Protocol for a scoping review to support development of a CONSORT extension for randomised controlled trials using cohorts and routinely collected health dataSection of Neonatal Medicine, Department of Medicine, Imperial College London, London, United Kingdom.
Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, United Kingdom.
Centre for Journalology, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa ON, Canada.
Centre for Clinical Trials and Methodology, Barts Institute of Population Health Science, Queen Mary University, London, United Kingdom.
Department of Family Medicine, Western University, London, United Kingdom; Institute for Clinical Evaluative Sciences, Toronto ON, Canada.
Department of Pediatrics and School of Epidemiology and Public Health, University of Ottawa, Ottawa ON, Canada; Institute for Clinical Evaluative Sciences, Ottawa ON, Canada; Division of Gastroenterology, Hepatology and Nutrition, Children's Hospital of Eastern Ontario, Ottawa ON, Canada.
Health Services Research Unit, University of Aberdeen, Aberdeen, United Kingdom.
Department of Cardiology, Clinical Sciences, Lund University, Lund, Sweden.
Section of Neonatal Medicine, Department of Medicine, Imperial College London, London, United Kingdom.
Sorbonne Paris Cité Epidemiology and Statistics Research Center, INSERM, UMR1153, Paris, France; Centre d'Épidémiologie Clinique, Hôpital Hôtel Dieu, Assistance Publique-Hôpitaux de Paris, Paris, France; Faculté de Médecine, Université Paris Descartes, Sorbonne Paris Cité, Paris, France.
Lady Davis Institute for Medical Research, Jewish General Hospital, Montréal QC, Canada; Department of Psychology, McGill University, Montréal QC, Canada.
Scleroderma Society of Ontario, Hamilton, ON, Canada; Scleroderma Canada, Hamilton ON, Canada.
Health E-Research Centre, School of Health Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, United Kingdom; Division of Pharmacoepidemiology and Clinical Pharmacology, Faculty of Science, Utrecht University, Utrecht, Netherlands.
Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton ON, Canada.
Department of Psychiatry, Dalhousie University, Halifax NS, Canada.
Department of Epidemiology, University Medical Center Utrecht, Utrecht, Netherlands; Department of Epidemiology, University of Utrecht, Utrecht, Netherlands.
NPEU Clinical Trials Unit, National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.
Lady Davis Institute for Medical Research, Jewish General Hospital, Montréal QC, Canada; Department of Psychology, McGill University, Montréal QC, Canada; Department of Psychiatry, McGill University, Montreal QC, Canada; Departments of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal QC, Canada; Department of Medicine, McGill University, Montreal QC, Canada; Departments of Educational and Counselling Psychology, McGill University, Montreal QC, Canada.
Show others and affiliations
2018 (English)In: BMJ Open, E-ISSN 2044-6055, Vol. 8, no 8, article id e025266
Article, review/survey (Refereed) Published
Abstract [en]
Introduction: Randomised controlled trials (RCTs) conducted using cohorts and routinely collected health data, including registries, electronic health records and administrative databases, are increasingly used in healthcare intervention research. The development of an extension of the CONsolidated Standards of Reporting Trials (CONSORT) statement for RCTs using cohorts and routinely collected health data is being undertaken with the goal of improving reporting quality by setting standards early in the process of uptake of these designs. To develop this extension to the CONSORT statement, a scoping review will be conducted to identify potential modifications or clarifications of existing reporting guideline items, as well as additional items needed for reporting RCTs using cohorts and routinely collected health data.
Methods and analysis: In separate searches, we will seek publications on methods or reporting or that describe protocols or results from RCTs using cohorts, registries, electronic health records and administrative databases. Data sources will include Medline and the Cochrane Methodology Register. For each of the four main types of RCTs using cohorts and routinely collected health data, separately, two investigators will independently review included publications to extract potential checklist items. A potential item will either modify an existing CONSORT 2010, Strengthening the Reporting of Observational Studies in Epidemiology or REporting of studies Conducted using Observational Routinely collected health Data item or will be proposed as a new item. Additionally, we will identify examples of good reporting in RCTs using cohorts and routinely collected health data.
Ethics and dissemination: The proposed scoping review will help guide the development of the CONSORT extension statement for RCTs conducted using cohorts and routinely collected health data.
Place, publisher, year, edition, pages
BMJ Publishing Group Ltd, 2018. Vol. 8, no 8, article id e025266
Keywords [en]
cohort, consort, randomized controlled trials, reporting guideline, routinely collected health data, rcts
National Category
General Practice
Identifiers
URN: urn:nbn:se:oru:diva-69722DOI: 10.1136/bmjopen-2018-025266ISI: 000446470200204PubMedID: 30082372Scopus ID: 2-s2.0-85053158143OAI: oai:DiVA.org:oru-69722DiVA, id: diva2:1257629
Note
Funding Agency:
Wellcome Trust
2018-10-222018-10-222024-01-16Bibliographically approved