2015
DOI: 10.1136/bmj.h5651
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Three simple rules to ensure reasonably credible subgroup analyses

Abstract: The limitations of subgroup analyses are well established—false positives due to multiple comparisons, false negatives due to inadequate power, and limited ability to inform individual treatment decisions because patients have multiple characteristics that vary simultaneously. In this article, we apply Bayes’s rule to determine the probability that a positive subgroup analysis is a true positive. From this framework, we derive simple rules to determine when subgroup analyses can be performed as hypothesis test… Show more

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Cited by 212 publications
(180 citation statements)
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“…identical pathogens) might help overcome some of the challenges faced in sepsis research (Cohen et al, 2015). Here we applied the new Sepsis-3 definition to both the discovery GWAS and the sequencing study and we wanted to avoid multiplicity issues that arise if subgroups are defined post-hoc (Sun et al, 2014, Burke et al, 2015). However, the validation GWA studies addressed a slightly different phenotype spectrum (e.g.…”
Section: Discussionmentioning
confidence: 99%
“…identical pathogens) might help overcome some of the challenges faced in sepsis research (Cohen et al, 2015). Here we applied the new Sepsis-3 definition to both the discovery GWAS and the sequencing study and we wanted to avoid multiplicity issues that arise if subgroups are defined post-hoc (Sun et al, 2014, Burke et al, 2015). However, the validation GWA studies addressed a slightly different phenotype spectrum (e.g.…”
Section: Discussionmentioning
confidence: 99%
“…30 Methodological recommendations for study design, analysis and interpretation of such subgroup analyses are available including the need for clear terminology. 7, 41, 59, 65, 69 In this study we attempt to distinguish between variables that demonstrated treatment effect modification for stratified care outcomes from those that were predictive of patient outcomes regardless of treatment. We use treatment effect modifiers are used for variables measured at baseline that demonstrated an interaction with the stratified care treatment outcomes (ie.…”
Section: Introductionmentioning
confidence: 99%
“…This study adhered to criteria for a best practice analytical approach to subgroup analyses67 with the exception that secondary outcomes (ie, resilience protective factor outcomes) were examined in subgroups, and the proposed subgroup analyses were not published a priori. In terms of further limitations, the number of comparisons undertaken within this study may have increased the risk of type 1 error and led to the sole significant result; however, the use of a formal statistical interaction test, rather than examination of intervention effect within individual subgroups, reduces this risk 76. In the overall study, the proportion of enrolled students completing both the baseline and follow-up surveys was below 50%, and while typical for school-based research,77 it may limit the generalisability of the study results.…”
Section: Discussionmentioning
confidence: 98%