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Protocol for a scoping review to support development of a CONSORT extension for randomised controlled trials using cohorts and routinely collected health data
Behavioural Science Institute, Clinical Psychology, Radboud University, Nijmegen, Gelderland, Netherlands.
Lady Davis Institute for Medical Research, Jewish General Hospital, Montréal QC, Canada.
Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
Library Services, Children's Hospital of Eastern Ontario, Ottawa ON, Canada.
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2018 (English)In: BMJ Open, ISSN 2044-6055, E-ISSN 2044-6055, Vol. 8, no 8, article id e025266Article, 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
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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

Available from: 2018-10-22 Created: 2018-10-22 Last updated: 2018-10-22Bibliographically approved

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Fröbert, Ole

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