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

Trials

David Nunan¹  Emily R. Smith²  Noah A. Haber³  Sarah E. Wieten³ 

[1] Centre for Evidence Based Medicine, University of Oxford;Department of Global Health, Milken Institute School of Public Health, George Washington University;Meta-Research Innovation Center at Stanford (METRICS), Stanford University;

关键词: Non-pharmaceutical interventions;    Masks;    Ethics;    DANMASK-19;    Statistical power;   

DOI  :  10.1186/s13063-021-05755-y

来源: DOAJ

【 摘 要 】

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.

【 授权许可】

Unknown