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)

ObjectivesRandomised 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 exten...

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Published in	BMJ open Vol. 11; no. 4; p. e049093
Main Authors	Imran, Mahrukh, Kwakkenbos, Linda, McCall, Stephen J, McCord, Kimberly A, Fröbert, Ole, Hemkens, Lars G, Zwarenstein, Merrick, Relton, Clare, Rice, Danielle B, Langan, Sinéad M, Benchimol, Eric I, Thabane, Lehana, Campbell, Marion K, Sampson, Margaret, Erlinge, David, Verkooijen, Helena M, Moher, David, Boutron, Isabelle, Ravaud, Philippe, Nicholl, Jon, Uher, Rudolf, Sauvé, Maureen, Fletcher, John, Torgerson, David, Gale, Chris, Juszczak, Edmund, Thombs, Brett D
Format	Journal Article
Language	English
Published	England BMJ Publishing Group LTD 29.04.2021 BMJ Publishing Group
Series	Original research
Subjects	Antibiotics Clinical trials Electronic health records Funding general medicine (see internal medicine) Health Care Service and Management, Health Policy and Services and Health Economy Health Sciences Hälso- och sjukvårdsorganisation, hälsopolitik och hälsoekonomi Hälsovetenskap Life Sciences Medical and Health Sciences Medical Publishing and Peer Review Medical research Medicin och hälsovetenskap statistics & research methods Systematic review United Kingdom > UK statistics & research methods clinical trials general medicine (see internal medicine)
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Abstract	ObjectivesRandomised 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.MethodsThe 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.Results27 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.ConclusionUptake 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.
AbstractList	ObjectivesRandomised 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.MethodsThe 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.Results27 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.ConclusionUptake 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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.
Author	McCord, Kimberly A Nicholl, Jon Benchimol, Eric I Imran, Mahrukh Juszczak, Edmund Kwakkenbos, Linda Thabane, Lehana Fröbert, Ole Campbell, Marion K Moher, David Uher, Rudolf Boutron, Isabelle McCall, Stephen J Torgerson, David Sampson, Margaret Fletcher, John Thombs, Brett D Rice, Danielle B Langan, Sinéad M Ravaud, Philippe Relton, Clare Verkooijen, Helena M Gale, Chris Erlinge, David Zwarenstein, Merrick Sauvé, Maureen Hemkens, Lars G
AuthorAffiliation	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 27 Department of Psychiatry , Dalhousie University , Halifax , Nova Scotia , Canada 8 Department of Family Medicine , Western University , London , Ontario , Canada 30 British Medical Journal , London , UK 15 Children's Hospital of Eastern Ontario Research Institute , Ottawa , Ontario , Canada 21 University of Utrecht , Utrecht , Netherlands 24 Centre d’Épidémiologie Clinique , Hôpital Hôtel Dieu, Assistance Publique–Hôpitaux de Paris , Paris , France 2 Behavioural Science Institute, Clinical Psychology , Radboud University , Nijmegen , Netherlands 28 Scleroderma Society of Ontario , Hamilton , Ontario , Canada 18 Library Services , Children’s Hospital of Eastern Ontario , Ontario , Ottawa , Canada 6 Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research , University Hosp
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DOI	10.1136/bmjopen-2021-049093
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Snippet	ObjectivesRandomised controlled trials conducted using cohorts and routinely collected data, including registries, electronic health records and administrative... Randomised controlled trials conducted using cohorts and routinely collected data, including registries, electronic health records and administrative... Objectives Randomised controlled trials conducted using cohorts and routinely collected data, including registries, electronic health records and... OBJECTIVESRandomised controlled trials conducted using cohorts and routinely collected data, including registries, electronic health records and administrative... Objectives Randomised controlled trials conducted using cohorts and routinely collected data, including registries, electronic health records and... OBJECTIVES: Randomised controlled trials conducted using cohorts and routinely collected data, including registries, electronic health records and...
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SubjectTerms	Antibiotics Clinical trials Electronic health records Funding general medicine (see internal medicine) Health Care Service and Management, Health Policy and Services and Health Economy Health Sciences Hälso- och sjukvårdsorganisation, hälsopolitik och hälsoekonomi Hälsovetenskap Life Sciences Medical and Health Sciences Medical Publishing and Peer Review Medical research Medicin och hälsovetenskap statistics & research methods Systematic review
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Title	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)
URI	http://dx.doi.org/10.1136/bmjopen-2021-049093 https://www.ncbi.nlm.nih.gov/pubmed/33926985 https://www.proquest.com/docview/2519627043 https://search.proquest.com/docview/2520881834 https://hal.science/hal-04369495 https://pubmed.ncbi.nlm.nih.gov/PMC8094349 https://urn.kb.se/resolve?urn=urn:nbn:se:oru:diva-91650 https://lup.lub.lu.se/record/94d4ad22-0451-4018-8233-44b8fc992961 https://doaj.org/article/410a1924625c4c05b0b5381363ed9add
Volume	11
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