Statistically significant differences versus convincing evidence of real treatment effects : an analysis of the false positive risk for single-centre trials in anaesthesia

Copyright © 2023 The Author(s). Published by Elsevier Ltd.. All rights reserved..

BACKGROUND: The American Statistical Association has highlighted problems with null hypothesis significance testing and outlined alternative approaches that may 'supplement or even replace P-values'. One alternative is to report the false positive risk (FPR), which quantifies the chance the null hypothesis is true when the result is statistically significant.

METHODS: We reviewed single-centre, randomised trials in 10 anaesthesia journals over 6 yr where differences in a primary binary outcome were statistically significant. We calculated a Bayes factor by two methods (Gunel, Kass). From the Bayes factor we calculated the FPR for different prior beliefs for a real treatment effect. Prior beliefs were quantified by assigning pretest probabilities to the null and alternative hypotheses.

RESULTS: For equal pretest probabilities of 0.5, the median (inter-quartile range [IQR]) FPR was 6% (1-22%) by the Gunel method and 6% (1-19%) by the Kass method. One in five trials had an FPR ≥20%. For trials reporting P-values 0.01-0.05, the median (IQR) FPR was 25% (16-30%) by the Gunel method and 20% (16-25%) by the Kass method. More than 90% of trials reporting P-values 0.01-0.05 required a pretest probability >0.5 to achieve an FPR of 5%. The median (IQR) difference in the FPR calculated by the two methods was 0% (0-2%).

CONCLUSIONS: Our findings suggest that a substantial proportion of single-centre trials in anaesthesia reporting statistically significant differences provide limited evidence of real treatment effects, or, alternatively, required an implausibly high prior belief in a real treatment effect.

CLINICAL TRIAL REGISTRATION: PROSPERO (CRD42023350783).

Medienart:

E-Artikel

Erscheinungsjahr:

2024

Erschienen:

2024

Enthalten in:

Zur Gesamtaufnahme - volume:132

Enthalten in:

British journal of anaesthesia - 132(2024), 1 vom: 29. Jan., Seite 116-123

Sprache:

Englisch

Beteiligte Personen:

Sidebotham, David [VerfasserIn]
Dominick, Felicity [VerfasserIn]
Deng, Carolyn [VerfasserIn]
Barlow, Jake [VerfasserIn]
Jones, Philip M [VerfasserIn]

Links:

Volltext

Themen:

Anaesthesia
Bayes' theorem
Bayes factor
False positive risk
Journal Article
Research design
Review
Sample size
Significance testing

Anmerkungen:

Date Completed 05.01.2024

Date Revised 05.01.2024

published: Print-Electronic

Citation Status MEDLINE

doi:

10.1016/j.bja.2023.10.036

funding:

Förderinstitution / Projekttitel:

PPN (Katalog-ID):

NLM365216933