Protocol for a scoping review to support development of a CONSORT extension for randomised controlled trials using cohorts and routinely collected health data

Linda Kwakkenbos; Mahrukh Imran; Kimberly A McCord; Margaret Sampson; Ole Fröbert; Chris Gale; Lars G Hemkens; Sinead M Langan; David Moher; Clare Relton; Merrick Zwarenstein; Eric I Benchimol; Isabelle Boutron; Marion K Campbell; David Erlinge; Sena Jawad; Philippe Ravaud; Danielle B Rice; Maureen Sauve; Tjeerd P van Staa; Lehana Thabane; Rudolf Uher; Helena M Verkooijen; Edmund Juszczak; Brett D Thombs

doi:10.1136/bmjopen-2018-025266

Protocol for a scoping review to support development of a CONSORT extension for randomised controlled trials using cohorts and routinely collected health data

BMJ Open. 2018 Aug 5;8(8):e025266. doi: 10.1136/bmjopen-2018-025266.

Authors

Linda Kwakkenbos¹, Mahrukh Imran², Kimberly A McCord³, Margaret Sampson⁴, Ole Fröbert⁵, Chris Gale⁶, Lars G Hemkens³, Sinead M Langan⁷, David Moher⁸, Clare Relton⁹, Merrick Zwarenstein^{10

11}, Eric I Benchimol^{12

13

14}, Isabelle Boutron^{15

16

17}, Marion K Campbell¹⁸, David Erlinge¹⁹, Sena Jawad⁶, Philippe Ravaud^{15

16

17}, Danielle B Rice^{2

20}, Maureen Sauve^{21

22}, Tjeerd P van Staa^{23

24}, Lehana Thabane²⁵, Rudolf Uher²⁶, Helena M Verkooijen^{27

28}, Edmund Juszczak²⁹, Brett D Thombs^{2

20

30

31

32

33}

Affiliations

¹ Behavioural Science Institute, Clinical Psychology, Radboud University, Nijmegen, Gelderland, Netherlands.
² Lady Davis Institute for Medical Research, Jewish General Hospital, Montréal, Quebec, Canada.
³ Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
⁴ Library Services, Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada.
⁵ Department of Cardiology, Faculty of Health, Örebro University, Örebro, UK.
⁶ Section of Neonatal Medicine, Department of Medicine, Imperial College London, London, UK.
⁷ Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.
⁸ Centre for Journalology, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
⁹ Centre for Clinical Trials and Methodology, Barts Institute of Population Health Science, Queen Mary University, London, UK.
¹⁰ Department of Family Medicine, Western University, London, UK.
¹¹ Institute for Clinical Evaluative Sciences, Toronto, Ontario, Canada.
¹² Department of Pediatrics and School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada.
¹³ Institute for Clinical Evaluative Sciences, Ottawa, Ontario, Canada.
¹⁴ Division of Gastroenterology, Hepatology and Nutrition, Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada.
¹⁵ Sorbonne Paris Cité Epidemiology and Statistics Research Center, INSERM, UMR1153, Paris, France.
¹⁶ Centre d'Épidémiologie Clinique, Hôpital Hôtel Dieu, Assistance Publique-Hôpitaux de Paris, Paris, France.
¹⁷ Faculté de Médecine, Université Paris Descartes, Sorbonne Paris Cité, Paris, France.
¹⁸ Health Services Research Unit, University of Aberdeen, Aberdeen, UK.
¹⁹ Department of Cardiology, Clinical Sciences, Lund University, Lund, Sweden.
²⁰ Department of Psychology, McGill University, Montréal, Québec, Canada.
²¹ Scleroderma Society of Ontario, Hamilton, Ontario, Canada.
²² Scleroderma Canada, Hamilton, Ontario, Canada.
²³ Health e-Research Centre, School of Health Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.
²⁴ Division of Pharmacoepidemiology and Clinical Pharmacology, Faculty of Science, Utrecht University, Utrecht, The Netherlands.
²⁵ Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.
²⁶ Department of Psychiatry, Dalhousie University, Halifax, Nova Scotia, Canada.
²⁷ Department of Epidemiology, University Medical Center Utrecht, Utrecht, The Netherlands.
²⁸ Department of Epidemiology, University of Utrecht, Utrecht, The Netherlands.
²⁹ NPEU Clinical Trials Unit, National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
³⁰ Department of Psychiatry, McGill University, Montreal, Quebec, Canada.
³¹ Departments of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Quebec, Canada.
³² Department of Medicine, McGill University, Montreal, Quebec, Canada.
³³ Departments of Educational and Counselling Psychology, McGill University, Montreal, Quebec, Canada.

Abstract

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.

Keywords: cohort; consort; randomized controlled trials; rcts; reporting guideline; routinely collected health data.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Administrative Claims, Healthcare
Cohort Studies*
Electronic Health Records
Guidelines as Topic*
Humans
Randomized Controlled Trials as Topic / standards*
Registries
Research Design / standards*
Review Literature as Topic

Abstract

Publication types

MeSH terms

Grants and funding