Methods and results used in the development of a consensus-driven extension to the Consolidated Standards of Reporting Trials (CONSORT) statement for trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE)

Mahrukh Imran; Linda Kwakkenbos; Stephen J McCall; Kimberly A McCord; Ole Fröbert; Lars G Hemkens; Merrick Zwarenstein; Clare Relton; Danielle B Rice; Sinéad M Langan; Eric I Benchimol; Lehana Thabane; Marion K Campbell; Margaret Sampson; David Erlinge; Helena M Verkooijen; David Moher; Isabelle Boutron; Philippe Ravaud; Jon Nicholl; Rudolf Uher; Maureen Sauvé; John Fletcher; David Torgerson; Chris Gale; Edmund Juszczak; Brett D Thombs

doi:10.1136/bmjopen-2021-049093

Methods and results used in the development of a consensus-driven extension to the Consolidated Standards of Reporting Trials (CONSORT) statement for trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE)

BMJ Open. 2021 Apr 29;11(4):e049093. doi: 10.1136/bmjopen-2021-049093.

Authors

Mahrukh Imran¹, Linda Kwakkenbos², Stephen J McCall^{3

4

5}, Kimberly A McCord⁶, Ole Fröbert⁷, Lars G Hemkens⁶, Merrick Zwarenstein^{8

9}, Clare Relton¹⁰, Danielle B Rice^{1

11}, Sinéad M Langan¹², Eric I Benchimol^{13

14

15}, Lehana Thabane¹⁶, Marion K Campbell¹⁷, Margaret Sampson¹⁸, David Erlinge¹⁹, Helena M Verkooijen^{20

21}, David Moher²², Isabelle Boutron^{23

24

25}, Philippe Ravaud^{23

24

25}, Jon Nicholl²⁶, Rudolf Uher²⁷, Maureen Sauvé^{28

29}, John Fletcher³⁰, David Torgerson³¹, Chris Gale³², Edmund Juszczak^{3

33}, Brett D Thombs^{34

35}

Affiliations

¹ Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Québec, Canada.
² Behavioural Science Institute, Clinical Psychology, Radboud University, Nijmegen, Netherlands.
³ National Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
⁴ Center for Research on Population and Health, Faculty of Health Sciences, American University of Beirut, Ras Beirut, Lebanon.
⁵ Institute of Applied Health Sciences, School of Medicine, Medical Sciences and Nutrition, University of Aberdeen, Aberdeen, UK.
⁶ Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
⁷ Faculty of Health, Department of Cardiology, Örebro University, Örebro, Sweden.
⁸ Department of Family Medicine, Western University, London, Ontario, Canada.
⁹ IC/ES Western, London, Ontario, Canada.
¹⁰ Centre for Clinical Trials and Methodology, Barts Institute of Population Health Science, Queen Mary University, London, UK.
¹¹ Department of Psychology, McGill University, Montreal, Quebec, Canada.
¹² Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.
¹³ Department of Pediatrics and School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada.
¹⁴ ICES uOttawa, Ottawa, Ontario, Canada.
¹⁵ Children's Hospital of Eastern Ontario Research Institute, Ottawa, Ontario, Canada.
¹⁶ Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.
¹⁷ Health Services Research Unit, University of Aberdeen, Aberdeen, UK.
¹⁸ Library Services, Children's Hospital of Eastern Ontario, Ontario, Ottawa, Canada.
¹⁹ Department of Cardiology, Clinical Sciences, Lund University, Lund, Sweden.
²⁰ University Medical Center Utrecht, Utrecht, Netherlands.
²¹ University of Utrecht, Utrecht, Netherlands.
²² Centre for Journalology, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
²³ INSERM, Paris, France.
²⁴ Centre d'Épidémiologie Clinique, Hôpital Hôtel Dieu, Assistance Publique-Hôpitaux de Paris, Paris, France.
²⁵ Faculté de Médecine, Université Paris Descartes, Sorbonne Paris Cité, Paris, France.
²⁶ School of Health and Related Research, University of Sheffield, Sheffield, UK.
²⁷ Department of Psychiatry, Dalhousie University, Halifax, Nova Scotia, Canada.
²⁸ Scleroderma Society of Ontario, Hamilton, Ontario, Canada.
²⁹ Scleroderma Canada, Hamilton, Ontario, Canada.
³⁰ British Medical Journal, London, UK.
³¹ York Trials Unit, Department of Health Sciences, University of York, York, UK.
³² Neonatal Medicine, School of Public Health, Faculty of Medicine, Imperial College London, London, UK.
³³ Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.
³⁴ Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Québec, Canada brett.thombs@mcgill.ca.
³⁵ Departments of Psychiatry; Epidemiology, Biostatistics and Occupational Health; Medicine; and Educational and Counselling Psychology; and Biomedical Ethics Unit, McGill University, Montreal, Quebec, Canada.

Abstract

Objectives: Randomised controlled trials conducted using cohorts and routinely collected data, including registries, electronic health records and administrative databases, are increasingly used in healthcare intervention research. A Consolidated Standards of Reporting Trials (CONSORT) statement extension for trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE) has been developed with the goal of improving reporting quality. This article describes the processes and methods used to develop the extension and decisions made to arrive at the final checklist.

Methods: The development process involved five stages: (1) identification of the need for a reporting guideline and project launch; (2) conduct of a scoping review to identify possible modifications to CONSORT 2010 checklist items and possible new extension items; (3) a three-round modified Delphi study involving key stakeholders to gather feedback on the checklist; (4) a consensus meeting to finalise items to be included in the extension, followed by stakeholder piloting of the checklist; and (5) publication, dissemination and implementation of the final checklist.

Results: 27 items were initially developed and rated in Delphi round 1, 13 items were rated in round 2 and 11 items were rated in round 3. Response rates for the Delphi study were 92 of 125 (74%) invited participants in round 1, 77 of 92 (84%) round 1 completers in round 2 and 62 of 77 (81%) round 2 completers in round 3. Twenty-seven members of the project team representing a variety of stakeholder groups attended the in-person consensus meeting. The final checklist includes five new items and eight modified items. The extension Explanation & Elaboration document further clarifies aspects that are important to report.

Conclusion: Uptake of CONSORT-ROUTINE and accompanying Explanation & Elaboration document will improve conduct of trials, as well as the transparency and completeness of reporting of trials conducted using cohorts and routinely collected data.

Keywords: clinical trials; general medicine (see internal medicine); statistics & research methods.

Publication types

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

MeSH terms

Checklist
Consensus
Delphi Technique
Research Design*
Routinely Collected Health Data*

Abstract

Publication types

MeSH terms

Grants and funding