Development process of a consensus-driven CONSORT extension for randomised trials using an adaptive design
Year: 2018
Type: article
Abstract: BACKGROUND: Adequate reporting of adaptive designs (ADs) maximises their potential benefits in the conduct of clinical trials. Transparent reporting can help address some obstacles and concerns relating to the use of ADs. Currently, there are deficiencies in the reporting of AD trials. To overcome this, we have developed a consensus-driven extension to the CONSORT statement for randomised trials using an AD. This paper describes the processes and methods used to develop this extension rather than detailed explanation of the guideline. METHODS: We developed the guideline in seven overlapping stages: 1) Building on prior research to inform the need for a guideline; 2) A scoping literature review to inform future stages; 3) Drafting the first checklist version involving an External Expert Panel; 4) A two-round Delphi process involving international, multidisciplinary, and cross-sector key stakeholders; 5) A consensus meeting to advise which reporting items to retain through voting, and to discuss the structure of what to include in the supporting explanation and elaboration (E&E) document; 6) Refining and finalising the checklist; and 7) Writing-up and dissemination of the E&E document. The CONSORT Executive Group oversaw the entire development process. RESULTS: Delphi survey response rates were 94/143 (66%), 114/156 (73%), and 79/143 (55%) in rounds 1, 2, and across both rounds, respectively. Twenty-seven delegates from Europe, the USA, and Asia attended the consensus meeting. The main checklist has seven new and nine modified items and six unchanged items with expanded E&E text to clarify further considerations for ADs. The abstract checklist has one new and one modified item together with an unchanged item with expanded E&E text. The E&E document will describe the scope of the guideline, the definition of an AD, and some types of ADs and trial adaptations and explain each reporting item in detail including case studies. CONCLUSIONS: We hope that making the development processes, methods, and all supporting information that aided decision-making transparent will enhance the acceptability and quick uptake of the guideline. This will also help other groups when developing similar CONSORT extensions. The guideline is applicable to all randomised trials with an AD and contains minimum reporting requirements.
Source: BMC Medicine
Authors: Munyaradzi Dimairo, Elizabeth Coates, Philip Pallmann, Susan Todd, Steven A. Julious, Thomas Jaki, James Wason, Adrian P. Mander, Christopher J. Weir, Franz Koenig, Marc K. Walton, Katie Biggs, Jon Nicholl, Toshimitsu Hamasaki, Michael A. Proschan, John A. Scott, Yuki Ando, Daniel Hind, Douglas G. Altman
Institutions: University of Sheffield, Cardiff University, University of Reading, Lancaster University, University of Cambridge, MRC Biostatistics Unit, Newcastle University, University of Edinburgh, Medical University of Vienna, National Cerebral and Cardiovascular Center, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Center for Biologics Evaluation and Research, United States Food and Drug Administration, Pharmaceuticals and Medical Devices Agency, University of Oxford
Language: English
Subfield: Statistics and Probability
Field: Mathematics
Domain: Physical Sciences
Open Access status: gold
Estimated APC paid: $4,190
Awards: Adaptive Clinical Trials, Enhancing the CONSORT initiative: renewal of intellectual support for the CONSORT Group, G3587225636, Design and Analysis of Clinical Trials in Small Population, G4364043755, Renewal of the Network of Hubs for Trials Methodology Research., G5451637898, Effective and efficient conduct of trials and meta-analyses, Utility of Adaptive Designs in Public Funded Clinical Trials, Improving treatment for patients by design, Renewal of the Network of Hubs for Trials Methodology Research.
OpenAlex ID: W2901843701