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Introduction: Current care plans for stroke survivors typically focus on acute management, resulting in many stroke survivors being discharged to their communities without adequate follow-up, despite their often experiencing significant post-stroke complications, such as post-stroke spasticity (PSS). While studies have explored the incidence and prevalence of PSS, little is known about how early PSS develops and how many stroke survivors develop 'problematic' PSS that would benefit from pharmacological treatment., Methods and Analysis: EPITOME is a prospective, international, observational, epidemiological study of participants (aged 18-90 years) who develop paresis within days 3-14 of a first-ever stroke that occurred within the past 4 weeks. Participants at sites across seven different countries are monitored remotely at 2 weeks and 1, 2, 3, 6, 9 and 12 months post-stroke to detect the possible onset of PSS using the Post-stroke Spasticity Monitoring Questionnaire (PSMQ). If the PSMQ indicates the possible presence of PSS, participants undergo a full in-clinic assessment to confirm the presence of PSS. For participants with confirmed PSS, the severity and distribution of spasticity is documented, and the investigator assesses whether the participant has spasticity that could benefit from pharmacological therapy. Participants without clinically confirmed PSS return to remote monitoring., Ethics and Dissemination: Ethics approval was obtained in all seven participating countries. Results will be published at international meetings and in an international peer-reviewed journal. Lay summaries will be prepared to accompany the primary paper and will also be provided to study participants., Trial Registration Number: ClinicalTrials.gov NCT06055725., Competing Interests: Competing interests: RDZ, LSB, SB, SG, DHH, RP and AP are investigators in the EPITOME study and either they or their institutions receive payment for participation from Ipsen. In addition, RDZ reports research funding from Ipsen and AbbVie, consulting fees from Ipsen, royalties from Demos Medical for the Textbook of Stroke Recovery and Rehabilitation, and participation in a data safety monitoring board for SPR Therapeutics. SG reports research funding from Bundesministerium fur Bildung und Forschung (BMBF), Disabled Facilities Grants (DFG), Universitätsmedizin Mainz, Abbott, Boston Scientific, Böhringer Foundation, Magventure, Precisis, Innovationsfond GBA and lecture fees from Abbott, AbbVie, Bial, BVDN, Ipsen, and UCB. SS is a patient representative of Different Strokes and has no financial disclosures to report. SM, SP and PM are employed by Ipsen. AP reports consultancy for Ipsen, Merz and AbbVie., (© Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group.)

Objectives: This exploratory study was conducted to find out how well the concept of evidence-based research (EBR) is known among European health researchers with substantial clinical research experience, and which barriers affect the use of an EBR approach. The concept of EBR implies that researchers use evidence synthesis to justify new studies and to inform their design., Design: A cross-sectional exploratory survey study., Setting and Participants: The survey was conducted among European health researchers. Respondents included 205 health researchers (physicians, nurses, dentists, allied health researchers and members of other professions involved in health research) with a doctoral degree or at least 5 years of research experience., Primary and Secondary Outcome Measures: The primary outcome measures were the level of awareness of the concept of EBR and the presence of barriers affecting the use of an EBR approach. Secondary outcome measures include correlations between sociodemographic characteristics (eg, profession) and awareness of EBR., Results: We discovered that 84.4% of the respondents initially indicated their awareness of the concept of EBR. Nevertheless, 22.5% of them concluded that, on reading the definition, they either do not know or do not fully comprehend the concept of EBR. The main barriers affecting the use of an EBR approach were related to organisational issues, such as not being attributed resources (30.5% of the respondents), time (24.8%) or access to implement it (14.9%)., Conclusions: Despite the limitations, this study clearly shows that ongoing initiatives are necessary to raise awareness about the importance of implementing the EBR approach in health research. This paper contributes to a discussion of the issues that obstruct the implementation of the EBR approach and potential solutions to overcome these issues, such as improving the knowledge and skills necessary to practice the EBR approach., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: The majority of adolescents do not meet guidelines for healthy behaviours, posing major risks for developing multiple non-communicable diseases. Unhealthy lifestyles seem more prevalent in urban than rural areas, with the neighbourhood environment as a mediating pathway. How to develop and implement sustainable and effective interventions focused on adolescent health and well-being in urban vulnerable life situations is a key challenge. This paper describes the protocol of a Youth-centred Participatory Action (YoPA) project aiming to tailor, implement, and evaluate social and physical environmental interventions., Methods and Analysis: In diverse urban environments in Denmark, the Netherlands, Nigeria and South Africa, we will engage a dynamic group of 15-20 adolescents (12-19 years) growing up in vulnerable life situations and other key stakeholders (eg, policy makers, urban planners, community leaders) in local co-creation communities. Together with academic researchers and local stakeholders, adolescents will take a leading role in mapping the local system; tailoring; implementing and evaluating interventions during participatory meetings over the course of 3 years. YoPA applies a participatory mixed methods design guided by a novel Systems, User perspectives, Participatory co-creation process, Effects, Reach, Adoption, Implementation and Maintenance framework assessing: (i) the local systems, (ii) user perspectives, (iii) the participatory co-creation process, (iv) effects, (v) reach, (vi) adoption, (vii) implementation and (viii) maintenance of interventions. Through a realist evaluation, YoPA will explore why and how specific outcomes were reached (or not) in each setting (n=800-1000 adolescents in total)., Ethics and Dissemination: This study received approval from the ethics committees in Denmark, the Netherlands, Nigeria and South Africa and will be disseminated via various collaborative dissemination activities targeting multiple audiences. We will obtain informed consent from all participants. We envision that our YoPA co-creation approach will serve as a guide for participation of adolescents in vulnerable life situations in implementation of health promotion and urban planning in Europe, Africa and globally., Trial Registration Number: NCT06181162., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Introduction: While the factors commonly associated with an increased risk of child maltreatment (CM) were found to be increased during COVID-19, reports of actual maltreatment showed varying trends. Similarly, evidence regarding the impact of COVID-19 on CM within the European Cooperation on Science and Technology and Network Collaborative (COST) Action countries remains inconsistent. This scoping review aims to explore the extent and nature of evidence pertaining to CM within the countries affiliated with the Child Abuse and Neglect in Europe Action Network (Euro-CAN), funded by the COST., Methods and Analysis: Key electronic databases were searched to identify eligible papers, reports and other material published between January 2020 and April 2023: PubMed, EMBASE, PsycINFO, Social Policy and Practice, Scopus and Web of Science. To cover the breadth of evidence, a systematic and broad search strategy was applied using a combination of keywords and controlled vocabulary for four concepts: children, maltreatment, COVID-19 and Euro-CAN countries, without restrictions on study design or language. Grey literature was searched in OpenGrey and Google Scholar. Two reviewers will independently screen full-text publications for eligibility and undertake data extraction, using a customised grid. The screening criteria and data charting will be piloted by the research team.The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) extension for scoping reviews will be followed to present the results. Results will be summarised in a tabular form and narratively., Ethics and Dissemination: This review will identify and summarise publicly available data, without requiring ethical approval. The findings will be disseminated to the Euro-CAN Network and reported to the COST Association. They will also be published in a peer-reviewed journal. This protocol is registered on Open Science Framework., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Hospitals remain the cornerstone of health systems in European countries. Therefore, the financial sustainability of hospitals constitutes an important determinant of healthcare provision security. The fragmentary data available indicate that hospitals in many European countries are continuously facing financial deficits and/or insolvency problems. Yet a comparative analysis of hospital financial performance across European countries has been lacking. The proposed review will, therefore, fill in an important research gap and build a knowledge base on the topic of assessing and monitoring the financial sustainability of hospitals in Europe. The general objective is to identify, synthetise and map existing evidence on hospital financial performance across European countries., Methods and Analysis: This scoping review will follow six stages: (1) defining the research question, (2) identifying relevant literature, (3) studies selection, (4) data extraction, (5) collating, summarising and reporting of results and (6) consultation process and involvement of knowledge users. The following databases will be searched:(1) Medline via PubMed, (2) Web of Science Core Collection, (3) Scopus and (4) ProQuest Central. In addition, a Google Engine search will also be performed. Furthermore, reference lists of relevant papers will be visually scanned to identify further studies of interest. The review will include both quantitative and qualitative empirical studies as well as theoretical papers and technical reports. The PRISMA extension for a Scoping Review checklist will be used for reporting., Ethics and Dissemination: Formal ethical approval is not required because no primary data will be collected in this study. Results will be published in a peer-reviewed journal. The findings will also be disseminated through conference presentations and summaries to key stakeholders., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Linking healthcare data sets can create valuable resources for research, particularly when investigating rare exposures or outcomes. However, across Europe, the permissions processes required to access data can be complex. This paper documents the processes required by the EUROlinkCAT study investigators to research the health and survival of children with congenital anomalies in Europe., Methods: Eighteen congenital anomaly registries in 14 countries provided information on all the permissions required to perform surveillance of congenital anomalies and to link their data on live births with available vital statistics and healthcare databases for research. Small number restrictions imposed by data providers were also documented., Results: The permissions requirements varied substantially, with certain registries able to conduct congenital anomaly surveillance as part of national or regional healthcare provision, while others were required to obtain ethics approvals or informed consent. Data linkage and analysis for research purposes added additional layers of complexity for registries, with some required to obtain several permissions, including ethics approvals to link the data. Restrictions relating to small numbers often resulted in a registry's data on specific congenital anomalies being unusable., Conclusion: The permissions required to obtain and link data on children with congenital anomalies varied greatly across Europe. The variation and complexity present a significant obstacle to the use of such data, especially in large data linkage projects. Furthermore, small number restrictions severely limited the research that could be performed for children with specific rare congenital anomalies., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.)

Objectives: Research on resilience to the COVID-19 pandemic has primarily focused on health system resilience. The purpose of this paper is to: (1) develop a broader understanding of societal resilience to shocks by evaluating resilience in three systems: health, economic and fundamental rights and freedoms and (2) to further operationalise resilience in terms of robustness, resistance and recovery., Settings: 22 European countries were selected based on the availability of data in the health, fundamental rights and freedoms, and economic systems during the first wave of the COVID-19 pandemic in early 2020., Design: This study uses time series data to assess resilience in health, fundamental rights and freedoms, and economic systems. An overall resilience was estimated, as well as three of its components: robustness, resistance and recovery., Results: Six countries exhibited an outlier excess mortality peak compared with the prepandemic period (2015-2019). All countries experienced economic repercussions and implemented diverse measures affecting individual rights and freedoms. Three main groups of countries were identified: (1) high health and high or moderate economic and/or fundamental rights and freedoms resilience, (2) moderate health and fundamental rights and freedoms resilience and (3) low resilience in all three systems., Conclusions: The classification of countries into three groups provides valuable insights into the multifaceted nature of multisystemic resilience during the first wave of the COVID-19 pandemic. Our study highlights the importance of considering both health and economic factors when assessing resilience to shocks, as well as the necessity of safeguarding individual rights and freedoms during times of crisis. Such insights can inform policy decisions and aid in the development of targeted strategies to enhance resilience in the face of future challenges., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.)

Introduction: Long-term survival after childhood cancer often comes at the expense of late, adverse health conditions. However, survivorship care is frequently not available for adult survivors in Europe. The PanCareFollowUp Consortium therefore developed the PanCareFollowUp Care Intervention, an innovative person-centred survivorship care model based on experiences in the Netherlands. This paper describes the protocol of the prospective cohort study (Care Study) to evaluate the feasibility and the health economic, clinical and patient-reported outcomes of implementing PanCareFollowUp Care as usual care in four European countries., Methods and Analysis: In this prospective, longitudinal cohort study with at least 6 months of follow-up, 800 childhood cancer survivors will receive the PanCareFollowUp Care Intervention across four study sites in Belgium, Czech Republic, Italy and Sweden, representing different healthcare systems. The PanCareFollowUp Care Intervention will be evaluated according to the Reach, Effectiveness, Adoption, Implementation and Maintenance framework. Clinical and research data are collected through questionnaires, a clinic visit for multiple medical assessments and a follow-up call. The primary outcome is empowerment, assessed with the Health Education Impact Questionnaire. A central data centre will perform quality checks, data cleaning and data validation, and provide support in data analysis. Multilevel models will be used for repeated outcome measures, with subgroup analysis, for example, by study site, attained age, sex or diagnosis., Ethics and Dissemination: This study will be conducted in accordance with the guidelines of Good Clinical Practice and the Declaration of Helsinki. The study protocol has been reviewed and approved by all relevant ethics committees. The evidence and insights gained by this study will be summarised in a Replication Manual, also including the tools required to implement the PanCareFollowUp Care Intervention in other countries. This Replication Manual will become freely available through PanCare and will be disseminated through policy and press releases., Trial Registration Number: Netherlands Trial Register (NL8918; https://www.trialregister.nl/trial/8918)., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.)

Introduction: In Europe, alcohol consumption is responsible for many diseases, disabilities, injuries and premature deaths. In France, alcohol consumption represents an important health burden, due to its frequency, scale and the serious damage it causes. One of the keys to addressing the problem would appear to be the adoption of harm and risk reduction approaches. In order to operationalise this strategy, the Nouvelle Aquitaine Regional Health Agency is funding three different programmes to reduce the harm and risks associated with alcohol consumption: Alcochoix, Iaca and ETP (Education Thérapeutique du Patient) Conso-repère . We are interested in understanding how, under what circumstances, through which mechanisms and for which population the different programmes work., Methods and Analysis: The ECIAE study (a cross-evaluation of the 3 programs Iaca/Alcochoix/ ETP (Patient Therapeutic Education) is a theory-based evaluation where the realist evaluation method is used to explore effects, intervention mechanisms and the influence of context on outcomes. This realist evaluation is based on multiple case studies in two nested levels. At the first level, each centre implementing the programme will represent a case. At the second level, each programme will represent a case in which a set of activities is conducted to achieve risk reduction objectives., Ethics and Dissemination: The project will be carried out in full compliance with existing legislation and international conventions. It was subject to analysis, including a privacy impact assessment conducted by the Data Protection Officer of the University of Bordeaux. The University of Bordeaux has ensured that all the regulatory procedures related to the ECIAE study have been carried out. The dissemination plan includes scientific papers, seminars, a report and recommendation and a public restitution. The study will provide evidence-based results to help health authorities roll out strategies to reduce risks and harm associated with alcohol use., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Women are more likely than men to provide unpaid care work. Previous research has shown that lack of support for various forms of unpaid care work and work-family conflicts have negative impacts on caregivers' mental health, especially among female caregivers. COVID-19 containment measures may exacerbate existing gender inequalities both in terms of unpaid care work and adverse mental health outcomes. This scoping review protocol describes the systematic approach to review published literature from March 2020 onwards to identify empirical studies and grey literature on the mental health impact of COVID-19 containment measures on subgroups of unpaid caregivers at the intersection of gender and other categories of social difference (eg, ethnicity, age, class) in Europe., Methods and Analysis: This scoping review is informed and guided by Arksey and O'Malley's methodological framework. We will search the databases Medline, PsycINFO, Scopus, CINAHL, Social Sciences Abstracts, Sociological Abstracts as well as Applied Social Sciences Index & Abstracts (ASSIA) and hand-search reference lists of selected articles to identify relevant peer-reviewed studies. We will conduct a grey literature search using Google Scholar and targeted hand-search on known international and European websites and include reports, working papers, policy briefs and book chapters that meet the inclusion criteria. Studies that report gender-segregated findings for mental health outcomes associated with unpaid care work in the context of COVID-19 containment measures in Europe will be included. Two reviewers will independently screen all abstracts and full texts for inclusion, and extract general information, study characteristics and relevant findings. Results will be synthesized narratively., Ethics and Dissemination: This study is a review of published literature; ethics approval is not warranted. The findings of this study will inform public health research and policy. The results will be disseminated through a peer-reviewed publication and conference presentations., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: To examine the accessibility and quality of drug company payment data in Europe., Design: Comparative policy review of payment data in countries with different regulatory approaches to disclosure., Setting: 37 European countries., Participants: European Federation of Pharmaceutical Industries and Associations, its trade group and their drug company members; eurosfordocs.eu, an independent database integrating payments disclosed by companies and trade groups; regulatory bodies overseeing payment disclosure., Main Outcome Measures: Regulatory approaches to disclosure (self-regulation, public regulation, combination of the two); data accessibility (format, structure, searchability, customisable summary statistics, downloadability) and quality (spectrum of disclosed characteristics, payment aggregation, inclusion of taxes, recipient or donor identifiers)., Results: Of 30 countries with self-regulation, five had centralised databases, with Disclosure UK displaying the highest accessibility and quality. In 23 of the remaining countries with self-regulation and available data, disclosures were published in the portable document format (PDF) on individual company websites, preventing the public from understanding payment patterns. Eurosfordocs.eu had greater accessibility than any industry-run database, but the match between the value of payments integrated in eurosfordocs.eu and summarised separately by industry in seven countries ranged between 56% and 100% depending on country. Eurosfordocs.eu shared quality shortcomings with the underlying industry data, including ambiguities in identifying payments and their recipients. Public regulation was found in 15 countries, used either alone (3), in combination (4) or in parallel with (8) self-regulation. Of these countries, 13 established centralised databases with widely ranging accessibility and quality, and sharing some shortcomings with the industry-run databases. The French database, Transparence Santé, had the highest accessibility and quality, exceeding that of Disclosure UK., Conclusions: The accessibility and quality of payment data disclosed in European countries are typically low, hindering investigation of financial conflicts of interest. Some improvements are straightforward but reaching the standards characterising the widely researched US Open Payments database requires major regulatory change., Competing Interests: Competing interests: We have read and understood the BMJ Group policy on declaration of interests and declare the following interests: PO’s PhD student was supported by a grant from Sigma Pharmaceuticals, a UK pharmacy wholesaler and distributor (not a pharmaceutical company). The PhD work funded by Sigma Pharmaceuticals is unrelated to the subject of this paper. LM and PAJ are members of Euros for Docs, a non-profit organization registered in France that seeks to promote transparency of drug company funding in the healthcare sector by making payment data accessible and complete across Europe. PAJ is employed by Haute Autorité de Santé, the French independent health technology assessment organisation. SM’s partner is employed by PRA Health Sciences, a global Contract Research Organization whose custumers include many pharmaceutical companies., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.)

Introduction: Congenital anomalies (CAs) are a major cause of infant mortality, childhood morbidity and long-term disability. Over 130 000 children born in Europe every year will have a CA. This paper describes the EUROlinkCAT study, which is investigating the health and educational outcomes of children with CAs for the first 10 years of their lives., Methods and Analysis: EUROCAT is a European network of population-based registries for the epidemiological surveillance of CAs. EUROlinkCAT is using the EUROCAT infrastructure to support 22 EUROCAT registries in 14 countries to link their data on births with CAs to mortality, hospital discharge, prescription and educational databases. Once linked, each registry transforms their case data into a common data model (CDM) format and they are then supplied with common STATA syntax scripts to analyse their data. The resulting aggregate tables and analysis results are submitted to a central results repository (CRR) and meta-analyses are performed to summarise the results across all registries. The CRR currently contains data on 155 594 children with a CA followed up to age 10 from a population of 6 million births from 1995 to 2014., Ethics: The CA registries have the required ethics permissions for routine surveillance and transmission of anonymised data to the EUROCAT central database. Each registry is responsible for applying for and obtaining additional ethics and other permissions required for their participation in EUROlinkCAT., Dissemination: The CDM and associated documentation, including linkage and standardisation procedures, will be available post-EUROlinkCAT thus facilitating future local, national and European-level analyses to improve healthcare. Recommendations to improve the accuracy of routinely collected data will be made.Findings will provide evidence to inform parents, health professionals, public health authorities and national treatment guidelines to optimise diagnosis, prevention and treatment for these children with a view to reducing health inequalities in Europe., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.)

Objective: To analyse the trajectory of empathy throughout the degree programme of medicine in a Spanish school of medicine., Design: Longitudinal, prospective 5-year study, between October 2014 and June 2019., Setting: Students from a Spanish university of medicine., Participants: Two voluntary cohorts of undergraduate medical students from two different school years were invited to participate (n=135 (cohort 1, C1) and 106 (cohort 2, C2) per school year). Finally, a total number of 174 students (102 (C1, 71.6% women) and 72 (C2, 70.8% women) students, respectively) were monitored for 5 years. Each cohort was divided in two subcohorts of paired and unpaired students that were analysed to check possible social desirability bias., Primary Outcome Measure: The Jefferson Scale of Empathy (JSE)., Results: The cohort of 102 students (C1) monitored between their first and fifth years of study (71.6% women) showed an improvement among paired women of 2.15 points in total JSE score (p=0.01) and 2.39 points in cognitive empathy (p=0.01); in the unpaired female cohort the increase was of 2.32 points (cognitive empathy) (p=0.02). The cohort of 72 students (C2) monitored between their second and sixth years of study (70.8% women) displayed a cognitive empathy increase of 2.32 points (p=0.04) in the paired group of women. There were no significant differences between paired and unpaired results for either cohort. Empathy scores among men did not decrease., Conclusions: The empathy of medical students at our school did not decline along grade years. In fact, it improved slightly, particularly cognitive empathy, among women. This paper contributes to enlarge data from Europe, where longitudinal studies are scarce. It supports the idea that there may be global geo-sociocultural differences; however, more studies comparing different school settings are needed., 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.)

Objective: To identify the factors that shape and characterise experiences of prehospital practitioners (PHPs), families and bystanders in the context of death and dying outside of the hospital environment where PHPs respond., Design: A scoping review using Arksey and O'Malley's five-stage framework. Papers were analysed using thematic analysis., Data Sources: MEDLINE; Embase; CINAHL; Scopus; Social Sciences Citation Index (Web of Science), ProQuest Dissertations & Theses A&I (Proquest), Health Technology Assessment database; PsycINFO; Grey Literature Report and PapersFirst were searched from January 2000 to May 2019., Eligibility Criteria for Selecting Studies: Qualitative and mixed methods studies reporting the experiences of PHPs, families and bystanders of death and dying in prehospital settings as a result of natural causes, trauma, suicide and homicide, >18 years of age, in Europe, USA, Canada, Australia and New Zealand., Results: Searches identified 15 352 papers of which 51 met the inclusion criteria. The review found substantial evidence of PHP experiences, except call handlers, and papers reporting family and bystander experiences were limited. PHP work was varied and complex, while confident in clinical work, they felt less equipped to deal with the emotion work, especially with an increasing role in palliative and end-of-life care. Families and bystanders reported generally positive experiences but their support needs were rarely explored., Conclusions: To the best of our knowledge this is the first review that explores the experiences of PHPs, families and bystanders. An important outcome is identifying current gaps in knowledge where further empirical research is needed. The paucity of evidence suggested by this review on call handlers, families and bystanders presents opportunities to investigate their experiences in greater depth. Further research to address the current knowledge gaps will be important to inform future policy and practice., Competing Interests: Competing interests: Alison Richardson is a National Institute for Health Research (NIHR) senior investigator. HP is in receipt of an NIHR Clinical Doctoral Fellowship., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.)

Introduction: Poor lower wound care is an avoidable patient harm. Compression therapy is an effective way of treating non-ischaemic lower limbs wounds, but it is not always used appropriately. There are many guidelines which set out how compression therapy should be used, but there is dearth of evidence about how it is actually used at a population level across Europe., Aim: The aim of this scoping review is to map the evidence published in English relating to the use of compression therapy to treat lower limb wounds across Europe., Methods: This scoping review will be conducted in line with the Joanna Briggs Institute and Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Protocols and Scoping Reviews guidance. A search for relevant publications will be conducted on variety of databases and key websites in order to identify a comprehensive range of relevant literature. Peer reviewed empirical papers, theoretical papers and other publications in English relating to the use of compression therapy across Europe will be considered for inclusion., Ethics and Dissemination: Ethical and research governance for this scoping review is not required because we will only gather secondary data. Our results will be disseminated to the widest possible audience through an open access paper in a peer reviewed international journal, conference presentations and a plain English summary. The results of this scoping review will be used by a panel of Key Opinion Leaders from across Europe to develop a driver diagram to underpin subsequent lower limb wound care improvement efforts., Competing Interests: Competing interests: One of the authors, NC is employed by the European Wound Management Association., (© 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.)

Introduction: Epidemiological data on dementia is not available in many European countries and regions due to the high cost and complexity of conducting large scale dementia screening studies. The available epidemiological studies identify potentially substantial variation in the prevalence of dementia over time and across Europe., Methods: In this paper we generate simulations of the number of dementia cases in Ireland from 1991 to 2036 using a three-state Markov illness-death model. Parameters values are selected for each simulation from a range using a random parameter search pattern. We employ a novel calibration method which exploits the strong relationship between dementia, ageing and mortality. Simulation weights are generated based on differences between observed and modelled cohorts of older people and the reported number of deaths from dementia. Irish Census data from 1991 to 2016 and the number of recorded deaths due to dementia in 2018 are used as calibration points. A weighted average projection of the number of dementia cases is generated., Results: We estimate a weighted average number of cases of dementia in 2016 of 54 877 increasing to 98 946 in 2036; this estimate is substantially lower than the estimates generated using extrapolation methods. We show the wide range of possible outcomes given the range in the available parameter estimates and show that irrespective of whether the incidence rate of dementia is declining the number of cases of dementia is rapidly increasing due to population ageing., Conclusion: Previous studies have used parameter estimates from meta-analyses of the literature or from individual studies. In this paper we supplement these with a calibration approach using observed cause of death and population age structure data. These additional sources of data can be used to generate estimates of dementia prevalence in any country or region which has census data and data on deaths due to dementia., 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.)

Introduction: Type 2 diabetes mellitus (T2DM) is a common and heterogeneous disease. Using advanced analytic approaches to explore real-world data may identify different disease characteristics, responses to treatment and progression patterns. Insulin glargine 300 units/mL (Gla-300) is a second-generation basal insulin analogue with preserved glucose-lowering efficacy but reduced risk of hypoglycaemia. The purpose of the REALI pooled analysis described in this paper is to advance the understanding of the effectiveness and real-world safety of Gla-300 based on a large European patient database of postmarketing interventional and observational studies., Methods and Analysis: In the current round of pooling, REALI will include data from up to 10 000 subjects with diabetes mellitus (mostly T2DM) from 20 European countries. Outcomes of interest include change from baseline to week 24 in haemoglobin A 1c , fasting plasma glucose, self-measured plasma glucose, body weight, insulin dose, incidence and rate of any-time-of-the-day and nocturnal hypoglycaemia. The data pool is being investigated using two complementary methodologies: a conventional descriptive, univariate and multivariable prognostic analysis; and a data-mining approach using subgroup discovery to identify phenotypic clusters of patients who are highly associated with the outcome of interest. By mid-2019, deidentified data of 7584 patients were included in the REALI database, with a further expected increase in patient number in 2020 as a result of pooling additional studies., Ethics and Dissemination: The proposed study does not involve collection of primary data. Moreover, all individual study protocols were approved by independent local ethics committees, and all study participants provided written informed consent. Furthermore, patient data is deidentified before inclusion in the REALI database. Hence, there is no requirement for ethical approval. Results will be disseminated via peer-reviewed publications and presentations at international congresses as data are analysed., Competing Interests: Competing interests: NF: research, travel or consultancy: Takeda, Pfizer, Biogen, Tesaro, Allergan, Ipsen, Sanofi and AstraZeneca. RCB: speakers’ bureau: Sanofi, Merck, Sharp & Dohme, Bristol-Myers Squibb, AstraZeneca and Janssen; Advisory panel: Merck, Sharp & Dohme, Eli Lilly, Sanofi and Johnson & Johnson. PG: research: AstraZeneca, Novo Nordisk and Sanofi; speakers' bureau and consultancy: Abbott, Amgen, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Novo Nordisk, Sanofi, Servier and Takeda. DM: consultancy and/or speakers’ bureau: Almirall, Ascensia, AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Eli Lilly, Ferrer, Janssen, Menarini, Merck, Sharp & Dohme, Novartis, Novo Nordisk and Sanofi. DMW: speakers’ bureau and consultancy/advisory panel: Amgen, AstraZeneca, Boehringer Ingelheim, MSD (Merck & Co.), Novartis, Novo Nordisk and Sanofi. GB: IVIDATA employee on behalf of Sanofi. CM: IDDI employee. MR: Quinten employee. AC and MB: Sanofi employees., (© 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: Marginalised communities such as homeless people, people who use drugs (PWUD), lesbian, gay, bisexual, transgender and intersex people (LGBTI), prisoners, sex workers and undocumented migrants are at high risk of poor health and yet face substantial barriers in accessing health and support services. The Nobody Left Outside (NLO) Service Design Checklist aims to promote a collaborative, evidence-based approach to service design and monitoring based on equity, non-discrimination and community engagement., Methods: The Checklist was a collaborative project involving nine community advocacy organisations, with a focus on homeless people, PWUD, LGBTI people, prisoners, sex workers, and undocumented migrants. The Checklist was devised via a literature review; two NLO platform meetings; a multistakeholder policy workshop and an associated published concept paper; two conference presentations; and stakeholder consultation via a European Commission-led Thematic Network (including webinar)., Results: The NLO Checklist has six sections in line with the WHO Health Systems Framework. These are: (1) service delivery, comprising design stage (6 items), services provided (2 items), accessibility and adaptation (16 items), peer support (2 items); (2) health workforce (12 items); (3) health information systems (7 items); (4) medical products and technologies (1 item); (5) financing (3 items); and (6) leadership and governance (7 items). It promotes the implementation of integrated (colocated or linked) healthcare services that are community based and people centred. These should provide a continuum of needs-based health promotion, disease prevention, diagnosis, treatment and management, together with housing, legal and social support services, in alignment with the goals of universal health coverage and the WHO frameworks on integrated, people-centred healthcare., Conclusions: The Checklist is offered as a practical tool to help overcome inequalities in access to health and support services. Policymakers, public health bodies, healthcare authorities, practitioner bodies, peer support workers and non-governmental organisations can use it when developing, updating or monitoring services for target groups. It may also assist civil society in wider advocacy efforts to improve access for underserved communities., Competing Interests: Competing interests: JVL reports research grants from AbbVie, Gilead and MSD, outside of the submitted work. LB is an employee of Interel (Brussels, Belgium), which received fees from MSD as part of the grant supporting the NLO initiative., (© 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.)

Objectives: This paper aims to investigate resident, facility and country characteristics associated with length of stay in long-term care facilities (LTCFs) across six European countries., Setting: Data from a cross-sectional study of deceased residents, conducted in LTCFs in Belgium, England, Finland, Italy, the Netherlands and Poland., Participants: All residents aged 65 years and older at admission who died in a 3-month period residing in a proportional random sample of LTCFs were included., Primary and Secondary Outcome Measures: The primary outcome was length of stay in days, calculated from date of admission and date of death. Resident, facility and country characteristics were included in a proportional hazards model., Results: The proportion of deaths within 1 year of admission was 42% (range 32%-63%). Older age at admission (HR 1.04, 95% CI 1.03 to 1.06), being married/in a civil partnership at time of death (HR 1.47, 95% CI 1.13 to 1.89), having cancer at time of death (HR 1.60, 95% CI 1.22 to 2.10) and admission from a hospital (HR 1.84, 95% CI 1.43 to 2.37) or another LTCF (HR 1.81, 95% CI 1.37 to 2.40) were associated with shorter lengths of stay across all countries. Being female (HR 0.72, 95% CI 0.57 to 0.90) was associated with longer lengths of stay., Conclusions: Length of stay varied significantly between countries. Factors prior to LTCF admission, in particular the availability of resources that allow an older adult to remain living in the community, appear to influence length of stay. Further research is needed to explore the availability of long-term care in the community prior to admission and its influence on the trajectories of LTCF residents in Europe., 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.)

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

Introduction: Health systems in North America and Europe have been criticised for their lack of safety, efficiency and effectiveness despite rising healthcare costs. In response, healthcare leaders and researchers have articulated the need to transform current health systems into continuously and rapidly learning health systems (LHSs). While digital technology has been envisioned as providing the transformational power for LHSs by generating timely evidence and supporting best care practices, it remains to be ascertained if it is indeed playing this role in current LHS initiatives. This paper presents a protocol for a scoping review that aims at providing a comprehensive understanding of how and to what extent digital technology is used within LHSs. Results will help to identify gaps in the literature as a means to guide future research on this topic., Methods and Analysis: Multiple databases and grey literature will be searched with terms related to learning health systems. Records selection will be done in duplicate by two reviewers applying pre-defined inclusion and exclusion criteria. Data extraction from selected records will be done by two reviewers using a piloted data charting form. Results will be synthesised through a descriptive numerical summary and a mapping of digital technology use onto types of LHSs and phases of learning within LHSs., Ethics and Dissemination: Ethical approval is not required for this scoping review. Preliminary results will be shared with stakeholders to account for their perspectives when drawing conclusions. Final results will be disseminated through presentations at relevant conferences and publications in peer-reviewed journals., 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.)

Introduction: Including the patient perspective is important to achieve optimal outcomes in the treatment of rheumatoid arthritis (RA). Ample qualitative studies exist on patient outcomes in RA. A Belgian study recently unravelled what matters most to patients throughout the overwhelming and rapidly evolving early stage of RA. The present study, European Qualitative research project on Patient-preferred outcomes in Early Rheumatoid Arthritis (EQPERA) was created to contribute to a more universal understanding of patient-preferred health and treatment outcomes by integrating the perspectives of patients with early RA from three European countries., Methods and Analysis: In EQPERA, a qualitative, explorative, longitudinal study will be implemented in The Netherlands and Sweden, parallel to the methods applied in the previously conducted Belgian study. In each country, a purposive sample of patients with early RA will be individually interviewed 3-6 months after start of the initial RA treatment and subsequently, the same participants will be invited to take part in a focus group 12-18 months after RA treatment initiation. Data collection and analysis will be independently conducted by the local research teams in their native language. A meta-analysis of the local findings will be performed to explore and describe similarities, differences and patterns across countries., Ethics and Dissemination: Ethics approval was granted by the responsible local ethics committees. EQPERA follows the recommendations of the Declaration of Helsinki. Two main papers are foreseen (apart from the data reporting on the local findings) for peer-reviewed publication., 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.)

Introduction: Promoting physical activity (PA) and reducing sedentary behaviour (SB) may exert beneficial effects on the older adult population, improving behavioural, functional, health and psychosocial outcomes in addition to reducing health, social care and personal costs. This paper describes the planned economic evaluation of SITLESS, a multicountry three-armed pragmatic randomised controlled trial (RCT) which aims to assess the short-term and long-term effectiveness and cost-effectiveness of a complex intervention on SB and PA in community-dwelling older adults, based on exercise referral schemes enhanced by a group intervention providing self-management strategies to encourage lifestyle change., Methods and Analysis: A within-trial economic evaluation and long-term model from both a National Health Service/personal social services perspective and a broader societal perspective will be undertaken alongside the SITLESS multinational RCT. Healthcare costs (hospitalisations, accident and emergency visits, appointment with health professionals) and social care costs (eg, community care) will be included in the economic evaluation. For the cost-utility analysis, quality-adjusted life-years will be measured using the EQ-5D-5L and capability well-being measured using the ICEpop CAPability measure for Older people (ICECAP-O) questionnaire. Other effectiveness outcomes (health related, behavioural, functional) will be incorporated into a cost-effectiveness analysis and cost-consequence analysis.The multinational nature of this RCT implies a hierarchical structure of the data and unobserved heterogeneity between clusters that needs to be adequately modelled with appropriate statistical and econometric techniques. In addition, a long-term population health economic model will be developed and will synthesise and extrapolate within-trial data with additional data extracted from the literature linking PA and SB outcomes with longer term health states.Methods guidance for population health economic evaluation will be adopted including the use of a long-time horizon, 1.5% discount rate for costs and benefits, cost consequence analysis framework and a multisector perspective., Ethics and Dissemination: The study design was approved by the ethics and research committee of each intervention site: the Ethics and Research Committee of Ramon Llull University (reference number: 1314001P) (Fundació Blanquerna, Spain), the Regional Committees on Health Research Ethics for Southern Denmark (reference number: S-20150186) (University of Southern Denmark, Denmark), Office for Research Ethics Committees in Northern Ireland (ORECNI reference number: 16/NI/0185) (Queen's University of Belfast) and the Ethical Review Board of Ulm University (reference number: 354/15) (Ulm, Germany). Participation is voluntary and all participants will be asked to sign informed consent before the start of the study.This project has received funding from the European Union's Horizon 2020 research and innovation programme under grant agreement number 634 270. This article reflects only the authors' view and the Commission is not responsible for any use that may be made of the information it contains.The findings of the study will be disseminated to different target groups (academia, policymakers, end users) through different means following the national ethical guidelines and the dissemination regulation of the Horizon 2020 funding agency.Use of the EuroQol was registered with the EuroQol Group in 2016.Use of the ICECAP-O was registered with the University of Birmingham in March 2017., Trial Registration Number: NCT02629666; Pre-results., 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 a need for fast-acting, non-injection antiagitation treatments that are well tolerated and can be used outside of healthcare facilities. In phase II/III trials, an inhaled formulation of loxapine (ADASUVE®), a well-established, first-generation antipsychotic agent, provided rapid control of mild to moderate agitation in the hospital setting. The present study was designed to investigate the safety and efficacy of inhaled loxapine when self-administered outside the hospital setting., Methods and Analysis: This phase IV, multicentre, single-arm, open-label clinical trial is being conducted in five countries in Europe: Spain, Germany, Norway, Romania and Austria. The aim is to include approximately 500 patients with schizophrenia or bipolar disorder who previously received and responded well to inhaled loxapine in the hospital setting. Eligible patients will be followed up for 6 months from baseline. They will be given a 10 mg dose of inhaled loxapine to self-administer outside the hospital setting to treat an agitation episode, should one occur. Patients will also be given a short-acting beta-agonist bronchodilator for treatment of possible severe respiratory side effects. The primary endpoint is incidence of serious adverse events (AEs) and respiratory AEs of special interest related to use of inhaled loxapine outside the hospital setting. Secondary endpoints include incidence of other AEs, Clinical Global Impression-Improvement scores up to 2 hours after self-administration of inhaled loxapine, time to improvement of agitation, patient satisfaction with treatment, treatment outcomes according to agitation severity and concordance between the patient (or a family member/caregiver) and the physician in scoring of agitation severity and the decision to self-administer inhaled loxapine., Ethics and Dissemination: The protocol received ethics committee approval in the participating countries between January and August 2016. The results of this study will be disseminated through one or more scientific papers., Trial Registration Number: EudraCT2015-003331-36; NCT02525991; Pre-results., Competing Interests: Competing interests: All authors are employees of Ferrer Internacional S.A., (© 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: Electronic healthcare databases (EHDs) are useful tools for drug development and safety evaluation but their heterogeneity of structure, validity and access across Europe complicates the conduct of multidatabase studies. In this paper, we provide insight into available EHDs to support regulatory decisions on medicines., Methods: EHDs were identified from publicly available information from the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance resources database, textbooks and web-based searches. Databases were selected using criteria related to accessibility, longitudinal dimension, recording of exposure and outcomes, and generalisability. Extracted information was verified with the database owners., Results: A total of 34 EHDs were selected after applying key criteria relevant for regulatory purposes. The most represented regions were Northern, Central and Western Europe. The most frequent types of data source were electronic medical records (44.1%) and record linkage systems (29.4%). The median number of patients registered in the 34 data sources was 5 million (range 0.07-15 million) while the median time covered by a database was 18.5 years. Paediatric patients were included in 32 databases (94%). Completeness of information on drug exposure was variable. Published validation studies were found for only 17 databases (50%). Some level of access exists for 25 databases (73.5%), and 23 databases (67.6%) can be linked through a personal identification number to other databases with parent-child linkage possible in 7 (21%) databases. Eight databases (23.5%) were already transformed or were in the process of being transformed into a common data model that could facilitate multidatabase studies., Conclusion: A Few European databases meet minimal regulatory requirements and are readily available to be used in a regulatory context. Accessibility and validity information of the included information needs to be improved. This study confirmed the fragmentation, heterogeneity and lack of transparency existing in many European EHDs., 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 early diffusion of indirect comparison meta-analytic methods to study drugs., Design: Systematic literature synthesis., Data Sources: Cochrane Database of Systematic Reviews, EMBASE, MEDLINE, Scopus and Web of Science., Study Selection: English language papers that used indirect comparison meta-analytic methods to study the efficacy or safety of three or more interventions, where at least one was a drug., Data Extraction: The number of publications and authors was plotted by year and type: methodological contribution, review or empirical application. Author and methodological details were summarised for empirical applications, and animated coauthorship networks were created to visualise contributors by country and affiliation type (academia, industry, government or other) over time., Results: We identified 477 papers (74 methodological contributions, 42 reviews and 361 empirical applications) by 1689 distinct authors from 1997 to 2013. Prior to 2002, only three applications were published, with contributions from the USA (n=2) and Canada (n=1). The number of applications gradually increased annually with rapid uptake between 2011 and 2013 (n=254, 71%). Early diffusion occurred primarily in Europe with the first application credited to the UK in 2003. Application spread to other European countries in 2005, and may have been supported by regulatory requirements for drug approval. By the end of 2013, contributions included 49% credited to Europe (22% UK, 27% other), 37% credited to North America (11% Canada, 26% USA) and 14% from other regions., Conclusion: Indirect comparison meta-analytic methods are an important innovation for health research. Although Canada and the USA were the first to apply these methods, Europe led their diffusion. The increase in uptake of these methods may have been facilitated by acceptance by regulatory agencies, which are calling for more comparative drug effect data to assist in drug accessibility and reimbursement decisions., 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.)

Objectives: This paper investigates (1) how social relationships (SRs) relate to the frequency of general practitioner (GP) visits among middle-aged and older adults in Europe, (2) if SRs moderate the association between self-rated health and GP visits, and (3) how the associations vary regarding employment status., Methods: Data stem from the Survey of Health, Ageing and Retirement in Europe project (wave 4, 56 989 respondents, 50 years or older). GP use was assessed by frequency of contacts with GPs in the last 12 months. Predictors were self-rated health and structural (Social Integration Index (SII), social contact frequency) and functional (emotional closeness) aspects of SR. Regressions were used to measure the associations between GP use and those predictors. Sociodemographic and socioeconomic factors were used as covariates. Additional models were computed with interactions., Results: Analyses did not reveal significant associations of functional and structural aspects of SR with frequency of GP visits (SII: incidence rate ratio (IRR)=0.99, 95% CI 0.97 to 1.01, social contact frequency: IRR=1.04, 95% CI 1.00 to 1.07, emotional closeness: IRR=1.02, 95% CI 1.00 to 1.04). Moderator analyses showed that 'high social contact frequency people' with better health had more statistically significant GP visits than 'low social contact frequency people' with better health. Furthermore, people with poor health and an emotionally close network showed a significantly higher number of GP visits compared with people with same health, but less close networks. Three-way interaction analyses indicated employment status specific behavioural patterns with regard to SR and GP use, but coefficients were mostly not significant. All in all, the not employed groups showed a higher number of GP visits., Conclusions: Different indicators of SR showed statistically insignificantly associations with GP visits. Consequently, the relevance of SR may be rated rather low in quantitative terms for investigating GP use behaviour of middle-aged and older adults in Europe. Nevertheless, investigating the two-way and three-way interactions indicated potential inequalities in GP use due to different characteristics of SR accounting for health and employment status., 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.)

Introduction: Improving our understanding of outbreaks due to antibiotic-resistant bacteria (ARB) and their control is critical in the current public health scenario. The threat of outbreaks due to ARB requires multifaceted efforts. However, a global overview of epidemiological characteristics of outbreaks due to ARB and effective infection control measures is missing. In this paper, we describe the protocol of a systematic review aimed at mapping and characterising the epidemiological aspects of outbreaks due to ARB and infection control measures in European countries., Methods and Analysis: The databases MEDLINE, Web of Knowledge and Cochrane library will be searched using a 3-step search strategy. Selection of articles for inclusion will be performed by 2 reviewers using predefined eligibility criteria. All study designs will be included if they report an outbreak and define the microbiological methods used for microorganism identification. The target bacteria will be methicillin-resistant and vancomycin-resistant Staphylococcus aureus, vancomycin-resistant Enterococcus, ceftazidime-resistant and carbapenem-resistant Acinetobacter baumannii, ceftazidime-resistant and carbapenem-resistant Pseudomonas aeruginosa, ciprofloxacin-resistant Escherichia coli, extended-spectrum β-lactamase-producing E. coli and Klebsiella pneumoniae, carbapenem-resistant and carbapenamase-producing Enterobacteriaceae. Data will be extracted using a tailored pilot tested form and the quality of reporting will be assessed using the ORION (Outbreak Reports and Intervention Studies Of Nosocomial infections) tool. Data will be synthesised and reported by the type of ARB, setting and country. Infection control measures and bundles of measures will be described. The effectiveness will be reported as defined by the authors. Regression analysis will be used to define independent factors associated with outbreaks' control. Heterogeneity between studies will be assessed by forest plots and I² statistics., Ethics and Dissemination: Ethical approval is not applicable for this study. Findings will be disseminated through journal publication and conference presentations and talks., Competing Interests: FS is an employee of AstraZeneca, an EFPIA (European Federation of Pharmaceutical Industries and Association) member company in the IMI JU and costs related to his research contributions were covered by AstraZeneca as in-kind contribution under the IMI JU agreement., (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/.)

Introduction: Increasing numbers of the population are living with long-term life-limiting conditions with a significant proportion characterised by multimorbidity. Patients with these conditions often experience high volumes of clinical interaction involving them, their caregivers and healthcare providers in complex patterns of organising, coordinating, negotiating and managing care. A better understanding of the sources of experienced complexity and multimorbidity, from the patient perspective is paramount to improve capacity and manage workload to promote improved experience of illness, more effective healthcare utilisation and improved healthcare outcomes. To better understand the sources of complexity we will undertake an evidence synthesis of qualitative studies of patient and informal carer experiences of three common long-term life-limiting conditions. We will investigate what is known about these diseases at different stages in disease progression, treatment regimens and places of care., Method and Analysis: We will include qualitative studies of patients' and carers' (aged >18) accounts of their experiences of healthcare provision in a range of settings and healthcare systems. We will conduct an extensive electronic database search of publications in English between 2000 and 2014. Results and discussions sections of the papers will be regarded as formal data using the constant comparison method of qualitative analysis. From the meta-synthesis results, we will build a conceptual model of mechanisms and processes that shape patients' journeys towards end of life to suggest where in the patient journey new interventions to improve patient and carer experience can be developed and delivered. The study is being conducted between 1 December 2014 and 31 December 2015., Ethics and Dissemination: No human subjects or personal data are involved and no ethical issues are anticipated. An important element of dissemination is informing user communities about the practical implications of the work through workshops, meetings and social media. Scientific results will be published in peer reviewed journals and disseminated through conferences., Trial Registration Number: PROSPERO CRD42014014547., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)

Objective: Non-communicable diseases (NCDs) are the biggest cause of death in Europe putting an unsustainable burden on already struggling health systems. Increases in obesity are a major cause of NCDs. This paper projects the future burden of coronary heart disease (CHD), stroke, type 2 diabetes and seven cancers by 2030 in 53 WHO European Region countries based on current and past body mass index (BMI) trends. It also tests the impact of obesity interventions on the future disease burden., Setting and Participants: Secondary data analysis of country-specific epidemiological data using a microsimulation modelling process., Interventions: The effect of three hypothetical scenarios on the future burden of disease in 2030 was tested: baseline scenario, BMI trends go unchecked; intervention 1, population BMI decreases by 1%; intervention 2, BMI decreases by 5%., Primary and Secondary Outcome Measures: Quantifying the future burden of major NCDs and the impact of interventions on this future disease burden., Results: By 2030 in the whole of the European region, the prevalence of diabetes, CHD and stroke and cancers was projected to reach an average of 3990, 4672 and 2046 cases/100 000, respectively. The highest prevalence of diabetes was predicted in Slovakia (10 870), CHD and stroke-in Greece (11 292) and cancers-in Finland (5615 cases/100 000). A 5% fall in population BMI was projected to significantly reduce cumulative incidence of diseases. The largest reduction in diabetes and CHD and stroke was observed in Slovakia (3054 and 3369 cases/100 000, respectively), and in cancers was predicted in Germany (331/100 000)., Conclusions: Modelling future disease trends is a useful tool for policymakers so that they can allocate resources effectively and implement policies to prevent NCDs. Future research will allow real policy interventions to be tested; however, better surveillance data on NCDs and their risk factors are essential for research and policy., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)