Cigarette smoking as a risk factor for schizophrenia or all non-affective psychoses.

BACKGROUND: Smoking tobacco is regarded as an epiphenomenon in patients with schizophrenia when it may be causal. We aimed to examine whether smoking status is related to the onset of schizophrenia or the broader diagnosis of non-affective psychosis, including schizophrenia. METHODS: We used data from The Health Improvement Network primary care database to identify people aged 15-24 between 1 January 2004 and 31 December 2009. We followed them until the earliest of: first diagnosis of schizophrenia (or psychosis), patient left the practice, practice left THIN, patient died or 31 December 2014. RESULTS: In men, incidence rates for schizophrenia per 100 000 person years at risk were higher in smoking initiators (non-smoker who became a smoker during the study) than in non-smokers (adjusted IRR 1.94; 95% CI 1.29-2.91) and higher still in smokers (adjusted IRR 3.32; 95% CI 2.67-4.14). Among women, the incidence rate of schizophrenia was higher in smokers than in non-smokers (adjusted IRR 1.50; 95% CI 1.06-2.12), but no higher in smoking initiators than non-smokers. For non-affective psychosis, the pattern was similar for men but more evident in women where psychosis incidence rates were higher in smoking initiators (adjusted IRR 1.90; 95% CI 1.40-2.56) and in smokers (adjusted IRR 2.13; 95% CI 1.76-2.57) than in non-smokers. CONCLUSIONS: We found an important and strong association between smoking and incidence of schizophrenia. Smoking may increase risk through as yet unknown pathways or smoking may share genetic risk with schizophrenia and non-affective psychoses.

Engagement With Motivational Interviewing and Cognitive Behavioral Therapy Components of a Web-Based Alcohol Intervention, Elicitation of Change Talk and Sustain Talk, and Impact on Drinking Outcomes: Secondary Data Analysis.

BACKGROUND: Down Your Drink (DYD) is a widely used unguided web-based alcohol moderation program for the general public based on cognitive behavioral therapy (CBT) and motivational interviewing (MI); it provides users with many opportunities to enter free-text responses. OBJECTIVE: The aim of this study was to assess participants' use of key CBT and MI components, the presence of change talk and sustain talk within their responses, and whether these data are associated with drinking outcomes after 3 months. METHODS: An exploratory secondary data analysis was conducted on data collected in 2008 from the definitive randomized trial of DYD (N=503). Past week alcohol use at baseline and 3-month follow-up were measured with the TOT-AL. Covariates included baseline alcohol use, age, gender, education level, and word count of the responses. Use of MI and CBT components and presence of change talk and sustain talk were coded by two independent coders (Cohen κ range 0.91-1). Linear model regressions on the subsample of active users (n=410) are presented along with a negative binomial regression. RESULTS: The most commonly used component was the listing of pros and cons of drinking. The number of listed high-risk situations was associated with lower alcohol use at 3-month follow-up (Badj -2.15, 95% CI -3.92 to -0.38, P=.02). Findings on the effects of the percentage of change talk and the number of listed strategies to deal with high-risk situations were inconsistent. CONCLUSIONS: An unguided web-based alcohol moderation program can elicit change talk and sustain talk. This secondary analysis suggests that the number of listed high-risk situations can predict alcohol use at 3-month follow-up. Other components show inconsistent findings and should be studied further.

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.

Evaluation of the BD Max StaphSR Assay for Rapid Identification of Staphylococcus aureus and Methicillin-Resistant S. aureus in Positive Blood Culture Broths.

We evaluated the performance of the BD Max StaphSR assay for the direct detection of Staphylococcus aureus from blood culture medium. In a two-center trial, 155 blood cultures from the BD Bactec FX system and 212 from the bioMérieux BacT/Alert system were tested; 170 bottles yielded S. aureus, and all were identified correctly by the BD Max StaphSR assay. The assay required approximately 2.5 h, thus allowing rapid identification of blood cultures flagged positive.

Comparative evaluation of the Diagenode multiplex PCR assay on the BD max system versus a routine in-house assay for detection of Bordetella pertussis.

This study looked at 128 nasopharyngeal aspirates (NPA) and 162 throat swabs (TS) tested with the Diagenode multiplex assay on the BD Max system versus our in-house Bordetella pertussis PCR. Sensitivity and specificity were 97.3% and 100% for NPA and 88.3% and 98% for TS, respectively. Of positive NPA, 42.1% were coinfected with respiratory viruses.

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.

Unintended consequences of patient online access to health records: a qualitative study in UK primary care.

BACKGROUND: Health systems are seeking to harness digital tools to promote patient autonomy and increase the efficiency of care worldwide. The NHS Long Term Plan created the right for patients to access 'digital first' primary care by 2023-2024, including online patient access to full medical records. AIM: To identify and understand the unintended consequences of online patient access to medical records. DESIGN AND SETTING: Qualitative interview study in 10 general practices in South West and North West England. METHOD: Semi-structured individual interviews with 13 patients and 16 general practice staff with experience of patient online access to health records. RESULTS: Online access generated unintended consequences that negatively impacted patients' understanding of their health care, with patients finding surprising or difficult to interpret information. Online access impacted GPs' documentation practices, such as when GPs pre-emptively attempted to minimise potential misunderstandings to aid patient understanding of their health care. In other cases, this negatively impacted the quality of the records and patient safety when GPs avoided documenting speculations or concerns. Contrary to assumptions that workload would be reduced, online access introduced extra work, such as managing and monitoring access, and taking measures to prevent possible harm to patients. CONCLUSION: The unintended consequences described by both staff and patients show that, to achieve the intended consequences set out in NHS policy, additional work is necessary to prepare records for sharing and to prepare patients about what to expect. It is crucial that practices are adequately supported and resourced to manage the unintended consequences of online access, now that it is the default position. A table of potential unintended consequences and mitigation measures is provided to aid practice managers and clinicians implementing online access.

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.

Subjective well-being amongst community-dwelling elders: what determines satisfaction with life? Findings from the Dublin Healthy Aging Study.

BACKGROUND: Life satisfaction is a subjective expression of well-being and successful aging. Subjective well-being is a major determinant of health outcomes in older people. The aim of this study was to determine which factors predicted well-being in older people living in the community as measured by their satisfaction with life. METHODS: The relationship between life satisfaction, as measured by the Life Satisfaction Index (LSI-A) and physical, cognitive and demographic variables was examined in 466 older people living in the community using a stepwise regression model. RESULTS: Depression, loneliness, neuroticism, extraversion, recent participation in physical activity, age and self-reported exhaustion, were the independent predictors of life satisfaction in our elderly cohort. CONCLUSION: Subjective well-being, as measured by the Life Satisfaction Scale, is predicted by depression, loneliness, personality traits, recent participation in physical activity and self-reported exhaustion. The mental and emotional status of older individuals, as well as their engagement in physical activity, are as important as physical functionality when it comes to life satisfaction as a measure of well-being and successful aging. These areas represent key targets for intervention.

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.

Web-Based Structured Education for Type 2 Diabetes: Interdisciplinary User-Centered Design Approach.

BACKGROUND: Digital health research encompasses methods from human-computer interaction and health research. OBJECTIVE: This paper aims to describe how these methods were combined to develop HeLP-Diabetes: Starting Out, a web-based structured education program for people newly diagnosed with type 2 diabetes. METHODS: The development process consisted of three phases: initial design for effectiveness, optimization for usability, and in the wild testing in the National Health Service with people newly diagnosed with type 2 diabetes, and further revisions. We adopted an iterative user-centered approach and followed steps from the human-computer interaction design life cycle and the Medical Research Council guidelines on developing and evaluating complex interventions. RESULTS: The initial design process resulted in an 8-session program containing information and behavior change techniques targeting weight loss, being more active, and taking medication. The usability testing was highlighted at an early stage, where changes needed to be made to the language and layout of the program. The in the wild testing provided data on uptake of and barriers to use. The study suggested low uptake and completion of the program, but those who used it seemed to benefit from it. The qualitative findings suggested that barriers to use included an expectation that the program would take too long. This informed refinements to the program. CONCLUSIONS: The use of interdisciplinary methods resulted in an iterative development process and refinements to the program that were based on user needs and data on uptake. The final intervention was more suitable for a definitive evaluation than the initial version. The description of our approach informs other digital health researchers on how to make interventions more sensitive to user needs.

Unintended consequences of online consultations: a qualitative study in UK primary care.

BACKGROUND: Health services are increasingly using digital tools to deliver care, and online consultations are being widely adopted in primary care settings. The intended consequences of online consultations are to increase patient access to care and increase the efficiency of care. AIM: To identify and understand the unintended consequences of online consultations in primary care. DESIGN AND SETTING: Qualitative interview study in eight general practices using online consultation tools in South West and North West England between February 2019 and January 2020. METHOD: Thematic analysis of semi-structured interviews with 19 patients and 18 general practice staff. RESULTS: Consequences of online consultations were identified that restricted patient access to care by making it difficult for some patients to communicate effectively with a GP and disadvantaging digitally-excluded patients. This stemmed from patient uncertainty about how their queries were dealt with, and whether practices used online consultations as their preferred method for patients to contact the practice. Consequences were identified that limited increases in practice efficiency by creating additional work, isolation, and dissatisfaction for some staff. CONCLUSION: Unintended consequences often present operational challenges that are foreseeable and partly preventable. However, these challenges must be recognised and solutions resourced sufficiently. Not everyone may benefit and local decisions will need to be made about trade-offs. Process changes tailored to local circumstances are critical to making effective use of online consultation tools. Unintended consequences also present clinical challenges that result from asynchronous communication. Online consultation tools favour simple, well-formulated information exchange that leads to diffuse relationships and a more transactional style of medicine.

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.

Association of practice size and pay-for-performance incentives with the quality of diabetes management in primary care.

BACKGROUND: Not enough is known about the association between practice size and clinical outcomes in primary care. We examined this association between 1997 and 2005, in addition to the impact of the Quality and Outcomes Framework, a pay-for-performance incentive scheme introduced in the United Kingdom in 2004, on diabetes management. METHODS: We conducted a retrospective open-cohort study using data from the General Practice Research Database. We enrolled 422 general practices providing care for 154,945 patients with diabetes. Our primary outcome measures were the achievement of national treatment targets for blood pressure, glycated hemoglobin (HbA(1c)) levels and total cholesterol. RESULTS: We saw improvements in the recording of process of care measures, prescribing and achieving intermediate outcomes in all practice sizes during the study period. We saw improvement in reaching national targets after the introduction of the Quality and Outcomes Framework. These improvements significantly exceeded the underlying trends in all practice sizes for achieving targets for cholesterol level and blood pressure, but not for HbA(1c) level. In 1997 and 2005, there were no significant differences between the smallest and largest practices in achieving targets for blood pressure (1997 odds ratio [OR] 0.98, 95% confidence interval [CI] 0.82 to 1.16; 2005 OR 0.92, 95% CI 0.80 to 1.06 in 2005), cholesterol level (1997 OR 0.94, 95% CI 0.76 to 1.16; 2005 OR 1.1, 95% CI 0.97 to 1.40) and glycated hemoglobin level (1997 OR 0.79, 95% CI 0.55 to 1.14; 2005 OR 1.05, 95% CI 0.93 to 1.19). INTERPRETATION: We found no evidence that size of practice is associated with the quality of diabetes management in primary care. Pay-for-performance programs appear to benefit both large and small practices to a similar extent.