Acceptability of a digital health intervention alongside physiotherapy to support patients following anterior cruciate ligament reconstruction.

BACKGROUND: Physiotherapy rehabilitation following surgical reconstruction to the Anterior Cruciate Ligament (ACL) can take up to 12 months to complete. Given the lengthy rehabilitation process, a blended intervention can be used to compliment face-to-face physiotherapy with a digital exercise intervention. In this study, we used TRAK, a web-based tool that has been developed to support knee rehabilitation, which provides individually tailored exercise programs with videos, instructions and progress logs for each exercise, relevant health information and a contact option that allows a patient to email a physiotherapist for additional support. The aim of this study was to evaluate the acceptability of TRAK-based blended intervention in post ACL reconstruction rehabilitation. METHODS: A qualitative research design using semi-structured interviews was used on a convenience sample of participants following an ACL reconstruction, and their treating physiotherapists, in a London NHS hospital. Participants were asked to use TRAK alongside face-to-face physiotherapy for 16 weeks. Interviews were carried out, audio recorded, transcribed verbatim and coded by two researchers independently. Data were analyzed using thematic analysis. RESULTS: Of the 25 individuals that were approached to be part of the study, 24 consented, comprising 8 females and 16 males, mean age 30 years. 17 individuals used TRAK for 16 weeks and were available for interview. Four physiotherapists were also interviewed. The six main themes identified from patients were: the experience of TRAK rehabilitation, personal characteristics for engagement, strengths and weaknesses of the intervention, TRAK in the future and attitudes to digital healthcare. The main themes from the physiotherapist interviews were: potential benefits, availability of resources and service organization to support use of TRAK. CONCLUSIONS: TRAK was found to be an acceptable method of delivering ACL rehabilitation alongside face-to-face physiotherapy. Patients reported that TRAK, specifically the videos, increased their confidence and motivation with their rehabilitation. They identified ways in which TRAK could be developed in the future to meet technological expectations and further support rehabilitation. For Physiotherapists time and availability of computers affected acceptability. Organization of care to support integration of digital exercise interventions such as TRAK into a blended approach to rehabilitation is required.

Financial Incentives and Inequalities in Smoking Cessation Interventions in Primary Care: Before-and-After Study.

INTRODUCTION: The Quality and Outcomes Framework (QOF) is a financial incentive scheme that rewards UK general practices for providing evidence-based care, including smoking cessation advice mainly as a secondary prevention intervention. We examined the effects on smoking outcomes and inequalities of a local version of QOF (QOF+), which ran from 2008 to 2011 and extended financial incentives to the provision of cessation advice as a primary prevention intervention. METHODS: Before-and-after study using data from 28 general practices in Hammersmith & Fulham, London, United Kingdom. We used logistic regression to examine changes in smoking outcomes associated with QOF+ within and between sociodemographic groups. RESULTS: Recording of smoking status increased from 55.5% to 64.3% for men (P < .001) and from 67.9% to 75.8% for women (P < .001). All groups benefitted from the increase, but younger patients remained less likely to be asked about smoking than older patients. White patients were less likely to be asked than those from other ethnic groups. Smoking cessation advice increased from 32.7% to 54.0% for men (P < .001) and from 35.4% to 54.1% for women (P < .01) and there was little variation between groups for this outcome. Recorded smoking prevalence reduced from 25.0% to 20.8% for men (P < .001) and from 16.1% to 12.5% for women (P < .001). White patients and those from more deprived areas remained more likely to be smokers than other groups. CONCLUSION: The introduction of QOF+ was associated with general improvements in recording of smoking outcomes, but inequalities in ascertainment and smoking prevalence with respect to age, ethnicity, and deprivation persisted.

The Effectiveness of Prompts to Promote Engagement With Digital Interventions: A Systematic Review.

BACKGROUND: Digital interventions have been effective in improving numerous health outcomes and health behaviors; furthermore, they are increasingly being used in different health care areas, including self-management of long-term conditions, mental health, and health promotion. The full potential of digital interventions is hindered by a lack of user engagement. There is an urgent need to develop effective strategies that can promote users' engagement with digital interventions. One potential method is the use of technology-based reminders or prompts. OBJECTIVE: To evaluate the effectiveness of technology-based strategies for promoting engagement with digital interventions. METHODS: Cochrane Collaboration guidelines on systematic review methodology were followed. The search strategy was executed across 7 electronic databases: the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, Web of Science, the Education Resources Information Center (ERIC), PsycINFO, and the Cumulative Index to Nursing and Allied Health Literature (CINAHL). Databases were searched from inception to September 13, 2013, with no language or publication type restrictions, using three concepts: randomized controlled trials, digital interventions, and engagement. Gray literature and reference lists of included studies were also searched. Titles and abstracts were independently screened by 2 authors, then the full texts of potentially eligible papers were obtained and double-screened. Data from eligible papers were extracted by one author and checked for accuracy by another author. Bias was assessed using the Cochrane risk of bias assessment tool. Narrative synthesis was performed on all included studies and, where appropriate, data were pooled using meta-analysis. All findings were reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. RESULTS: A total of 14 studies were included in the review with 8774 participants. Of the 14 studies, 9 had sufficient data to be included in the meta-analyses. The meta-analyses suggested that technology-based strategies can potentially promote engagement compared to no strategy for dichotomous outcomes (relative risk [RR] 1.27, 95% CI 1.01-1.60, I(2)=71%), but due to considerable heterogeneity and the small sample sizes in most studies, this result should be treated with caution. No studies reported adverse or economic outcomes. Only one study with a small sample size compared different characteristics; the study found that strategies promoting new digital intervention content and those sent to users shortly after they started using the digital intervention were more likely to engage users. CONCLUSIONS: Overall, studies reported borderline positive effects of technology-based strategies on engagement compared to no strategy. However, the results have to be interpreted with caution. More research is needed to replicate findings and understand which characteristics of the strategies are effective in promoting engagement and how cost-effective they are.

Qualitative user experience evaluation of the MS trust's online treatment decision aid tool's accommodation of planning pregnancy.

Background: Decision-making about treatment when planning a pregnancy (family planning) is complex for women living with multiple sclerosis (MS). Decision tools can help this process, in 2016 MS Trust launched their online digital treatment decision tool to support people with MS. Objectives: To evaluate user-experience of this tool by exploring women's opinions about its content, interface, and usefulness in the context of family planning; and to synthesize recommendations to improve the tool. Methods: Thirty participants qualitatively evaluated the tool using Think Aloud methodology. Sessions were conducted online using Microsoft Teams and were video recorded. Transcription was automated and data were thematically analyzed. Results: Women's first impression was that the tool presented a lot of information at once, which was difficult to take in, and they found it difficult to navigate. Although the tool was helpful in allowing them to compare treatment options, the filters were confusing, and the information related to pregnancy sometimes contradicted advice from their healthcare practitioners. They suggested rewording the pregnancy recommendations and filters, updating some content, and making some changes to the interface to meet users' cognitive needs. Conclusion: The MS Trust treatment decision tool is excellent in helping women with treatment choices at initial diagnosis. However, it is not currently as useful when considering family plans. Recommendations were conveyed to MS Trust where some are now applied to the new live version and the rest are to be considered for future updating projects.

Prevalence and predictors of water pipe and cigarette smoking among secondary school students in London.

INTRODUCTION: Water pipe tobacco smoking appears to be an increasing public health concern, with anecdotal reports of higher prevalence than cigarette smoking among young people in some high-income countries. We examined the prevalence and predictors of water pipe and cigarette smoking among students attending secondary schools in a deprived, ethnically diverse part of inner London. METHODS: We conducted a 96-item, validated smoking habits questionnaire with 2,399 students from Years 8, 10, and 12/13 from 15 secondary schools in Brent, northwest London. Multilevel logistic regression models were used to examine predictors of current and ever cigarette and water pipe smoking. RESULTS: Current water pipe smoking prevalence was more than double that of cigarette smoking prevalence (7.6% vs. 3.4%, p < .001). One in 4 students had tried water pipe compared with 1 in 6 who had tried cigarette smoking (24.0% vs. 15.8%, p < .001). Significant predictors of ever water pipe use include being in a higher age group, South Asian or Middle Eastern ethnicity, and personal, family, or friends tobacco use. Significant predictors of ever cigarette use include being in a higher age group, White ethnicity, and personal, family, or friends tobacco use. Students attending schools with more water pipe cafes within 0.5 miles were more likely to be current water pipe users (AOR = 2.43, 95% CI = 1.33-4.42). CONCLUSIONS: Water pipe smoking may be more prevalent than cigarette smoking among young people in some high-income countries. Improved surveillance and dedicated tobacco control interventions are required to better understand the epidemiology of water pipe use and address its growing use.

Beyond guidelines: A qualitative clinical stakeholder study of optimal management of anterior cruciate ligament rehabilitation.

AIMS: This study gathered expert perspectives in the management of anterior cruciate ligament (ACL) rehabilitation to explore current practice, variations in care and optimal management strategies. MATERIALS AND METHODS: This was a qualitative semi-structured interview study. The participants' experiences were considered in terms of their roles as employees, managers, clinicians and professional gatekeepers. Purposive and snowball sampling were used to recruit physiotherapists and orthopaedic surgeons. Participants were included if they had a proven record in clinical management or research involving ACL patients. Persons were excluded if they could not speak English. Interviews were conducted in person, via skype or over the phone at a time convenient to the participant. Data was analysed using a framework analysis and critical realist approach. RESULTS: Results included 24 interviews that were conducted with 19 physiotherapists and 5 surgeons. Themes of variation in current care and optimal care were explored including subthemes of patient centred practice, evidence based medicine, resources, self-management, multidisciplinary teamwork, training and expertise were explored. Participant's perceptions of current care were that it was a location 'lottery' that significantly varied for patients across the UK. CONCLUSIONS: Stakeholders identified that optimal management should be patient centred and incorporate adequate equipment, specific training for physiotherapists and a closely communicating multidisciplinary team. Research is needed to explore cost effective models of optimal rehabilitation that include return to sport strategies.

Impact of fatigue as the primary determinant of functional limitations among patients with post-COVID-19 syndrome: a cross-sectional observational study.

OBJECTIVES: To describe self-reported characteristics and symptoms of treatment-seeking patients with post-COVID-19 syndrome (PCS). To assess the impact of symptoms on health-related quality of life (HRQoL) and patients' ability to work and undertake activities of daily living. DESIGN: Cross-sectional single-arm service evaluation of real-time user data. SETTING: 31 post-COVID-19 clinics in the UK. PARTICIPANTS: 3754 adults diagnosed with PCS in primary or secondary care deemed suitable for rehabilitation. INTERVENTION: Patients using the Living With Covid Recovery digital health intervention registered between 30 November 2020 and 23 March 2022. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was the baseline Work and Social Adjustment Scale (WSAS). WSAS measures the functional limitations of the patient; scores of ≥20 indicate moderately severe limitations. Other symptoms explored included fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue), depression (Patient Health Questionnaire-Eight Item Depression Scale), anxiety (Generalised Anxiety Disorder Scale, Seven-Item), breathlessness (Medical Research Council Dyspnoea Scale and Dyspnoea-12), cognitive impairment (Perceived Deficits Questionnaire, Five-Item Version) and HRQoL (EQ-5D). Symptoms and demographic characteristics associated with more severe functional limitations were identified using logistic regression analysis. RESULTS: 3541 (94%) patients were of working age (18-65); mean age (SD) 48 (12) years; 1282 (71%) were female and 89% were white. 51% reported losing ≥1 days from work in the previous 4 weeks; 20% reported being unable to work at all. Mean WSAS score at baseline was 21 (SD 10) with 53% scoring ≥20. Factors associated with WSAS scores of ≥20 were high levels of fatigue, depression and cognitive impairment. Fatigue was found to be the main symptom contributing to a high WSAS score. CONCLUSION: A high proportion of this PCS treatment-seeking population was of working age with over half reporting moderately severe or worse functional limitation. There were substantial impacts on ability to work and activities of daily living in people with PCS. Clinical care and rehabilitation should address the management of fatigue as the dominant symptom explaining variation in functionality.

Assessing the Acceptability and Effectiveness of Mobile-Based Physical Activity Interventions for Midlife Women During Menopause: Systematic Review of the Literature.

BACKGROUND: Midlife women with menopausal symptoms are less likely to meet the recommended level of physical activity (PA). Promoting PA among women in midlife could reduce their risk of cardiovascular diseases and perhaps improve menopausal symptoms. Mobile PA interventions in the form of smartphone apps and wearable activity trackers can potentially encourage users to increase PA levels and address time and resource barriers to PA. However, evidence on the acceptability and effectiveness of these interventions among midlife women is unclear. OBJECTIVE: This systematic review evaluated the effectiveness, acceptability, and active behavior change techniques (BCTs) of mobile PA technologies among midlife menopausal women. METHODS: A mixed methods systematic review of qualitative and quantitative studies was conducted. MEDLINE (Ovid), Embase, Scopus, CINAHL, Web of Science, SPORTDiscus, CENTRAL, PsycINFO, and the ProQuest Sports Medicine and Education Index were systematically searched. Studies were selected and screened according to predetermined eligibility criteria. In total, 2 reviewers independently assessed the risk of bias using the Mixed Methods Appraisal Tool and completed BCT mapping of the included interventions using the BCT Taxonomy v1. RESULTS: A total of 12 studies were included in this review. Overall risk of bias was "Moderate to high" in 58% (7/12) of the included studies and "low" in 42% (5/12) of the studies. Of the 12 studies, 7 (58%) assessed changes in PA levels. The pooled effect size of 2 randomized controlled trials resulted in a small to moderate increase in moderate to vigorous PA of approximately 61.36 weekly minutes among midlife women, at least in the short term (95% CI 17.70-105.01; P=.006). Although a meta-analysis was not feasible because of heterogeneity, positive improvements were also found in a range of menopause-related outcomes such as weight reduction, anxiety management, sleep quality, and menopause-related quality of life. Midlife women perceived mobile PA interventions to be acceptable and potentially helpful in increasing PA and daily steps. The average number of BCTs per mobile PA intervention was 8.8 (range 4-13) according to the BCT Taxonomy v1. "Self-monitoring of behaviour," "Biofeedback," and "Goal setting (behaviour)" were the most frequently described BCTs across the included interventions. CONCLUSIONS: This review demonstrated that mobile PA interventions in the form of smartphone apps and wearable trackers are potentially effective for small to moderate increases in moderate to vigorous PA among midlife women with menopausal symptoms. Although menopause is a natural condition affecting half the population worldwide, there is a substantial lack of evidence to support the acceptability and effectiveness of mobile PA interventions on menopause-related outcomes, which needs further investigation. TRIAL REGISTRATION: PROSPERO CRD42021273062; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=273062.

Digital Health Intervention Design and Deployment for Engaging Demographic Groups Likely to Be Affected by the Digital Divide: Protocol for a Systematic Scoping Review.

BACKGROUND: Digital health interventions refer to interventions designed to support health-related knowledge transfer and are delivered via digital technologies, such as mobile apps. Digital health interventions are a double-edged sword: they have the potential to reduce health inequalities, for example, by making treatments available remotely to rural populations underserved by health care facilities or by helping to overcome language barriers via in-app translation services; however, if not designed and deployed with care, digital health interventions also have the potential to increase health inequalities and exacerbate the effects of the digital divide. OBJECTIVE: The aim of this study is to review ways to mitigate the digital divide through digital health intervention design, deployment, and engagement mechanisms sensitive to the needs of digitally excluded populations. METHODS: This protocol outlines the procedure for a systematic scoping review that follows the methodology recommended by the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) guidance. The following databases will be searched for primary research studies published in English from October 1, 2011, to October 1, 2021: Cochrane Library, Epistemonikos, NICE Evidence, PROSPERO, PubMed (with MEDLINE and Europe PMC), and Trip. In addition, the following sources of gray literature will be searched: Conference Proceedings Citation Index, Health Management Information Consortium, International HTA Database, OpenGrey, The Grey Literature Report, Google Scholar Basic Search UK, MedNar Deep Web Search Engine, and Carrot2. We will select publications that meet the following inclusion criteria: primary research papers that evaluated digital health interventions that describe features of digital health intervention design and deployment that enable or hinder access to and engagement with digital health interventions by adults from demographic groups likely to be affected by the digital divide (eg, older age, minority ethnic groups, lower income, and lower education level). A random selection of 25 publications identified from the search will be double screened by four reviewers. If there is >75% agreement for included/excluded publications, the team will continue to screen all the identified publications. For all included publications, study characteristics will be extracted by one author and checked for agreement by a second author, with any disagreements resolved by consensus among the study team. Consultation digital health intervention design and deployment, and digital health intervention users will also be conducted in parallel. RESULTS: The review is underway and is anticipated to be completed by September 2022. CONCLUSIONS: The results will have implications for researchers and policy makers using digital health interventions for health improvement peripandemic and post pandemic, and will inform best practices in the design and delivery of digital health interventions. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/32538.

Development, deployment and evaluation of digitally enabled, remote, supported rehabilitation for people with long COVID-19 (Living With COVID-19 Recovery): protocol for a mixed-methods study.

INTRODUCTION: Long COVID-19 is a distressing, disabling and heterogeneous syndrome often causing severe functional impairment. Predominant symptoms include fatigue, cognitive impairment ('brain fog'), breathlessness and anxiety or depression. These symptoms are amenable to rehabilitation delivered by skilled healthcare professionals, but COVID-19 has put severe strain on healthcare systems. This study aims to explore whether digitally enabled, remotely supported rehabilitation for people with long COVID-19 can enable healthcare systems to provide high quality care to large numbers of patients within the available resources. Specific objectives are to (1) develop and refine a digital health intervention (DHI) that supports patient assessment, monitoring and remote rehabilitation; (2) develop implementation models that support sustainable deployment at scale; (3) evaluate the impact of the DHI on recovery trajectories and (4) identify and mitigate health inequalities due to the digital divide. METHODS AND ANALYSIS: Mixed-methods, theoretically informed, single-arm prospective study, combining methods drawn from engineering/computer science with those from biomedicine. There are four work packages (WP), one for each objective. WP1 focuses on identifying user requirements and iteratively developing the intervention to meet them; WP2 combines qualitative data from users with learning from implementation science and normalisation process theory, to promote adoption, scale-up, spread and sustainability of the intervention; WP3 uses quantitative demographic, clinical and resource use data collected by the DHI to determine illness trajectories and how these are affected by use of the DHI; while WP4 focuses on identifying and mitigating health inequalities and overarches the other three WPs. ETHICS AND DISSEMINATION: Ethical approval obtained from East Midlands - Derby Research Ethics Committee (reference 288199). Our dissemination strategy targets three audiences: (1) Policy makers, Health service managers and clinicians responsible for delivering long COVID-19 services; (2) patients and the public; (3) academics. TRIAL REGISTRATION NUMBER: Research Registry number: researchregistry6173.

Impact of the introduction and withdrawal of financial incentives on the delivery of alcohol screening and brief advice in English primary health care: an interrupted time-series analysis.

AIM: To evaluate the impact of the introduction and withdrawal of financial incentives on alcohol screening and brief advice delivery in English primary care. DESIGN: Interrupted time-series using data from The Health Improvement Network (THIN) database. Data were split into three periods: (1) before the introduction of financial incentives (1 January 2006-31 March 2008); (2) during the implementation of financial incentives (1 April 2008-31 March 2015); and (3) after the withdrawal of financial incentives (1 April 2015-31 December 2016). Segmented regression models were fitted, with slope and step change coefficients at both intervention points. SETTING: England. PARTICIPANTS: Newly registered patients (16+) in 500 primary care practices for 2006-16 (n = 4 278 723). MEASUREMENTS: The outcome measures were percentage of patients each month who: (1) were screened for alcohol use; (2) screened positive for higher-risk drinking; and (3) were reported as having received brief advice on alcohol consumption. FINDINGS: There was no significant change in the percentage of newly registered patients who were screened for alcohol use when financial incentives were introduced. However, the percentage fell (P < 0.001) immediately when incentives were withdrawn, and fell by a further 2.96 [95% confidence interval (CI) = 2.21-3.70] patients per 1000 each month thereafter. After the introduction of incentives, there was an immediate increase of 9.05 (95% CI = 3.87-14.23) per 1000 patients screening positive for higher-risk drinking, but no significant further change over time. Withdrawal of financial incentives was associated with an immediate fall in screen-positive rates of 29.96 (95% CI = 19.56-40.35) per 1000 patients, followed by a rise each month thereafter of 2.14 (95% CI = 1.51-2.77) per 1000. Screen-positive patients recorded as receiving alcohol brief advice increased by 20.15 (95% CI = 12.30-28.00) per 1000 following the introduction of financial incentives, and continued to increase by 0.39 (95% CI = 0.26-0.53) per 1000 monthly until withdrawal. At this point, delivery of brief advice fell by 18.33 (95% CI = 11.97-24.69) per 1000 patients and continued to fall by a further 0.70 (95% CI = 0.28-1.12) per 1000 per month. CONCLUSIONS: Removing a financial incentive for alcohol prevention in English primary care was associated with an immediate and sustained reduction in the rate of screening for alcohol use and brief advice provision. This contrasts with no, or limited, increase in screening and brief advice delivery rates following the introduction of the scheme.

Relationship between popularity and the likely efficacy: an observational study based on a random selection on top-ranked physical activity apps.

OBJECTIVES: To explore the relationship between popularity of mobile application (apps) for physical activity (PA) and their likely efficacy. The primary objective was to assess the association between app popularity (indicated by user ratings) and likely efficacy (indicated by the number of Behaviour Change Techniques (BCT) present). The secondary objective was to assess the relationship between user ratings and those BCTs that have been shown to be effective in increasing PA. DESIGN: Observational study. METHODS: 400 top-ranked free and paid apps from iTunes and Google Play stores were screened, and were included if the primary behaviour targeted was PA and they had stand-alone functionality. The outcome variable of user rating was dichotomised into high (4, 5 stars) or low (1, 2, 3 stars) rating. SETTING: iTunes and Google Play app stores. PARTICIPANTS: No individual participants but the study used user-led rating system in the app store. PRIMARY AND SECONDARY OUTCOME MEASURES: BCTs and user rating. RESULTS: Of 400 apps, 156 were eligible and 65 were randomly selected, downloaded and assessed by two reviewers. There was no relationship overall between star ratings and the number of BCTs present, nor between star ratings and the presence of BCTs known to be effective in increasing PA. App store was strongly associated with star ratings, with lower likelihood of finding 4 or 5 stars in iTunes compared with Google Play (OR 0.74, 95% CI 0.73 to 0.76, p<0.001). CONCLUSIONS: The findings of this study suggest that popularity does not necessarily imply the likelihood of effectiveness. Hence, public health impact is unlikely to be achieved by allowing market forces to 'prescribe' what is used by the public.

Quality of Publicly Available Physical Activity Apps: Review and Content Analysis.

BACKGROUND: Within the new digital health landscape, the rise of health apps creates novel prospects for health promotion. The market is saturated with apps that aim to increase physical activity (PA). Despite the wide distribution and popularity of PA apps, there are limited data on their effectiveness, user experience, and safety of personal data. OBJECTIVE: The purpose of this review and content analysis was to evaluate the quality of the most popular PA apps on the market using health care quality indicators. METHODS: The top-ranked 400 free and paid apps from iTunes and Google Play stores were screened. Apps were included if the primary behavior targeted was PA, targeted users were adults, and the apps had stand-alone functionality. The apps were downloaded on mobile phones and assessed by 2 reviewers against the following quality assessment criteria: (1) users' data privacy and security, (2) presence of behavior change techniques (BCTs) and quality of the development and evaluation processes, and (3) user ratings and usability. RESULTS: Out of 400 apps, 156 met the inclusion criteria, of which 65 apps were randomly selected to be downloaded and assessed. Almost 30% apps (19/65) did not have privacy policy. Every app contained at least one BCT, with an average number of 7 and a maximum of 13 BCTs. All but one app had commercial affiliation, 12 consulted an expert, and none reported involving users in the app development. Only 12 of 65 apps had a peer-reviewed study connected to the app. User ratings were high, with only a quarter of the ratings falling below 4 stars. The median usability score was excellent-86.3 out of 100. CONCLUSIONS: Despite the popularity of PA apps available on the commercial market, there were substantial shortcomings in the areas of data safety and likelihood of effectiveness of the apps assessed. The limited quality of the apps may represent a missed opportunity for PA promotion.

DIAMOND (DIgital Alcohol Management ON Demand): a feasibility RCT and embedded process evaluation of a digital health intervention to reduce hazardous and harmful alcohol use recruiting in hospital emergency departments and online.

BACKGROUND: The harmful use of alcohol is a causal factor in more than 200 disease and injury conditions and leads to over 3 million deaths every year worldwide. Relatively few problem alcohol users access treatment due to stigma and lack of services. Alcohol-specific digital health interventions (DHI) may help them, but trial data comparing DHI with face-to-face treatment are lacking. METHODS: We conducted a feasibility RCT of an alcohol DHI, testing recruitment, online data-collection and randomisation processes, with an embedded process evaluation. Recruitment ran from October 2015 for 12 months. Participants were adults, drinking at hazardous and harmful levels, recruited from hospital emergency departments (ED) in London or recruited online. Participants were randomised to HeLP-Alcohol, a six module DHI with weekly reminder prompts (phone, email or text message), or to face-to-face treatment as usual (TAU). Participants were invited to take part in qualitative interviews after the trial. RESULTS: The trial website was accessed 1074 times: 420 people completed online eligibility questionnaires; 350 did not meet eligibility criteria, 51 declined to participate, and 19 were recruited and randomised. Follow-up data were collected from three participants (retention 3/19), and four agreed to be interviewed for the process evaluation. The main themes of the interviews were:Participants were not at equipoise. They wanted to try the website and were disappointed to be randomised to face-to-face, so they were less engaged and dropped out.Other reasons for drop out included not accepting that they had a drink problem; problem drinking interfering with their ability to take part in a trial or forgetting appointments; having a busy life and being randomised to TAU made it difficult to attend appointments. CONCLUSIONS: This feasibility RCT aimed to test recruitment, randomisation, retention, and data collection methods, but recruited only 19 participants. This illustrates the importance of undertaking feasibility studies prior to fully powered RCTs. From the qualitative interviews we found that potential recruits were not at equipoise for recruitment. An alternative methodology, for example a preference RCT recruiting from multiple locations, needs to be explored in future trials. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number: ISRCTN31789096.

DIAMOND (DIgital Alcohol Management ON Demand): a mixed methods feasibility RCT and embedded process evaluation of a digital health intervention to reduce hazardous and harmful alcohol use.

BACKGROUND: Alcohol is a major risk factor for preventable illness, with huge cost to healthcare economies. There is a role for alcohol-specific digital health interventions (DHI), but there have been few randomised controlled trials (RCT) comparing DHI with face-to-face treatment. Such trials are complex and face obstacles in recruitment and retention. METHODS: Mixed-methods feasibility RCT of an alcohol DHI, testing recruitment, online data-collection and randomisation processes, with an embedded process evaluation. Recruitment ran from October 2014 for 9 months. Participants were adults drinking at hazardous and harmful levels, attending four community drug and alcohol services (CDAS) in London. Participants completed baseline demographic, alcohol-related and other psychological questionnaires online and were randomised to HeLP-Alcohol, a six-module DHI with weekly reminder prompts (phone, email or text message), which mirrors face-to-face treatment, or to face-to-face treatment at CDAS. Alcohol counsellors took part in qualitative interviews at the end of the study. RESULTS: Alcohol counsellors screened 1253 patients. One thousand one hundred eighty-nine did not meet inclusion criteria so were excluded: 579 were dependent drinkers, 548 had health conditions that made them ineligible to take part and 62 were ineligible for other reasons including homelessness. Of the 64 patients who were eligible to take part, 54 declined to participate, with 36 stating a preference for face-to-face treatment, 13 gave no reason, and 5 gave other reasons including not wanting to use a computer. Ten consented but then 3 changed their minds, so we were able to randomise 7 participants to the study (11% of eligible). Five alcohol counsellors agreed to be interviewed for the process evaluation and provided the following feedback: Although most of their colleagues were enthusiastic about the trial, some were not at equipoise in recruiting; potential participants also declared strong preference to intervention arm from the outset. These factors affected recruitment. Counsellors also lacked time to undertake the data inputting and follow-up of participants in addition to their everyday work. CONCLUSIONS: This feasibility study aimed to test recruitment, randomisation, retention and data collection methods but recruited only 7 participants so these aims were not fully achieved. This illustrates to all researchers of complex interventions the importance of conducting feasibility studies and is generalisable to areas other than alcohol research. CDAS were seeing larger numbers of non-dependent drinkers with complex additional problems than alcohol commissioners expected. CDAS clients and some counsellors were not at equipoise for recruitment. Alternative settings for recruitment need to be explored in future trials. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number: ISRCTN31789096, DOI 10.1186/ISRCTN31789096.

Taxonomy for the Rehabilitation of Knee Conditions (TRAK), a Digital Intervention to Support the Self-Care Components of Anterior Cruciate Ligament Rehabilitation: Protocol of a Feasibility Study.

BACKGROUND: Rupture of the anterior cruciate ligament (ACL) is common, especially in the active population. In defining the problem of ACL rehabilitation, this study draws from the knowledge that improved self-care, strength, and fitness are associated with better outcomes. Traditional rehabilitation involves regular physiotherapy, but it is not clear what the optimal way for delivering rehabilitation is, and it varies widely across the world. Evidence for treatments are discussed in the literature, however standard length of rehabilitation and frequency of appointments are unknown. Additionally, current rehabilitation models in the National Health Service (NHS) struggle with catering to large volumes of patients and the lengthy time span over which rehabilitation is delivered. The use of eHealth (the Internet in health care) has been successful at delivering behavior change to a number of diverse patient groups. In physiotherapy, problems such as exercise compliance, exercise technique, and managing a broad program of rehabilitation and advice can be challenging. An eHealth intervention called Taxonomy for the Rehabilitation of Knee Conditions (TRAK) to support self-management and behavior change has been developed by patients and clinicians, and acceptability studies have yielded positive results. TRAK is not an exercise rehabilitation protocol; it is a tool to support ACL rehabilitation with personalized plans, prompts, and logs to help adherence and videos and instructions to improve quality and address queries. The patients have their own log-ins and can email their physiotherapist through the website. This novel platform is directly in line with current NHS England, National Institute for Health and Care Excellence, and NHS Improvement agendas that call for rehabilitation initiatives using both technology and supported self-management for patients. This study forms part of a research platform to identify a best practice model of ACL care from the literature and opinions of key stakeholders. Patients' exercise programs and duration of treatment are still based on individual needs, but use of the website may offer improved self-management and function and reduced health resource use. OBJECTIVE: This is a feasibility study to establish recruitment, retention, sample size estimates, and practicality of collecting outcome measures to inform a future trial comparing the TRAK intervention, which has been rigorously designed to address the challenges of ACL rehabilitation, to usual care. METHODS: This is a feasibility study comparing 2 groups: standard care and standard care plus eHealth. It will use convergent parallel mixed methods where both qualitative and quantitative data are sought for a more thorough understanding of the objectives. Primary outcomes relate to feasibility, including recruitment, retention, and usage. Secondary outcomes relate to health resource use and patient-rated outcome measures. RESULTS: This research expects to establish the feasibility of a full-scale randomized controlled trial to explore whether patients who use an eHealth intervention to support ACL rehabilitation have better outcomes plus improved self-efficacy and reduced health resource use than a usual care group. CONCLUSIONS: The study will provide essential information to support the development and powering of a future clinical trial of eHealth and physiotherapy for patients with ACL reconstruction in the NHS.

Monitoring of alcohol consumption in primary care among adults with bipolar disorder: A cross-sectional and retrospective cohort study.

BACKGROUND: Screening for alcohol use disorders is an important priority in the healthcare of people with bipolar disorder, incentivised in UK primary care since 2011, through the Quality and Outcomes Framework (QOF). The extent of alcohol monitoring in primary care, and impact of QOF, is unknown. The aim was to examine recording of alcohol consumption in primary care. METHODS: Poisson regression of biennial alcohol recording rates between 2000 and 2013 among 14,051 adults with bipolar disorder and 90,023 adults without severe mental illness (SMI), from 484 general practices contributing to The Health Improvement Network UK-wide primary care database. RESULTS: Alcohol recording rates among people with bipolar disorder increased from 88.6 records per 1000 person-years (95% confidence interval 81.2-96.6) in 2000/2002 to 837.4 records per 1000 person-years (817.4-858.0) in 2011/2013; a more than nine-fold increase, mainly occurring after the introduction of the QOF incentive in 2011. In 2000/2002 alcohol recording levels among people with bipolar disorder were not statistically significantly different from those without SMI (adjusted rate ratio 0.96, 0.88-1.05). By 2011/2013, people with bipolar disorder were over four times as likely to have an alcohol record: adjusted rate ratio 4.45 (4.15-4.77). LIMITATIONS: The routinely collected data may be incomplete. Alcohol data entered as free-text was not captured. CONCLUSIONS: The marked rise in alcohol consumption recording highlights what can be achieved. It is most likely attributable to QOF, suggesting that QOF, or similar schemes, can be powerful tools in promoting aspects of healthcare.

The effectiveness of technology-based strategies to promote engagement with digital interventions: a systematic review protocol.

BACKGROUND: Digital interventions provide effective and potentially cost-effective models for improving health outcomes as they deliver health information and services that are widely disseminated, confidential, and can be tailored to needs of the individual user. Digital interventions have been used successfully for health promotion, mental health, and for enabling self-management of long-term conditions. However, their effectiveness is limited by low usage rates, with non-engagement a major challenge. Hence, it is crucial to find effective strategies to increase user engagement with digital interventions. OBJECTIVE: This systematic review will aim to evaluate the effectiveness of technology-based strategies to promote engagement with digital interventions. METHODS: We will follow Cochrane Collaboration guidelines on systematic review methodology. The search strategy will be executed across seven e-databases (including MEDLINE, EMBASE, PsycINFO, CINAHL) using the concepts "digital intervention" and "engagement", limited by study type (randomized controlled trial). Grey literature and reference lists of included studies will be searched. Titles and abstracts will be independently screened by 2 authors. Then the full text of potentially eligible papers will be obtained and double screened. Data from eligible papers will be extracted by 1 author and checked for accuracy by another author. Bias will be assessed using the Cochrane bias assessment tool. Narrative synthesis will report on all included studies, and where appropriate, data will be pooled using meta-analysis. All findings will be reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Sources of heterogeneity will be further investigated if required. RESULTS: Our research is in progress. The final draft of the systematic review is being written and will be submitted before the end of 2015. CONCLUSIONS: The review findings will inform researchers and digital intervention providers about optimal use of technology-based strategies to promote engagement with digital interventions. TRIAL REGISTRATION: PROSPERO International Prospective Register of Systematic Reviews: CRD42014010164; http://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42014010164#.VTZmmiFViko (Archived by WebCite at http://www.webcitation.org/6XxQC8fT8).

DIgital Alcohol Management ON Demand (DIAMOND) feasibility randomised controlled trial of a web-based intervention to reduce alcohol consumption in people with hazardous and harmful use versus a face-to-face intervention: protocol.

BACKGROUND: "Hazardous and harmful" drinkers make up approximately 23 % of the adult population in England. However, only around 10 % of these people access specialist care, such as face-to-face extended brief treatment in community alcohol services. This may be due to stigma, difficulty accessing services during working hours, a shortage of trained counsellors and limited provision of services in many places. Web-based alcohol treatment programmes may overcome these barriers and may better suit people who are reluctant or unable to attend face-to-face services, but there is a gap in the evidence base for the acceptability, effectiveness and cost-effectiveness of these programmes compared with treatment as usual (TAU) in community alcohol services. This study aims investigate the feasibility of all parts of a randomised controlled trial (RCT) of a psychologically informed web-based alcohol treatment programme called Healthy Living for People who use Alcohol (HeLP-Alcohol) versus TAU in community alcohol services, e.g. recruitment and retention, online data collection methods, and the use and acceptability of the intervention to participants. METHODS: A feasibility RCT delivered in north London community alcohol services, comparing HeLP-Alcohol with TAU. Potential participants are aged ≥18 years referred or self-referred for hazardous and harmful use of alcohol, without co-morbidities or other complex problems. The main purpose of this study is to demonstrate the feasibility of recruiting participants to the study and will test online methods for collecting baseline demographic and outcome questionnaire data, randomising participants and collecting 3-month follow-up data. The acceptability of this intervention will be measured by recruitment and retention rates, automated log-in data collection and an online service satisfaction questionnaire. The feasibility of using tailored text message, email or phone prompt to maintain engagement with the intervention will also be explored. Results of the study will inform a definitive Phase 3 RCT. RESULTS: Recruitment started on 26 September 2014 and will run for 1 year. CONCLUSION: The proposed trial will provide data to inform a fully powered non-inferiority effectiveness and cost-effectiveness RCT comparing HeLP-Alcohol with TAU. TRIAL REGISTRATION: ISRCTN31789096.