Rigorous reporting of stepped wedge cluster randomised controlled trials: development of a flow diagram template

التفاصيل البيبلوغرافية
العنوان: Rigorous reporting of stepped wedge cluster randomised controlled trials: development of a flow diagram template
المؤلفون: Gray, Heather, Weir, Christopher J., Keerie, Catriona, McQueen, Jean, Bain, Brenda, Brady, Marian
المصدر: Gray , H , Weir , C J , Keerie , C , McQueen , J , Bain , B & Brady , M 2017 , ' Rigorous reporting of stepped wedge cluster randomised controlled trials: development of a flow diagram template ' , Paper presented at European Forum for Research in Rehabilitation (EFRR) 2017 , Glasgow , United Kingdom , 24/05/17 - 27/05/17 pp. 22 . < http://www.efrr2017.comTest/ >
سنة النشر: 2017
مصطلحات موضوعية: Stepped Wedge Trial Design, cluster randomised controlled trial, flow diagrams, demo, psy
الوصف: Background: Stepped wedge cluster randomised controlled trials (SW-CRCT) are increasingly used in rehabilitation research. Current Consolidated Standards for Reporting Trials (CONSORT) diagram templates are unsuited to depicting the flow of participants through this trial design. Thus, reporting to CONSORT standards is challenging. A recent systematic review highlighted the poor-quality reporting of SW-CRCTs, identifying that 33.3% failed to include a CONSORT flow diagram. Aim: To develop a SW-CRCT flow diagram template with capacity to accurately depict participant movement (patients and staff) through study phases and across sites in the Stroke Oral healthCare pLan Evaluation (SOCLE II: nct01954121). Methods: Following ethical approval we recruited 325 patients and 112 staff across four study sites and collected data during usual care, intervention and enhanced care study phases. Working collaboratively a team of experienced rehabilitation researchers, trial methodologists and statisticians, explored various approaches to inform the development of a unique flow diagram. We sought to develop a template that was flexible enough to accommodate the reporting of complex pragmatic SW-CRTs, but which also enabled selective filtering of information to support the reporting of specific aspects of the trial. Results: Our SW-CRCT CONSORT flow diagram template elucidates the patients and staff in SOCLE II that were: screened; consented; withdrawn (and later returned); discharged; trained, transferred and contributed to data collection at specific time points. Conclusion: Using Mocrosoft Vision 2010 software our flow diagram template can be adapted by others.
نوع الوثيقة: conference object
اللغة: English
العلاقة: https://researchonline.gcu.ac.uk/en/publications/25fbb68d-205a-47de-ab58-f1112bff23b1Test
الإتاحة: https://researchonline.gcu.ac.uk/en/publications/25fbb68d-205a-47de-ab58-f1112bff23b1Test
حقوق: undefined
رقم الانضمام: edsbas.840C5ACA
قاعدة البيانات: BASE