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Introduction: Aboriginal and Torres Strait Islander peoples are the First Peoples of Australia. Up to 45% of dementia in these populations is due to potentially modifiable risk factors. The Dementia Prevention and Risk Management Program for Aboriginal Australians (DAMPAA) is an Aboriginal Health Practitioner led programme that aims to reduce cognitive decline and functional impairment in older Aboriginal people., Methods: Design: DAMPAA is a multisite, randomised controlled trial aiming to deliver and evaluate a culturally appropriate risk factor management programme., Population: Community-dwelling Aboriginal people aged 45-90 years., Intervention: Participants will be randomly assigned to either usual care (control) or to a group programme comprising exercise and health education yarning sessions and pharmacist-delivered medication reviews delivered over a 12-month period., Primary Outcome: Cognitive function (Kimberley Indigenous Cognitive Assessment (KICA)-Cog score), daily function (KICA-Activities of Daily Living (ADL) score) and quality of life (Good Spirit, Good Life and EQ-5D-5L scores)., Secondary Outcomes: Process evaluation interviews, cardiovascular risk factors, falls and death. Process evaluation will be conducted with qualitative methods. Quantitative outcomes will be analysed with generalised linear mixed models., Ethics and Dissemination: The study was approved by the Western Australian Aboriginal Health Ethics Committee and the University of Western Australia Human Research Ethics Committee. Study results will be published in peer-reviewed journals and presented at scientific meetings. We will also develop and disseminate a comprehensive DAMPAA toolkit for health services. The study's findings will guide future prevention strategies and outline a comprehensive process evaluation that may be useful in other Aboriginal health research to contextualise findings., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Introduction Aboriginal and Torres Strait Islander peoples are the First Peoples of Australia. Up to 45% of dementia in these populations is due to potentially modifiable risk factors. The Dementia Prevention and Risk Management Program for Aboriginal Australians (DAMPAA) is an Aboriginal Health Practitioner led programme that aims to reduce cognitive decline and functional impairment in older Aboriginal people.Methods Design: DAMPAA is a multisite, randomised controlled trial aiming to deliver and evaluate a culturally appropriate risk factor management programme. Population: Community-dwelling Aboriginal people aged 45–90 years. Intervention: Participants will be randomly assigned to either usual care (control) or to a group programme comprising exercise and health education yarning sessions and pharmacist-delivered medication reviews delivered over a 12-month period. Primary outcome: Cognitive function (Kimberley Indigenous Cognitive Assessment (KICA)-Cog score), daily function (KICA-Activities of Daily Living (ADL) score) and quality of life (Good Spirit, Good Life and EQ-5D-5L scores). Secondary outcomes: Process evaluation interviews, cardiovascular risk factors, falls and death. Process evaluation will be conducted with qualitative methods. Quantitative outcomes will be analysed with generalised linear mixed models.Ethics and dissemination The study was approved by the Western Australian Aboriginal Health Ethics Committee and the University of Western Australia Human Research Ethics Committee. Study results will be published in peer-reviewed journals and presented at scientific meetings. We will also develop and disseminate a comprehensive DAMPAA toolkit for health services. The study’s findings will guide future prevention strategies and outline a comprehensive process evaluation that may be useful in other Aboriginal health research to contextualise findings.

Introduction: Hyperlipidaemia contributes a significant proportion of modifiable cardiovascular disease (CVD) risk, which is a condition that disproportionally affects disadvantaged socioeconomic communities, with death rates in the most deprived areas being four times higher than those in the least deprived. With the national CVD Prevention programme being delivered to minimise risk factors, no evidence is available on what has been implemented in primary care for deprived populations. This study describes the protocol for the development of a tailored intervention aiming to optimise lipid management in primary care settings to help reduce inequalities in CVD risks and improve outcomes in deprived communities., Methods and Analysis: A mixed-methods approach will be employed consisting of four work packages: (1) rapid review and logic model; (2) assessment and comparison of CVD risk management for deprived with non-deprived populations in Northern England to England overall; (3) interviews with health professionals; and (4) intervention development. A systematic search and narrative synthesis will be undertaken to identify evidence-based interventions and targeted outcomes in deprived areas. General practice-level data will be assessed to establish the profile of lipid management, compared with the regional and national levels. Health professionals involved in the organisation and delivery of routine lipid management to deprived populations will be interviewed to understand the implementation and delivery of current lipid management and associated challenges. The prototype intervention will be informed by the evidence generated from workpackages 1-3, which will be reviewed and assessed using the nominal group technique to reach consensus. Training and skills development materials will also be developed as needed., Ethics and Dissemination: Ethics approval has been obtained from the Faculty of Medical Sciences Research Ethics Committee at Newcastle University, UK. Findings will be disseminated to the participating sites, participants, commissioners, and in peer-reviewed journals and academic conferences., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.)

Introduction: The postdischarge suicide risk among psychiatric patients is significantly higher than it is among patients with other diseases and general population. The brief contact interventions (BCIs) are recommended to decrease suicide risk in areas with limited mental health service resources like China. This study aims to develop a postdischarge suicide intervention strategy based on BCIs and evaluate its implementability under the implementation outcome framework., Methods and Analysis: This study will invite psychiatric patients and family members, clinical and community mental health service providers as the community team to develop a postdischarge suicide intervention strategy. The study will recruit 312 patients with psychotic symptoms and 312 patients with major depressive disorder discharged from Shenzhen Kangning Hospital (SKH) in a Sequential Multiple Assignment Randomised Trial. Participants will be initially randomised into two intervention groups to receive BCIs monthly and weekly, and they will be rerandomised into three intervention groups to receive BCIs monthly, biweekly and weekly at 3 months after discharge according to the change of their suicide risk. Follow-ups are scheduled at 1, 3, 6 and 12 months after discharge. With the intention-to-treat approach, generalised estimating equation and survival analysis will be applied. This study will also collect qualitative and quantitative information on implementation and service outcomes from the community team., Ethics/dissemination: This study has received ethical approval from the Ethics Committee Review Board of SKH. All participants will provide written informed consent prior to enrolment. The findings of the study will be disseminated through peer-reviewed scientific journals, conference presentations. A project report will be submitted to the National Natural Science Foundation of China as the concluding report of this funded project, and to the mental health authorities in the Shenzhen to refine and apply evidence-based and pragmatic interventions into health systems for postdischarge suicide prevention., Trial Registration Number: NCT04907669., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction Hyperlipidaemia contributes a significant proportion of modifiable cardiovascular disease (CVD) risk, which is a condition that disproportionally affects disadvantaged socioeconomic communities, with death rates in the most deprived areas being four times higher than those in the least deprived. With the national CVD Prevention programme being delivered to minimise risk factors, no evidence is available on what has been implemented in primary care for deprived populations. This study describes the protocol for the development of a tailored intervention aiming to optimise lipid management in primary care settings to help reduce inequalities in CVD risks and improve outcomes in deprived communities.Methods and analysis A mixed-methods approach will be employed consisting of four work packages: (1) rapid review and logic model; (2) assessment and comparison of CVD risk management for deprived with non-deprived populations in Northern England to England overall; (3) interviews with health professionals; and (4) intervention development. A systematic search and narrative synthesis will be undertaken to identify evidence-based interventions and targeted outcomes in deprived areas. General practice-level data will be assessed to establish the profile of lipid management, compared with the regional and national levels. Health professionals involved in the organisation and delivery of routine lipid management to deprived populations will be interviewed to understand the implementation and delivery of current lipid management and associated challenges. The prototype intervention will be informed by the evidence generated from workpackages 1–3, which will be reviewed and assessed using the nominal group technique to reach consensus. Training and skills development materials will also be developed as needed.Ethics and dissemination Ethics approval has been obtained from the Faculty of Medical Sciences Research Ethics Committee at Newcastle University, UK. Findings will be disseminated to the participating sites, participants, commissioners, and in peer-reviewed journals and academic conferences.

Introduction: Stroke is a leading cause of death and disability. The development of dementia after stroke is common. Vascular risk factors (VRF) which contribute to stroke risk can also contribute to cognitive decline, especially in vascular dementia (VaD). There is no established treatment for VaD, therefore strategies for prevention could have major health resource implications. This study was designed to assess whether patients with early cognitive decline after stroke/transient ischaemic attack (TIA) can be easily identified and whether target-driven VRF management can prevent progression to dementia., Objectives: The primary objective is to establish the feasibility of recruitment and retention of patients with early cognitive decline to a randomised controlled trial of enhanced VRF management. Secondary objectives include: (a) to determine the potential clinical benefit of the intervention; (b) to estimate the sample size for a future definitive multicentre randomised controlled trial; (c) to inform a future economic evaluation; (d) to explore the link between VRF control and the incidence of cognitive impairment on longitudinal follow-up in a UK population after stroke/TIA with current routine management., Methods: 100 patients with cognitive decline poststroke/TIA will be recruited from stroke services at the Norfolk and Norwich University Hospital. After collection of baseline data, they will be randomised to intervention (3 monthly follow-up with enhanced management) or control (treatment as usual by the general practitioner). At 12 months outcomes (repeat cognitive testing, VRF assessment) will be assessed. A further 100 patients without cognitive decline will be recruited to a parallel observational group from the same site. At 12 months they will have repeat cognitive testing., Ethics and Dissemination: Ethical approval has been granted in England. Dissemination is planned via publication in peer-reviewed medical journals and presentation at relevant conferences., Trial Registration Number: 42688361; Pre-results., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Objectives: To use Population Health Management (PHM) methods to identify and characterise individuals at high-risk of severe COVID-19 for which shielding is required, for the purposes of managing ongoing health needs and mitigating potential shielding-induced harm., Design: Individuals at 'high risk' of COVID-19 were identified using the published national 'Shielded Patient List' criteria. Individual-level information, including current chronic conditions, historical healthcare utilisation and demographic and socioeconomic status, was used for descriptive analyses of this group using PHM methods. Segmentation used k-prototypes cluster analysis., Setting: A major healthcare system in the South West of England, for which linked primary, secondary, community and mental health data are available in a system-wide dataset. The study was performed at a time considered to be relatively early in the COVID-19 pandemic in the UK., Participants: 1 013 940 individuals from 78 contributing general practices., Results: Compared with the groups considered at 'low' and 'moderate' risk (ie, eligible for the annual influenza vaccination), individuals at high risk were older (median age: 68 years (IQR: 55-77 years), cf 30 years (18-44 years) and 63 years (38-73 years), respectively), with more primary care/community contacts in the previous year (median contacts: 5 (2-10), cf 0 (0-2) and 2 (0-5)) and had a higher burden of comorbidity (median Charlson Score: 4 (3-6), cf 0 (0-0) and 2 (1-4)). Geospatial analyses revealed that 3.3% of rural and semi-rural residents were in the high-risk group compared with 2.91% of urban and inner-city residents (p<0.001). Segmentation uncovered six distinct clusters comprising the high-risk population, with key differentiation based on age and the presence of cancer, respiratory, and mental health conditions., Conclusions: PHM methods are useful in characterising the needs of individuals requiring shielding. Segmentation of the high-risk population identified groups with distinct characteristics that may benefit from a more tailored response from health and care providers and policy-makers., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.)

Objectives: COVID-19 presents a risk of infection and transmission for operating theatre teams. Guidelines to protect patients and staff emerged and changed rapidly based on expert opinion and limited evidence. This paper presents the experiences and innovations developed by international surgical teams during the early stages of the pandemic to attempt to mitigate risk., Design: In-depth, semistructured interviews were audio recorded, transcribed and analysed thematically using methods of constant comparison., Participants: 43 participants, including surgeons from a range of specialties (primarily general surgery, otolaryngology, neurosurgery, cardiothoracic and ophthalmology), anaesthetists and those in nursing roles., Setting: The UK, Italy, Spain, the USA, China and New Zealand between March and May 2020., Results: Surgical teams sought to mitigate COVID-19 risks by modifying their current practice with an abundance of strategies and innovations. Communication and teamwork played an integral role in how teams adapted, although participants reflected on the challenges of having to improvise in real time. Uncertainties remained about optimal surgical practice and there were significant tensions where teams were forced to balance what was best for patients while contemplating their own safety., Conclusions: The perceptions of risks during a pandemic such as COVID-19 can be complex and context dependent. Management of these risks in surgery must be driven by evidence-based practice resulting from a pragmatic and novel approach to collation of global evidence. The context of surgery has changed dramatically, and surgical teams have developed a plethora of innovations. There is an urgent need for high-quality evidence to inform surgical practice that optimises the safety of both patients and healthcare professionals as the COVID-19 pandemic unfolds., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.)

Objectives: To explore relevant Finnish stakeholders' perceptions on the automatic substitution of biological medicines with particular focus on medication safety and issues that need to be considered to create an appropriate model for automatic biological product substitution., Design: Qualitative interview study., Methods: Data were collected in semistructured individual (n=17), pair (n=7) and group (n=8) interviews (32 interviews, 62 participants) in 2018. Participants represented a wide range of stakeholders involved in the pharmacotherapy process: community pharmacists (n=8 interviews), authorities (n=7), prescribers (n=7), pharmaceutical industry and wholesalers (n=6), patients/customers (n=2), hospital pharmacists (n=1) and nurses (n=1). Inductive content analysis was performed., Results: Benefits of automatic substitution were identified as cost savings, more patients receiving biological treatments and enhanced continuity of treatment. Six major risk categories were identified: (1) the patient's medication is interrupted or complicated temporarily or permanently, (2) the patient uses two products with the same active substance, (3) the traceability of the product is compromised, (4) the patient cannot get into healthcare in case of problems, (5) the patient does not receive substitution-related advice from a pharmacy and (6) the patient is distracted by the support material he/she receives. Several risk mitigation measures were commonly mentioned: medication and device counselling by pharmacists (n=23), infrequent substitution interval (n=15) and better knowledge on biosimilars among healthcare providers (n=13)., Conclusion: Automatic substitution of biologics is associated with risks that should be prospectively managed before implementing the procedure. The substitution also introduces new tasks and communication needs to those involved in actual medication use process, particularly to community pharmacists who will be responsible for substitution and counselling the patients., Competing Interests: Competing interests: HMT has participated in a congress for which participation fee was sponsored by Roche Oy., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: To assess developments over time in the capture, curation and use of quality and safety information in managing hospital services., Setting: Four acute National Health Service hospitals in England., Participants: 111.5 hours of observation of hospital board and directorate meetings, and 72 hours of ward observations. 86 interviews with board level and middle managers and with ward managers and staff., Results: There were substantial improvements in the quantity and quality of data produced for boards and middle managers between 2013 and 2016, starting from a low base. All four hospitals deployed data warehouses, repositories where datasets from otherwise disparate departmental systems could be managed. Three of them deployed real-time ward management systems, which were used extensively by nurses and other staff., Conclusions: The findings, particularly relating to the deployment of real-time ward management systems, are a corrective to the many negative accounts of information technology implementations. The hospital information infrastructures were elements in a wider move, away from a reliance on individual professionals exercising judgements and towards team-based and data-driven approaches to the active management of risks. They were not, though, using their fine-grained data to develop ultrasafe working practices., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY. Published by BMJ.)

Introduction: Hospitalised patients with nasogastric/nasoenteric tube (NGT/NET) are at constant risk of incidents; therefore, healthcare professionals need to routinely monitor risks and adopt strategies for patient safety and quality of care., Aim: This study aimed to evaluate the NGT/NET-related incidents in hospitalised patients and associated factors., Methods: This is a multicentre study, with a prospective cohort design. Data will be collected at the general medical ward of seven Brazilian hospitals in the north, northeast, southeast and south. The sample will consist of 391 patients that require an NGT/NET during hospitalisation. Three different methods will be used to identify the incidents: (1) healthcare professionals and patients/caregivers will be required to report any NGT/NET-related incidents; (2) researchers will visit the wards to get information about the incidents with healthcare professionals and patients/caregivers; (3) the researchers will review the medical records looking for information on the occurrence of any NGT/NET-related incidents. Demographic, clinical and therapeutic details will be obtained from the medical records and will be registered in an electronic data collection tool developed for the purposes of this study. The complexity of patients will be assessed by the Patient Classification System, and the severity of comorbid diseases will be assessed through the Charlson Comorbidity Index., Implication for Practice: The results may encourage the use of evidence effectively to influence the scientific foundation for clinical practice and the development of evidence-based policies that will prevent, manage and eliminate complications caused by NGT/NET-related incidents, and improve the quality and safety of care provided to hospitalised patients., Ethics and Dissemination: The study has been approved by the Research Ethics Committee. Detailed information about the study can be provided by the principal investigator. The findings will be reported through academic journals, seminar and conference presentations, social media, print media, the internet and community/stakeholder engagement activities., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: The Medical Protection Society (MPS) is a leading protection organisation for healthcare professionals worldwide. In the UK and Ireland, a small minority of MPS members experience significantly more medicolegal cases than their peers and are invited to participate in a risk education (RE) remediation process. To understand more about this educational intervention, we sought to explore participating doctors' views of their experiences of this process and identify self-reported performance improvements and what elements of the intervention could be improved., Design: Qualitative semistructured telephone interviews with a convenience sample of doctors with significantly more medicolegal cases than their peers identified by MPS., Setting: UK and Ireland MPS members., Participants: A convenience sample of 20 general medical practitioners and hospital specialists from a total of 79 who completed the RE process (25.3% response rate), with a particular focus on the Member Risk Review programme, between November 2013 and October 2015., Results: 19 participants were male and 16 were based in general medical (office) practice. Three key themes were generated: personal and professional impacts and actions (eg, member has taken action to reduce clinical workload); comprehension and validity of RE interventions (eg, risks were related to wider patient management); and feedback and proposals (eg, the supportive nature of the educational interventions should be clear from the start). A number of recommendations were made by participants to improve the RE process and enhance the educational experience., Conclusions: The RE process was largely valued by participants with many reporting that participation led to some positive professional behaviour changes and improvements in practice processes and personal well-being., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

IntroductionDiagnostic processes in the emergency department (ED) involve multiple interactions among individuals who interface with information systems to access and record information. A better understanding of diagnostic processes is needed to mitigate errors. This paper describes a study protocol to map diagnostic processes in the ED as a foundation for developing future error mitigation strategies.Methods and analysisThis study of an adult and a paediatric academic ED uses a prospective mixed methods case study design informed by an ED-specific diagnostic decision-making model (the modified ED-National Academies of Sciences, Engineering and Medicine (NASEM) model) and two cognitive theories (dual process theory and distributed cognition). Data sources include audio recordings of patient and care team interactions, electronic health record data, observer field notes and stakeholder interviews. Multiple qualitative analysis methods will be used to explore diagnostic processes in situ, including systems information flow, human-human and human-system interactions and contextual factors influencing cognition. The study has three parts. Part 1 involves prospective field observations of patients with undifferentiated symptoms at high risk for diagnostic error, where each patient is followed throughout the entire care delivery process. Part 2 involves observing individual care team providers over a 4-hour window to capture their diagnostic workflow, team coordination and communication across multiple patients. Part 3 uses interviews with key stakeholders to understand different perspectives on the diagnostic process, as well as perceived strengths and vulnerabilities, in order to enrich the ED-NASEM diagnostic model.Ethics and disseminationThe University of Michigan Institutional Review Board approved this study, HUM00156261. This foundational work will help identify strengths and vulnerabilities in diagnostic processes. Further, it will inform the future development and testing of patient, provider and systems-level interventions for mitigating error and improving patient safety in these and other EDs. The work will be disseminated through journal publications and presentations at national and international meetings.

Objectives: The development and implementation of incident reporting systems within healthcare continues to be a fundamental strategy to reduce preventable patient harm and improve the quality and safety of healthcare. We sought to identify factors contributing to patient safety incident reporting., Design: To facilitate improvements in incident reporting, a theoretical framework, encompassing factors that act as barriers and enablers ofreporting, was developed. Embase, Ovid MEDLINE(R) and PsycINFO were searched to identify relevant articles published between January 1980 and May 2014. A comprehensive search strategy including MeSH terms and keywords was developed to identify relevant articles. Data were extracted by three independent researchers; to ensure the accuracy of data extraction, all studies eligible for inclusion were rescreened by two reviewers., Results: The literature search identified 3049 potentially eligible articles; of these, 110 articles, including >29 726 participants, met the inclusion criteria. In total, 748 barriers were identified (frequency count) across the 110 articles. In comparison, 372 facilitators to incident reporting and 118 negative cases were identified. The top two barriers cited were fear of adverse consequences (161, representing 21.52% of barriers) and process and systems of reporting (110, representing 14.71% of barriers). In comparison, the top two facilitators were organisational (97, representing 26.08% of facilitators) and process and systems of reporting (75, representing 20.16% of facilitators)., Conclusion: A wide range of factors contributing to engagement in incident reporting exist. Efforts that address the current tendency to under-report must consider the full range of factors in order to develop interventions as well as a strategic policy approach for improvement., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Objectives: To minimise adverse events in healthcare, various large-scale incident reporting and learning systems have been developed worldwide. Nevertheless, learning from patient safety incidents is going slowly. Local, unit-based reporting systems can help to get faster and more detailed insight into unit-specific safety issues. The aim of our study was to gain insight into types and causes of patient safety incidents in hospital units and to explore differences between unit types., Design: Prospective observational study., Setting: 10 emergency medicine units, 10 internal medicine units and 10 general surgery units in 20 hospitals in the Netherlands participated. Patient safety incidents were reported by healthcare providers. Reports were analysed with root cause analysis. The results were compared between the 3 unit types., Results: A total of 2028 incidents were reported in an average reporting period of 8 weeks per unit. More than half had some consequences for patients, such as a prolonged hospital stay or longer waiting time, and a small number resulted in patient harm. Significant differences in incident types and causes were found between unit types. Emergency units reported more incidents related to collaboration, whereas surgical and internal medicine units reported more incidents related to medication use. The distribution of root causes of surgical and emergency medicine units showed more mutual similarities than those of internal medicine units., Conclusions: Comparable incidents and causes have been found in all units, but there were also differences between units and unit types. Unit-based incident reporting gives specific information and therefore makes improvements easier. We conclude that unit-based incident reporting has an added value besides hospital-wide or national reporting systems that already exist in various countries., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/)

IntroductionHuman papillomavirus (HPV) testing is replacing cytology in primary screening. Its limited specificity demands using a second (triage) test to better identify women at high-risk of cervical disease. Cytology represents the immediate triage but its low sensitivity might hamper HPV testing sensitivity, particularly in low-income and middle-income countries (LMICs), where cytology performance has been suboptimal. The ESTAMPA (EStudio multicéntrico de TAMizaje y triaje de cáncer de cuello uterino con pruebas del virus del PApiloma humano; Spanish acronym) study will: (1) evaluate the performance of different triage techniques to detect cervical precancer and (2) inform on how to implement HPV-based screening programmes in LMIC.Methods and analysisWomen aged 30-64 years are screened with HPV testing and Pap across 12 study centres in Latin America. Screened positives have colposcopy with biopsy and treatment of lesions. Women with no evident disease are recalled 18 months later for another HPV test; those HPV-positive undergo colposcopy with biopsy and treatment as needed. Biological specimens are collected in different visits for triage testing, which is not used for clinical management. The study outcome is histological high-grade squamous intraepithelial or worse lesions (HSIL+) under the lower anogenital squamous terminology. About 50 000 women will be screened and 500 HSIL+ cases detected (at initial and 18 months screening). Performance measures (sensitivity, specificity and predictive values) of triage techniques to detect HSIL+ will be estimated and compared with adjustment by age and study centre.Ethics and disseminationThe study protocol has been approved by the Ethics Committee of the International Agency for Research on Cancer (IARC), of the Pan American Health Organisation (PAHO) and by those in each participating centre. A Data and Safety Monitoring Board (DSMB) has been established to monitor progress of the study, assure participant safety, advice on scientific conduct and analysis and suggest protocol improvements. Study findings will be published in peer-reviewed journals and presented at scientific meetings.Trial registration numberNCT01881659.

Introduction: Fewer than half of all people at highest risk of a cardiovascular event are receiving and adhering to best practice recommendations to lower their risk. In this project, we examine the role of an e-health-assisted consumer-focused strategy as a means of overcoming these gaps between evidence and practice. Consumer Navigation of Electronic Cardiovascular Tools (CONNECT) aims to test whether a consumer-focused e-health strategy provided to Aboriginal and Torres Strait Islander and non-indigenous adults, recruited through primary care, at moderate-to-high risk of a cardiovascular disease event will improve risk factor control when compared with usual care., Methods and Analysis: Randomised controlled trial of 2000 participants with an average of 18 months of follow-up to evaluate the effectiveness of an integrated consumer-directed e-health portal on cardiovascular risk compared with usual care in patients with cardiovascular disease or who are at moderate-to-high cardiovascular disease risk. The trial will be augmented by formal economic and process evaluations to assess acceptability, equity and cost-effectiveness of the intervention. The intervention group will participate in a consumer-directed e-health strategy for cardiovascular risk management. The programme is electronically integrated with the primary care provider's software and will include interactive smart phone and Internet platforms. The primary outcome is a composite endpoint of the proportion of people meeting the Australian guideline-recommended blood pressure (BP) and cholesterol targets. Secondary outcomes include change in mean BP and fasting cholesterol levels, proportion meeting BP and cholesterol targets separately, self-efficacy, health literacy, self-reported point prevalence abstinence in smoking, body mass index and waist circumference, self-reported physical activity and self-reported medication adherence., Ethics and Dissemination: Primary ethics approval was received from the University of Sydney Human Research Ethics Committee and the Aboriginal Health and Medical Research Council. Results will be disseminated via the usual scientific forums including peer-reviewed publications and presentations at international conferences, Clinical Trials Registration Number: ACTRN12613000715774.

Objectives: Stroke is a major cause of morbidity and mortality. This study aimed to investigate secular trends in stroke across the UK., Design: This study aimed to investigate recent trends in the epidemiology of stroke in the UK. The study was a time-trend analysis from 1999 to 2008 within the UK General Practice Research Database. Outcome measures were incidence and prevalence of stroke, stroke mortality, rate of secondary cardiovascular events, and prescribing of pharmacological therapy for primary and secondary prevention of cardiovascular disease., Results: The study cohort included 32,151 patients with a first stroke. Stroke incidence fell by 30%, from 1.48/1000 person-years in 1999 to 1.04/1000 person-years in 2008 (p<0.001). Stroke prevalence increased by 12.5%, from 6.40/1000 in 1999 to 7.20/1000 in 2008 (p<0.001). 56-day mortality after first stroke reduced from 21% in 1999 to 12% in 2008 (p<0.0001). Prescribing of drugs to control cardiovascular risk factors increased consistently over the study period, particularly for lipid lowering agents and antihypertensive agents. In patients with atrial fibrillation, use of anticoagulants prior to first stroke did not increase with increasing stroke risk., Conclusion: Stroke incidence in the UK has decreased and survival after stroke has improved in the past 10 years. Improved drug treatment in primary care is likely to be a major contributor to this, with better control of risk factors both before and after incident stroke. There is, however, scope for further improvement in risk factor reduction in high-risk patients with atrial fibrillation.

Background: Patient engagement in safety has shown positive effects in preventing or reducing adverse events and potential safety risks. Capturing and utilising patient-reported safety incident data can be used for service learning and improvement., Objective: The aim of this study was to characterise the nature of patient-reported safety incidents in primary care., Design: Secondary analysis of two cross sectional studies., Participants: Adult patients from Australian and English primary care settings., Measures: Patients' self-reported experiences of safety incidents were captured using the validated Primary Care Patient Measure of Safety questionnaire. Qualitative responses to survey items were analysed and categorised using the Primary Care Patient Safety Classification System. The frequency and type of safety incidents, contributory factors, and patient and system level outcomes are presented., Results: A total of 1329 patients (n=490, England; n=839, Australia) completed the questionnaire. Overall, 5.3% (n=69) of patients reported a safety incident over the preceding 12 months. The most common incident types were administration incidents (n=27, 31%) (mainly delays in accessing a physician) and incidents involving diagnosis and assessment (n=16, 18.4%). Organisation of care accounted for 27.6% (n=29) of the contributory factors identified in the safety incidents. Staff factors (n=13, 12.4%) was the second most commonly reported contributory factor. Where an outcome could be determined, patient inconvenience (n=24, 28.6%) and clinical harm (n=21, 25%) (psychological distress and unpleasant experience) were the most frequent., Conclusions: The nature and outcomes of patient-reported incidents differ markedly from those identified in studies of staff-reported incidents. The findings from this study emphasise the importance of capturing patient-reported safety incidents in the primary care setting. The patient perspective can complement existing sources of safety intelligence with the potential for service improvement., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: To investigate the impact of standardisation of the perioperative protocol based on the Joint Commission International (JCI) accreditation guidelines for operating time in cataract surgery., Design: Retrospective observational study., Setting: Single centre in Japan., Participants: Between March 2014 and June 2016, 3127 patients underwent cataract surgery under topical anaesthesia including 2581 and 546 patients before and after JCI accreditation, respectively., Primary and Secondary Outcomes: We compared three time periods, comprising the preprocedure/surgery time (pre-PT), PT and post-PT, and total PT (TPT) of cataract surgery between patients before and after JCI accreditation, by regression analysis adjusted for age, sex and cataract surgery-associated confounders., Results: The main outcomes were pre-PT, PT, post-PT and TPT. Pre-PT (19.8±10.5 vs 13.9±8.5 min, p<0.001) and post-PT (3.5±4.6 vs 2.6±2.1 min, p<0.001) significantly decreased after JCI accreditation, while PT did not significantly change (16.8±6.7 vs 16.2±6.3 min, p=0.065). Consequently, TPT decreased on average by 7.3 min per person after JCI accreditation (40.1±13.4 vs 32.8±10.9 min, p<0.001). After adjusting for confounders, pre-PT (β=-5.82 min, 95% CI -6.75 to -4.88), PT (β=-0.76 min, 95% CI -1.34 to -1.71), post-PT (β=-0.85 min, 95% CI -1.24 to -0.45) and TPT (β=-7.43 min, 95% CI -8.61 to -6.24) were significantly shortened after JCI accreditation., Conclusion: Perioperative protocol standardisation, based on JCI accreditation, shortened TPT in cataract surgery under local anaesthesia., Competing Interests: Competing interests: Yes, there are competing interests for one or more authors and I have provided a Competing Interests statement in my manuscript., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: African American adults are disproportionately burdened by chronic diseases, particularly at younger ages. Developing culturally appropriate interventions is paramount to closing the gap in these health inequities. The purpose of this systematic review is to critically evaluate health promotion interventions for African Americans delivered in two environments that are frequented by this population: barbershops and hair salons. Characteristics of effective interventions will be identified and evidence for the effectiveness of these interventions will be provided. Results of this review will inform future health promotion efforts for African Americans particularly focused on the leading health inequities in obesity-related chronic diseases: cardiovascular disease, cancer and type 2 diabetes., Methods and Analysis: Subject headings and keywords will be used to search for synonyms of 'barbershops,' 'hair salons' and 'African Americans' to identify all relevant articles (from inception onwards) in the following databases: Academic Search Ultimate, Cumulative Index of Nursing and Allied Health Literature, Embase, PsycINFO, PubMed, Web of Science (Science Citation Index and Social Sciences Citation Index) and ProQuest Dissertations. Experimental and quasi-experimental studies for adult ( > 18 years) African Americans delivered in barbershops and hair salons will be included. Eligible interventions will include risk reduction/management of obesity-related chronic disease: cardiovascular disease, cancer and type 2 diabetes. Two reviewers will independently screen, select and extract data and a third will mediate disagreements. The methodological quality (or risk of bias) of individual studies will be appraised using the Effective Public Health Practice Project Quality Assessment Tool. Quality and content of the evidence will be narratively synthesised., Ethics and Dissemination: Since this is a protocol for a systematic review, ethical approval is not required. Findings from the review will be widely disseminated through conference presentations, peer-reviewed publications and traditional and social media outlets., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Intra-hospital transportation (IHT) might compromise patient safety because of different care settings and higher demand on the human operation. Reports regarding the incidence of IHT-related patient safety events and human failures remain limited., Objective: To perform a retrospective analysis of IHT-related events, human failures and unsafe acts., Setting: A hospital-wide process for the IHT and database from the incident reporting system in a medical centre in Taiwan., Participants: All eligible IHT-related patient safety events between January 2010 to December 2015 were included., Main Outcome Measures: Incidence rate of IHT-related patient safety events, human failure modes, and types of unsafe acts., Results: There were 206 patient safety events in 2 009 013 IHT sessions (102.5 per 1 000 000 sessions). Most events (n=148, 71.8%) did not involve patient harm, and process events (n=146, 70.9%) were most common. Events at the location of arrival (n=101, 49.0%) were most frequent; this location accounted for 61.0% and 44.2% of events with patient harm and those without harm, respectively (p<0.001). Of the events with human failures (n=186), the most common related process step was the preparation of the transportation team (n=91, 48.9%). Contributing unsafe acts included perceptual errors (n=14, 7.5%), decision errors (n=56, 30.1%), skill-based errors (n=48, 25.8%), and non-compliance (n=68, 36.6%). Multivariate analysis showed that human failure found in the arrival and hand-off sub-process (OR 4.84, p<0.001) was associated with increased patient harm, whereas the presence of omission (OR 0.12, p<0.001) was associated with less patient harm., Conclusions: This study shows a need to reduce human failures to prevent patient harm during intra-hospital transportation. We suggest that the transportation team pay specific attention to the sub-process at the location of arrival and prevent errors other than omissions. Long-term monitoring of IHT-related events is also warranted., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Objectives: To combat overcrowding in emergency departments, ambulance clinicians (ACs) are being encouraged to make on-site assessments regarding patients' need for conveyance to hospital, and this is creating new and challenging demands for ACs. This study aimed to describe ACs' experiences of assessing non-conveyed patients., Design: A phenomenological interview study based on a reflective lifeworld research approach., Setting: The target area for the study was Stockholm, Sweden, which has a population of approximately 2.3 million inhabitants. In this area, 73 ambulances perform approximately just over 200 000 ambulance assignments annually, and approximately 25 000 patients are non-conveyed each year., Informants: 11 ACs., Methods: In-depth open-ended interviews., Results: ACs experience uncertainty regarding the accuracy of their assessments of non-conveyed patients. In particular, they fear conducting erroneous assessments that could harm patients. Avoiding hasty decisions is important for conducting safe patient assessments. Several challenging paradoxes were identified that complicate the non-conveyance situation, namely; responsibility, education and feedback paradoxes. The core of the responsibility paradox is that the increased responsibility associated with non-conveyance assessments is not accompanied with appropriate organisational support. Thus, frustration is experienced. The education paradox involves limited and inadequate non-conveyance education. This, in combination with limited support from non-conveyance guidelines, causes the clinical reality to be perceived as challenging and problematic. Finally, the feedback paradox relates to the obstruction of professional development as a result of an absence of learning possibilities after assessments. Additionally, ACs also described loneliness during non-conveyance situations., Conclusions: This study suggests that, for ACs, performing non-conveyance assessments means experiencing a paradoxical professional existence. Despite these aggravating paradoxes, however, complex non-conveyance assessments continue to be performed and accompanied with limited organisational support. To create more favourable circumstances and, hopefully, safer assessments, further studies that focus on these paradoxes and non-conveyance are needed., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: Organisational and workplace cultures are fundamental determinants of health systems performance; through better understanding of the dimensions of culture there is the potential to influence them, and subsequently improve safety and quality of care, as well as the experiences of both patients and staff. One promising conceptual framework for studying culture in healthcare is person-environment (P-E) fit. Comprising person-organisational (P-O) and person-group (P-G) components, P-E fit is defined as the extent to which individuals are compatible with their work environment. The aim of this study was to examine the associations of P-O and P-G fit with staff outcomes in mental healthcare., Setting and Participants: Participants (n=213) were staff and volunteers at 31 primary mental health facilities across six states of Australia., Primary and Secondary Outcome Measures: Staff outcomes, comprising burnout (depersonalisation and emotional exhaustion), job satisfaction and work stress., Design: A multidimensional survey tool was used to measure P-O and P-G fit, and staff outcomes. Multiple regression analyses were used to test the associations between fit and outcome measures., Results: The regression analyses indicated that, based on a Bonferroni adjusted alpha value of α=00417, P-O fit accounted for 36.6% of the variability in satisfaction (F=8.951, p≤0.001); 27.7% in emotional exhaustion (F=6.766, p≤0.001); 32.8% in depersonalisation (F=8.646, p≤0.001); and 23.5% in work stress (F=5.439, p≤0.001). The P-G fit results were less conclusive, with P-G fit accounting for 15.8% of the variability in satisfaction (F=4.184, p≤0.001); 10.0% in emotional exhaustion (F=2.488, p=0.014); 28.6% in depersonalisation (F=8.945, p≤0.001); and 10.4% in work stress (F=2.590, p=0.032). There was no statistically significant increase in the variability accounted for when the interaction term of P-O and P-G fit was added to the regression., Conclusions: The findings highlight that staff's perception of their workplace and organisational culture can have implications for staff well-being., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: Effective secondary stroke prevention strategies are suboptimally used. Novel development of interventions to enable healthcare professionals and stroke survivors to manage risk factors for stroke recurrence are required. We sought to engage key stakeholders in the design and evaluation of an intervention informed by a learning health system approach, to improve risk factor management and secondary prevention for stroke survivors with multimorbidity., Design: Qualitative, including focus groups, semistructured interviews and usability evaluations. Data was audio recorded, transcribed and coded thematically., Participants: Stroke survivors, carers, health and social care professionals, commissioners, policymakers and researchers., Setting: Stroke survivors were recruited from the South London Stroke Register; health and social care professionals through South London general practices and King's College London (KCL) networks; carers, commissioners, policymakers and researchers through KCL networks., Results: 53 stakeholders in total participated in focus groups, interviews and usability evaluations. Thirty-seven participated in focus groups and interviews, including stroke survivors and carers (n=11), health and social care professionals (n=16), commissioners and policymakers (n=6) and researchers (n=4). Sixteen participated in usability evaluations, including stroke survivors (n=8) and general practitioners (GPs; n=8). Eight themes informed the collaborative design of DOTT (Deciding On Treatments Together), a decision aid integrated with the electronic health record system, to be used in primary care during clinical consultations between the healthcare professional and stroke survivor. DOTT aims to facilitate shared decision-making on personalised treatments leading to improved treatment adherence and risk control. DOTT was found acceptable and usable among stroke survivors and GPs during a series of evaluations., Conclusions: Adopting a user-centred data-driven design approach informed an intervention that is acceptable to users and has the potential to improve patient outcomes. A future feasibility study and subsequent clinical trial will provide evidence of the effectiveness of DOTT in reducing risk of stroke recurrence., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.)

Data from clinical trials are needed to guide the safe and effective use of medicines in children. Clinical trials are challenging to design and implement in all populations, and children present additional considerations. Several regions including the UK, USA and Europe have established clinical trial infrastructure to capitalise on expertise and promote clinical trials enrolling children. Our objective is to describe the partnerships and operational considerations for the development of paediatric clinical trials infrastructure in Canada. We describe the design and conduct of four emergency room paediatric trials, with four separate sponsors, across four provinces in parallel. Operations discussed include multisite contract development, centralised risk-based data monitoring, ethical review and patient engagement. We conclude with lessons learnt, additional challenges and potential solutions to facilitate drug development for children in Canada., Competing Interests: Competing interests: The Innovation in Paediatric Clinical Trials (iPCT) project is funded by an Innovative Clinical Trials Multi-year Grant from the Canadian Institutes of Health Research, as part of the Strategy for Patient-Oriented Research and in partnership with the Alberta Children’s Hospital Research Institute, Centre Hospitalier Universitaire Sainte-Justine, Children’s Hospital Research Institute of Manitoba, Children’s Hospital of Eastern Ontario Research Institute, Hospital for Sick Children Research Institute, Research Manitoba, University of Western Ontario and Women & Children’s Health Research Institute. The authors have no conflicts of interest to disclose., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: To develop a risk-stratified intervention strategy and evaluate its effect on reducing surgical complications., Design: A multicentre prospective study with preintervention and postintervention stages: period I (January to June 2015) to develop the intervention strategy and period II (January to June 2016) to evaluate its effectiveness., Setting: Four academic/teaching hospitals representing major Chinese administrative and economic regions., Participants: All surgical (elective and emergent) inpatients aged ≥14 years with a minimum hospital stay of 24 hours, who underwent a surgical procedure requiring an anesthesiologist., Interventions: Targeted complications were grouped into three categories (common, specific, serious) according to their incidence pattern, severity and preventability. The corresponding expert consensus-generated interventions, which focused on both regulating medical practices and managing inherent patient-related risks, were implemented in a patient-tailored way via an electronic checklist system., Primary and Secondary Outcomes: Primary outcomes were (1) in-hospital death/confirmed death within 30 days after discharge and (2) complications during hospitalisation. Secondary outcome was length of stay (LOS)., Results: We included 51 030 patients in this analysis (eligibility rate 87.7%): 23 413 during period I, 27 617 during period II. Patients' characteristics were comparable during the two periods. After adjustment, the mean number of overall complications per 100 patients decreased from 8.84 to 7.56 (relative change 14.5%; P<0.0001). Specifically, complication rates decreased from 3.96 to 3.65 (7.8%) for common complications (P=0.0677), from 0.50 to 0.36 (28.0%) for specific complications (P=0.0153) and from 3.64 to 2.88 (20.9%) for serious complications (P<0.0001). From period I to period II, there was a decreasing trend for mortality (from 0.64 to 0.53; P=0.1031) and median LOS (by 1 day; P=0.8293), without statistical significance., Conclusions: Implementing a risk-stratified intervention strategy may be a target-sensitive, convenient means to improve surgical outcomes., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: To explore: (1) the views of Australian physiotherapists regarding potential implementation of non-medical prescribing in Australia, (2) how the geographical location and health sector in which a clinician works may influence their perceptions and (3) the perceptions of Australian physiotherapists about how physiotherapist prescribing might impact the care that the profession can provide., Design: A cross-sectional descriptive survey using open and closed questions., Setting: Participants completed an online questionnaire., Participants: 883 Australian Health Professionals Registration Authority (AHPRA)-registered physiotherapists, working across all states and territories., Outcome Measures: An online questionnaire was developed by a panel of subject experts and pretested (n=10) for internal consistency. A hyperlink to the questionnaire was emailed to all members of the Australian Physiotherapy Association. A reminder email was sent 4 weeks later. Quantitative data were analysed descriptively, with use of absolute risk reductions (ARRs) and 95% CIs to determine the likelihood that health sector or geographical location were associated with specific views. Thematic analysis enabled synthesis of the qualitative data., Results: 79.0% participants felt that physiotherapist prescribing should be introduced in Australia, with 71.2% wanting to train as prescribers. Clinical governance, risk management, regulation of clinicians and the development of an education framework were identified as priorities for implementation. Participants working in the private sector were significantly more likely to train as prescribers than those in the public sector (ARR 9.9%; 95% CI 3.5 to 16.4) or educational/research institutions (ARR 23.3%; 95% CI 12.8 to 33.8), with city dwellers significantly more likely to train compared with physiotherapists in remote regions (ARR 19.8%; 95% CI 0.8 to 39.2). Physiotherapist prescribing was predicted to improve efficiency of healthcare delivery, access to medicines and reductions in healthcare costs., Conclusions: AHPRA-registered physiotherapists perceive that the introduction of autonomous physiotherapist prescribing would be beneficial for the Australian population and should be introduced. Decision makers should consider the results of this survey in conjunction with cost-benefit and risk analysis when planning the introduction of physiotherapist prescribing., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: To characterise the costs, including for environmental surveillance (ES), of the Global Polio Laboratory Network (GPLN) that provides laboratory support to the Global Polio Eradication Initiative (GPEI)., Design and Participants: We conducted a survey of the network across 92 countries of the 146 GPLN laboratories plus three non-GPLN laboratories that concentrate environmental samples to collect information about their activities, characteristics and costs during 2016. We estimate the total costs using regression of reported responses and complementing the findings with GPEI data., Results: We received responses from 132 (89%) of the 149 laboratories, with variable response rates for individual questions. We estimate that processing samples of patients with acute flaccid paralysis leads to total costs of approximately $28 million per year (2016 US$) based on extrapolation from reported costs of $16 million, of which 61% were supported by internal (national) funds. Fifty-nine (45%) of the 132 responding laboratories reported supporting ES and we estimate an additional $5.3 million of recurring costs for ES activities performed by the laboratories. The reported costs do not include an estimated additional $10 million of annual global and regional costs to coordinate and support the GPLN. On average, the staff supported by funding for polio in the responding laboratories spent 30% of their time on non-polio activities. We estimate total costs for laboratory support of approximately $43 million (note that this estimate does not include any field or other non-laboratory costs of polio surveillance)., Conclusions: Although countries contribute significantly to the GPLN financing, many laboratories currently depend on GPEI funds, and these laboratories also support the laboratory component of surveillance activities for other diseases. Sustaining critical global surveillance for polioviruses and transitioning support for other disease programmes will require continued significant funding after polio certification., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: The Heart Manual (HM) is the UK's leading facilitated home-based cardiac rehabilitation (CR) programme for individuals recovering from myocardial infarction and revascularisation. This audit explored patient-reported outcomes of home-based CR in relation to current Scottish, UK and European guidelines., Setting: Patients across the UK returned their questionnaire after completing the HM programme to the HM Department (NHS Lothian)., Participants: Qualitative data from 457 questionnaires returned between 2011 and 2018 were included for thematic analysis. Seven themes were identified from the guidelines. This guided initial deductive coding and provided the basis for inductive subthemes to emerge., Results: Themes included: (1) health behaviour change and modifiable risk reduction, (2) psychosocial support, (3) education, (4) social support, (5) medical risk management, (6) vocational rehabilitation and (7) long-term strategies and maintenance. Both (1) and (2) were reported as having the greatest impact on patients' daily lives. Subthemes for (1) included: guidance, engagement, awareness, consequences, attitude, no change and motivation. Psychosocial support comprised: stress management, pacing, relaxation, increased self-efficacy, validation, mental health and self-perception. This was followed by (3) and (4). Patients less frequently referred to (5), (6) and (7). Additional themes highlighted the impact of the HM programme and that patients attributed the greatest impact to a combination of all the above themes., Conclusions: This audit highlighted the HM as comprehensive and inclusive of key elements proposed by Scottish, UK and EU guidelines. Patients reported this had a profound impact on their daily lives and proved advantageous for CR., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: There is an epidemic of opioid use related to adverse events and deaths in the USA. The rates of chronic pain, mental illness and substance use disorder are higher at the Veterans Health Administration (VHA) compared with the general US population. The 2016 Comprehensive Addiction and Recovery Act requires the VHA to improve opioid therapy strategies in treating patients and to ensure responsible prescribing practices. The Stratification Tool for Opioid Risk Mitigation (STORM) is a web-based dashboard that prioritises review of VHA patients receiving opioids based on their risk. The VHA Partnered Evidence-based Policy Resource Center is coordinating a multiyear evaluation of STORM and aspects of the VHA policy that mandate case review of patients identified by STORM as very high risk., Methods and Analysis: This stepped-wedge cluster randomised controlled trial will test two hypotheses: (1) VHA medical centres randomised to facilitation for not meeting the targeted case review rate will achieve lower opioid-related serious adverse events (SAEs), relative to facilities not randomised to facilitation and (2) Patients whose cases are required to be reviewed will have a lower rate of opioid-related SAEs compared with comparable risk patients whose cases are not required to be reviewed. Patients who receive an opioid prescription at VHA medical centres will be followed for a minimum of 3 months after their first opioid prescription. Follow-up will continue until the last day of the project or death. The data will be analysed using an intention-to-treat approach with patient-month-level Cox proportional hazards models for both interventions., Ethics and Dissemination: Evaluation of the randomised roll-out was approved by the VA Boston Healthcare System Institutional Review Board (IRB) and Research & Development Committees (Protocol # 3069). Findings will be published in peer-reviewed journals and presentations at national conference meetings., Trial Registration Number: ISRCTN16012111., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Objectives: To study older peoples' experiences with an interactive internet platform for cardiovascular self-management, to assess which factors influence initial and sustained engagement. To assess their views on future use within primary care., Design: Qualitative semistructured interview study, with thematic analysis., Setting: Primary care in the Netherlands., Participants: People ≥65 years with an increased risk of cardiovascular disease who used the 'Healthy Ageing Through Internet Counselling in the Elderly' internet platform with remote support of a coach. Participants were selected using a purposive sampling method based on gender, age, level of education, cardiovascular history, diabetes, duration of participation and login frequency., Results: We performed 17 interviews with 20 participants, including three couples. In the initial phase, platform engagement was influenced by perceived computer literacy of the participants, user-friendliness, acceptability and appropriateness of the intervention and the initial interaction with the coach. Sustained platform use was mainly facilitated by a relationship of trust with the coach. Other facilitating factors were regular automatic and personal reminders, clear expectations of the platform, incorporation into daily routine, social support and a loyal and persistent attitude. Perceived lack of change in content of the platform could work both stimulating and discouraging. Participants supported the idea of embedding the platform into the primary care setting., Conclusions: Human support is crucial to initial and sustained engagement of older people in using an interactive internet platform for cardiovascular self-management. Regular reminders further facilitate sustained use, and increased tailoring to personal preference is recommended. Embedding the platform in primary healthcare may enhance future adoption., Trial Registration Number: ISRCTN48151589; Pre-results., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Background: Adverse events (AEs) epidemiology is the first step to improve practice in the healthcare system. Usually, the preferred method used to estimate the magnitude of the problem is the retrospective cohort study design, with retrospective reviews of the medical records. However this data collection involves a sophisticated sampling plan, and a process of intensive review of sometimes very heavy and complex medical records. Cross-sectional survey is also a valid and feasible methodology to study AEs., Objectives: The aim of this study is to compare AEs detection using two different methodologies: cross-sectional versus retrospective cohort design., Setting: Secondary and tertiary hospitals in five countries: Argentina, Colombia, Costa Rica, Mexico and Peru., Participants: The IBEAS Study is a cross-sectional survey with a sample size of 11 379 patients. The retrospective cohort study was obtained from a 10% random sample proportional to hospital size from the entire IBEAS Study population., Methods: This study compares the 1-day prevalence of the AEs obtained in the IBEAS Study with the incidence obtained through the retrospective cohort study., Results: The prevalence of patients with AEs was 10.47% (95% CI 9.90 to 11.03) (1191/11 379), while the cumulative incidence of the retrospective cohort study was 19.76% (95% CI 17.35% to 22.17%) (215/1088). In both studies the highest risk of suffering AEs was seen in Intensive Care Unit (ICU) patients. Comorbid patients and patients with medical devices showed higher risk., Conclusion: The retrospective cohort design, although requires more resources, allows to detect more AEs than the cross-sectional design., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)