ArticleBMJ (Clinical research ed.)2020
The Adaptive designs CONSORT Extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design.
Article in BMJ (Clinical research ed.), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04636671 (Randomized Controlled Trial of Methylprednisolone Versus Dexamethasone in COVID-19 Pneumonia), which is not on this map. Cited by 84 papers, 7 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Randomized Controlled Trial of Methylprednisolone Versus Dexamethasone in COVID-19 Pneumonia (MEDEAS Trial)
Who cites it
84 citing papers in PubMed, 7 syntheses or guidelines pooled it.
- Pooled it
- Confidence Intervals for Adaptive Trial Designs I: A Methodological Review.Statistics in medicine · 2025Pooled it
- Adaptive designs in clinical trials: a systematic review-part I.BMC medical research methodology · 2024Pooled it
- A systematic review of randomised controlled trials with adaptive and traditional group sequential designs - applications in cardiovascular clinical trials.BMC medical research methodology · 2023Pooled it
- Methodology and design of platform trials: a meta-epidemiological study.Journal of clinical epidemiology · 2023Pooled it
- Randomised controlled trials in pre-hospital trauma: a systematic mapping review.Scandinavian journal of trauma, resuscitation and emergency medicine · 2021Pooled it
- Interventions for treatment of COVID-19: A living systematic review with meta-analyses and trial sequential analyses (The LIVING Project).PLoS medicine · 2020Pooled it
- Trial
- Procalcitonin testing combined with NEWS2 evaluation compared with usual care based on NEWS2 for identification of sepsis and antibiotic initiation in the emergency department in England and Wales (PRONTO): a multicentre, randomised, controlled, open-label, phase 3 trial.The Lancet. Respiratory medicine · 2026Trial
- Brief Digital Interventions for Psychological Distress: An AI-Enhanced Response-Adaptive Randomized Clinical Trial.JAMA network open · 2025Trial
- Oral Regimens for Rifampin-Resistant, Fluoroquinolone-Susceptible Tuberculosis.The New England journal of medicine · 2025Trial
- Trial
- Analyzing the Impact of Mobile App Engagement on Mental Health Outcomes: Secondary Analysis of the Unwinding Anxiety Program.Journal of medical Internet research · 2022Trial
- Randomized Trial of Fetal Surgery for Severe Left Diaphragmatic Hernia.The New England journal of medicine · 2021Trial
- Effect of Early Treatment With Hydroxychloroquine or Lopinavir and Ritonavir on Risk of Hospitalization Among Patients With COVID-19: The TOGETHER Randomized Clinical Trial.JAMA network open · 2021Trial
- Article
- BEST-BAO: a multicentre, prospective, randomised controlled trial of endovascular treatment with or without intravenous thrombolysis in acute ischaemic stroke due to basilar artery occlusion - study protocol and rationale.Stroke and vascular neurology · 2026Article
- Adaptive trials in low back pain and osteoarthritis: How common are they and when should they be used? A systematic review from ClinicalTrials.gov.Osteoarthritis and cartilage open · 2026Review
- Reporting of dog-assisted intervention trials: extension of the SPIRIT 2025 and CONSORT 2025 statement.BMC medical research methodology · 2026Article
- Designs of the clinical trials aiming at evaluating cell and gene therapy products: A critical appraisal from a literature review.Molecular therapy. Advances · 2026Review
24 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
20 authors.
Funding
Abstract
Adaptive designs (ADs) allow pre-planned changes to an ongoing trial without compromising the validity of conclusions and it is essential to distinguish pre-planned from unplanned changes that may also occur. The reporting of ADs in randomised trials is inconsistent and needs improving. Incompletely reported AD randomised trials are difficult to reproduce and are hard to interpret and synthesise. This consequently hampers their ability to inform practice as well as future research and contributes to research waste. Better transparency and adequate reporting will enable the potential benefits of ADs to be realised.This extension to the Consolidated Standards Of Reporting Trials (CONSORT) 2010 statement was developed to enhance the reporting of randomised AD clinical trials. We developed an Adaptive designs CONSORT Extension (ACE) guideline through a two-stage Delphi process with input from multidisciplinary key stakeholders in clinical trials research in the public and private sectors from 21 countries, followed by a consensus meeting. Members of the CONSORT Group were involved during the development process.The paper presents the ACE checklists for AD randomised trial reports and abstracts, as well as an explanation with examples to aid the application of the guideline. The ACE checklist comprises seven new items, nine modified items, six unchanged items for which additional explanatory text clarifies further considerations for ADs, and 20 unchanged items not requiring further explanatory text. The ACE abstract checklist has one new item, one modified item, one unchanged item with additional explanatory text for ADs, and 15 unchanged items not requiring further explanatory text.The intention is to enhance transparency and improve reporting of AD randomised trials to improve the interpretability of their results and reproducibility of their methods, results and inference. We also hope indirectly to facilitate the much-needed knowledge transfer of innovative trial designs to maximise their potential benefits.
Indexed as
Identifiers
What OpenQuestion holds
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.