The Adaptive designs CONSORT Extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design

There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

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.

Related collections

Most cited references 214

Record: found
Abstract: found
Article: not found

CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials.

Kenneth F Schulz, Douglas G. Altman, David Moher (2010)

The CONSORT (Consolidated Standards of Reporting Trials) statement is used worldwide to improve the reporting of randomized, controlled trials. Schulz and colleagues describe the latest version, CONSORT 2010, which updates the reporting guideline based on new methodological evidence and accumulating experience.

0 comments Cited 789 times – based on 0 reviews      Review now

Bookmark

Record: found
Abstract: found
Article: not found

Systematic Review of the Empirical Evidence of Study Publication Bias and Outcome Reporting Bias

Kerry Dwan, Douglas G. Altman, Juan A. Arnaiz … (2008)

Background The increased use of meta-analysis in systematic reviews of healthcare interventions has highlighted several types of bias that can arise during the completion of a randomised controlled trial. Study publication bias has been recognised as a potential threat to the validity of meta-analysis and can make the readily available evidence unreliable for decision making. Until recently, outcome reporting bias has received less attention. Methodology/Principal Findings We review and summarise the evidence from a series of cohort studies that have assessed study publication bias and outcome reporting bias in randomised controlled trials. Sixteen studies were eligible of which only two followed the cohort all the way through from protocol approval to information regarding publication of outcomes. Eleven of the studies investigated study publication bias and five investigated outcome reporting bias. Three studies have found that statistically significant outcomes had a higher odds of being fully reported compared to non-significant outcomes (range of odds ratios: 2.2 to 4.7). In comparing trial publications to protocols, we found that 40–62% of studies had at least one primary outcome that was changed, introduced, or omitted. We decided not to undertake meta-analysis due to the differences between studies. Conclusions Recent work provides direct empirical evidence for the existence of study publication bias and outcome reporting bias. There is strong evidence of an association between significant results and publication; studies that report positive or significant results are more likely to be published and outcomes that are statistically significant have higher odds of being fully reported. Publications have been found to be inconsistent with their protocols. Researchers need to be aware of the problems of both types of bias and efforts should be concentrated on improving the reporting of trials.

0 comments Cited 433 times – based on 0 reviews      Review now

Bookmark

Record: found
Abstract: found
Article: not found

Surgical resection with or without preoperative chemotherapy in oesophageal cancer: a randomised controlled trial.

(2002)

The outlook for patients with oesophageal cancer undergoing surgical resection with curative intent is poor. We aimed to assess the effects of preoperative chemotherapy on survival, dysphagia, and performance status in this group of patients. 802 previously untreated patients with resectable oesophageal cancer of any cell type were randomly allocated either two 4-day cycles, 3 weeks apart, of cisplatin 80 mg/m(2) by infusion over 4 h plus fluorouracil 1000 mg/m(2) daily by continuous infusion for 4 days followed by surgical resection (CS group, n=400), or resection alone (S group, 402). Clinicians could choose to give preoperative radiotherapy to all their patients irrespective of randomisation. Primary outcome measure was survival time. Analysis was by intention to treat. No patients dropped out of the study. Resection was microscopically complete in 233 (60%) of 390 assessable CS patients and 215 (54%) of 397 S patients (p<0.0001). Postoperative complications were reported in 146 (41%) CS and 161 (42%) S patients. Overall survival was better in the CS group (hazard ratio 0.79; 95% CI 0.67-0.93; p=0.004). Median survival was 512 days (16.8 months) in the CS group compared with 405 days (13.3 months) in the S group (difference 107 days; 95% CI 30-196), and 2-year survival rates were 43% and 34% (difference 9%; 3-14). Two cycles of preoperative cisplatin and fluorouracil improve survival without additional serious adverse events in the treatment of patients with resectable oesophageal cancer.

0 comments Cited 256 times – based on 0 reviews      Review now

Bookmark

All references

Author and article information

Journal

Journal ID (nlm-ta): BMJ

Journal ID (iso-abbrev): BMJ

Journal ID (publisher-id): BMJ-UK

Journal ID (hwp): bmj

Title: The BMJ

Publisher: BMJ Publishing Group Ltd.

ISSN (Print): 0959-8138

ISSN (Electronic): 1756-1833

Publication date Collection: 2020

Publication date (Electronic): 17 June 2020

Volume: 369

Electronic Location Identifier: m115

Affiliations

[1 ]School of Health and Related Research, University of Sheffield, Sheffield S1 4DA, UK

[2 ]Centre for Trials Research, Cardiff University, UK

[3 ]MRC Biostatistics Unit, University of Cambridge, UK

[4 ]Institute of Health and Society, Newcastle University, UK

[5 ]Department of Mathematics and Statistics, University of Reading, UK

[6 ]Department of Mathematics and Statistics, Lancaster University, UK

[7 ]Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, UK

[8 ]Centre for Medical Statistics, Informatics, and Intelligent Systems, Medical University of Vienna, Austria

[9 ]Janssen Pharmaceuticals, USA

[10 ]National Cerebral and Cardiovascular Center, Japan

[11 ]National Institute of Allergy and Infectious Diseases, National Institutes of Health, USA

[12 ]Division of Biostatistics in the Center for Biologics Evaluation and Research, Food and Drug Administration, USA

[13 ]Pharmaceuticals and Medical Devices Agency, Japan

[14 ]Centre for Statistics in Medicine, University of Oxford, UK

Author notes

Correspondence to: M Dimairo m.dimairo@ 123456sheffield.ac.uk ; mdimairo@ 123456gmail.com

Author information

Munyaradzi Dimairo https://orcid.org/0000-0002-9311-6920

Article

Publisher ID: dimm050350

DOI: 10.1136/bmj.m115

PMC ID: 7298567

PubMed ID: 32554564

SO-VID: 78dcac57-0e4a-4f3d-a450-38dd675f2fd2

License:

This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/.

The Adaptive designs CONSORT Extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design

Read this article at

Abstract

Related collections

Karger: Coronavirus / COVID-19

Most cited references 214

CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials.

Systematic Review of the Empirical Evidence of Study Publication Bias and Outcome Reporting Bias

Surgical resection with or without preoperative chemotherapy in oesophageal cancer: a randomised controlled trial.

Author and article information

Journal

Affiliations

Author notes

Author information

Article

History

Categories

Comments

Comment on this article

Similar content 80

Cited by 35

Most referenced authors 3,430