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OBJECTIVES: To understand factors associated with errors using an established paper-based early warning score (EWS) system. We investigated the types of error, where they are most likely to occur, and whether 'errors' can predict subsequent changes in patient vital signs. METHODS: Retrospective analysis of prospectively collected early warning system database from a single large UK teaching hospital. RESULTS: 16 795 observation sets, from 200 postsurgical patients, were collected. Incomplete observation sets were more likely to contain observations which should have led to an alert than complete observation sets (15.1% vs 7.6%, p

Introduction Mild cognitive impairment is one of the consequences of ageing, causing functional disability, a poor quality of life and an increased socioeconomic expenditure. Evidence shows that patients go through a long preclinical stage in which cognitive deficits appear subtly until they reach the threshold of dementia. Non-pharmacological interventions have been gaining ground as prevention of modifiable factors of cognitive decline such as obesity, diabetes, physical inactivity or social isolation. Along these lines, Information and Communication Technologies (ICTs) can be a tool for cognitive stimulation, cognitive training and cognitive rehabilitation. The main objective of the systematic review will be to review and analyse the use of ICTs for the improvement of cognitive functions in healthy older adult population aged 50 and over, for the prevention of cognitive impairment Methods A systematic review will be conducted including randomised clinical trials in adults without diseases or accidents associated with cognitive impairment, and whom have used ICTs for the improvement of cognitive functions between 2010 and 2020 in English or Spanish. The articles that report data on cognitive function by domain, for example, memory or executive functions, or by test will be included. The databases Medline (PubMed), CinahlPlus, Scopus, ISI WoS, CENTRAL and IEEE Xplore will be searched. Studies that meet the inclusion criteria will be analysed according to the Cochrane RoB2 tool for risk of bias assessment. Ethics and dissemination Ethical approval is not necessary as this is a systematic review. The results will be published in scientific journals, as well as in specialised congresses on the subject of study This paper is a result of the NEXTPERCEPTION project (www.nextperception.eu), which is jointly funded by the European Commission and national funding agencies under the ECSEL joint undertaking. Agencia Estatal de Investigación (AEI). AEI/10.13039/501100011033. PCI2020-112270. Ministery of Science and Innovation (MICINN). CERCA Programme / Generalitat de Catalunya. IRBLleida - Fundació Dr. Pifarré. This paper was also funded by College of Nurses of Lleida, University of Lleida (Aid to promote research in deficit areas) and Predoctoral staff in Training Program University of Lleida, Jade Plus, and La Caixa Bank Foundation 2019

Worldwide, there are at least 230 million invasive procedures performed annually and most of us will undergo several in our lifetime. There is therefore a need for high-quality evidence to underpin this clinical area. Currently, however, there is no widely accepted definition of an invasive procedure and the terms ‘surgery’ and ‘interventional procedure’ are characterised inconsistently. We propose a definition for invasive procedures which addresses the limitations of those currently available. Our definition was developed from an analysis of the 3946 papers from the last decade. A preliminary definition was created based on existing definitions and applied to a variety of papers reporting all types of procedures. This definition was continuously updated and applied iteratively to all articles. The definition has three key components: (1) method of access to the body, (2) instrumentation and (3) requirement for operator skill. It therefore encapsulates all types of invasive procedure regardless of the method of access to the body (incision, natural orifice or percutaneous access), and is relevant whatever the clinical discipline (eg, obstetric, cardiac, dental, interventional cardiology or radiology). Crucially, the definition excludes medicinal products, except where their administration occurs within an invasive procedure (and thereby involves operator skill). The application of a universal definition of an invasive procedure will (1) inform the selection of relevant methods for study design, (2) streamline evidence synthesis and (3) improve research tracking, helping to identify evidence gaps and direct research funds.

IntroductionGlobal rates of type 2 diabetes (T2D) are on the rise and there is a need for both effective and replicable interventions to decrease this incidence. Systematic reviews highlight the efficacy of diet and exercise interventions in decreasing T2D risk; however, no review to date provides clear information regarding intervention details (eg, what is delivered, by whom, to whom, when, and mode of delivery). This paper outlines the protocol for a scoping review summarising intervention characteristics of diet and exercise programmes for individuals at risk for T2D. From the included studies and through the use of the Template for Intervention Description and Replication (TIDieR), the scoping review that results from this protocol paper will provide a narrative analysis of how diabetes prevention programmes are being reported and implemented.MethodsA comprehensive search strategy is outlined to identify studies within Medline, CINAHL, PsycINFO, EMBASE and SPORTDiscus. The search strategy will include terms relating to diet and exercise interventions and diabetes risk. To determine eligible studies, predefined inclusion and exclusion criteria will be used independently by two review authors. To be included, studies must be delivering a diet and/or exercise intervention among adults who have been identified as at risk for developing T2D with an outcome related to diabetes prevention. Data extraction of those studies that meet inclusion criteria will be guided by the TIDieR).Ethics and disseminationEthical approval is not required as this review will be using previously collected data. Review findings will be presented at scientific conferences and published in a peer-reviewed journal.

IntroductionDepression and alcohol use disorders are international public health priorities for which there is a substantial treatment gap. Brief mental health interventions delivered by lay health workers in primary care services may reduce this gap. There is limited economic evidence assessing the cost-effectiveness of such interventions in low-income and middle-income countries. This paper describes the proposed economic evaluation of a health systems intervention testing the effectiveness, cost-effectiveness and cost-utility of two task-sharing approaches to integrating services for common mental disorders with HIV and diabetes primary care services.Methods and analysisThis evaluation will be conducted as part of a three-armed cluster randomised controlled trial of clinical effectiveness. Trial clinical outcome measures will include primary outcomes for risk of depression and alcohol use, and secondary outcomes for risk of chronic disease (HIV and diabetes) treatment failure. The cost-effectiveness analysis will evaluate cost per unit change in Alcohol Use Disorder Identification Test and Centre for Epidemiological Studies scale on Depression scores as well as cost per unit change in HIV RNA viral load and haemoglobin A1c, producing results of provider and patient cost per patient year for each study arm and chronic disease. The cost utility analyses will provide results of cost per quality-adjusted life year gained. Additional analyses relevant for implementation including budget impact analyses will be conducted to inform the development of a business case for scaling up the country’s investment in mental health services.Ethics and disseminationThe Western Cape Department of Health (WCDoH) (WC2016_RP6_9), the South African Medical Research Council (EC 004-2/2015), the University of Cape Town (089/2015) and Oxford University (OxTREC 2–17) provided ethical approval for this study. Results dissemination will include policy briefs, social media, peer-reviewed papers, a policy dialogue workshop and press briefings.Trial registration numberPACTR201610001825405.

© Author(s) (or their employer(s)) 2019., [Introduction]: Transparency and completeness of health research is highly variable, with important deficiencies in the reporting of methods and results of studies. Reporting guidelines aim to improve transparency and quality of research reports, and are often developed by consortia of journal editors, peer reviewers, authors, consumers and other key stakeholders. The objective of this study will be to investigate the characteristics of scientific collaboration among developers and the citation metrics of reporting guidelines of health research. [Methods and analysis]: This is the study protocol for a cross-sectional analysis of completed reporting guidelines indexed in the Enhancing the QUAlity and Transparency Of health Research Network Library. We will search PubMed/MEDLINE and the Web of Science. Screening, selection and data abstraction will be conducted by one researcher and verified by a second researcher. Potential discrepancies will be resolved via discussion. We will include published papers of reporting guidelines written in English. Published papers will have to meet the definition of a reporting guideline related to health research (eg, a checklist, flow diagram or explicit text), with no restrictions by study design, medical specialty, disease or condition. Raw data from each included paper (including title, publication year, journal, subject category, keywords, citations, and the authors’ names, author’s affiliated institution and country) will be exported from the Web of Science. Descriptive analyses will be conducted (including the number of papers, citations, authors, countries, journals, keywords and main collaboration metrics). We will identify the most prolific authors, institutions, countries, journals and the most cited papers. Network analyses will be carried out to study the structure of collaborations., FC-L and RT-S are supported by the Institute of Health Carlos III/CIBERSAM. MJP is supported by an Australian National Health and Medical Research Council Early Career Fellowship (1088535). BH is supported by a New Investigator Award from the Canadian Institutes of Health Research and the Drug Safety and Effectiveness Network. MR is supported by the Institute of Health Carlos III/Spanish Health Services Research on Chronic Patients Network (REDISSEC). DM is supported by a University Research Chair, University of Ottawa.

ObjectiveCardiovascular disease (CVD) is a leading cause of morbidity and mortality globally, and prevention of CVD is a public health priority. This paper aims to describe the perspectives of general practitioners (GPs) on the prevention of CVD across different contexts.DesignSystematic review and thematic synthesis of qualitative studies using the Enhancing Transparency of Reporting the Synthesis of Qualitative research (ENTREQ) framework.Data sourcesMEDLINE, Embase, PsycINFO and CINAHL from database inception to April 2018.Eligibility criteria for selecting studiesWe included qualitative studies on the perspectives of GPs on CVD prevention.Data extraction and synthesisWe used HyperRESEARCH to code the primary papers and identified themes.ResultsWe selected 34 studies involving 1223 participants across nine countries. We identified six themes: defining own primary role (duty to prescribe medication, refraining from risking patients’ lives, mediating between patients and specialists, delegating responsibility to patients, providing holistic care); trusting external expertise (depending on credible evidence and opinion, entrusting care to other health professionals, integrating into patient context); motivating behavioural change for prevention (highlighting tangible improvements, negotiating patient acceptance, enabling autonomy and empowerment, harnessing the power of fear, disappointment with futility of advice); recognising and accepting patient capacities (ascertaining patient’s drive for lifestyle change, conceding to ingrained habits, prioritising urgent comorbidities, tailoring to patient environment and literacy); avoiding overmedicalisation (averting long-term dependence on medications, preventing a false sense of security, minimising stress of sickness) and minimising economic burdens (avoiding unjustified costs to patients, delivering practice within budget, alleviating healthcare expenses).ConclusionsGPs sought to empower patients to prevent CVD, but consideration of patients’ individual factors was challenging. Community-based strategies for assessing CVD risk involving other health professionals, and decision aids that address the individuality of the patient’s health and environment, may support GPs in their decisions regarding CVD prevention.

Objective To characterise the early diffusion of indirect comparison meta-analytic methods to study drugs. Design Systematic literature synthesis. Data sources Cochrane Database of Systematic Reviews, EMBASE, MEDLINE, Scopus and Web of Science. Study selection English language papers that used indirect comparison meta-analytic methods to study the efficacy or safety of three or more interventions, where at least one was a drug. Data extraction The number of publications and authors was plotted by year and type: methodological contribution, review or empirical application. Author and methodological details were summarised for empirical applications, and animated coauthorship networks were created to visualise contributors by country and affiliation type (academia, industry, government or other) over time. Results We identified 477 papers (74 methodological contributions, 42 reviews and 361 empirical applications) by 1689 distinct authors from 1997 to 2013. Prior to 2002, only three applications were published, with contributions from the USA (n=2) and Canada (n=1). The number of applications gradually increased annually with rapid uptake between 2011 and 2013 (n=254, 71%). Early diffusion occurred primarily in Europe with the first application credited to the UK in 2003. Application spread to other European countries in 2005, and may have been supported by regulatory requirements for drug approval. By the end of 2013, contributions included 49% credited to Europe (22% UK, 27% other), 37% credited to North America (11% Canada, 26% USA) and 14% from other regions. Conclusion Indirect comparison meta-analytic methods are an important innovation for health research. Although Canada and the USA were the first to apply these methods, Europe led their diffusion. The increase in uptake of these methods may have been facilitated by acceptance by regulatory agencies, which are calling for more comparative drug effect data to assist in drug accessibility and reimbursement decisions.

Objectives The maternal near-miss case review (NMCR) has been promoted by WHO as an approach to improve quality of care (QoC) at facility level. This systematic review synthesises evidence on the effectiveness of the NMCR on QoC and maternal and perinatal health outcomes in low-income and middle-income countries (LMICs). Methods Studies were searched for in six electronic databases (MEDLINE, Index Medicus, Web of Science, the Cochrane library, Embase, LILACS), with no language restrictions. Two authors independently screened papers and selected them for inclusion and independently extracted data. Maternal mortality was the primary outcome. Secondary outcomes included any outcome informing on any of the six dimensions of QoC: efficacy, safety, efficiency, equity, accessibility and timely care, acceptability and patient-centred care. Results Out of 24 822 papers retrieved, 17 studies from 11 countries were included. Maternal mortality measured before and after the implementation of the NMCR cycle significantly decreased (OR 0.77, 95% CI 0.61 to 0.98, eight studies, 55 573 043 women; I2=39%). A statistically significant reduction in the incidence of uterine rupture, postpartum haemorrhage and maternal sepsis was observed in three out of six studies. Ten studies reporting on maternal care process all showed some significant improvement when measured against predefined standards. All studies reported that the NMCR resulted in some amelioration of the facility structure (physical structure, staffing, equipment, training, organisation of care). Newborn outcomes were overall poorly reported; four studies showed no significant difference in perinatal mortality. Patient satisfaction and equity were also poorly reported. Conclusions Policy makers may consider implementing the maternal NMCR cycle approach among strategies aiming at improving QoC and reducing maternal mortality and morbidity in LMIC. Future studies should better document the effectiveness of the NMCR cycle particularly on outcomes reflecting patient-centred care and cost-effectiveness.

Objective The current policy of measles vaccination at 9 months of age was decided in the mid-1970s. The policy was not tested for impact on child survival but was based on studies of seroconversion after measles vaccination at different ages. The authors examined the empirical evidence for the six underlying assumptions. Design Secondary analysis. Data sources and methods These assumptions have not been research issues. Hence, the authors examined case reports to assess the empirical evidence for the original assumptions. The authors used existing reviews, and in December 2011, the authors made a PubMed search for relevant papers. The title and abstract of papers in English, French, Portuguese, Spanish, German and Scandinavian languages were assessed to ascertain whether the paper was potentially relevant. Based on cumulative measles incidence figures, the authors calculated how many measles cases had been prevented assuming everybody was vaccinated at a specific age, how many ‘vaccine failures’ would occur after the age of vaccination and how many cases would occur before the specific age of vaccination. In the combined analyses of several studies, the authors used the Mantel–Haenszel weighted RR stratifying for study or age groups to estimate common trends. Setting and participants African community studies of measles infection. Primary and secondary outcomes Consistency between assumptions and empirical evidence and the predicted effect on mortality. Results In retrospect, the major assumptions were based on false premises. First, in the single study examining this point, seronegative vaccinated children had considerable protection against measles infection. Second, in 18 community studies, vaccinated measles cases (‘vaccine failures’) had threefold lower case death than unvaccinated cases. Third, in 24 community studies, infants had twofold higher case death than older measles cases. Fourth, the only study examining the assumption that ‘vaccine failures’ lead to lack of confidence found the opposite because vaccinated children had milder measles infection. Fifth, a one-dose policy was recommended. However, the two randomised trials of early two-dose measles vaccination compared with one-dose vaccination found significantly reduced mortality until 3 years of age. Thus, current evidence suggests that the optimal age for a single dose of measles vaccine should have been 6 or 7 months resulting in fewer severe unvaccinated cases among infants but more mild ‘vaccine failures’ among older children. Furthermore, the two-dose trials indicate that measles vaccine reduces mortality from other causes than measles infection. Conclusions Many lives may have been lost by not determining the optimal age of measles vaccination. Since seroconversion continues to be the basis for policy, the current recommendation is to increase the age of measles vaccination to 12 months in countries with limited measles transmission. This policy may lead to an increase in child mortality., Article summary Article focus An empirical analysis of the six assumptions underlying the current measles vaccination policy for low-income countries. Determine the implications for child survival of not testing the optimal measles vaccination policy. Key messages All six assumptions were flawed; most important were the assumptions that seronegative vaccinated children are fully susceptible to measles infection, that the severity of measles is the same in vaccinated cases (‘vaccine failures’) and in unvaccinated children, that the severity of measles infection is the same in infancy or later and that it had to be a one-dose programme. The current evidence suggests that the optimal age for a single dose of measles vaccine would probably have been 6 or 7 months of age had vaccination at different ages been tested in randomised trials with overall child mortality as the outcome. An early two-dose schedule at 4–5 months and 9 months of age would have been even better in terms of reducing child mortality. Strengths and limitations of this study The current measles vaccination policy for low-income countries is not based on any evidence about the impact on overall child survival. The literature search and assessment was only carried out by one researcher. There are few studies testing some of the assumptions. However, for the two key assumptions relating to severity of measles in vaccinated infants and children, there is ample evidence that suggests that measles is less severe in vaccinated cases.

Objectives To investigate the feasibility of using research papers cited in clinical guidelines as a way to track the impact of particular funding streams or sources. Setting In recent years, medical research funders have made efforts to enhance the understanding of the impact of their funded research and to provide evidence of the ‘value’ of investments in particular areas of research. One of the most challenging areas of research evaluation is around impact on policy and practice. In the UK, the National Institute of Health and Clinical Excellence (NICE) provide clinical guidelines, which bring together current high-quality evidence on the diagnosis and treatment of clinical problems. Research referenced in these guidelines is an indication of its potential to have real impact on health policy and practice. Design This study is based on analysis of the authorship and funding attribution of research cited in two NICE clinical guidelines: dementia and chronic obstructive pulmonary disease. Results Analysis identified that around a third of papers cited in the two NICE guidelines had at least one author based in the UK. In both cases, about half of these UK attributed papers contained acknowledgements which allowed the source of funding for the research to be identified. The research cited in these guidelines was found to have been supported by a diverse set of funders from different sectors. The study also investigated the contribution of research groups based in universities, industry and the public sector. Conclusions The study found that there is great potential for guidelines to be used as sources of information on the quality of the research used in their development and that it is possible to track the source of the funding of the research. The challenge is in harnessing the relevant information to track this in an efficient way., Article summary Article focus Explore the feasibility of extracting the funding source of research papers cited in clinical guidelines. Identify who funded the research which supports the guideline development. Investigate the shared characteristics of the publications cited in the two guidelines chosen for the study (dementia and chronic obstructive pulmonary disease). Key messages Looking at citation in clinical guidelines could potentially be used as one of the tools in the impact evaluators toolkit. For this methodology to be fully exploited, the accessibility of data and acknowledgement of funders in articles need to be improved. This study helps to investigate the connection between funding inputs with changes in medical practice and the pathways for these to arise. Strengths and limitations of this study An assumption is made that the fact that a research article is cited in a clinical guideline is a proxy for potential impact; however, this impact is not proven in this study. The methodology relies on the correct and full attribution of funders in research articles; however, evidence shows that this information can be incomplete. NICE guidelines are very closely linked with the National Health Service in the UK, as such this limits actual results of the study, but the methodology could be applied to other similar documents.

IntroductionIn 2001, 50%–55% of French-speaking minority communities did not have access to health services in French in Canada. Although Canada is officially a bilingual country, reports indicate that many healthcare services offered in French in Anglophone provinces are insufficient or substandard, leading to healthcare discrepancies among Canada’s minority Francophone communities.ObjectivesThe primary aim of this scoping systematic review was to identify existing gaps in HIV-care delivery to Francophone minorities living with HIV in Canada.Study designScoping systematic review.Data sourcesSearch for studies published between 1990 and November 2019 reporting on health and healthcare in Francophone populations in Canada. Nine databases were searched, including Medline, Cumulative Index to Nursing and Allied Health Literature, the Cochrane Library, the National Health Service Economic Development Database, Global Health, PsychInfo, PubMed, Scopus and Web of Science.Study selectionEnglish or French language studies that include data on French-speaking people with HIV in an Anglophone majority Canadian province.ResultsThe literature search resulted in 294 studies. A total of 230 studies were excluded after duplicates were removed. The full texts of 43 potentially relevant papers were retrieved for evaluation and data extraction. Forty-one studies were further excluded based on failure to meet the inclusion criteria leaving two qualitative studies that met our inclusion criteria. These two studies reported on barriers on access to specialised care by Francophone and highlighted difficulties experienced by healthcare professionals in providing quality healthcare to Francophone patients in Ontario and Manitoba.ConclusionThe findings of this scoping systematic review highlight the need for more HIV research on linguistic minority communities and should inform health policymaking and HIV/AIDS community organisations in providing HIV care to Francophone immigrants and Canadians.

This paper outlines the protocol for a quasiexperimental study1 to test the implementation of primary healthcare (PHC)-based measurement, advice and treatment for heavy drinking and comorbid depression at the municipal level in three Latin American countries, Colombia, Mexico and Peru (Scale-up of Prevention and Management of Alcohol Use Disorders and Comorbid Depression in Latin America (SCALA) study). Heavy drinking is a cause of considerable disability, morbidity and mortality.2 Heavy drinking is a causal factor for some communicable diseases (including TB and HIV/AIDS), for many non-communicable diseases (NCDs, including cancers, cardiovascular diseases and gastrointestinal diseases) and for many mental and behavioural disorders, including depression, dementias and suicide.3 4 In PHC settings, two-fifths of people with heavy drinking have depression, with risks of incident depression higher for heavier as opposed to lighter drinkers.5 In addition to its role in the aetiology of depression, heavy drinking is associated with worsening the depression course, including suicide risk, impaired social functioning and impaired …

IntroductionA recently recognised form of chronic kidney disease (CKD) of unknown origin (CKDu) is afflicting communities, mostly in rural areas in several regions of the world. Prevalence studies are being conducted in a number of countries, using a standardised protocol, to estimate the distribution of estimated glomerular filtration rate (eGFR), and thus identify communities with a high prevalence of reduced glomerular filtration rate (GFR). In this paper, we propose a standardised minimum protocol for cohort studies in high-risk communities aimed at investigating the incidence of, and risk factors for, early kidney dysfunction.Methods and analysisThis generic cohort protocol provides the information to establish a prospective population-based cohort study in low-income settings with a high prevalence of CKDu. This involves a baseline survey that included key elements from the DEGREE survey (eg, using the previously published DEGREE methodology) of a population-representative sample, and subsequent follow-up visits in young adults (without a pre-existing diagnosis of CKD (eGFR2), proteinuria or risk factors for CKD at baseline) over several years. Each visit involves a core questionnaire, and collection and storage of biological samples. Local capacity to measure serum creatinine will be required so that immediate feedback on kidney function can be provided to participants. After completion of follow-up, repeat measures of creatinine should be conducted in a central laboratory, using reference standards traceable to isotope dilution mass spectrometry (IDMS) quality control material to quantify the main outcome of eGFR decline over time, alongside a description of the early evolution of disease and risk factors for eGFR decline.Ethics and disseminationEthical approval will be obtained by local researchers, and participants will provide informed consent before the study commences. Participants will typically receive feedback and advice on their laboratory results, and referral to a local health system where appropriate.

IntroductionThe importance of health-related quality of life (HRQoL) is increasing and many healthcare authorities recommend the use of measures that account for both mortality and morbidity. This study will determine, for the first time in Romania, value sets for EuroQoL-five-dimensions-3-level (EQ-5D-3L) and EQ-5D-5L questionnaires and their population norms (study 1). It will also compare the HRQoL (measured with EQ-5D-5L) of Roma communities in Romania with that of the general population (study 2).Methods and analysisCross-sectional studies of face-to-face interviews conducted in representative samples of the Romanian general population and Romanian Roma communities. 1614 non-institutionalised adults older than 18 years will be interviewed using a computer-assisted interview for study 1. Participants will complete EQ-5D-3L and 5L, 13 composite time trade-off tasks (cTTO), 7 discrete choice experiment questions (DCE) and sociodemographic questions. For study 2, 606 non-institutionalised self-identified Roma people older than 18 years will be interviewed using a pencil-and-paper interview. Participants will complete EQ-5D-5L and the same sociodemographic questions as for study 1. The 3L value set will be estimated using econometric models and the cTTO data. cTTO and DCE data will be used for the 5L value set. Population norms will be reported by age and gender. The ORs for reporting different levels of problems and the most common health states in the population will be estimated. For study 2, t-tests and analysis of variance will be used to explore differences between groups in HRQoL and for each EQ-5D.Ethics and disseminationEthics approval was given by the National Bioethics Committee of Medicines and Medical Devices Romania and Newcastle University’s Research Ethics Committee. Results will be published in peer-reviewed journals, presented at scientific conferences and on the project’s website. The EQ-5D-5L anonymised datasets will be deposited in a centralised repository. Two public workshops with local authorities, physicians and patients’ associations will be held.

ObjectivesSuicide rates in India are among the highest in the world, equating to over 200 000 suicides annually. Reports of suicides are a routine feature in major newspapers in India, and reporters may selectively present ‘newsworthy’ suicide stories. The aim of this paper was to systematically investigate whether mass media reports of suicides reflect the epidemiological data on suicide in a high suicide state in India.DesignWe undertook a content analysis study to extract sociodemographic data on suicides reported among nine of the most highly read daily newspapers in the high suicide southern state of Tamil Nadu between June and December 2016. A total of 1258 newspaper articles were retrieved containing reports on 1631 suicides. Two-tailed binomial tests on aggregate frequencies assessed whether the sociodemographic characteristics of suicides in the newspaper articles were different to the population suicide statistics for Tamil Nadu.ResultsWe identified some statistically significant discrepancies between suicide characteristics in the population and the media. Suicides involving females (pConclusionsThe suicide characteristics in the print media were not entirely representative of suicides in the broader Tamil Nadu population, which may lead the general public to develop misunderstandings about suicide in their state. The discrepancies we identified will inform tailored suicide prevention education for media professionals.

IntroductionAlcohol use and misuse are associated with substantial health and social issues in Australia and internationally. Pricing policy is considered as one of the most effective means to reduce risky drinking and related harms. This protocol paper describes a study that will model and estimate the effects, effectiveness and cost–benefit of alcohol pricing policy initiatives in reducing risky drinking, health and social harms, and health inequalities among subpopulations in Australia.Methods and analysisThe study is a modelling and epidemiological study using data from various resources, such as survey, previous literatures and response agencies. A number of statistical procedures will be undertaken to evaluate the impact of different alcohol pricing policy initiatives on various outcomes, including alcohol consumption in population subgroups, and health and social problems, and to measure health inequalities and cost-effectiveness of those proposed pricing policies, such as a 10% tax increase on all alcohol beverages or introduction of a minimum unit price.Ethics and disseminationThe ethics approval of this study was obtained from the College Human Ethics Sub-Committee of the La Trobe University on 9 November 2017 (Ref: S17-206). While examining the heterogeneous effects of price policy across population subgroups, this study will provide the first comprehensive estimates of the likely impacts of alcohol price changes on health inequalities. The study will also provide sophisticated economic analyses of the impact of price policy changes, which is critical information for policy makers and will assist policy makers in directing resources to a more efficient alcohol strategy. Results will be made available to communities and societies, health departments and other researchers.

IntroductionIt is notoriously challenging to implement evidence-based care and to update and improve healthcare practices. One reason for the difficulty is the complexity of healthcare and the powerful influence of context on implementation and improvement efforts. Thus, there is a need for multifaceted, flexible change methods that takes these complexities into consideration. One approach that has the potential in this regard is soft systems methodology (SSM). However, little is known about how SSM has been applied in healthcare settings, making it difficult to assess the usefulness of SSM for implementation science or improvement research. The aim of the proposed scoping review is to examine and map the use and outcomes of SSM in healthcare.Methods and analysisThe review will adapt the framework outlined by Arksey and O’Malley (2005). Citations will be uncovered through a comprehensive database search of the peer-reviewed literature. Two reviewers will conduct a two-stage review and selection process where the titles/abstracts are examined followed by a screening of full texts of the selected citations. Reference lists of included citations will be snowballed to identify potential additional citations. Inclusion criteria are English language, peer-reviewed empirical papers focusing on the application of SSM in a healthcare setting. Both general information about the citations and information related to the objective of the review will be extracted from the included citations and entered into a data charting form. The extracted information will be reported in diagrams and tables and summarised to present a narrative account of the literature. The proposed review will provide information on the potential for using SSM to affect change in healthcare.Ethics and disseminationNo primary data will be collected, and thus ethical permission is unnecessary. Dissemination of results include peer-reviewed publications and conference presentations.

IntroductionAccess to high-quality primary healthcare is limited for remote residents in Australia. Increasingly, remote health services are reliant on short-term or ‘fly-in, fly-out/drive-in, drive-out’ health workforce to deliver primary healthcare. A key strategy to achieving health service access equity, particularly evident in remote Australia, has been the development of Aboriginal Community Controlled Health Services (ACCHSs). This study aims to generate new knowledge about (1) the impact of short-term staffing in remote and rural ACCHSs on Aboriginal and Torres Strait Islander communities; (2) the potential mitigating effect of community control; and (3) effective, context-specific evidence-based retention strategies.Methods and analysisThis paper describes a 3-year, mixed methods study involving 12 ACCHSs across three states. The methods are situated within an evidence-based programme logic framework for rural and remote primary healthcare services. Quantitative data will be used to describe staffing stability and turnover, with multiple regression analyses to determine associations between independent variables (population size, geographical remoteness, resident staff turnover and socioeconomic status) and dependent variables related to patient care, service cost, quality and effectiveness. Qualitative assessment will include interviews and focus groups with clinical staff, clinic users, regionally-based retrieval staff and representatives of jurisdictional peak bodies for the ACCHS sector, to understand the impact of short-term staff on quality and continuity of patient care, as well as satisfaction and acceptability of services.Ethics and disseminationThe study has ethics approval from the Human Research Ethics Committee of the Northern Territory Department of Health and Menzies School of Health Research (project number DR03171), Central Australian Human Research Ethics Committee (CA-19-3493), Western Australian Aboriginal Health Ethics Committee (WAAHEC-938) and Far North Queensland Human Research Ethics Committee (HREC/2019/QCH/56393). Results will be disseminated through peer-reviewed journals, the project steering committee and community/stakeholder engagement activities to be determined by each ACCHS.

Introduction: The gradual changes over the decades in the longevity and aging of European society as a whole can be directly related to the prolonged decline in the birth rate and increase in life expectancy. According to the WHO, there is an increased risk of dementia or other cognitive disorders as the population ages, which have a major impact on public health. Mild cognitive impairment (MCI) is described as a greater than expected cognitive decline for an individual's age and level of education, but that does not significantly interfere with activities of daily living. Patients with MCI exhibit a higher risk of dementia compared with others in the same age group, but without a cognitive decline, have impaired walking, and a 50% greater risk of falling. The urban lifestyle and advent of smartphones, mobility, and immediate access to all information via the internet, including health information, has led to a totally disruptive change in most general aspects. This systematic review protocol is aimed at evaluating the effectiveness of technology-based interventions in the detection, prevention, monitoring, and treatment of patients at risk or diagnosed with MCI. Methods and analysis: This review protocol follows the recommendations of the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols reporting guidelines. The search will be performed on MEDLINE (PubMed), CENTRAL, CINAHL Plus, ISI Web of Science, and Scopus databases from 2010 to 2020. Studies of interventions either randomized clinical trials or pre-post non-randomized quasi-experimental designs, published in English and Spanish will be included. Articles that provide relevant information on the use of technology and its effectiveness in interventions that assess improvements in early detection, prevention, follow-up, and treatment of the patients at risk or diagnosed with MCI will be included. Ethics and dissemination: Ethics committee approval is not required. The results will be disseminated in publications and congresses. Keywords: dementia; geriatric medicine; health informatics; mental health; preventive medicine. This paper is a result of the NEXTPERCEPTION project (www.nextperception.eu), which is jointly funded by the European Commission and national funding agencies under the ECSEL joint undertaking (grant agreement: 876487). This research was funded by the Agencia Estatal de Investigación (AEI/10.13039/501100011033) Ministry of Science and Innovation (MICINN) (PCI2020-112270) CERCA Programme/Generalitat de Catalunya. IRBLleida - Fundació Dr. Pifarré.

IntroductionTransition from child and adolescent mental health services (CAMHS) to community or adult mental health services (AMHS) is a highly problematic health systems hurdle, especially for transition-aged youth. A planned and purposeful transition process is often non-existent or experienced negatively by youth and their caregivers. Stakeholders, including youth and their caregivers, have demanded interventions to support more effective transitions, such a transition navigator. The transition navigator model uses a navigator to facilitate complex transitions from acute care CAMHS to community or AMHS. However, despite the widespread implementation of this model, there has been no evaluation of the programme, hindering its scalability. This paper describes the study protocol of the Navigator Evaluation Advancing Transitions study that aims to collaborate with patients, caregivers and clinicians in the evaluation of the navigator model.Methods and analysisA pre and post mixed-method study will be conducted, using the Triple Aim Framework, to evaluate the navigator model. We will recruit participants from one large tertiary and two community hospitals in Toronto, Canada. For the quantitative portion of the study, we will recruit a sample of 45 youth (15 at each site), aged 16–18, and their caregivers at baseline (referral to navigator) (T1) and 6 months (T2). Youth and caregiver participants will complete a set of standardised measures to assess mental health, service utilisation, and satisfaction outcomes. For the qualitative portion of the study, semistructured interviews will be conducted at 6 months (T2) with youth, their caregivers and clinicians to better understand their experience and satisfaction with the model.Ethics and disseminationResearch Ethics Board (REB) approval has been obtained from the lead research sites, the University of Toronto and the Hospital for Sick Children. The results of the study will be reported in peer-reviewed publications, webinars and conferences and to all relevant stakeholders.

ObjectivesTo evaluate the effectiveness of the onlineClimate Schools: Ecstasy and Emerging Drugs moduleover 2 years, and examine the impact of intervention dose on outcomes.DesignCluster randomised controlled trial.SettingSecondary schools in Australia.Participants1126 students (aged 14.9 years) from 11 schools.InterventionFive schools were randomly allocated to the four-lesson internet-basedClimate Schools: Ecstasy and Emerging Drugsmodule. This universal intervention uses cartoon storylines to deliver harm-minimisation information about ecstasy and new psychoactive substances (NPS). It was delivered during health education classes over 4 weeks. Six schools were randomised to the control group (health education as usual). Participants were not blinded to intervention allocation.Outcomes measuresStudents completed self-report surveys at baseline, post-test, 6, 12 and 24 months post-baseline. Intentions to use ecstasy and NPS (including synthetic cannabis and synthetic stimulants), knowledge about ecstasy and NPS and lifetime use of ecstasy and NPS were assessed. This paper reports the results at 24 months post-baseline.AnalysisMixed effects regressions were conducted to analyse intervention effects from baseline to 24 months. Post hoc analyses using Inverse Probability of Treatment Weighting compared controls with students who: i) completed all four lessons (‘full dose’) and ii) partially completed the intervention (≤three lessons, ‘incomplete dose’).ResultsPrimary analyses found that controls were significantly more likely to intend on using synthetic cannabis compared with intervention group students (OR=3.56, p=0.01). Results from the weighted analyses indicated that controls reported significantly lower knowledge about ecstasy (p=0.001) and NPS (p=0.04) compared with the full-dose group. No significant differences were observed between the incomplete dose and control groups.ConclusionsThe online intervention was effective in modifying students’ intentions to use synthetic cannabis up to 24 months; however, this study highlights the importance of delivering prevention programmes in full to maximise student outcomes.Trial registration numberACTRN12613000708752.

Objective This study aimed to elucidate the top five key priorities and barriers to chronic care in the health system of Abu Dhabi, United Arab Emirates (UAE). Design A modified Delphi study was performed to reach consensus on priority areas and barriers to the development of the Chronic Care Model in the health system of Abu Dhabi. Individual wireless audience response devices (keypads) linked to a computer were used to reduce 28 priorities and 20 barriers to the top five during three iterative rounds over three consecutive days. Setting Chronic care services for patients with diabetes, cardiovascular diseases and cancer, in both private and publicly funded healthcare services in the emirate of Abu Dhabi. Participants A purposive sample of 20 health systems’ experts were recruited. They were front-line healthcare workers from the public and private sector working in the delivery of care for patients with diabetes, cardiovascular diseases and cancer. Results The ‘overall organizational leadership in chronic illness care’ was ranked as the most important priority to address (26.3%) and ‘patient compliance’ was ranked as the most important barrier (36.8%) to the development of the Chronic Care Model. Conclusions This study has identified the current priorities and barriers to improving chronic care within Abu Dhabi’s healthcare system. Our paper addresses the UAE’s 2021 Agenda of achieving a world-class healthcare system, and findings may help inform strategic changes required to achieve this mission.

Introduction Prevention of overweight and obesity in childhood is a priority because of associated acute and chronic conditions in childhood and later in life, which place significant burden on health systems. Evidence suggests prevention should engage a range of actions and actors and target multiple levels. The Whole of Systems Trial Of Prevention Strategies for childhood obesity (WHO STOPS) will evaluate the outcomes of a novel systems-based intervention that aims to engage whole communities in a locally led multifaceted response. This paper describes the planned economic evaluation of WHO STOPS and examines the methodological challenges for economic evaluation of a complex systems-based intervention. Methods and analysis Economic evaluation alongside a stepped-wedge cluster randomised controlled trial in regional and rural communities in Victoria, Australia. Cost-effectiveness and cost–utility analyses will provide estimates of the incremental cost (in $A) per body mass index unit saved and quality adjusted life year gained. A Markov cohort model will be employed to estimate healthcare cost savings and benefits over the life course of children. The dollar value of community resources harnessed for the community-led response will be estimated. Probabilistic uncertainty analyses will be undertaken to test sensitivity of results to plausible variations in all trial-based and modelled variables. WHO STOPS will also be assessed against other implementation considerations (such as sustainability and acceptability to communities and other stakeholders). Ethics and dissemination The trial is registered by the Australian New Zealand Clinical Trials Registry (ACTRN12616000980437). Full ethics clearances have been received for all methods described below: Deakin University’s Human Research Ethics Committee 2014-279, Deakin University’s Human Ethics Advisory Group-Health (HEAG-H) HEAG-H 194_2014, HEAG-H 17 2015, HEAG-H 155_2014, HEAG-H 197_2016, HEAG-H 118_2017, the Victorian Department of Education and Training 2015_002622 and the Catholic Archdiocese of Ballarat. Trial findings (including economic evaluation) will be published in peer-reviewed journals and presented at international conferences. Collected data and analyses will be made available in accordance with journal policies and study ethics approvals. Results will be presented to relevant government authorities with an interest in cost-effectiveness of these types of interventions. Trial registration number ACTRN12616000980437; Pre-results.

IntroductionTransoral robotic surgery (TORS) has been adopted in some parts of the world as an innovative approach to the resection of oropharyngeal tumours. The development, details and outcomes of early-to-later phase evaluation of this technique and the quality of evidence to support its adoption into practice have hitherto not been summarised. The aim of this review is to identify and summarise the early and later phase studies of, and evidence for, TORS and to understand how early phase studies report intervention development, governance procedures and selection and reporting of outcomes to optimise methods for using the Idea, Development, Exploration, Assessment, Long-term follow-up (IDEAL) framework for surgical innovation that informs evidence-based practice. The protocol has been written in line with the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols checklist.Methods and analysisElectronic searches in OVID SP versions of Medline and EMBASE, the Cochrane Central Register of Controlled Trials and the Cochrane Database of Systematic Reviews from the start of indexing to 30 April 2017 will identify studies reporting TORS. At least two independent researchers will identify studies for inclusion. Two researchers will extract data from each paper. Studies will be categorised into IDEAL stages of study design from ‘pre-IDEAL’ to randomised controlled trials (stage 3). Data will be collected about the (1) novel intervention and criteria for modification, (2) governance arrangements and patient information provision, (3) outcome domains selected and reported and (4) quality of study design, conduct and reporting. Descriptive statistics and a narrative synthesis will be presented.Ethics and disseminationThe results of this systematic review will be presented at relevant conferences. The methods will be used to inform future reviews exploring other novel surgical innovations. The findings will be published in a peer-reviewed journal. This study does not require ethical approval.

IntroductionTuberculosis (TB) remains a significant public health problem in South Asia. Tobacco use increases the risks of TB infection and TB progression. TheTB& Tobaccoplacebo-controlled randomised trial aims to (1) assess the effectiveness of the tobacco cessation medication cytisine versus placebo when combined with behavioural support and (2) implement tobacco cessation medication and behavioural support as part of general TB care in Bangladesh and Pakistan. This paper summarises the process and context evaluation protocol embedded in the effectiveness–implementation hybrid design.Methods and analysisWe are conducting a mixed-methods process and context evaluation informed by an intervention logic model that draws on the UK Medical Research Council’s Process Evaluation Guidance. Our approach includes quantitative and qualitative data collection on context, recruitment, reach, dose delivered, dose received and fidelity. Quantitative data include patient characteristics, reach of recruitment among eligible patients, routine trial data on dose delivered and dose received, and a COM-B (‘capability’, ‘opportunity’, ‘motivation’ and ‘behaviour’) questionnaire filled in by participating health workers. Qualitative data include semistructured interviews with TB health workers and patients, and with policy-makers at district and central levels in each country. Interviews will be analysed using the framework approach. The behavioural intervention delivery is audio recorded and assessed using a predefined fidelity coding index based on behavioural change technique taxonomy.Ethics and disseminationThe study complies with the guidelines of the Declaration of Helsinki. Ethics approval for the study and process evaluation was granted by the University of Leeds (qualitative components), University of York (trial data and fidelity assessment), Bangladesh Medical Research Council and Bangladesh Drug Administration (trial data and qualitative components) and Pakistan Medical Research Council (trial data and qualitative components). Results of this research will be disseminated through reports to stakeholders and peer-reviewed publications and conference presentations.Trial registration numberISRCTN43811467; Pre-results.

The present manuscript was granted by the Public Health Initiatives Programme (PT06), financed by EEA Grants Financial Mechanism 2009-2014. For further information, please visit http//www.eeagrants.gov.pt/.AA receives a grant from the Portuguese Foundation for Science and Technology (FCT), reference PD/BD/105822/2014. Introduction Economic recession periods can pose accentuated risks to population's mental health and well-being as well as additional threats to health systems. Users and health professionals are key stakeholders in care delivery; however, little attention has been given to their experiences of the crisis. This paper presents a qualitative study protocol to assess users' and health professionals' perceptions about the effects of the post-2008 economic recession on mental health and care delivery in the Lisbon Metropolitan Area, Portugal. Methods and analysis The methodology to assess perceived effects of the economic recession by primary care users and professionals on population mental health, well-being and provision of care is presented. Focus groups with users and semistructured interviews with health professionals will be carried out in three primary healthcare units in Lisbon areas especially affected by the crisis. Thematic analysis of full-transcribed interviews will be conducted using an iterative and reflexive approach. Ethics and dissemination The study protocol was approved by the Ethics Committee of NOVA Medical School, NOVA University of Lisbon. The findings will be useful for other researchers and policy-makers to develop and implement the assessment of prevailing experiences of users and health professionals on the effects of the economic recession on mental health and quality of care in primary health context, promoting their involvement and contribution to services responsiveness. publishersversion published

IntroductionEmergency percutaneous coronary intervention (PCI) of the culprit lesion for patients with acute myocardial infarctions is an accepted practice. A majority of patients present with multivessel disease with additional relevant stenoses apart from the culprit lesion. In haemodynamically stable patients, there is increasing evidence from randomised trials to support the practice of immediate complete revascularisation. However, in the presence of cardiogenic shock, the optimal management strategy for additional non-culprit lesions is unknown. A multicentre randomised controlled trial, CULPRIT-SHOCK, is examining whether culprit vessel only PCI with potentially subsequent staged revascularisation is more effective than immediate multivessel PCI. This paper describes the intended economic evaluation of the trial.Methods and analysisThe economic evaluation will be conducted using a pre-trial decision model and within-trial analysis. The modelling-based analysis will provide expected costs and health outcomes, and incremental cost-effectiveness ratio over the lifetime for the cohort of patients included in the trial. The within-trial analysis will provide estimates of cost per life saved at 30 days and in 1 year, and estimates of health-related quality of life. Bootstrapping and cost-effectiveness acceptability curves will be used to address any uncertainty around these estimates. Different types of regression models within a generalised estimating equation framework will be used to examine how the total cost and quality-adjusted life years are explained by patients’ characteristics, revascularisation strategy, country and centre. The cost-effectiveness analysis will be from the perspective of each country’s national health services, where costs will be expressed in euros adjusted for purchasing power parity.Ethics and disseminationEthical approval for the study was granted by the local Ethics Committee at each recruiting centre. The economic evaluation analyses will be published in peer-reviewed journals of the concerned literature and communicated through the profiles of the authors atwww.twitter.comandwww.researchgate.net.Trial registration numberNCT01927549; Pre-results.

IntroductionCancer is one of the leading causes of death globally and many jurisdictions have developed population-based cancer screening programmes to reduce the public health burden of disease. However, screening participation remains suboptimal. Social media and other mobile health (mHealth) technologies are increasingly being used for health promotion and behaviour change. This paper reports on the protocol for a systematic review exploring the effect of social media and other mHealth interventions on cancer screening participation and intention.Methods and analysisThis protocol is reported in accordance with the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) checklist. We will include any randomised controlled trials or quasi-experimental studies with a pre/post design conducted in adults ≥18 years of age that report on the effectiveness of a social media or mHealth intervention on screening participation or intention (inclusive of breast, cervical, colorectal, prostate and lung cancer). Interventions will be inclusive of those delivered online or through a computer using an established social media platform or a new purpose-built platform, or those delivered through cellphones or other wireless technologies. Any comparator will be acceptable (control group, alternate intervention or pre/post design). We will search Medline, EMBASE, PsycINFO, Scopus, CINAHL, the Cochrane Central Register of Controlled Trials, and Communication and Mass Media Complete from 1 January 2000 to 31 May 2019. Two independent reviewers will screen titles, abstracts and full-text articles with conflicts resolved through discussion or by a third reviewer, as needed. The two reviewers will also independently complete risk of bias assessments for each included study. We will report on the characteristics of the studies, participants and interventions in descriptive narrative form and report the absolute and relative differences in screening and intention attributable to social media and mobile technology interventions.Ethics and disseminationAs this is a systematic review, ethical approval for conduct of this study is not required. We will pursue publication of study results in a relevant peer-reviewed journal and report our findings according to the PRISMA checklist.Trial registration numberCRD42019139615.

IntroductionThe effects of interventions targeting weight loss on physical health are well described, yet the evidence for mental health is less clear. It is essential to better understand the impact of weight management interventions on mental health to optimise care and minimise risk of harm. We will assess the effect of behavioural weight management interventions on mental health in adults with overweight and obesity.Methods and analysisThe systematic review will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidance. We will include behavioural weight management interventions with a diet and/or physical activity component focusing on weight loss for adults with a body mass index ≥25 kg/m2. Randomised controlled trials (RCTs) and cluster RCTs will be the only eligible study designs. Outcomes of interest will be related to mental health. The following databases were searched from inception to 07 May 2019: MEDLINE, Embase, Cochrane database (CENTRAL), PsycINFO, ASSIA, AMED and CINAHL. The search strategy was based on four concepts: (1) adults, defined as ≥18 years, with overweight/obesity, defined as BMI ≥25kg/m², (2) weight management interventions, (3) mental health outcomes and (4) study design. The search was restricted to English-language published papers, with no other restrictions applied. Two stage screening for eligibility will be completed by two independent reviewers, with two independent reviewers completing data extraction and risk of bias assessment. Data permitting, a random-effects meta-analysis of outcomes, subgroup analyses and meta-regression will be conducted. If not appropriate, narrative synthesis and ‘levels of evidence’ assessment will be completed.Ethics and disseminationEthical approval is not required as primary data will not be collected. The completed systematic review will be disseminated in a peer-reviewed journal, at conferences and contribute towards the lead author’s PhD thesis.PROSPERO registration numberCRD42019131659.

IntroductionWhy some people develop chronic pain following an acute episode of low back pain is unknown. Recent cross-sectional studies have suggested a relationship between aberrant sensorimotor cortex activity and pain persistence. The UPWaRD (Understanding persistent Pain Where it ResiDes) cohort study is the first prospective, longitudinal investigation of sensorimotor cortex activity in low back pain. This paper describes the development of a causal model and statistical analysis plan for investigating the causal effect of sensorimotor cortex activity on the development of chronic low back pain.Methods and analysisSensorimotor cortex activity was assessed within 6 weeks of low back pain onset using somatosensory evoked potentials and transcranial magnetic stimulation mapping techniques. Chronic low back pain is defined as ongoing pain (Numerical Rating score ≥1) or disability (Roland Morris Disability Questionnaire score ≥3) at 6 months follow-up. Variables that could confound the relationship between sensorimotor cortex activity and chronic low back pain were identified using a directed acyclic graph and content expertise was used to specify known causal paths. The statistical model was developed ‘a priori’ to control for confounding variables identified in the directed acyclic graph, allowing an unbiased estimate of the causal effect of sensorimotor activity in acute low back pain on the development of chronic pain. The statistical analysis plan was finalised prior to follow-up of all participants and initiation of analysis.Ethics and disseminationEthical approval has been obtained from Western Sydney University Human Research Ethics Committee (H10465) and from Neuroscience Research Australia (SSA: 16/002). Dissemination will occur through presentations at national and international conferences and publications in international peer-reviewed journals.Trial registration numberACTRN12619000002189 (retrospectively registered)

IntroductionMelanoma is Australia’s fourth most common cancer. Early detection is fundamental in maximising health outcomes and minimising treatment costs. To date, population-based screening programmes have not been justified in health economic studies. However, a skin surveillance approach targeting high-risk individuals could improve the cost-benefit ratio.Methods and analysisThis paper describes a 2-year longitudinal randomised controlled trial (RCT) to compare routine clinical care (control) with an intensive skin surveillance programme (intervention) consisting of novel three-dimensional (3D) total-body photography (TBP), sequential digital dermoscopy and melanoma-risk stratification, in a high-risk melanoma cohort. Primary outcomes will evaluate clinical, economic and consumer impact of the intervention. Clinical outcomes will evaluate differences in the rate of lesion excisions/biopsies per person, benign to malignant ratio for excisions and thickness of melanomas diagnosed. A health economic analysis using government data repositories will capture healthcare utilisation and costs relating to skin surveillance. Consumer questionnaires will examine intervention acceptability, the psychological impact, and attitudes towards melanoma risk and sun protective behaviour. Secondary outcomes include the development of a holistic risk algorithm incorporating clinical, phenotypic and genetic factors to facilitate the identification of those most likely to benefit from this surveillance approach. Furthermore, the feasibility of integrating the intervention with teledermatology to enhance specialist care in remote locations will be evaluated. This will be the first RCT to compare a targeted surveillance programme utilising new 3D TBP technology against current routine clinical care for individuals at high risk of melanoma.Ethics and disseminationThis study has received Human Research Ethics Committee (HREC) approval from both Metro South Health HREC (HREC/17/QPAH/816) and The University of Queensland HREC (2018000074).Trial registration numberANZCTR12618000267257; Pre-results.

IntroductionDepression is highly prevalent and the leading contributor to the burden of disease in young people worldwide, making it an ongoing priority for early intervention. As the current evidence-based interventions of medication and psychological therapy are only modestly effective, there is an urgent need for additional treatment strategies. This paper describes the rationale of the Improving Mood with Physical ACTivity (IMPACT) trial. The primary aim of the IMPACT trial is to determine the effectiveness of a physical activity intervention compared with psychoeducation, in addition to routine clinical care, on depressive symptoms in young people. Additional aims are to evaluate the intervention effects on anxiety and functional outcomes and examine whether changes in physical activity mediate improvements in depressive symptoms.Methods and analysisThe study is being conducted in six youth mental health services across Australia and is using a parallel-group, two-arm, cluster randomised controlled trial design, with randomisation occurring at the clinician level. Participants aged between 12 years and 25 years with moderate to severe levels of depression are randomised to receive, in addition to routine clinical care, either: (1) a physical activity behaviour change intervention or (2) psychoeducation about physical activity. The primary outcome will be change in the Quick Inventory of Depressive Symptomatology, with assessments occurring at baseline, postintervention (end-point) and 6-month follow-up from end-point. Secondary outcome measures will address additional clinical outcomes, functioning and quality of life. IMPACT is to be conducted between May 2014 and December 2019.Ethics and disseminationEthical approval was obtained from the University of Melbourne Human Research Ethics Committee on 8 June 2014 (HREC 1442228). Trial findings will be published in peer-reviewed journals and presented at conferences. Key messages will also be disseminated by the youth mental health services organisation (headspace National Youth Mental Health Foundation).Trial registration numberACTRN12614000772640.

IntroductionThe management of critically ill patients is challenged by increasing population age and prevalence of comorbid diseases. High-quality intensive care nursing practice is imperative to accommodate these issues. The roles of the nurse practitioner (NP) and the acute care NP have existed for decades in the USA, Canada and Australia but are still evolving in Europe. Some European countries have introduced the advanced practice nurse (APN), but the current standard of the advanced level of nursing is variable and consensus regarding the framework, role and definition is lacking. Literature and evidence are sparse as well. Identification of skills and competencies required for the APN is warranted. Mapping skills and competencies will enable future educational harmonisation and facilitate mobility of the advanced-level intensive care nursing workforce across Europe. The aim of our scoping review is to identify literature describing skills, competencies and policies characterising advanced nursing practice in intensive care across Europe.Methods and analysisWe will apply a five-stage scoping review methodology with a comprehensive systematic literature search as outlined by Arksey and O’Malley. In collaboration with a research librarian, we will search nine interdisciplinary databases and grey literature for publications originating in European countries in 1992–2018. Using a two-stage screening process with Covidence to remove duplicates, we will first scan the title and abstract and then perform full-text review to determine the eligibility of the papers. Qualitative content analysis will be used to chart the data.Ethics and disseminationOur study is a part of the European Union-funded INACTIC project (International Nursing Advanced Competency-based Training for Intensive Care) with the overall aim of developing a common European curriculum for advanced practice critical care nursing. Results from this scoping review mapping the evidence of APNs in Europe will be presented at national and international conferences and published in a peer-reviewed journal.

IntroductionCommunity-based Participatory Women’s Groups (PWGs) have proven to be an effective intervention to improve maternal and child health (MCH) outcomes in low/middle-income countries (LMICs). Less is known about how PWGs exert their effects in LMICs and virtually nothing is known about the contextual issues, processes and power relationships that affect PWG outcomes in high resource settings. The aim of this systematic review is to synthesise and critically analyse the current evidence on how and why PWGs improve the quality of MCH care. We aim to demonstrate how PWGs function and why PWG interventions contribute to social and health outcomes.Methods and analysisThe protocol will follow Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols guidelines. The databases Medline (Ovid): Cumulative Index to Nursing and Allied Health Literature (Ebsco); Informit health suite Scopus, Australian HealthInfoNet, the Cochrane Library and other sources will be searched under broad categories: intervention, context and outcomes to 30 June 2019.Ethics and disseminationAs only secondary data will be analysed; ethical approval is not required. The review will be disseminated to relevant organisations and presented in peer-reviewed papers and at conferences. This will be the first attempt to summarise the current available evidence on the characteristics, contextual influences and mechanisms that are associated with the outcomes and effectiveness of PWGs.PROSPERO registration numberCRD42019126533.

IntroductionEnvironmental exposures are intertwined with mental health outcomes. People are exposed to the environments in which they currently live, and to a multitude of environments along their daily movements and through their residential relocations. However, most research assumes that people are immobile, disregarding that such dynamic exposures also serve as stressors or buffers potentially associated with depression and suicide risk. The aim of the Dynamic Urban Environmental Exposures on Depression and Suicide (NEEDS) study is to examine how dynamic environmental exposures along people’s daily movements and over their residential histories affect depression and suicide mortality in the Netherlands.Methods and analysisThe research design comprises two studies emphasising the temporality of exposures. First, a cross-sectional study is assessing how daily exposures correlate with depression. A nationally representative survey was administered to participants recruited through stratified random sampling of the population aged 18–65 years. Survey data were enriched with smartphone-based data (eg, Global Positioning System tracking, Bluetooth sensing, social media usage, communication patterns) and environmental exposures (eg, green and blue spaces, noise, air pollution). Second, a longitudinal population register study is addressing the extent to which past environmental exposures over people’s residential history affect suicide risk later in life. Statistical and machine learning-based models are being developed to quantify environment–health relations.Ethics and disseminationEthical approval (FETC17-060) was granted by the Ethics Review Board of Utrecht University, The Netherlands. Project-related findings will be disseminated at conferences and in peer-reviewed journal papers. Other project outcomes will be made available through the project’s web page,http://www.needs.sites.uu.nl.

IntroductionAccess to primary healthcare (PHC) has a fundamental influence on health outcomes, particularly for members of vulnerable populations. Innovative Models Promoting Access-to-Care Transformation (IMPACT) is a 5-year research programme built on community-academic partnerships. IMPACT aims to design, implement and evaluate organisational innovations to improve access to appropriate PHC for vulnerable populations. Six Local Innovation Partnerships (LIPs) in three Australian states (New South Wales, Victoria and South Australia) and three Canadian provinces (Ontario, Quebec and Alberta) used a common approach to implement six different interventions. This paper describes the protocol to evaluate the processes, outcomes and scalability of these organisational innovations.Methods and analysisThe evaluation will use a convergent mixed-methods design involving longitudinal (pre and post) analysis of the six interventions. Study participants include vulnerable populations, PHC practices, their clinicians and administrative staff, service providers in other health or social service organisations, intervention staff and members of the LIP teams. Data were collected prior to and 3–6 months after the interventions and included interviews with members of the LIPs, organisational process data, document analysis and tools collecting the cost of components of the intervention. Assessment of impacts on individuals and organisations will rely on surveys and semistructured interviews (and, in some settings, direct observation) of participating patients, providers and PHC practices.Ethics and disseminationThe IMPACT research programme received initial ethics approval from St Mary’s Hospital (Montreal) SMHC #13–30. The interventions received a range of other ethics approvals across the six jurisdictions. Dissemination of the findings should generate a deeper understanding of the ways in which system-level organisational innovations can improve access to PHC for vulnerable populations and new knowledge concerning improvements in PHC delivery in health service utilisation.

IntroductionTreatment fidelity is a complex, multifaceted evaluative process which refers to whether a studied intervention was delivered as intended. Monitoring and enhancing fidelity is one recommendation of the TiDIER (Template for Intervention Description and Replication) checklist, as fidelity can inform interpretation and conclusions drawn about treatment effects. Despite the methodological and translational benefits, fidelity strategies have been used inconsistently within health behaviour intervention studies; in particular, within aphasia intervention studies, reporting of fidelity remains relatively rare. This paper describes the development of a fidelity protocol for the Action Success Knowledge (ASK) study, a current cluster randomised trial investigating an early mood intervention for people with aphasia (a language disability caused by stroke).Methods and analysisA novel fidelity protocol and tool was developed to monitor and enhance fidelity within the two arms (experimental treatment and attention control) of the ASK study. The ASK fidelity protocol was developed based on the National Institutes of Health Behaviour Change Consortium fidelity framework.Ethics and disseminationThe study protocol was approved by the Darling Downs Hospital and Health Service Human Research Ethics Committee in Queensland, Australia under the National Mutual Acceptance scheme of multicentre human research projects. Specific ethics approval was obtained for those participating sites who were not under the National Mutual Agreement at the time of application. The monitoring and ongoing conduct of the research project is in line with requirements under the National Mutual Acceptance. On completion of the trial, findings from the fidelity reviews will be disseminated via publications and conference presentations.Trial registration numberACTRN12614000979651.

Networks are everywhere. Health systems and public health settings are experimenting with multifarious forms. Governments and providers are heavily investing in networks with an expectation that they will facilitate the delivery of better services and improve health outcomes. Yet, we lack a suitable conceptual framework to evaluate the effectiveness and sustainability of clinical and health networks. This paper aims to present such a framework to assist with rigorous research and policy analysis. The framework was designed as part of a project to evaluate the effectiveness and sustainability of health networks. We drew on systematic reviews of the literature on networks and communities of practice in health care, and on theoretical and evidence-based studies of the evaluation of health and non-health networks. Using brainstorming and mind-mapping techniques in expert advisory group sessions, we assessed existing network evaluation frameworks and considered their application to extant health networks. Feedback from stakeholders in network studies that we conducted was incorporated. The framework encompasses network goals, characteristics and relationships at member, network and community levels, and then looks at network outcomes, taking into account intervening variables. Finally, the short-term, medium-term and long-term effectiveness of the network needs to be assessed. The framework provides an overarching contribution to network evaluation. It is sufficiently comprehensive to account for many theoretical and evidence-based contributions to the literature on how networks operate and is sufficiently flexible to assess different kinds of health networks across their life-cycle at community, network and member levels. We outline the merits and limitations of the framework and discuss how it might be further tested.

IntroductionLow back pain (LBP) is the leading cause of disability worldwide, with prevalence doubling in the past 14 years. To date, prognostic screening tools display poor discrimination and offer no net benefit of screening over and above a ‘treat all’ approach. Characteristics of the primary sensory (S1) and motor (M1) cortices may predict the development of chronic LBP, yet the prognostic potential of these variables remains unknown. The Understanding persistent Pain Where it ResiDes (UPWaRD) study aims to determine whether sensorimotor cortex activity, an individual’s capacity for plasticity and psychosocial factors in the acute stage of pain, predict LBP outcome at 6 months. This paper describes the methods and analysis plan for the development of the prediction model.Methods and analysisThe study uses a multicentre prospective longitudinal cohort design with 6-month follow-up. 120 participants, aged 18 years or older, experiencing an acute episode of LBP (less than 6 weeks duration) will be included. Primary outcomes are pain and disability.Ethics and disseminationEthical approval has been obtained from Western Sydney University Human Research Ethics Committee (H10465) and from Neuroscience Research Australia (SSA: 16/002). Dissemination will occur through presentations at national and international conferences and publications in international peer-reviewed journals.Trial registration numberACTRN12619000002189; Pre-results.

ObjectivesThis paper aims to describe the degree to which general practitioners (GPs) explore suicidal behaviour among depressed patients in the Netherlands.DesignAn observational study of consultations between GPs and depressed patients.Setting39 sentinel GP practices within the Netherlands in 2017.ParticipantsPatients with a registration of depression.Primary and secondary outcome measuresPrimary outcome measure is suicide exploration by the GP. Secondary outcome measures at patient level, assessed by surveying GPs, include prevalence and severity of suicidal thoughts. Secondary outcome measures at GP level include follow-up actions of GP and reasons not to explore suicidality.ResultsA total of 1034 questionnaires were included in the analyses. GPs assessed and explored suicidality in 44% of patients with depression (66% in patients with a new episode of depression). GPs explored suicidal feelings more often in patients with a new episode of depression (OR 4.027, pConclusionGPs explored suicidal thoughts in less than half of all depressed patients and in two-thirds of patients with a new episode of depression. Suicide prevention training is recommended to enhance suicide exploration.

ObjectivesTo analyse trends in the academic literature applying complexity science to healthcare, focusing specifically on bibliometric characteristics and indicators of influence.DesignThis study reports a bibliometric analysis via a systematic search of the academic literature applying complexity science to healthcare.MethodA search of four academic databases was performed on 19 April 2018. Article details were downloaded and screened against inclusion criteria (peer-reviewed journal articles applying complexity science to healthcare). Publication and content data were then collected from included articles, with analysis focusing on trends over time in the types and topics of articles, and where they are published. We also analysed the influence of this body of work through citation and network analyses.ResultsArticles on complexity science in healthcare were published in 268 journals, though a much smaller subset was responsible for a substantial proportion of this literature. USA contributed the largest number of articles, followed by the UK, Canada and Australia. Over time, the number of empirical and review articles increased, relative to non-empirical contributions. However, in general, non-empirical literature was more influential, with a series of introductory conceptual papers being the most influential based on both overall citations and their use as index references within a citation network. The most common topics of focus were health systems and organisations generally, and education, with recent uptake in research, policy, and change and improvement.ConclusionsThis study identified changes in the types of articles on complexity science in healthcare published over time, and their content. There was evidence to suggest a shift from conceptual work to the application of concrete improvement strategies and increasingly in-depth examination of complex healthcare systems. We also identified variation in the influence of this literature at article level, and to a lesser extent by topic of focus.

International audience; PDFSmoking and tobaccoProtocolStudy protocol for a pragmatic randomised controlled trial evaluating efficacy of a smoking cessation e-‘Tabac Info Service’: ee-TIS trial L Cambon1,2, P Bergman3, Al Le Faou4,5, I Vincent3, B Le Maitre5, A Pasquereau6, P Arwidson6, D Thomas5,7,8, F Alla2,3Author affiliations Chaire de Recherche en prévention des cancers, UMR 6051 (CRAPE), EHESP, Paris, France EA 4360, APEMAC, Université de Lorraine, Nancy, France CNAMTS, Paris, France Centre Addiction, Hôpital Européen Georges Pompidou, Pôle Psychiatrie-Addictologie, Hôpitaux Universitaires Paris-Ouest, Paris, France Société Francophone de Tabacologie, Ollainville, France Santé Publique France, Saint maurice, France Université Paris VI CHU Pitié-Salpêtrière, Paris, France APHP, Institut de cardiologie, Hopital de la Pitié-Salpêtrière, Paris, France Correspondence to Dr Linda Cambon; Linda.cambon@ehesp.fr AbstractIntroduction A French national smoking cessation service, Tabac Info Service, has been developed to provide an adapted quitline and a web and mobile application involving personalised contacts (eg, questionnaires, advice, activities, messages) to support smoking cessation. This paper presents the study protocol of the evaluation of the application (e-intervention Tabac Info Service (e-TIS)). The primary objective is to assess the efficacy of e-TIS. The secondary objectives are to (1) describe efficacy variations with regard to users' characteristics, (2) analyse mechanisms and contextual conditions of e-TIS efficacy.Methods and analyses The study design is a two-arm pragmatic randomised controlled trial including a process evaluation with at least 3000 participants randomised to the intervention or to the control arm (current practices). Inclusion criteria are: aged 18 years or over, current smoker, having completed the online consent forms, possessing a mobile phone with android or apple systems and using mobile applications, wanting to stop smoking sooner or later. The primary outcome is the point prevalence abstinence of 7 days at 6 months later. Data will be analysed in intention to treat (primary) and per protocol analyses. A logistic regression will be carried out to estimate an OR (95% CI) for efficacy. A multivariate multilevel analysis will explore the influence on results of patients' characteristics (sex, age, education and socioprofessional levels, dependency, motivation, quit experiences) and contextual factors, conditions of use, behaviour change techniques.Ethics and dissemination The study protocol was reviewed by the ethical and deontological institutional review board of the French Institute for Public Health Surveillance on 18 April 2016. The findings of this study will allow us to characterise the efficacy of e-TIS and conditions of its efficacy. These findings will be disseminated through peer-reviewed articles.

Introduction Sepsis is a leading global cause of morbidity and mortality, and is more common at the extremes of age. Moreover, the cost of in-hospital care for elderly patients with sepsis is significant. There are indications from experimental and observational studies that aspirin may reduce inflammation associated with infection. This paper describes the rationale and design of the AspiriN To Inhibit SEPSIS (ANTISEPSIS) trial, a substudy of ASPirin in Reducing Events in the Elderly (ASPREE). ANTISEPSIS primarily aims to determine whether low-dose aspirin reduces sepsis-related deaths in older people. Additionally, it will assess whether low-dose aspirin reduces sepsis-related hospitalisations and sepsis-related Intensive Care Unit (ICU) admissions. Methods and analysis ASPREE is a double-blinded, randomised, placebo-controlled primary prevention trial that will determine whether daily low-dose aspirin extends disability-free longevity in 19 000 healthy older people recruited in Australia and the USA. The ANTISEPSIS substudy involves additional ASPREE trial data collection to assess the impact of daily low-dose aspirin on sepsis-related events in the 16 703 ASPREE participants aged 70 years and over, recruited in Australia. The intervention is a daily 100 mg dose of enteric-coated aspirin versus matching placebo, with 1:1 randomisation. The primary outcome for the ANTISEPSIS substudy is the incidence of sepsis-related death in eligible patients. The incidence of sepsis-related hospital and ICU admissions are secondary outcomes. ANTISEPSIS is to be conducted between 2012 and 2018. Discussion This substudy will determine whether aspirin, an inexpensive and accessible therapy, safely reduces sepsis-related deaths and hospitalisations in older Australians. If shown to be the case, this would have profound effects on the health of older Australians. Trial registration number Pre-results, ACTRN12613000349741.

Introduction Antidepressants are commonly prescribed during pregnancy; however, there are inconsistent data on the safety of these medications during the prenatal period. To address this gap, this study will investigate short-term and long-term neurodevelopmental, physical and mental health, and educational outcomes of children who have been exposed to selective serotonin reuptake inhibitors (SSRIs) or selective serotonin norepinephrine reuptake inhibitors (SNRIs) and/or maternal depression during pregnancy. Methods and analysis Administrative data will be linked to generate 4 population-based exposed groups from all children born in Manitoba between 1996 and 2014 whose mother had at least 2 prescriptions for either an SSRI or SNRI: (1) throughout the prenatal period (beginning of pregnancy until birth); (2) in the first trimester (≤14 weeks gestation); (3) in the second trimester (15–26 weeks gestation); (4) in the third trimester (≥27 weeks gestation) and 1 population-based unexposed group consisting of children whose mothers had a diagnosis of mood or anxiety disorder during pregnancy but did not use antidepressants. Propensity scores and inverse probability treatment weights will be used to adjust for confounding. Multivariate regression modelling will determine whether, compared with untreated mood/anxiety disorder, prenatal exposure to antidepressant medications is associated with: (1) adverse birth and neonatal outcomes, including: preterm birth, low birth weight, low Apgar scores, respiratory distress, congenital malformations and persistent pulmonary hypertension; (2) adverse early childhood outcomes, including: early childhood education challenges, diagnosis of neurodevelopmental disorders and diagnosis of mental disorders. We will determine if exposure effects differ between SSRIs and SRNIs, and determine if exposure effects differ between gestation timing of exposure to antidepressants. Ethics and dissemination Ethical approval was obtained from the University of Manitoba Health Research Ethics Board. Dissemination of results will include engagement of stakeholders and patients, writing of reports for policymakers and patients, and publication of scientific papers.

IntroductionSystematic reviews collate trial data to provide evidence to support clinical decision-making. For effective synthesis, there must be consistency in outcome reporting. There is no agreed set of outcomes for reporting the effect of burn care interventions. Issues with outcome reporting have been identified, although not systematically investigated. This study gathers empirical evidence on any variation in outcome reporting and assesses the need for a core outcome set for burn care research.MethodsElectronic searches of four search engines were undertaken from January 2012 to December 2016 for randomised controlled trials (RCTs), using medical subject headings and free text terms including ‘burn’, ‘scald’ ‘thermal injury’ and ‘RCT’. Two authors independently screened papers, extracted outcomes verbatim and recorded the timing of outcome measurement. Duplicate outcomes (exact wording ± different spelling), similar outcomes (albumin in blood, serum albumin) and identical outcomes measured at different times were removed. Variation in outcome reporting was determined by assessing the number of unique outcomes reported across all included trials. Outcomes were classified into domains. Bias was reduced using five researchers and a patient working independently and together.Results147 trials were included, of which 127 (86.4%) were RCTs, 13 (8.8%) pilot studies and 7 (4.8%) RCT protocols. 1494 verbatim clinical outcomes were reported; 955 were unique. 76.8% of outcomes were measured within 6 months of injury. Commonly reported outcomes were defined differently. Numbers of unique outcomes per trial varied from one to 37 (median 9; IQR 5,13). No single outcome was reported across all studies demonstrating inconsistency of reporting. Outcomes were classified into 54 domains. Numbers of outcomes per domain ranged from 1 to 166 (median 11; IQR 3,24).ConclusionsThis review has demonstrated heterogeneity in outcome reporting in burn care research which will hinder amalgamation of study data. We recommend the development of a Core Outcome Set.PROSPERO registration numberCRD42017060908.

Objectives(1) To identify national policies for England and local policies for Southampton City that are relevant to maternal and child health. (2) To quantify the extent to which these policies meet the international standards for nutrition and physical activity initiatives set out in the WHO Global Action Plan for the Prevention and Control of Non-Communicable Diseases (WHO Action Plan).DesignThe policy appraisal process involved three steps: (1) identifying policy documents relevant to maternal and infant health, (2) developing a policy appraisal framework from the WHO Action Plan, and (3) analysing the policies using the framework.SettingEngland and Southampton City.Participants57 national and 10 local policies.ResultsAcross both national and local policies, priority areas supporting public health processes, such as evidence-based practice, were adopted more frequently than the action-oriented areas targeting maternal and child dietary and physical activity behaviours. However, the policy option managing conflicts of interest was rarely considered in the national policies (12%), particularly in white papers or evidence-based guidelines. For the action-oriented priority areas, maternal health policy options were more frequently considered than those related to child health or strengthening health systems. Complementary feeding guidance (9%) and workforce training in empowerment skills (14%) were the least frequent action-oriented policy options adopted among the national policies. The maternal nutrition-focused and workforce development policy options were least frequent among local policies adopted in 10% or fewer. Macroenvironmental policy options tended to have a lower priority than organisational or individual options among national policies (p=0.1) but had higher priority among local policies (p=0.02).ConclusionsFurther action is needed to manage conflicts of interest and adopt policy options that promote a system-wide approach to address non-communicable diseases caused by poor diet and physical inactivity.

IntroductionPromoting physical activity (PA) and reducing sedentary behaviour (SB) may exert beneficial effects on the older adult population, improving behavioural, functional, health and psychosocial outcomes in addition to reducing health, social care and personal costs. This paper describes the planned economic evaluation of SITLESS, a multicountry three-armed pragmatic randomised controlled trial (RCT) which aims to assess the short-term and long-term effectiveness and cost-effectiveness of a complex intervention on SB and PA in community-dwelling older adults, based on exercise referral schemes enhanced by a group intervention providing self-management strategies to encourage lifestyle change.Methods and analysisA within-trial economic evaluation and long-term model from both a National Health Service/personal social services perspective and a broader societal perspective will be undertaken alongside the SITLESS multinational RCT. Healthcare costs (hospitalisations, accident and emergency visits, appointment with health professionals) and social care costs (eg, community care) will be included in the economic evaluation. For the cost-utility analysis, quality-adjusted life-years will be measured using the EQ-5D-5L and capability well-being measured using the ICEpop CAPability measure for Older people (ICECAP-O) questionnaire. Other effectiveness outcomes (health related, behavioural, functional) will be incorporated into a cost-effectiveness analysis and cost-consequence analysis.The multinational nature of this RCT implies a hierarchical structure of the data and unobserved heterogeneity between clusters that needs to be adequately modelled with appropriate statistical and econometric techniques. In addition, a long-term population health economic model will be developed and will synthesise and extrapolate within-trial data with additional data extracted from the literature linking PA and SB outcomes with longer term health states.Methods guidance for population health economic evaluation will be adopted including the use of a long-time horizon, 1.5% discount rate for costs and benefits, cost consequence analysis framework and a multisector perspective.Ethics and disseminationThe study design was approved by the ethics and research committee of each intervention site: the Ethics and Research Committee of Ramon Llull University (reference number: 1314001P) (Fundació Blanquerna, Spain), the Regional Committees on Health Research Ethics for Southern Denmark (reference number: S-20150186) (University of Southern Denmark, Denmark), Office for Research Ethics Committees in Northern Ireland (ORECNI reference number: 16/NI/0185) (Queen’s University of Belfast) and the Ethical Review Board of Ulm University (reference number: 354/15) (Ulm, Germany). Participation is voluntary and all participants will be asked to sign informed consent before the start of the study.This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement number 634 270. This article reflects only the authors' view and the Commission is not responsible for any use that may be made of the information it contains.The findings of the study will be disseminated to different target groups (academia, policymakers, end users) through different means following the national ethical guidelines and the dissemination regulation of the Horizon 2020 funding agency.Use of the EuroQol was registered with the EuroQol Group in 2016.Use of the ICECAP-O was registered with the University of Birmingham in March 2017.Trial registration numberNCT02629666; Pre-results.

IntroductionTask shifting interventions are intended to both deliver clinically effective treatments to reduce disease burden and address health inequities or population vulnerability. Little is known about how health equity and population vulnerability are defined and measured in research focused on task shifting. This systematic review will address the following questions: Among task shifting interventions in high-income settings that have been studied using randomised controlled trials or variants, how are health inequity or population vulnerability identified and defined? What methods and indicators are used to describe, characterise and measure the population’s baseline status and the intervention’s impacts on inequity and vulnerability?Methods and analysisStudies were identified through database searches (MEDLINE, Embase, CINAHL, PsycINFO and Web of Science). Eligible studies will be randomised controlled trials published since 2004, conducted in high-income countries, concerning task shifting interventions to treat any disease, in any population that may face health disadvantage as defined by the PROGRESS-Plus framework (place of residence, race/ethnicity/culture/language, occupation, gender/sex, religion, social capital, socioeconomic position, age, disability, sexual orientation, other vulnerable groups). We will conduct independent and duplicate title and abstract screening, then identify related papers from the same programme of research through further database and manual searching. From each programme of research, we will extract study details, and definitions and measures of health equity or population vulnerability based on the PROGRESS-Plus framework. Two investigators will assess the quality of reporting and measurement related to health equity and vulnerability using a scale developed for this study. A narrative synthesis will highlight similarities and differences between the gathered studies and offer critical analyses and implications.Ethics and disseminationThis review does not involve primary data collection, does not constitute research on human subjects and is not subject to additional institutional ethics review or informed consent procedures. Dissemination will include open-access peer-reviewed publication and academic conference presentations.PROSPERO Registration Number CRD42017049959.

Background The maternal near-miss cases review (NMCR), a type of clinical audit, proved to be effective in improving quality of care and decreasing maternal mortality in low/middle-income countries (LMICs). However, challenges in its implementation have been described. Objectives Synthesising the evidence on facilitators and barriers to the effective implementation of NMCR in LMICs. Design Systematic review of qualitative studies. Data sources MEDLINE, LILACS, Global Health Library, SCI-EXPANDED, SSCI, Cochrane library and Embase were searched in December 2017. Eligibility criteria for selecting studies Qualitative studies exploring facilitators and/or barriers of implementing NMCR in LMIC were included. Data extraction and synthesis Two independent reviewers extracted data, performed thematic analysis and assessed risk of bias. Results Out of 25 361 papers retrieved, 9 studies from Benin, Brazil, Burkina Faso, Cote D’Ivoire, Ghana, Malawi, Morocco, Tanzania, Uganda could be included in the review. The most frequently reported barriers to NMCR implementation were the following: absence of national guidelines and local protocols; insufficient training on how to perform the audit; lack of leadership, coordination, monitoring and supervision; lack of resources and work overload; fear of blame and punishment; poor knowledge of evidenced-based medicine; hierarchical differences among staff and poor understating of the benefits of the NMCR. Major facilitators to NMCR implementation included: good leadership and coordination; training of all key staff; a good cultural environment; clear staff’s perception on the benefits of conducting audit; patient empowerment and the availability of external support. Conclusions In planning the NMCR implementation in LMICs, policy-makers should consider actions to prevent and mitigate common challenges to successful NMCR implementation. Future studies should aim at documenting facilitators and barriers to NMCR outside the African Region.