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Guidelines for Reporting Trial Protocols and Completed Trials Modified Due to the COVID-19 Pandemic and Other Extenuating Circumstances: The CONSERVE 2021 Statement.
JAMA. 2021 07 20; 326(3):257-265.JAMA

Abstract

Importance

Extenuating circumstances can trigger unplanned changes to randomized trials and introduce methodological, ethical, feasibility, and analytical challenges that can potentially compromise the validity of findings. Numerous randomized trials have required changes in response to the COVID-19 pandemic, but guidance for reporting such modifications is incomplete.

Objective

As a joint extension for the CONSORT and SPIRIT reporting guidelines, CONSERVE (CONSORT and SPIRIT Extension for RCTs Revised in Extenuating Circumstances) aims to improve reporting of trial protocols and completed trials that undergo important modifications in response to extenuating circumstances.

Evidence

A panel of 37 international trial investigators, patient representatives, methodologists and statisticians, ethicists, funders, regulators, and journal editors convened to develop the guideline. The panel developed CONSERVE following an accelerated, iterative process between June 2020 and February 2021 involving (1) a rapid literature review of multiple databases (OVID Medline, OVID EMBASE, and EBSCO CINAHL) and gray literature sources from 2003 to March 2021; (2) consensus-based panelist meetings using a modified Delphi process and surveys; and (3) a global survey of trial stakeholders.

Findings

The rapid review yielded 41 673 citations, of which 38 titles were relevant, including emerging guidance from regulatory and funding agencies for managing the effects of the COVID-19 pandemic on trials. However, no generalizable guidance for all circumstances in which trials and trial protocols might face unanticipated modifications were identified. The CONSERVE panel used these findings to develop a consensus reporting guidelines following 4 rounds of meetings and surveys. Responses were received from 198 professionals from 34 countries, of whom 90% (n = 178) indicated that they understood the concept definitions and 85.4% (n = 169) indicated that they understood and could use the implementation tool. Feedback from survey respondents was used to finalize the guideline and confirm that the guideline's core concepts were applicable and had utility for the trial community. CONSERVE incorporates an implementation tool and checklists tailored to trial reports and trial protocols for which extenuating circumstances have resulted in important modifications to the intended study procedures. The checklists include 4 sections capturing extenuating circumstances, important modifications, responsible parties, and interim data analyses.

Conclusions and Relevance

CONSERVE offers an extension to CONSORT and SPIRIT that could improve the transparency, quality, and completeness of reporting important modifications to trials in extenuating circumstances such as COVID-19.

Authors+Show Affiliations

Division of Emergency Medicine, Department of Family and Community Medicine, University of Toronto, Toronto, Ontario, Canada. Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada.Hospital for Sick Children, Department of Paediatrics, University of Toronto, Toronto, Ontario, Canada.National Health and Medical Research Council, Canberra, Australia.Clinical Trials Unit, Medicines and Healthcare Products Regulatory Agency, London, England.Berman Institute of Bioethics, Johns Hopkins University, Baltimore, Maryland.Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology, and Neuroscience, King's College London, London, England.Université de Paris, AP-HP, Paris, France.Departments of Medicine, Epidemiology and Biostatistics, and Philosophy, Western University, London, Ontario, Canada.National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, Australia.Department of Health Care Management, Technische Universität Berlin, Berlin, Germany.University of Nottingham, Nottingham, England. National Institute for Health Research, Nottingham, England.WCG Statistics Collaborative, Washington, DC.Centre for Journalology, Clinical Epidemiology Program, Ottawa Hospital Research Institute, School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada.Clinical Trials Ontario, Toronto, Ontario, Canada.Office of Oncologic Diseases, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.Tufts Center for the Study of Drug Development, Boston, Massachusetts.Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, University of Oxford, Oxford, England.Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.Chinese Clinical Trial Registry, Sichuan University, Chengdu, China.Gerstein Science Information Centre, University of Toronto, Toronto, Ontario, Canada.FHI 360, Durham, North Carolina. School of Medicine, University of North Carolina at Chapel Hill.Gerstein Science Information Centre, University of Toronto, Toronto, Ontario, Canada.Centre of Research in Epidemiology and Statistics, Université de Paris, Inserm, Paris, France.Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut. The BMJ , London, England.Deputy Editor, JAMA. Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois.Canadian Institutes of Health Research Institute of Musculoskeletal Health and Arthritis, Ottawa, Ontario, Canada.University of Texas Health Science Center, San Antonio.Alcohol, Tobacco, and Other Drugs Research Unit, South African Medical Research Council, Cape Town, South Africa.Lawrence Berkeley National Laboratory, Berkeley, California.The Lancet , London, England.Office of Extramural Research, Division of Human Subjects Research, National Institutes of Health, Bethesda, Maryland.Department of Disease Control and Environmental Health, School of Public Health, Makerere University, Kampala, Uganda.Centre for Evidence-Based Medicine Odense (CEBMO) and Cochrane Denmark, University of Southern Denmark, Odense, Denmark.ClinicalTrials.gov, National Library of Medicine, National Institutes of Health, Bethesda, Maryland.Centre for Health Research and Development, Society for Applied Studies, New Delhi, India.Applied Health Research Centre, St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.Women's College Research Institute, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.No affiliation info available

Pub Type(s)

Consensus Development Conference
Journal Article
Research Support, N.I.H., Intramural

Language

eng

PubMed ID

34152382

Citation

Orkin, Aaron M., et al. "Guidelines for Reporting Trial Protocols and Completed Trials Modified Due to the COVID-19 Pandemic and Other Extenuating Circumstances: the CONSERVE 2021 Statement." JAMA, vol. 326, no. 3, 2021, pp. 257-265.
Orkin AM, Gill PJ, Ghersi D, et al. Guidelines for Reporting Trial Protocols and Completed Trials Modified Due to the COVID-19 Pandemic and Other Extenuating Circumstances: The CONSERVE 2021 Statement. JAMA. 2021;326(3):257-265.
Orkin, A. M., Gill, P. J., Ghersi, D., Campbell, L., Sugarman, J., Emsley, R., Steg, P. G., Weijer, C., Simes, J., Rombey, T., Williams, H. C., Wittes, J., Moher, D., Richards, D. P., Kasamon, Y., Getz, K., Hopewell, S., Dickersin, K., Wu, T., ... Chan, A. W. (2021). Guidelines for Reporting Trial Protocols and Completed Trials Modified Due to the COVID-19 Pandemic and Other Extenuating Circumstances: The CONSERVE 2021 Statement. JAMA, 326(3), 257-265. https://doi.org/10.1001/jama.2021.9941
Orkin AM, et al. Guidelines for Reporting Trial Protocols and Completed Trials Modified Due to the COVID-19 Pandemic and Other Extenuating Circumstances: the CONSERVE 2021 Statement. JAMA. 2021 07 20;326(3):257-265. PubMed PMID: 34152382.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Guidelines for Reporting Trial Protocols and Completed Trials Modified Due to the COVID-19 Pandemic and Other Extenuating Circumstances: The CONSERVE 2021 Statement. AU - Orkin,Aaron M, AU - Gill,Peter J, AU - Ghersi,Davina, AU - Campbell,Lisa, AU - Sugarman,Jeremy, AU - Emsley,Richard, AU - Steg,Philippe Gabriel, AU - Weijer,Charles, AU - Simes,John, AU - Rombey,Tanja, AU - Williams,Hywel C, AU - Wittes,Janet, AU - Moher,David, AU - Richards,Dawn P, AU - Kasamon,Yvette, AU - Getz,Kenneth, AU - Hopewell,Sally, AU - Dickersin,Kay, AU - Wu,Taixiang, AU - Ayala,Ana Patricia, AU - Schulz,Kenneth F, AU - Calleja,Sabine, AU - Boutron,Isabelle, AU - Ross,Joseph S, AU - Golub,Robert M, AU - Khan,Karim M, AU - Mulrow,Cindy, AU - Siegfried,Nandi, AU - Heber,Joerg, AU - Lee,Naomi, AU - Kearney,Pamela Reed, AU - Wanyenze,Rhoda K, AU - Hróbjartsson,Asbjørn, AU - Williams,Rebecca, AU - Bhandari,Nita, AU - Jüni,Peter, AU - Chan,An-Wen, AU - ,, PY - 2021/6/22/pubmed PY - 2021/7/27/medline PY - 2021/6/21/entrez SP - 257 EP - 265 JF - JAMA JO - JAMA VL - 326 IS - 3 N2 - Importance: Extenuating circumstances can trigger unplanned changes to randomized trials and introduce methodological, ethical, feasibility, and analytical challenges that can potentially compromise the validity of findings. Numerous randomized trials have required changes in response to the COVID-19 pandemic, but guidance for reporting such modifications is incomplete. Objective: As a joint extension for the CONSORT and SPIRIT reporting guidelines, CONSERVE (CONSORT and SPIRIT Extension for RCTs Revised in Extenuating Circumstances) aims to improve reporting of trial protocols and completed trials that undergo important modifications in response to extenuating circumstances. Evidence: A panel of 37 international trial investigators, patient representatives, methodologists and statisticians, ethicists, funders, regulators, and journal editors convened to develop the guideline. The panel developed CONSERVE following an accelerated, iterative process between June 2020 and February 2021 involving (1) a rapid literature review of multiple databases (OVID Medline, OVID EMBASE, and EBSCO CINAHL) and gray literature sources from 2003 to March 2021; (2) consensus-based panelist meetings using a modified Delphi process and surveys; and (3) a global survey of trial stakeholders. Findings: The rapid review yielded 41 673 citations, of which 38 titles were relevant, including emerging guidance from regulatory and funding agencies for managing the effects of the COVID-19 pandemic on trials. However, no generalizable guidance for all circumstances in which trials and trial protocols might face unanticipated modifications were identified. The CONSERVE panel used these findings to develop a consensus reporting guidelines following 4 rounds of meetings and surveys. Responses were received from 198 professionals from 34 countries, of whom 90% (n = 178) indicated that they understood the concept definitions and 85.4% (n = 169) indicated that they understood and could use the implementation tool. Feedback from survey respondents was used to finalize the guideline and confirm that the guideline's core concepts were applicable and had utility for the trial community. CONSERVE incorporates an implementation tool and checklists tailored to trial reports and trial protocols for which extenuating circumstances have resulted in important modifications to the intended study procedures. The checklists include 4 sections capturing extenuating circumstances, important modifications, responsible parties, and interim data analyses. Conclusions and Relevance: CONSERVE offers an extension to CONSORT and SPIRIT that could improve the transparency, quality, and completeness of reporting important modifications to trials in extenuating circumstances such as COVID-19. SN - 1538-3598 UR - https://www.unboundmedicine.com/medline/citation/34152382/Guidelines_for_Reporting_Trial_Protocols_and_Completed_Trials_Modified_Due_to_the_COVID-19_Pandemic_and_Other_Extenuating_Circumstances:_The_CONSERVE_2021_Statement. L2 - https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2021.9941 DB - PRIME DP - Unbound Medicine ER -