Centre for Digital Transformation of Health - Research Publications
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ItemToward clinical digital phenotyping: a timely opportunity to consider purpose, quality, and safety.(Springer Science and Business Media LLC, 2019)The use of data generated passively by personal electronic devices, such as smartphones, to measure human function in health and disease has generated significant research interest. Particularly in psychiatry, objective, continuous quantitation using patients' own devices may result in clinically useful markers that can be used to refine diagnostic processes, tailor treatment choices, improve condition monitoring for actionable outcomes, such as early signs of relapse, and develop new intervention models. If a principal goal for digital phenotyping is clinical improvement, research needs to attend now to factors that will help or hinder future clinical adoption. We identify four opportunities for research directed toward this goal: exploring intermediate outcomes and underlying disease mechanisms; focusing on purposes that are likely to be used in clinical practice; anticipating quality and safety barriers to adoption; and exploring the potential for digital personalized medicine arising from the integration of digital phenotyping and digital interventions. Clinical relevance also means explicitly addressing consumer needs, preferences, and acceptability as the ultimate users of digital phenotyping interventions. There is a risk that, without such considerations, the potential benefits of digital phenotyping are delayed or not realized because approaches that are feasible for application in healthcare, and the evidence required to support clinical commissioning, are not developed. Practical steps to accelerate this research agenda include the further development of digital phenotyping technology platforms focusing on scalability and equity, establishing shared data repositories and common data standards, and fostering multidisciplinary collaborations between clinical stakeholders (including patients), computer scientists, and researchers.
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Iteme-Mental Health Program Usage Patterns in Randomized Controlled Trials and in the General Public to Inform External Validity Considerations: Sample Groupings Using Cluster Analyses.(JMIR Publications Inc., 2021-03-11)BACKGROUND: Randomized controlled trials (RCTs) with vigorous study designs are vital for determining the efficacy of treatments. Despite the high internal validity attributed to RCTs, external validity concerns limit the generalizability of results to the general population. Bias can be introduced, for example, when study participants who self-select into a trial are more motivated to comply with study conditions than are other individuals. These external validity considerations extend to e-mental health (eMH) research, especially when eMH tools are designed for public access and provide minimal or no supervision. OBJECTIVE: Clustering techniques were employed to identify engagement profiles of RCT participants and community users of a self-guided eMH program. This exploratory approach inspected actual, not theorized, RCT participant and community user engagement patterns. Both samples had access to the eMH program over the same time period and received identical usage recommendations on the eMH program website. The aim of this study is to help gauge expectations of similarities and differences in usage behaviors of an eMH tool across evaluation and naturalistic contexts. METHODS: Australian adults signed up to myCompass, a self-guided online treatment program created to reduce mild to moderate symptoms of negative emotions. They did so either by being part of an RCT onboarding (160/231, 69.6% female) or by accessing the program freely on the internet (5563/8391, 66.30% female) between October 2011 and October 2012. During registration, RCT participants and community users provided basic demographic information. Usage metrics (number of logins, trackings, and learning activities) were recorded by the system. RESULTS: Samples at sign-up differed significantly in age (P=.003), with community users being on average 3 years older (mean 41.78, SD 13.64) than RCT participants (mean 38.79, SD 10.73). Furthermore, frequency of program use was higher for RCT participants on all usage metrics compared to community users through the first 49 days after registration (all P values <.001). Two-step cluster analyses revealed 3 user groups in the RCT sample (Nonstarters, 10-Timers, and 30+-Timers) and 2 user groups in the community samples (2-Timers and 20-Timers). Groups seemed comparable in patterns of use but differed in magnitude, with RCT participant usage groups showing more frequent engagement than community usage groups. Only the high-usage group among RCT participants approached myCompass usage recommendations. CONCLUSIONS: Findings suggested that external validity concerns of RCT designs may arise with regards to the predicted magnitude of eMH program use rather than overall usage styles. Following up RCT nonstarters may help provide unique insights into why individuals choose not to engage with an eMH program despite generally being willing to participate in an eMH evaluation study. Overestimating frequency of engagement with eMH tools may have theoretical implications and potentially impact economic considerations for plans to disseminate these tools to the general public.
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ItemDigital health at fifteen: more human (more needed).(Springer Science and Business Media LLC, 2019-03-18)There is growing appreciation that the success of digital health - whether digital tools, digital interventions or technology-based change strategies - is linked to the extent to which human factors are considered throughout design, development and implementation. A shift in focus to individuals as users and consumers of digital health highlights the capacity of the field to respond to secular developments, such as the adoption of person-centred care and consumer health technologies. We argue that this project is not only incomplete, but is fundamentally 'uncompletable' in the face of a highly dynamic landscape of both technological and human challenges. These challenges include the effects of consumerist, technology-supported care on care delivery, the rapid growth of digital users in low-income and middle-income countries and the impacts of machine learning. Digital health research will create most value by retaining a clear focus on the role of human factors in maximising health benefit, by helping health systems to anticipate and understand the person-centred effects of technology changes and by advocating strongly for the autonomy, rights and safety of consumers.
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ItemA cluster randomised controlled trial evaluating the effectiveness of eHealth-supported patient recruitment in primary care research: the TRANSFoRm study protocol.(Springer Science and Business Media LLC, 2015-02-03)BACKGROUND: Opportunistic recruitment is a highly laborious and time-consuming process that is currently performed manually, increasing the workload of already busy practitioners and resulting in many studies failing to achieve their recruitment targets. The Translational Medicine and Patient Safety in Europe (TRANSFoRm) platform enables automated recruitment, data collection and follow-up of patients, potentially improving the efficiency, time and costs of clinical research. This study aims to assess the effectiveness of TRANSFoRm in improving patient recruitment and follow-up in primary care trials. METHODS/DESIGN: This multi-centre, parallel-arm cluster randomised controlled trial will compare TRANSFoRm-supported with standard opportunistic recruitment. Participants will be general practitioners and patients with gastro-oesophageal reflux disease from 40 primary care centres in five European countries. Randomisation will take place at the care centre level. The intervention arm will use the TRANSFoRm tools for recruitment, baseline data collection and follow-up. The control arm will use web-based case report forms and paper self-completed questionnaires. The primary outcome will be the proportion of eligible patients successfully recruited at the end of the 16-week recruitment period. Secondary outcomes will include the proportion of recruited patients with complete baseline and follow-up data and the proportion of participants withdrawn or lost to follow-up. The study will also include an economic evaluation and measures of technology acceptance and user experience. DISCUSSION: The study should shed light on the use of eHealth to improve the effectiveness of recruitment and follow-up in primary care research and provide an evidence base for future eHealth-supported recruitment initiatives. Reporting of results is expected in October 2015. TRIAL REGISTRATION: EudraCT: 2014-001314-25.
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ItemThe evolution of mobile apps for asthma: an updated systematic assessment of content and tools.(Springer Science and Business Media LLC, 2015-03-23)BACKGROUND: Interest in mobile apps that support long-term conditions such as asthma is matched by recognition of the importance of the quality and safety of apps intended for patient use. We assessed how changes over a 2-year period affected the clinical suitability of apps providing self-management information and tools for people with asthma by updating a review first performed in 2011. METHODS: Systematic content assessment of all apps for iOS and Android examining the comprehensiveness of asthma information, consistency with the evidence base for asthma self-management and adherence to best practice principles for trustworthy content, comparing the quality of apps available in 2011 to those released since. RESULTS: Between 2011 and 2013, numbers of asthma apps more than doubled from 93 to 191, despite withdrawal of 25% (n = 23/93) of existing apps. Newer apps were no more likely than those available in 2011 to include comprehensive information, such as the use of action plans, or offer guidance consistent with evidence; 13% (n = 19/147) of all apps, and 39% (n = 9/23) of those intended to manage acute asthma, recommended self-care procedures unsupported by evidence. Despite increases in the numbers of apps targeting specific skills, such as acute asthma management (n = 12 to 23) and inhaler technique (from n = 2 to 12), the proportion consistent with guidelines (17%, n = 4/23) and inhaler instructions (25%, n = 3/12), respectively, was low, and most apps provided only either basic information about asthma (50%, n = 75/147) or simple diary functions (24%, n = 36/147). CONCLUSIONS: In addition to persisting questions about clinical quality and safety, dynamic aspects of app turnover and feature evolution affect the suitability of asthma apps for use in routine care. The findings underline the need for coordinated quality assurance processes that can adapt to changing clinical and information governance-related risks, ensure compliance with the evidence base and reflect local variations in clinical practice. It is unclear if substantial clinical benefits can be realized from a landscape dominated by low quality generic information apps and tools that do not adhere to accepted medical practice.
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ItemImpact of 'stretch' targets for cardiovascular disease management within a local pay-for-performance programme.(Public Library of Science (PLoS), 2015)Pay-for-performance programs are often aimed to improve the management of chronic diseases. We evaluate the impact of a local pay for performance programme (QOF+), which rewarded financially more ambitious quality targets ('stretch targets') than those used nationally in the Quality and Outcomes Framework (QOF). We focus on targets for intermediate outcomes in patients with cardiovascular disease and diabetes. A difference-in-difference approach is used to compare practice level achievements before and after the introduction of the local pay for performance program. In addition, we analysed patient-level data on exception reporting and intermediate outcomes utilizing an interrupted time series analysis. The local pay for performance program led to significantly higher target achievements (hypertension: p-value <0.001, coronary heart disease: p-values <0.001, diabetes: p-values <0.061, stroke: p-values <0.003). However, the increase was driven by higher rates of exception reporting (hypertension: p-value <0.001, coronary heart disease: p-values <0.03, diabetes: p-values <0.05) in patients with all conditions except for stroke. Exception reporting allows practitioners to exclude patients from target calculations if certain criteria are met, e.g. informed dissent of the patient for treatment. There were no statistically significant improvements in mean blood pressure, cholesterol or HbA1c levels. Thus, achievement of higher payment thresholds in the local pay for performance scheme was mainly attributed to increased exception reporting by practices with no discernable improvements in overall clinical quality. Hence, active monitoring of exception reporting should be considered when setting more ambitious quality targets. More generally, the study suggests a trade-off between additional incentive for better care and monitoring costs.
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ItemUnaddressed privacy risks in accredited health and wellness apps: a cross-sectional systematic assessment.(Springer Science and Business Media LLC, 2015-09-07)BACKGROUND: Poor information privacy practices have been identified in health apps. Medical app accreditation programs offer a mechanism for assuring the quality of apps; however, little is known about their ability to control information privacy risks. We aimed to assess the extent to which already-certified apps complied with data protection principles mandated by the largest national accreditation program. METHODS: Cross-sectional, systematic, 6-month assessment of 79 apps certified as clinically safe and trustworthy by the UK NHS Health Apps Library. Protocol-based testing was used to characterize personal information collection, local-device storage and information transmission. Observed information handling practices were compared against privacy policy commitments. RESULTS: The study revealed that 89% (n = 70/79) of apps transmitted information to online services. No app encrypted personal information stored locally. Furthermore, 66% (23/35) of apps sending identifying information over the Internet did not use encryption and 20% (7/35) did not have a privacy policy. Overall, 67% (53/79) of apps had some form of privacy policy. No app collected or transmitted information that a policy explicitly stated it would not; however, 78% (38/49) of information-transmitting apps with a policy did not describe the nature of personal information included in transmissions. Four apps sent both identifying and health information without encryption. Although the study was not designed to examine data handling after transmission to online services, security problems appeared to place users at risk of data theft in two cases. CONCLUSIONS: Systematic gaps in compliance with data protection principles in accredited health apps question whether certification programs relying substantially on developer disclosures can provide a trusted resource for patients and clinicians. Accreditation programs should, as a minimum, provide consistent and reliable warnings about possible threats and, ideally, require publishers to rectify vulnerabilities before apps are released.
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ItemSmartphone apps for calculating insulin dose: a systematic assessment.(Springer Science and Business Media LLC, 2015-05-06)BACKGROUND: Medical apps are widely available, increasingly used by patients and clinicians, and are being actively promoted for use in routine care. However, there is little systematic evidence exploring possible risks associated with apps intended for patient use. Because self-medication errors are a recognized source of avoidable harm, apps that affect medication use, such as dose calculators, deserve particular scrutiny. We explored the accuracy and clinical suitability of apps for calculating medication doses, focusing on insulin calculators for patients with diabetes as a representative use for a prevalent long-term condition. METHODS: We performed a systematic assessment of all English-language rapid/short-acting insulin dose calculators available for iOS and Android. RESULTS: Searches identified 46 calculators that performed simple mathematical operations using planned carbohydrate intake and measured blood glucose. While 59% (n = 27/46) of apps included a clinical disclaimer, only 30% (n = 14/46) documented the calculation formula. 91% (n = 42/46) lacked numeric input validation, 59% (n = 27/46) allowed calculation when one or more values were missing, 48% (n = 22/46) used ambiguous terminology, 9% (n = 4/46) did not use adequate numeric precision and 4% (n = 2/46) did not store parameters faithfully. 67% (n = 31/46) of apps carried a risk of inappropriate output dose recommendation that either violated basic clinical assumptions (48%, n = 22/46) or did not match a stated formula (14%, n = 3/21) or correctly update in response to changing user inputs (37%, n = 17/46). Only one app, for iOS, was issue-free according to our criteria. No significant differences were observed in issue prevalence by payment model or platform. CONCLUSIONS: The majority of insulin dose calculator apps provide no protection against, and may actively contribute to, incorrect or inappropriate dose recommendations that put current users at risk of both catastrophic overdose and more subtle harms resulting from suboptimal glucose control. Healthcare professionals should exercise substantial caution in recommending unregulated dose calculators to patients and address app safety as part of self-management education. The prevalence of errors attributable to incorrect interpretation of medical principles underlines the importance of clinical input during app design. Systemic issues affecting the safety and suitability of higher-risk apps may require coordinated surveillance and action at national and international levels involving regulators, health agencies and app stores.
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ItemBiofeedback for treatment of awake and sleep bruxism in adults: systematic review protocol.(Springer Science and Business Media LLC, 2014-05-02)BACKGROUND: Bruxism is a disorder of jaw-muscle activity characterised by repetitive clenching or grinding of the teeth which results in discomfort and damage to dentition. The two clinical manifestations of the condition (sleep and awake bruxism) are thought to have unrelated aetiologies but are palliated using similar techniques. The lack of a definitive treatment has prompted renewed interest in biofeedback, a behaviour change method that uses electronic detection to provide a stimulus whenever bruxism occurs. This systematic review aims to provide a comprehensive overview of the state of research into biofeedback for bruxism; to assess the efficacy and acceptability of biofeedback therapy in management of awake bruxism and, separately, sleep bruxism in adults; and to compare findings between the two variants. METHODS: A systematic review of published literature examining biofeedback as an intervention directed at controlling primary bruxism in adults. We will search electronic databases and the grey literature using a predefined search strategy to identify randomised and non-randomised studies, technical reports and patents. Searches will not be restricted by language or date and will be expanded through contact with authors and experts, and by following up reference lists and citations. Two authors, working independently, will conduct screening of search results, study selection, data extraction and quality assessment and a third will resolve any disagreements. The primary outcomes of acceptability and effectiveness will be assessed using only randomised studies, segregated by bruxism subtype. A meta-analysis of these data will be conducted only if pre-defined conditions for quality and heterogeneity are met, otherwise the data will be summarized in narrative form. Data from non-randomised studies will be used to augment a narrative synthesis of the state of technical developments and any safety-related issues. PROSPERO registration number: CRD42013006880. DISCUSSION: Biofeedback is not new, but its place in the clinical management of bruxism remains unclear. New research, and the availability of miniaturized consumer-grade devices, makes a systematic review timely to guide treatment decisions and inform future research.
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ItemApps for asthma self-management: a systematic assessment of content and tools.(Springer Science and Business Media LLC, 2012-11-22)BACKGROUND: Apps have been enthusiastically adopted by the general public. They are increasingly recognized by policy-makers as a potential medium for supporting self-management of long-term conditions. We assessed the degree to which current smartphone and tablet apps for people with asthma offer content and tools of appropriate quality to support asthma self-management. METHODS: We adapted systematic review methodology to the assessment of apps. We identified English-language asthma apps for all ages through a systematic search of official app stores. We systematically assessed app content using criteria derived from international guidelines and systematic review of strategies for asthma self-management. We covered three domains: comprehensiveness of asthma information, consistency of advice with evidence and compliance with health information best practice principles. RESULTS: We identified 103 apps for asthma in English, of which 56 were sources of information about the condition and 47 provided tools for the management of asthma. No apps offered both types of functionality. Only three information apps approached our definition of comprehensiveness of information about asthma. No apps provided advice on lay management of acute asthma that included details of appropriate reliever medication use. In 32 of 72 instances, apps made unequivocal recommendations about strategies for asthma control or prophylaxis that were unsupported by current evidence. Although 90% of apps stated a clear purpose, compliance with other best practice principles for health information was variable. Contact details were located for 55%, funding source for 18% and confidentiality policy for 17%. CONCLUSIONS: No apps for people with asthma combined reliable, comprehensive information about the condition with supportive tools for self-management. Healthcare professionals considering recommending apps to patients as part of asthma self-management should exercise caution, recognizing that some apps like calculators may be unsafe; that no current app will meet the need of every patient; and that ways of working must be adapted if apps are to be introduced, supported and sustained in routine care. Policy-makers need to consider the potential role for assurance mechanisms in relation to apps. There remains much to be done if apps are to find broad use in clinical practice; clinicians cannot recommend tools that are inaccurate, unsafe or lack an evidence base.