Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
Gewählte Publikation:
SHR Neuro Krebs Kardio Lipid Stoffw Microb
Fingerhut, A; Uranues, S; Dziri, C; Ma, J; Vernerey, D; Kurihara, H; Stiegler, P.
Interaction analysis of subgroup effects in randomized trials: the essential methodological points.
Sci Rep. 2024; 14(1): 12619
Doi: 10.1038/s41598-024-62896-1
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- Co-Autor*innen der Med Uni Graz
- Stiegler Philipp
- Uranüs Selman
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- Abstract:
- Subgroup analysis aims to identify subgroups (usually defined by baseline/demographic characteristics), who would (or not) benefit from an intervention under specific conditions. Often performed post hoc (not pre-specified in the protocol), subgroup analyses are prone to elevated type I error due to multiple testing, inadequate power, and inappropriate statistical interpretation. Aside from the well-known Bonferroni correction, subgroup treatment interaction tests can provide useful information to support the hypothesis. Using data from a previously published randomized trial where a p value of 0.015 was found for the comparison between standard and Hemopatch® groups in (the subgroup of) 135 patients who had hand-sewn pancreatic stump closure we first sought to determine whether there was interaction between the number and proportion of the dependent event of interest (POPF) among the subgroup population (patients with hand-sewn stump closure and use of Hemopatch®), Next, we calculated the relative excess risk due to interaction (RERI) and the "attributable proportion" (AP). The p value of the interaction was p = 0.034, the RERI was - 0.77 (p = 0.0204) (the probability of POPF was 0.77 because of the interaction), the RERI was 13% (patients are 13% less likely to sustain POPF because of the interaction), and the AP was - 0.616 (61.6% of patients who did not develop POPF did so because of the interaction). Although no causality can be implied, Hemopatch® may potentially decrease the POPF after distal pancreatectomy when the stump is closed hand-sewn. The hypothesis generated by our subgroup analysis requires confirmation by a specific, randomized trial, including only patients undergoing hand-sewn closure of the pancreatic stump after distal pancreatectomy.Trial registration: INS-621000-0760.
- Find related publications in this database (using NLM MeSH Indexing)
- Humans - administration & dosage
- Randomized Controlled Trials as Topic - administration & dosage
- Pancreatectomy - administration & dosage
- Female - administration & dosage
- Male - administration & dosage
- Pancreas - surgery
- Find related publications in this database (Keywords)
- Secondary analysis
- Interaction analysis
- Subgroup analysis
- Relative excess risk due to interaction
- Attributable proportion
- Randomized trial
- Distal pancreatectomy
- Post-operative pancreatic fistula
- Hemopatch (R)