GuidelineBMC medicine2018
Development process of a consensus-driven CONSORT extension for randomised trials using an adaptive design.
Guideline in BMC medicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
28 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Confidence Intervals for Adaptive Trial Designs I: A Methodological Review.Statistics in medicine · 2025Pooled it
- A systematic survey of randomised trials that stopped early for reasons of futility.BMC medical research methodology · 2020Pooled it
- Advice only versus advice and a physiotherapy programme for acute traumatic anterior shoulder dislocation: the ARTISAN RCT.Health technology assessment (Winchester, England) · 2024Trial
- Trial
- Development of a robotic training curriculum for visceral and gastrointestinal surgical trainees: an international Delphi study.Surgical endoscopy · 2026Article
- Development of a robotic training curriculum for visceral and gastrointestinal surgical trainees: an international Delphi study.The British journal of surgery · 2026Article
- Development of a Robotic Training Curriculum for Visceral and Gastrointestinal Surgical Trainees: An International Delphi Study.United European gastroenterology journal · 2026Article
- Article
- Development of START-EDI guidelines for reporting equality, diversity and inclusion in research: a study protocol.BMJ open · 2025Article
- Randomization in clinical trials with small sample sizes using group sequential designs.PloS one · 2025Article
- Sample size in multistakeholder Delphi surveys: at what minimum sample size do replicability of results stabilize?Journal of clinical epidemiology · 2024Article
- Reporting and communication of sample size calculations in adaptive clinical trials: a review of trial protocols and grant applications.BMC medical research methodology · 2024Review
- Long-term health outcomes for patients with obstructive sleep apnea: placing the Agency for Healthcare Research and Quality report in context-a multisociety commentary.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2024Article
- A Systematic Scoping Review of Essential Methodological Elements for Developing a Tool to Improve the Reporting of Consensus Studies in Classification, Diagnostic Criteria, and Guidelines Development.Journal of multidisciplinary healthcare · 2024Article
- Bayes' Theorem in Neurocritical Care: Principles and Practice.Neurocritical care · 2023Review
- Article
- Article
- Utilising benefit-risk assessments within clinical trials-a protocol for the BRAINS project.Trials · 2021Article
- Adding flexibility to clinical trial designs: an example-based guide to the practical use of adaptive designs.BMC medicine · 2020Article
- Pragmatic, adaptive clinical trials: Is 2020 the dawning of a new age?Contemporary clinical trials communications · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
19 authors.
Funding
Abstract
backgroundAdequate 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.
methodsWe 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.
resultsDelphi 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.
conclusionsWe 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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.