4.5 Article

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

期刊

BMJ-BRITISH MEDICAL JOURNAL
卷 369, 期 -, 页码 -

出版社

BMJ PUBLISHING GROUP
DOI: 10.1136/bmj.m115

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资金

  1. National Institute for Health Research (NIHR) Clinical Trials Unit Support Funding scheme [MR/L004933/-2/N90]
  2. Medical Research Council (MRC) Network of Hubs for Trials Methodology Research (HTMR) [MR/L004933/-2/N90]
  3. NIHR CTU Support Funding scheme
  4. MRC HTMR
  5. NIHR [NIHR-SRF-2015-08-001]
  6. Edinburgh Clinical Trials Unit
  7. University of Sheffield via the Sheffield Clinical Trials Unit and the NIHR CTU Support Funding scheme
  8. MRC HTMR grant [MR/L004933/1-R/N/P/B1]
  9. MRC [MR/N028171/1, MC_UU_00002/6, MR/L004933/2] Funding Source: UKRI

向作者/读者索取更多资源

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.

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