bluuebunny/crossref_metadata_2025_split huggingface dataset:
Cohort profile: The Swedish National Register of Urinary Bladder Cancer (SNRUBC) and the Bladder Cancer Data Base Sweden (BladderBaSe)
Authors: Häggström Christel , Liedberg Fredrik , Hagberg Oskar , Aljabery Firas , Ströck Viveka , Hosseini Abolfazl , Gårdmark Truls , Sherif Amir , Malmström Per-Uno , Garmo Hans , Jahnson Staffan , Holmberg Lars 
Published: September 2017

PurposeTo monitor the quality of bladder cancer care, the Swedish National Register of Urinary Bladder Cancer (SNRUBC) was initiated in 1997. During 2015, in order to study trends in incidence, effects of treatment and survival of men and women with bladder cancer, we linked the SNRUBC to other national healthcare and demographic registers and constructed the Bladder Cancer Data Base Sweden (BladderBaSe).ParticipantsThe SNRUBC is a nationwide register with detailed information on 97% of bladder cancer cases in Sweden as compared with the Swedish Cancer Register. Participants in the SNRUBC have registered data on tumour characteristics at diagnosis, and for 98% of these treatment data have been captured. From 2009, the SNRUBC holds data on 88% of eligible participants for follow-up 5 years after diagnosis of non-muscle invasive bladder cancer, and from 2011, data on surgery details and complications for 85% of participants treated with radical cystectomy. The BladderBaSe includes all data in the SNRUBC from 1997 to 2014, and additional covariates and follow-up data from linked national register sources on comorbidity, socioeconomic factors, detailed information on readmissions and treatment side effects, and causes of death.Findings to dateStudies based on data in the SNRUBC have shown inequalities in survival and treatment indication by gender, regions and hospital volume. The BladderBaSe includes 38 658 participants registered in SNRUBC with bladder cancer diagnosed from 1 January 1997 to 31 December 2014. The BladderBaSe initiators are currently in collaboration with researchers from the SNRUBC investigating different aspects of bladder cancer survival.Future plansThe SNRUBC and the BladderBaSe project are open for collaborations with national and international research teams. Collaborators can submit proposals for studies and study files can be uploaded to servers for remote access and analysis. For more information, please contact the corresponding author.
Thiazide diuretics and the risk of hip fracture after stroke: a population-based propensity-matched cohort study using Taiwan’s National Health Insurance Research Database
Authors: Lin Shu-Man , Yang Shih-Hsien , Cheng Hung-Yu , Liang Chung-Chao , Huang Huei-Kai 
Published: September 2017

ObjectivesThis study aimed to investigate the association between thiazide use and the risk of hip fracture after stroke.SettingA population-based, propensity-matched cohort study was conducted on the basis of Taiwan’s National Health Insurance Research Database.ParticipantsPatients with newly diagnosed ischaemic stroke between 2000 and 2011 were included. After propensity score matching, 7470 patients were included, of whom 3735 received thiazides and 3735 did not.Outcome measuresHRs for developing hip fractures within 2 years after stroke were calculated using Cox proportional hazards regression model with adjustments for sociodemographic and coexisting medical conditions.ResultsOverall, patients using thiazides after stroke had a lower risk of hip fracture than those not using thiazides (8.5 vs 13.9 per 1000 person-years, adjusted HR=0.64, 95% CI 0.46 to 0.89, p=0.007). Further sensitivity analysis based on the duration of thiazide use revealed that the risk of hip fracture tended to decrease as the duration of exposure of thiazides increased. However, the effect was significant only in patients with long-term use of thiazides (using thiazides for >365 days within 2 years after stroke), with a 59% reduction in the risk of hip fracture when compared with patients not using thiazide (adjusted HR=0.41, 95% CI 0.22 to 0.79, p=0.008).ConclusionsThe long-term use of thiazides is associated with a decreased risk of hip fracture after stroke.
Presentation approaches for enhancing interpretability of patient-reported outcomes (PROs) in meta-analysis: a protocol for a systematic survey of Cochrane reviews
Authors: Devji Tahira , Johnston Bradley C , Patrick Donald L , Bhandari Mohit , Thabane Lehana , Guyatt Gordon H 
Published: September 2017

IntroductionMeta-analyses of clinical trials often provide sufficient information for decision-makers to evaluate whether chance can explain apparent differences between interventions. Interpretation of the magnitude and importance of treatment effects beyond statistical significance can, however, be challenging, particularly for patient-reported outcomes (PROs) measured using questionnaires with which clinicians have limited familiarity. The objectives of our study are to systematically evaluate Cochrane systematic review authors’ approaches to calculation, reporting and interpretation of pooled estimates of patient-reported outcome measures (PROMs) in meta-analyses.Methods and analysisWe will conduct a methodological survey of a random sample of Cochrane systematic reviews published from 1 January 2015 to 1 April 2017 that report at least one statistically significant pooled result for at least one PRO in the abstract. Author pairs will independently review all titles, abstracts and full texts identified by the literature search, and they will extract data using a standardised data extraction form. We will extract the following: year of publication, number of included trials, number of included participants, clinical area, type of intervention(s) and control(s), type of meta-analysis and use of the Grading of Recommendations, Assessment, Development and Evaluation approach to rate the quality of evidence, as well as information regarding the characteristics of PROMs, calculation and presentation of PROM effect estimates and interpretation of PROM effect estimates. We will document and summarise the methods used for the analysis, reporting and interpretation of each summary effect measure. We will summarise categorical variables with frequencies and percentages and continuous outcomes as means and/or medians and associated measures of dispersion.Ethics and disseminationEthics approval for this study is not required. We will disseminate the results of this review in peer-reviewed publications and conference presentations.
Clinical examination, critical care ultrasonography and outcomes in the critically ill: cohort profile of the Simple Intensive Care Studies-I
Authors: Hiemstra Bart , Eck Ruben J , Koster Geert , Wetterslev JÃ¸rn , Perner Anders , PettilÃ¤ Ville , Snieder Harold , Hummel Yoran M , Wiersema Renske , de Smet Anne Marie G A , Keus Frederik , van der Horst Iwan C C 
Published: September 2017

PurposeIn the Simple Intensive Care Studies-I (SICS-I), we aim to unravel the value of clinical and haemodynamic variables obtained by physical examination and critical care ultrasound (CCUS) that currently guide daily practice in critically ill patients. We intend to (1) measure all available clinical and haemodynamic variables, (2) train novices in obtaining values for advanced variables based on CCUS in the intensive care unit (ICU) and (3) create an infrastructure for a registry with the flexibility of temporarily incorporating specific (haemodynamic) research questions and variables. The overall purpose is to investigate the diagnostic and prognostic value of clinical and haemodynamic variables.ParticipantsThe SICS-I includes all patients acutely admitted to the ICU of a tertiary teaching hospital in the Netherlands with an ICU stay expected to last beyond 24 hours. Inclusion started on 27 March 2015.Findings to dateOn 31 December 2016, 791 eligible patients fulfilled our inclusion criteria of whom 704 were included. So far 11 substudies with additional variables have been designed, of which six were feasible to implement in the basic study, and two are planned and awaiting initiation. All researchers received focused training for obtaining specific CCUS images. An independent Core laboratory judged that 632 patients had CCUS images of sufficient quality.Future plansWe intend to optimise the set of variables for assessment of the haemodynamic status of the critically ill patient used for guiding diagnostics, prognosis and interventions. Repeated evaluations of these sets of variables are needed for continuous improvement of the diagnostic and prognostic models. Future plans include: (1) more advanced imaging; (2) repeated clinical and haemodynamic measurements; (3) expansion of the registry to other departments or centres; and (4) exploring possibilities of integration of a randomised clinical trial superimposed on the registry.Study registration numberNCT02912624; Pre-results.
Cross-sector user and provider perceptions on experiences of shared-care clozapine: a qualitative study
Authors: Sowerby Camilla , Taylor Denise 
Published: September 2017

Objectives(1) To explore individual perceptions on experiences of people receiving and/or delivering a shared-care clozapine serviceand (2) to gain an understanding of effectiveness and acceptability of shared-care clozapine.DesignInterpretative phenomenological analysis guided the delivery and analysis of a semistructured interview and focus group study designed to explore participant experience of shared-care clozapine. Ethical approval 13/EM/0286 was gained in July 2013 from East Midlands—Nottingham 1 REC.ParticipantsEight stakeholder groups from Adult and Forensic Mental Health involved in shared-care clozapine provision delivered in primary care were identified for recruitment from one mental health trust in England (six different groups of healthcare professionals (HCPs), clozapine service users (CSUs) and their carers). To be eligible for recruitment, all potential participants had to be either providing, receiving or the carer of a person receiving clozapine by shared care.Results32 HCPs and 6 CSUs were recruited and 14 interviews and 6 participant homogenous focus groups were run. Four shared superordinate themes were identified: Clozapine Process, The Sharing of Care, The Provision of Care and Multi-professional Relationships. Differences between Adult and Forensic engagement in shared care were noted and both HCP and CSU relationships were mapped to the Wish conceptual framework of relationships to provide insight into how shared-care clozapine can provide a mechanism for provision of person-centred care, which was present in the Forensic HCP–CSU but not General Adult HCP–CSU relationship.ConclusionsThe Forensic HCP/CSU relationship demonstrated how cross-sector working through shared-care clozapine can provide a mechanism for provision of person-centred care by enabling a person-centred focus to care delivery which supported CSUs to live as independently as possible. Person-centred care demonstrably improves patient care outcomes and wider implementation of shared-care clozapine could provide greater integration of people with serious mental illness and reduce stigma within the community while improving patient outcomes.
Development of a physical activity monitoring tool for Thai medical schools: a protocol for a mixed methods study
Authors: Wattanapisit Apichai , Vijitpongjinda Surasak , Saengow Udomsak , Amaek Waluka , Thanamee Sanhapan , Petchuay Prachyapan 
Published: September 2017

IntroductionPhysical activity (PA) is important in promoting health, as well as in the treatment and prevention of diseases. However, insufficient PA is still a global health problem and it is also a problem in medical schools. PA training in medical curricula is still sparse or non-existent. There is a need for a comprehensive understanding of the extent of PA in medical schools through several indicators, including people, places and policies. This study includes a survey of the PA prevalence in a medical school and development of a tool, the Medical School Physical Activity Report Card (MSPARC), which will contain concise and understandable infographics and information for exploring, monitoring and reporting information relating to PA prevalence.Methods and analysisThis mixed methods study will run from January to September 2017. We will involve the School of Medicine, Walailak University, Thailand, and its medical students (n=285). Data collection will consist of both primary and secondary data, divided into four parts: general information, people, places and policies. We will investigate the PA metrics about (1) people: the prevalence of PA and sedentary behaviours; (2) place: the quality and accessibility of walkable neighbourhoods, bicycle facilities and recreational areas; and (3) policy: PA promotion programmes for medical students, education metrics and investments related to PA. The MSPARC will be developed using simple symbols, infographics and short texts to evaluate the PA metrics of the medical school.Ethics and disseminationThis study has been approved by the Human Research Ethics Committee of Walailak University (protocol number: WUEC-16-005-01). Findings will be published in peer-reviewed journals and presented at national or international conferences. The MSPARC and full report will be disseminated to relevant stakeholders, policymakers, staff and clients.
Influence of allocation concealment and intention-to-treat analysis on treatment effects of physical therapy interventions in low back pain randomised controlled trials: a protocol of a meta-epidemiological study
Authors: Almeida Matheus Oliveira , Saragiotto Bruno T , Maher Chris G , Pena Costa Leonardo Oliveira 
Published: September 2017

IntroductionMeta-epidemiological studies examining the influence of methodological characteristics, such as allocation concealment and intention-to-treat analysis have been performed in a large number of healthcare areas. However, there are no studies investigating these characteristics in physical therapy interventions for patients with low back pain. The aim of this study is to investigate the influence of allocation concealment and the use of intention-to-treat analysis on estimates of treatment effects of physical therapy interventions in low back pain clinical trials.Methods and analysisSearches on PubMed, Embase, Cochrane Database of Systematic Reviews, Physiotherapy Evidence Database (PEDro) and CINAHL databases will be performed. We will search for systematic reviews that include a meta-analysis of randomised controlled trials that compared physical therapy interventions in patients with low back pain with placebo or no intervention, and have pain intensity or disability as the primary outcomes. Information about selection (allocation concealment) and attrition bias (intention-to-treat analysis) will be extracted from the PEDro database for each included trial. Information about bibliographic data, study characteristics, participants’ characteristics and study results will be extracted. A random-effects model will be used to provide separate estimates of treatment effects for trials with and without allocation concealment and with and without intention-to-treat analysis (eg, four estimates). A meta-regression will be performed to measure the association between methodological features and treatment effects from each trial. The dependent variable will be the treatment effect (the mean between-group differences) for the primary outcomes (pain or disability), while the independent variables will be the methodological features of interest (allocation concealment and intention-to-treat analysis). Other covariates will include sample size and sequence generation.Ethics and disseminationNo ethical approval will be required for this study. The study findings will be published in a peer-reviewed journal and presented at international conferences.Registration numberInternational Prospective Register of Systematic Reviews (CRD42016052347).
Association between vomiting in the first trimester and preterm birth: a retrospective birth cohort study in Wuhan, China
Authors: Hu Ronghua , Chen Yawen , Zhang Yiming , Qian Zhengmin , Liu Yan , Vaughn Michael G , Xu Shunqing , Zheng Tongzhang , Liu Mingzhu , Zhang Bin 
Published: September 2017

ObjectiveAlthough vomiting in the first trimester has been reported to be associated with preterm birth (PTB), findings supporting this association remain inconsistent. Our aim was to assess the association between vomiting and PTB, as well as evaluate if the association is modified by pre-pregnancy body mass index (BMI).DesignA retrospective cohort study.SettingWuhan, a central city of China.ParticipantsA total of 317 463 pregnant women who had a live, singleton newborn from 1 January 2010 to 23 May 2016 were enrolled in our study.Main outcome measurePTB was defined as gestational age <37 gestational weeks. Gestational age was calculated using reports from mothers based on the first day of their last menstrual period. An ultrasound was routinely used to determine gestational age before 12 gestational weeks.ResultsOf the 317 463 pregnant women, 29.88% (94 857) experienced vomiting in the first trimester and 5.00% (15 889) experienced a PTB. Vomiting in the first trimester increased the risk for PTB and the multivariable adjusted OR was 1.05 (95% CI 1.02 to 1.09). In the stratified analyses, the association of vomiting in the first trimester was significant among underweight women (adjusted OR=1.08, 95% CI 1.04 to 1.17) and normal pre-pregnancy BMI women (adjusted OR=1.06, 95% CI 1.02 to 1.11), but not in overweight women (adjusted OR=1.01, 95% CI 0.90 to 1.14) and obese women (adjusted OR=0.93, 95% CI 0.73 to 1.19).ConclusionsOur study indicates that vomiting in the first trimester was associated with PTB. Additionally, women with underweight and normal pre-pregnancy BMI who experienced vomiting are more likely to have a PTB.
Building a collaborative culture in cardiothoracic operating rooms: pre and postintervention study protocol for evaluation of the implementation of teamSTEPPS training and the impact on perceived psychological safety
Authors: Dahl Aaron Benjamin , Ben Abdallah Arbi , Maniar Hersh , Avidan Michael Simon , Bollini Mara L , Patterson George Alexander , Steinberg Aaron , Scaggs Katie , Dribin Brenda V , Ridley Clare H 
Published: September 2017

IntroductionThe importance of effective communication, a key component of teamwork, is well recognised in the healthcare setting. Establishing a culture that encourages and empowers team members to speak openly in the cardiothoracic (CT) operating room (OR) is necessary to improve patient safety in this high-risk environment.Methods and analysisThis study will take place at Barnes-Jewish Hospital, an academic hospital in affiliation with Washington University School of Medicine located in the USA. All team members participating in cardiac and thoracic OR cases during this 17-month study period will be identified by the primary surgical staff attending on the OR schedule.TeamSTEPPS (Team Strategies and Tools to Enhance Performance and Patient Safety) training course will be taught to all CT OR staff. Before TeamSTEPPS training, staff will respond to a 39-item questionnaire that includes constructs from the Agency for Healthcare Research and Quality Hospital Survey on Patient Safety Culture, Edmondson’s ‘Measure of psychological safety’ questionnaire, and questionnaires on turnover intentions, job satisfaction and ‘burnout’. The questionnaires will be readministered at 6 and 12 months.The primary outcomes to be assessed include the perceived psychological safety of CT OR team members, the overall effect of TeamSTEPPS on burnout and job satisfaction, and observed turnover rate among the OR nurses. As secondary outcomes, we will be assessing self-reported rates of medical error and near misses in the ORs with a questionnaire at the end of each case.Ethics and disseminationEthics approval is not indicated as this project does not meet the federal definitions of research requiring the oversight of the Institutional Review Board (IRB). Patient health information (PHI) will not be generated during the implementation of this project. Results of the trial will be made accessible to the public when published in a peer-reviewed journal following the completion of the study.
Protocol for a randomised controlled implementation trial of point-of-care viral load testing and task shifting: the Simplifying HIV TREAtment and Monitoring (STREAM) study
Authors: Dorward Jienchi , Garrett Nigel , Quame-Amaglo Justice , Samsunder Natasha , Ngobese Hope , Ngomane Noluthando , Moodley Pravikrishnen , Mlisana Koleka , Schaafsma Torin , Donnell Deborah , Barnabas Ruanne , Naidoo Kogieleum , Abdool Karim Salim , Celum Connie , Drain Paul K 
Published: September 2017

IntroductionAchieving the Joint United Nations Programme on HIV and AIDS 90-90-90 targets requires models of HIV care that expand antiretroviral therapy (ART) coverage without overburdening health systems. Point-of-care (POC) viral load (VL) testing has the potential to efficiently monitor ART treatment, while enrolled nurses may be able to provide safe and cost-effective chronic care for stable patients with HIV. This study aims to demonstrate whether POC VL testing combined with task shifting to enrolled nurses is non-inferior and cost-effective compared with laboratory-based VL monitoring and standard HIV care.Methods and analysisThe STREAM (Simplifying HIV TREAtment and Monitoring) study is an open-label, non-inferiority, randomised controlled implementation trial. HIV-positive adults, clinically stable at 6 months after ART initiation, will be recruited in a large urban clinic in South Africa. Approximately 396 participants will be randomised 1:1 to receive POC HIV VL monitoring and potential task shifting to enrolled nurses, versus laboratory VL monitoring and standard South African HIV care. Initial clinic follow-up will be 2-monthly in both arms, with VL testing at enrolment, 6 months and 12 months. At 6 months (1 year after ART initiation), stable participants in both arms will qualify for a differentiated care model involving decentralised ART pickup at community-based pharmacies. The primary outcome is retention in care and virological suppression at 12 months from enrolment. Secondary outcomes include time to appropriate entry into the decentralised ART delivery programme, costs per virologically suppressed patient and cost-effectiveness of the intervention compared with standard care. Findings will inform the scale up of VL testing and differentiated care in HIV-endemic resource-limited settings.Ethics and disseminationEthical approval has been granted by the University of KwaZulu-Natal Biomedical Research Ethics Committee (BFC296/16) and University of Washington Institutional Review Board (STUDY00001466). Results will be presented at international conferences and published in academic peer-reviewed journals.Trial registrationNCT03066128; Pre-results.