristics may be used to refine the analysis
(e.g., relationship) that correlates a member of a population with
a particular intervention, based on the health related
characteristics of the member.
[0424] A relationship is established between the health related
characteristics and a health condition. The type of analysis used
to establish the relationship is implementation dependant and may
vary as a function of the data available information being
requested (e.g., explain the similarities/dissimilarities of the
health related characteristics of members having the condition,
predict future incidences, or both). The analysis may be dependent
on the number of dependent variables (e.g., the health condition(s)
associated with data) and/or independent variables (e.g., health
related characteristics) that are being analyzed in the
relationship and/or the objective of the analysis being performed.
For example, the analysis may include the use of statistical
analysis techniques such as classical, Bayesian, and/or machine
learning techniques. Classical analysis techniques may include
multivariate statistical techniques simple regression, multiple
regression, factor analysis, item analysis multivariate analysis of
variance, discriminant analysis, path analysis, cluster analysis,
multidimensional scaling, rule induction, and/or least squares
estimation. In one embodiment, multiple regression may be used to
determine the relationship between one dependent variable (e.g.,
whether a person has diabetes) and multiple independent variables
(i.e., multiple other health related characteristics, such as
weight, gender, age, dietary habits, walking/running/exercise,
etc.). Other techniques, such as in factor analysis, cluster
analysis, and multivariate techniques may be used when the desired
relationship is associated with multiple dependent variables and
multiple independent variables. Generic model-fitting or
classification algorithms e.g., neural networks (e.g., back
propagation, feed-forward networks, etc.), meta-learning techniques
such as boost, etc., may be applied for predictive data mining.
Predictive data mining techniques may be desired when the accuracy
of a prediction is of higher priority, regardless of whether or not
the models or techniques used to generate the prediction is
interpretable or open to simple explanation. That is, data mining
techniques may be desired when the objective is to predict the
future occurrence of a health condition, as opposed to analyze the
existing relationship among the health related characteristics that
leads to the health condition. As mentioned, the selection of the
particular analysis technique(s) is implementation dependent and
may be based on factors such as user preference, the data to
analyze, and the number of dependent and/or independent variables,
the objectives of the analysis. Therefore, in one embodiment of the
present disclosure, the person analyzing the health of the
population may specify the analysis techniques to be used, or the
analysis system may automatically determine the appropriate
technique(s) to use.
[0425] In one embodiment, data analysis using deep neural network
techniques may be used to establish a predictive relationship
between the health related characteristics and one or more health
conditions. For example, the health related characteristics
associated with members known to have a particular health
condition, may be used to "train" the neural network. There are
several types of neural network models. The selection of which
model or combination to use may be implementation dependent, and
implementation accuracy may vary based on model used, data
analyzed, and desired objective of the model. In one embodiment,
the model used is a back propagation network. The back propagation
network may receive the health related characteristics associated
with the members known to have a particular health condition, along
with the characteristics of members known not to have the
characteristic. The resulting "trained" neural network may then be
able to receive the health related characteristics of a member to
predict whether they will acquire the health condition. In one
embodiment, the neural network output is a number (e.g., between
zero and one), that may be used to indicate that the member has a
determined likelihood of having an incidence of the condition
(e.g., 75%), if they do not already have it. As was discussed
above, the resulting likelihood of occurrence may be used to rank
the population in terms of likelihood of acquiring the condition.
This ranking may then be used to prioritize intervention
strategies.
[0426] In addition to establishing a likelihood of occurrence of
the health condition, the internal organization of the neural
network may be analyzed to determine which health related
characteristics where most relevant to the condition. For example,
a back propagation network includes multiple weighted
interconnections between the input factors and the output. The
weighted interconnections may be reviewed and correlated with the
input health related characteristics. In this manner, the
characteristics having more relevance (e.g., a higher weighting
value) may be identified. These relevant characteristics may then
be reviewed to establish the pre-detectable characteristics of
associated with the health condition. For example, the established
health related characteristics may already be pre-detectable
characteristics (e.g., the amount of salt consumed per day, the
amount of saturated fat consumed per day). However, if the
established health related characteristics are not pre-detectable
characteristics, then further analysis may be performed to break
the characteristics into the pre-detectable characteristics. For
example, if being overweight is established as a relevant health
related characteristic, then further analysis may be performed to
determine what pre-detectable characteristics lead to being
overweight, and which of these pre-detectable characteristics did
members being analyzed exhibit. In one embodiment, all of the
factors associated with being overweight may be treated as being
relevant. Alternatively, the potential pre-detectable
characteristics are used to further refine the relationship to
establish which of the pre-detectable characteristics plays a role
in being overweight, when overweight is a factor in having a
particular health condition, e.g., diabetes.
[0427] In one embodiment, if multiple regression is the analysis
technique used, an equation associated with the relationship may
be: Y=b1X1+b2.times.2+ . . . bnXn+c, where the b's are the
regression coefficients, representing the amount the dependent
variable Y (e.g., likelihood of contracting a health condition)
changes when the independent variable (the X's, e.g., the health
related characteristics) change 1 unit. The c is the constant,
where the regression line intercepts the y axis, representing the
amount the dependent variable Y will be when all the independent
variables are 0. In one embodiment, a determination may be made
regarding whether any transformation (e.g., log functions, square
roots, etc.) are needed to the proposed relationship (or equation).
For example, should the log of a health related characteristic be
used in the relationship, should the square root of a health
related characteristic be used in the relationship, etc. As will be
discussed, the form of the equation, e.g., whether one or more
transformations are used, may be determined by the user, by the
analysis system, or a combination thereof.
[0428] In one embodiment, different relationships may be created,
e.g., using different transformations or different health related
characteristics for the multiple regression analysis, and analyzed
to determine which relationships perform better than others.
Goodness of Fit analysis techniques such as R2, RMS, P Value, F
ratios, standard error, etc., may be used to establish performance
characteristics of the relationships. For example, techniques such
as R2, which establish the percent of variance in the dependent
variable (e.g., the part characteristic cost), explained
collectively by the independent variables (e.g. the other part
characteristics). By using R2, for example, an assessment may be
made regarding which relationship best explains the variance in the
dependent variable in response to the independent variables. RMS
provides an indication of which model best predicts future aspects
of a part, or part to be designed.
[0429] In one embodiment, a threshold level of desired performance
may be established for the relationship. If the relationship does
not meet the threshold level of desired performance, then the user
may be notified that the established relationship does not meet the
desired level of accuracy, the desired level of ability to explain
the variance in the dependent variable in response to the
independent variables, or desired level of ability to predict
future characteristics of the part. If multiple relationships are
being compared with each other, and none of them exceed the desired
level of success, then the user may be notified of which
relationship performed best, but that none of them met the desired
threshold. If multiple relationships are tested and one or more
exceed the threshold, the best one may be selected, or they may all
be provided to the user for selection.
[0430] One method for performing population health management
includes establishing a plurality of health related characteristics
associated with the population; establishing a relationship between
the health related characteristics and at least one health
condition; and analyzing at least a portion of said population in
response to said relationship. The system can predict a likelihood
of at least one of said members developing said at least one health
condition, in response to said relationship and/or the members
health related characteristics. The system can determine a
prevalence of a health condition within said population in response
to said health related characteristics. The plurality of health
related characteristics associated with said population can be done
by establishing a plurality of self-reported characteristics
associated with at least a portion of said population. A prevalence
of the health condition can be determined by: establishing a
plurality of claims associated with at least one os said members,
said claims including at least one of a drug claim and a medical
claim; cross checking said plurality of claims (such as over a
period of time, or over a number of tests); and establishing said
prevalence in response to said cross checked claims. The system
includes predicting a member's likelihood of developing a condition
with a stage of said condition in response to said prediction. The
system can predict a time period associated with said development.
The system can classify said population in response to said
prediction, and then prioritize treatment of the population in
response to said prediction.
[0431] The system can recommend an intervention in response to said
predicted likelihood of development. This can be done by
establishing a plurality of intervention recommendations associated
with said condition; establishing a success characteristics of said
recommended intervention; establishing at least one of a readiness
to change characteristic and a self-efficacy characteristic of said
member; and recommending said intervention in response to said
plurality of intervention recommendations, associated intervention
success characteristics, and member health related characteristics,
said health characteristics including said self-efficacy and said
readiness to change characteristic.
[0432] The system can monitor failure/successful characteristic of
said intervention, and determining causes resulting in said success
characteristic. The system can capture a plurality of self-reported
data associated with at least a portion of said population having
said condition. The self-reported data includes at least one of a
lifestyle characteristic, a family history characteristic, and a
health characteristic. The predictive relationship can be done by
establishing at least one objective of said relationship;
dynamically selecting a statistical analysis technique in response
to said objective; and establishing said relationship in response
to said statistical analysis technique. The predictive relationship
can be applied to at least a portion of said population; and
predicting a likelihood of developing said condition in response to
said application.
[0433] The system can be configured to analyze the health of a
population having multiple members. In one embodiment, the method
includes the steps of establishing a plurality of health related
characteristics associated with the population, the characteristics
including a plurality of pre-detectable characteristics,
establishing a relationship between the health related
characteristics and the health condition, and predicting an
incident of the health condition associated with at least one of
the members, in response to the relationship. The health condition
may be any type of physical or mental health condition, disease,
and/or ailment. For exemplary purposes the method and system will
be discussed as they may relate to the health condition diabetes. A
repository of health related characteristics associated with a
population may be collected. The health related characteristics may
be collected through sources such as medical claims, drug claims,
and self-reported information. The characteristics may include
health characteristics, lifestyle characteristics, and family
history characteristics. The characteristics may include the amount
of saturated fat, unsaturated fat, fiber, salt, alcohol,
cholesterol, etc. that a member consumes in a give time period. The
characteristics may include weight characteristic, such as a
member's weight, BMI (Body Mass Index), abdominal girth, etc. The
characteristics may also include the person's blood pressure,
standing heart rate, exercise habits (type and duration), and
whether the member has hypertension. The health related
characteristics of the population may be analyzed to establish the
prevalence of diabetes among the population. For example, a medical
claim having an ICD code with the prefix 250 is an indicator that
the member may have diabetes. In addition, drug claims having a
medication code descriptive of an anti-diabetes medication are
indicators that the member has diabetes. The medical and/or drug
claims are analyzed to determine if two claims indicating a member
may have diabetes, and that are separated by at least three months,
occur. If two claims meeting the criteria are identified, then the
member is determined to have diabetes. For example, if two separate
ICD codes occur, separated by at least three months, or one such
ICD code occurs and one drug code for anti diabetes medication
occur, e.g., separated by at least three months, then the member
may be determined to have diabetes.
[0434] Once the population has been analyzed to establish who has
diabetes, the historical health related characteristics of the
diabetics are then used to establish a relationship between
diabetes and the health related characteristics. For example, the
health related characteristics are used to establish a neural
network model, or regression model. The trained neural network
and/or regression model will then be able to predict the likelihood
a member of the population will acquire diabetes. In one
embodiment, the neural network will also be able to establish who
has, or may acquire, the related diabetic characteristics of
metabolic syndrome and or glucose intolerance. Alternatively, these
may be inputs to the neural network if available.
[0435] The established relationship may be reviewed to determine
what the pre-detectable characteristics associated with diabetes
are. For example, it may be determined that salt intake,
consumption of saturated fats, and alcohol consumption are three
leading pre-detectable characteristics of acquiring diabetes. In
addition, it may be determined that smoking is not a pre-detectable
characteristic associated with diabetes. The population may then be
reviewed using the established relationship. The health related
characteristics of each member of the population not known to have
diabetes may be analyzed using the relationship. The analysis may
indicate the likelihood the person will acquire diabetes (e.g., 75%
likely). In addition, the pre-detectable characteristics associated
with diabetes that are exhibited by the person may be identified.
In this manner, the likelihood of the acquiring diabetes may be
established along with what pre-detectable characteristics are the
primary contributors to this particular member having diabetes.
[0436] Once the population's health related characteristics are
analyzed, the population may be ranked by the individual member's
likelihood of acquiring diabetes. In this manner, the type of
intervention may be recommended based on the risk of acquiring
diabetes, and the pre-detectable characteristics the member
exhibits. In one embodiment, the interventions may be recommended
by using another relationship (or an elaboration of the predictive
relationship) to automatically make the recommendation based on the
health related characteristics of the member, which may include the
likelihood of acquiring diabetes and specific pre-detectable
characteristics exhibited, self-efficacy and readiness to change
characteristics of the member, etc. In one embodiment, the
intervention may include additional questionnaires or interviews to
acquire more specific information associated with diabetes from the
individual. Other forms of intervention include one on one
counseling to convince the member of the seriousness of diabetes,
the risk of acquiring diabetes associated with them, the ability to
delay or prevent the onset of diabetes by changing specified
lifestyle characteristics, and the specific actions the member may
take to modify specific aspects of their lifestyle associated with
the pre-detectable characteristics. For example, if dietary issues
are causing the member to be overweight, the intervention may
include, suggested changes to dietary consumption, cookbooks
directed towards the desired diet, or even corporate sponsored diet
counseling or involvement in a commercial diet control program. The
specific intervention recommended may be based on the likelihood of
acquiring diabetes the person has, the members willingness to
change their diet and belief that they will be successful in long
term dietary change, and how much of a factor dietary issues were
in establishing this particular members likelihood of acquiring
diabetes.
[0437] Once the intervention recommendation is provided additional
monitoring may occur to determine if the member followed through
with the recommendation (including why they did or didn't follow
through), whether the intervention helped reduce the targeted
characteristic (e.g., the targeted pre-detectable characteristic),
and when the intervention did reduce the targeted characteristics,
whether the ultimate occurrence of diabetes was either delayed
(which may be a subjective determination) or prevented altogether.
The results of this monitoring may then be used to update the
established relationships. In addition, as incidents of diabetes
occur, the health related characteristics of effected member may be
used to further refine the established predictive relationship. In
this manner, the health of the population may be analyzed and
managed relative to diabetes.
[0438] The system can receive data from electronic medical records
(EMRs), activity data from patient watches and wearable devices,
population demographic information from govt databases, consumer
profile information from credit card companies or consumer sales
companies, provider (doctor, dentist, caregiver) entered
information, one or more output registry databases. The EMRs may
span multiple applications, multiple providers, multiple patients,
multiple conditions, multiple venues, multiple facilities, multiple
organizations, and/or multiple communities. Embodiments of the EMRs
may include one or more data stores of healthcare records, which
may include one or more computers or servers that facilitate the
storing and retrieval of the healthcare records. In some
embodiments, one or more EMRs may be implemented as a cloud-based
platform or may be distributed across multiple physical locations.
Example embodiments of the EMRs may include hospital, ambulatory,
clinic, health exchange, and health plan records systems. The EMRs
may further include record systems, which store real-time or near
real-time patient (or user) information, such as wearable, bedside,
or in-home patient monitors, for example. It is further
contemplated that embodiments of the EMRs may use distinct clinical
ontologies, nomenclatures, vocabularies, or encoding schemes for
clinical information, or clinical terms. Further, in some
embodiments, the EMRs may be affiliated with two or more separate
health care entities and/or venues that use two or more distinct
nomenclatures.
[0439] In embodiments, the EMRs described herein may include
healthcare data. As used herein, healthcare data refers to any
healthcare or medical care data related or relevant to a patient.
Healthcare data may include, but is not limited to, clinical data
and healthcare-related financial data. Clinical data, as used
herein, refers to any healthcare or medical data particular to a
patient. In embodiments, clinical data can be medical care or
healthcare data resulting from or associated with a health or
medical service performed in association with a clinician in a
healthcare environment (e.g., lab test, diagnostic test, clinical
encounter, ecare, evisit, etc.). Clinical data may include, but is
not limited to, a health history of a patient, a diagnosis, a
clinician assessment, clinician narrative, a treatment, a family
history (including family health history and/or family genetics),
an immunization record, a medication, age, gender, date of birth,
laboratory values, diagnostics, a test result, an allergy, a
reaction, a procedure performed, a social history, an advanced
directive, frequency and/or history of healthcare facility visits,
current healthcare providers and/or current healthcare provider
location, preferred pharmacy, prescription benefit management data,
an alert, claims data, a vital, data traditionally captured at the
point of care or during the care process, a combination thereof,
and the like. In the same or alternative embodiments, the clinical
data may include medical compliance information. In certain
embodiments, medical compliance information refers to a level of
compliance of a particular patient with one or more prescribed
medical treatments, such as medications, diet, physical therapy,
follow up healthcare visits, and the like. In one or more
embodiments, the clinical data may include data obtained from the
natural language processing of one or more clinical assessments
and/or clinical narratives.
[0440] In certain embodiments, healthcare-related financial data
can refer to any financial information relevant to a patient, such
as insurance data, claims data, payer data, etc. Such healthcare
data (e.g., clinical data and healthcare-related financial data)
may be submitted by a patient, a care provider, a payer, etc. In
certain embodiments where the healthcare data is being submitted by
anyone other than the patient, the patient may be required to
approve of such submission and/or may opt-in to or opt-out of
having such healthcare data being submitted.
[0441] In embodiments, activity data can refer to health actions or
activities performed by a patient outside of, or remote from, a
healthcare environment. Embodiments of activity data may include
one or more data stores of activity data, which may include one or
more computers or servers that facilitate the storing and retrieval
of the activity data. In some embodiments, the activity data may be
implemented as a cloud-based platform or may be distributed across
multiple physical locations. Example embodiments of the activity
data may include nutrition information and/or exercise information
for a patient. In certain embodiments, at least a portion of the
activity data may be recorded utilizing a personal fitness tracker,
a smart phone, and/or an application provided by a smart phone. In
various embodiments, the activity data may include data obtained
from a patient's car. For example, in such embodiments, the
activity data include data on the amount of driving the patient
does versus the amount of walking the patient does.
[0442] In one or more embodiments, the activity data may be
submitted by a patient, a third party associated with a personal
fitness tracker and/or smart phone (such as a software developer or
device manufacturer), a care provider, a payer, etc. In certain
embodiments where the activity is being submitted by anyone other
than the patient, the patient may be required to approve of such
submission and/or may opt-in to or opt-out of having such
healthcare data being submitted.
[0443] The patient and/or population demographic information may
include age, gender, date of birth, address, phone number, contact
preferences, primary spoken language, technology access (e.g.,
internet, phone, computer, etc.), transportation (e.g., common
modes of transportation), education level, motivation level, work
status (student, full-time, retired, unemployed, etc.), and/or
income. In certain embodiments, the patient and/or population
demographic information may include community resource information,
which may include, but is not limited to, fitness facility
information, pharmacy information, food bank information, grocery
store information, public assistance programs, homeless shelters,
etc. In embodiments, the motivation level can include the level of
motivation a particular patient has for maintaining their health,
which may be derived from other information (e.g., data from
personal fitness tracker, indication the patient regularly visits a
clinician for check-ups, consumer profile information, etc.).
Embodiments of the patient and/or population demographic
information may include one or more data stores of demographic
information which may include one or more computers or servers that
facilitate the storing and retrieval of the demographic
information. In some embodiments, the patient and/or population
demographic information may be implemented as a cloud-based
platform or may be distributed across multiple physical locations.
In embodiments, the patient and/or population demographics may be
obtained through any source known to one skilled in the art. For
example, in certain embodiments, at least a portion of the patient
and/or population demographic information may be submitted by a
third party that relies on census data. In various embodiments, the
patient and/or population demographic information may be obtained
from more than one source. In one embodiment, the patient may
submit any or all of the patient and/or population demographic
information. In certain embodiments, all or a portion of the
patient and/or population demographic information may be anonymized
using techniques known to one skilled in the art.
[0444] In one or more embodiments, the consumer profile information
may include any or all of the spending habits of one or more
patients within a population. For instance, in certain embodiments,
the consumer profile information may include information associated
with grocery store purchases, athletic or exercise equipment
purchases, restaurant purchases, and/or purchases of vitamins
and/or supplements. Embodiments of the consumer profile information
may include one or more data stores of consumer profile information
which may include one or more computers or servers that facilitate
the storing and retrieval of the consumer profile information. In
some embodiments, the consumer profile information may be
implemented as a cloud-based platform or may be distributed across
multiple physical locations. In one embodiment, a patient may
provide the consumer profile information, for example, by linking
checking account and/or checking account purchase information to at
least a portion of the population health management system and/or
to a health insurance carrier.
[0445] The care provider information may include any information
relating to a particular care provider or healthcare facility. In
one embodiment, the care provider information may include
information relating to the number of healthcare providers and
their specialties at a particular care provider location. In the
same or alternative embodiments, the care provider information may
include information relating to non-personnel type resources at a
particular care provider location, such as the amount and types of
medications and/or the amount and types of surgical or other
medical equipment. In one embodiment, the care provider information
may include one or more of address and contact information,
accepted payer information, status on accepting new patients,
transactional systems, primary spoken language, hospital
affiliations, and/or care delivery models. In embodiments, the care
provider information may include information relating to the
availability of any or all resources at a particular healthcare
facility including personnel and/or non-personnel resources.
Embodiments of the care provider information may include one or
more data stores of care provider information which may include one
or more computers or servers that facilitate the storing and
retrieval of the care provider information. In some embodiments,
the care provider information may be implemented as a cloud-based
platform or may be distributed across multiple physical locations.
In one embodiment, the care provider information can be provided by
a healthcare provider, and/or a third party, such as an insurance
provider or management entity.
[0446] Information in the output registry databases may be
categorized or classified according to, for example, claims,
diagnoses, wellness, satisfaction, population directories, and the
like. In various embodiments, each output registry may be used by,
for example, a healthcare organization to manage the health of a
population segment. In one or more embodiments, each output
registry may be condition specific. By way of example, a healthcare
organization or clinician may manage diabetic patients within a
proscribed geographic area. The condition in this example is
diabetes mellitus and the output registry may help the healthcare
organization manage a population segment with this condition. The
output registry may, in one aspect, include identified patients
within a population segment who have this condition or have risk
factors that may lead to the development of diabetes, for example.
The output registry may further include grouped patients within an
identified segment by degree of severity or risk, such as those
grouped by the grouping component of the population health server.
The grouped patients in an output registry may facilitate the
generation of interventions or action workflows designed to reduce
disease severity or risk and to improve outcome. Additional uses
for the output registries are to measure outcomes related to
treatment interventions and also to attribute patients within the
identified segment to appropriate healthcare providers (e.g.,
primary care physicians, care managers health coaches, specialists
such as endocrinologists, podiatrists, and the like).
[0447] In embodiments, the plurality of EMRs may be associated with
a plurality of healthcare providers, a plurality of patients, a
plurality of medical conditions, a plurality of healthcare venues
and/or facilities, a plurality of organizations, and/or a plurality
of communities. In certain embodiments, in addition to or in place
of the healthcare data, the system can receive activity data from
fitness devices, demographic information, e.g., the patient and/or
population demographic information; consumer information, e.g., the
consumer profile information; and provider information, e.g., the
care provider information.
[0448] The system can identify a population of patients based on a
set of criteria, which may, in one example, be received from a
clinician device such as a blood pressure unit, among others. In
one or more embodiments, the set of criteria may include one or
more medical conditions. In the same or alternative embodiments,
the set of criteria may include demographic information of one or
more patients, such as age, gender, race, and/or location of
residence. In one or more embodiments, the system may utilize any
or all of the information and data such as: healthcare data, e.g.,
the healthcare data present in one or more EMRs; activity data;
demographic information, e.g., the patient and/or population
demographic information; consumer profile information; and care
provider information.
[0449] In certain embodiments, to identify as many people as
possible in a population that may have or have a particular medical
condition of interest, the system may utilize clinical data, such
as lab test results, in combination with other healthcare data. In
such embodiments, the particular medical condition can be any
condition where specific types of clinical information, e.g., lab
test results, may be used to identify one or more patients that
have or may have that condition. Exemplary conditions may include,
but are not limited to, diabetes and heart disease. For example, in
embodiments, the system may utilize diagnostic information,
medication information, and/or one or more lab test results to
identify a patient as having or potentially having diabetes. In
such embodiments, by using information from one or more lab test
results, the system may identify one or more patients that have
diabetes or may have diabetes, even if they have not been formally
diagnosed with diabetes or have not been prescribed diabetes
medication. In the same or alternative embodiments, the system may
utilize lab test results in combination with other healthcare data
to identify pre-condition patients, which may allow early
intervention to prevent a patient from developing a particular
condition.
[0450] In one or more embodiments, the system can identify subsets
of a population not based on a medical condition. For instance, in
such embodiments, the system can identify subsets of a population
based on aspects of one or more patients in a population of
patients, e.g., age, gender, primary spoken language, income level,
healthcare motivation level, education level, technology access
(e.g., phone, computer, etc.), contact preferences, work status
(student, full-time, unemployed, retired, etc.), healthcare
facility visit history and frequency, advanced directives, and/or
consumer profile information.
[0451] In various embodiments, the system can identify subsets of a
population based on non-medical aspects of patients, specific care
provider information, and/or population and/or community based
resources in order to enable actions and care planning, measure
compliance, improve care transitions, optimize utilization of
resources, and contain costs.
[0452] In one or more embodiments, the system can group a
population of patients based on a clinically relevant data from the
EMRs. For example, in embodiments, the clinical data may include
one or more of medication information, laboratory values,
diagnostics, clinical narratives, and clinician assessments. In the
same or alternative embodiments, the clinical data may include data
obtained from the natural language processing of one or more
clinical assessments and/or clinical narratives. In certain
embodiments, the system can group a population of patients based on
diagnostic codes, intervention codes, insurance claims, and/or
medication information associated with each patient. The system can
also group patients using substantially similar attributes can
include one or more of disease risk levels and/or scores, one or
more disease stages, and/or one or more healthcare objectives. For
example, in certain embodiments, the system can group a population
of patients, such as a population of patients identified as having
or potentially having diabetes, into at least two groups
corresponding to Type I and Type II diabetes.
[0453] The system can group based on venue location, specialty,
spoken language, readmission rate, medical and/or prescription
compliance level, socioeconomic status, address, employment status,
marital status, education level, age, sex, dependents, race,
ethnicity, insurance status, and primary spoken language,
associated healthcare support system, and/or utilization level of
healthcare facilities (including pharmacies). The grouping can
finely classify individual patients as having a low, medium, or
high medication compliance risk based on information related to the
ability to access a pharmacy, the ability to pay for medications,
and/or the presence of medication gaps in the healthcare record. In
other embodiments, individual patients may be grouped based on the
number of appointments made, the number of appointments scheduled,
the number of appointments attended, the number of missed
appointments, the type of appointment, the date and time of the
appointment, the visit location, the venue, and whether or not the
patient acknowledged the appointment (e.g., was the patient aware
of the appointment). The system can predict patients as having a
low, medium, or high level of compliance with filling prescriptions
based, at least in part, on the number of prescriptions written,
the number of prescriptions filled, and the date and time the
prescriptions were filled.
[0454] The information includes genetic data. The system can model
diseases as the result of multiple genetic mutations interacting
with environmental factors, diet and lifestyle choices, microbiome
differences and metabolic responses.
[0455] In one embodiment, the medical data includes sequenced body
fluid samples containing circulating tumor cells (CTCs) and
cell-free DNA (cfDNA). CTCs have an intact, viable nucleus; express
cytokeratins, which demonstrate epithelial origin; have an absence
of CD45, indicating the cell is not of hematopoietic origin; and
have morphology consistent with cancer, often larger cells with
irregularity cell or subcellular morphology. Cytokeratin negative
(CK-) CTCs are cancer stem cells or cells undergoing epithelial
mesenchymal transition (EMT). CK-CTCs may be the most resistant and
most prone to metastasis; express neither cytokeratins nor CD45;
have morphology similar to a cancer cell; and have gene or protein
expression or genomics associated with cancer. Apoptotic CTCs are
traditional CTCs that are undergoing apoptosis (cell death).
Measuring traditional CTC to apoptotic CTCs ratio from baseline to
therapy provides clues to a therapy's efficacy in targeting and
killing cancer cells. Small CTCs are cells that are cytokeratin
positive and CD45 negative but have a size and shape similar to
white blood cells. Importantly, small CTCs have cancer specific
biomarkers that identify them as CTCs. Small CTCs have been
implicated in progressive disease and differentiation into small
cell carcinomas which often require a different therapeutic course.
CTC Clusters are made up of two or more individual circulating
tumor cells bound together. The CTC cluster can be made up of
traditional, small or CK-CTCs. CTC clusters have cancer specific
biomarkers that identify them as CTCs and are associated with
increased metastatic risk and poor prognosis.
[0456] In another embodiment, the medical data is captured from
sequenced from microvesicles isolated from a sample taken of a
bodily fluid from a subject. As used herein, a "bodily fluid"
refers to a sample of fluid isolated from anywhere in the body of
the subject, preferably a peripheral location, including but not
limited to, for example, blood, plasma, serum, urine, sputum,
spinal fluid, pleural fluid, nipple aspirates, lymph fluid, fluid
of the respiratory, intestinal, and genitourinary tracts, tear
fluid, saliva, breast milk, fluid from the lymphatic system, semen,
cerebrospinal fluid, intra-organ system fluid, ascitic fluid,
bronchoalveolar lavage (BAL), cyst fluid, tumor cyst fluid,
amniotic fluid and combinations thereof. Preferably, the bodily
fluid is plasma, serum, cerebrospinal fluid, ascites fluid,
bronchoaveolar lavage, or cyst fluid. In some embodiments, it is
preferable that the bodily fluid sample is within the range of 2-20
ml. In some aspects, it may be preferable to use a larger volume of
sample for increased accuracy in detecting rare genetic mutations,
such as the BRAF mutation described herein. In some aspects, the
bodily fluid sample is within the range of 1 to 25 ml, for example,
from 2 to 25 ml, from 2 to 20 ml, from 2 to 15 ml, from 2 to 10 ml,
from 4 to 25 ml, from 4 to 20 ml, from 4 to 15 ml, from 4 to 10 ml,
from 6 to 25 ml, from 6 to 20 ml, from 6 to 15 ml, from 6 to 10 ml,
from 8 to 25 ml, from 8 to 20 ml, from 8 to 15 ml, from 10 to 25
ml, from 10 to 20 ml, from 10 to 15 ml, from 15 to 25 ml or from 15
to 20 ml.
[0457] Following the isolation of microvesicles from a biological
sample, nucleic acid may be extracted from the isolated or enriched
microvesicle fraction. Nucleic acid molecules can be isolated from
a microvesicle using any number of procedures, which are well-known
in the art, the particular isolation procedure chosen being
appropriate for the particular biological sample. The extracted
nucleic acids can be DNA and/or RNA. In some embodiments, the DNA
is extracted. In some embodiments, RNA is extracted. In some
embodiments, both DNA and RNA are extracted. The RNA can be
messenger RNA, transfer RNA, ribosomal RNA, small RNAs, non-coding
RNAs.
[0458] In one embodiment, the extracted nucleic acid is RNA. RNAs
are then preferably reverse-transcribed into complementary DNAs
before further amplification. Such reverse transcription may be
performed alone or in combination with an amplification step. One
example of a method combining reverse transcription and
amplification steps is reverse transcription polymerase chain
reaction (RT-PCR). The analysis of nucleic acids present in the
microvesicles is quantitative and/or qualitative. For quantitative
analysis, the amounts (expression levels), either relative or
absolute, of specific nucleic acids of interest within the
microvesicles are measured with methods known in the art (described
below). For qualitative analysis, the species of specific nucleic
acids of interest within the microvesicles, whether wild type or
variants, can be identified.
[0459] The system can capture comics data, including genomics,
transcriptomics, proteomics, and metabolomics data, to understand
the biology of an organism and its response to environmental
stimuli or genetic perturbation. Metabolome refers to the complete
set of small-molecule metabolites (such as metabolic intermediates,
hormones and other signaling molecules, and secondary metabolites)
found in a sample. Analytes in a metabolomic sample comprise highly
complex mixture. This complex mixture can be simplified prior to
detection by separating some analytes from others. For analysis by
mass spectrometry the analytes are transferred to the gas phase
using electron ionization (EI), chemical ionization (CI), or
electrospray ionization (ESI), among others. Identification
leverages the distinct patterns in which analytes fragment which
can be thought of as a mass spectral fingerprint; libraries exist
that allow identification of a metabolite according to this
fragmentation pattern. Alternatively, nuclear magnetic resonance
(NMR) spectroscopy does not rely on separation of the analytes, and
the sample can thus be recovered for further analyses.
[0460] Once metabolic composition is determined, data reduction
techniques can be used to elucidate patterns and connections. A
principal component analysis (PCA) can be used to efficiently
reduce the dimensions of a dataset to a few which explain the
greatest variation. When analyzed in the lower-dimensional PCA
space, clustering of samples with similar metabolic fingerprints
can be detected. This clustering can elucidate patterns and assist
in the determination of disease biomarkers--metabolites that
correlate most with class membership. Metabolic profiling
(especially of urine or blood plasma samples) detects the
physiological changes caused by toxic insult of a chemical (or
mixture of chemicals). In many cases, the observed changes can be
related to specific syndromes, e.g. a specific lesion in liver or
kidney. Metabolomics can be used for determining the phenotype
caused by a genetic manipulation, such as gene deletion or
insertion. Nutrigenomics is a generalised term which links
genomics, transcriptomics, proteomics and metabolomics to human
nutrition. In general a metabolome in a given body fluid is
influenced by endogenous factors such as age, sex, body composition
and genetics as well as underlying pathologies. Metabolomics can be
used to determine a biological endpoint, or metabolic fingerprint,
which reflects the balance of all these forces on an individual's
metabolism. The system can also be used to study environmental
metabolomics to characterize the interactions of organisms with
their environment.
[0461] In one embodiment, metabolites and immune cell function
correlating with exercise can be tracked. Blood draws and resting
echocardiogram are taken. The patient exercises on a treadmill for
approximately 15 minutes, followed by another echocardiogram. After
the exercise and echocardiograms, periodic blood draws are done
over the course of several hours. The metabolites with elevated
levels are correlated with echocardiogram, electrocardiogram, VO2
max testing, and vascular ultrasound evaluation to identify
metabolites associated with exercise and they are tracked over time
to predict the patient's fitness level.
[0462] The system can monitor disease (e.g. cancer) progression or
recurrence in a subject. These methods include isolating
microvesicles from a bodily fluid of an individual and analyzing
nucleic acid within the microvesicles to create a genetic profile
of the microvesicles. The presence/absence of a certain genetic
aberration/profile is used to indicate the presence/absence of the
disease (e.g. cancer) in the subject. For example, the process
includes detecting the presence or absence of one or more mutations
in the extracted DNA and RNA, and the presence of the one or more
mutations in the extracted DNA and RNA indicates the presence of a
disease or other medical condition in the subject or a higher
predisposition of the subject to develop a disease or other medical
condition.
[0463] The liquid biopsy process is performed periodically over
time, and the results reviewed, to monitor the progression or
regression of the disease, or to determine recurrence of the
disease. Put another way, a change in the genetic profile indicates
a change in the disease state in the subject. The period of time to
elapse between sampling of microvesicles from the subject, for
performance of the isolation and analysis of the microvesicle, will
depend upon the circumstances of the subject, and is to be
determined by the skilled practitioner. For example, a gene which
is targeted by the therapy can be monitored for the development of
mutations which make it resistant to the therapy, upon which time
the therapy can be modified accordingly. The monitored gene may
also be one which indicates specific responsiveness to a specific
therapy.
[0464] The data processed by the system of FIG. 11 is reflective of
a large population by including participants from diverse social,
racial/ethnic, and ancestral populations living in a variety of
geographies, social environments, and economic circumstances, and
from all age groups and health statuses. One embodiment applies
precision medicine treatment to many diseases, including common
diseases such as diabetes, heart disease, Alzheimer's, obesity, and
mental illnesses like depression, bipolar disorder, and
schizophrenia, as well as rare diseases. Importantly, the system
can focus on ways to increase an individual's chances of remaining
healthy throughout life.
[0465] In an implementation, social network information may be
maintained in a computer graph structure with nodes and edges such
that each node represents a user or an organization in the network
and each edge represents a known direct connection between two
nodes. A number of attributes described within social networks may
be stored in a database, associated with each user (also referred
to herein as nodes) and strength of influence (also referred to
herein as edges or distances). In some embodiments, the engine may
be further configured to determine distances to one or more of the
patient members closest to a current patient's biological data with
a diameter of at least one grouping and to indicate that the new
patient is associated with the grouping based on the comparison. In
various embodiments, the engine is further configured to determine
if the distance to one or more of the patient members closest to
the new patient's filtered biological data is greater than a
diameter of each grouping and to indicate that the new patient is
not associated with each grouping based on the comparison. The
medical characteristic may comprise a clinical outcome.
[0466] In one implementation, nodes may comprise attributes that
include but are not limited to: a unique identifier assigned such
as a user's name, address and/or other items of information; unique
identifiers for the node in each external social network containing
the node, statistical summaries of the node's network, and pointers
to the user's medical data. In an implementation, edges of the
social network may comprise attributes that include but are not
limited to the unique identifiers of the two nodes that are
connected by the edge, the source of the node's information (i.e.
the external social network), the assigned social influence from
the first node to the second node, and the assigned social
influence from the second node to the first node, and statistical
summaries of the edge's contribution to the network.
[0467] The above mentioned examples are not intended to be
limiting, and it is intended that any medical data is included
within the scope of this disclosure. In an implementation, a user
may be able to designate which health provider sites or medical
sites that may be desirable to obtain information from, or the
sites may be automatically selected. The social health content may
be presented to the user or alternatively to a health professional
for assessment. For example, a user may be presented with a list of
all of her medical connections from her health history sites. In
such an example the user may wish to select all of the available
connections, or may wish to limit the selection to only a certain
number of connections. A user may be asked to assign a strength of
influence (for example, a numerical value) for each of the
connections received from the social networks. In an
implementation, the method will receive user influence information
(data) by asking the user to assign a strength of influence for a
connection that represents the user's similarity to another user.
Likewise, the method will receive user influence information (data)
by asking the user to assign a strength of influence for a
connection that represents the medical influence that any other
user may have over the user herself. The strength of influence
information may be recorded into memory as an influence metric.
Influence metrics may be discussed in the terms of distance, even
though an actual distance may not exist between the points of
social data used in the method. A list of recommendations may be
created for the user base on his medical neighborhood and the
behavior of others within the health/medical neighborhood. For
example, if influential patients of the neighborhood are using and
talking about certain medication or treatment modalities, it is
likely that the user may desire to apply the same
medication/treatment. As such, a timely recommendation from a
research would prove beneficial to both the treating professional
and the patient/user.
[0468] Exemplary systems and methods for disease management are
provided. In various embodiments, a method comprises identifying
similar patient clusters, generating groups and interconnections of
the groups, each group having one or more members that share
medical similarities, each interconnection interconnecting
groupings that share at least one common member, determining
whether a new member shares medical similarities with the one or
more members of each group and associating the new member with one
or more groups. The similarities may represent similarities of
measurements of gene expressions or similarities of sequencing.
[0469] In one embodiment, the system includes cluster the data
based on a metric, and display the groupings and the
interconnections based on the clusters. The filtering function may
be a density estimation function. The metric may be a Pearson
correlation.
[0470] Additionally, the system can monitor biomarkers for
individual diseases such as high blood pressure or diabetes. A
biomarker is "a characteristic that is objectively measured and
evaluated as an indicator of normal biological processes,
pathogenic processes, or pharmacologic responses to a therapeutic
intervention." A biomarker may be measured on a biosample (as a
blood, urine, or tissue test), it may be a recording obtained from
a person (blood pressure, ECG, or Holter), or it may be an imaging
test (echocardiogram or CT scan). Biomarkers can indicate a variety
of health or disease characteristics, including the level or type
of exposure to an environmental factor, genetic susceptibility,
genetic responses to exposures, markers of subclinical or clinical
disease, or indicators of response to therapy. Thus, a simplistic
way to think of biomarkers is as indicators of disease trait (risk
factor or risk marker), disease state (preclinical or clinical), or
disease rate (progression).16 Accordingly, biomarkers can be
classified as antecedent biomarkers (identifying the risk of
developing an illness), screening biomarkers (screening for
subclinical disease), diagnostic biomarkers (recognizing overt
disease), staging biomarkers (categorizing disease severity), or
prognostic biomarkers (predicting future disease course, including
recurrence and response to therapy, and monitoring efficacy of
therapy). In one embodiment, blood testing is done to determine
different components of the immune system as well as lipids and
glucose metabolism. An ultrasound image is created by placing a
transducer which sends sound waves and receives reflections from
inside the body. Those reflections are computerized to recreate a
picture of the arteries of the neck. The thickness of the carotid
artery called intima-media thickness is a reflection of early
cholesterol build-up in the carotid arteries. The ultrasound of the
femoral arteries is also done to measure arterial stiffness, a good
measure of vascular health. Ultrasound of the abdominal aorta is
used to screen for abdominal aortic aneurysms.
[0471] The endothelium is the inner lining of blood vessels. The
endothelium regulates blood flow and maintains vessel health.
Several studies have shown that endothelial dysfunction is a risk
factor for cardiovascular disease. Peripheral arterial tonometry is
a method to assess endothelial function using a device positioned
at the fingertips and a blood pressure cuff (response after
deflation of the blood pressure cuff).
[0472] An echocardiogram is a diagnostic test which generates
images of the heart by bouncing high frequency sound off the
structures of the heart and recording the returned echoes and
processing them into images. The sound is transmitted and received
with a transducer placed upon the chest.
[0473] For example, biomarkers for use in distinguishing, or aiding
in distinguishing, atherosclerotic subjects from
non-atherosclerotic subjects include 3-methylhistidine, p-cresol
sulfate, mannose, glucose, and/or gluconate, and combinations
thereof. In one aspect biomarkers for use in methods relating to
atherosclerosis using plasma samples from a subject include one or
more of 3-methylhistidine, p-cresol sulfate, mannose, glucose,
gluconate, among others. In one embodiment, cardiovascular disease
(CVD) biomarkers are processed by the system. For example, CVD
related biomarkers can be tracked such as ADMA, asymmetrical
dimethyl arginine; Apo B, apolipoprotein B; CETP, cholesterol ester
transfer protein; GPX1, glutathione peroxidase; IL, interleukin;
IMT, intimal-medial thickness; Lp(a), lipoprotein a; LpPLA2,
lipoprotein-associated phospholipase A2; LV, left ventricle; LVH,
LV hypertrophy; MMP, matrix metalloproteinase; MPO,
myeloperoxidase; SAA, serum amyloid A; sCD40L, soluble CD40 ligand;
sICAM, soluble intercellular adhesion molecule; PAI-1, plasminogen
activator inhibitor 1; PET, positron emission tomography; TIMP,
tissue inhibitor of matrix metalloproteinases; and TPA, tissue
plasminogen activator.
[0474] Generally, people with type 1 diabetes present with acute
symptoms of diabetes and markedly elevated blood glucose levels.
Because of the acute onset of symptoms, most cases of type 1
diabetes are detected soon after symptoms develop. Type 2 diabetes
is frequently not diagnosed until complications appear, and
approximately one-third of all people with diabetes may be
undiagnosed. Individuals at high risk should be screened for
diabetes and pre-diabetes. In one embodiment, the system analyzes
clinical risk models that include individuals who are overweight
(BMI.gtoreq.25 kg/m2*) and have additional risk factors including:
are habitually physically inactive, have a first-degree relative
with diabetes, are members of a high-risk ethnic population (e.g.,
African American, Latino, Native American, Asian American, Pacific
Islander), have delivered a baby weighing.gtoreq.9 lb or have been
diagnosed with GDM, are hypertensive (.gtoreq.140/90 mmHg), have an
HDL cholesterol level<35 mg/dl (0.90 mmol/1) and/or a
triglyceride level>250 mg/dl (2.82 mmol/1), have PCOS, on
previous testing, had IGT or IFG, have other clinical conditions
associated with insulin resistance (e.g., PCOS or acanthosis
nigricans), have a history of vascular disease.
[0475] The system can monitor urinary protein associated with
diabetes mellitus. They include defense proteins
(.alpha.1-antitrypsin, Complement factor H, C3, B, I, C7, 9),
Alpha-1-antichymotrypsin precursor, Antithrombin-III,
Alpha-2-glycoprotein 1, zinc, Ig gama 1 chain C region, Alpha and
beta-2-microglobulin, Alpha-2-antiplasmin precursor, Vitronectin
precursor); Transport (Serotransferrin precursor, Ceruloplasmin
precursor, Hemopexin, AMBP protein, Albumin, Haptoglobin precursor,
Transthyretin precursor, VDBP); Metabolism (ApoA-1, ApoA-II
precursor, Apo-D, Alpha-1B-glycoprotein, Beta-2-glycoprotein 1
precursor, Prostaglandin H2 D-isomerase precursor,
Alpha-2-HS-glycoprotein precursor, E-cadherin, Dystroglycan
precursor, Fibrinogen beta chain precursor); Signal transduction
(Kininogen precursor, B-factor, properdin, Clusterin,
Angiotensinogen, Sulfated glycoprotein 2, retinol-binding protein
4, Epidermal growth factor) and cell development protein such as
Lumican precursor. [0476] The system can track proteins in human
serum of patients having diabetes mellitus such as: [0477]
Cytokines and cytokine-related proteins Leptin, TNF-alpha, IL-6
[0478] Immune-related proteins MCP-1 [0479] Proteins involved in
fibrinolytic system PAI-1 [0480] Tissue factor
[0481] Complement and complement-related proteins Adipsin
(complement factor D), ASP, Adiponectin Lipids and proteins for
lipid metabolism or transport Lipoprotein lipase (LPL),
Apolipoprotein E, Apolipoprotein A1, Apolipoprotein A2,
Apolipoprotein B+, Apolipoprotein H, Apolipoprotein C1, C2, NEFAs,
Cholesterol ester transferase protein (CETP),
[0482] Inflammatory proteins C-reactive protein (CRP),
.alpha.-tumor necrosis factor (.alpha.TNF)
[0483] Individuals at high risk for developing diabetes are made
aware of the many benefits of modest weight loss and participating
in regular physical activity. The system can generate
recommendations and track patient compliance. Follow-up counseling
is important for success and a coach can be assigned to help the
patient. Monitoring for the development of diabetes in those with
pre-diabetes is performed regularly using mobile fitness devices.
The system can also recommend appropriate treatment given for,
other CVD risk factors (e.g., tobacco use, hypertension,
dyslipidemia). Because of possible side effects and cost, there is
insufficient evidence to support the use of drug therapy. An
intensive lifestyle modification program has been shown to be very
effective (.about.58% reduction after 3 years). Use of the
pharmacologic agents metformin, acarbose, orlistat, and
rosiglitazone has also been shown to decrease incident diabetes to
various degrees. Of note, however, each of these drugs may cause
side effects of varying severity in a small number of
individuals.
[0484] Physical activity and behavior modification are important
components of weight loss programs and are most helpful in
maintenance of weight loss. Thus, lifestyle change should be the
primary approach to weight loss. The system recommends and monitors
structured programs that emphasize lifestyle changes, including
education, reduced energy and fat (.about.30% of total energy)
intake, regular physical activity, and regular participant contact
to achieve produce long-term weight loss on the order of 5-7% of
starting weight. Saturated fat intake should be <7% of total
calories. Intake of trans fat should be minimized. The system
monitors carbohydrate, whether by carbohydrate counting, exchanges,
camera detection or experience-based estimation, for glycemic
control.
[0485] The methods and systems as disclosed herein may comprise, or
comprise the use of, predicting, diagnosing, and/or prognosing a
status or outcome of a disease or condition in a subject based on
one or more biomedical outputs. Predicting, diagnosing, and/or
prognosing a status or outcome of a disease in a subject may
comprise diagnosing a disease or condition, identifying a disease
or condition, determining the stage of a disease or condition,
assessing the risk of a disease or condition, assessing the risk of
disease recurrence, assessing reproductive risk, assessing genetic
risk to a fetus, assessing the efficacy of a drug, assessing risk
of an adverse drug reaction, predicting optimal drug dosage,
predicting drug resistance, or a combination thereof.
[0486] The samples disclosed herein may be from a subject suffering
from a cancer. The sample may comprise malignant tissue, benign
tissue, or a mixture thereof. The cancer may be a recurrent and/or
refractory cancer. Examples of cancers include, but are not limited
to, sarcomas, carcinomas, lymphomas or leukemias.
[0487] Additional diseases and/or conditions include, but are not
limited to, atherosclerosis, inflammatory diseases, autoimmune
diseases, rheumatic heart disease. Examples of inflammatory
diseases include, but are not limited to, acne vulgaris,
Alzheimer's, ankylosing spondylitis, arthritis (osteoarthritis,
rheumatoid arthritis (RA), psoriatic arthritis), asthma,
atherosclerosis, celiac disease, chronic prostatitis, Crohn's
disease, colitis, dermatitis, diverticulitis, fibromyalgia,
glomerulonephritis, hepatitis, irritable bowel syndrome (IBS),
systemic lupus erythematous (SLE), nephritis, Parkinson's disease,
pelvic inflammatory disease, sarcoidosis, ulcerative colitis, and
vasculitis.
[0488] Examples of autoimmune diseases include, but are not limited
to, acute disseminated encephalomyelitis (ADEM), Addison's disease,
agammaglobulinemia, alopecia greata, amyotrophic Lateral Sclerosis,
ankylosing spondylitis, antiphospholipid syndrome, antisynthetase
syndrome, atopic allergy, atopic dermatitis, autoimmune aplastic
anemia, autoimmune cardiomyopathy, autoimmune enteropathy,
autoimmune hemolytic anemia, autoimmune hepatitis, autoimmune inner
ear disease, autoimmune lymphoproliferative syndrome, autoimmune
peripheral neuropathy, autoimmune pancreatitis, autoimmune
polyendocrine syndrome, autoimmune progesterone dermatitis,
autoimmune thrombocytopenic purpura, autoimmune urticaria,
autoimmune uveitis, Balo disease/Balo concentric sclerosis,
Behcet's disease, Berger's disease, Bickerstaffs encephalitis, Blau
syndrome, bullous pemphigoid, Castleman's disease, celiac disease,
Chagas disease, chronic inflammatory demyelinating polyneuropathy,
chronic recurrent multifocal osteomyelitis, chronic obstructive
pulmonary disease, Churg-Strauss syndrome, cicatricial pemphigoid,
Cogan syndrome, cold agglutinin disease, complement component 2
deficiency, contact dermatitis, cranial arteritis, CREST syndrome,
Crohn's disease, Cushing's syndrome, cutaneous leukocytoclastic
angiitis, Dego's diseasevDercum's disease, dermatitis
herpetiformis, dermatomyositis, diabetes mellitus type 1, diffuse
cutaneous systemic sclerosis, Dressler's syndrome, drug-induced
lupus, discoid lupus erythematosus, eczema, endometriosis,
enthesitis-related arthritis, eosinophilic fasciitis, eosinophilic
gastroenteritisvepidermolysis bullosa acquisita, erythema nodosum,
erythroblastosis fetalis, essential mixed cryoglobulinemia, Evan's
syndrome, fibrodysplasia ossificans progressiva, fibrosing
alveolitis (or idiopathic pulmonary fibrosis), gastritis,
gastrointestinal pemphigoid, giant cell arteritis,
glomerulonephritis, Goodpasture's syndrome, Graves' disease,
Guillain-Barre syndrome (GBS), Hashimoto's encephalopathy,
Hashimoto's thyroiditisvHenoch-Schonlein purpuravherpes gestationis
aka gestational pemphigoid, hidradenitis suppurativa, Hughes-Stovin
syndrome, hypogammaglobulinemia, idiopathic inflammatory
demyelinating diseases, idiopathic pulmonary fibrosis, IgA
nephropathy, inclusion body myositis, chronic inflammatory
demyelinating polyneuropathyvinterstitial cystitis, juvenile
idiopathic arthritis aka juvenile rheumatoid arthritis, Kawasaki's
disease, Lambert-Eaton myasthenic syndrome, leukocytoclastic
vasculitis, Lichen planus, Lichen sclerosus, linear IgA disease
(LAD), Lou Gehrig's disease (Also Amyotrophic lateral sclerosis),
lupoid hepatitis aka autoimmune hepatitis, lupus erythematosus,
Majeed syndrome, Meniere's disease, microscopic polyangiitis, mixed
connective tissue disease, morphea, Mucha-Habermann disease,
multiple sclerosis, myasthenia gravis, myositis, neuromyelitis
optica (also Devic's disease), neuromyotonia, occular cicatricial
pemphigoid, opsoclonus myoclonus syndrome, Ord's thyroiditis,
palindromic rheumatism, PANDAS (pediatric autoimmune
neuropsychiatric disorders associated with streptococcus),
paraneoplastic cerebellar degeneration, paroxysmal nocturnal
hemoglobinuria (PNH), Parry Romberg syndrome, Parsonage-Turner
syndrome, Pars planitis, pemphigus vulgaris, pernicious anaemia,
perivenous encephalomyelitis, POEMS syndrome, polyarteritis nodosa,
polymyalgia rheumatica, polymyositis, primary biliary cirrhosis,
primary sclerosing cholangitis, progressive inflammatory
neuropathy, psoriasis, psoriatic arthritis, pyoderma gangrenosum,
pure red cell aplasia, Rasmussen's encephalitis, Raynaud
phenomenon, relapsing polychondritis, Reiter's syndrome, restless
leg syndrome, retroperitoneal fibrosis, rheumatoid arthritis,
rheumatic fever, sarcoidosis, Schmidt syndrome another form of APS,
Schnitzler syndrome, scleritis, scleroderma, serum sickness,
Sjogren's syndrome, spondyloarthropathy, Stiff person syndrome,
subacute bacterial endocarditis (SBE), Susac's syndrome, Sweet's
syndrome, sympathetic ophthalmia, Takayasu's arteritis, temporal
arteritis (also known as "giant cell arteritis"), thrombocytopenia,
Tolosa-Hunt syndrome, transverse myelitis, ulcerative colitis,
undifferentiated connective tissue disease different from mixed
connective tissue disease, undifferentiated spondyloarthropathy,
urticarial vasculitis, vasculitis, vitiligo, and Wegener's
granulomatosis.
[0489] The methods and systems as provided herein may also be
useful for detecting, monitoring, diagnosing and/or predicting a
subject's response to an implanted device. Exemplary medical
devices include but are not limited to stents, replacement heart
valves, implanted cerebella stimulators, hip replacement joints,
breast implants, and knee implants.
[0490] The methods and systems as disclosed herein may be used for
monitoring the health of a fetus using whole or partial genome
analysis of nucleic acids derived from a fetus, as compared to the
maternal genome. For example, nucleic acids can be useful in
pregnant subjects for fetal diagnostics, with fetal nucleic acids
serving as a marker for gender, rhesus D status, fetal aneuploidy,
and sex-linked disorders. The methods and systems as disclosed
herein may identify fetal mutations or genetic abnormalities. The
methods and systems as disclosed herein can enable detection of
extra or missing chromosomes, particularly those typically
associated with birth defects or miscarriage. The methods and
systems as disclosed herein may comprise, or comprise the use of,
the diagnosis, prediction or monitoring of autosomal trisomies
(e.g., Trisomy 13, 15, 16, 18, 21, or 22) and may be based on the
detection of foreign molecules. The trisomy may be associated with
an increased chance of miscarriage (e.g., Trisomy 15, 16, or 22).
Alternatively, the trisomy that is detected is a liveborn trisomy
that may indicate that an infant may be born with birth defects
(e.g., Trisomy 13 (Patau Syndrome), Trisomy 18 (Edwards Syndrome),
and Trisomy 21 (Down Syndrome)). The abnormality may also be of a
sex chromosome (e.g., XXY (Klinefelter's Syndrome), XYY (Jacobs
Syndrome), or XXX (Trisomy X). The methods disclosed herein may
comprise one or more genomic regions on the following chromosomes:
13, 18, 21, X, or Y. For example, the foreign molecule may be on
chromosome 21 and/or on chromosome 18, and/or on chromosome 13. The
one or more genomic regions may comprise multiple sites on multiple
chromosomes.
[0491] Further fetal conditions that can be determined based on the
methods and systems herein include monosomy of one or more
chromosomes (X chromosome monosomy, also known as Turner's
syndrome), trisomy of one or more chromosomes (13, 18, 21, and X),
tetrasomy and pentasomy of one or more chromosomes (which in humans
is most commonly observed in the sex chromosomes, e.g., XXXX, XXYY,
XXXY, XYYY, XXXXX, XXXXY, XXXYY, XYYYY and XXYYY), monoploidy,
triploidy (three of every chromosome, e.g., 69 chromosomes in
humans), tetraploidy (four of every chromosome, e.g., 92
chromosomes in humans), pentaploidy and multiploidy.
[0492] The methods and systems as disclosed may comprise detecting,
monitoring, quantitating, or evaluating one or more
pathogen-derived nucleic acid molecules or one or more diseases or
conditions caused by one or more pathogens. Exemplary pathogens
include, but are not limited to, Bordetella, Borrelia, Brucella,
Campylobacter, Chlamydia, Chlamydophila, Clostridium,
Corynebacterium, Enterococcus, Escherichia, Francisella,
Haemophilus, Helicobacter, Legionella, Leptospira, Listeria,
Mycobacterium, Mycoplasma, Neisseria, Pseudomonas, Rickettsia,
Salmonella, Shigella, Staphylococcus, Streptococcus, Treponema,
Vibrio, or Yersinia. Additional pathogens include, but are not
limited to, Mycobacterium tuberculosis, Streptococcus, Pseudomonas,
Shigella, Campylobacter, and Salmonella.
[0493] The disease or conditions caused by one or more pathogens
may comprise tuberculosis, pneumonia, foodborne illnesses, tetanus,
typhoid fever, diphtheria, syphilis, leprosy, bacterial vaginosis,
bacterial meningitis, bacterial pneumonia, a urinary tract
infection, bacterial gastroenteritis, and bacterial skin infection.
Examples of bacterial skin infections include, but are not limited
to, impetigo which may be caused by Staphylococcus aureus or
Streptococcus pyogenes; erysipelas which may be caused by a
streptococcus bacterial infection of the deep epidermis with
lymphatic spread; and cellulitis which may be caused by normal skin
flora or by exogenous bacteria.
[0494] The pathogen may be a fungus, such as, Candida, Aspergillus,
Cryptococcus, Histoplasma, Pneumocystis, and Stachybotrys. Examples
of diseases or conditions caused by a fungus include, but are not
limited to, jock itch, yeast infection, ringworm, and athlete's
foot.
[0495] The pathogen may be a virus. Examples of viruses include,
but are not limited to, adenovirus, coxsackievirus, Epstein-Barr
virus, Hepatitis virus (e.g., Hepatitis A, B, and C), herpes
simplex virus (type 1 and 2), cytomegalovirus, herpes virus, HIV,
influenza virus, measles virus, mumps virus, papillomavirus,
parainfluenza virus, poliovirus, respiratory syncytial virus,
rubella virus, and varicella-zoster virus. Examples of diseases or
conditions caused by viruses include, but are not limited to, cold,
flu, hepatitis, AIDS, chicken pox, rubella, mumps, measles, warts,
and poliomyelitis.
[0496] The pathogen may be a protozoan, such as Acanthamoeba (e.g.,
A. astronyxis, A. castellanii, A. culbertsoni, A. hatchetti, A.
polyphaga, A. rhysodes, A. healyi, A. divionensis), Brachiola
(e.g., B connori, B. vesicularum), Cryptosporidium (e.g., C.
parvum), Cyclospora (e.g., C. cayetanensis), Encephalitozoon (e.g.,
E. cuniculi, E. hellem, E. intestinalis), Entamoeba (e.g., E.
histolytica), Enterocytozoon (e.g., E. bieneusi), Giardia (e.g., G.
lamblia), Isospora (e.g, I. belli), Microsporidium (e.g., M.
africanum, M. ceylonensis), Naegleria (e.g., N. fowleri), Nosema
(e.g., N. algerae, N. ocularum), Pleistophora, Trachipleistophora
(e.g., T. anthropophthera, T. hominis), and Vittaforma (e.g., V.
corneae).
[0497] The methods and systems as disclosed herein may comprise, or
comprise the use of, treating and/or preventing a disease or
condition in a subject based on one or more biomedical outputs. The
one or more biomedical outputs may recommend one or more therapies.
The one or more biomedical outputs may suggest, select, designate,
recommend or otherwise determine a course of treatment and/or
prevention of a disease or condition. The one or more biomedical
outputs may recommend modifying or continuing one or more
therapies. Modifying one or more therapies may comprise
administering, initiating, reducing, increasing, and/or terminating
one or more therapies. The one or more therapies comprise an
anti-cancer, antiviral, antibacterial, antifungal,
immunosuppressive therapy, or a combination thereof. The one or
more therapies may treat, alleviate, or prevent one or more
diseases or indications.
[0498] Examples of anti-cancer therapies include, but are not
limited to, surgery, chemotherapy, radiation therapy,
immunotherapy/biological therapy, photodynamic therapy. Anti-cancer
therapies may comprise chemotherapeutics, monoclonal antibodies
(e.g., rituximab, trastuzumab), cancer vaccines (e.g., therapeutic
vaccines, prophylactic vaccines), gene therapy, or combination
thereof.
[0499] The one or more therapies may comprise an antimicrobial.
Generally, an antimicrobial refers to a substance that kills or
inhibits the growth of microorganisms such as bacteria, fungi,
virus, or protozoans. Antimicrobial drugs either kill microbes
(microbicidal) or prevent the growth of microbes (microbiostatic).
There are mainly two classes of antimicrobial drugs, those obtained
from natural sources (e.g., antibiotics, protein synthesis
inhibitors (such as aminoglycosides, macrolides, tetracyclines,
chloramphenicol, polypeptides)) and synthetic agents (e.g.,
sulphonamides, cotrimoxazole, quinolones). In some instances, the
antimicrobial drug is an antibiotic, anti-viral, anti-fungal,
anti-malarial, anti-tuberculosis drug, anti-leprotic, or
anti-protozoal.
[0500] Antibiotics are generally used to treat bacterial
infections. Antibiotics may be divided into two categories:
bactericidal antibiotics and bacteriostatic antibiotics. Generally,
bactericidals may kill bacteria directly where bacteriostatics may
prevent them from dividing. Antibiotics may be derived from living
organisms or may include synthetic antimicrobials, such as the
sulfonamides. Antibiotics may include aminoglycosides, such as
amikacin, gentamicin, kanamycin, neomycin, netilmicin, tobramycin,
and paromomycin. Alternatively, antibiotics may be ansamycins
(e.g., geldanamycin, herbimycin), cabacephems (e.g., loracarbef),
carbapenems (e.g., ertapenem, doripenem, imipenem, cilastatin,
meropenem), glycopeptides (e.g., teicoplanin, vancomycin,
telavancin), lincosamides (e g, clindamycin, lincomycin,
daptomycin), macrolides (e.g., azithromycin, clarithromycin,
dirithromycin, erythromycin, roxithromycin, troleandomycin,
telithromycin, spectinomycin, spiramycin), nitrofurans (e.g.,
furazolidone, nitrofurantoin), and polypeptides (e.g., bacitracin,
colistin, polymyxin B).
[0501] In some instances, the antibiotic therapy includes
cephalosporins such as cefadroxil, cefazolin, cefalotin, cefalexin,
cefaclor, cefamandole, cefoxitin, cefprozil, cefuroxime, cefixime,
cefdinir, cefditoren, cefoperazone, cefotaxime, cefpodoxime,
ceftazidime, ceftibuten, ceftizoxime, ceftriaxone, cefepime,
ceftaroline fosamil, and ceftobiprole.
[0502] The antibiotic therapy may also include penicillins.
Examples of penicillins include amoxicillin, ampicillin,
azlocillin, carbenicillin, cloxacillin, dicloxacillin,
flucloxacillin, mezlocillin, methicillin, nafcillin, oxacillin,
penicillin g, penicillin v, piperacillin, temocillin, and
ticarcillin.
[0503] Alternatively, quinolines may be used to treat a bacterial
infection. Examples of quinilones include ciprofloxacin, enoxacin,
gatifloxacin, levofloxacin, lomefloxacin, moxifloxacin, nalidixic
acid, norfloxacin, ofloxacin, trovafloxacin, grepafloxacin,
sparfloxacin, and temafloxacin.
[0504] In some instances, the antibiotic therapy comprises a
combination of two or more therapies. For example, amoxicillin and
clavulanate, ampicillin and sulbactam, piperacillin and tazobactam,
or ticarcillin and clavulanate may be used to treat a bacterial
infection.
[0505] Sulfonamides may also be used to treat bacterial infections.
Examples of sulfonamides include, but are not limited to, mafenide,
sulfonamidochrysoidine, sulfacetamide, sulfadiazine, silver
sulfadiazine, sulfamethizole, sulfamethoxazole, sulfanilimide,
sulfasalazine, sulfisoxazole, trimethoprim, and
trimethoprim-sulfamethoxazole (co-trimoxazole) (tmp-smx).
[0506] Tetracyclines are another example of antibiotics.
Tetracyclines may inhibit the binding of aminoacyl-tRNA to the
mRNA-ribosome complex by binding to the 30S ribosomal subunit in
the mRNA translation complex. Tetracyclines include demeclocycline,
doxycycline, minocycline, oxytetracycline, and tetracycline.
Additional antibiotics that may be used to treat bacterial
infections include arsphenamine, chloramphenicol, fosfomycin,
fusidic acid, linezolid, metronidazole, mupirocin, platensimycin,
quinupristin/dalfopristin, rifaximin, thiamphenicol, tigecycline,
tinidazole, clofazimine, dapsone, capreomycin, cycloserine,
ethambutol, ethionamide, isoniazid, pyrazinamide, rifampicin,
rifamycin, rifabutin, rifapentine, and streptomycin.
[0507] Antiviral therapies are a class of medication used
specifically for treating viral infections. Like antibiotics,
specific antivirals are used for specific viruses. They are
relatively harmless to the host, and therefore can be used to treat
infections. Antiviral therapies may inhibit various stages of the
viral life cycle. For example, an antiviral therapy may inhibit
attachment of the virus to a cellular receptor. Such antiviral
therapies may include agents that mimic the virus associated
protein (VAP and bind to the cellular receptors. Other antiviral
therapies may inhibit viral entry, viral uncoating (e.g.,
amantadine, rimantadine, pleconaril), viral synthesis, viral
integration, viral transcription, or viral translation (e.g.,
fomivirsen). In some instances, the antiviral therapy is a
morpholino antisense. Antiviral therapies should be distinguished
from viricides, which actively deactivate virus particles outside
the body.
[0508] Many of the antiviral drugs available are designed to treat
infections by retroviruses, mostly HIV. Antiretroviral drugs may
include the class of protease inhibitors, reverse transcriptase
inhibitors, and integrase inhibitors. Drugs to treat HIV may
include a protease inhibitor (e.g., invirase, saquinavir, kaletra,
lopinavir, lexiva, fosamprenavir, norvir, ritonavir, prezista,
duranavir, reyataz, viracept), integrase inhibitor (e.g.,
raltegravir), transcriptase inhibitor (e.g., abacavir, ziagen,
agenerase, amprenavir, aptivus, tipranavir, crixivan, indinavir,
fortovase, saquinavir, Intelence.TM., etravirine, isentress,
viread), reverse transcriptase inhibitor (e.g., delavirdine,
efavirenz, epivir, hivid, nevirapine, retrovir, AZT, stuvadine,
truvada, videx), fusion inhibitor (e.g., fuzeon, enfuvirtide),
chemokine coreceptor antagonist (e.g., selzentry, emtriva,
emtricitabine, epzicom, or trizivir). Alternatively, antiretroviral
therarapies may be combination therapies, such as atripla (e.g.,
efavirenz, emtricitabine, and tenofovira disoproxil fumarate) and
completer (emtricitabine, rilpivirine, and tenofovir disoproxil
fumarate). Herpes viruses, best known for causing cold sores and
genital herpes, are usually treated with the nucleoside analogue
acyclovir. Viral hepatitis (A-E) are caused by five unrelated
hepatotropic viruses and are also commonly treated with antiviral
drugs depending on the type of infection. Influenza A and B viruses
are important targets for the development of new influenza
treatments to overcome the resistance to existing neuraminidase
inhibitors such as oseltamivir.
[0509] In some instances, the antiviral therapy may comprise a
reverse transcriptase inhibitor. Reverse transcriptase inhibitors
may be nucleoside reverse transcriptase inhibitors or
non-nucleoside reverse transcriptase inhibitors. Nucleoside reverse
transcriptase inhibitors may include, but are not limited to,
combivir, emtriva, epivir, epzicom, hivid, retrovir, trizivir,
truvada, videx ec, videx, viread, zerit, and ziagen. Non-nucleoside
reverse transcriptase inhibitors may comprise edurant, intelence,
rescriptor, sustiva, and viramune (immediate release or extended
release).
[0510] Protease inhibitors are another example of antiviral drugs
and may include, but are not limited to, agenerase, aptivus,
crixivan, fortovase, invirase, kaletra, lexiva, norvir, prezista,
reyataz, and viracept. Alternatively, the antiviral therapy may
comprise a fusion inhibitor (e.g., enfuviride) or an entry
inhibitor (e.g., maraviroc).
[0511] Additional examples of antiviral drugs include abacavir,
acyclovir, adefovir, amantadine, amprenavir, ampligen, arbidol,
atazanavir, atripla, boceprevir, cidofovir, combivir, darunavir,
delavirdine, didanosine, docosanol, edoxudine, efavirenz,
emtricitabine, enfuvirtide, entecavir, famciclovir, fomivirsen,
fosamprenavir, foscarnet, fosfonet, fusion inhibitors, ganciclovir,
ibacitabine, immunovir, idoxuridine, imiquimod, indinavir, inosine,
integrase inhibitor, interferons (e.g., interferon type I, II,
III), lamivudine, lopinavir, loviride, maraviroc, moroxydine,
methisazone, nelfinavir, nevirapine, nexavir, nucleoside analogues,
oseltamivir, peg-interferon alfa-2a, penciclovir, peramivir,
pleconaril, podophyllotoxin, protease inhibitors, raltegravir,
reverse transcriptase inhibitors, ribavirin, rimantadine,
ritonavir, pyramidine, saquinavir, stavudine, tea tree oil,
tenofovir, tenofovir disoproxil, tipranavir, trifluridine,
trizivir, tromantadine, truvada, valaciclovir, valganciclovir,
vicriviroc, vidarabine, viramidine, zalcitabine, zanamivir, and
zidovudine.
[0512] An antifungal drug is medication that may be used to treat
fungal infections such as athlete's foot, ringworm, candidiasis
(thrush), serious systemic infections such as cryptococcal
meningitis, and others. Antifungals work by exploiting differences
between mammalian and fungal cells to kill off the fungal organism.
Unlike bacteria, both fungi and humans are eukaryotes. Thus, fungal
and human cells are similar at the molecular level, making it more
difficult to find a target for an antifungal drug to attack that
does not also exist in the infected organism.
[0513] Antiparasitics are a class of medications which are
indicated for the treatment of infection by parasites, such as
nematodes, cestodes, trematodes, infectious protozoa, and amoebae.
Like antifungals, they must kill the infecting pest without serious
damage to the host.
[0514] Various dietary chemicals act on the human genome, either
directly or indirectly, to alter gene expression or structure.
Nutrients may act directly as ligands for transcription factor
receptors; may be metabolized by primary or secondary metabolic
pathways, thereby altering concentrations of substrates or
intermediates involved in gene regulation or cell signaling; or
alter signal transduction pathways and signaling. The degree to
which diet influences the balance between healthy and disease
states depends on an individual's genetic makeup. The system
includes monitoring nutrigenomics and metabolomics using mass
spectroscopic techniques to identify multiple analytes in parallel
and detect gene expression in response to an environment.
[0515] In one embodiment, proteomics workflows identify the
proteins in a sample. In shotgun proteomics, the sample's proteins
are solubulized and digested into short peptides of 10-20
amino-acids using a proteolytic enzyme. The resulting peptide
mixture is separated in time according to the peptides' physical
and chemical properties using liquid chromatography and analyzed in
real-time by the mass-spectrometer. As the peptides with similar
physicochemical properties elute from the column, the mass
spectrometer acquires survey scans to identify and select the most
abundant peptide ions for analysis by tandem mass-spectrometry.
Mass spectrometry measures the mass of molecules and atoms. The
molecules to be analyzed are transformed into charged, gas-phase
ions which can be manipulated and detected by the mass
spectrometer. One embodiment is a quantum dot mass spectrometer
with an array of different dots each filtering specific wavelengths
of light. Each dot only lets through a certain wavelength of light
and the dots are so small they can be printed onto a thin film and
can be placed on top of a camera or they can be deposited onto each
camera pixel sensor.
[0516] Various open-source and commercial tandem mass-spectrometry
search engines can be used including Mascot from company Matrix
Science, and SEQUEST available from Thermo Fisher, or open source
software such as X!Tandem and OMSSA. The automated acquisition of
tandem mass spectra in conjunction with liquid-chromatography can
be done, and tandem mass-spectrometry search engines analyze these
shotgun proteomics datasets to identify the sample's proteins. The
search engines match the tandem mass spectra with peptide sequences
from a protein sequence database and use the identified peptides to
infer the protein content of the sample. A mass analyzer uses
electrical, magnetic, and RF fields to separate the gas-phase ions
in time or space before they are counted and detected.
[0517] The system recommends dietary intervention based on
knowledge of nutritional requirement, nutritional status, and
genotype (i.e., "individualized nutrition") can be used to prevent,
mitigate or cure chronic disease. In another preferred embodiment
the physiological data includes epigenetic data, genetic data,
genomic data, and nutrigenomic data. In a further preferred
embodiment, the physiological data comprises measurements of heart
rate, breathing rate and volume and blood pressure. In a still
further preferred embodiment, the physiological data includes
measurements of weight, BMI, HDL, LDL, cholesterol, glucose,
lipids, HbAlc, blood pressure, biomarkers of inflammation,
TNF-.alpha., HsCRP, leukotrienes, prostaglandins, and hormones. In
a more preferred embodiment, the hormones comprise insulin,
glucagon, and leptins. In another preferred embodiment the
physiological data is collected before and after consumption of a
food item. In a yet further preferred embodiment the disease or
disorder is selected from type 2 diabetes. mellitus (T2DM),
obesity, metabolic syndrome, Alzheimer's disease, cardiovascular
disease, and cancer. In a most preferred embodiment, the disease or
disorder is type 2 diabetes mellitus.
[0518] For coronary syndromes, potential biomarkers include the
following:
TABLE-US-00004 Unstable Plaque LV Plaque plaque rupture Thrombosis
ischemia Necrosis remodeling LDL MMP-9 sCD40L PAI-1 IMA cTNT BNP ox
LDL MPO PIGF sCD40L FFA cTNI NT-ProBNP CRP ICAM PAPP-A VwF Choline
CK-MB MMP IL-6 VCAM VCAM D-dimer BNP Myg IL-10 ?IL-6/TF IL-18 Fbg
TNF-.sub.--
[0519] Biomarkers that may be elevated at each phase of coronary
disease are displayed in the above sequence, where sCD40L indicates
soluble CD40 ligand; Fbg, fibrinogen; FFA, free fatty acid; ICAM,
intercellular adhesion molecule; IL, interleukin; IMA, ischemia
modified albumin; MMP, matrix metalloproteinases; MPO,
myeloperoxidase; Myg, myoglobin; NT-proBNP, N-terminal proBNP;
Ox-LDL, oxidized low-density lipoprotein; PAI-1, plasminogen
activator inhibitor; PAPP-A, pregnancy-associated plasma protein-A;
PlGF, placental growth factor; TF, tissue factor; TNF, tumor
necrosis factor; TNI, troponin I; TNT, troponin T; VCAM, vascular
cell adhesion molecule; and VWF, von Willebrand factor.
[0520] In the following example, an exemplary process for providing
interoperability between a device within the base station network
(and an external device at a clinic or hospital is described.
Pseudo-code for the device interoperability process is as follows:
[0521] Hospital/Clinic devices and In-Network devices requests
registration with remote server (S42) [0522] Remote server forwards
registration request to all base stations, which in turn register
hospital/clinic device (S44) [0523] Hospital device requests
application data from server, which in turn forwards request to
base station (S46) [0524] Base station searches for a responsive
device from its registration list and forwards request to
responsive device over preferred communication channel (S48) [0525]
Responsive device replies to base station with data (S50) [0526]
Base station reformats data to match requestor's preference (S52)
[0527] Base station forwards formatted data to hospital/clinic
device through the remote server (S54)
[0528] In this example, a doctor at a hospital, clinic or doctor
office registers and authenticates with the remote server. In a
thin-client application, the server maintains all patient
information in its database. Upon authentication, the server polls
the base station for the latest information and displays the
patient screens for the doctor. In this case, the server uses
secure HTTP (SHTTP) protocol for communication with the base
station and the base station performs auto-translation among
devices. For example, a hospital EKG device can store time series
EKG data in XML format, while a home based EKG device can store
compressed EKG data. The base station can translate the Open EKG
format to the uncompressed XML data.
[0529] In another embodiment, instead of having the doctor using a
thin-client, a remote user such as a patient representative
(attorney in fact), family member, or a doctor can be running
his/her own computer system that is registered with the server 200
as an authorized user. The server 200 forwards such registration to
the base station and the base station registers the doctor's
computer as an authorized doctor base station in the network. The
doctor base station in turn communicates with devices in the
doctor's office such as digital scales, blood pressure measurement
devices, digital X-ray machines, glucose measurement devices,
digital scanners such as computer aided tomography (CAT) scanners
and nuclear magnetic resonance (NMR) scanners, among others. These
devices capture patient information through a unique patient
identifier and the data is stored in the doctor base station and
can also be uploaded to the remote server 200 to store data. Since
numerous base stations can exist that provide medical information
on a patient (different doctors/specialists, different hospitals
and care centers), the server performs data synchronization to
ensure that all base stations have access to the latest
information.
[0530] To allow the remote person such as a physician or a family
member to monitor a patient, a plurality of user interface modules
enable the remote person to control each appliance and to display
the data generated by the appliance. In one example scenario, an
EKG sensor wirelessly communicates with the patient base station
and outputs a continuous EKG waveform. A pattern recognizer or
analyzer positioned at the doctor's station accepts waveform data
and generates a variety of statistics that characterize the
waveform and can generate alarms or messages to the doctor if
certain predefined conditions are met. While it is operating, the
EKG sends its waveform data to its subscribing components or
modules at the doctor's office and the analyzer processes the data
and sends summaries or recommendations to the doctor for viewing.
If, during the operation of this network of components, any of
these components experience an event that compromises its ability
to support the protocol (e.g., the EKG unit is disconnected or
deactivated from the base station), then the affected components
notify the remote base station of a disconnected appliance. When
finished with the EKG data sampling, the user may "deselect" the
device on the user interface framework, which results in the EKG
user interface module being disabled and terminating data
collection by the EKG device. In turn, the protocol instructs each
of the leased components to terminate its subscriptions. The
protocol then notifies the registry that it is vacating its lease
on these components and tells the user interface event handler that
it is ending.
[0531] The system can support procedure-centric workflow management
such as those described in Application Serial No. 20060122865. In
one example, the system manages a workflow involving a specialist,
an electronic medical record (EMR) or other external patient
information system, a referring provider, a rural health care
facility, and appropriate appliances (e.g., modalities)
corresponding to the particular procedure of interest. In one
example, the specialist's workflow includes capturing/reviewing
patient history, which itself entails reviewing prior procedures,
reviewing prior data and/or digital images, reviewing problem lists
in communication with the EMR, capturing/reviewing patient physical
and history information in communication with EMR, and reviewing
lab results in communication with EMR. The workflow further
includes capturing follow-up orders in communication with EMR. In
addition, the workflow also involves capturing procedure results
and corresponding data obtained during the procedure, and
distributing such data in communication with a referring provider
and rural facility. Finally, in communication with external devices
or appliances, the specialist receives the captured data from the
procedure and reviews/interprets the data or digital images.
Workflow management as described here includes recognition of
various roles of people involved in workflows, whether they are
different types of caregivers or different types of patients.
[0532] In one embodiment, the authentication source is a trusted
key distribution center (KDC) and the authentication type is user
IDs with passwords. The initial authentication can also be based on
public key. The public key infrastructure (PKI) system can be used
where the authentication source is a certificate authority (CA) and
the authentication type is challenge/response. Another
authentication system called the secure remote password (SRP)
protocol authenticates clients to servers securely, in cases where
the client must memorize a small secret (like a password) and
carries no other secret information, and where the server carries a
verifier which allows it to authenticate the client but which, if
compromised, would not allow someone to impersonate the client.
[0533] In one embodiment, a device first appears on a network. The
device searches the local cache for information regarding the base
station. If base station information is found, the device attempts
to contact the base station and setup a connection. Otherwise if
the information is not found, then a discovery request is sent. The
discovery request may be sent via a broadcast or a multicast. In
this regard, the device sends out a discovery request and all the
devices in the network neighborhood should receive the message and
respond appropriately. The device agent examines the responses to
determine and/or confirm the base station. If the device does not
discover the base station, the system assumes that there is no base
station in the network neighborhood at present and repeats the
discovery request process until a base station is found. Otherwise,
if the device discovers the base station, the connection token is
saved (an XML message that tells where the device communicator is
located and how to contact it) in the cache for later usage. The
cache may allow for faster discovery but it may also expire due to
the feature that devices may join and leave the network. Therefore
a time-to-live (TTL) may be attached so that after a certain period
the cached data may be considered expired. A check may also be
preformed to ensure that the device exists before a network
connection is initiated. To provide a generalized format, XML may
be used to provide an easily expandable and hierarchical
representation. XML may also be used to aggregate information from
other agents and send back results from service providers to device
through the base station.
[0534] A multitude of standards address mid to high data rates for
voice, PC LANs, video, among others. ZigBee provides good bandwidth
with low latency and very low energy consumption for long battery
lives and for large device arrays. Bluetooth provides higher speed
(and higher power consumption) for cell phone headset applications,
among others. Variants of the 802.11 standard (802.11b, 802.11g,
802.11a) provide yet faster data transmission capability with
correspondingly high power consumption. Other devices include WiMAX
(802.16) and ultrawideband devices that are very high in power
consumption and provide long range and/or video capable
transmission.
[0535] Device discovery and service discovery are provided for each
class of devices (Zigbee or Bluetooth, for example). For
interoperability, a local discovery mapper running on the personal
server or a remote discovery mapper running on a remote server is
provided to enable Zigbee services to be advertised to Bluetooth
devices and vice versa, for example In other implementations, the
services of ZigBee devices can be advertised to body PAN devices
(PAN devices that are attached to a biological being such as humans
or pets), Bluetooth devices, cellular devices, UWB devices, WiFi,
and WiMAX devices, among others.
[0536] The appliances can communicate data conforming to the
interoperable format over one of: cellular protocol, ZigBee
protocol, Bluetooth protocol, WiFi protocol, WiMAX protocol, USB
protocol, ultrawideband protocol. The appliances can communicate
over two or more protocols. The first medical appliance can
transmit the first vital information over a first protocol (such as
Bluetooth protocol) to a computer, wherein the computer transmits
the first vital information to the second medical appliance over a
second protocol (such as ZigBee protocol). The computer can then
transmit to a hospital or physician office using broadband such as
WiMAX protocol or cellular protocol. The computer can perform the
interoperable format conversion for the appliances or devices, or
alternatively each appliance or device can perform the format
conversion. Regardless of which device performs the protocol
conversion and format conversion, the user does not need to know
about the underlying format or protocol in order to use the
appliances. The user only needs to plug an appliance into the
network, the data transfer is done automatically so that the
electronic "plumbing" is not apparent to the user. In this way, the
user is shielded from the complexity supporting
interoperability.
[0537] Another exemplary process for monitoring a patient is
discussed next. The process starts with patient registration (1000)
and collection of information on patient (1002). Next, the process
selects a treatment template based on treatment plan for similar
patients (1004). The process generates a treatment plan from the
template and customizes the treatment plan (1006). The system
considers the following factors: medical condition, amount of
weight to lose, physician observations regarding mental state of
the patient.
[0538] In the event the patient has extensive or contraindicating
medical history or information, the system alerts the doctor to
manually review the patient file and only generate recommendations
with authorization from a doctor.
[0539] The doctor subsequently reviews and discusses the customized
plan with the patient. In one embodiment, during the discussion,
the doctor offers the patient the opportunity to enroll in the
automated monitoring program. For a monthly or yearly fee, the
system would provide the patient with periodic encouragements or
comments from the system or the physician. In one embodiment, the
doctor can provide the patient with an optional monitoring hardware
that measures patient activity (such as accelerometers) and/or
vital signs (such as EKG amplifiers).
[0540] Upon user enrollment, the system's workflow helps the doctor
with setting goals with the patient, establishing a bond of trust
and loyalty, and providing positive feedback for improving
compliance. Loyalty to the practitioner initially produces higher
compliance, emphasizing that establishing a close relationship
helps. By providing rapid feedback through instant messaging or
emails, the system helps doctors earn the patient's respect and
trust, set goals together with the patient, and praise progress
when it occurs.
[0541] Once enrolled, the system collects data on patient
compliance with a treatment plan (1008). This can be done using
mobile devices with sensors such as MEMS devices including
accelerometer and others as described more fully below.
Alternatively, the system periodically requests patient data will
be weighed, measured, body fat calculated, blood pressure, resting
heart rate and overall well-being. In one embodiment, the system
provides a daily (7 days a week) counseling process using texting,
email or social network communications.
[0542] The process also accumulates reward points for patient to
encourage healthy activities, such as jogging, walking, or
gardening (1010). The process also compares patient progress with
other patients (1012) and sends automatic encouraging messages to
patients (1014). Upon patient authorization, the system announces
the patient's goals and progress to a social network such as
Facebook. The social network strengthens the patient's will for
dieting and exercise by the "extent to which individuals perceive
that significant others encourage choice and participation in
decision-making, provide a meaningful rationale, minimize pressure,
and acknowledge the individual's feelings and perspectives." The
system supplements the treatment through social supports at home
and encourages the patient to make their family and close friends
aware of their condition and the expectations of diet and exercise.
This will provide the patient with encouragement and
accountability.
[0543] Periodically, the system shows patient status to doctor
(1016) and presents recommendations to doctor on preventive steps,
such as check-ups and basic blood tests (1018). Automatically, the
system schedules in person consultation for patient and doctor
(1020). Captured progress data can be viewed by the physicians and
patients using a web based system. The physician can review all
interactions between the system and the patient. The physician is
able to see their progress reports, interactive e mail which
includes daily menus and notes between the service and the patient.
The physician will be able to check on the patient's progress at
any time of day or night. The system improves the Doctor-Patient
relationship and influences compliance.
[0544] The system's interactive behavior combines four key
elements: just-in-time information, automation in checking with
patients, persuasive techniques or messaging, and user control
elements. In one embodiment, reports about the user's calorie
consumption and exercise activity over time, and in comparison to
similarly situated people, are generated.
[0545] The system provides meaningful feedback, allowing customers
to "see" their food consumption, exercise and the impact of
changes. When calories from eating go up between months, a graph
depicts so and by how much. Without the system's report to
conveniently compare food consumption and exercise from one week to
the next, it would be much harder to track those changes. Feedback
provides the information crucial to bring about self-awareness of
one's actions.
[0546] Additionally, the greater value of the system is that it
provides useful information about what other similar users' actions
and impacts are like. The report shows where the patient's energy
intake and outtake are in comparison to the healthiest and the
average person. This information serves as a descriptive norm,
letting customers know where they are in the spectrum of average
and healthy people. When customers see that they are below or even
just above average, they want to move "up" on the exercise but
reduce their calorie intake. As humans, users are programmed to
want to be unique . . . but not too unique--they want to have
"normal" food consumption and normal health.
[0547] With regard to the message persuasiveness, content is
positive and targeted to the user's specific situation. The system
provides action opportunities with its reports. If the user is
mildly overweight, it might offer a suggestion of having salad with
a low calorie dressing for dinner. One embodiment provides a
"marketplace" concept, which means that the suggestion would be
accompanied by, say, a coupon for salad at a local restaurant. In
one embodiment, the system has prior relationships with partners
such as restaurants that would offer meals with preset calorie and
can send the user coupons to different partners on different days,
thus providing users with a wide range of healthy food selections.
The system's power lies in its ability to simultaneously prep
individuals for action and give them an easy opportunity to do
so.
[0548] In sum, the system's feedback is effective because: [0549]
It is provided frequently, as soon after the consumption behavior
as possible. [0550] It is clearly and simply presented. [0551] It
is customized to the patient's specific medical condition. [0552]
It is provided relative to a meaningful standard of comparison.
[0553] It is provided over an extended period of time. [0554] It
includes specific food consumption and calorie breakdown. [0555] It
is interactive through instant messaging, email, or social
networks.
[0556] In one embodiment, body analysis data is determined from
enrollment data, and include: body mass ratio, pounds of lean
muscle mass, percentage of body fat and an optimal range for the
specific individual of that percentage, pounds of body fat and an
optimal range of body fat for that specific individual, and
suggested pounds of body fat to lose. The body analysis includes
the following: Basal Metabolic Rate (BMR) is the number of calories
burned by the patient's lean body mass in a 24 hour period at
complete rest using formulas such as the Harris-Benedict formula or
other suitable formulas. Specific Dynamic Action of Foods (SDA) is
the numbers of calories required to process and utilize consumed
foods (in one case estimated at 5-15% of BMR, depending on
personalization). Resting Energy Expenditure (REE) is the sum of
BMR and SDA and represents the number of calories that the
patient's body requires in a 24 hour period at complete rest. The
system determines a Program Recommendation Total Caloric Intake as
the caloric supplement required to achieve weight loss of
approximately 2 pounds per week. Medications or stimulating
substances (such as caffeine, gingsen, or diethylpropion) to assist
in weight loss may be recommended and if so the program increases
calorie consumption based on a model of the patient's response to
such substances.
[0557] In one embodiment using the optional mobile monitoring
hardware, the system determines Activities of Daily Living (ADL) as
the number of calories burned by the patient's body during normal
daily activities using accelerometers. The accelerometers can also
determine the Calories Burned by Exercise as the number of calories
burned by the exercises selected by the patient. Also included, is
the level and intensity of the patient's activities. In one
embodiment without the optional mobile monitoring hardware, the
system approximates the Activities of Daily Living (ADL) as an
average of calories expected to be burned by the patient's body
during normal daily activities, and in one case is estimated at 20%
or REE. The system can also receive averaged approximations of
Calories Burned by Exercise is the number of calories burned by the
exercises selected by the patient. Also included, is the level and
intensity of the patient's activities.
[0558] An exemplary process for monitoring patient food intake is
discussed next. The process first determines and recommends optimal
diet based on patient parameters (1030). To monitor progress, the
process takes user entered calorie data and optionally captures
images of meals using a mobile device such as a mobile camera
(1032). The process then translates images of the meals into
calories (1034). The patient's actual diet is then compared to with
the recommended diet (1036).
[0559] In one embodiment, the camera captures images of the food
being served to the patient. The image is provided to an image
search system such as the Google image search engine, among others.
The search returns the likely type of food in the dish, and an
estimation of the container volume is done. In one embodiment, the
volume can be done using a 3D reconstruction using two or more
images of the food found as the intersection of the two projection
rays (triangulation). The two images from the 2D images are
selected to form a stereo pair and from dense sets of points,
correspondences between the two views of a scene of the two images
are found to generate a 3D reconstruction is done to estimate the
3D volume of each food item.
[0560] The system determines and looks up a database that contains
calorie per unit volume for the dish being served, and multiplies
the food volume estimate with the calorie per unit volume for the
type of food to arrive at the estimated total calorie for the dish.
The user is presented with the estimate and the details of how the
estimation was arrived at are shown so the user can correct the
calorie estimation if needed.
[0561] Next is an exemplary exercise recommendation and monitoring
process. First, the process determines and recommends an exercise
routine that is customized to the patient's medical condition
(1040). The process then captures patient exercise activity using
micro-electromechanical systems (MEMS) sensors (1042). The MEMS
sensors can include Accelerometer, Gyroscope, Magnetometer,
Pressure sensor, Temperature, and Humidity sensor, among others.
The process then correlates actual patient activity with the
recommended exercises (1044).
[0562] An exemplary process for applying the power of social
networking to health is discussed next. The process collects data
from crowd (1050). The process then compares the performance of the
patient with similar patients (1052). The process engages and
motivates through Social Network Encouragement (1054).
[0563] The system or method described herein may be deployed in
part or in whole through a machine that executes software programs
on a server such as server, domain server, Internet server,
intranet server, and other variants such as secondary server, host
server, distributed server, or other such computer or networking
hardware on a processor. The processor may be a part of a server,
client, network infrastructure, mobile computing platform,
stationary computing platform, or other computing platform. The
processor may be any kind of computational or processing device
capable of executing program instructions, codes, binary
instructions or the like that may directly or indirectly facilitate
execution of program code or program instructions stored thereon.
In addition, other devices required for execution of methods as
described in this application may be considered as a part of the
infrastructure associated with the server.
[0564] The system or method described herein may be deployed in
part or in whole through network infrastructures. The network
infrastructure may include elements such as computing devices,
servers, routers, hubs, firewalls, clients, wireless communication
devices, personal computers, communication devices, routing
devices, and other active and passive devices, modules or
components as known in the art. The computing or non-computing
device(s) associated with the network infrastructure may include,
apart from other components, a storage medium such as flash memory,
buffer, stack, RAM, ROM, or the like. The processes, methods,
program codes, and instructions described herein and elsewhere may
be executed by the one or more network infrastructural
elements.
* * * * *
References