PMID- 38030552 OWN - NLM STAT- MEDLINE DCOM- 20240105 LR - 20240105 IS - 1471-6771 (Electronic) IS - 0007-0912 (Linking) VI - 132 IP - 1 DP - 2024 Jan TI - Statistically significant differences versus convincing evidence of real treatment effects: an analysis of the false positive risk for single-centre trials in anaesthesia. PG - 116-123 LID - S0007-0912(23)00616-5 [pii] LID - 10.1016/j.bja.2023.10.036 [doi] AB - 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). CI - Copyright (c) 2023 The Author(s). Published by Elsevier Ltd.. All rights reserved. FAU - Sidebotham, David AU - Sidebotham D AD - Department of Cardiothoracic and ORL Anaesthesia, Auckland City Hospital, Auckland, New Zealand; Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland, New Zealand; Department of Anaesthesiology, Faculty of Health Sciences, University of Auckland, New Zealand. Electronic address: dsidebotham@adhb.govt.nz. FAU - Dominick, Felicity AU - Dominick F AD - Department of Cardiothoracic and ORL Anaesthesia, Auckland City Hospital, Auckland, New Zealand. FAU - Deng, Carolyn AU - Deng C AD - Department of Anaesthesiology, Faculty of Health Sciences, University of Auckland, New Zealand; Department of Anaesthesia and Perioperative Medicine, Auckland City Hospital, Auckland, New Zealand. FAU - Barlow, Jake AU - Barlow J AD - Department of Cardiothoracic and ORL Anaesthesia, Auckland City Hospital, Auckland, New Zealand; Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland, New Zealand. FAU - Jones, Philip M AU - Jones PM AD - Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Jacksonville, FL, USA. LA - eng PT - Journal Article PT - Review DEP - 20231128 PL - England TA - Br J Anaesth JT - British journal of anaesthesia JID - 0372541 SB - IM MH - Humans MH - Bayes Theorem MH - Data Interpretation, Statistical MH - Research Design MH - *Anesthesia MH - *Anesthesiology OTO - NOTNLM OT - Bayes factor OT - Bayes' theorem OT - anaesthesia OT - false positive risk OT - research design OT - sample size OT - significance testing EDAT- 2023/11/30 00:42 MHDA- 2024/01/05 06:43 CRDT- 2023/11/29 22:06 PHST- 2023/07/19 00:00 [received] PHST- 2023/10/29 00:00 [revised] PHST- 2023/10/31 00:00 [accepted] PHST- 2024/01/05 06:43 [medline] PHST- 2023/11/30 00:42 [pubmed] PHST- 2023/11/29 22:06 [entrez] AID - S0007-0912(23)00616-5 [pii] AID - 10.1016/j.bja.2023.10.036 [doi] PST - ppublish SO - Br J Anaesth. 2024 Jan;132(1):116-123. doi: 10.1016/j.bja.2023.10.036. Epub 2023 Nov 28.