The Fragility of Statistically Significant Results in Randomized Clinical Trials for COVID-19.
JAMA Netw Open
; 5(3): e222973, 2022 03 01.
Article
em En
| MEDLINE
| ID: mdl-35302631
ABSTRACT
Importance Interpreting results from randomized clinical trials (RCTs) for COVID-19, which have been published rapidly and in vast numbers, is challenging during a pandemic. Objective:
To evaluate the robustness of statistically significant findings from RCTs for COVID-19 using the fragility index. Design, Setting, andParticipants:
This cross-sectional study included COVID-19 trial articles that randomly assigned patients 11 into 2 parallel groups and reported at least 1 binary outcome as significant in the abstract. A systematic search was conducted using PubMed to identify RCTs on COVID-19 published until August 7, 2021. Exposures Trial characteristics, such as type of intervention (treatment drug, vaccine, or others), number of outcome events, and sample size. Main Outcomes andMeasures:
Fragility index.Results:
Of the 47 RCTs for COVID-19 included, 36 (77%) were studies of the effects of treatment drugs, 5 (11%) were studies of vaccines, and 6 (13%) were of other interventions. A total of 138â¯235 participants were included in these trials. The median (IQR) fragility index of the included trials was 4 (1-11). The medians (IQRs) of the fragility indexes of RCTs of treatment drugs, vaccines, and other interventions were 2.5 (1-6), 119 (61-139), and 4.5 (1-18), respectively. The fragility index among more than half of the studies was less than 1% of each sample size, although the fragility index as a proportion of events needing to change would be much higher. Conclusions and Relevance This cross-sectional study found a relatively small number of events (a median of 4) would be required to change the results of COVID-19 RCTs from statistically significant to not significant. These findings suggest that health care professionals and policy makers should not rely heavily on individual results of RCTs for COVID-19.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
COVID-19
Tipo de estudo:
Clinical_trials
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Observational_studies
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Prevalence_studies
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Prognostic_studies
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Risk_factors_studies
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Systematic_reviews
Limite:
Humans
Idioma:
En
Ano de publicação:
2022
Tipo de documento:
Article