bluuebunny/crossref_metadata_2025_split huggingface dataset:
A protocol for an economic evaluation of a polypill in patients with established or at high risk of cardiovascular disease in a UK NHS setting: RUPEE (NHS) study
Authors: Crossan Catriona , Dehbi Hakim-Moulay , Williams Hilarie , Poulter Neil , Rodgers Anthony , Jan Stephen , Thom Simon , Lord Joanne 
Published: March 2018

IntroductionThe ‘Use of a Multi-drug Pill in Reducing cardiovascular Events’ (UMPIRE) trial was a randomised controlled clinical trial evaluating the impact of a polypill strategy on adherence to indicated medication in a population with established cardiovascular disease (CVD) of or at high risk thereof. The aim of Researching the UMPIRE Processes for Economic Evaluation in the National Health Service (RUPEE NHS) is to estimate the potential health economic impact of a polypill strategy for CVD prevention within the NHS using UMPIRE trial and other relevant data. This paper describes the design of a modelled economic evaluation of the impact of increased adherence to the polypill versus usual care among the UK UMPIRE participants.Methods and analysisAs recommended by the International Society for Pharmacoeconomics and Outcomes Research and the Society for Medical Decision Making modelling guidelines, a review of published CVD models was undertaken to identify the most appropriate modelling approach and structure. The review was carried out in the electronic databases, MEDLINE and EMBASE. 40 CVD models were identified from 57 studies, the majority of economic models were health state transition cohort models and individual-level simulation models. The findings were discussed with clinical experts to confirm the approach and structure. An individual simulation approach was identified as the most suitable method to capture the heterogeneity in the population at CVD risk. RUPEE-NHS will use UMPIRE trial data on adherence to estimate the long-term cost-effectiveness of the polypill strategy.DisseminationThe evaluation findings will be presented in open-access scientific and healthcare policy journals and at national and international conferences. We will also present findings to NHS policy makers and pharmaceutical companies.
Postpartum urinary tract infection by mode of delivery: a Danish nationwide cohort study
Authors: Gundersen Tina Djernis , Krebs Lone , Loekkegaard Ellen Christine Leth , Rasmussen Steen Christian , Glavind Julie , Clausen Tine Dalsgaard 
Published: March 2018

ObjectivesTo examine the association between postpartum urinary tract infection and intended mode of delivery as well as actual mode of delivery.DesignRetrospective cohort study.Setting and participantsAll live births in Denmark between 2004 and 2010 (n=450 856). Births were classified by intended caesarean delivery (n=45 053) or intended vaginal delivery (n=405 803), and by actual mode of delivery: spontaneous vaginal delivery, operative vaginal delivery, emergency or planned caesarean delivery in labour or prelabour.Primary and secondary outcome measuresThe primary outcome measure was postpartum urinary tract infection (n=16 295) within 30 days post partum, defined as either a diagnosis of urinary tract infection in the National Patient Registry or redemption of urinary tract infection-specific antibiotics recorded in the Register of Medicinal Product Statistics.ResultsWe found that 4.6% of women with intended caesarean delivery and 3.5% of women with intended vaginal delivery were treated for postpartum urinary tract infection.Women with intended caesarean delivery had a significantly increased risk of postpartum urinary tract infection compared with women with intended vaginal delivery (OR 1.33, 95% CI 1.27 to 1.40), after adjustment for age at delivery, smoking, body mass index, educational level, gestational diabetes mellitus, infection during pregnancy, birth weight, preterm delivery, preterm prelabour rupture of membranes, pre-eclampsia, parity and previous caesarean delivery (adjusted OR 1.24, 95% CI 1.17 to 1.46).Using actual mode of delivery as exposure, all types of operative delivery had an equally increased risk of postpartum urinary tract infection compared with spontaneous vaginal delivery.ConclusionsCompared with intended vaginal delivery, intended caesarean delivery was significantly associated with a higher risk of postpartum urinary tract infection. Future studies should focus on reducing routine catheterisation prior to operative vaginal delivery as well as improving procedures related to catheterisation.
Psychological interventions for positive symptoms in schizophrenia: protocol for a network meta-analysis of randomised controlled trials
Authors: Bighelli Irene , Salanti Georgia , Reitmeir Cornelia , Wallis Sofia , Barbui Corrado , Furukawa Toshi A , Leucht Stefan 
Published: March 2018

IntroductionThere is rising awareness that we need multidisciplinary approaches integrating psychological treatments for schizophrenia, but a comprehensive evidence based on their relative efficacy is lacking. We will conduct a network meta-analysis (NMA), integrating direct and indirect comparisons from randomised controlled trials (RCTs) to rank psychological treatments for schizophrenia according to their efficacy, acceptability and tolerability.Methods and analysisWe will include all RCTs comparing a psychological treatment aimed at positive symptoms of schizophrenia with another psychological intervention or with a no treatment condition (waiting-list and treatment as usual). We will include studies on adult patients with schizophrenia, excluding specific subpopulations (eg, first-episode patients or patients with psychiatric comorbidities). Primary outcome will be the change in positive symptoms on a published rating scale. Secondary outcomes will be acceptability (dropout), change in overall and negative symptoms of schizophrenia, response, relapse, adherence, depression, quality of life, functioning and adverse events. Published and unpublished studies will be sought through database searches, trial registries and websites. Study selection and data extraction will be conducted by at least two independent reviewers. We will conduct random-effects NMA to synthesise all evidences for each outcome and obtain a comprehensive ranking of all treatments. NMA will be conducted in Stata and R within a frequentist framework. The risk of bias in studies will be evaluated using the Cochrane Risk of Bias tool and the credibility of the evidence will be evaluated using an adaptation of the Grading of Recommendations Assessment, Development and Evaluation framework to NMA, recommended by the Cochrane guidance. Subgroup and sensitivity analyses will be conducted to assess the robustness of the findings.Ethics and disseminationNo ethical issues are foreseen. Results from this study will be published in peer-reviewed journals and presented at relevant conferences.PROSPERO registration numberCRD42017067795.
Prevalence and factors associated with exposure to secondhand smoke (SHS) among young people: a cross-sectional study from the Gambia
Authors: Jallow Isatou K , Britton John , Langley Tessa 
Published: March 2018

BackgroundAnnually, 600 000 deaths are attributed to exposure of non-smokers to secondhand smoke (SHS). These include 165 000 among children, about 60% of which occur in Africa and Southeast Asia. As of 2017, only seven countries in the African region had comprehensive smoke-free legislation covering all public places. Given the increasing prevalence of smoking in many low-income countries, preventing exposure to SHS is an urgent public health priority, particularly in Sub-Saharan Africa.ObjectivesThe objective of this study is to obtain a reliable and nationally representative estimate of the prevalence of exposure to SHS and to identify the major risk factors among young people in The Gambia.Settings and methodsWe used a two-stage cluster random sampling to select students in secondary schools throughout The Gambia and a self-administered questionnaire to collect data on demographic characteristics and detailed indicators of exposure to SHS.ResultsOf the 10 392 eligible students, 10 289 (99%; 55% girls and 44% boys, age 12–20 years) participated. The proportion of students reporting any exposure to SHS was 97.0% (enclosed public places 59.2%, outdoor public places 61.4%, school 21.3% and home 38.2%), with 96.4% reporting some exposure outside the home. Exposure to SHS in the home was more common in girls and among older students. Parental education, living with parents and being sent to purchase cigarettes were associated with exposure to SHS both within and outside the home. More than 50% of students supported public smoking ban in both enclosed and outdoor public places. About 35% of students were unaware of the harmful effects of exposure to SHS.ConclusionsExposure to SHS is highly prevalent among students in The Gambia and occurs mostly outside of the home. Interventions to reduce SHS exposure in students are urgently needed.
What are healthcare providers’ understandings and experiences of compassion? The healthcare compassion model: a grounded theory study of healthcare providers in Canada
Authors: Sinclair Shane , Hack Thomas F , Raffin-Bouchal Shelley , McClement Susan , Stajduhar Kelli , Singh Pavneet , Hagen Neil A , Sinnarajah Aynharan , Chochinov Harvey Max 
Published: March 2018

BackgroundHealthcare providers are considered the primary conduit of compassion in healthcare. Although most healthcare providers desire to provide compassion, and patients and families expect to receive it, an evidence-based understanding of the construct and its associated dimensions from the perspective of healthcare providers is needed.ObjectivesThe aim of this study was to investigate healthcare providers’ perspectives and experiences of compassion in order to generate an empirically derived, clinically informed model.DesignData were collected via focus groups with frontline healthcare providers and interviews with peer-nominated exemplary compassionate healthcare providers. Data were independently and collectively analysed by the research team in accordance with Straussian grounded theory.Setting and participants57 healthcare providers were recruited from urban and rural palliative care services spanning hospice, home care, hospital-based consult teams, and a dedicated inpatient unit within Alberta, Canada.ResultsFive categories and 13 associated themes were identified, illustrated in the Healthcare Provider Compassion Model depicting the dimensions of compassion and their relationship to one another. Compassion was conceptualised as—a virtuous and intentional response to know a person, to discern their needs and ameliorate their suffering through relational understanding and action.ConclusionsAn empirical foundation of healthcare providers’ perspectives on providing compassionate care was generated. While the dimensions of the Healthcare Provider Compassion Model were congruent with the previously developed Patient Model, further insight into compassion is now evident. The Healthcare Provider Compassion Model provides a model to guide clinical practice and research focused on developing interventions, measures and resources to improve it.
Tools for assessing risk of reporting biases in studies and syntheses of studies: a systematic review
Authors: Page Matthew J , McKenzie Joanne E , Higgins Julian P T 
Published: March 2018

BackgroundSeveral scales, checklists and domain-based tools for assessing risk of reporting biases exist, but it is unclear how much they vary in content and guidance. We conducted a systematic review of the content and measurement properties of such tools.MethodsWe searched for potentially relevant articles in Ovid MEDLINE, Ovid Embase, Ovid PsycINFO and Google Scholar from inception to February 2017. One author screened all titles, abstracts and full text articles, and collected data on tool characteristics.ResultsWe identified 18 tools that include an assessment of the risk of reporting bias. Tools varied in regard to the type of reporting bias assessed (eg, bias due to selective publication, bias due to selective non-reporting), and the level of assessment (eg, for the study as a whole, a particular result within a study or a particular synthesis of studies). Various criteria are used across tools to designate a synthesis as being at ‘high’ risk of bias due to selective publication (eg, evidence of funnel plot asymmetry, use of non-comprehensive searches). However, the relative weight assigned to each criterion in the overall judgement is unclear for most of these tools. Tools for assessing risk of bias due to selective non-reporting guide users to assess a study, or an outcome within a study, as ‘high’ risk of bias if no results are reported for an outcome. However, assessing the corresponding risk of bias in a synthesis that is missing the non-reported outcomes is outside the scope of most of these tools. Inter-rater agreement estimates were available for five tools.ConclusionThere are several limitations of existing tools for assessing risk of reporting biases, in terms of their scope, guidance for reaching risk of bias judgements and measurement properties. Development and evaluation of a new, comprehensive tool could help overcome present limitations.
Cost-effectiveness of enhanced recovery in hip and knee replacement: a systematic review protocol
Authors: Murphy Jacqueline , Pritchard Mark G , Cheng Lok Yin , Janarthanan Roshni , Leal José 
Published: March 2018

IntroductionHip and knee replacement represents a significant burden to the UK healthcare system. ‘Enhanced recovery’ pathways have been introduced in the National Health Service (NHS) for patients undergoing hip and knee replacement, with the aim of improving outcomes and timely recovery after surgery. To support policymaking, there is a need to evaluate the cost-effectiveness of enhanced recovery pathways across jurisdictions. Our aim is to systematically summarise the published cost-effectiveness evidence on enhanced recovery in hip and knee replacement, both as a whole and for each of the various components of enhanced recovery pathways.Methods and analysisA systematic review will be conducted using MEDLINE, EMBASE, Econlit and the National Health Service Economic Evaluations Database. Separate search strategies were developed for each database including terms relating to hip and knee replacement/arthroplasty, economic evaluations, decision modelling and quality of life measures.We will extract peer-reviewed studies published between 2000 and 2017 reporting economic evaluations of preoperative, perioperative or postoperative enhanced recovery interventions within hip or knee replacement. Economic evaluations alongside cohort studies or based on decision models will be included. Only studies with patients undergoing elective replacement surgery of the hip or knee will be included. Data will be extracted using a predefined pro forma following best practice guidelines for economic evaluation, decision modelling and model validation.Our primary outcome will be the cost-effectiveness of enhanced recovery (entire pathway and individual components) in terms of incremental cost per quality-adjusted life year. A narrative synthesis of all studies will be presented, focussing on cost-effectiveness results, study design, quality and validation status.Ethics and disseminationThis systematic review is exempted from ethics approval because the work is carried out on published documents. The results of the review will be disseminated in a peer-reviewed academic journal and at conferences.PROSPERO registration numberCRD42017059473.
Understanding and scaffolding Danish schoolteachers’ motivation for using classroom-based physical activity: study protocol for a mixed methods study
Authors: Knudsen Louise Stjerne , Skovgaard Thomas , Bredahl Thomas 
Published: March 2018

IntroductionThe benefits of physical activity for children’s health, both mental and physical, and its positive effects on academic achievement are well established. Research also emphasises that schools could provide a natural setting for regular physical activity. There is, however, a limited amount of knowledge about teachers’ views when it comes to integrating physical activity as part of teaching. The aim of this study is to understand teachers’ motivation for integrating physical activity as part of teaching and to assess their need for guidance and support.Methods and analysisThe study uses an explanatory sequential mixed-methods design. Schools from across Denmark are included in the sample. The design comprises two separated phases—a quantitative and qualitative phase. The quantitative phase is guided by the self-determination theory where teachers’ motivation will be measured using the Work Task Motivation Scale for Teachers. The theory of scaffolding guides the qualitative phase, which consists of in-depth interviews with participants selected from the quantitative phase based on levels of motivation and on demographic information. In accordance with the study aims, the analysis of data will identify teachers’ internal and external levels of motivation. The purpose of the qualitative phase is to enhance understanding of teachers’ motivation and of their need for support in the use of physical activity in teaching.Ethics and disseminationAll relevant ethics approvals have been acquired. All participants in this study will provide written informed consent prior to data collection. All data emerging from the quantitative and qualitative phase will be anonymised for analysis. Ethics approval was requested from the Regional Committee on Health Research Ethics for Southern Denmark approval ID S-20162000–40 and the Danish Data Protection Agency approval ID 16/15491). The study was deemed not notifiable by both authorities.Trial registration numberNCT02894346; Pre-results.
Randomised controlled trial protocol to evaluate a fixed dose prothrombin complex concentrate against the variable dose in vitamin K antagonist related bleeding (PROPER3)
Authors: Abdoellakhan Rahat A , Khorsand Nakisa , Van Hest Reinier M , Veeger Nic , Ter Avest Ewoud , Ypma Paula F , Faber Laura M , Meijer Karina 
Published: March 2018

IntroductionThere is currently little evidence for the optimal dosing strategy of four-factor prothrombin complex concentrates (PCC) in vitamin K antagonist (VKA)-related bleeds. The generally accepted dosing strategy is the use of a variable dose calculated using patient-specific characteristics as per manufacturer’s instruction. However, evidence exists that the use of a fixed low dose of 1000 international units of factor IX (IU fIX) might also suffice. Recent studies indicate that in terms of haemostatic effectiveness, the fixed dosing strategy might be even superior to the variable dosing strategy. The PROPER3 (PROthrombin complex concentrate: Prospective Evaluation and Rationalisation, number 3) study aims to confirm the non-inferiority, and explore superiority, in haemostatic effectiveness of the fixed PCC dosing strategy compared with the variable dosing strategy in VKA-related extracranial bleeding emergencies.Methods and analysisThe study is designed as a randomised controlled multicentre non-inferiority trial. Eligibility criteria are an indication for PCC due to VKA-related extracranial bleeding in subjects 18 years of age or older. The control group will receive a variable dose, determined by patient-specific bodyweight and international normalised ratio. The intervention group is dosed a fixed 1000 IU fIX PCC. Primary outcome is the haemostatic effectiveness of both treatments, as defined by the 2016 International Society on Thrombosis and Haemostasis (ISTH) criteria. The sample size is set at 155 patients per treatment arm, requiring 310 patients in total. Non-inferiority on the proportion (risk) difference of the primary outcome will be evaluated using the asymptotic Wald test for non-inferiority. The non-inferiority margin is set at 6%. The primary analysis will be based on the per-protocol population.Ethics and disseminationStudy results will be published in an international journal, communicated to discipline-specific associations and presented at (inter)national meetings and congresses.Trial registration numberEUCTR2014-000392-33; Pre-results.
Device complications with addition of defibrillation to cardiac resynchronisation therapy for primary prevention
Authors: Barra Sérgio , Providência Rui , Boveda Serge , Duehmke Rudolf , Narayanan Kumar , Chow Anthony W , Piot Olivier , Klug Didier , Defaye Pascal , Gras Daniel , Deharo Jean-Claude , Milliez Paul , Da Costa Antoine , Mondoly Pierre , Gonzalez-Panizo Jorge , Leclercq Christophe , Heck Patrick , Virdee Munmohan , Sadoul Nicolas , Le Heuzey Jean-Yves , Marijon Eloi 
Published: March 2018

ObjectiveIn patients indicated for cardiac resynchronisation therapy (CRT), the choice between a CRT-pacemaker (CRT-P) versus defibrillator (CRT-D) remains controversial and indications in this setting have not been well delineated. Apart from inappropriate therapies, which are inherent to the presence of a defibrillator, whether adding defibrillator to CRT in the primary prevention setting impacts risk of other acute and late device-related complications has not been well studied and may bear relevance for device selection.MethodsObservational multicentre European cohort study of 3008 consecutive patients with ischaemic or non-ischaemic dilated cardiomyopathy and no history of sustained ventricular arrhythmias, undergoing CRT implantation with (CRT-D, n=1785) or without (CRT-P, n=1223) defibrillator. Using propensity score and competing risk analyses, we assessed the risk of significant device-related complications requiring surgical reintervention. Inappropriate shocks were not considered except those due to lead malfunction requiring lead revision.ResultsAcute complications occurred in 148 patients (4.9%), without significant difference between groups, even after considering potential confounders (OR=1.20, 95% CI 0.72 to 2.00, p=0.47). During a mean follow-up of 41.4±29 months, late complications occurred in 475 patients, giving an annual incidence rate of 26 (95% CI 9 to 43) and 15 (95% CI 6 to 24) per 1000 patient-years in CRT-D and CRT-P patients, respectively. CRT-D was independently associated with increased occurrence of late complications (HR=1.68, 95% CI 1.27 to 2.23, p=0.001). In particular, when compared with CRT-P, CRT-D was associated with an increased risk of device-related infection (HR 2.10, 95% CI 1.18 to 3.45, p=0.004). Acute complications did not predict overall late complications, but predicted device-related infection (HR 2.85, 95% CI 1.71 to 4.56, p<0.001).ConclusionsCompared with CRT-P, CRT-D is associated with a similar risk of periprocedural complications but increased risk of long-term complications, mainly infection. This needs to be considered in the decision of implanting CRT with or without a defibrillator.