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ObjectivesA wide range of electronic devices can be used for data collection of patient-reported outcome (PRO) measures in subjects with chronic obstructive pulmonary disease (COPD). Although comparisons between electronic and paper-based PRO measures have been undertaken in asthmatics, it is currently uncertain whether electronic questionnaires work equally as well as paper versions in elderly subjects with COPD. The aim of this study was to compare the responses to paper and electronic versions of the Evaluating Respiratory Symptoms in COPD (E-RS) and the COPD Assessment Test (CAT).DesignA randomised cross-over design was used to compare the responses to paper and electronic versions of the two tools. The interval between the two administrations was 1 week.SettingElectronic versions were self-administered under supervision using a tablet computer at our outpatient clinic (secondary care hospital in Japan) while paper questionnaires completed at home were requested to be returned by mail. It was intended that half of the patients completed the electronic versions of both questionnaires first, followed by the paper versions while the other half completed the paper versions first.ParticipantsEighty-one subjects with stable COPD were included.ResultsThe E-RS total scores (possible range 0–40) were 6.8±7.4 and 5.0±6.6 in the paper-based and electronic versions, respectively, and the CAT scores (possible range 0–40) were 10.0±7.4 and 8.6±7.8. In both questionnaires, higher scores indicate worse status. The relationship between electronic and paper versions showed significant reliability for both the E-RS total score and CAT score (intraclass correlation coefficient=0.82 and 0.89, respectively; both pConclusionsIn both cases, the two versions of the same questionnaire cannot be used interchangeably even though they have both been validated.

ObjectivesOriginally developed as a paper questionnaire, the electronic Epworth Sleepiness Scale (ESS) is widely used in sleep clinics and sleep population research. Despite potential differences between computer-based and conventional questionnaire delivery, studies have not evaluated the agreement between electronic and paper versions of the ESS. Given the widespread use of the ESS, a bias between results would present considerable data concerns. Thus, the aim of this study was to examine agreement between electronic and paper ESS responses in obstructive sleep apnoea (OSA).DesignWe undertook a secondary analysis of baseline data from a randomised controlled trial (ANZCTR: ACTRN12611000847910).SettingData were collected in a tertiary sleep research laboratory located in Sydney, Australia.ParticipantsData were analysed from 112 adult patients with OSA.MeasurementsPatients were given the English version of the ESS as part of a battery of sleep laboratory questionnaires. They completed electronic and subsequently paper ESS questionnaires on the same day.ResultsWe found no significant difference between electronic and paper ESS questionnaires (mean=0.1, SD=2.1, 95% CI −0.3 to 0.5, P=0.57) or heteroscedasticity. There was no evidence of bias along the range of the measure. 95% limits of agreement at 4.3 and −4.1 were comparable with previous data.ConclusionsWe found no evidence of bias between electronic and paper ESS questionnaires in this sample of patients with OSA, as the two formats displayed sufficient agreement to be clinically comparable. Regardless of severity, patients reported the same level of daytime sleepiness with the same level of accuracy across both measures.Trial registration numberACTRN12611000847910; Pre-results.

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

IntroductionAutism spectrum conditions (ASC) develop early in life and are thought to last a lifetime. However, ASC research has two major knowledge gaps that hinder progression in understanding the concept of ASC and in providing proper support for autistic adults: (1) the majority of knowledge about ASC mainly stems from childhood studies so little is known about older autistic adults and (2) while it is broadly recognised that ASC is a heterogeneous condition, we do not yet understand the differences in trajectories leading to their future outcome. We aim to fill both knowledge gaps.Methods and analysisA multistage overlapping cohort design assessing (cognitive) ageing in ASC is designed to obtain an accelerated longitudinal data set. Data, including a multitude of questionnaires, diagnostics and cognitive tests, are collected over four waves within a 10-year time frame. This will provide information regarding actual changes in quality of life, co-occurring health conditions and cognition as well as the possibility to test external validity and temporal stability in newly formed behavioural subtypes. Participants consist of three groups of adults aged 20–90 years: (1) with a clinical diagnosis of ASC, (2) with a clinical diagnosis of attention deficit hyperactivity disorder (ADHD) but no ASC, (3) no ASC/ADHD (ie, comparison group). The sample size differs between waves and instruments. Detailed analysis plans will be preregistered in AsPredicted or at the Open Science Framework.Ethics and disseminationEthical approval for this study was obtained from the ethical review board of the Department of Psychology of the University of Amsterdam (wave 1 2011-PN-1952 and 2013-PN-2668, wave 2 2015-BC-4270, waves 3 and 4 2018-BC-9285). In line with the funding policies of the grant organisation funding this study, future papers will be published open access.

IntroductionCompared with the rest of the UK and Western Europe, England has high rates of the infectious disease tuberculosis (TB). TB is curable, although treatment is for at least 6 months and longer when disease is drug resistant. If patients miss too many doses (non-adherence), they may transmit infection for longer and the infecting bacteria may develop resistance to the standard drugs used for treatment. Non-adherence may therefore risk both their health and that of others. Within England, certain population groups are thought to be at higher risk of non-adherence, but the factors contributing to this have been insufficiently determined, as have the best interventions to promote adherence. The objective of this study was to develop a manualised package of interventions for use as part of routine care within National Health Services to address the social and cultural factors that lead to poor adherence to treatment for TB disease.Methods and analysisThis study uses a mixed-methods approach, with six study components. These are (1) scoping reviews of the literature; (2) qualitative research with patients, carers and healthcare professionals; (3) development of the intervention; (4) a pilot randomised controlled trial of the manualised intervention; (5) a process evaluation to examine clinical utility; and (6) a cost analysis.Ethics and disseminationThis study received ethics approval on 24 December 2018 from Camberwell St. Giles Ethics Committee, UK (REC reference 18/LO/1818). Findings will be published and disseminated through peer-reviewed publications and conference presentations, published in an end of study report to our funder (the National Institute for Health Research, UK) and presented to key stakeholders.Trial registration numberNCT95243114Secondary identifying numbersUniversity College London/University College London Hospitals Joint Research Office 17/0726.National Institute for Health Research, UK 16/88/06.

ObjectiveTo compare online and paper-based screening for depression and anxiety in adults with cystic fibrosis (CF).Design and settingCross-sectional study in CF clinics in Ireland and through the Cystic Fibrosis Ireland online community.Participants160 adult patients aged 18 or above were recruited. Of these, 147 were included in the analysis; 83 online and 64 paper-based. The remaining 13 were excluded because of incomplete data.MeasuresDepression and anxiety were measured using the Hospital Anxiety and Depression Scale (HADS). Data on pulmonary function (forced expiratory volume in 1 s %) and body mass index were self-reported based on clinical assessments. Sociodemographic data were collected.ResultsCompared with the paper-based participants, the online participants were more likely to be female (61.7% vs 48.4%), older (mean 32.2 vs 28.2 years) and were more likely to be married (32.5% vs 15.6%), living with their spouse or partner (42.5% vs 22.6%) and working either full time (33.7% vs 15.9%) or part time (30.1%vs 17.5%). The prevalence rates of elevated anxiety and depression were not significantly different (P=0.71 and P=0.56). HADS anxiety and depression scores were not statistically different between online (P=0.83) and paper-based (P=0.92) participants based on Mann-Whitney U test. A significant negative correlation was found between depression and pulmonary function (r=−0.39, P=0.01) and anxiety and pulmonary function (r=−0.36, P=0.02). Based on Cronbach’s alpha, there were no statistically significant differences between the online and paper-based participants on the internal consistency of the HADS anxiety (P=0.073) and depression (P=0.378) scales.ConclusionsOur findings suggest that online and paper-based screening for depression and anxiety in adult patients with CF yield comparable findings on prevalence rates and scores, associations with health and internal consistency of subscales. This study highlights that online screening offers an alternative method to paper-based screening. Further research with a larger sample and assessment of measurement equivalence between online and paper based screening is needed to confirm our results.

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

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

IntroductionChronic kidney disease (CKD) management in the UK is usually primary care based, with National Institute for Health and Care Excellence (NICE) guidelines defining criteria for referral to secondary care nephrology services. Estimated glomerular filtration rate (eGFR) is commonly used to guide timing of referrals and preparation of patients approaching renal replacement therapy. However, eGFR lacks sensitivity for progression to end-stage renal failure; as a consequence, the international guideline group, Kidney Disease: Improving Global Outcomes has recommended the use of a risk calculator. The validated Kidney Failure Risk Equation may enable increased precision for the management of patients with CKD; however, there is little evidence to date for the implication of its use in routine clinical practice. This study will aim to determine the impact of the Kidney Failure Risk Equation on the redesignation of patients with CKD in the UK for referral to secondary care, compared with NICE CKD guidance.Method and analysisThis is a cross-sectional population-based observational study using The Health Improvement Network database to identify the impact of risk-based designation for referral into secondary care for patients with CKD in the UK. Adult patients registered in primary care and active in the database within the period 1 January 2016 to 31 March 2017 with confirmed CKD will be analysed. The proportion of patients who meet defined risk thresholds will be cross-referenced with the current NICE guideline recommendations for referral into secondary care along with an evaluation of urinary albumin–creatinine ratio monitoring.Ethics and disseminationApproval was granted by The Health Improvement Network Scientific Review Committee (Reference number: 18THIN061). Study outcomes will inform national and international guidelines including the next version of the NICE CKD guideline. Dissemination of findings will also be through publication in a peer-reviewed journal, presentation at conferences and inclusion in the core resources of the Think Kidneys programme.

Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology is used to assess and report certainty of evidence and strength of recommendations. This GRADE concept article is not GRADE guidance but introduces certainty of net benefit, defined as the certainty that the balance between desirable and undesirable health effects is favourable. Determining certainty of net benefit requires considering certainty of effect estimates, the expected importance of outcomes and variability in importance, and the interaction of these concepts. Certainty of net harm is the certainty that the net effect is unfavourable. Guideline panels using or testing this approach might limit strong recommendations to actions with a high certainty of net benefit or against actions with a moderate or high certainty of net harm. Recommendations may differ in direction or strength from that suggested by the certainty of net benefit or harm when influenced by cost, equity, acceptability or feasibility.

IntroductionThe occurrence of thyroid cancer is increasing throughout the developed world and since the 1990s has become the fastest increasing malignancy. In 2014, a total of 2693 Australians and 302 New Zealanders were diagnosed with thyroid cancer, with this number projected to rise to 3650 in 2018. The purpose of this protocol is to establish a binational population-based clinical quality registry with the aim of monitoring and improving the quality of care provided to patients diagnosed with thyroid cancer in Australia and New Zealand.Methods and analysisThe Australian and New Zealand Thyroid Cancer Registry (ANZTCR) aims to capture clinical data for all patients over the age of 16 years with thyroid cancer, confirmed by histopathology report, who have been diagnosed, assessed or treated at a contributing hospital. A multidisciplinary steering committee was formed which, with operational support from Monash University, established the ANZTCR in early 2017. The pilot phase of the registry is currently operating in Victoria, New South Wales, Queensland, Western Australia and South Australia, with over 20 sites expected to come on board across Australia in 2018. A modified Delphi process was undertaken to determine the clinical quality indicators to be reported by the registry, and a minimum data set was developed comprising information regarding thyroid cancer diagnosis, pathology, surgery and 90-day follow-up.Future plansThe establishment of the ANZTCR provides the opportunity for Australia and New Zealand to further understand current practice in the treatment of thyroid cancer and identify variation in outcomes. The engagement of endocrine surgeons in supporting this initiative is crucial. While the pilot registry has a focus on early clinical outcomes, it is anticipated that future collection of longer term outcome data particularly for patients with poor prognostic disease will add significant further value to the registry.

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

IntroductionChronic stress has adverse effects on health. Adults and children from low-income families are subject to multiple sources of stress. Existing literature about economic hardship mostly focuses on either adults or children but not both. Moreover, there is limited knowledge on the relationship between parental generalised stress and child health problems. This study aims to explore the bidirectional relationship between parental stress and child health in Chinese low-income families and to identify other modifiable factors influencing this relationship.Methods and analysisThis prospective cohort study will sample 254 low-income parent–child pairs and follow them up for 24 months with assessments at three time points (baseline, 12 and 24 months) on parental stress, health-related quality of life (HRQOL) and child health and behaviour using both subjective measures and objective physiological parameters. This study will collect data using standardised measures on HRQOL and behaviours of children as well as on HRQOL, mental health and stress levels of parents along with physiological tests of allostatic load and telomere length. The mediating or moderating effect of family harmony, parenting style and neighbourhood conditions will also be assessed. Data will be analysed using latent growth modelling and cross-lagged path analysis modelling to examine the bidirectional effect of parental stress and child health over time. Mediation and moderation analysis will also be conducted to examine the mechanism by which the variables relate.Ethics and disseminationThis study was approved by the institutional review board of the University of Hong Kong—the Hospital Authority Hong Kong West Cluster, reference no: UW 16-415. The study findings will be disseminated through peer-reviewed publications and international conferences.Trial registration numberNCT03185273; Pre-results.

INTRODUCTION: Across the globe, peer support groups have emerged as a community-led approach to accessing support and connecting with others with cancer experiences. Little is known about qualities required to lead a peer support group or how to determine suitability for the role. Organisations providing assistance to cancer support groups and their leaders are currently operating independently, without a standard national framework or published guidelines. This protocol describes the methods that will be used to generate pragmatic consensus-based minimum standards and an accessible structured interview with user manual to guide the selection and development of cancer support group leaders. METHODS AND ANALYSIS: We will: (A) identify and collate peer-reviewed literature that describes qualities of support group leaders through a systematic review; (B) content analyse eligible documents for information relevant to requisite knowledge, skills and attributes of group leaders generally and specifically to cancer support groups; (C) use an online reactive Delphi method with an interdisciplinary panel of experts to produce a clear, suitable, relevant and appropriate structured interview comprising a set of agreed questions with behaviourally anchored rating scales; (D) produce a user manual to facilitate standard delivery of the structured interview; (E) pilot the structured interview to improve clinical utility; and (F) field test the structured interview to develop a rational scoring model and provide a summary of existing group leader qualities. ETHICS AND DISSEMINATION: The study is approved by the Department Human Ethics Advisory Group of The University of Melbourne. The study is based on voluntary participation and informed written consent, with participants able to withdraw at any time. The results will be disseminated at research conferences and peer review journals. Presentations and free access to the developed structured interview and user manual will be available to cancer agencies.

ObjectivesDysfunction after transient ischaemic attack (TIA) and minor stroke is often underestimated by clinical measures. Patient-reported outcome measures used in value-based healthcare may help in detecting these problems. The Patient-Reported Outcomes Measurement Information System 10-Question Short Form (PROMIS-10 Global Health) is a concise patient-centred outcome measuring tool proposed for assessing health status in patients who had stroke. This study aims to address the validity of the Dutch PROMIS-10 in patients who had stroke in the Netherlands and also aims to compare telephone versus on-paper assessment.DesignObservational cohort study.SettingSingle-centre hospital in the Netherlands.Participants75 patients who were diagnosed with TIA or minor stroke and discharged without rehabilitation treatment 1 year ago (between December 2014 and January 2016) completed the study.Primary and secondary outcome measuresPROMIS-10 physical (PH) and mental health (MH) scores assessed 1 year poststroke on paper (n=37) and by telephone (n=38) was compared with RAND-36 physical and mental component scores assessed on paper.ResultsPROMIS-10 and RAND-36 correlated significantly in PH, r=0.81 (95% CI 0.69 to 0.88), and MH, r=0.76 (95% CI 0.64 to 0.85). Paper-and-pencil assessed correlations were r=0.87 and 0.79 for PH and MH, respectively. Telephone assessed correlations were r=0.76 and 0.73 for PH and MH, respectively. Internal consistency analysis indicated high reliabilities for both health components of the PROMIS-10, all Cronbach’s α>0.70.ConclusionsThe Dutch PROMIS-10 was found to strongly correlate with the RAND-36. Paper-and-pencil assessment was found to have a higher correlation than telephone assessment. This study provides support for the use of the Dutch PROMIS-10 in assessing health status in patients after TIA and minor stroke.

Introduction The overall aim of this project is to help develop knowledge about primary care delivery models likely to improve the accessibility, quality and efficiency of care. Operationally, this objective will be achieved through supporting and evaluating 8 primary care team pilot sites that rely on an expanded nursing role within a more intensive team-based, interdisciplinary setting. Methods and analysis The first research component is aimed at supporting the development and implementation of the pilot projects, and is divided into 2 parts. The first part is a logical analysis based on interpreting available scientific data to understand the causal processes by which the objectives of the intervention being studied may be achieved. The second part is a developmental evaluation to support teams in the field in a participatory manner and thereby learn from experience. Operationally, the developmental evaluation phase mainly involves semistructured interviews. The second component of the project design focuses on evaluating pilot project results and assessing their costs. This component is in turn made up of 2 parts. Part 1 is a pre-and-post survey of patients receiving the intervention care to analyse their care experience. In part 2, each patient enrolled in part 1 (around 4000 patients) will be matched with 2 patients followed within a traditional primary care model, so that a comparative analysis of the accessibility, quality and efficiency of the intervention can be performed. The cohorts formed in this way will be followed longitudinally for 4 years. Ethics and dissemination The project, as well as all consent forms and research tools, have been accepted by 2 health sciences research ethics committees. The procedures used will conform to best practices regarding the anonymity of patients.

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

IntroductionEvidence suggests bowel scope screening (BSS) can significantly reduce an individual’s risk of developing colorectal cancer (CRC). BSS for 55 year olds was therefore introduced to the English Bowel Cancer Screening Programme (BCSP) in 2013. However, the benefits are only gained from test completion and uptake is low (43%). Primary care involvement has consistently shown benefits to cancer screening uptake and so this study aims to build on this knowledge and evaluate general practitioner (GP) practice led interventions designed to increase BSS attendance.Methods and analysisA three-arm randomised controlled trial will be conducted to evaluate three interventions: one intervention for prospective BSS invitees (primer letter with locally tailored leaflet sent by an individual’s GP practice) and two interventions for those who do not attend their BSS appointment (a self-referral letter sent by an individual’s GP practice and a patient navigation call made on behalf of an individual’s GP practice). The trial will be set in Yorkshire. Individuals soon to receive their invitation to attend BSS at one of the Hull and East Yorkshire Bowel Cancer Screening centre sites, will be randomly assigned to one of three groups: control (usual care; no input from GP practice), Intervention group A (primer letter/leaflet and a self-referral letter), Intervention group B (primer letter/leaflet and a patient navigation call). Attendance data will be obtained from the BCSP database (via National Health Service (NHS) Digital) 3 months after the last intervention. Regression analysis will compare uptake, and additional clinical outcomes, across the three groups. The analysis will be multivariate and adjust for several covariates including gender and area-level deprivation.Ethics and disseminationNHS ethical approval has been obtained from London-Harrow Research Ethics Committee. The results will be submitted for publication in a peer-reviewed journal and presented at conferences.Trial registration numberISRCTN16252122; Pre-results.

ObjectiveAt the end of 2012, the Indonesian government enacted tobacco control regulation (PP 109/2012) that included stricter tobacco advertising, promotion and sponsorship (TAPS) controls. The PP did not ban all forms of TAPS and generated a great deal of media interest from both supporters and detractors. This study aims to analyse stakeholder arguments regarding the adoption and implementation of the regulation as presented through news media converge.DesignContent analysis of 213 news articles reporting on TAPS and the PP that were available from the Factiva database and the Google News search engine.SettingIndonesia, 24 December 2012–29 February 2016.MethodsArguments presented in the news article about the adoption and implementation of the PP were coded into 10 supportive and 9 opposed categories. The news actors presenting the arguments were also recorded. Kappa statistic were calculated for intercoder reliability.ResultsOf the 213 relevant news articles, 202 included stakeholder arguments, with a total of 436 arguments coded across the articles. More than two-thirds, 69% (301) of arguments were in support of the regulation, and of those, 32.6% (98) agreed that the implementation should be enhanced. Of 135 opposed arguments, the three most common were the potential decrease in government revenue at 26.7% (36), disadvantage to the tobacco industry at 18.5% (25) and concern for tobacco farmers and workers welfare at 11.1% (15). The majority of the in support arguments were made by national government, tobacco control advocates and journalists, while the tobacco industry made most opposing arguments.ConclusionsAnalysing the arguments and news actors provides a mapping of support and opposition to an essential tobacco control policy instrument. Advocates, especially in a fragmented and expansive geographic area like Indonesia, can use these findings to enhance local tobacco control efforts.

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

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

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

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

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

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

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

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

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

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

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

ObjectivesWhile the uptake of value-based health care (VBHC) is remarkable, uncertainty prevails regarding the most important actions and practices in establishing a value-based healthcare system. In this paper, we generate expert consensus on the most important aspects of VBHC.DesignThe Delphi technique was used to reach consensus on the most important practices in moving towards a value-based healthcare system.Setting and participantsA Dutch expert panel consisting of nine members participated in a two-round survey.Primary and secondary outcome measuresWe developed 39 initial items based on the pioneering literature on VBHC and recent health policies in the Netherlands. Experts rated the importance of each item on a 4-point Likert scale. Experts could change items or add new ones as they saw fit. We retained items that were rated (very) important by ≥80% of the panel.ResultsAfter two survey rounds, 32 items (72%) were included through expert consensus. Experts unanimously agree on the importance of shared decision-making, with this item uniquely obtaining the maximum score. Experts also reached consensus on the importance of outcome measurements, a focus on medical conditions, and full cycles of care. No consensus was reached on the importance of benchmarking.ConclusionThis paper provides new insight into the most important actions and practices for establishing a value-based healthcare system in the Netherlands. Interestingly, several of our findings contrast with the pioneering literature on VBHC. This raises the question whether VBHC’s widespread international uptake indicates its actual implementation, or rather that the original concept primarily serves as an inspiring idea.

ObjectivesExperience of intimate partner violence (IPV) is associated with adverse health and psychosocial outcomes for women. However, rigorous economic evaluations of interventions targeting IPV prevention are rare. This paper analyses the cost-effectiveness of Unite for a Better Life (UBL), a gender-transformative intervention designed to prevent IPV and HIV risk behaviours among men, women and couples.DesignWe use an economic evaluation nested within a large-scale cluster randomised controlled trial, analysing financial and economic costs tracked contemporaneously.SettingUBL was implemented in rural southern Ethiopia between 2013 and 2015.ParticipantsThe randomised controlled trial included 6770 households in 64 villages.InterventionsUBL is an intervention delivered within the context of the Ethiopian coffee ceremony, a culturally established forum for community discussion, and designed to assist participants to build skills for healthy, non-violent, equitable relationships.Primary and secondary outcome measuresThis paper reports on the unit cost and cost-effectiveness of the interventions implemented. Cost-effectiveness is measured as the cost per case of past-year physical and/or sexual IPV averted.ResultsThe estimated annualised cost of developing and implementing UBL was 2015 US$296 772, or approximately 2015 US$74 per individual directly participating in the intervention and 2015 US$5 per person annually for each community-level beneficiary (woman of reproductive age in intervention communities). The estimated cost per case of past-year physical and/or sexual IPV averted was 2015 US$2726 for the sample of direct beneficiaries, and 2015 US$194 for the sample of all community-level beneficiaries.ConclusionsUBL is an effective and cost-effective intervention for the prevention of IPV in a low and middle-income country setting. Further research should explore strategies to quantify the positive effects of the intervention across other domains.Trial registration numberNCT02311699 (ClinicalTrials.gov); AEARCTR-0000211 (AEA Registry)

IntroductionA physically active lifestyle during pregnancy improves maternal and offspring health but can be difficult to follow. In Denmark, less than 40% of pregnant women meet physical activity (PA) recommendations. The FitMum study aims to explore strategies to increase PA during pregnancy among women with low PA and assess the health effects of PA. This paper presents the FitMum protocol, which evaluates the effects of structured supervised exercise training or motivational counselling supported by health technology during pregnancy on PA level and health of mother and offspring.Methods and analysisA single-site three-arm randomised controlled trial that aims to recruit 220 healthy, pregnant women with gestational age (GA) no later than week 15 and whose PA level does not exceed one hour/week. Participants are randomised to one of three groups: structured supervised exercise training consisting of three weekly exercise sessions, motivational counselling supported by health technology or a control group receiving standard care. The interventions take place from randomisation until delivery. The primary outcome is min/week of moderate-to-vigorous intensity PA (MVPA) as determined by a commercial activity tracker, collected from randomisation until GA of 28 weeks and 0-6 days, and the secondary outcome is gestational weight gain (GWG). Additional outcomes are complementary measures of PA; clinical and psychological health parameters in participant, partner and offspring; analyses of blood, placenta and breastmilk samples; process evaluation of interventions; and personal understandings of PA.Ethics and disseminationThe study is approved by the Danish National Committee on Health Research Ethics (# H-18011067) and the Danish Data Protection Agency (# P-2019-512). Findings will be disseminated via peer-reviewed publications, at conferences, and to health professionals via science theatre performances.Trial registration numberNCT03679130.Protocol versionThis paper was written per the study protocol version 8 dated 28 August 2019.

IntroductionThis review will explore the characteristics of service delivery-related interventions to improve maternal and newborn health in low-income and middle-income countries, comparing three common framing approaches of these interventions (referred to as archetypes), namely, quality improvement (QI), health system strengthening (HSS) and implementation science (IS), over the last 20 years.Methods and analysisThis study will review the literature on health service interventions from 2000 to 2020. This will be achieved by searching for English peer-reviewed articles in the following electronic databases EBSCOhost, PubMed, Web of Science, MASCOT/Wotro Map of Maternal Health Research and Google scholar. We will develop a systematic search strategy using a combination of keywords and Boolean operators AND/OR. Eligibility screening and data extraction will be conducted by two independent reviewers, and disagreements resolved by a third independent reviewer. Analyses will be conducted in two steps, a quantitative and a qualitative phase. The quantitative phase will provide a descriptive profile of papers, including the category (QI, HSS, IS, mixed or other) of papers. In the follow-up qualitative phase, all three reviewers will independently code for key concepts in a subset of papers, jointly selected as representing each archetype, and analysed in batches until concept saturation is achieved.Ethics and disseminationThis review does not require ethical approval. The results will be published as an article in a peer-reviewed journal and presented to stakeholders involved in implementing health system interventions in maternal and newborn.

ObjectivesThe objective of this study was to systematically review and synthesise qualitative papers exploring views and experiences of acne and its treatments among people with acne, their carers and healthcare professionals (HCPs).DesignSystematic review and synthesis of qualitative papers.MethodsPapers were identified through Medline, EMBASE, PubMed, PsychINFO and CINAHL on 05 November 2019, forward and backward citation searching, Google Scholar and contacting authors. Inclusion criteria were studies reporting qualitative data and analysis, studies carried out among people with acne, their carers or HCPs and studies comprising different skin conditions, including acne. The title and abstracts of papers were independently screened by three researchers. Appraisal was carried out using the adapted Critical Appraisal Skills Programme tool. Thematic synthesis was used to synthesise findings.ResultsA total of 20 papers were included from six countries. Papers explored; experiences living with acne, psychosocial impact of acne, views on causation of acne, perceptions of acne treatments, ambivalence and ambiguity in young people’s experience of acne and HCPs’ attitudes towards acne management. Findings suggest that people often viewed acne as short-term and that this had implications for acne management, particularly long-term treatment adherence. People often felt that the substantial impact of acne was not recognised by others, or that their condition was ‘trivialised’ by HCPs. The sense of a lack of control over acne and control over treatment was linked to both psychological impact and treatment adherence. Concerns and uncertainty over acne treatments were influenced by variable advice and information from others.ConclusionsPeople need support with understanding the long-term management of acne, building control over acne and its treatments, acknowledging the impact and appropriate information to reduce the barriers to effective treatment use.PROSPERO registration numberCRD42016050525.

ObjectivesPeople with intellectual disability are vulnerable in terms of health service provision due to increased comorbidity, higher dependency and cognitive impairment. This review explored the literature to ascertain what reasonable adjustments are evident in acute care to support people with intellectual disability, ensuring they have fair access and utilisation of health services.DesignScoping review.SettingAcute care settings.MethodsFive databases were systematically searched to identify studies that reported on the implementation of reasonable adjustments. Authors worked in pairs to screen studies for inclusion, data were extracted and charted and findings were synthesised according to content and themes.ResultsOf the 7770 records identified, six studies were included in the review. The volume of evidence was influenced by specific inclusion criteria, and only papers that reported on the actual implementation of a reasonable adjustment within an acute care setting were included. Many papers reported on the concept of reasonable adjustment; however, few identified its applications in practice.ConclusionsThe scoping review highlights a lack of research on the practice and implementation of reasonable adjustments within acute care settings. There is a need for increased support, education and the provision of intellectual disability specialists across acute care settings.

ObjectiveTo identify the advantages and disadvantages that group practices have on patients, physicians and healthcare systems.Study designA scoping review was performed based on the methodology proposed by Arksey and O’Malley, and refined by Levac et al. Titles and abstracts were screened by two reviewers. A quantitative analysis was performed to assess the type, year and region of publication, as well as the population studied. A qualitative descriptive analysis was performed to identify common themes.Study settingMEDLINE, EMBASE and Cochrane databases were searched from database inception to October 2018 for papers which assessed outcomes relevant to the research question.ResultsOur search strategy returned 2408 papers and 98 were included in the final analysis. Most papers were from the USA, were surveys and assessed physician outcomes. Advantages of group practices for patients included improved satisfaction and quality of care. Studies of physicians reported improved quality of life and income, while disadvantages included increased stress due to poor interpersonal relationships. Studies of healthcare systems reported improved efficiency and better utilisation of resources.ConclusionsGroup practices have many benefits for patients and physicians. However, further work needs to be done assessing patient outcomes and establishing the elements that make a group practice successful.

IntroductionPatient-centred care is pivotal to clinical practice and medical education. The practice of evidence-based medicine (EBM) and shared decision-making (SDM) are complementary aspects of patient-centred care, but they are frequently taught and reported as independent entities. To effectively perform all steps of EBM, clinicians need to include patients in SDM conversations, however, the uptake of this has been slow and inconsistent. A solution may be the incorporation of SDM into EBM training programmes, but such programmes do not routinely include SDM skills development. This scoping review will survey the literature on the kinds of EBM and SDM educational programmes that exist for recently qualified doctors, programmes that incorporate the teaching of both EBM and SDM skills, as well as identifying research gaps in the literature.Methods and analysisLiterature searches will be conducted in the databases Medline, Embase, Scopus and Cochrane Library. Bibliographies of key articles and their citing references will also be hand-searched and assessed for inclusion. Selected grey literature will be included. Papers must be written in English, or provide English abstracts, and date from 1996 to the present day.Two independent reviewers will screen titles and abstracts, check full texts of selected papers for eligibility and extract the data. Any disagreement will be resolved, and consensus reached, if necessary, with the assistance of a third reviewer. Qualitative and quantitative studies that address educational interventions for either EBM, SDM or both will be included. Data extraction tables will present bibliographic information, populations, interventions, context and outcomes. Data will be summarised using tables and figures and a description of findings.Ethics and disseminationThis review will synthesise information from publicly available publications and does not require ethics approval. The results will be disseminated via conference presentations and publications in medical journals.

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

As currently conceived, precision public health is at risk of becoming precision medicine at a population level. This paper outlines a framework for precision public health that, in contrast to its current operationalisation, is consistent with public health principles because it integrates factors at all levels, while illuminating social position as a fundamental determinant of health and health inequities. We review conceptual foundations of public health, outline a proposed framework for precision public health and describe its operationalisation within research and practice. Social position shapes individuals’ unequal experiences of the social determinants of health. Thus, in our formulation, precision public health investigates how multiple dimensions of social position interact to confer health risk differently for precisely defined population subgroups according to the social contexts in which they are embedded, while considering relevant biological and behavioural factors. It leverages this information to uncover the precise and intersecting social structures that pattern health outcomes, and to identify actionable interventions within the social contexts of affected groups. We contend that studies informed by this framework offer greater potential to improve health than current conceptualisations of precision public health that do not address root causes. Moreover, expanding beyond master categories of social position and operationalising these categories in more precise ways across time and place can enrich public health research through greater attention to the heterogeneity of social positions, their causes and health effects, leading to the identification of points of intervention that are specific enough to be useful in reducing health inequities. Failure to attend to this level of particularity may mask the true nature of health risk, the causal mechanisms at play and appropriate interventions. Conceptualised thus, precision public health is a research endeavour with much to offer by way of understanding and intervening on the causes of poor health and health inequities.As currently conceived, precision public health is at risk of becoming precision medicine at a population level. This paper outlines a framework for precision public health that, in contrast to its current operationalization, is consistent with public health principles because it integrates factors at all levels, while illuminating social position as a fundamental determinant of health and health inequities. We review conceptual foundations of public health, outline a proposed framework for precision public health and describe its operationalization within research and practice. Social position shapes individuals’ unequal experiences of the social determinants of health. Thus, in our formulation, precision public health investigates how multiple dimensions of social position interact to confer health risk differently for precisely defined population subgroups according to the social contexts in which they are embedded, while considering relevant biological and behavioural factors. It leverages this information to uncover the precise and intersecting social structures that pattern health outcomes, and to identify actionable interventions within the social contexts of affected groups. We contend that studies informed by this framework offer greater potential to improve health than current conceptualizations of precision public health that do not address root causes. Moreover, expanding beyond master categories of social position and operationalizing these categories in more precise ways across time and place can enrich public health research through greater attention to the heterogeneity of social positions, their causes and health effects, leading to identification of points of intervention that are specific enough to be useful in reducing health inequities. Failure to attend to this level of particularity may mask the true nature of health risk, the causal mechanisms at play and appropriate interventions. Conceptualized thus, precision public health is a research endeavour with much to offer by way of understanding and intervening on the causes of poor health and health inequities.

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.

ObjectiveUsing meta-regression this paper sets out the minimum change in body mass index-SD score (BMI-SDS) required to improve adiposity as percentage body fat for children and adolescents with obesity.DesignMeta-regression.SettingStudies were identified as part of a large-scale systematic review of the following electronic databases: AMED, Embase, MEDLINE via OVID, Web of Science and CENTRAL via Cochrane library.ParticipantsIndividuals aged 4–19 years with a diagnosis of obesity according to defined BMI thresholds.InterventionsStudies of lifestyle treatment interventions that included dietary, physical activity and/or behavioural components with the objective of reducing obesity were included. Interventions of Primary and secondary outcome measuresTo be included in the review, studies had to report baseline and post-intervention BMI-SDS or change measurements (primary outcome measures) plus one or more of the following markers of metabolic health (secondary outcome measures): adiposity measures other than BMI; blood pressure; glucose; inflammation; insulin sensitivity/resistance; lipid profile; liver function. This paper focuses on adiposity measures only. Further papers in this series will report on other outcome measures.ResultsThis paper explores the potential impact of BMI-SDS reduction in terms of change in percentage body fat. Thirty-nine studies reporting change in mean percentage body fat were analysed. Meta-regression demonstrated that reduction of at least 0.6 in mean BMI-SDS ensured a mean reduction of percentage body fat mass, in the sense that the associated 95% prediction interval for change in mean percentage body fat was wholly negative.ConclusionsInterventions demonstrating reductions of 0.6 BMI-SDS might be termed successful in reducing adiposity, a key purpose of weight management interventions.Trial registration numberCRD42016025317.

ObjectiveThe objective of the paper was to investigate the spatial distribution and correlates of tobacco smoking in various regions of Zambia.MethodsThis paper adopts a cross-sectional study design. The study used data from the 2013/2014 Zambia Demographic Health Survey which is a nationwide health survey conducted in all the 10 provinces. A random sample of men and women from 15 920 households was successfully selected and interviewed. All women aged 15–49 and men aged 15–59 who were either permanent residents of the households or visitors present in the households on the night before the survey were eligible to be interviewed.ResultsThe results show that 8.2% and 11% of Zambians in urban and rural areas smoke, respectively. In urban areas, the risk of being a cigarette smoker was 2.31 (CI: 1.69 to 3.16) and 2.03 (CI: 1.36 to 3.02) times higher for the divorced and separated. However, the risk of being a cigarette smoker was lower for those with some formal education. In rural areas, the risk of being a cigarette smoker was lower for the married (relative risk ratios (RRR): 0.69, CI: 0.55 to 0.86) and those with a formal education. Nevertheless, in rural areas, the risk of being a pipe and other smoker was higher for those who were self-employed (RRR: 8.46, CI: 2.95 to 24.20) and with an occupation (RRR: 2.37, CI: 1.39 to 4.02) but was lower among women.ConclusionTobacco smoking varies between and within regions as well as provinces. Therefore, interventions to curbsmoking should target specific demographic, socioeconomic and cultural factors and how they are spatially distributed.

ObjectiveTo identify and synthesise existing literature exploring the impact of relational and informational continuity of care on preferred place of death, hospital admissions and satisfaction for palliative care patients in qualitative, quantitative and mixed methods literature.DesignA mixed methods rapid review.MethodsPUBMED, PsychINFO, CINAHL were searched from June 2008 to June 2018 in order to identify original peer reviewed, primary qualitative, quantitative or mixed methods research exploring the impact of continuity of care for people receiving palliative care. Synthesis methods as outlined by the Cochrane Qualitative and Implementation Methods Group were applied to qualitative studies while meta-analyses for quantitative data were planned.OutcomesThe impact of interventions designed to promote continuity of care for people receiving palliative care on the following outcomes was explored: achieving preferred place of death, satisfaction with care and avoidable hospital admissions.Results18 eligible papers were identified (11 qualitative, 6 quantitative and 1 mixed methods papers). In all, 1951 patients and 190 family caregivers were recruited across included studies. Meta-analyses were not possible due to heterogeneity in outcome measures and tools used. Two studies described positive impact on facilitating preferred place of death. Four described a reduction in avoidable hospital admissions. No negative impacts of interventions designed to promote continuity were reported. Patient satisfaction was not assessed in quantitative studies. Participants described a significant impact on their experiences as a result of the lack of informational and relational continuity.ConclusionsThis rapid review highlights the impact that continuity of care can have on the experiences of patients receiving palliative care. The evidence for the impact of continuity on place of death and hospital admissions is limited. Methods for enhancing, and recording continuity should be considered in the design and development of future healthcare interventions to support people receiving palliative care.

ObjectiveTo assess the magnitude of suicide rates in the first week and first month postdischarge following psychiatric hospitalisation.DesignMeta-analysis of relevant English-language, peer-reviewed papers published in MEDLINE, PsycINFO or Embase between 01 January 1945 and 31 March 2017 and supplemented by hand searching and personal communication. A generalised linear effects model was fitted to the number of suicides, with a Poisson distribution, log link and log of person years as an offset. A random effects model was used to calculate the overall pooled rates and within subgroups in sensitivity analyses.Outcome measuresSuicides per 100 000 person years in the first week and the first month after discharge from psychiatric hospitalisation.ResultsThirty-four included papers comprised 29 studies that reported suicides in the first month postdischarge (3551 suicides during 222 546 patient years) and 24 studies that reported suicides in the first week postdischarge (1928 suicides during 60 880 patient years). The pooled estimate of the suicide rate in the first month postdischarge suicide was 2060 per 100 000 person years (95% CI=1300 to 3280, I2=90). The pooled estimate of the suicide rate in the first week postdischarge suicide was 2950 suicides per 100 000 person years (95% CI=1740 to 5000, I2=88). Eight studies that were included after personal communication had lower pooled rates of suicide than studies included after data extraction and there was evidence of publication bias towards papers reporting a higher rate of postdischarge suicide.ConclusionAcknowledging the presence of marked heterogeneity between studies and the likelihood of bias towards publication of studies reporting a higher postdischarge suicide rate, the first week and first month postdischarge following psychiatric hospitalisation are periods of extraordinary suicide risk. Short-term follow-up of discharged patients should be augmented with greater focus on safe transition from hospital to community care.PROSPERO registration numberPROSPERO registration CRD42016038169

ObjectivesThe objective of this study is to investigate whether papers reporting research on Chinese transplant recipients comply with international professional standards aimed at excluding publication of research that: (1) involves any biological material from executed prisoners; (2) lacks Institutional Review Board (IRB) approval and (3) lacks consent of donors.DesignScoping review based on Arksey and O’Mallee’s methodological framework.Data sourcesMedline, Scopus and Embase were searched from January 2000 to April 2017.Eligibility criteriaWe included research papers published in peer-reviewed English-language journals reporting on outcomes of research involving recipients of transplanted hearts, livers or lungs in mainland China.Data extraction and synthesisData were extracted by individual authors working independently following training and benchmarking. Descriptive statistics were compiled using Excel.Results445 included studies reported on outcomes of 85 477 transplants. 412 (92.5%) failed to report whether or not organs were sourced from executed prisoners; and 439 (99%) failed to report that organ sources gave consent for transplantation. In contrast, 324 (73%) reported approval from an IRB. Of the papers claiming that no prisoners’ organs were involved in the transplants, 19 of them involved 2688 transplants that took place prior to 2010, when there was no volunteer donor programme in China.DiscussionThe transplant research community has failed to implement ethical standards banning publication of research using material from executed prisoners. As a result, a large body of unethical research now exists, raising issues of complicity and moral hazard to the extent that the transplant community uses and benefits from the results of this research. We call for retraction of this literature pending investigation of individual papers.

ObjectiveLack of access to mental health services during the perinatal period is a significant public health concern in the UK. Barriers to accessing services may occur at multiple points in the care pathway. However, no previous reviews have investigated multilevel system barriers or how they might interact to prevent women from accessing services. This review examines women, their family members’ and healthcare providers’ perspectives of barriers to accessing mental health services for women with perinatal mental illness in the UK.DesignA systematic review and meta-synthesis of qualitative studies.Data sourcesQualitative studies, published between January 2007 and September 2018, were identified in MEDLINE, PsycINFO, EMBASE and CINAHL electronic databases, handsearching of reference lists and citation tracking of included studies. Papers eligible for inclusion were conducted in the UK, used qualitative methods and were focused on women, family or healthcare providers working with/or at risk of perinatal mental health conditions. Quality assessment was conducted using the Critical Appraisal Skills Programme for qualitative studies.ResultsOf 9882 papers identified, 35 studies met the inclusion criteria. Reporting of emergent themes was informed by an existing multilevel conceptual model. Barriers to accessing mental health services for women with perinatal mental illness were identified at four levels: Individual (eg, stigma, poor awareness), organisational (eg, resource inadequacies, service fragmentation), sociocultural (eg, language/cultural barriers) and structural (eg, unclear policy) levels.ConclusionsComplex, interlinking, multilevel barriers to accessing mental health services for women with perinatal mental illness exist. To improve access to mental healthcare for women with perinatal mental illness multilevel strategies are recommended which address individual, organisational, sociocultural and structural-level barriers at different stages of the care pathway.PROSPERO registration numberCRD42017060389.

ObjectivesThis paper describes the systematic development and piloting of a highly tailored text and voice message intervention to increase adherence to medication in primary care.MethodsFollowing the Medical Research Council guidance, this paper describes (a) the systematic development of the theoretical framework, based on review of theories and meta-analyses of effectiveness; (b) the systematic development of the delivery mode, intervention content and implementation procedures, based on consultations, face-to-face interviews, think-aloud protocols, focus groups, systematic reviews, patient and public involvement/engagement input, intervention pre-test; and (c) the piloting of the intervention, based on a 1-month intervention; and follow-up assessment including interviews and questionnaires. The mixed-methods analysis combined findings from the parallel studies complementarily.Resultsintervention development suggested the target behaviour of the intervention should be the tablets taken at a regular time of the day. It recommended that patients could be more receptive to intervention content when they initiate medication taking or they change prescription plan; and more emphasis is needed to patients’ consent process. Intervention piloting suggested high intervention engagement with, and fidelity of, the intervention content; which included a combination of behaviour change techniques, and was highly tailored to patients’ beliefs and prescription plan. Patients reported that the intervention content increased awareness about the necessity to take and maintain adherent to medication, reinforced social support and habit formation, and reminded them to take medication as prescribed.ConclusionTailored automated text and voice message interventions are feasible ways to improve medication adherence as an adjunct to primary care.Trial registration numberISRCTN10668149.

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

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