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IntroductionFront-line health workers in remote health facilities are the first contact of the formal health sector and are confronted with life-saving decisions. Health information systems (HIS) support the collection and use of health related data. However, HIS focus on reporting and are unfit to support decisions. Since data tools are paper-based in most primary healthcare settings, we have produced an innovative Paper-based Health Information System in Comprehensive Care (PHISICC) using a human-centred design approach. We are carrying out a cluster randomised controlled trial in three African countries to assess the effects of PHISICC compared with the current systems.Methods and analysisStudy areas are in rural zones of Côte d’Ivoire, Mozambique and Nigeria. Seventy health facilities in each country have been randomly allocated to using PHISICC tools or to continuing to use the regular HIS tools. We have randomly selected households in the catchment areas of each health facility to collect outcomes’ data (household surveys have been carried out in two of the three countries and the end-line data collection is planned for mid-2021). Primary outcomes include data quality and use, coverage of health services and health workers satisfaction; secondary outcomes are additional data quality and use parameters, childhood mortality and additional health workers and clients experience with the system. Just prior to the implementation of the trial, we had to relocate the study site in Mozambique due to unforeseen logistical issues. The effects of the intervention will be estimated using regression models and accounting for clustering using random effects.Ethics and disseminationEthics committees in Côte d’Ivoire, Mozambique and Nigeria approved the trials. We plan to disseminate our findings, data and research materials among researchers and policy-makers. We aim at having our findings included in systematic reviews on health systems interventions and future guidance development on HIS.Trial registration numberPACTR201904664660639; Pre-results.

IntroductionChronic breathlessness is a common and debilitating symptom, associated with high healthcare use and reduced quality of life. Challenges and delays in diagnosis for people with chronic breathlessness frequently occur, leading to delayed access to therapies. The overarching hypothesis is a symptom-based approach to diagnosis in primary care would lead to earlier diagnosis, and therefore earlier treatment and improved longer-term outcomes including health-related quality of life. This study aims to establish the feasibility of a multicentre cluster randomised controlled trial to assess the clinical and cost-effectiveness of a structured diagnostic pathway for breathlessness in primary care.Methods and analysisTen general practitioner (GP) practices across Leicester and Leicestershire will be cluster randomised to either a structured diagnostic pathway (intervention) or usual care. The structured diagnostic pathway includes a panel of investigations within 1 month. Usual care will proceed with patient care as per normal practice. Eligibility criteria include patients presenting with chronic breathlessness for the first time, who are over 40 years old and without a pre-existing diagnosis for their symptoms. An electronic template triggered at the point of consultation with the GP will aid opportunistic recruitment in primary care. The primary outcome for this feasibility study is recruitment rate. Secondary outcome measures, including time to diagnosis, will be collected to help inform outcomes for the future trial and to assess the impact of an earlier diagnosis. These will include symptoms, health-related quality of life, exercise capacity, measures of frailty, physical activity and healthcare utilisation. The study will include nested qualitative interviews with patients and healthcare staff to understand the feasibility outcomes, explore what is ‘usual care’ and the study experience.Ethics and disseminationThe Research Ethics Committee Nottingham 1 has provided ethical approval for this research study (REC Reference: 19/EM/0201). Results from the study will be disseminated by presentations at relevant meetings and conferences including British Thoracic Society and Primary Care Respiratory Society, as well as by peer-reviewed publications and through patient presentations and newsletters to patients, where available.Trial registration numberISRCTN14483247.

IntroductionHormone replacement therapy (HRT) can help women experiencing menopausal symptoms, but usage has declined due to uncertainty around risks of cancer and some cardiovascular diseases (CVD). Moreover, improved cancer survival rates mean that more women who survive cancer go on to experience menopausal symptoms. Understanding these relationships is important so that women and their clinicians can make informed decisions around the risks and benefits of HRT. This study’s primary aim is to determine the association between HRT use after cancer diagnosis and the risk of cancer-specific mortality. The secondary aims are to investigate the risks of HRT on subsequent cancer, all-cause mortality and CVD.Methods and analysisWe will conduct a population-based longitudinal cohort study of 18–79 year-old women diagnosed with cancer between 1998 and 2020, using the QResearch database. The main exposure is HRT use, categorised based on compound, dose and route of administration, and modelled as a time-varying covariate. Analysis of HRT use precancer and postcancer diagnosis will be conducted separately. The primary outcome is cancer-specific mortality, which will be stratified by cancer site. Secondary outcomes include subsequent cancer diagnosis, CVD (including venous thrombo-embolism) and all-cause mortality. Adjustment will be made for key confounders such as age, body mass index, ethnicity, deprivation index, comorbidities, and cancer grade, stage and treatment. Statistical analysis will include descriptive statistics and Cox proportional hazards models to calculate HRs and 95% CIs.Ethics and disseminationEthical approval for this project was obtained from the QResearch Scientific Committee (Ref: OX24, project title ‘Use of hormone replacement therapy and survival from cancer’). This project has been, and will continue to be, supported by patient and public involvement panels. We intend to the submit the findings for peer-reviewed publication in an academic journal and disseminate them to the public through Cancer Research UK.

IntroductionPeople of Ashkenazi Jewish (AJ) ancestry are more likely than unselected populations to have a BRCA1/2 pathogenic variant, which cause a significantly increased risk of breast, ovarian and prostate cancer. Three specific BRCA1/2 pathogenic variants, referred to as BRCA-Jewish founder mutations (B-JFM), account for >90% of BRCA1/2 pathogenic variants in people of AJ ancestry. Current practice of identifying eligible individuals for BRCA testing based on personal and/or family history has been shown to miss at least 50% of people who have one of these variants. Here we describe the protocol of the JeneScreen study—a study established to develop and evaluate two different population-based B-JFM screening programmes, offered to people of Jewish ancestry in Sydney and Melbourne, Australia.Methods and analysisTo rmeasure the acceptability of population-based B-JFM screening in Australia, two screening programmes using different methodologies have been developed. The Sydney JeneScreen programme provides information and obtains informed consent by way of an online tool. The Melbourne JeneScreen programme does this by way of community sessions attended in person. Participants complete questionnaires to measure clinical and psychosocial outcomes at baseline, and for those who have testing, 2 weeks postresult. Participants who decline testing are sent a questionnaire regarding reasons for declining. Participants with a B-JFM are sent questionnaires 12-month and 24-month post-testing. The questionnaires incorporate validated scales, which measure anxiety, decisional conflict and regret, and test-related distress and positive experiences, and other items specifically developed or adapted for the study. These measures will be assessed for each programme and the two population-based B-JFM screening methods will be compared.Ethics and disseminationInstitutional Human Research Ethics Committee approval was obtained from the South Eastern Area Health Service Human Research Ethics Committee: HREC Ref 16/125.Following the analysis of the study results, the findings will be disseminated widely through conferences and publications, and directly to participants in writing.

IntroductionMen who have sex with men (MSM) are one of the most at-risk group for contracting HIV in the USA. However, the HIV epidemic impacts some groups of MSM disproportionately. Latino MSM comprise 25.1% of new HIV infections among MSM between the ages of 13 and 29 years. The daily medication tenofovir/emtricitabine was approved by the Food and Drug Administration for pre-exposure prophylaxis (PrEP) in 2012 and has demonstrated strong efficacy in reducing HIV acquisition.Methods and analysisThrough extensive formative research, this study uses a pilot randomised controlled trial design and will examine the feasibility and acceptability of a patient navigation intervention designed to address multiple barriers to improve engagement in the PrEP continuum among 60 Latino MSM between the ages of 18 and 29 years. The patient navigation intervention will be compared with usual care plus written information to evaluate the feasibility and acceptability of the intervention and study methods and the intervention’s potential in improving PrEP continuum behaviours. The results will be reviewed for preparation for a future full-scale efficacy trial.Ethics and disseminationThis study was approved by the institutional review board at San Diego State University and is registered at ClinicalTrials.gov. The intervention development process, plan and the results of this study will be shared through peer-reviewed journal publications, conference presentations and healthcare system and community presentations.Registration detailsRegistered under the National Institutes of Health’s ClinicalTrials.gov (NCT04048382) on 7 August 2019 and approved by the San Diego State University (HS-2017–0187) institutional review board. This study began on 5 August 2019 and is estimated to continue through 31 March 2021. The clinical trial is in the pre-results stage.

ObjectiveTo understand how, and under what circumstances community participation in water and sanitation interventions impacts the availability of safe water and sanitation, a change in health status or behaviour and the longevity of water, sanitation and hygiene (WASH) resources and services.DesignRealist review.Data sourcesPubMed, Web of Science and Scopus databases were used to identify papers from low-income and middle-income countries from 2010 to 2020.Eligibility criteria for selecting studiesCriteria were developed for papers to be included. The contribution of each paper was assessed based on its relevance and rigour (eg, can it contribute to context, mechanism or outcome, and is the method used to generate that information credible).AnalysisInductive and deductive coding was used to generate context–mechanism–outcome configurations.Results73 studies conducted in 29 countries were included. We identified five mechanisms that explained the availability, change and longevity outcomes: (1) accountability (policies and procedures to hold communities responsible for their actions and outcomes of an intervention), (2) diffusion (spread of an idea or behaviour by innovators over time through communication among members of a community), (3) market (the interplay between demand and supply of a WASH service or resource), (4) ownership (a sense of possession and control of the WASH service or resource) and (5) shame (a feeling of disgust in one’s behaviour or actions). Contextual elements identified included community leadership and communication, technical skills and knowledge, resource access and dependency, committee activity such as the rules and management plans, location and the level of community participation.ConclusionsThe findings highlight five key mechanisms impacted by 19 contextual factors that explain the outcomes of community water and sanitation interventions. Policymakers, programme implementers and institutions should consider community dynamics, location, resources, committee activity and practices and nature of community participation, before introducing community water and sanitation interventions.

IntroductionA growing number of technology-based interventions are used to support the health and quality of life of nursing home residents. The onset of COVID-19 and recommended social distancing policies that followed led to an increased interest in technology-based solutions to provide healthcare and promote health. Yet, there are no comprehensive resources on technology-based healthcare solutions that describe their efficacy for nursing home residents. This systematic review will identify technology-based interventions designed for nursing home residents and describe the characteristics and effects of these interventions concerning the distinctive traits of nursing home residents and nursing facilities. Additionally, this paper will present practical insights into the varying intervention approaches that can assist in the delivery of broad digital health solutions for nursing home residents amid and beyond the impact of COVID-19.Methods and analysisDatabases including the PubMed, PsycINFO, CINAHL and Scopus will be used to identify articles related to technology-based interventions for nursing home residents published between 1 January 2010 to 30 September 2021. Titles, abstracts and full-text papers will be reviewed against the eligibility criteria. The Cochrane Collaboration evaluation framework will be adopted to examine the risk of bias of the included study. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses procedures will be followed for the reporting process and implications for existing interventions and research evaluated by a multidisciplinary research team.Ethics and disseminationAs the study is a protocol for a systematic review, ethical approval is not required. The study findings will be disseminated via peer-reviewed publications and conference presentations.Trial registration numberCRD 42020191880.

BackgroundIndividual behaviour changes, such as hand hygiene and physical distancing, are required on a population scale to reduce transmission of infectious diseases such as COVID-19. However, little is known about effective methods of communicating risk reducing information, and how populations might respond.ObjectiveTo synthesise evidence relating to what (1) characterises effective public health messages for managing risk and preventing infectious disease and (2) influences people’s responses to messages.DesignA rapid systematic review was conducted. Protocol is published on Prospero CRD42020188704.Data sourcesElectronic databases were searched: Ovid Medline, Ovid PsycINFO and Healthevidence.org, and grey literature (PsyarXiv, OSF Preprints) up to May 2020.Study selectionAll study designs that (1) evaluated public health messaging interventions targeted at adults and (2) concerned a communicable disease spread via primary route of transmission of respiratory and/or touch were included. Outcomes included preventative behaviours, perceptions/awareness and intentions. Non-English language papers were excluded.SynthesisDue to high heterogeneity studies were synthesised narratively focusing on determinants of intentions in the absence of measured adherence/preventative behaviours. Themes were developed independently by two researchers and discussed within team to reach consensus. Recommendations were translated from narrative synthesis to provide evidence-based methods in providing effective messaging.ResultsSixty-eight eligible papers were identified. Characteristics of effective messaging include delivery by credible sources, community engagement, increasing awareness/knowledge, mapping to stage of epidemic/pandemic. To influence intent effectively, public health messages need to be acceptable, increase understanding/perceptions of health threat and perceived susceptibility.DiscussionThere are four key recommendations: (1) engage communities in development of messaging, (2) address uncertainty immediately and with transparency, (3) focus on unifying messages from sources and (4) frame messages aimed at increasing understanding, social responsibility and personal control. Embedding principles of behavioural science into public health messaging is an important step towards more effective health-risk communication during epidemics/pandemics.

BackgroundThere are few examples of the practical application of the concepts of social accountability, as defined by the World Bank and WHO, to health system change. This paper describes a robust approach led by First Nations Health Authority and the Rural Coordination Centre of British Columbia. This was achieved using partnerships in British Columbia, Canada, where the health system features inequities in service and outcomes for rural and Indigenous populations. Social accountability is achieved when all stakeholders come together simultaneously as partners and agree on a path forward. This approach has enabled socially accountable healthcare, effecting change in the healthcare system by addressing the needs of the population.InnovationOur innovative approach uses social accountability engagement to counteract persistent health inequities. This involves an adaptation of the Boelen Health Partnership model (policymakers, health administrators, health professionals, academics and community members) extended by addition of linked sectors (eg, industry and not-for-profits) to the ‘Partnership Pentagram Plus’. We used appreciative inquiry and deliberative dialogue focused on the rural scale and integrating Indigenous ways of knowing along with western scientific traditions (‘two-eyed seeing’). Using this approach, partners are brought together to identify common interests and direction as a learning community. Equitable engagement and provision of space as ‘peers’ and ‘partners’ were key to this process. Groups with varying perspectives came together to create solutions, building on existing strengths and new collaborative approaches to address specific issues in the community and health services delivery. A resulting provincial table reflecting the Pentagram Plus model has fostered policies and practices over the last 3 years that have resulted in meaningful collaborations for health service change.ConclusionThis paper presents the application of the ‘Partnership Pentagram Plus’ approach and uses appreciative inquiry and deliberative dialogue to bring about practical and positive change to rural and Indigenous communities.

ObjectivesMultimorbidity – the co-occurrence of at least two chronic diseases in an individual-is an important public health challenge in ageing societies. The vast majority of multimorbidity research takes a cross-sectional approach, but longitudinal approaches to understanding multimorbidity are an emerging research area, being encouraged by multiple funders. To support development in this research area, the aim of this study is to scope the methodological approaches and substantive findings of studies which have investigated longitudinal multimorbidity trajectories.DesignWe conducted a systematic search for relevant studies in four online databases (Medline, Scopus, Web of Science, and Embase) using pre-defined search terms and inclusion and exclusion criteria. The search was complemented by searching reference lists of relevant papers. From the selected studies we systematically extracted data on study methodology and findings, and summarised them in a narrative synthesis.ResultsWe identified 34 studies investigating multimorbidity longitudinally, all published in the last decade, and predominantly in high-income countries from the Global North. Longitudinal approaches employed included constructing change variables, multilevel regression analysis (e.g. growth curve modelling), longitudinal group-based methodologies (e.g. latent class modelling), analysing disease transitions, and visualisation techniques. Commonly identified risk factors for multimorbidity onset and progression were older age, higher socio-economic and area-level deprivation, overweight, and poorer health behaviours.ConclusionThe nascent research area employs a diverse range of longitudinal approaches that characterize accumulation and disease combinations, and to a lesser extent disease sequencing and progression. Gaps include understanding the long-term, life course determinants of different multimorbidity trajectories, and doing so in across diverse populations, including those from low and middle-income countries. This can provide a detailed picture of morbidity development, with important implications from a clinical and intervention perspective.STRENGTHS AND LIMITATIONS OF THE STUDYThis is the first systematic review to focus on studies that take a longitudinal, rather than cross-sectional, approach to multimorbidity.Systematic searches of online academic databases were performed using pre-defined search terms, as well as searching of reference lists, and this is reported using PRISMA guidelines.For selected papers, data was double extracted using standardised proformas to aid narrative synthesis.Due to the heterogeneity of the studies included, their weaknesses were described in the narrative synthesis, but we did not perform quality assessment using standardised tools.

ObjectivesWe aimed to review the international literature to understand the enablers of and barriers to effective clinical supervision in the workplace and identify the benefits of effective clinical supervision.DesignA rapid evidence review.Data sourcesFive databases (CINAHL, OVID Embase, OVID Medline, OVID PsycInfo and ProQuest) were searched to ensure inclusion and breadth of healthcare professionals.Eligibility criteriaStudies identifying enablers and barriers to effective clinical supervision across healthcare professionals in a Western context between 1 January 2009 and 12 March 2019.Data extraction and synthesisAn extraction framework with a detailed inclusion/exclusion criteria to ensure rigour was used to extract data. Data were analysed using a thematic qualitative synthesis. These themes were used to answer the research objectives.ResultsThe search identified 15 922 papers, reduced to 809 papers following the removal of duplicates and papers outside the inclusion criteria, with 135 papers being included in the full review. Enablers identified included regular supervision, occurs within protected time, in a private space and delivered flexibly. Additional enablers included supervisees being offered a choice of supervisor; supervision based on mutual trust and a positive relationship; a cultural understanding between supervisor and supervisee; a shared understanding of the purpose of supervision, based on individual needs, focused on enhancing knowledge and skills; training and feedback being provided for supervisors; and use of a mixed supervisor model, delivered by several supervisors, or by those trained to manage the overlapping (and potentially conflicting) needs of the individual and the service. Barriers included a lack of time, space and trust. A lack of shared understanding to the purpose of the supervision, and a lack of ongoing support and engagement from leadership and organisations were also found to be barriers to effective clinical supervision.ConclusionsThis review identified several enablers of and barriers to effective clinical supervision and the subsequent benefits of effective clinical supervision in a healthcare setting.

IntroductionThe COVID-19 pandemic has resulted in significant morbidity and mortality and devastated economies globally. Among groups at increased risk are healthcare workers (HCWs) and ethnic minority groups. Emerging evidence suggests that HCWs from ethnic minority groups are at increased risk of adverse COVID-19-related outcomes. To date, there has been no large-scale analysis of these risks in UK HCWs or ancillary workers in healthcare settings, stratified by ethnicity or occupation, and adjusted for confounders. This paper reports the protocol for a prospective longitudinal questionnaire study of UK HCWs, as part of the UK-REACH programme (The United Kingdom Research study into Ethnicity And COVID-19 outcomes in Healthcare workers).Methods and analysisA baseline questionnaire will be administered to a national cohort of UK HCWs and ancillary workers in healthcare settings, and those registered with UK healthcare regulators, with follow-up questionnaires administered at 4 and 8 months. With consent, questionnaire data will be linked to health records with 25-year follow-up. Univariate associations between ethnicity and clinical COVID-19 outcomes, physical and mental health, and key confounders/explanatory variables will be tested. Multivariable analyses will test for associations between ethnicity and key outcomes adjusted for the confounder/explanatory variables. We will model changes over time by ethnic group, facilitating understanding of absolute and relative risks in different ethnic groups, and generalisability of findings.Ethics and disseminationThe study is approved by Health Research Authority (reference 20/HRA/4718), and carries minimal risk. We aim to manage the small risk of participant distress about questions on sensitive topics by clearly participant information that the questionnaire covers sensitive topics and there is no obligation to answer these or any other questions, and by providing support organisation links. Results will be disseminated with reports to Government and papers submitted to pre-print servers and peer reviewed journals.Trial registration numberISRCTN11811602; Pre-results.

ObjectivesIn response to demographic and health system pressures, the development of non-medical advanced clinical practice (ACP) roles is a key component of National Health Service workforce transformation policy in the UK. This review was undertaken to establish a baseline of evidence on ACP roles and their outcomes, impacts and implementation challenges across the UK.DesignA scoping review was undertaken following JBI methodological guidance.Methods13 online databases (Medline, CINAHL, ASSIA, Embase, HMIC, AMED, Amber, OT seeker, PsycINFO, PEDro, SportDiscus, Osteopathic Research and PenNutrition) and grey literature sources were searched from 2005 to 2020. Data extraction, charting and summary was guided by the PEPPA-Plus framework. The review was undertaken by a multi-professional team that included an expert lay representative.Results191 papers met the inclusion criteria (any type of UK evidence, any sector/setting and any profession meeting the Health Education England definition of ACP). Most papers were small-scale descriptive studies, service evaluations or audits. The papers reported mainly on clinical aspects of the ACP role. Most papers related to nursing, pharmacy, physiotherapy and radiography roles and these were referred to by a plethora of different titles. ACP roles were reported to be achieving beneficial impacts across a range of clinical and health system outcomes. They were highly acceptable to patients and staff. No significant adverse events were reported. There was a lack of cost-effectiveness evidence. Implementation challenges included a lack of role clarity and an ambivalent role identity, lack of mentorship, lack of continuing professional development and an unclear career pathway.ConclusionThis review suggests a need for educational and role standardisation and a supported career pathway for advanced clinical practitioners (ACPs) in the UK. Future research should: (i) adopt more robust study designs, (ii) investigate the full scope of the ACP role and (iii) include a wider range of professions and sectors.

IntroductionBig data research has grown considerably over the last two decades. This presents new ethical challenges around consent, data storage and anonymisation. Big data research projects require public support to succeed and it has been argued that one way to achieve this is through public involvement and engagement. To better understand the role public involvement and engagement can play in big data research, we will review the current literature. This protocol describes the planned review methods.Methods and analysisOur review will be conducted in two stages. In the first stage, we will conduct a scoping review using Arksey and O’Malley methodology to comprehensively map current evidence on public involvement and engagement in big data research. Databases (CINAHL, Health Research Premium Collection, PubMed, Scopus, Web of Science) and grey literature will be searched for eligible papers. We provide a narrative description of the results based on a thematic analysis. In the second stage, out of papers found in the scoping review which discuss involvement and engagement strategies, we will conduct a systematic review following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, exploring the delivery and effectiveness of these strategies. We will conduct a qualitative synthesis. Relevant results from the quantitative studies will be extracted and placed under qualitative themes. Individual studies will be appraised through Mixed Methods Appraisal Tool (MMAT), we will then assess the overall confidence in each finding through Confidence in the Evidence from Reviews of Qualitative research (GRADE-CERQual). Results will be reported in a thematic and narrative way.Ethics and disseminationThis protocol sets out how the review will be conducted to ensure rigour and transparency. Public advisors were involved in its development. Ethics approval is not required. Review findings will be presented at conferences and published in peer-reviewed journals.

IntroductionBreaking bad news and dealing with difficult patient encounters is a skill that medical residents must learn during their curriculum. Many different tools are available to measure communication quality, but their development and validation processes are often missing. In this paper, we present the protocol of a systematic review aiming to identify the validated tools for measuring communication skills or communication effectiveness with parents in a paediatrics setting in general, including for difficult patient encounters.Methods and analysisWe will conduct our systematic review in accordance with the methodology suggested by COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) and will report this paper following the guidelines of the Preferred Reporting Items for Systematic reviews and Meta-Analyses. We will include the studies in which authors developed and/or validated tools for assessing the quality of communication with families by residents and/or physicians during patient encounters in paediatric settings. Studies assessing communication in telemedicine and studies that use the tool to measure a different outcome than its validation will be excluded. Our search strategy will be developed by a scientific librarian and validated using the Peer Review of Electronic Search Strategy (PRESS) tool. Two reviewers will independently screen the studies for selection, extract data of the ones included and assess their level of risk of bias using the COSMIN Risk of Bias checklist. We will perform a narrative synthesis on the study selection process, the characteristics of studies and study population, the characteristics of tools identified, their process of development and/or validation and their psychometric properties. If sufficient data are available, we will do quantitative analyses for each psychometric property.Ethics and disseminationApproval from an ethics committee is not required, as there is no primary data collection. Our findings will be disseminated through a peer-reviewed publication and at local, national and international conferences.PROSPERO registration numberCRD42020151642.

IntroductionCommunities of practice are used for knowledge sharing and learning in health settings. However, more needs to be known to understand how they work, if they work different in different settings and what outcomes they might generate. Of particular interest is their potential role in health literacy development.Methods and analysisThis realist review will be undertaken in seven stages, aiming to develop a framework to show how the various contexts of communities of practice in health settings trigger mechanisms that lead to improved health literacy outcomes. The first stage of a realist review is considered important as it clarifies the scope of the review, yet it is rarely elaborated in detail. This paper describes this first stage in detail and shows how scoping techniques can support drafting an initial framework which can guide the rest of the review. After the initial scoping review, the subsequent stages follow an iterative and recurring process (until saturation is reached) that includes searching and appraising evidence, extracting and organising results, and analysing and summarising. The review will then generate conclusions and recommendations for stakeholders seeking to use communities of practice for their health literacy challenges. Findings of the scoping review are presented in this paper as part of the methods description to show the relevance of conducting a scoping review prior to a realist review.Ethics and disseminationEthical review is not required for this review. Experts and stakeholders will be involved in the process after the first stage to increase the quality of the process and to ensure practical relevance and uptake. This review focuses on communities of practice and health literacy, yet findings will likely be relevant for other health settings. Findings will be disseminated through stakeholders, publications, presentations and formal and informal reports.

IntroductionPrevious reviews of mobile messaging for individuals with musculoskeletal pain have shown positive effects on pain and disability. However, the configuration of digital content, method of presentation and interaction, dose and frequency needed for optimal results remain unclear. Patient preferences concerning such systems are also unclear. Addressing these knowledge gaps, incorporating evidence from both experimental and observational studies, may be useful to understand the extent of the relevant literature, and to influence the design and outcomes of future messaging systems. We aim to map information that could be influential in the design of future mobile messaging systems for individuals with musculoskeletal pain conditions, and to summarise the findings of efficacy, effectiveness, and economics derived from both experimental and observational studies.Methods and analysisWe will include studies describing the development and/or use of mobile messaging to support adults (≥18 years) with acute or chronic musculoskeletal pain. We will exclude digital health studies that lack a mobile messaging component, or those targeted at other health conditions unrelated to the bones, muscles and connective tissues, or involving surgical or patients with cancer, or studies involving solely healthy individuals. Our sources of information will be online databases and reference lists of relevant papers. We will include papers published in English in the last 10 years. Two pairs of independent reviewers will screen, select and extract the data, with any disagreements mediated by a third reviewer. We will report the results according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for scoping reviews checklist. We will synthesise the findings in a tabular format and provide a descriptive summary.Ethics and disseminationFormal ethical approval is not required. We will disseminate the findings through publication in a peer-reviewed journal, relevant conferences, and relevant consumer forums.Trial registrationOpen Science Framework https://osf.io/8mzya; DOI: 10.17605/OSF.IO/8MZYA.

IntroductionIn patients with myocardial infarction, the decision to treat a nonculprit lesion is generally based on its physiological significance. However, deferral of revascularisation based on nonischaemic fractional flow reserve (FFR) values in these patients results in less favourable outcomes compared with patients with stable coronary artery disease, potentially caused by vulnerable nonculprit lesions. Intravascular optical coherence tomography (OCT) imaging allows for in vivo morphological assessment of plaque ‘vulnerability’ and might aid in the detection of FFR-negative lesions at high risk for recurrent events.Methods and analysisThe PECTUS-obs study is an international multicentre prospective observational study that aims to relate OCT-derived vulnerable plaque characteristics of nonflow limiting, nonculprit lesions to clinical outcome in patients with myocardial infarction. A total of 438 patients presenting with myocardial infarction (ST-elevation myocardial infarction and non-ST-elevation myocardial infarction) will undergo OCT-imaging of any FFR-negative nonculprit lesion for detection of plaque vulnerability. The primary study endpoint is a composite of major adverse cardiovascular events (all-cause mortality, nonfatal myocardial infarction or unplanned revascularisation) at 2-year follow-up. Secondary endpoints will be the same composite at 1-year and 5-year follow-up, target vessel failure, target vessel revascularisation, target lesion failure and target lesion revascularisation.Ethics and disseminationThis study has been approved by the Medical Ethics Committee of the region Arnhem-Nijmegen. The results of this study will be disseminated in a main paper and additional papers with subgroup analyses.Trial registration numberNCT03857971.

ObjectivesA key barrier in supporting health research capacity development (HRCD) is the lack of empirical measurement of competencies to assess skills and identify gaps in research activities. An effective tool to measure HRCD in healthcare workers would help inform teams to undertake more locally led research. The objective of this systematic review is to identify tools measuring healthcare workers’ individual capacities to conduct research.DesignSystematic review and narrative synthesis using Preferred Reporting Items for Systematic Reviews and Meta-Analyses checklist for reporting systematic reviews and narrative synthesis and the Critical Appraisals Skills Programme (CASP) checklist for qualitative studies.Data sources11 databases were searched from inception to 16 January 2020. The first 10 pages of Google Scholar results were also screened.Eligibility criteriaWe included papers describing the use of tools/to measure/assess HRCD at an individual level among healthcare workers involved in research. Qualitative, mixed and quantitative methods were all eligible. Search was limited to English language only.Data extraction and synthesisTwo authors independently screened and reviewed studies using Covidence software, and performed quality assessments using the extraction log validated against the CASP qualitative checklist. The content method was used to define a narrative synthesis.ResultsThe titles and abstracts for 7474 unique records were screened and the full texts of 178 references were reviewed. 16 papers were selected: 7 quantitative studies; 1 qualitative study; 5 mixed methods studies; and 3 studies describing the creation of a tool. Tools with different levels of accuracy in measuring HRCD in healthcare workers at the individual level were described. The Research Capacity and Culture tool and the ‘Research Spider’ tool were the most commonly defined. Other tools designed for ad hoc interventions with good generalisability potential were identified. Three papers described health research core competency frameworks. All tools measured HRCD in healthcare workers at an individual level with the majority adding a measurement at the team/organisational level, or data about perceived barriers and motivators for conducting health research.ConclusionsCapacity building is commonly identified with pre/postintervention evaluations without using a specific tool. This shows the need for a clear distinction between measuring the outcomes of training activities in a team/organisation, and effective actions promoting HRCD. This review highlights the lack of globally applicable comprehensive tools to provide comparable, standardised and consistent measurements of research competencies.PROSPERO registration numberCRD42019122310.

IntroductionVirtual communities of practice (VCoPs) use a common online platform to provide healthcare professionals with the opportunity to access highly specialised knowledge, build a professional support network and promote the translation of research evidence into practice. There is limited reporting of how best to design and administer VCoPs within healthcare organisations. The primary aim of this scoping review is to identify the best methods used to establish and maintain VCoPs. Findings shall be used to develop a flexible framework to guide the establishment and facilitation of a VCoP for healthcare professionals to ensure the translation of falls prevention clinical guidelines into practice.Methods and analysisA five-stage scoping review process will be followed based on Arksey and O’Malley’s framework and refined by the Joanna Briggs Institute Methodology. An initial limited search of PubMed and Cumulative Index to Nursing and Allied Health Literature will identify relevant studies and assist with search term development. This will be followed by a search of five online databases to identify papers published from January 2010 until November 2020. Papers will be independently screened by two reviewers, and data extracted and analysed using a reporting framework. Qualitative data will be analysed thematically and numerical synthesis of the data will be conducted.Results and disseminationThe results of this scoping review will highlight the best ways to design and manage VCoPs in healthcare organisations. The findings will be presented at relevant stakeholder workshops, conferences and published in peer-reviewed journals.

Patient-reported outcomes (PROs) are used in clinical trials to provide valuable evidence on the impact of disease and treatment on patients' symptoms, function and quality of life. High-quality PRO data from trials can inform shared decision-making, regulatory and economic analyses and health policy. Recent evidence suggests the PRO content of past trial protocols was often incomplete or unclear, leading to research waste. To address this issue, international, consensus-based, PRO-specific guidelines were developed: the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)-PRO Extension. The SPIRIT-PRO Extension is a 16-item checklist which aims to improve the content and quality of aspects of clinical trial protocols relating to PRO data collection to minimise research waste, and ultimately better inform patient-centred care. This SPIRIT-PRO explanation and elaboration (E&E) paper provides information to promote understanding and facilitate uptake of the recommended checklist items, including a comprehensive protocol template. For each SPIRIT-PRO item, we provide a detailed description, one or more examples from existing trial protocols and supporting empirical evidence of the item's importance. We recommend this paper and protocol template be used alongside the SPIRIT 2013 and SPIRIT-PRO Extension paper to optimise the transparent development and review of trial protocols with PROs. ispartof: BMJ OPEN vol:11 issue:6 ispartof: location:England status: published

IntroductionA 2011 paper proposed a working taxonomy of implementation outcomes, their conceptual distinctions and a two-pronged research agenda on their role in implementation success. Since then, over 1100 papers citing the manuscript have been published. Our goal is to compare the field’s progress to the originally proposed research agenda, and outline recommendations for the next 10 years. To accomplish this, we are conducting the proposed scoping review.Methods and analysisOur approach is informed by Arksey and O’Malley’s methodological framework for conducting scoping reviews. We will adhere to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews. We first aim to assess the degree to which each implementation outcome has been investigated in the literature, including healthcare settings, clinical populations and innovations represented. We next aim to describe the relationship between implementation strategies and outcomes. Our last aim is to identify studies that empirically assess relationships among implementation and/or service and client outcomes. We will use a forward citation tracing approach to identify all literature that cited the 2011 paper in the Web of Science (WOS) and will supplement this with citation alerts sent to the second author for a 6-month period coinciding with the WOS citation search. Our review will focus on empirical studies that are designed to assess at least one of the identified implementation outcomes in the 2011 taxonomy and are published in peer-reviewed journals. We will generate descriptive statistics from extracted data and organise results by these research aims.Ethics and disseminationNo human research participants will be involved in this review. We plan to share findings through a variety of means including peer-reviewed journal publications, national conference presentations, invited workshops and webinars, email listservs affiliated with our institutions and professional associations, and academic social media.

IntroductionChronic venous leg ulcer (VLU) healing is a complex clinical problem. It requires intervention from skilled, costly, multidisciplinary wound-care teams, working with patients to manage their care. Compression therapy has been shown to help heal venous ulcers and to reduce recurrence, with some evidence suggesting the value of exercise as well. These activities require health education and health literacy (HL) as patients must process, understand and consistently apply health information for successful self-management. Research suggests that those most vulnerable to VLUs also tend to have limited HL, but there have been no reviews examining the state of HL in patients with previous or active VLUs. This scoping review aims to examine the level of HL in VLU patients and how HL may link to self-management behaviours (particularly exercise and compression adherence), and their VLU healing generally.Methods and analysisWe will use Preferred Reporting Items for Systematic Reviews and Meta-Analyses Scoping Review guidelines and the Levac methodology framework to explore eligible papers that examine the effect of HL on their exercise and compression adherence. Electronic databases will be searched (MEDLINE, EMBASE, the Cochrane Library, PsycInfo and Health, OpenGray), examining for all papers on these subjects published between 2000 and 2020. All studies describing compression and or exercise during VLU management will be included. Study characteristics will be recorded; qualitative data will be extracted and evaluated. Quantitative data will be extracted and summarised.Ethics and disseminationWe will disseminate results through peer-reviewed publications. We will use data (ie, journal articles) from publicly available platforms; so, this study does not require ethical review. The consultation step will be carried out with patients, carers and health professionals as part of an established wound consumer group.

IntroductionFrail older adults are particularly vulnerable to functional decline and adverse outcomes because they lack the necessary resistance and ability to cope. Rehabilitation services for the frail older adults are thus vital and require clarification. The aim of this review is to identify and map the scope and breadth of literature regarding rehabilitation of the frail older adults to develop a holistic rehabilitation service in primary healthcare in rural areas. The concept of rehabilitation, how rehabilitation services are organised, how patients and next of kin are involved in planning and evaluating services during rehabilitation, as well as reported results will be identified and mapped.Methods and analysisThis scoping review will be conducted based on the methodology developed by Arksey and O’Malley. The search strategy will aim to locate both published and unpublished studies in relevant databases. Key information sources include CINAHL, MEDLINE, Embase, ProQuest and Google Scholar. Data will be extracted from papers that all three reviewers have chosen to include in the review. All three reviewers will participate in screening, assessment and selection of studies against the inclusion criteria for the review and work in teams of two. The full text of selected citations will be assessed in detail against the inclusion criteria by the same teams. Data will be extracted from papers included in the scoping review by two of the reviewers. Modifications will be detailed in the full review report. Any disagreements that arise between two reviewers will be resolved through discussion or with the third reviewer’s mediation. A narrative summary of the findings will be presented accompanied by tables that reflect the objective of the review.Ethics and disseminationData will be obtained only from already publicly available materials. Special ethical approval is, therefore, not required.

IntroductionThe application of advanced technologies in paediatric rehabilitation to improve performance and enhance everyday functioning shows considerable promise. The aims of this systematic review are to investigate the effectiveness of robotic-assisted therapy for upper extremity function in children and adolescents with cerebral palsy and to extend the scope of intervention from empirical evidence.Methods and analysisMultiple databases, including MEDLINE (Ovid), PubMed, CINAHL, Scopus, Web of Science, Cochrane Library and IEEE Xplore, will be comprehensively searched for relevant randomised controlled trials and non-randomised studies. The grey literature will be accessed on the ProQuest Dissertations & Theses Global database, and a hand search from reference lists of previous articles will be performed. The papers written in English language will be considered, with no limitation on publication date. Two independent reviewers will identify eligible studies, evaluate the level of evidence (the Oxford Centre for Evidence-Based Medicine) and appraise methodological quality and risk of bias (the Standard quality assessment criteria for evaluating primary research papers from a variety of fields (QualSyst tool); the Grading of Recommendations Assessment, Development and Evaluation). Data will be appropriately extracted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guideline. A narrative synthesis will be provided to summarise the results, and a meta-analysis will be conducted if there is sufficient homogeneity across outcomes.PROSPERO registration numberCRD42020205818.Ethics and disseminationEthical approval is not required for this study. The findings will be disseminated via a peer-reviewed journal and international conferences.

IntroductionThere is an increasing body of evidence to suggest that visibility of prostate cancer on magnetic resonance (MRI) may be related to likelihood of adverse pathological outcomes. Biochemical recurrence (BCR) after radical prostatectomy remains a significant clinical challenge and a means of predicting likelihood of this prior to surgery could inform treatment choice. It appears that MRI could be a potential candidate strategy for BCR prediction, and as such, there is a need to review extant literature on the prognostic capability of MRI. Here, we describe a protocol for a systematic review and meta-analysis of the utility of biparametric MRI (bpMRI) and multiparametric MRI (mpMRI) in predicting BCR following radical prostatectomy for prostate cancer treatment.Methods and analysisPubMed, MEDLINE, Embase and Cochrane databases will be searched and screening will be guided by the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. In order to meet the inclusion criteria, papers must be English-language articles involving patients who have had bpMRI or mpMRI for suspected prostate cancer and have undergone radical prostatectomy as definitive therapy. Patients must have had prostate-specific antigen monitoring before and after surgery. All relevant papers published from July 1977 to October 2020 will be eligible for inclusion. The Newcastle-Ottawa score will be used to determine the quality and bias of the studies. This protocol is written in-line with the PRISMA protocol 2015 checklist.Ethics and disseminationThere are no relevant ethical concerns. Dissemination of this protocol will be via peer-reviewed journals as well as national and international conferences.PROSPERO registration numberCRD42020206074.

ObjectivesTo capture the extent and nature of intellectual disability nursing publications in Ireland.DesignScoping review using Arksey and O’Malley approach.Data sourcesSix databases (PsycINFO, CINAHL, Medline, Academic Search Complete, Scopus, Embase) were searched along with a web-based search of the eight academic institutions delivering intellectual disability nurse education in Ireland for publications indexed from the earliest available date to the 31 December 2020.Eligibility criteriaPublications by an academic, practitioner or student working in intellectual disability practice or education in Ireland relating to intellectual disability nursing, care or education.Data extraction and synthesisData pertaining to type of paper/design, authors (academic/professional/student), year, collaboration (national/international), topic/content area and title were extracted from each paper. Data were analysed by two authors using Colorafi and Evans content analysis steps where data was tabulated, and a narrative synthesis undertaken.ResultsThe reporting of the review is in line with the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) and PRISMA extension for Scoping Reviews Checklist. Database and web-based searching resulting 245 articles meeting the criteria for this review. Through content analysis the 245 articles were mapped onto six themes: supporting inclusion, future planning, aspects of health, interventions, education, professional development and research, and personal and professional accounts of caring.ConclusionsThis review highlights the extent and nature of intellectual disability publications by academic, practitioner or student working in intellectual disability nursing in Ireland together with opportunities for future growth and development. From the findings it is apparent that there is an ongoing need for intellectual disability nurses to define their role across the full trajectory of health provision and to make visible their role in person-family centred support, inclusion, and contributions in health education, health promotion and health management.

ObjectivesThe aim of this scoping review was to identify pre-existing interventions to support the well-being of healthcare workers during a pandemic or other crisis and to assess the quality of these interventions.DesignArksey and O’Malley’s five-stage scoping review framework was used to identify the types of evidence available in the field of well-being interventions for healthcare workers during a pandemic. PubMed, PsycINFO, Embase, Scopus, Web of Science, CINAHL and ERIC databases were searched to find interventions for the well-being of doctors during pandemics. Owing to a lack of results, this search was expanded to all healthcare workers and to include any crisis. Databases were searched in June 2020 and again in October 2020.Inclusion/exclusion criteriaArticles were included that studied healthcare workers, reported an intervention design and were specifically designed for use during a pandemic or other crisis. Well-being was defined broadly and could include psychological, physical, social or educational interventions.ResultsSearching produced 10 529 total academic references of which 2062 were duplicates. This left 8467 references. Of these, 16 met our inclusion criteria and were included in data extraction. During data extraction, three more papers were excluded. This left 13 papers to summarise and report. Of these 13 papers, 6 were prospective studies and 7 were purely descriptive. None of the interventions were theoretically informed in their development and the quality of the evidence was generally deemed poor.ConclusionsThere are no high-quality, theory-based interventions for the well-being of healthcare workers during a pandemic or other crisis. Given that previous pandemics have been shown to have a negative effect on healthcare workers well-being, it is imperative this shortcoming is addressed. This scoping review highlights the need for high-quality, theory-based and evidence-based interventions for the well-being of healthcare workers during a pandemic.

IntroductionMeasures of health-related quality-of-life (HRQoL) are increasingly important for evaluating healthcare interventions and treatments, understanding the burden of disease, identifying health inequities, allocating health resources and for use in epidemiological studies. Although many HRQoL measures developed for use in adult populations are robust, they are not necessarily designed, or appropriate, to measure HRQoL for children/youth. Furthermore, the appropriateness of HRQoL measures for use with Indigenous child/youth populations has not been closely examined. The aims of this scoping review are to (1) identify and describe empirical studies using HRQoL measures among children/youth (aged 8–17 years) from Indigenous populations within the Pacific Rim, (2) summarise the study designs and modes of HRQoL measure administration, (3) describe the key dimensions of the identified HRQoL measures used among Indigenous populations, including specifically among Māori and (4) map the HRQoL measure dimensions to commonly used Māori models of health.Methods and analysisThe scoping review framework developed by Arksey and O’Malley and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for scoping reviews guidelines will be followed for best practice and reporting. An iterative search of peer-reviewed published empirical research reporting the use of child/youth HRQoL measures among Indigenous populations will be conducted. This literature will be identified across the following five databases: Ovid (Medline), PubMed, Scopus, Web of Science and CINHAL. The search will be restricted to papers published in English between January 1990 and June 2020. Two reviewers will independently review the papers in two stages. A third reviewer will resolve any discrepancies that arise. A data charting form will be completed using data extracted from each paper.Ethics and disseminationEthical approval was not required for this scoping review. Dissemination will include publication of the scoping review in a peer-reviewed journal. This scoping review will inform a larger research project (HRC 20/166).

ObjectivesSummarise studies of outdoor green space exposure and brain health measures related to Alzheimer’s disease and related disorders (ADRD), and determine scientific gaps for future research.DesignRapid review of primary research studies.Methods and outcomesPubMed, Embase and Web of Science Core Collection were searched for articles meeting the criteria published on/before 13 February 2020. The review excluded papers not in English, focused on transient states (eg, mental fatigue) or not using individual-level measures of brain health (eg, average school test scores). Brain health measures of interest included cognitive function, clinical diagnosis of cognitive impairment/dementia/ADRD and brain biomarkers such as those from MRI, measures typically associated with ADRD risk and disease progression.ResultsTwenty-two papers were published from 2012 to 2020, 36% on ConclusionsPublished studies suggest positive green space-brain health associations across the life course, but the methods and cohorts were limited and heterogeneous. Future research using racially/ethnically and geographically diverse cohorts, life course methods and more specific green space and brain health measures (eg, time spent in green spaces, ADRD biomarkers) will strengthen evidence for causal associations.

ObjectiveTo examine the extent, nature and quality of literature on the impact of the COVID-19 pandemic on the mental health of imprisoned people and prison staff.DesignScoping review.Data sourcesPubMed, Embase, CINAHL, Global Health, Cochrane, PsycINFO, PsychExtra, Web of Science and Scopus were searched for any paper from 2019 onwards that focused on the mental health impact of COVID-19 on imprisoned people and prison staff. A grey literature search focused on international and government sources and professional bodies representing healthcare, public health and prison staff was also performed. We also performed hand searching of the reference lists of included studies.Eligibility criteria for selection of studiesAll papers, regardless of study design, were included if they examined the mental health of imprisoned people or prison staff specifically during the COVID-19 pandemic. Imprisoned people could be of any age and from any countries. All languages were included. Two independent reviewers quality assessed appropriate papers.ResultsOf 647 articles found, 83 were eligible for inclusion, the majority (58%) of which were opinion pieces. The articles focused on the challenges to prisoner mental health. Fear of COVID-19, the impact of isolation, discontinuation of prison visits and reduced mental health services were all likely to have an adverse effect on the mental well-being of imprisoned people. The limited research and poor quality of articles included mean that the findings are not conclusive. However, they suggest a significant adverse impact on the mental health and well-being of those who live and work in prisons.ConclusionsIt is key to address the mental health impacts of the pandemic on people who live and work in prisons. These findings are discussed in terms of implications for getting the balance between infection control imperatives and the fundamental human rights of prison populations.

IntroductionThe impacts of violence have a significant effect on health and well-being, particularly for women and children. Violence within families is widely recognised as a complex problem constituted by constantly interacting and evolving social, economic, health and cultural elements. Calls for integrated services have arisen from growing understanding about the implications of this complexity, which suggest family violence and solutions to it are generated endogenously from the reflexive nonlinear interactions of system agents. Despite these calls for integration, services designed to support families impacted by violence and the systems that design and fund them are often responsive only to one part of the problem and might not pay attention to agent interactions and their adaptive reflexivity. This paper outlines a scoping protocol to explore how integrated approaches to family violence are conceptualised in current literature, with innovative use of a complexity theory lens.MethodOur scoping review protocol follows the framework outlined by Arksey and O’Malley and refined by Levac. It searches 6 databases, 3 journals and 10 websites using keywords to capture the notion of integration and a complex adaptive system, namely the participant (system agents), concept (system agent interaction) and the context (family violence). Selection criteria require the articles to be written in English, have full-text article available, and were published after 2010. Items selected also need to be evidence based showing interaction between system agents. Applying complexity theory, sensitises us to the reflexive patterns of interaction between system elements and routine ways of interacting.Ethics and disseminationThe nature of this review means that ethics approval is not required. Findings will be disseminated via academic publications, conferences and discussions with policy decision-makers. The findings will be used to develop a plan for stakeholder consultation to share and validate learnings and inform future research.

IntroductionFollow-up care is important for gastric cancer survivors, but follow-up strategies for gastric cancer survivors remain inconsistent, and compliance of gastric cancer survivors with follow-up care is very low. Understanding the needs and preferences of gastric cancer survivors is conducive to developing appropriate and acceptable follow-up strategies, thereby improving patient compliance. Discrete choice experiments can quantify individual needs and preferences. However, to date, there is no discrete choice experiment on the preferences of gastric cancer survivors, and no studies have examined how gastric cancer survivors make choices based on different characteristics of follow-up. This paper outlines an ongoing discrete choice experiment that aims to (1) explore follow-up service-related characteristics that may affect gastric cancer survivors’ choices about their follow-up, (2) elicit how gastric cancer survivors consider the trade-offs among different follow-up service options using discrete choice experiment, (3) determine whether gastric cancer survivors’ needs and preferences for follow-up vary due to the economy, politics, technology and culture in different regions.Methods and analysisSix attributes were developed through a literature review, semistructured interviews and experts and focus group discussions. A fractional factorial design was used to evaluate the interaction between attributes. A multiple logit model will be used to understand the trade-off between the follow-up characteristics of gastric cancer survivors. A mixed logit model will be used to explore the willingness to pay and uptake rate of gastric cancer survivors for follow-up attributes and further explore the preferences of different groups.Ethics and disseminationThis study was approved by the ethics committee of the School of Nursing, Jilin University. The results of this study will be shared through online blogs, policy briefs, seminars and peer-reviewed journal articles and will be used to modify the current strategy of gastric cancer survivors’ follow-up services according to economic development and regional culture.

PurposeThis paper describes the Women’s Health Accelerometry Collaboration, a consortium of two prospective cohort studies of women age 62 years or older, harmonised to explore the association of accelerometer-assessed physical activity and sedentary behaviour with cancer incidence and mortality.ParticipantsA total of 23 443 women (age mean 73.4, SD 6.8) living in the USA and participating in an observational study were included; 17 061 from the Women’s Health Study (WHS) and 6382 from the Women’s Health Initiative Objective Physical Activity and Cardiovascular Health (WHI/OPACH) Study.Findings to dateAccelerometry, cancer outcomes and covariate harmonisation was conducted to align the two cohort studies. Physical activity and sedentary behaviour were measured using similar procedures with an ActiGraph GT3X+ accelerometer, worn at the hip for 1 week, during 2011–2014 for WHS and 2012–2014 for WHI/OPACH. Cancer outcomes were ascertained via ongoing surveillance using physician adjudicated cancer diagnosis. Relevant covariates were measured using questionnaire or physical assessments. Among 23 443 women who wore the accelerometer for at least 10 hours on a single day, 22 868 women wore the accelerometer at least 10 hours/day on ≥4 of 7 days. The analytical sample (n=22 852) averaged 4976 (SD 2669) steps/day and engaged in an average of 80.8 (SD 46.5) min/day of moderate-to-vigorous, 105.5 (SD 33.3) min/day of light high and 182.1 (SD 46.1) min/day of light low physical activity. A mean of 8.7 (SD 1.7) hours/day were spent in sedentary behaviour. Overall, 11.8% of the cohort had a cancer diagnosis (other than non-melanoma skin cancer) at the time of accelerometry measurement. During an average of 5.9 (SD 1.6) years of follow-up, 1378 cancer events among which 414 were fatal have occurred.Future plansUsing the harmonised cohort, we will access ongoing cancer surveillance to quantify the associations of physical activity and sedentary behaviour with cancer incidence and mortality.

ObjectivesThis study describes the successful implementation and outputs of a combined clinical academic training programme for doctors in their first postgraduate year in Ireland, the Academic Internship Track (AIT).DesignThe AIT was evaluated using the Context, Input, Process and Product model. Literature reviews, meetings with key stakeholders, reviews of similar established programmes overseas, a survey of undergraduate medical students, exit survey, scientific outputs and career trajectory monitoring were all implemented in the programme evaluation.SettingThe AIT represents collaboration amongst all six intern training networks in Ireland.ResultsKey stakeholders indicated support and significant interest in establishing the AIT. The input evaluation informed programme design which incorporates protected time to carry out a research project, a named supervisor, a bursary and access to dedicated study days. Since the programme’s launch in 2017, there has been 100% uptake of posts and 0% attrition. Exiting participants indicate high levels of satisfaction with the programme; 92% reported having benefited from participation. Over 90% intend remaining in Ireland in both the immediate and longer terms. Fifty-seven per cent of participants in the first 3 years of the programme had succeeded in publishing a research article or review paper in a peer-reviewed journal.ConclusionsNow in its fourth year, AIT remains a highly sought-after programme and is perceived to be beneficial to one’s career. Participants in the programme have contributed significantly to their field of interest despite being in the earliest career stages. The programme has the potential to help retain medical talent in Ireland.

IntroductionThe Children and Young People’s Health Partnership (CYPHP) Evelina London Model of Care is a new approach to integrated care delivery for children and young people (CYP) with common health complaints and chronic conditions. CYPHP includes population health management (services shaped by data-driven understanding of population and individual needs, applied in this case to enable proactive case finding and tailored biopsychosocial care), specialist clinics with multidisciplinary health teams and training resources for professionals working with CYP. This complex health system strengthening programme has been implemented in South London since April 2018 and will be evaluated using a cluster randomised controlled trial with an embedded process evaluation. This protocol describes the within-trial and beyond-trial economic evaluation of CYPHP.Methods and analysisThe economic evaluation will identify, measure and value resources and health outcome impacts of CYPHP compared with enhanced usual care from a National Health Service/Personal Social Service and a broader societal perspective. The study population includes 90 000 CYP under 16 years of age in 23 clusters (groups of general practitioner (GP) practices) to assess health service use and costs, with more detailed cost-effectiveness analysis of a targeted sample of 2138 CYP with asthma, eczema or constipation (tracer conditions). For the cost-effectiveness analysis, health outcomes will be measured using the Paediatric Quality of Life Inventory and quality-adjusted life years (QALYs) using the Child Health Utility 9 Dimensions (CHU-9D) measure. To account for changes in parental well-being, the Warwick-Edinburg Mental Well-being Scale will be integrated with QALYs in a cost–benefit analysis. The within-trial economic evaluation will be complemented by a novel long-term model that expands the analytical horizon to 10 years. Analyses will adhere to good practice guidelines and National Institute for Health and Care Excellence public health reference case.Ethics and disseminationThe study has received ethical approval from South West-Cornwall and Plymouth Research Ethics Committee (REC Reference: 17/SW/0275). Results will be submitted for publication in peer-reviewed journals, made available in briefing papers for local decision-makers, and provided to the local community through website and public events. Findings will be generalisable to community-based models of care, especially in urban settings.Trial registration numberNCT03461848.

ObjectiveTo investigate the care needs of dying patients and their family caregivers in hospice and palliative care in mainland China.MethodsA search for English and Chinese quantitative and qualitative studies was performed using the following English databases: PubMed (Medline), CINAHL and PsycINFO, as well as Chinese databases: SinoMed and CNKI. The records were independently screened by two reviewers and critiqued using Joanna Briggs Institute Critical Appraisal tools. All quantitative data were transformed into qualitative data, which were converted into textual descriptions. Due to the diversity of included studies, a three-step analysis was performed: narrative summary, thematic analysis and presentation of integrated results in a narrative form. The qualitative findings were pooled using the meta-aggregation approach.ResultsThe literature search identified 2964 papers after removing duplicates, from which 18 were included (9 quantitative and 9 qualitative studies). All studies were conducted in mainland China. Quantitative studies involved cross-sectional surveys, and qualitative studies involved interviews for data collection. Two synthesised results of patients’ needs were identified, including needs to be comfortable and experience a good death. Another two synthesised results of family caregivers’ needs included needs to care for and improve the quality of life of patients, and to care for themselves well.ConclusionThis study identified that patients and family caregivers have an increasing demand for professional care at the end of life. Professionals, especially nurses, should enact a patients’ demand-centred practice to overcome the challenges of organisation, education, emotion and communication to provide high-quality end-of-life care.

ObjectivesImportations of novel variants of concern (VOC), particularly B.1.617.2, have become the impetus behind recent outbreaks of SARS-CoV-2. Concerns around the impact on vaccine effectiveness, transmissibility and severity are now driving the public health response to these variants. This paper analyses the patterns of growth in hospitalisations and confirmed cases for novel VOCs by age groups, geography and ethnicity in the context of changing behaviour, non-pharmaceutical interventions (NPIs) and the UK vaccination programme. We seek to highlight where strategies have been effective and periods that have facilitated the establishment of new variants.DesignWe have algorithmically linked the most complete testing and hospitalisation data in England to create a data set of confirmed infections and hospitalisations by SARS-CoV-2 genomic variant. We have used these linked data sets to analyse temporal, geographic and demographic distinctions.Setting and participantsThe setting is England from October 2020 to July 2021. Participants included all COVID-19 tests that included RT-PCR CT gene target data or underwent sequencing and hospitalisations that could be linked to these tests.MethodsTo calculate the instantaneous growth rate for VOCs we have developed a generalised additive model fit to multiple splines and varying day of the week effects. We have further modelled the instantaneous reproduction number Rt for the B.1.1.7 and B.1.617.2 variants and included a doubly interval censored model to temporally adjust the confirmed variant cases.ResultsWe observed a clear replacement of the predominant B.1.1.7 by the B.1.617.2 variant without observing sustained exponential growth in other novel variants. Modelled exponential growth of RT PCR gene target triple-positive cases was initially detected in the youngest age groups, although we now observe across all ages a very small doubling time of 10.7 (95% CI 9.1 to 13.2) days and 8 (95% CI 6.9 to 9.1) days for cases and hospitalisations, respectively. We observe that growth in RT PCR gene target triple-positive cases was first detected in the Indian ethnicity group in late February, with a peak of 0.06 (95% CI 0.07 to 0.05) in the instantaneous growth rate, but is now maintained by the white ethnicity groups, observing a doubling time of 6.8 (95% CI 4.9 to 11) days. Rt analysis indicates a reproduction number advantage of 0.45 for B.1.617.2 relative to B.1.1.7, with the Rt value peaking at 1.85 for B.1.617.2.ConclusionsOur results illustrate a clear transmission advantage for the B.1.617.2 variant and the growth in hospitalisations illustrates that this variant is able to maintain exponential growth within age groups that are largely doubly vaccinated. There are concerning signs of intermittent growth in the B.1.351 variant, reaching a 28-day doubling time peak in March 2021, although this variant is presently not showing any evidence of a transmission advantage over B.1.617.2. Step 1b of the UK national lockdown easing was sufficient to precipitate exponential growth in B.1.617.2 cases for most regions and younger adult age groups. The final stages of NPI easing appeared to have a negligible impact on the growth of B.1.617.2 with every region experiencing sustained exponential growth from step 2. Nonetheless, early targeted local NPIs appeared to markedly reduced growth of B.1.617.2. Later localised interventions, at a time of higher prevalence and greater geographic dispersion of this variant, appeared to have a negligible impact on growth.

IntroductionChronic hip pain in middle-aged and older adults is common and disabling. Patient-centred care of chronic hip pain requires a comprehensive understanding of how people with chronic hip pain view their health problem and its care. This paper outlines a protocol to synthesise qualitative evidence of middle-aged and older adults' views, beliefs, expectations and preferences about their chronic hip pain and its care.Methods and analysisWe will perform a qualitative evidence synthesis using a framework approach. We will conduct this study in accord with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) Statement and the Enhancing Transparency in Reporting the synthesis of Qualitative research checklist. We will search MEDLINE, CINAHL, The Cochrane Central Register of Controlled Trials, EMBASE and PsycINFO using a comprehensive search strategy. A priori selection criteria include qualitative studies involving samples with a mean age over 45 and where 80% or more have chronic hip pain. Two or more reviewers will independently screen studies for eligibility, assess methodological strengths and limitations using the Critical Appraisal Skills Programme qualitative studies checklist, perform data extraction and synthesis and determine ratings of confidence in each review finding using the Grading of Recommendations Assessment, Development and Evaluation—Confidence in the Evidence from Reviews of Qualitative research approach. Data extraction and synthesis will be guided by the Common-Sense Model of Self-Regulation. All authors will contribute to interpreting, refining and finalising review findings. This protocol is registered on PROSPERO and reported according to the PRISMA Statement for Protocols (PRISMA-P) checklist.Ethics and disseminationEthics approval is not required for this systematic review as primary data will not be collected. The findings of the review will be disseminated through publication in an academic journal and scientific conferences.PROSPERO registration numberPROSPERO registration number: CRD42021246305.

BackgroundThe COVID-19 pandemic has resulted in a range of unprecedented disruptions to maternity care with documented impacts on perinatal outcomes such as stillbirth and preterm birth. Metropolitan Melbourne has endured one of the longest and most stringent lockdowns in globally. This paper presents the protocol for a multicentre study to monitor perinatal outcomes in Melbourne, Australia, during the COVID-19 pandemic.MethodsMulticentre observational study analysing monthly deidentified maternal and newborn outcomes from births >20 weeks at all 12 public maternity services in Melbourne. Data will be merged centrally to analyse outcomes and create run charts according to established methods for detecting non-random ‘signals’ in healthcare. Perinatal outcomes will include weekly rates of total births, stillbirths, preterm births, neonatal intensive care admissions, low Apgar scores and fetal growth restriction. Maternal outcomes will include weekly rates of: induced labour, caesarean section, births before arrival to hospital, postpartum haemorrhage, length of stay, general anaesthesia for caesarean birth, influenza and COVID-19 vaccination status, and gestation at first antenatal visit. A prepandemic median for all outcomes will be calculated for the period of January 2018 to March 2020. A significant shift is defined as ≥6 consecutive weeks, all above or below the prepandemic median. Additional statistical analyses such as regression, time series and survival analyses will be performed for an in-depth examination of maternal and perinatal outcomes of interests.Ethics and disseminationEthics approval for the collaborative maternity and newborn dashboard project has been obtained from the Austin Health (HREC/64722/Austin-2020) and Mercy Health (ref. 2020-031).Trial registration numberACTRN12620000878976; Pre-results.

ObjectivesAccurate civil registration and vital statistics (CRVS) systems are the primary data source to measure the impact of the COVID-19 pandemic on mortality. This study assesses how the pandemic impacted CRVS system processes in Loreto region of Peru, one of the worst affected countries globally.DesignQualitative study.SettingLoreto, a remote region, which had the highest reported mortality rate in Peru during the pandemic.ParticipantsSemistructured individual interviews and documentary analysis were conducted between September 2020 and May 2021 with 28 key informants from eight institutions involved in death certification. Key informants were identified using a purposive sampling strategy commencing at the Health Directorate of Loreto, and the snowball method was used where a participant suggested another organisation or person. Information from key informants was used to compare business process maps of the CRVS system before and during the pandemic.ResultsDuring early May 2020, there were seven times more registered deaths than in earlier years, but key informants believed this underestimated mortality by 20%–30%. During the pandemic, families had to interact with more institutions during the death certification process. Several issues disrupted death certification processes, including the burden of increased deaths, the Environmental Health Directorate often removing a body without the family’s express agreement, the creation of COVID-19 cemeteries where no death certificate was needed for burial, greater participation of funeral homes that often used outdated paper forms, and closure of civil registry offices. There was increased use of the online National Death System (SINADEF) but many users had problems with access.ConclusionsThe pandemic substantially disrupted CRVS processes in Loreto, making death certification more difficult, placing greater burden on the family and leading to more participation from unregulated organisations such as funeral homes or cemeteries. These disruptions were impacted by limitations of the CRVS system’s processes before the pandemic.

ObjectivesThe overall study aim is to clarify the relation of endogenous sex hormones with major health outcomes in men. This paper reports a systematic review focusing on published estimates for testosterone associations.SettingCommunity-dwelling men.Participants20 180 adult men participated in the final set of studies identified and selected from a systematic review. Eligible studies included prospective cohort studies with plasma or serum testosterone concentrations measured for adult men using mass spectrometry with at least 5 years of follow-up data and one of the specified outcome measures recorded. Only published or grey literature items written in English were considered.Primary and secondary outcome measuresPlanned prospective outcome measures: cardiovascular disease (CVD) events, CVD deaths, all-cause mortality, cancer deaths, cancer diagnoses, cognitive decline, dementia. Meta-analyses were of the most frequently reported outcomes in selected studies: CVD deaths and all-cause mortality. Succinct characterisations of testosterone associations with other outcomes are also presented.ResultsScreening of 1994 deduplicated items identified 9 suitable studies, with an additional 2 identified by colleagues (11 in total). Summary estimates of mean testosterone concentration and age at recruitment for 20 180 adult men were 15.4±0.7 nmol/L and 64.9±3.3 year. Despite considerable variation in mean testosterone, a metaregression estimated no significant dependence on mean age at recruitment among studies (slope=−0.03, 95% CI −0.11 to 0.06). Meta-analyses demonstrated negligible heterogeneity and no significant effect of a 5 nmol/L increase in testosterone on the risk of all-cause mortality (HR=0.96, 95% CI 0.89 to 1.03) or death from CVD (HR=0.95, 95% CI 0.83 to 1.08).ConclusionsAnalyses of published estimates did not demonstrate associations of endogenous testosterone with CVD deaths or with all-cause mortality. Suggested further research includes the planned individual participant data meta-analyses for selected studies, enabling the investigation of non-linear summary effects.PROSPERO registration numberPROSPERO: CRD42019139668.

IntroductionThis paper presents a study protocol for a comparative effectiveness evaluation of abiraterone acetate against enzalutamide in clinical practice, two cancer drugs given to patients suffering from advanced prostate cancer.Method and analysisThe protocol designs a comparative-effectiveness analysis of abiraterone acetate against enzalutamide. With the substantial number of covariates a two-step procedure is suggested in choosing relevant covariates in the matching design. In the first step, an exploratory factor analysis reduces the dimension of a large set of continuous covariates to nine factors. In the second step, we reduce the dimension of the covariates, interactions and second order terms for the continuous covariates using propensity score estimation. The final design makes use of a genetic matching algorithm. The study protocol provides a detailed statistical analysis plan of the analysis sample derived from the matching design. The analysis will make use of linear regression and robust inference adjusted for multisignificance testing.DiscussionAs in a randomised experiment the focus is on the design of the assignment to treatment. This allows the publication of this preanalysis plan before having access to outcome data. This means that the p values will be correct if the maintained assumption of uncounfoundedness is valid. Given that is p-hacking is substantial problem in empirical research, this is a substantial strength of this study. However, while design yields, balance on the observed covariates one cannot discard the possibility that unobserved confounders are not balanced. For that reason, sensitivity tests for the maintained assumption of uncounfoundedness are presented.Ethics and disseminationThe study was approved by the Regional Ethical Review Board in Uppsala, Sweden (Dnr 2017/482). Results will be published in a peer-reviewed journal and distributed to relevant stakeholders in healthcare.

IntroductionMeasurement-based care (MBC) represents the approach of regularly using symptom rating scales to guide patient care decisions in mental healthcare. MBC is an effective, feasible and acceptable approach to enhance clinical outcomes in various disciplines, including medicine, psychology, social work and psychotherapy. Yet, it is infrequently used by clinicians, potentially due to limited education for care providers. The objective of this scoping review is to survey the characteristics of MBC educational programmes for undergraduate, graduate and postgraduate clinical trainees in mental healthcare.Methods and analysisUsing database-tailored search strategies, we plan on searching Medline, PsycINFO, Embase, CINAHL and Cochrane Central for relevant studies. Thereafter, we will analyse the selected studies to extract information on the delivery of educational programmes, the clinical and educational outcomes of these programmes, and the potential enablers and barriers to MBC education. In this paper, we articulate the protocol for this scoping review.Ethics and disseminationThis scoping review does not require research ethics approval. The findings from this scoping review will be incorporated into the creation of a novel MBC curriculum and handbook. Results will be disseminated at appropriate national or international conferences, as well as in a peer-reviewed journal publication.

IntroductionOn 15 March 2019, a white supremacist gunman opened fire in two mosques in Christchurch, New Zealand, during Friday prayers, killing 51 people and injuring 40. The event was witnessed by at least 250 survivors and also live streamed on social media, leading to widespread and repeated exposure within the community. It is expected that survivors, families and community members will be at increased risk of developing mental disorders due to the scale and violence of these attacks.This protocol describes the first phase of a proposed longitudinal study to screen and assess the long-term impacts of the terrorist attack on members of the Christchurch Muslim community, to determine clinical need and facilitate access to appropriate interventions and to gain insights into working with such a traumatised, ethnically diverse population. It has been developed in close collaboration with members of that community.Methods and analysisA mixed-method design is described, combining self-report measures with a clinician-administered diagnostic interview. Participants include Christchurch Muslims aged 18 years and over, with a target sample size of n=200. Analyses will determine prevalence of major mental disorders, while regression analyses will model the relationship between pre-event features, trauma exposure and mental disorders. A small number of participants, stratified by exposure type, will also take part in a qualitative interview in English. All study information and self-report measures are provided in translations based on the ethnolinguistic composition of the group and are available in paper and online versions.Ethics and disseminationEthical approval was granted by the New Zealand Health and Disability Ethics Committee 19/NTA/147. All participants provide informed consent, either written or online via REDCap software. Findings will be disseminated initially to the impacted community, then by publication in scientific journals, presentations and to government agencies.Trial registration numberThe study is registered with the Australian New Zealand Clinical Trials Registry, ACTRN12620000909921.

IntroductionNeonates and young infants with diagnosed or highly suspected glaucoma require an examination under anaesthesia to achieve accurate intraocular pressure (IOP) measurements, since crying or squinting of the eyes may increase IOP and lead to falsely high values. IOP considerably depends on perioperative variables such as haemodynamic factors, anaesthetics, depth of anaesthesia and airway management. The aim of this paper is to report the design and baseline characteristics of EyeBIS, which is a study to develop a standardised anaesthetic protocol for the measurement of IOP under anaesthesia in childhood glaucoma, by investigating the link between the magnitude of IOP and depth of anaesthesia.Methods and analysisThis is a single-centre, prospective cohort study in 100 children with diagnosed or highly suspected glaucoma all undergoing ophthalmological examination under general anaesthesia. 20 children, who undergo general anaesthesia for other reasons, are included as controls. The primary outcome measure is the establishment of a standardised anaesthetic protocol for IOP measurement in childhood glaucoma by assessing the relationship between IOP and depth of anaesthesia (calculated as an electroencephalography variable, the bispectral index), with special emphasis on airway management and haemodynamic parameters. The dependence of IOP under anaesthesia on airway management and haemodynamic parameters will be described, using a mixed linear model. Restricting the model to patients with healthy eyes will allow to determine a 95% reference region, in which 95% of the measurement values of patients with healthy eyes can be expected.Ethics and disseminationThe study has been approved by the local ethics committee of the Medical Association of Rhineland-Palatine (Ethik-Kommisssion der Landesaerztekammer Rheinland-Pfalz), Germany (approval number: 2019-14207). This work will be disseminated by publication of peer-reviewed manuscripts, presentation in abstract form at national and international scientific meetings and data sharing with other investigators.Trial registration numberClinicalTrials.gov Registry (NCT03972852).

IntroductionThe number of people living in homeless hostels in the UK has steadily increased over the past decade. Despite people experiencing homelessness often having considerable health problems and a range of complex needs frequently in association with addictions, the experiences of hostel staff and residents especially in relation to accessing health and social care support have seldom been explored. The aim of this paper is to identify the barriers and facilitators to accessing health and social care services for people living in homeless hostels.DesignExploratory qualitative baseline data were collected as part of an intervention to facilitate palliative care in-reach into hostels.Setting/participantsInterviews were conducted with 33 participants; 18 homeless hostel managers/support staff and 15 people experiencing homelessness, from six homeless hostels in London and Kent.ResultsThree themes were identified (1) internal and external service barriers to health and social care access due to stigma, lack of communication and information sharing from services and assumptions around capacity and the role of the hostel, (2) the impact of lack of health and social care support on hostel staff leading to burnout, staff going beyond their job role and continuous support given to residents, (3) potential facilitators to health and social care access such in-reach and support from those who understand this population and hostel staff training.DiscussionResidents have multiple complex needs yet both hostel staff and residents face stigma and barriers accessing support from external services. Positive relationships were described between hostel residents and staff, which can be an essential step in engaging with other services. People experiencing homelessness urgently need better access to person-centred, trauma-informed support ideally via in-reach from people who understand the needs of the population.

ObjectiveThis paper describes the development of a tool for assessing organisational readiness to conduct knowledge translation (KT) among academic institutions in low-income and middle-income countries (LMICs).DesignA literature review and stakeholder consultation process were conducted to identify constructs relevant for assessing KT readiness in LMICs. These were face-validated with LMIC stakeholders and organised into a Likert-scale questionnaire.ParticipantsThe questionnaire was distributed to researchers based at six LMIC academic institutions and members of a global knowledge-to-action thematic working group.Outcome measuresAn exploratory factor analysis was used to identify underlying dimensions for assessing institutional readiness to conduct KT.Results111 respondents with varied KT experiences from 10 LMICs were included in the analysis. We selected 5 factors and 23 items, with factor loadings from 0.40 to 0.77. These factors include (1) institutional climate, (2) organisation change efficacy, (3) prioritisation and cosmopolitanism, (4) self-efficacy, and (5) financial resources. These factors accounted for 69% of the total variance, with Cronbach’s alpha coefficients of 0.78, 0.73, 0.62, 0.68 and 0.52, respectively.ConclusionsThis study identifies a tool for assessing readiness of LMIC academic institutions to conduct KT and unique opportunities for building capacity. The organisational focus of these factors underscores the need for strategies that address organisational systems and structures in addition to individual skills. Future research will be conducted to understand determinants of these factors and develop a comprehensive set of capacity building strategies responsive to academic institutions in LMICs.

ObjectiveMany studies have documented significant associations between religion and spirituality (R/S) and health, but relatively few prospective analyses exist that can support causal inferences. To date, there has been no systematic analysis of R/S survey items collected in US cohort studies. We conducted a systematic content analysis of all surveys ever fielded in 20 diverse US cohort studies funded by the National Institutes of Health (NIH) to identify all R/S-related items collected from each cohort’s baseline survey through 2014.DesignAn R|S Ontology was developed from our systematic content analysis to categorise all R/S survey items identified into key conceptual categories. A systematic literature review was completed for each R/S item to identify any cohort publications involving these items through 2018.ResultsOur content analysis identified 319 R/S survey items, reflecting 213 unique R/S constructs and 50 R|S Ontology categories. 193 of the 319 extant R/S survey items had been analysed in at least one published paper. Using these data, we created the R|S Atlas (https://atlas.mgh.harvard.edu/), a publicly available, online relational database that allows investigators to identify R/S survey items that have been collected by US cohorts, and to further refine searches by other key data available in cohorts that may be necessary for a given study (eg, race/ethnicity, availability of DNA or geocoded data).ConclusionsR|S Atlas not only allows researchers to identify available sources of R/S data in cohort studies but will also assist in identifying novel research questions that have yet to be explored within the context of US cohort studies.

IntroductionDespite calls for screening tools to help providers monitor long-term opioid therapy (LTOT) harms, and identify patients likely to experience harms of discontinuation, such screening tools do not yet exist. Current assessment tools are infeasible to use routinely in primary care and focus mainly on behaviours suggestive of opioid use disorder to the exclusion of other potential harms. This paper describes a study protocol to develop two screening tools that comprise one integrated instrument,Screen toEvaluate andTreat (SET). SET1 will indicate if LTOT may be harmful to continue (yes or no), and SET2 will indicate if tapering to discontinue opioids may be harmful to initiate (yes or no). Patients receiving LTOT who screen positive on the SET tools should receive subsequent additional assessment. SET will give providers methods that are feasible to implement routinely to facilitate more intensive and comprehensive monitoring of patients on LTOT and decision-making about discontinuation.Methods and analysisWe will develop the screening tools, SET1 and SET2, concurrently. Tool development will be done in stages: (1) comprehensive literature searches to yield an initial item pool for domains covered by each screening tool; (2) qualitative item analyses using interviews, expert review and cognitive interviewing, with subsequent item revision, to yield draft versions of each tool; and (3) field testing of the draft screening tools to assess internal consistency, test–retest reliability and convergent and discriminant validity.Ethics and disseminationEthical approval was obtained from the Institutional Review Boards of Stanford University and the University of California, San Francisco for the VA Palo Alto Health Care System, and the VA San Francisco Healthcare System, respectively. Findings will be disseminated through peer-reviewed manuscripts and presentations at research conferences.