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The True Colours remote symptom monitoring system: A decade of evolution (Preprint)

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The True Colours remote mood monitoring system was developed over a decade ago by researchers, psychiatrists, and software engineers at the University of Oxford to allow patients to report on a range of symptoms via text messages, Web interfaces, or mobile phone apps. The system has evolved to encompass a wide range of measures, including psychiatric symptoms, quality of life, and medication. Patients are prompted to provide data according to an agreed personal schedule: weekly, daily, or at specific times during the day. The system has been applied across a number of different populations, for the reporting of mood, anxiety, substance use, eating and personality disorders, psychosis, self-harm, and inflammatory bowel disease, and it has shown good compliance. Over the past decade, there have been over 36,000 registered True Colours patients and participants in the United Kingdom, with more than 20 deployments of the system supporting clinical service and research delivery. The system has been adopted for routine clinical care in mental health services, supporting more than 3000 adult patients in secondary care, and 27,263 adolescent patients are currently registered within Oxfordshire and Buckinghamshire. The system has also proven to be an invaluable scientific resource as a platform for research into mood instability and as an electronic outcome measure in randomized controlled trials. This paper aimed to report on the existing applications of the system, setting out lessons learned, and to discuss the implications for tailored symptom monitoring, as well as the barriers to implementation at a larger scale.
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The True Colours Remote Symptom Monitoring System: A Decade
of Evolution
Sarah M Goodday1,2*, PhD; Lauren Atkinson1,3, MSc; Guy Goodwin1,4, FMedSci; Kate Saunders1,4, DPhil, MRCPsych,
FHEA; Matthew South1, PhD; Clare Mackay1,4, PhD; Mike Denis1, MSc; Chris Hinds1,5, PhD; Mary-Jane
Attenburrow1,4*, MBBS, MRCPsych; Jim Davies5,6, PhD; James Welch5,7, BA (Oxon); William Stevens6, PhD; Karen
Mansfield1, PhD; Juulia Suvilehto1, PhD; John Geddes1,4, MD, MRCPsych
1Department of Psychiatry, University of Oxford, Oxford, United Kingdom
24YouandMe, Seattle, WA, United States
3Oxford Center for Human Brain Activity, University of Oxford, Oxford, United Kingdom
4Oxford Health NHS Foundation Trust, Oxford, United Kingdom
5Big Data Institute, University of Oxford, Oxford, United Kingdom
6Department of Computer Science, University of Oxford, Oxford, United Kingdom
7NIHR Oxford Biomedical Research Centre, University of Oxford, Oxford, United Kingdom
*these authors contributed equally
Corresponding Author:
Sarah M Goodday, PhD
Department of Psychiatry
University of Oxford
Warneford Lane
Oxford, OX3 7JX
United Kingdom
Phone: 44 (0)1865 618200
Email: sarah.goodday@psych.ox.ac.uk
Abstract
The True Colours remote mood monitoring system was developed over a decade ago by researchers, psychiatrists, and software
engineers at the University of Oxford to allow patients to report on a range of symptoms via text messages, Web interfaces, or
mobile phone apps. The system has evolved to encompass a wide range of measures, including psychiatric symptoms, quality of
life, and medication. Patients are prompted to provide data according to an agreed personal schedule: weekly, daily, or at specific
times during the day. The system has been applied across a number of different populations, for the reporting of mood, anxiety,
substance use, eating and personality disorders, psychosis, self-harm, and inflammatory bowel disease, and it has shown good
compliance. Over the past decade, there have been over 36,000 registered True Colours patients and participants in the United
Kingdom, with more than 20 deployments of the system supporting clinical service and research delivery. The system has been
adopted for routine clinical care in mental health services, supporting more than 3000 adult patients in secondary care, and 27,263
adolescent patients are currently registered within Oxfordshire and Buckinghamshire. The system has also proven to be an
invaluable scientific resource as a platform for research into mood instability and as an electronic outcome measure in randomized
controlled trials. This paper aimed to report on the existing applications of the system, setting out lessons learned, and to discuss
the implications for tailored symptom monitoring, as well as the barriers to implementation at a larger scale.
(J Med Internet Res 2020;22(1):e15188) doi: 10.2196/15188
KEYWORDS
symptom assessment; signs and symptoms; digital health; ecological momentary assessment; mood disorders
Introduction
The advancement of digital technology will gradually continue
to shape how we measure, monitor, and manage health. A wide
range of digital symptom monitoring tools exist, but there is a
lack of evidence regarding their effectiveness in a health care
context, particularly in the area of mental health. Such evidence
will arise only from studies involving significant usage,
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conducted in close partnership with clinicians, patients, and
managers. For example, digital tools for patient-reported
outcome measures (PROMs) are becoming standard practice in
randomized controlled trials (RCTs) in many areas [1], and
meta-analyses [2,3] have confirmed their equivalence with
paper-based approaches.
True Colours is a digital tool, developed over a decade ago by
psychiatrists, software engineers, and researchers at the
University of Oxford, which has achieved significant usage.
The initial version was used for remote monitoring of mood
disorders, allowing patients and their clinicians to record and
review symptom change. The recognized need to capture and
monitor higher frequency phenotype information, particularly
for conditions such as bipolar disorder (BD), is not new. Hard
copy symptom monitoring diaries have been used for decades.
However, these are limited by practicality issues.
The True Colours system has many advantages over paper-based
approaches toward the capturing of detailed, timed phenotype
information, including the following: the ability to prompt for
contemporaneous input, the automatic calculation of summary
scores, the visualization of changes over time, and the provision
of real time, as well as historical data to support clinical review,
assessment, and early intervention. From a research perspective,
the tool has additional advantages: eliminating errors in the
transcription of information from paper forms, supporting a
higher frequency of prompted, directed phenotyping, and
reducing the recall bias associated with the recording of
symptoms. Subsequent versions of the tool have added new
functionality for data entry, patient or cohort management, and
research delivery.
The system has been applied across several patient, participant,
and high-risk populations, being used across 21 unique research
and clinical service settings in the Oxfordshire and
Buckinghamshire regions in the United Kingdom. Over the past
decade, there have been over 36,000 registered True Colours
participants from whom over 1.4 million questionnaire responses
have been collected. Several feasibility studies and clinical
service applications support the potential of True Colours as a
larger scale symptom monitoring system, an electronic PROM,
and a tool for digital phenotyping. This paper aimed to describe
the evolution of the tool, its applications, and achievements and
to discuss the potential for future wider application and
integration.
Research Applications
The True Colours system was originally designed to monitor
mood symptoms in adult patients with BD, attending the BD
Research Clinic at the Department of Psychiatry at the
University of Oxford, and it was designed for use in clinical
trials, evolving from the Oxford University Symptom
Monitoring System [4,5]. The original version of the system
involved automated weekly prompts, delivered by text message
or email (chosen by preference), for patients to complete
self-reported measures of symptoms, including depression
(16-item Quick Inventory of depressive symptoms) [6] and
mania (5-item Altman Self Rating Mania Scale) [7], and other
measures, such as anxiety (Generalized Anxiety Disorder
Scale–7) [8], quality of life (EQ-5D) [9], and lifestyle behaviors.
The system has expanded to include a wide range of symptoms
from validated scales and bespoke measures tailored to specific
research projects. As part of the True Colours platform, total
symptom scores were presented graphically via a secure website
and made available to patients, participants, and clinicians upon
request. Over the past decade, the use of True Colours has
expanded to several different research cohorts and patient
populations (Figure 1).
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Figure 1. Evolution and applications of True Colours. AMoSS: Automated Monitoring of Symptom Severity Study; BD: bipolar disorder; BDRN:
Bipolar Disorder Research Network; CEQUEL: Comparative evaluation of quetiapine plus lamotrigine; COMBO: Collaborative Care Model for Bipolar
Disorder; FIMM: Facilitated Integrated Mood Management; FWwTC: Feeling Well with True Colours; IBD: inflammatory bowel disease; LQD: lithium
versus quetiapine augmentation for treatment resistant depression; MIMM: Manualized Integrated Mood Management; OxBREaD: Oxford Brain Body
Research into Eating Disorders; OxCAMS: Oxford Study of Calcium Channel Antagonism, Cognition, Mood instability and Sleep; OxLith: Oxford
Lithium Trial; RCT: randomized controlled trial.
The OXTEXT Program
Earlier work involving the University of Oxford Symptom
Monitoring System established that technology-assisted
symptom monitoring was acceptable to patients over a period
of 36 weeks with 75% compliance [4], meaning that, on average,
patients reported symptoms in response to prompts 75% of the
time over follow-up. The OXTEXT program was dedicated to
developing and validating the True Colours remote symptom
monitoring system for patients, at a larger scale. Across several
projects, the program revised the software after in-depth patient
consultation, established a cohort of well-characterized patients
with BD by using the improved system, determined the potential
cost-effectiveness of this remote capture tool in clinical service,
and tested remote mood monitoring as a potential intervention
via RCTs (OXTEXT research studies 1-6). Several publications
resulted from these studies, largely from the OXTEXT-1 cohort
comprising up to 367 patients (16 years of age) from
Oxfordshire, with a Diagnostic and Statistical Manual of Mental
Disorders-IV diagnosis of BD (BDI, BDII, or BD-not otherwise
specified), with some patients completing up to 81 months of
continuous weekly mood measures. Compliance and
acceptability of the True Colours system in the OXTEXT-1
cohort were excellent, with low attrition (<2%) and a median
of less than 8% of weeks of missing data that did not differ by
key sociodemographic factors or by mood score [10]. This pilot
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work has demonstrated support for the feasibility of True
Colours as a remote mood monitoring system in patients with
mood disorders [4,10], and it has lent important insights into
detectable mood instability that differentiates clinical course
[5] and other BD patient characteristics, including cognitive
functioning [10,11].
The OXTEXT-2 study [12] assessed participant’s compliance
with monitoring, their mental health resource use (including
hospitalizations and face-to-face and phone contact with mental
health staff), and service and medication costs, before and during
their first 12 months of engagement with True Colours.
Compliance with monitoring was high, with a median response
completion rate of 92% for both Web-based and SMS symptom
reporting and all patients continuing to report during the duration
of the study. The introduction of True Colours was thought
likely to reduce service costs, but this was not supported in
OXTEXT-2. In fact, when associated with enhanced specialist
care, medication costs increased over the first year of
monitoring. This illustrated that studies of any digital addition
to care need to account for all possible confounders relating to
mood monitoring and mental health service costs. OXTEXT-2
did not examine nonmental health service costs, and larger
economic evaluations of the True Colours system are required
and are being conducted.
The True Colours system was also utilized as part of a
psycho-education intervention for 121 patients with BD in an
RCT (OXTEXT-6) [13]. The Facilitated Integrated Mood
Management (FIMM) [14] study condition involved True
Colours mood monitoring, a psycho-education manual, and
individual sessions with a facilitator. This was compared with
Manualized Integrated Mood Management, which only involved
the psycho-education manual. Patients in the FIMM arm showed
better knowledge of BD, and greater BD knowledge was
associated with a high number of months in remission over
1-year follow-up [13]. Of note, True Colours in isolation is not
intended as an intervention, but it may improve symptoms via
insight into patients about their symptoms and closer, more
accurate monitoring by clinicians, which will require further
study.
The OXTEXT-7 study commenced in 2013 involving a trial
rolled out to all 11 community mental health treatment services
across Oxfordshire and Buckinghamshire titled as Feeling Well
with True Colours (FWwTC). The goal of FWwTC was to offer
patients a self-monitoring system that could allow care
interventions to be tailored to the individual. Patients and
clinicians create tailored symptom monitoring schedules on the
basis of the type of symptom measure, frequency of prompts
(weekly, daily, and several times a day), and reminder
frequency. This study was a stepped-wedge, cluster randomized
design. In this design, all services eventually implemented
FWwTC, but the time at which they were trained to implement
FWwTC was randomized to compare outcomes in treatment
services before and after the introduction of FWwTC. The aim
of this phase of OXTEXT was to apply True Colours to other
patient populations (including those experiencing depression,
anxiety, psychosis, alcohol and drug use, and BD) and test the
feasibility and cost-effectiveness of such a tool in a larger scale
secondary care setting. Experience from this trial is currently
being synthesized, and it has proved heuristically useful [15],
although uptake across clinical services was a challenge,
illustrating the considerable barriers to innovation that persist
in the National Health Service and other medical services.
Digital Phenotyping Studies
Digital phenotyping is the individual-level high-resolution data
capture enabled by digital devices. The promise in this data
capture is its ability to collect passive or active information in
a real-world setting unbound to clinical visits. This affords the
opportunity to discover new trajectories of signs and symptoms
of disease, resulting in refined phenotypes and better detection
and management of illness. The Collaborative Network for
Bipolar Research to Improve Outcomes (ConBrio) [16] was a
translational research program aimed at bringing together basic
and clinician scientists in mathematics, computational biology,
cognitive neuroscience, and neuroimaging. Central to the
ConBrio program is the use of True Colours complemented by
other methods for deep and frequent mood phenotyping to
accelerate understanding and treatment of BD. This program
has supported several projects, such as the Automated
Monitoring of Symptom Severity Study (AMoSS), the use of
True Colours in several RCTs, for example, Oxford Study of
Calcium Channel Antagonism, Cognition, Mood instability and
Sleep (OxCaMS) and Oxford Lithium Trial (OxLith), and other
large phenotyping studies from the BD Research Network
(BDRN) [17].
Automated Monitoring of Symptom Severity Study
Taking advantage of the developments in digital technology
and ubiquity of mobile phones, the AMoSS study introduced a
mobile phone app, Mood Zoom, to facilitate a higher frequency
of symptom monitoring and included wearable devices as
measures of objective symptoms. The Mood Zoom questionnaire
comprises mood state descriptor items that are rated on a scale
from 1 to 7 [18], which could be completed several times a day.
Mood Zoom was used alongside weekly True Colours mood
monitoring to help understand, in greater detail, mood episodes
and mood instability in patients with BD and borderline
personality disorder, as well as healthy volunteers in a sample
of 139 patients with 3 months of continuous data (as per
protocol) but with over 12 months of continuous data (for those
willing to continue). The introduction of a mobile phone app
also enabled the collection of passive background data, such as
number of texts or calls and geolocation [19], which could
reflect proxies of behavior associated with BD and how they
are associated with mood, an emerging area with promise for
the identification of behavioral markers of impending BD-related
episodes [20]. Quantitative [18,21-23] studies have supported
the feasibility and acceptability of the use of the Mood Zoom
app and True Colours for daily and weekly symptom monitoring
in patients with BD, borderline personality disorder, and
controls. Specifically, attrition was low in the AMoSS cohort,
with only 1 subject withdrawing and 8 subjects being excluded
because of providing data for less than 2 months. Median
adherence for the Mood Zoom and weekly measures was greater
than 80% and 85%, respectively, and it remained stable over
the study follow-up [18]. A qualitative study of 20 subjects from
the AMoSS cohort provided support for the fact that reporting
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on symptoms once daily was of no inconvenience, and it was
felt that the system contributed to insights into personal
symptoms and patterns [24]. Additional themes from this study
highlight the importance of tailoring patient preferences into
symptom reporting tools.
In recent studies, additional objective physiological measures,
derived from Fitbit and wrist-worn accelerometers, were
included, along with daily and weekly mood monitoring [22]
as well as the proteus patch [21,25] that provides an estimate
of heart rate. These studies have contributed insights into
detectable variability of sleep patterns in patients with BD and
borderline personality disorder, which map onto observable
symptoms of low and irritable mood [21] and variability in
mood [25]. The additional add-on of wearables offers an exciting
line of inquiry into objective symptoms of illness-alleviating
biases relating to subjective reporting of symptoms. This
potentially supports downstream applications of True Colours,
with the inclusion of additional devices for the measurement of
objective symptoms, which will be important for deeper insights
into early signs of disease.
Other Mood-Related Research Applications
The BDRN [17] adopted the True Colours system, engaging
815 research participants (815/4080, 19.97% of invited existing
BDRN participants) with mood disorders [26]. BDRN
participants with a diagnosis of BDII were more likely to register
with True Colours. Approximately 78.2% (637/815) of
registered participants completed 3 months of symptom
reporting, approximately 51.1% (413/808) of the participants
completed more than 1 year, and some participants continued
mood monitoring for up to 3 years, demonstrating the feasibility
of such a remote mood monitoring system at a larger scale.
An international application of True Colours is from the
Canadian Flourish High-risk Offspring Study [27], recruiting
young offspring of a parent with BD. The Flourish group has
piloted the Web-based True Colours monitoring system in 50
high-risk offspring of a bipolar parent and 108 control offspring
of psychiatrically well parents. Compliance was good over 30
days, with approximately 80% and greater than 90% of high-risk
and control offspring completing daily ratings, respectively,
and no difference in compliance between study groups. Daily
mood scores significantly differentiated the high-risk from
control offspring, and irregularity in weekly mood and anxiety
scores was higher in high-risk offspring with remitted major
mood disorders compared with those with no lifetime history
of major mood disorders [27].
Additional studies from the University of Oxford have made
use of the True Colours system to elucidate mood variability in
BD, involving determining the different nonlinear time series
processes of mood instability and analytic techniques for
appropriately detecting it from high-frequency time series data
[5,28], as well as its associations with mental imagery [29].
Application to Randomized Controlled Trials
RCTs of treatment efficacy in psychiatric disorders are
expensive and lengthy, given the needed follow-up time for full
Diagnostic and Statistical Manual of Mental Disorders threshold
mood episodes to develop. Traditional endpoint assessments
using paper and pencil questionnaires or clinician-rated
diagnostic episodes also ignore clinically significant symptoms
not meeting full diagnostic threshold between episodes [30] and
cognitive dysfunction [31], which could be used to determine
earlier and more proximal treatment effects. Several RCTs have
used True Colours as both primary electronic outcome
assessments and secondary higher frequency outcome
measurements. For example, a 12-week double blind RCT
(CEQUEL) [32] assessed combination therapy with quetiapine
plus lamotrigine versus quetiapine monotherapy plus lamotrigine
placebo on depressive symptoms in 266 patients (16 years)
with BD, recruited across 27 different United Kingdom clinics.
Another completed single blind RCT (OASIS) [33] of 3755
university students across the United Kingdom used True
Colours to measure outcomes to determine the effectiveness of
a Web-based cognitive behavioral therapy for insomnia and
other psychiatric symptoms, including psychosis, mood, and
anxiety.
Other mood-related applications of True Colours for outcome
assessment in ongoing RCTs include the OxLith [34], aimed to
compare lithium with placebo on mood instability in adult
patients with BD; a trial assessing the clinical effectiveness and
cost-effectiveness of lithium versus quetiapine augmentation
for treatment-resistant depression [35]; and OxCaMS [36],
which aims to assess the impact of a calcium channel blocker
on cognition and brain activity in adults with mood instability.
Finally, the Oxford Brain Body Research into Eating Disorders
study [37] involves a pilot trial to assess the safety, acceptability,
and feasibility of deep brain stimulation in patients diagnosed
with severe eating disorders. Other funded large trials involving
the True Colours system under development include the
Pramipexole Therapy in Treatment Resistant Depression and
Bipolar Depression (PAX-D and PAX-BD) [38,39].
Expansion to Other Populations
As the research and clinical utility of True Colours became
evident, it naturally branched out to other populations and
research contexts. The Cognition and Mood Evolution across
Time study is aimed at measuring cognition and brain activity
in healthy participants with various levels of mood instability—a
useful application of True Colours, with the inclusion of daily
mood monitoring and cognitive tasks [40].
The True Colours system has also been modified for community
outpatients, with a diagnosis of psychosis using forensic
psychiatric services (FOXWEB risk violence tool). This research
application involved the development of a Web-based violence
risk monitoring tool for psychosis, which provides visual
feedback of patient scores to clinicians to guide risk assessment
[41], and this is being further piloted in inpatients.
The Brief Interventions for Self-Harm (BIRSH) clinic [42] has
piloted True Colours for self-harm prevention in patients (13-65
years) presenting to accident and emergency departments. The
aim of this ongoing research and service evaluation application
was to determine the effectiveness of a new clinical service
incorporating remote symptom monitoring to reduce self-harm
repetition and health service costs.
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The True Colours inflammatory bowel disease (IBD) group has
expanded the True Colours schedule to include daily measures
of ulcerative colitis and Crohn’s disease symptoms, as well as
fortnightly quality-of-life and other validated measures of
disease activity. The initial aim of the True Colours IBD project
was to develop and test the feasibility of a predictive index of
IBD. A 6-month pilot in 66 patients supported the initial
feasibility of this system, with 76% adherence rate for daily
measures and 86% patient retention [43]. Further work has
supported associations between daily IBD symptom measures
and biological measures of disease activity [44], and this has
facilitated the prediction of whether escalation of therapy or
clinical investigation would be needed [45]. Qualitative findings
from this work suggest that patients felt more in control and
empowered by the True Colours IBD system [43].
Clinical Service Applications
Several of the noted research applications have evolved into the
use of True Colours for a purely patient monitoring and/or
clinician monitoring tool, despite little infrastructure and
resources to do so. As of January 10, 2019, almost 3000 patients
with any psychiatric condition and more than 700 clinicians
have registered with True Colours in adult community mental
health treatment service clinics across Oxfordshire and
Buckinghamshire. The uniqueness of this application of remote
monitoring of symptoms is in the individualized approach. This
enables patients to choose, in consultation with their health care
professional, how they would like to self-monitor, directly
aligning from qualitative work suggesting the preference of
flexibility and personalization in a symptom monitoring tool
[24]. The system has also been taken up by child and adolescent
mental health services across the Oxfordshire region, with
27,263 registered users.
True Colours IBD is a prime showcase of what True Colours
could evolve into—an integrated platform for individualized
patient and clinician monitoring of symptoms and quality-of-life
outcomes, with the potential to predict when more symptoms
are expected and prevent unnecessary clinic visits. With further
validation, the implications this model could have for reducing
health care costs and burden on individuals are extensive. Since
September 2019, there are currently more than 750 registered
IBD patients, within the John Radcliffe Hospital in Oxfordshire,
using True Colours as a monitoring tool. True Colours has also
been applied as a patient-reported outcome monitoring tool in
clinical service clinics, testing the effectiveness of Ketamine as
a therapy for treatment-resistant depression [46] and for
self-harm risk assessment as an extension to the ongoing pilot
work conducted by BIRSH [42]. Finally, the Collaborative Care
Model for BD is an ongoing project aimed at testing the
feasibility of True Colours in a primary care setting to
understand perspectives of the True Colours system from both
patients and clinicians. This project also aims to engage different
services (primary and secondary care clinicians) in the
collaborative treatment of patients through the sharing of True
Colours symptom ratings.
Discussion
Over the past decade, True Colours has transformed from a
simple text message prompt and reply system to a personalized
Web-based symptom monitoring tool. This tool is now applied
across a number of clinical populations and is integrated into
several clinics as part of routine clinical care across the
Oxfordshire and Buckinghamshire regions. A small team at the
University of Oxford and the Big Data Institute has been
supporting the continued use of True Colours and its application
across a wide range of settings. Despite the relatively little
resource that has been put into sustaining this system, its
progress and scale, to date, are quite impressive, largely driven
by small independent research grants.
The utility of True Colours as a research tool is unequivocal.
The existing research involving this tool has contributed to
considerable advancements in knowledge of mood instability
and its correlates in mood and personality disorders, which
would not have been possible with traditional aperiodic research
or clinic assessments. The potential linkage of True Colours’
patient-reported data to electronic medical records data currently
available within United Kingdom–Clinical Record Interactive
Search—a national research platform comprising deidentified
electronic patient medical records—could yield a rich source
of high-frequency phenotyping information for future research.
This data linkage could provide continuous measures of
patient-reported symptoms occurring in real time, which could
be mapped onto hospital visits and acute episodes of illness.
This could afford the opportunity to fill in the gaps between
clinic visits and determine early subsyndromal phases of illness
that could reflect targets for prevention of episode recurrence
or worsening of symptoms—a substantial scientific and clinical
resource.
In 2017, there were 325,000 mobile health apps available
internationally, including lifestyle interventions, symptoms
trackers, and personal coaches [47]. A vast majority of these
tools are not evidence based, and their ability to accurately
measure symptoms or feasibly engage patients is largely
unknown [48,49]. Only about 25% of digital health app users
continue using the app after 10 uses [50], indicating challenges
with low retention. Furthermore, with the rapid turnaround of
digital health apps, it is difficult to rigorously test their
effectiveness or implement into practice before they become
obsolete [51]. Other symptom monitoring platforms include the
Chrono-record [52], a computer-based symptom monitoring
system, and the MONitoring treatment and pRediCtion BD
episode system [53], an Android-based mobile phone objective
and subjective symptom monitoring system designed for patients
with BD. Patientslikeme [54] is a digital health platform in the
United Kingdom, which involves a Web-based system that
enables patients to track symptoms and view other members’
health information. The Patientslikeme platform currently has
600,000 registered users, and it is meant to produce data for
research purposes and provide empowerment and community
to patients to track their own symptoms. These tools are useful
in unique ways, but these are yet to have any integration with
clinical service. In addition, they are targeted toward specific
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conditions or the broad reporting of symptoms, some untethered
to validated measures.
In an era where the digital health market is becoming
increasingly saturated, careful integration of these tools within
the health care system is crucial [55]. There is a need to develop
digital remote monitoring tools that are evidence based [56],
with infrastructure to support secure and sensitive personal
information and enable the growth of the tool in tandem with
rapidly developing digital technologies. Obvious barriers to this
potential integration surround buy-in from health care providers,
the potential to create inefficiencies, and data security concerns.
This underscores the needed infrastructure for such a remote
monitoring tool in clinical practice, with education for clinicians
on its purpose and use, an electronic system with ease of access,
and the flexibility and support to tailor the service to different
patient populations and clinical care contexts. Uptake within
clinical service will be a challenge and will require support from
several participating parties.
What is unique about True Colours is the pilot work behind the
tool’s feasibility across different patient populations, and its
use alongside clinical judgement. Its evolution has been guided
by several feasibility studies, clinical and software development
expertise, and, most importantly, participant, patient, and
clinician feedback. The concept of True Colours as an integrated
clinical care model offers benefits to patients through the
returning of simple, visually effective symptom summaries,
empowering individuals to play an active role in their health,
which alone could have a therapeutic effect, as seen in other
areas of medicine, such as oncology [57,58]. For clinical
practice, this tool could enable clinicians to have access to
continuous health information from their patients unbound to
clinic visits, providing PROMs at higher frequencies and lending
insight into dynamic fluctuations in symptoms that cannot be
captured by traditional health measurement systems by
self-report measures recalling symptoms over long periods of
time. In turn, this could support real-time assessment and
management of chronic conditions while freeing up time and
resources for the National Health Service.
Acknowledgments
This work was funded by a Medical Research Council Mental Health Data Pathfinder Award. Additional funding for the True
Colours system has come from the National Institute for Health Research (NIHR) Oxford Health Biomedical Research Center.
This funding body had no role in the design, writing, or interpretation of this paper. The views expressed are those of the authors
and not necessarily those of the National Health Service, NIHR, or Department of Health.
Conflicts of Interest
JRG reports grants from United Kingdom Medical Research Council, grants from Wellcome, grants from NIHR, outside the
submitted work; JRG led the conception of True Colours, a digital phenotyping and outcome assessment tool, and JRG has
overseen its implementation in routine clinical practice and research studies. He is also an NIHR Senior Investigator and Director
of the NIHR Oxford Health Biomedical Research Centre. GG is an NIHR Emeritus Senior Investigator, holding shares in P1Vital
and P1Vital products, and has served as consultant, advisor, or CME speaker in the last 3 years for Allergan, Angelini, Compass
pathways, MSD, Janssen, Lundbeck (/Otsuka or /Takeda), Medscape, Minerva, P1Vital, Pfizer, Sage, Servier, Shire, and Sun
Pharma. All other authors report no conflict of interest related to this paper.
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Abbreviations
AMoSS: Automated Monitoring of Symptom Severity Study
BD: bipolar disorder
BDRN: BD Research Network
BIRSH: Brief Interventions for Self-Harm
ConBrio: Collaborative Network for Bipolar Research to Improve Outcomes
FIMM: Facilitated Integrated Mood Management
FWwTC: Feeling Well with True Colours
IBD: inflammatory bowel disease
NIHR: National Institute for Health Research
OxCaMS: Oxford Study of Calcium Channel Antagonism, Cognition, Mood instability and Sleep
OxLith: Oxford Lithium Trial
PROM: patient-reported outcome measure
RCT: randomized controlled trial
Edited by G Eysenbach; submitted 15.07.19; peer-reviewed by A Tsolaki, D Gustafson; comments to author 14.09.19; revised version
received 25.09.19; accepted 22.10.19; published 15.01.20
Please cite as:
Goodday SM, Atkinson L, Goodwin G, Saunders K, South M, Mackay C, Denis M, Hinds C, Attenburrow MJ, Davies J, Welch J,
Stevens W, Mansfield K, Suvilehto J, Geddes J
The True Colours Remote Symptom Monitoring System: A Decade of Evolution
J Med Internet Res 2020;22(1):e15188
URL: https://www.jmir.org/2020/1/e15188
doi: 10.2196/15188
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©Sarah M Goodday, Lauren Atkinson, Guy Goodwin, Kate Saunders, Matthew South, Clare Mackay, Mike Denis, Chris Hinds,
Mary-Jane Attenburrow, Jim Davies, James Welch, William Stevens, Karen Mansfield, Juulia Suvilehto, John Geddes. Originally
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... Smartphones in particular have been brought forward to play an important role in monitoring everyday fluctuations during treatment, in particular for the course of the illness, identification of an early treatment effect and prediction of upcoming deteriorations . The 'True Colors Remote Symptom Monitoring System' is a current example of digital monitoring for relapse prevention and can look back on a decade of digital patient monitoring ( Goodday et al., 2020 ), showing that digital phenotyping is closer to everyday clinical psychiatry, than sometimes assumed. The authors mention multiple benefits from this longitudinal monitoring program, including feedback towards patients, facilitating the interaction and letting them profit from playing an active role in their wellbeing ( Goodday et al., 2020 ). ...
... The 'True Colors Remote Symptom Monitoring System' is a current example of digital monitoring for relapse prevention and can look back on a decade of digital patient monitoring ( Goodday et al., 2020 ), showing that digital phenotyping is closer to everyday clinical psychiatry, than sometimes assumed. The authors mention multiple benefits from this longitudinal monitoring program, including feedback towards patients, facilitating the interaction and letting them profit from playing an active role in their wellbeing ( Goodday et al., 2020 ). Clinicians are also allowed to access continuous clinical data, showing fluctuations in symptom severity between visits which would remain unseen in traditional clinical monitoring visits ( Goodday et al., 2020 ), again facilitating patient profiling and stratification to inform treatment strategies. ...
... The authors mention multiple benefits from this longitudinal monitoring program, including feedback towards patients, facilitating the interaction and letting them profit from playing an active role in their wellbeing ( Goodday et al., 2020 ). Clinicians are also allowed to access continuous clinical data, showing fluctuations in symptom severity between visits which would remain unseen in traditional clinical monitoring visits ( Goodday et al., 2020 ), again facilitating patient profiling and stratification to inform treatment strategies. Here as well, it was shown, that efficacy can improve by optimizing the program and personalizing the level of resources needed, eventually directing resources towards those patients who would benefit most ( Goodday et al., 2020 ). ...
... Smartphones in particular have been brought forward to play an important role in monitoring everyday fluctuations during treatment, in particular for the course of the illness, identification of an early treatment effect and prediction of upcoming deteriorations . The 'True Colors Remote Symptom Monitoring System' is a current example of digital monitoring for relapse prevention and can look back on a decade of digital patient monitoring ( Goodday et al., 2020 ), showing that digital phenotyping is closer to everyday clinical psychiatry, than sometimes assumed. The authors mention multiple benefits from this longitudinal monitoring program, including feedback towards patients, facilitating the interaction and letting them profit from playing an active role in their wellbeing ( Goodday et al., 2020 ). ...
... The 'True Colors Remote Symptom Monitoring System' is a current example of digital monitoring for relapse prevention and can look back on a decade of digital patient monitoring ( Goodday et al., 2020 ), showing that digital phenotyping is closer to everyday clinical psychiatry, than sometimes assumed. The authors mention multiple benefits from this longitudinal monitoring program, including feedback towards patients, facilitating the interaction and letting them profit from playing an active role in their wellbeing ( Goodday et al., 2020 ). Clinicians are also allowed to access continuous clinical data, showing fluctuations in symptom severity between visits which would remain unseen in traditional clinical monitoring visits ( Goodday et al., 2020 ), again facilitating patient profiling and stratification to inform treatment strategies. ...
... The authors mention multiple benefits from this longitudinal monitoring program, including feedback towards patients, facilitating the interaction and letting them profit from playing an active role in their wellbeing ( Goodday et al., 2020 ). Clinicians are also allowed to access continuous clinical data, showing fluctuations in symptom severity between visits which would remain unseen in traditional clinical monitoring visits ( Goodday et al., 2020 ), again facilitating patient profiling and stratification to inform treatment strategies. Here as well, it was shown, that efficacy can improve by optimizing the program and personalizing the level of resources needed, eventually directing resources towards those patients who would benefit most ( Goodday et al., 2020 ). ...
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... ASRM, QIDS, EQ-5D and GAD-7 data were collected from 142 individuals as part of the AMoSS study [7] and the participants completed standardised questionnaires on a weekly basis using the True Colors mood monitoring system [18] after receiving a text or email prompt. Two of the 142 participants either withdrew consent or had no clinical diagnosis and were therefore excluded from analysis. ...
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The availability of mobile technologies has enabled the efficient collection of prospective longitudinal, ecologically valid self-reported clinical questionnaires from people with psychiatric diagnoses. These data streams have potential for improving the efficiency and accuracy of psychiatric diagnosis as well predicting future mood states enabling earlier intervention. However, missing responses are common in such datasets and there is little consensus as to how these should be dealt with in practice. In this study, the missing-response-incorporated log-signature method achieves roughly 74.8% correct diagnosis, with f1 scores for three diagnostic groups 66% (bipolar disorder), 83% (healthy control) and 75% (borderline personality disorder) respectively. This was superior to the naive model which excluded missing data and advanced models which implemented different imputation approaches, namely, k-nearest neighbours (KNN), probabilistic principal components analysis (PPCA) and random forest-based multiple imputation by chained equations (rfMICE). The log-signature method provided an effective approach to the analysis of prospectively collected mood data where missing data was common and should be considered as an approach in other similar datasets. Because of treating missing responses as a signal, its superiority also highlights that missing data conveys valuable clinical information.
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Background User feedback is crucial in the development of electronic self-monitoring tools for bipolar spectrum disorders (BSD). Previous studies have examined user experiences in small samples self-monitoring over relatively short time periods. We aimed to explore the experiences of a large sample of individuals with BSD engaged in long-term remote active electronic self-monitoring. Methods An online survey, containing closed and open questions, was sent to participants with BSD enrolled on the Bipolar Disorder Research Network (BDRN) True Colours mood-monitoring system. Questions related to experiences of using True Colours, including viewing mood graphs, and sharing data with healthcare professionals (HCPs) and/or family/friends. Results Response rate was 62.7 % (n = 362). 88.4 % reported finding using True Colours helpful. Commonly reported benefits were having a visual record of mood changes, patterns/triggers and identifying early warning signs. Limitations included questions not being comprehensive or revealing anything new. One third had shared their graphs, with 89.9 % finding it helpful to share with HCPs and 78.7 % helpful to share with family/friends. Perceived benefits included aiding communication and limitations included lack of interest/understanding from others. Limitations Responder bias may be present. Findings may not be generalisable to all research cohorts. Conclusions The majority of participants valued long-term self-monitoring. Personalisation and ease of use were important. A potential challenge is continued use when mood is long-term stable, highlighting the need for measures to be sensitive to small changes. Sharing self-monitoring data with HCPs may enhance communication of the lived experience of those with BSD. Future research should examine HCPs' perspectives.
Chapter
‘E-learning’ can be defined broadly as the use of internet technologies to deliver teaching and to enhance knowledge and performance. It is also referred to as web-based, online, distributed or internet-based learning (Ruiz et al. 2006). Many sites use ‘blended learning’, where e-learning is combined with in-person or virtual face-to-face instructor-led training. The increase in portability, power and connectivity of devices means that most smartphones can easily access information in real time (Marzano et al. 2017) and, of internet users worldwide, 93% access the internet via mobile devices (Johnson 2021). This means that access to the internet to gather information about mental health is immediate, but the vast number of information sites can easily become overwhelming for both patients and clinicians. A simple search for a single mental health topic generates a huge number and range of results. These vary from reviews of the evidence and primary research articles, to news articles and advertisements for treatment centres. The internet user is swamped with an array of sites of variable (and often unknown) quality, which are neither necessarily relevant to the original question nor ranked in order of reliability.
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Introduction Neurodegenerative and psychiatric disorders (NPDs) confer a huge health burden, which is set to increase as populations age. New, remotely delivered diagnostic assessments that can detect early stage NPDs by profiling speech could enable earlier intervention and fewer missed diagnoses. The feasibility of collecting speech data remotely in those with NPDs should be established. Methods and analysis The present study will assess the feasibility of obtaining speech data, collected remotely using a smartphone app, from individuals across three NPD cohorts: neurodegenerative cognitive diseases (n=50), other neurodegenerative diseases (n=50) and affective disorders (n=50), in addition to matched controls (n=75). Participants will complete audio-recorded speech tasks and both general and cohort-specific symptom scales. The battery of speech tasks will serve several purposes, such as measuring various elements of executive control (eg, attention and short-term memory), as well as measures of voice quality. Participants will then remotely self-administer speech tasks and follow-up symptom scales over a 4-week period. The primary objective is to assess the feasibility of remote collection of continuous narrative speech across a wide range of NPDs using self-administered speech tasks. Additionally, the study evaluates if acoustic and linguistic patterns can predict diagnostic group, as measured by the sensitivity, specificity, Cohen’s kappa and area under the receiver operating characteristic curve of the binary classifiers distinguishing each diagnostic group from each other. Acoustic features analysed include mel-frequency cepstrum coefficients, formant frequencies, intensity and loudness, whereas text-based features such as number of words, noun and pronoun rate and idea density will also be used. Ethics and dissemination The study received ethical approval from the Health Research Authority and Health and Care Research Wales (REC reference: 21/PR/0070). Results will be disseminated through open access publication in academic journals, relevant conferences and other publicly accessible channels. Results will be made available to participants on request. Trial registration number NCT04939818 .
Chapter
Mental health impacts the entire quality of life, psychological and physical well-being of people. There has been a serious rise in mental health issues reported worldwide. Yet, due to the lack of awareness and barriers to receiving mental healthcare such as social stigma, loss of confidentiality and financial limitations, majority of the mental health issues often go unreported. In today’s age of advanced Information and Communication Technology (ICT), various tools have been developed to offer mental healthcare services to the patients, right from the comfort of their home. Increasing access to smartphone applications and remote monitoring Internet of Things (IoT) systems offer people an opportunity of receiving therapy and consultation services in the most cost-effective and flexible manner. A range of mobile applications are commercially available to support the treatment of well-known anxiety and depression disorders; on the other hand, easy-to-access educational toys are also developed for improving cognitive and social skills of children. Despite the increasing acceptance of using digital technologies in the healthcare domain, there are some challenges associated with using these, specifically for mental healthcare. People may not have enough digital literacy to be able to use the smart technology applications and they also have concerns about security and confidentiality of their personal data. This chapter presents a detailed review of opportunities of using ICT for healthcare, various systems developed to provide mental health services, the challenges and future trends expected to further improve mental healthcare delivery in the near future.KeywordsMental healthICTAnxietyDepressionOnline therapies
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Background/aims: TrueColours ulcerative colitis (TCUC) is a comprehensive web-based program that functions through email, providing direct links to questionnaires. Several similar programs are available, however patient perspectives are unexplored. Methods: A pilot study was conducted to determine feasibility, usability and patient perceptions of real-time data collection (daily symptoms, fortnightly quality of life, 3 monthly outcomes). TCUC was adapted from a web-based program for patients with relapsing-remitting bipolar disorder, using validated UC indices. A semi-structured interview was developed and audio-recorded face-to-face interviews were conducted after 6 months of interaction with TCUC. Transcripts were coded in NVivo11, a qualitative data analysis software package. An inductive approach and thematic analysis was conducted. Results: TCUC was piloted in 66 patients for 6 months. Qualitative analysis currently defies statistical appraisal beyond "data saturation," even if it has more influence on clinical practice than quantitative data. A total of 28 face-to-face interviews were conducted. Six core themes emerged: awareness, control, decision-making, reassurance, communication and burden of treatment. There was a transcending overarching theme of patient empowerment, which cut across all aspects of the TCUC experience. Conclusions: Patient perception of the impact of real-time data collection was extremely positive. Patients felt empowered as a product of the self-monitoring format of TCUC, which may be a way of improving self-management of UC whilst also decreasing the burden on the individual and healthcare services.
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Background The discovery that voltage-gated calcium channel genes such as CACNA1C are part of the aetiology of psychiatric disorders has rekindled interest in the therapeutic potential of L-type calcium channel (LTCC) antagonists. These drugs, licensed to treat hypertension and angina, have previously been used in bipolar disorder, but without clear results. Neither is much known about the broader effects of these drugs on the brain and behaviour. Methods The Oxford study of Calcium channel Antagonism, Cognition, Mood instability and Sleep (OxCaMS) is a high-intensity randomised, double-blind, placebo-controlled experimental medicine study on the effect of the LTCC antagonist nicardipine in healthy young adults with mood instability. An array of cognitive, psychiatric, circadian, physiological, biochemical and neuroimaging (functional magnetic resonance imaging and magnetoencephalography) parameters are measured during a 4-week period, with randomisation to drug or placebo on day 14. We are interested in whether nicardipine affects the stability of these measures, as well as its overall effects. Participants are genotyped for the CACNA1C risk polymorphism rs1006737. Discussion The results will clarify the potential of LTCC antagonists for repurposing or modification for use in psychiatric disorders in which cognition, mood and sleep are affected. Trial registration ISRCTN, ISRCTN33631053. Retrospectively registered on 8 June 2018 (applied 17 May 2018). Electronic supplementary material The online version of this article (10.1186/s13063-019-3175-0) contains supplementary material, which is available to authorized users.
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Background A stepped wedge cluster randomised trial (SWCRT) is a multicentred study which allows an intervention to be rolled out at sites in a random order. Once the intervention is initiated at a site, all participants within that site remain exposed to the intervention for the remainder of the study. The time since the start of the study (“calendar time”) may affect outcome measures through underlying time trends or periodicity. The time since the intervention was introduced to a site (“exposure time”) may also affect outcomes cumulatively for successful interventions, possibly in addition to a step change when the intervention began. Methods Motivated by a SWCRT of self-monitoring for bipolar disorder, we conducted a simulation study to compare model formulations to analyse data from a SWCRT under 36 different scenarios in which time was related to the outcome (improvement in mood score). The aim was to find a model specification that would produce reliable estimates of intervention effects under different scenarios. Nine different formulations of a linear mixed effects model were fitted to these datasets. These models varied in the specification of calendar and exposure times. Results Modelling the effects of the intervention was best accomplished by including terms for both calendar time and exposure time. Treating time as categorical (a separate parameter for each measurement time-step) achieved the best coverage probabilities and low bias, but at a cost of wider confidence intervals compared to simpler models for those scenarios which were sufficiently modelled by fewer parameters. Treating time as continuous and including a quadratic time term performed similarly well, with slightly larger variations in coverage probability, but narrower confidence intervals and in some cases lower bias. The impact of misspecifying the covariance structure was comparatively small. Conclusions We recommend that unless there is a priori information to indicate the form of the relationship between time and outcomes, data from SWCRTs should be analysed with a linear mixed effects model that includes separate categorical terms for calendar time and exposure time. Prespecified sensitivity analyses should consider the different formulations of these time effects in the model, to assess their impact on estimates of intervention effects.
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Background: Hospitalized patients with cancer experience a high symptom burden, which is associated with poor health outcomes and increased healthcare utilization. However, studies investigating symptom monitoring interventions in this population are lacking. We conducted a pilot randomized trial to assess the feasibility and preliminary efficacy of a symptom monitoring intervention to improve symptom management in hospitalized patients with advanced cancer. Patients and methods: We randomly assigned patients with advanced cancer who were admitted to the inpatient oncology service to a symptom monitoring intervention or usual care. Patients in both arms self-reported their symptoms daily (Edmonton Symptom Assessment System and Patient Health Questionnaire-4). Patients assigned to the intervention had their symptom reports presented graphically with alerts for moderate/severe symptoms during daily team rounds. The primary endpoint of the study was feasibility. We defined the intervention as feasible if > 75% of participants hospitalized >2 days completed >2 symptom reports. We observed daily rounds to determine if clinicians discussed and developed a plan to address patients' symptoms. We used regression models to assess intervention effects on patients' symptoms throughout their hospitalization, readmission risk, and hospital length of stay (LOS). Results: Among 150 enrolled patients (81.1% enrollment), 94.2% completed >2 symptom reports. Clinicians discussed 60.4% of the symptom reports and developed a plan to address the symptoms highlighted by the symptom reports 20.8% of the time. Compared with usual care, intervention patients had a greater proportion of days with lower psychological distress (B=0.12, P=0.008), but no significant difference in the proportion of days with improved ESAS-physical symptoms (B=0.07, P=0.138). Intervention patients had lower readmission risk (hazard ratio=0.68, P=0.224), although this difference was not significant. We found no significant intervention effects on hospital LOS (B=0.16, P=0.862). Conclusions: This symptom monitoring intervention is feasible and demonstrates encouraging preliminary efficacy for improving patients' symptoms and readmission risk. ClinicalTrials.gov identifier NCT02891993.
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A growing number of clinical trials employ electronic media, in particular smartphones and tablets, to collect patient-reported outcome data. This is driven by the ubiquity of the technology, and an increased awareness of associated improvements in data integrity, quality and timeliness. Despite this, there remains a lingering question relating to the measurement equivalence of an instrument when migrated from paper to a screen-based format. As a result, researchers often must provide evidence demonstrating the measurement equivalence of paper and electronic versions, such as that recommended by the ISPOR ePRO Good Research Practices Task Force. In the last decade, a considerable body of work has emerged that overwhelmingly supports the measurement equivalence of instruments using screen-based electronic formats. Our review of key works derives recommendations on evidence needed to support electronic implementation. We recommend application of best practice recommendations is sufficient to conclude measurement equivalence with paper PROMs. In addition, we recommend that previous usability evidence in a representative group is sufficient, as opposed to per-study testing. Further, we conclude that this also applies to studies using multiple screen-based devices, including bring-your-own-device, if a minimum device specification can be ensured and the instrument is composed of standard response scale types.
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Background & aims Endoscopic assessment of ulcerative colitis (UC) is one of the most accurate measures of disease activity, but frequent endoscopic investigations are disliked by patients and expensive for the health care system. A minimally-invasive test that provides a surrogate measure of endoscopic activity is required. Methods Plasma Nuclear Magnetic Resonance (NMR) spectra from 40 patients with UC followed prospectively over 6 months were analysed with multivariate statistics. NMR metabolite profiles were compared with endoscopic (Ulcerative Colitis Endoscopic Index of Severity: UCEIS), histological (Nancy Index), and clinical (Simple Clinical Colitis Activity Index: SCCAI) severity indices, along with routine blood measurements. Results A blinded principal component analysis spontaneously separated metabolite profiles of patients with low (≤3) and high (>3) UCEIS. Orthogonal partial least squares discrimination analysis identified low and high UCEIS metabolite profiles with an accuracy of 77±5%. Plasma metabolites driving discrimination included decreases in lipoproteins and increases in isoleucine, valine, glucose, and myo-inositol in high compared to low UCEIS. This same metabolite profile distinguished between low (Nancy 0-1) and high histological activity (Nancy 3-4) with a modest though significant accuracy (65±6%) but was independent of SCCAI and all blood parameters measured. A different metabolite profile, dominated by changes in lysine, histidine, phenylalanine, and tyrosine, distinguished between improvement in UCEIS (decrease >1) and worsening (increase >1) over 6 months with an accuracy of 74±4%. Conclusion Plasma NMR metabolite analysis has the potential to provide a low-cost, minimally invasive technique that may be a surrogate for endoscopic assessment, with predictive capacity.
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The commercial market for technologies to monitor and improve personal health and sports performance is ever expanding. A wide range of smart watches, bands, garments, and patches with embedded sensors, small portable devices and mobile applications now exist to record and provide users with feedback on many different physical performance variables. These variables include cardiorespiratory function, movement patterns, sweat analysis, tissue oxygenation, sleep, emotional state, and changes in cognitive function following concussion. In this review, we have summarized the features and evaluated the characteristics of a cross-section of technologies for health and sports performance according to what the technology is claimed to do, whether it has been validated and is reliable, and if it is suitable for general consumer use. Consumers who are choosing new technology should consider whether it (1) produces desirable (or non-desirable) outcomes, (2) has been developed based on real-world need, and (3) has been tested and proven effective in applied studies in different settings. Among the technologies included in this review, more than half have not been validated through independent research. Only 5% of the technologies have been formally validated. Around 10% of technologies have been developed for and used in research. The value of such technologies for consumer use is debatable, however, because they may require extra time to set up and interpret the data they produce. Looking to the future, the rapidly expanding market of health and sports performance technology has much to offer consumers. To create a competitive advantage, companies producing health and performance technologies should consult with consumers to identify real-world need, and invest in research to prove the effectiveness of their products. To get the best value, consumers should carefully select such products, not only based on their personal needs, but also according to the strength of supporting evidence and effectiveness of the products.
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Background: Electronic longitudinal mood monitoring has been shown to be acceptable to patients with affective disorders within clinical settings, but its use in large-scale research has not yet been established. Methods: Using both postal and email invitations, we invited 4080 past research participants with affective disorders who were recruited into the Bipolar Disorder Research Network (BDRN) over a 10 year period to participate in online weekly mood monitoring. In addition, since January 2015 we have invited all newly recruited BDRN research participants to participate in mood monitoring at the point they were recruited into BDRN. Results: Online mood monitoring uptake among past participants was 20%, and among new participants to date was 46% with participants recruited over the last year most likely to register (61%). More than 90% mood monitoring participants engaged for at least one month, with mean engagement period greater than one year (58 weeks) and maximum engagement for longer than three years (165 weeks). There were no significant differences in the proportion of past and new BDRN participants providing data for at least 4 weeks (91%, 92% respectively), 3 months (78%, 82%), 6 months (65%, 54%) or one year (51%, 44%). Limitations: Our experiences with recruiting participants for electronic prospective mood monitoring may not necessarily generalise fully to research situations that are very different from those we describe. Conclusions: Large-scale electronic longitudinal mood monitoring in affective disorders for research purposes is feasible with uptake highest among newly recruited participants.
Article
Objectives To determine the compliance and clinical utility of weekly and daily mood symptom monitoring in adolescents and young adults at risk for mood disorder. Methods Fifty emerging adult offspring of bipolar parents were recruited from the Flourish Canadian high‐risk cohort study along with 108 university student controls. Participants were assessed by KSADS/SADS‐L semi‐structured interviews and used a remote capture method to complete weekly and daily mood symptom ratings using validated scales for 90 consecutive days. Hazard models and generalized estimating equations were used to determine differences in summary scores and regularity of ratings. Results 78% and 77% of high‐risk offspring and 97% and 93% of controls completed the first 30 days of weekly and daily ratings, respectively. There were no differences in drop‐out rates between groups over 90 days (high‐risk p=0.2149; controls p=0.9792). There were no differences in mean summary scores or regularity of weekly anxiety, depressive or hypomanic symptom ratings between high‐risk and control groups. However, high‐risk offspring compared to controls had daily ratings indicating lower positive affect and higher negative affect (p=0.0317). High‐risk offspring with remitted mood disorder compared to those without had more irregularity in weekly anxiety and depressive symptom ratings and daily ratings of lower positive affect, higher negative affect, and higher shame and self‐doubt (p=0.0365). Conclusions Findings support that high‐resolution symptom tracking may be a feasible and clinically useful approach to monitoring emerging psychopathology in young people at high‐risk of mood disorder onset or recurrence. This article is protected by copyright. All rights reserved.