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.

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.

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.

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.

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.

Feasibility randomised controlled trial comparing TRAK-ACL digital rehabilitation intervention plus treatment as usual versus treatment as usual for patients following anterior cruciate ligament reconstruction.

OBJECTIVES: To evaluate the feasibility of trialling taxonomy for the rehabilitation of knee conditions-ACL (TRAK-ACL), a digital health intervention that provides health information, personalised exercise plans and remote clinical support combined with treatment as usual (TAU), for people following ACL reconstruction. METHODS: The study design was a two-arm parallel randomised controlled trial (RCT). Eligible participants were English-speaking adults who had undergone ACL reconstruction within the last 12 weeks, had access to the internet and could provide informed consent. Recruitment took place at three sites in the UK. TRAK-ACL intervention was an interactive website informed by behaviour change technique combined with TAU. The comparator was TAU. Outcomes were: recruitment and retention; completeness of outcome measures at follow-up; fidelity of intervention delivery and engagement with the intervention. Individuals were randomised using a computer-generated random number sequence. Blinded assessors allocated groups and collected outcome measures. RESULTS: Fifty-nine people were assessed for eligibility at two of the participating sites, and 51 were randomised; 26 were allocated to TRAK-ACL and 25 to TAU. Follow-up data were collected on 44 and 40 participants at 3 and 6 months, respectively. All outcome measures were completed fully at 6 months except the Client Service Receipt Inventory. Two patients in each arm did not receive the treatment they were randomised to. Engagement with TRAK-ACL intervention was a median of 5 logins (IQR 3-13 logins), over 18 weeks (SD 12.2 weeks). CONCLUSION: TRAK-ACL would be suitable for evaluation of effectiveness in a fully powered RCT.

Switching treatments in clinically stable relapsing remitting multiple sclerosis patients planning for pregnancy.

BACKGROUND: The decision to have children can be complex, particularly for people with multiple sclerosis (MS). A key concern is the use of disease modifying drugs (DMDs) during pregnancy, and how continuing, stopping or switching them may affect the mother and child. In people with active MS, stopping medications puts the mother at risk of relapse and disease rebound. OBJECTIVES: Review evidence on the effect of different switching strategies in people with stable relapsing remitting MS (RRMS). METHODS: We searched MEDLINE, EMBASE, EMCARE, CINAHL, SCOPUS, Cochrane Library up to March 2020. Only papers in English were included and no other limits were applied. Seven articles were included: four cohorts, two case reports and one randomized controlled trial (RCT). RESULTS: Two strategies were found: de-escalating, which was associated with an increased risk of relapses, and switching between first line injectables, with no change in relapse rate observed. CONCLUSION: Evidence on the effect of switching strategy on disease course in stable RRMS patients planning for pregnancy is scarce, but when switching, current evidence suggests the risk of relapses mirrors known medication efficacy.

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.

Use of the TIDieR checklist to describe an online structured education programme for type 2 diabetes.

OBJECTIVES: The aim of structured education for type 2 diabetes is to improve knowledge, skills and confidence in self-management. It is recommended in the UK for everyone who is newly diagnosed with type 2 diabetes. We developed an on-line programme called HeLP-Diabetes: Starting Out to address poor uptake of face-to-face structured education. The aim of this paper is to describe the intervention in line with the Template for Intervention Description and Replication guide, which calls for better reporting of interventions. METHODS: The Template for Intervention Description and Replication guide provided the item headings for the description. These included the theoretical underpinning, materials, procedures, providers, and mode of delivery. RESULTS: The programme was developed to meet NICE requirements for structured education and therefore followed a structured curriculum with four sessions covering content such as what diabetes is and how it is treated, possible complications, and how lifestyle changes can improve health. Content was delivered in text, images and video, and behaviour change techniques, self-assessment and feedback were used to help people target key health behaviours. The programme was delivered entirely online, but the team were available for support via telephone. Email feedback and reminders were sent. CONCLUSIONS: The TIDieR checklist allowed us to provide a clear structure for the description of the intervention. However, it could not capture the full complexity of the programme, and intervention developers considering using it in the future may find that it needs to be adapted to make it more specific to their intervention.

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.

Internet-delivered attentional bias modification training (iABMT) for the management of chronic musculoskeletal pain: a protocol for a randomised controlled trial.

INTRODUCTION: Chronic musculoskeletal pain is a complex medical condition that can significantly impact quality of life. Patients with chronic pain demonstrate attentional biases towards pain-related information. The therapeutic benefits of modifying attentional biases by implicitly training attention away from pain-related information towards neutral information have been supported in a small number of published studies. Limited research however has explored the efficacy of modifying pain-related biases via the internet. This protocol describes a randomised, double-blind, internet-delivered attentional bias modification intervention, aimed to evaluate the efficacy of the intervention on reducing pain interference. Secondary outcomes are pain intensity, state and trait anxiety, depression, pain-related fear, and sleep impairment. This study will also explore the effects of training intensity on these outcomes, along with participants' perceptions about the therapy. METHODS AND ANALYSIS: The study is a double-blind, randomised controlled trial with four arms exploring the efficacy of online attentional bias modification training versus placebo training theorised to offer no specific therapeutic benefit. Participants with chronic musculoskeletal pain will be randomised to one of four groups: (1) 10-session attentional modification group; (2) 10-session placebo training group; (3) 18-session attentional modification group; or (4) 18-session placebo training group. In the attentional modification groups, the probe-classification version of the visual-probe task will be used to implicitly train attention away from threatening information towards neutral information. Following the intervention, participants will complete a short interview exploring their perceptions about the online training. In addition, a subgroup analysis for participants aged 16-24 and 25-60 will be undertaken. ETHICS AND DISSEMINATION: This study has been approved by the University of Southampton Research Ethics Committee. Results will be published in peer-reviewed journals, academic conferences, and in lay reports for pain charities and patient support groups. TRIAL REGISTRATION NUMBER: NCT02232100; Pre-results.

Feasibility, Acceptability, and Impact of a Web-Based Structured Education Program for Type 2 Diabetes: Real-World Study.

BACKGROUND: Structured education for people with type 2 diabetes improves outcomes, but uptake is low globally. In the United Kingdom in 2016, only 8.3% of people who were referred to education programs attended the program. We have developed a Web-based structured education program named Healthy Living for People with type 2 Diabetes (HeLP-Diabetes): Starting Out (HDSO), as an alternative to face-to-face courses. A Web-based program gives people more options for accessing structured education and may help improve overall uptake. OBJECTIVE: The aim was to explore the feasibility and acceptability of delivering a Web-based structured education program (named HeLP-Diabetes: Starting Out) in routine primary health care and its potential impact on self-efficacy and diabetes-related distress. METHODS: HDSO was delivered as part of routine diabetes services in primary health care in the United Kingdom, having been commissioned by local Clinical Commissioning Groups. Quantitative data were collected on uptake, use of the program, demographic characteristics, self-reported self-efficacy, and diabetes-related distress. A subsample of people with type 2 diabetes and health care professionals were interviewed about acceptability of the program. RESULTS: It was feasible to deliver the program, but completion rates were low: of 791 people with type 2 diabetes registered, only 74 (9.0%) completed it. Completers improved their self-efficacy (change in median score 2.5, P=.001) and diabetes-related distress (change in median score 6.0, P=.001). Interview data suggested that the course was acceptable, and that uptake and completion may be related to nonprioritization of structured education. CONCLUSIONS: The study provides evidence of the feasibility and acceptability of a Web-based structured education. However, uptake and completion rates were low, limiting potential population impact. Further research is needed to improve completion rates, and to determine the relative effectiveness of Web-based versus face-to-face education.

Sensitivity of RT-PCR testing of upper respiratory tract samples for SARS-CoV-2 in hospitalised patients: a retrospective cohort study.

Background: This study aimed to determine the sensitivity and specificity of reverse transcription PCR (RT-PCR) testing of upper respiratory tract (URT) samples from hospitalised patients with coronavirus disease 2019 (COVID-19), compared to the gold standard of a clinical diagnosis. Methods: All URT RT-PCR testing for severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) in NHS Lothian, Scotland, United Kingdom between the 7 th of February and 19 th April 2020 (inclusive) was reviewed, and hospitalised patients were identified. All URT RT-PCR tests were analysed for each patient to determine the sequence of negative and positive results. For those who were tested twice or more but never received a positive result, case records were reviewed, and a clinical diagnosis of COVID-19 allocated based on clinical features, discharge diagnosis, and radiology and haematology results. For those who had a negative RT-PCR test but a clinical diagnosis of COVID-19, respiratory samples were retested using a multiplex respiratory panel, a second SARS-CoV-2 RT-PCR assay, and a human RNase P control. Results: Compared to the gold standard of a clinical diagnosis of COVID-19, the sensitivity of a single upper respiratory tract RT-PCR for COVID-19 was 82.2% (95% confidence interval 79.0-85.1%).   The sensitivity of two upper respiratory tract RT-PCR tests increased sensitivity to 90.6% (CI 88.0-92.7%). A further 2.2% and 0.9% of patients who received a clinical diagnosis of COVID-19 were positive on a third and fourth test; this may be an underestimate of the value of further testing as the majority of patients 93.0% (2999/3226) only had one or two URT RT-PCR tests. Conclusions: The sensitivity of a single RT-PCR test of URT samples in hospitalised patients is 82.2%. Sensitivity increases to 90.6% when patients are tested twice.  A proportion of cases with clinically defined COVID-19 never test positive on URT RT-PCR despite repeat testing.

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.

Phenotypic and molecular detection methods for carbapenemase-producing organisms and their clinical significance at two Scottish tertiary care hospitals.

PURPOSE: This study evaluated in-house PCR testing for local identification of bacteria carrying the major carbapenemase genes (blaOXA-48-like, blaVIM, blaNDM, blaKPC and blaIMP). METHODOLOGY: Carbapenemase-producing organisms (CPOs) isolated from patients managed in two tertiary care hospitals in Scotland from September 2014-January 2017 were investigated. A combination of chromogenic screening agar (ChromID CARBA SMART), a carbapenem hydrolysis test (Rapidec Carba NP) and in-house real-time PCR for the blaOXA-48-like, blaVIM, blaNDM, blaKPC and blaIMP genes were utilized. All isolates were sent to the AMRHAI reference unit for confirmatory testing. RESULTS: During the 29-month study period 39 CPO were isolated from 34 patients. The average turnaround time for a workflow involving phenotypic and molecular testing was 4.2 days. PCR had a sensitivity and specificity of 100 %. The most common carbapenemase genes were blaOXA-48-like (31%), blaVIM (23%) and blaNDM (20%). Resistance to antimicrobials other than beta-lactams was common; the most active agents were colistin, amikacin and fosfomycin. Twenty-seven patients were considered to be colonized (although CPO detection influenced empiric antimicrobials in five) and a CPO was implicated in infection in seven patients (bacteraemia in immunocompromised patients, n=2; surgical site infections, n=2; osteomyelitis in a patient with diabetes mellitus, n=1; and urinary tract infections, n=2). All patients survived infection. CONCLUSION: In a lowincidence setting we demonstrate the efficacy of a combined local laboratory workflow for rapid detection of CPOs, incorporating phenotypic and molecular testing. In 7/34 patients the CPO was implicated as a pathogen and detection influenced antimicrobial decision-making in five colonized patients.