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Much ado about something: a response to 'COVID-19: underpowered randomised trials, or no randomised trials?'

Authors :
Noah A. Haber
Sarah E. Wieten
Emily R. Smith
David Nunan
Source :
Trials, Vol 22, Iss 1, Pp 1-4 (2021)
Publication Year :
2021
Publisher :
BMC, 2021.

Abstract

Abstract Non-pharmaceutical interventions (NPI) for infectious diseases such as COVID-19 are particularly challenging given the complexities of what is both practical and ethical to randomize. We are often faced with the difficult decision between having weak trials or not having a trial at all. In a recent article, Dr. Atle Fretheim argues that statistically underpowered studies are still valuable, particularly in conjunction with other similar studies in meta-analysis in the context of the DANMASK-19 trial, asking “Surely, some trial evidence must be better than no trial evidence?” However, informative trials are not always feasible, and feasible trials are not always informative. In some cases, even a well-conducted but weakly designed and/or underpowered trial such as DANMASK-19 may be uninformative or worse, both individually and in a body of literature. Meta-analysis, for example, can only resolve issues of statistical power if there is a reasonable expectation of compatible well-designed trials. Uninformative designs may also invite misinformation. Here, we make the case that—when considering informativeness, ethics, and opportunity costs in addition to statistical power—“nothing” is often the better choice.

Details

Language :
English
ISSN :
17456215
Volume :
22
Issue :
1
Database :
Directory of Open Access Journals
Journal :
Trials
Publication Type :
Academic Journal
Accession number :
edsdoj.80c986e95464cbc126642a8ed9314
Document Type :
article
Full Text :
https://doi.org/10.1186/s13063-021-05755-y