The Longitudinal Impact of Social Media Use on UK Adolescents' Mental Health: Longitudinal Observational Study.

BACKGROUND: Cross-sectional studies have found a relationship between social media use and depression and anxiety in young people. However, few longitudinal studies using representative data and mediation analysis have been conducted to understand the causal pathways of this relationship. OBJECTIVE: This study aims to examine the longitudinal relationship between social media use and young people's mental health and the role of self-esteem and social connectedness as potential mediators. METHODS: The sample included 3228 participants who were 10- to 15-year-olds from Understanding Society (2009-2019), a UK longitudinal household survey. The number of hours spent on social media was measured on a 5-point scale from "none" to "7 or more hours" at the ages of 12-13 years. Self-esteem and social connectedness (number of friends and happiness with friendships) were measured at the ages of 13-14 years. Mental health problems measured by the Strengths and Difficulties Questionnaire were assessed at the ages of 14-15 years. Covariates included demographic and household variables. Unadjusted and adjusted multilevel linear regression models were used to estimate the association between social media use and mental health. We used path analysis with structural equation modeling to investigate the mediation pathways. RESULTS: In adjusted analysis, there was a nonsignificant linear trend showing that more time spent on social media was related to poorer mental health 2 years later (n=2603, ß=.21, 95% CI −0.43 to 0.84; P=.52). In an unadjusted path analysis, 68% of the effect of social media use on mental health was mediated by self-esteem (indirect effect, n=2569, ß=.70, 95% CI 0.15-1.30; P=.02). This effect was attenuated in the adjusted analysis, and it was found that self-esteem was no longer a significant mediator (indirect effect, n=2316, ß=.24, 95% CI −0.12 to 0.66; P=.22). We did not find evidence that the association between social media and mental health was mediated by social connectedness. Similar results were found in imputed data. CONCLUSIONS: There was little evidence to suggest that more time spent on social media was associated with later mental health problems in UK adolescents. This study shows the importance of longitudinal studies to examine this relationship and suggests that prevention strategies and interventions to improve mental health associated with social media use could consider the role of factors like self-esteem.

Correction: The Longitudinal Impact of Social Media Use on UK Adolescents' Mental Health: Longitudinal Observational Study.

[This corrects the article DOI: 10.2196/43213.].

The effectiveness of using virtual patient educational tools to improve medical students' clinical reasoning skills: a systematic review.

BACKGROUND: Use of virtual patient educational tools could fill the current gap in the teaching of clinical reasoning skills. However, there is a limited understanding of their effectiveness. The aim of this study was to synthesise the evidence to understand the effectiveness of virtual patient tools aimed at improving undergraduate medical students' clinical reasoning skills. METHODS: We searched MEDLINE, EMBASE, CINAHL, ERIC, Scopus, Web of Science and PsycINFO from 1990 to January 2022, to identify all experimental articles testing the effectiveness of virtual patient educational tools on medical students' clinical reasoning skills. Quality of the articles was assessed using an adapted form of the MERSQI and the Newcastle-Ottawa Scale. A narrative synthesis summarised intervention features, how virtual patient tools were evaluated and reported effectiveness. RESULTS: The search revealed 8,186 articles, with 19 articles meeting the inclusion criteria. Average study quality was moderate (M = 6.5, SD = 2.7), with nearly half not reporting any measurement of validity or reliability for their clinical reasoning outcome measure (8/19, 42%). Eleven articles found a positive effect of virtual patient tools on reasoning (11/19, 58%). Four reported no significant effect and four reported mixed effects (4/19, 21%). Several domains of clinical reasoning were evaluated. Data gathering, ideas about diagnosis and patient management were more often found to improve after virtual patient use (34/47 analyses, 72%) than application of knowledge, flexibility in thinking and problem-solving (3/7 analyses, 43%). CONCLUSIONS: Using virtual patient tools could effectively complement current teaching especially if opportunities for face-to-face teaching or other methods are limited, as there was some evidence that virtual patient educational tools can improve undergraduate medical students' clinical reasoning skills. Evaluations that measured more case specific clinical reasoning domains, such as data gathering, showed more consistent improvement than general measures like problem-solving. Case specific measures might be more sensitive to change given the context dependent nature of clinical reasoning. Consistent use of validated clinical reasoning measures is needed to enable a meta-analysis to estimate effectiveness.

The use of experimental vignette studies to identify drivers of variations in the delivery of health care: a scoping review.

BACKGROUND: Identifying how unwarranted variations in healthcare delivery arise is challenging. Experimental vignette studies can help, by isolating and manipulating potential drivers of differences in care. There is a lack of methodological and practical guidance on how to design and conduct these studies robustly. The aim of this study was to locate, methodologically assess, and synthesise the contribution of experimental vignette studies to the identification of drivers of unwarranted variations in healthcare delivery. METHODS: We used a scoping review approach. We searched MEDLINE, Embase, Web of Science and CINAHL databases (2007-2019) using terms relating to vignettes and variations in healthcare. We screened title/abstracts and full text to identify studies using experimental vignettes to examine drivers of variations in healthcare delivery. Included papers were assessed against a methodological framework synthesised from vignette study design recommendations within and beyond healthcare. RESULTS: We located 21 eligible studies. Study participants were almost exclusively clinicians (18/21). Vignettes were delivered via text (n = 6), pictures (n = 6), video (n = 6) or interactively, using face-to-face, telephone or online simulated consultations (n = 3). Few studies evaluated the credibility of vignettes, and many had flaws in their wider study design. Ten were of good methodological quality. Studies contributed to understanding variations in care, most commonly by testing hypotheses that could not be examined directly using real patients. CONCLUSIONS: Experimental vignette studies can be an important methodological tool for identifying how unwarranted variations in care can arise. Flaws in study design or conduct can limit their credibility or produce biased results. Their full potential has yet to be realised.

Physician associate/assistant contributions to cancer diagnosis in primary care: a rapid systematic review.

BACKGROUND: Symptom recognition and timely referral in primary care are crucial for the early diagnosis of cancer. Physician assistants or associates (PAs) have been introduced in 18 healthcare systems across the world, with numbers increasing in some cases to address primary care physician shortages. Little is known about their impact on suspected cancer recognition and referral. This review sought to summarise findings from observational studies conducted in high income countries on PAs' competence and performance on processes concerned with the quality of recognition and referral of suspected cancer in primary care. METHOD: A rapid systematic review of international peer-reviewed literature was performed. Searches were undertaken on OVID, EMBASE, Web of Science, and CINAHL databases (2009-2019). Studies were eligible if they reported on PA skills, processes and outcomes relevant to suspected cancer recognition and referral. Title and abstract screening was followed by full paper review and data extraction. Synthesis of qualitative and quantitative findings was undertaken on three themes: deployment, competence, and performance. Preliminary findings were discussed with an expert advisory group to inform interpretation. RESULTS: From 883 references, 15 eligible papers were identified, of which 13 were from the USA. Seven studies reported on general clinical processes in primary care that would support cancer diagnosis, most commonly ordering of diagnostic tests (n = 6) and referrals to specialists (n = 4). Fewer papers reported on consultation processes, such as examinations or history taking (n = 3) Six papers considered PAs' competence and performance on cancer screening. PAs performed similarly to primary care physicians on rates of diagnostic tests ordered, referrals and patient outcomes (satisfaction, malpractice, emergency visits). No studies reported on the timeliness of cancer diagnosis. CONCLUSION: This review of peer-reviewed literature combined with advisory group interpretation suggests the introduction of PAs into primary care may maintain the quality of referrals and diagnostic tests needed to support cancer diagnosis. It also highlights the lack of research on several aspects of PAs' roles, including outcomes of the diagnostic process.

Using Virtual Patients to Explore the Clinical Reasoning Skills of Medical Students: Mixed Methods Study.

BACKGROUND: Improving clinical reasoning skills-the thought processes used by clinicians to formulate appropriate questions and diagnoses-is essential for reducing missed diagnostic opportunities. The electronic Clinical Reasoning Educational Simulation Tool (eCREST) was developed to improve the clinical reasoning of future physicians. A feasibility trial demonstrated acceptability and potential impacts; however, the processes by which students gathered data were unknown. OBJECTIVE: This study aims to identify the data gathering patterns of final year medical students while using eCREST and how eCREST influences the patterns. METHODS: A mixed methods design was used. A trial of eCREST across 3 UK medical schools (N=148) measured the potential effects of eCREST on data gathering. A qualitative think-aloud and semistructured interview study with 16 medical students from one medical school identified 3 data gathering strategies: Thorough, Focused, and Succinct. Some had no strategy. Reanalysis of the trial data identified the prevalence of data gathering patterns and compared patterns between the intervention and control groups. Patterns were identified based on 2 variables that were measured in a patient case 1 month after the intervention: the proportion of Essential information students identified and the proportion of irrelevant information gathered (Relevant). Those who scored in the top 3 quartiles for Essential but in the lowest quartile for Relevant displayed a Thorough pattern. Those who scored in the top 3 quartiles for Relevant but in the lowest quartile for Essential displayed a Succinct pattern. Those who scored in the top 3 quartiles on both variables displayed a Focused pattern. Those whose scores were in the lowest quartile on both variables displayed a Nonspecific pattern. RESULTS: The trial results indicated that students in the intervention group were more thorough than those in the control groups when gathering data. The qualitative data identified data gathering strategies and the mechanisms by which eCREST influenced data gathering. Students reported that eCREST promoted thoroughness by prompting them to continuously reflect and allowing them to practice managing uncertainty. However, some found eCREST to be less useful, and they randomly gathered information. Reanalysis of the trial data revealed that the intervention group was significantly more likely to display a Thorough data gathering pattern than controls (21/78, 27% vs 6/70, 9%) and less likely to display a Succinct pattern (13/78, 17% vs 20/70, 29%; χ23=9.9; P=.02). Other patterns were similar across groups. CONCLUSIONS: Qualitative data suggested that students applied a range of data gathering strategies while using eCREST and that eCREST encouraged thoroughness by continuously prompting the students to reflect and manage their uncertainty. Trial data suggested that eCREST led students to demonstrate more Thorough data gathering patterns. Virtual patients that encourage thoroughness could help future physicians avoid missed diagnostic opportunities and enhance the delivery of clinical reasoning teaching.

Use of Social Media to Promote Cancer Screening and Early Diagnosis: Scoping Review.

BACKGROUND: Social media is commonly used in public health interventions to promote cancer screening and early diagnosis, as it can rapidly deliver targeted public health messages to large numbers of people. However, there is currently little understanding of the breadth of social media interventions and evaluations, whether they are effective, and how they might improve outcomes. OBJECTIVE: This scoping review aimed to map the evidence for social media interventions to improve cancer screening and early diagnosis, including their impact on behavior change and how they facilitate behavior change. METHODS: Five databases and the grey literature were searched to identify qualitative and quantitative evaluations of social media interventions targeting cancer screening and early diagnosis. Two reviewers independently reviewed each abstract. Data extraction was carried out by one author and verified by a second author. Data on engagement was extracted using an adapted version of the key performance indicators and metrics related to social media use in health promotion. Insights, exposure, reach, and differing levels of engagement, including behavior change, were measured. The behavior change technique taxonomy was used to identify how interventions facilitated behavior change. RESULTS: Of the 23 publications and reports included, the majority (16/23, 70%) evaluated national cancer awareness campaigns (eg, breast cancer awareness month). Most interventions delivered information via Twitter (13/23, 57%), targeted breast cancer (12/23, 52%), and measured exposure, reach, and low- to medium-level user engagement, such as number of likes (9/23, 39%). There were fewer articles about colorectal and lung cancer than about breast and prostate cancer campaigns. One study found that interventions had less reach and engagement from ethnic minority groups. A small number of articles (5/23, 22%) suggested that some types of social media interventions might improve high-level engagement, such as intended and actual uptake of screening. Behavior change techniques, such as providing social support and emphasizing the consequences of cancer, were used to engage users. Many national campaigns delivered fundraising messages rather than actionable health messages. CONCLUSIONS: The limited evidence suggests that social media interventions may improve cancer screening and early diagnosis. Use of evaluation frameworks for social media interventions could help researchers plan more robust evaluations that measure behavior change. We need a greater understanding of who engages with these interventions to know whether social media can be used to reduce some health inequalities in cancer screening and early diagnosis. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2019-033592.

Online patient simulation training to improve clinical reasoning: a feasibility randomised controlled trial.

BACKGROUND: Online patient simulations (OPS) are a novel method for teaching clinical reasoning skills to students and could contribute to reducing diagnostic errors. However, little is known about how best to implement and evaluate OPS in medical curricula. The aim of this study was to assess the feasibility, acceptability and potential effects of eCREST - the electronic Clinical Reasoning Educational Simulation Tool. METHODS: A feasibility randomised controlled trial was conducted with final year undergraduate students from three UK medical schools in academic year 2016/2017 (cohort one) and 2017/2018 (cohort two). Student volunteers were recruited in cohort one via email and on teaching days, and in cohort two eCREST was also integrated into a relevant module in the curriculum. The intervention group received three patient cases and the control group received teaching as usual; allocation ratio was 1:1. Researchers were blind to allocation. Clinical reasoning skills were measured using a survey after 1 week and a patient case after 1 month. RESULTS: Across schools, 264 students participated (18.2% of all eligible). Cohort two had greater uptake (183/833, 22%) than cohort one (81/621, 13%). After 1 week, 99/137 (72%) of the intervention and 86/127 (68%) of the control group remained in the study. eCREST improved students' ability to gather essential information from patients over controls (OR = 1.4; 95% CI 1.1-1.7, n = 148). Of the intervention group, most (80/98, 82%) agreed eCREST helped them to learn clinical reasoning skills. CONCLUSIONS: eCREST was highly acceptable and improved data gathering skills that could reduce diagnostic errors. Uptake was low but improved when integrated into course delivery. A summative trial is needed to estimate effectiveness.

Health and social care costs at the end of life: a matched analysis of linked patient records in East London.

BACKGROUND: care in the final year of life accounts for 10% of inpatient hospital costs in UK. However, there has been little analysis of costs in other care settings. We investigated the publicly funded costs associated with the end of life across different health and social care settings. METHOD: we performed cross-sectional analysis of linked electronic health records of residents aged over 50 in a locality in East London, UK, between 2011 and 2017. Those who died during the study period were matched to survivors on age group, sex, deprivation, number of long-term conditions and time period. Mean costs were calculated by care setting, age and months to death. RESULTS: across 8,720 matched patients, the final year of life was associated with £7,450 (95% confidence interval £7,086-£7,842, P < 0.001) of additional health and care costs, 57% of which related to unplanned hospital care. Whilst costs increased sharply over the final few months of life in emergency and inpatient hospital care, in non-acute settings costs were less concentrated in this period. Patients who died at older ages had higher social care costs and lower healthcare costs than younger patients in their final year of life. CONCLUSIONS: the large proportion of costs relating to unplanned hospital care suggests that end-of-life planning could direct care towards more appropriate settings and lead to system efficiencies. Death at older ages results in an increasing proportion of care costs relating to social care than to healthcare, which has implications for an ageing society.

Translating academic research into guidance to support healthcare improvement: how should guidance development be reported?

BACKGROUND: There is interest internationally in improving the uptake of research evidence to inform health care quality and safety. This article focusses on guidance development from research studies as one method for improving research uptake. While we recognise that implementation strategies on the ´demand´ side for encouraging the uptake of research are important, e.g. knowledge brokers and university-practice collaborations, this article focusses on the ´production´ aspect of how guidance development is reported and the consequent influence this may have on end-users´ receptivity to evidence, in addition to other demand-side processes. MAIN TEXT: The article considers the following question: how is guidance developed and what are the implications for reporting? We address this question by reviewing examples of guidance development reporting from applied health research studies, then describe how we produced guidance for a national study of evidence use in decision-making on adopting innovations. The starting point for reflecting on our experiences is a vignette of the guidance ´launch´ event at a national conference. CONCLUSIONS: Implications for reporting guidance development and supporting improvement are discussed. These include the need to (a) produce reporting standards for the production of guidance to match reporting standards for other research methods, (b) acknowledge the ´informal´ or emergent aspects of producing guidance and its role within a wider knowledge mobilization strategy, (c) consider guidance development from projects as part of a wider knowledge mobilization strategy, and (d) encourage a receptive environment for guidance development and use, including researcher training, durable funding to support impact, and closer relations between research and practice.

Cost-effectiveness of preoperative biliary drainage for obstructive jaundice in pancreatic and periampullary cancer.

BACKGROUND: A recent Cochrane Review found that preoperative biliary drainage (PBD) in patients with resectable pancreatic and periampullary cancer undergoing surgery for obstructive jaundice is associated with similar mortality but increased serious morbidity compared with no PBD. Despite this clinical evidence of its lack of effectiveness, PBD is still in use. We considered the economic implications of PBD versus direct surgery for obstructive jaundice in patients with pancreatic and periampullary cancer. MATERIALS AND METHODS: Model-based cost-utility analysis estimating mean costs and quality-adjusted life years (QALYs) per patient from the perspective of the UK National Health Service over a 6-month time horizon. A decision tree model was constructed and populated with probabilities, outcomes, and cost data from published sources. One-way and probabilistic sensitivity analyses were undertaken. RESULTS: PBD was more costly than direct surgery (mean cost per patient £10,775 [$15,616] versus £8221 [$11,914]) and produced fewer QALYs (mean QALYs per patient 0.337 versus 0.343). Not performing PBD would result in cost savings of approximately £2500 ($3623) per patient to the National Health Service. PBD had <10% probability of being cost-effective at a maximum willingness to pay for a QALY of £20,000 ($28,986) to £30,000 ($43,478). CONCLUSIONS: There are significant cost savings to be gained by avoiding routine PBD in patients with resectable pancreatic and periampullary cancer where PBD is still routinely used in this context; this economic evidence should be used to support the clinical argument for a change in practice.

Cost-effectiveness of diagnostic laparoscopy for assessing resectability in pancreatic and periampullary cancer.

BACKGROUND: Surgical resection is the only curative treatment for pancreatic and periampullary cancer, but many patients undergo unnecessary laparotomy because tumours can be understaged by computerised tomography (CT). A recent Cochrane review found diagnostic laparoscopy can decrease unnecessary laparotomy. We compared the cost-effectiveness of diagnostic laparoscopy prior to laparotomy versus direct laparotomy in patients with pancreatic and periampullary cancer with resectable disease based on CT scanning. METHOD: Model based cost-utility analysis estimating mean costs and quality-adjusted life years (QALYs) per patient from the perspective of the UK National Health Service. A decision tree model was constructed using probabilities, outcomes and cost data from published sources. One-way and probabilistic sensitivity analyses were undertaken. RESULTS: When laparotomy following diagnostic laparoscopy occurred in a subsequent admission, diagnostic laparoscopy incurred similar mean costs per patient to direct laparotomy (£7470 versus £7480); diagnostic laparoscopy costs (£995) were offset by avoiding unnecessary laparotomy costs. Diagnostic laparoscopy produced significantly more mean QALYs per patient than direct laparotomy (0.346 versus 0.337). Results were sensitive to the accuracy of diagnostic laparoscopy and the probability that disease was unresectable. Diagnostic laparoscopy had 63 to 66% probability of being cost-effective at a maximum willingness to pay for a QALY of £20 000 to £30 000. When laparotomy was undertaken in the same admission as diagnostic laparoscopy the mean cost per patient of diagnostic laparoscopy increased to £8224. CONCLUSIONS: Diagnostic laparoscopy prior to laparotomy in patients with CT-resectable cancer appears to be cost-effective in pancreatic cancer (but not in periampullary cancer), when laparotomy following diagnostic laparoscopy occurs in a subsequent admission.

Factors influencing clinician and patient interaction with machine learning-based risk prediction models: a systematic review.

Machine learning (ML)-based risk prediction models hold the potential to support the health-care setting in several ways; however, use of such models is scarce. We aimed to review health-care professional (HCP) and patient perceptions of ML risk prediction models in published literature, to inform future risk prediction model development. Following database and citation searches, we identified 41 articles suitable for inclusion. Article quality varied with qualitative studies performing strongest. Overall, perceptions of ML risk prediction models were positive. HCPs and patients considered that models have the potential to add benefit in the health-care setting. However, reservations remain; for example, concerns regarding data quality for model development and fears of unintended consequences following ML model use. We identified that public views regarding these models might be more negative than HCPs and that concerns (eg, extra demands on workload) were not always borne out in practice. Conclusions are tempered by the low number of patient and public studies, the absence of participant ethnic diversity, and variation in article quality. We identified gaps in knowledge (particularly views from under-represented groups) and optimum methods for model explanation and alerts, which require future research.

Development of theoretically informed audit and feedback: An exemplar from a complex implementation strategy to improve asthma self-management in UK primary care.

RATIONALE: Audit and feedback is an evidence-based implementation strategy, but studies reporting the use of theory to guide design elements are limited. AIMS AND OBJECTIVES: Within the context of a programme of research aiming to improve the implementation of supported asthma self-management in UK primary care (IMPlementing IMProved Asthma self-management as RouTine [IMP2 ART]), we aimed to design and develop theoretically-informed audit and feedback that highlighted supported asthma self-management provision and areas for improvement in primary care general practices. METHOD: Aligned with the Medical Research Council (MRC) complex intervention framework, the audit and feedback was developed in three phases: (1) Development: literature and theory exploration, and prototype audit and feedback design; (2) Feasibility: eliciting feedback on the audit and feedback from general practice staff (n = 9); (3) Prepiloting: delivering the audit and feedback within the IMP2 ART implementation strategy (incorporating patient and professional resources and an asthma review template) and eliciting clinician feedback (n = 9). RESULTS: Audit and feedback design was guided by and mapped to existing literature suggestions and theory (e.g., Theoretical Domains Framework, Behaviour Change Technique Taxonomy). Feedback on the prototype audit and feedback confirmed feasibility but identified some refinements (a need to highlight supporting self-management and importance of asthma action plans). Prepiloting informed integration with other IMP2 ART programme strategies (e.g., patient resources and professional education). CONCLUSION: We conclude that a multistage development process including theory exploration and mapping, contributed to the design and delivery of the audit and feedback. Aligned with the MRC framework, the IMP2 ART strategy (incorporating the audit and feedback) is now being tested in a UK-wide cluster randomised controlled trial.

It matters what you measure: a systematic literature review examining whether young people in poorer socioeconomic circumstances are more at risk of chlamydia.

BACKGROUND: England has invested in chlamydia screening interventions for young people. It is not known whether young people in poorer socioeconomic circumstances (SEC) are at greater risk of chlamydia and therefore in greater need of screening. OBJECTIVE: To conduct a systematic review examining socioeconomic variations in chlamydia prevalence or positivity in young people. DATA SOURCES: Eight bibliographic databases using terms related to chlamydia and SEC, supplemented by website and reference searches. ELIGIBILITY: Studies published 1999-2011 in North America, Western Europe, Australia or New Zealand, including populations aged 15-24 years, with chlamydia prevalence or positivity diagnosed by nucleic acid amplification testing. APPRAISAL AND SYNTHESIS: Two reviewers independently screened references, extracted data, appraised studies meeting inclusion criteria and rated studies as high, medium or low according to their quality and relevance. Socioeconomic variations in chlamydia were synthesised for medium/high-rated studies only. RESULTS: No high-rated studies were identified. Eight medium-rated studies reported variations in chlamydia prevalence by SEC. In 6/8 studies, prevalence was higher in people of poorer SEC. Associations were more often significant when measured by education than when using other indicators. All studies measuring positivity were rated low. Across all studies, methodological limitations in SEC measurement were identified. CONCLUSIONS: The current literature is limited in its capacity to describe associations between SEC and chlamydia risk. The choice of SEC measure may explain why some studies find higher chlamydia prevalence in young people in disadvantaged circumstances while others do not. Studies using appropriate SEC indicators (eg, education) are needed to inform decisions about targeting chlamydia screening.

Asynchronous digital health interventions for reviewing asthma: A mixed-methods systematic review protocol.

INTRODUCTION: People living with asthma require regular reviews to address their concerns and questions, assess control, review medication, and support self-management. However, practical barriers to attending face-to-face consultations might limit routine reviews. Reviewing asthma using asynchronous digital health interventions could be convenient for patients and an efficient way of maintaining communication between patients and healthcare professionals and improving health outcomes. We, therefore, aim to conduct a mixed-methods systematic review to assess the effectiveness of reviewing asthma by asynchronous digital health interventions and explore the views of patients and healthcare professionals about the role of such interventions in delivering asthma care. METHODS: We will search MEDLINE, Embase, Scopus, PsycInfo, CINAHL, and Cochrane Library from 2001 to present without imposing any language restrictions. We are interested in studies of asynchronous digital health interventions used either as a single intervention or contributing to mixed modes of review. Two review authors will independently screen titles and abstracts, and retrieve potentially relevant studies for full assessment against the eligibility criteria and extract data. Disagreements will be resolved by discussion with the review team. We will use 'Downs and Black' checklist, 'Critical Appraisal Skills Programme', and 'Mixed Methods Appraisal Tool' to assess methodological quality of quantitative, qualitative, and mixed-methods studies respectively. After synthesising quantitative (narrative synthesis) and qualitative (thematic synthesis) data separately, we will integrate them following methods outlined in the Cochrane Handbook for Systematic Reviews of Interventions. CONCLUSION: The findings of this review will provide insights into the role of asynchronous digital health interventions in the routine care of people living with asthma. TRIAL REGISTRATION: Systematic review registration: PROSPERO registration number: CRD42022344224.

Development of a patient-centred electronic review template to support self-management in primary care: a mixed-methods study.

BACKGROUND: Electronic templates are frequently used in long-term condition (LTC) reviews (for example, asthma) to act as reminders and improve documentation; however, they can restrict patient-centred care and opportunities for patients to discuss concerns and self-management. AIM: The IMPlementing IMProved Asthma self-management as RouTine (IMP2ART) programme aimed to develop a patient-centred asthma review template that encourages supported self-management. DESIGN & SETTING: This was a mixed-methods study, which integrated qualitative and systematic review data, primary care Professional Advisory Group feedback, and qualitative data from clinician interviews. METHOD: Aligned with the Medical Research Council complex intervention framework, a template was developed in the following three phases: (1) development phase, which consisted of a qualitative exploration with clinicians and patients, a systematic review, and prototype template development; (2) feasibility pilot phase, which involved feedback from clinicians (n = 7); and (3) pre-piloting phase, which consisted of delivering the template within the IMP2ART implementation strategy (incorporating the template with patient and professional resources) and eliciting clinician feedback (n = 6). RESULTS: Template development was guided by the preliminary qualitative work and the systematic review. A prototype template was developed with an opening question to establish patient agendas, and a closing prompt to confirm agendas have been addressed and an asthma action plan provided. The feasibility pilot identified refinements needed, including focusing the opening question on asthma. Pre-piloting ensured integration with the IMP2ART strategy. CONCLUSION: Following the multi-stage development process, the implementation strategy, including the asthma review template, is now being tested in a cluster randomised controlled trial.

IMP2ART: development of a multi-level programme theory integrating the COM-B model and the iPARIHS framework, to enhance implementation of supported self-management of asthma in primary care.

BACKGROUND: Supported asthma self-management, incorporating an asthma action plan and annual clinical review, has been recommended by UK/global guidelines for over three decades. However, implementation remains poor, as only around a third of individuals receive basic asthma care, according to the UKs leading respiratory charity Asthma and Lung UK. A systematic review of implementation studies recommended that a whole systems approach targeting patients, healthcare professional education, and organisations is needed to improve implementation of supported asthma self-management in primary care. The IMPlementing IMProved Asthma self-management as RouTine (IMP2ART) is a national Hybrid-II implementation cluster randomised controlled trial that aims to evaluate such an approach. This paper describes the development of the implementation strategy for IMP2ART with particular focus on the integration of multiple level theories. METHODS: The Medical Research Council design and evaluation of complex interventions framework and the Person-Based Approach to intervention development were used as guidance for stages of strategy development. Specifically, we (i) set up a multidisciplinary team (including practicing and academic clinicians, health psychologists, public health and patient colleagues), (ii) reviewed and integrated evidence and theory, (iii) developed guiding principles, (iv) developed prototype materials, and (v) conducted a pre-pilot study before final refinement. RESULTS: The implementation strategy included resources for patients, team-based and individual healthcare professional education, practice audit and feedback, and an asthma review template, as well as a facilitator role accessible to primary care practices for 12 months. The synthesis of the integrated Promoting Action on Research Implementation in Health Services (iPARIHS) and Capability, Opportunity, Motivation and Behaviour (COM-B) frameworks led to an evolved framework bringing together important implementation and behaviour change elements which will be used as a basis for the study process evaluation. CONCLUSIONS: A description of rigorous implementation strategy development for the IMP2ART study is provided along with newly theorised integration of implementation and behaviour change science which may be of benefit to others targeting implementation in primary care. TRIAL REGISTRATION: ISRCTN15448074. Registered on 2nd December 2019.

IMPlementing IMProved Asthma self-management as RouTine (IMP2ART) in primary care: study protocol for a cluster randomised controlled implementation trial.

BACKGROUND: Asthma is a common long-term condition and major public health problem. Supported self-management for asthma that includes a written personalised asthma action plan, supported by regular professional review, reduces unscheduled consultations and improves asthma outcomes and quality of life. However, despite unequivocal inter/national guideline recommendations, supported self-management is poorly implemented in practice. The IMPlementing IMProved Asthma self-management as RouTine (IMP2ART) implementation strategy has been developed to address this challenge. The aim of this implementation trial is to determine whether facilitated delivery of the IMP2ART strategy increases the provision of asthma action plans and reduces unscheduled care in the context of routine UK primary care. METHODS: IMP2ART is a parallel group, cluster randomised controlled hybrid II implementation trial. One hundred forty-four general practices will be randomly assigned to either the IMP2ART implementation strategy or control group. Following a facilitation workshop, implementation group practices will receive organisational resources to help them prioritise supported self-management (including audit and feedback; an IMP2ART asthma review template), training for professionals and resources to support patients to self-manage their asthma. The control group will continue with usual asthma care. The primary clinical outcome is the between-group difference in unscheduled care in the second year after randomisation (i.e. between 12 and 24 months post-randomisation) assessed from routine data. Additionally, a primary implementation outcome of asthma action plan ownership at 12 months will be assessed by questionnaire to a random sub-group of people with asthma. Secondary outcomes include the number of asthma reviews conducted, prescribing outcomes (reliever medication and oral steroids), asthma symptom control, patients' confidence in self-management and professional support and resource use. A health economic analysis will assess cost-effectiveness, and a mixed methods process evaluation will explore implementation, fidelity and adaptation. DISCUSSION: The evidence for supported asthma self-management is overwhelming. This study will add to the literature regarding strategies that can effectively implement supported self-management in primary care to reduce unscheduled consultations and improve asthma outcomes and quality of life. TRIAL REGISTRATION: ISRCTN15448074. Registered on 2 December 2019.

Meta-evaluation of a whole systems programme, ActEarly: A study protocol.

INTRODUCTION: Living in an area with high levels of child poverty predisposes children to poorer mental and physical health. ActEarly is a 5-year research programme that comprises a large number of interventions (>20) with citizen science and co-production embedded. It aims to improve the health and well-being of children and families living in two areas of the UK with high levels of deprivation; Bradford in West Yorkshire, and the London Borough of Tower Hamlets. This protocol outlines the meta-evaluation (an evaluation of evaluations) of the ActEarly programme from a systems perspective, where individual interventions are viewed as events in the wider policy system across the two geographical areas. It includes investigating the programme's impact on early life health and well-being outcomes, interdisciplinary prevention research collaboration and capacity building, and local and national decision making. METHODS: The ActEarly meta-evaluation will follow and adapt the five iterative stages of the 'Evaluation of Programmes in Complex Adaptive Systems' (ENCOMPASS) framework for evaluation of public health programmes in complex adaptive systems. Theory-based and mixed-methods approaches will be used to investigate the fidelity of the ActEarly research programme, and whether, why and how ActEarly contributes to changes in the policy system, and whether alternative explanations can be ruled out. Ripple effects and systems mapping will be used to explore the relationships between interventions and their outcomes, and the degree to which the ActEarly programme encouraged interdisciplinary and prevention research collaboration as intended. A computer simulation model ("LifeSim") will also be used to evaluate the scale of the potential long-term benefits of cross-sectoral action to tackle the financial, educational and health disadvantages faced by children in Bradford and Tower Hamlets. Together, these approaches will be used to evaluate ActEarly's dynamic programme outputs at different system levels and measure the programme's system changes on early life health and well-being. DISCUSSION: This meta-evaluation protocol presents our plans for using and adapting the ENCOMPASS framework to evaluate the system-wide impact of the early life health and well-being programme, ActEarly. Due to the collaborative and non-linear nature of the work, we reserve the option to change and query some of our evaluation choices based on the feedback we receive from stakeholders to ensure that our evaluation remains relevant and fit for purpose.