文献检索文档翻译深度研究
Suppr Zotero 插件Zotero 插件
邀请有礼套餐&价格历史记录

新学期,新优惠

限时优惠:9月1日-9月22日

30天高级会员仅需29元

1天体验卡首发特惠仅需5.99元

了解详情
不再提醒
插件&应用
Suppr Zotero 插件Zotero 插件浏览器插件Mac 客户端Windows 客户端微信小程序
高级版
套餐订阅购买积分包
AI 工具
文献检索文档翻译深度研究
关于我们
关于 Suppr公司介绍联系我们用户协议隐私条款
关注我们

Suppr 超能文献

核心技术专利:CN118964589B侵权必究
粤ICP备2023148730 号-1Suppr @ 2025

适应性设计 CONSORT 扩展(ACE)声明:一份带有解释和说明指南的清单,用于报告使用适应性设计的随机试验。

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

机构信息

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

Centre for Trials Research, Cardiff University, UK.

出版信息

BMJ. 2020 Jun 17;369:m115. doi: 10.1136/bmj.m115.


DOI:10.1136/bmj.m115
PMID:32554564
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7298567/
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.

摘要

适应性设计(ADs)允许对正在进行的试验进行预先计划的更改,而不会影响结论的有效性,因此必须区分预先计划的更改和可能发生的未计划的更改。随机试验中 AD 的报告不一致,需要改进。未充分报告的 AD 随机试验难以重现,难以解释和综合。这反过来又阻碍了它们为实践以及未来的研究提供信息的能力,并导致了研究浪费。更好的透明度和充分的报告将使 AD 的潜在益处得以实现。本 CONSORT 2010 声明的扩展旨在增强随机 AD 临床试验的报告。我们通过来自 21 个国家的公共和私营部门临床试验研究多学科关键利益相关者的两阶段 Delphi 过程以及共识会议,制定了适应性设计 CONSORT 扩展(ACE)指南。CONSORT 小组的成员参与了制定过程。本文介绍了 AD 随机试验报告和摘要的 ACE 检查表,并提供了示例解释,以帮助应用指南。ACE 检查表包括七个新项目、九个修改项目、六个不变项目,这些项目增加了额外的解释性文本,进一步考虑了 AD 的情况,以及 20 个不变项目,不需要进一步的解释性文本。ACE 摘要检查表有一个新项目、一个修改项目、一个不变项目,带有 AD 的额外解释性文本,以及 15 个不变项目,不需要进一步的解释性文本。目的是提高透明度,改进 AD 随机试验的报告,以提高其结果的可解释性和方法、结果和推断的可重现性。我们还希望间接地促进急需的创新试验设计的知识转移,以最大限度地发挥其潜在益处。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2f19/7298567/36873d9db0f1/dimm050350.f3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2f19/7298567/9c8eb2b59579/dimm050350.f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2f19/7298567/30f6f016ec63/dimm050350.f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2f19/7298567/36873d9db0f1/dimm050350.f3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2f19/7298567/9c8eb2b59579/dimm050350.f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2f19/7298567/30f6f016ec63/dimm050350.f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2f19/7298567/36873d9db0f1/dimm050350.f3.jpg

相似文献

[1]
The Adaptive designs CONSORT Extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design.

BMJ. 2020-6-17

[2]
The adaptive designs CONSORT extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design.

Trials. 2020-6-17

[3]
Development process of a consensus-driven CONSORT extension for randomised trials using an adaptive design.

BMC Med. 2018-11-16

[4]
CONSORT 2025 statement: updated guideline for reporting randomised trials.

BMJ. 2025-4-14

[5]
CONSORT 2025 statement: Updated guideline for reporting randomised trials.

PLoS Med. 2025-4-14

[6]
CONSORT 2010 statement: extension checklist for reporting within person randomised trials.

Br J Dermatol. 2019-1-4

[7]
CONSORT-SPI 2018 Explanation and Elaboration: guidance for reporting social and psychological intervention trials.

Trials. 2018-7-31

[8]
Consolidated standards of reporting trials (CONSORT) and the completeness of reporting of randomised controlled trials (RCTs) published in medical journals.

Cochrane Database Syst Rev. 2012-11-14

[9]
Methods and results used in the development of a consensus-driven extension to the Consolidated Standards of Reporting Trials (CONSORT) statement for trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE).

BMJ Open. 2021-4-29

[10]
Reporting randomised trials of social and psychological interventions: the CONSORT-SPI 2018 Extension.

Trials. 2018-7-31

引用本文的文献

[1]
Confidence Intervals for Adaptive Trial Designs II: Case Study and Practical Guidance.

Stat Med. 2025-8

[2]
Confidence Intervals for Adaptive Trial Designs I: A Methodological Review.

Stat Med. 2025-8

[3]
My Back Exercise app: an automated exercise intervention supported by educational notifications, a sleep programme and diet advice to improve function in people with chronic non-specific low back pain - protocol for a superiority, adaptive multi-arm multi-stage randomised controlled trial.

BMJ Open. 2025-8-1

[4]
Clinical trials with interim analyses: standardizing terminology to increase clarity.

Trials. 2025-7-14

[5]
A Comprehensive Bibliometric Analysis of Biomedical Research Waste: Current Situation, Development, and Trends.

Med Sci Monit. 2025-6-27

[6]
Value-adaptive clinical trial designs for efficient delivery of publicly funded trials - a discussion of methods, case studies, opportunities and challenges.

BMC Med Res Methodol. 2025-6-5

[7]
Anxiolysis for laceration repair in children: study protocol for an open-label multicenter adaptive trial (ALICE).

PLoS One. 2025-6-4

[8]
Agile evaluation including two pragmatic trials on the uptake of a digital screening service.

NPJ Digit Med. 2025-5-26

[9]
CONSORT 2025 explanation and elaboration: updated guideline for reporting randomised trials.

BMJ. 2025-4-14

[10]
Lessons from the PROTECT-CH COVID-19 platform trial in care homes.

Health Technol Assess. 2025-4-9

本文引用的文献

[1]
Adaptive Designs: Results of 2016 Survey on Perception and Use.

Ther Innov Regul Sci. 2020-1

[2]
Adaptive Design: A Review of the Technical, Statistical, and Regulatory Aspects of Implementation in a Clinical Trial.

Ther Innov Regul Sci. 2020-1

[3]
TAILoR (TelmisArtan and InsuLin Resistance in Human Immunodeficiency Virus [HIV]): An Adaptive-design, Dose-ranging Phase IIb Randomized Trial of Telmisartan for the Reduction of Insulin Resistance in HIV-positive Individuals on Combination Antiretroviral Therapy.

Clin Infect Dis. 2020-5-6

[4]
CONSORT 2010 statement: extension to randomised crossover trials.

BMJ. 2019-7-31

[5]
Reporting of Multi-Arm Parallel-Group Randomized Trials: Extension of the CONSORT 2010 Statement.

JAMA. 2019-4-23

[6]
A Review of Clinical Trials With an Adaptive Design and Health Economic Analysis.

Value Health. 2019-3-14

[7]
Randomised trials with provision for early stopping for benefit (or harm): The impact on the estimated treatment effect.

Stat Med. 2019-3-19

[8]
COMPare: a prospective cohort study correcting and monitoring 58 misreported trials in real time.

Trials. 2019-2-14

[9]
Effect of Levocarnitine vs Placebo as an Adjunctive Treatment for Septic Shock: The Rapid Administration of Carnitine in Sepsis (RACE) Randomized Clinical Trial.

JAMA Netw Open. 2018-12-7

[10]
DELTA guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial.

BMJ. 2018-11-5

文献AI研究员

20分钟写一篇综述,助力文献阅读效率提升50倍

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索

推荐工具

医学文档翻译智能文献检索