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

Journal article

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.

Authors: Haber, NA; Wieten, SE; Smith, ER; Nunan, D

• Publication status: Published
• Peer review status: Peer reviewed
• Publisher: BioMed Central
• Journal: Trials
• Volume: 22
• Issue: 1
• Pages: 780-780
• Article number: 780
• Publication date: 2021-11-07
• DOI: 10.1186/s13063-021-05755-y
• EISSN: 1745-6215
• ISSN: 1745-6215
• Language: English
• Keywords: Statistics; Meta-analysis; Research design; Clinical trial; Psychiatry; Alternative medicine; Computer science; Psychological intervention; Context (archaeology); Statistical power; Coronavirus disease 2019 (COVID-19); Misinformation; Medicine