Protocol for the development of a CONSORT extension for RCTs using cohorts and routinely collected health data

doi:10.1186/s41073-018-0053-3

. 2018 Oct 29:3:9.

doi: 10.1186/s41073-018-0053-3. eCollection 2018.

Protocol for the development of a CONSORT extension for RCTs using cohorts and routinely collected health data

Linda Kwakkenbos¹, Edmund Juszczak², Lars G Hemkens³, Margaret Sampson⁴, Ole Fröbert⁵, Clare Relton⁶, Chris Gale⁷, Merrick Zwarenstein^{8

9}, Sinéad M Langan¹⁰, David Moher¹¹, Isabelle Boutron^{12

13

14}, Philippe Ravaud^{12

13

14}, Marion K Campbell¹⁵, Kimberly A Mc Cord³, Tjeerd P van Staa^{16

17}, Lehana Thabane¹⁸, Rudolf Uher¹⁹, Helena M Verkooijen^{20

21}, Eric I Benchimol^{22

23

24}, David Erlinge²⁵, Maureen Sauvé^{26

27}, David Torgerson²⁸, Brett D Thombs^{29

30

31

32

33

34}

Affiliations

¹ 1Behavioural Science Institute, Clinical Psychology, Radboud University, Nijmegen, the Netherlands.
² 2NPEU Clinical Trials Unit, National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
³ 3Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
⁴ 4Library Services, Children's Hospital of Eastern Ontario, Ottawa, Canada.
⁵ 5Department of Cardiology, Faculty of Health, Örebro University, Örebro, Sweden.
⁶ 6Centre for Clinical Trials and Methodology, Barts Institute of Population Health Science, Queen Mary University, London, UK.
⁷ 7Section of Neonatal Medicine, Department of Medicine, Imperial College London, Chelsea and Westminster Campus, London, UK.
⁸ 8Department of Family Medicine, Western University, London, Canada.
⁹ 9Institute for Clinical Evaluative Sciences, Toronto, Canada.
¹⁰ 10Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.
¹¹ 11Centre for Journalology, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada.
¹² 12INSERM, UMR1153, Paris, France.
¹³ 13Centre d'Épidémiologie Clinique, Hôpital Hôtel Dieu, Assistance Publique-Hôpitaux de Paris, Paris, France.
¹⁴ 14Faculté de Médecine, Université Paris Descartes, Sorbonne Paris Cité, Paris, France.
¹⁵ 15Health Services Research Unit, University of Aberdeen, Aberdeen, UK.
¹⁶ 16Health e-Research Centre, School of Health Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.
¹⁷ 17Faculty of Science, Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht University, Utrecht, the Netherlands.
¹⁸ 18Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada.
¹⁹ 19Department of Psychiatry, Dalhousie University, Halifax, Canada.
²⁰ 20University Medical Center Utrecht, Utrecht, the Netherlands.
²¹ 21University of Utrecht, Utrecht, the Netherlands.
²² 22Department of Pediatrics and School of Epidemiology and Public Health, University of Ottawa, Ottawa, Canada.
²³ 23Institute for Clinical Evaluative Sciences, Ottawa, Canada.
²⁴ 24Division of Gastroenterology, Hepatology and Nutrition, Children's Hospital of Eastern Ontario, Ottawa, Canada.
²⁵ 25Department of Cardiology, Clinical Sciences, Lund University, Lund, Sweden.
²⁶ Scleroderma Society of Ontario, Hamilton, Canada.
²⁷ Scleroderma Canada, Hamilton, Canada.
²⁸ 28York Trials Unit, Department of Health Sciences, University of York, York, UK.
²⁹ 29Lady Davis Institute for Medical Research, Jewish General Hospital, 4333 Cote Ste Catherine Road, Montreal, QC H3T 1E4 Canada.
³⁰ 30Department of Psychiatry, McGill University, Montreal, Canada.
³¹ 31Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Canada.
³² 32Department of Medicine, McGill University, Montreal, Canada.
³³ 33Department of Psychology, McGill University, Montreal, Canada.
³⁴ 34Department of Educational and Counselling Psychology, McGill University, Montreal, Canada.

PMID: 30397513
PMCID: PMC6205772
DOI: 10.1186/s41073-018-0053-3

Protocol for the development of a CONSORT extension for RCTs using cohorts and routinely collected health data

Linda Kwakkenbos et al. Res Integr Peer Rev. 2018.

. 2018 Oct 29:3:9.

doi: 10.1186/s41073-018-0053-3. eCollection 2018.

Authors

Affiliations

¹ 1Behavioural Science Institute, Clinical Psychology, Radboud University, Nijmegen, the Netherlands.
² 2NPEU Clinical Trials Unit, National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
³ 3Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
⁴ 4Library Services, Children's Hospital of Eastern Ontario, Ottawa, Canada.
⁵ 5Department of Cardiology, Faculty of Health, Örebro University, Örebro, Sweden.
⁶ 6Centre for Clinical Trials and Methodology, Barts Institute of Population Health Science, Queen Mary University, London, UK.
⁷ 7Section of Neonatal Medicine, Department of Medicine, Imperial College London, Chelsea and Westminster Campus, London, UK.
⁸ 8Department of Family Medicine, Western University, London, Canada.
⁹ 9Institute for Clinical Evaluative Sciences, Toronto, Canada.
¹⁰ 10Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.
¹¹ 11Centre for Journalology, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada.
¹² 12INSERM, UMR1153, Paris, France.
¹³ 13Centre d'Épidémiologie Clinique, Hôpital Hôtel Dieu, Assistance Publique-Hôpitaux de Paris, Paris, France.
¹⁴ 14Faculté de Médecine, Université Paris Descartes, Sorbonne Paris Cité, Paris, France.
¹⁵ 15Health Services Research Unit, University of Aberdeen, Aberdeen, UK.
¹⁶ 16Health e-Research Centre, School of Health Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.
¹⁷ 17Faculty of Science, Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht University, Utrecht, the Netherlands.
¹⁸ 18Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada.
¹⁹ 19Department of Psychiatry, Dalhousie University, Halifax, Canada.
²⁰ 20University Medical Center Utrecht, Utrecht, the Netherlands.
²¹ 21University of Utrecht, Utrecht, the Netherlands.
²² 22Department of Pediatrics and School of Epidemiology and Public Health, University of Ottawa, Ottawa, Canada.
²³ 23Institute for Clinical Evaluative Sciences, Ottawa, Canada.
²⁴ 24Division of Gastroenterology, Hepatology and Nutrition, Children's Hospital of Eastern Ontario, Ottawa, Canada.
²⁵ 25Department of Cardiology, Clinical Sciences, Lund University, Lund, Sweden.
²⁶ Scleroderma Society of Ontario, Hamilton, Canada.
²⁷ Scleroderma Canada, Hamilton, Canada.
²⁸ 28York Trials Unit, Department of Health Sciences, University of York, York, UK.
²⁹ 29Lady Davis Institute for Medical Research, Jewish General Hospital, 4333 Cote Ste Catherine Road, Montreal, QC H3T 1E4 Canada.
³⁰ 30Department of Psychiatry, McGill University, Montreal, Canada.
³¹ 31Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Canada.
³² 32Department of Medicine, McGill University, Montreal, Canada.
³³ 33Department of Psychology, McGill University, Montreal, Canada.
³⁴ 34Department of Educational and Counselling Psychology, McGill University, Montreal, Canada.

PMID: 30397513
PMCID: PMC6205772
DOI: 10.1186/s41073-018-0053-3

Abstract

Background: Randomized controlled trials (RCTs) are often complex and expensive to perform. Less than one third achieve planned recruitment targets, follow-up can be labor-intensive, and many have limited real-world generalizability. Designs for RCTs conducted using cohorts and routinely collected health data, including registries, electronic health records, and administrative databases, have been proposed to address these challenges and are being rapidly adopted. These designs, however, are relatively recent innovations, and published RCT reports often do not describe important aspects of their methodology in a standardized way. Our objective is to extend the Consolidated Standards of Reporting Trials (CONSORT) statement with a consensus-driven reporting guideline for RCTs using cohorts and routinely collected health data.

Methods: The development of this CONSORT extension will consist of five phases. Phase 1 (completed) consisted of the project launch, including fundraising, the establishment of a research team, and development of a conceptual framework. In phase 2, a systematic review will be performed to identify publications (1) that describe methods or reporting considerations for RCTs conducted using cohorts and routinely collected health data or (2) that are protocols or report results from such RCTs. An initial "long list" of possible modifications to CONSORT checklist items and possible new items for the reporting guideline will be generated based on the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) and The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statements. Additional possible modifications and new items will be identified based on the results of the systematic review. Phase 3 will consist of a three-round Delphi exercise with methods and content experts to evaluate the "long list" and generate a "short list" of key items. In phase 4, these items will serve as the basis for an in-person consensus meeting to finalize a core set of items to be included in the reporting guideline and checklist. Phase 5 will involve drafting the checklist and elaboration-explanation documents, and dissemination and implementation of the guideline.

Discussion: Development of this CONSORT extension will contribute to more transparent reporting of RCTs conducted using cohorts and routinely collected health data.

Keywords: Administrative data; CONSORT; Cohort; Electronic health records; Electronic medical records; Electronic patient records; RCTs; Randomized controlled trials; Registries; Reporting guideline; Routinely collected health data.

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Conflict of interest statement

Not applicable.Not applicable.The authors declare that they have no competing interests.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

**Fig. 1**
Summary of process, timeline, and knowledge translation strategy

See this image and copyright information in PMC

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References

1. Torgerson D, Torgerson C. Designing randomised trials. Basingstoke: Palgrave; 2008.
1. Schwartz D, Lellouch J. Explanatory and pragmatic attitudes in therapeutical trials. J Chronic Dis. 1967;20:637–648. doi: 10.1016/0021-9681(67)90041-0. - DOI - PubMed
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[1] Torgerson D, Torgerson C. Designing randomised trials. Basingstoke: Palgrave; 2008.

[2] Torgerson D, Torgerson C. Designing randomised trials. Basingstoke: Palgrave; 2008.

[3] Schwartz D, Lellouch J. Explanatory and pragmatic attitudes in therapeutical trials. J Chronic Dis. 1967;20:637–648. doi: 10.1016/0021-9681(67)90041-0. - DOI - PubMed

[4] Schwartz D, Lellouch J. Explanatory and pragmatic attitudes in therapeutical trials. J Chronic Dis. 1967;20:637–648. doi: 10.1016/0021-9681(67)90041-0. - DOI - PubMed

[5] Evans I, Thornton H, Chalmers I, Glasziou P. Testing treatments: better research for better healthcare. London: Pinter and Martin Ltd; 2011. - PubMed

[6] Evans I, Thornton H, Chalmers I, Glasziou P. Testing treatments: better research for better healthcare. London: Pinter and Martin Ltd; 2011. - PubMed

[7] McDonald AM, Knight RC, Campbell MK, Entwistle VA, Grant AM, Cook JA, et al. What influences recruitment to randomized controlled trials? A review of trials funded by two UK funding agencies. Trials. 2006;7:9. doi: 10.1186/1745-6215-7-9. - DOI - PMC - PubMed

[8] McDonald AM, Knight RC, Campbell MK, Entwistle VA, Grant AM, Cook JA, et al. What influences recruitment to randomized controlled trials? A review of trials funded by two UK funding agencies. Trials. 2006;7:9. doi: 10.1186/1745-6215-7-9. - DOI - PMC - PubMed

[9] Relton C, Torgerson D, O’Cathain A, Nicholl J. Rethinking pragmatic randomised controlled trials: introducing the “cohort multiple randomised controlled trial” design. BMJ. 2010;340:2. doi: 10.1136/bmj.c1066. - DOI - PubMed

[10] Relton C, Torgerson D, O’Cathain A, Nicholl J. Rethinking pragmatic randomised controlled trials: introducing the “cohort multiple randomised controlled trial” design. BMJ. 2010;340:2. doi: 10.1136/bmj.c1066. - DOI - PubMed

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Protocol for the development of a CONSORT extension for RCTs using cohorts and routinely collected health data

Affiliations

Protocol for the development of a CONSORT extension for RCTs using cohorts and routinely collected health data

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Abstract

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Abstract

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