Annals of internal medicine
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Heterogeneity of treatment effect (HTE) refers to the nonrandom variation in the magnitude or direction of a treatment effect across levels of a covariate, as measured on a selected scale, against a clinical outcome. In randomized controlled trials (RCTs), HTE is typically examined through a subgroup analysis that contrasts effects in groups of patients defined "1 variable at a time" (for example, male vs. female or old vs. young). The authors of this statement present guidance on an alternative approach to HTE analysis, "predictive HTE analysis." The goal of predictive HTE analysis is to provide patient-centered estimates of outcome risks with versus without the intervention, taking into account all relevant patient attributes simultaneously. ⋯ Both approaches can be used to predict differential absolute treatment effects, the most relevant scale for clinical decision making. The authors developed 4 sets of guidance: criteria to determine when risk-modeling approaches are likely to identify clinically important HTE, methodological aspects of risk-modeling methods, considerations for translation to clinical practice, and considerations and caveats in the use of effect-modeling approaches. The PATH Statement, together with its explanation and elaboration document, may guide future analyses and reporting of RCTs.
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Infection control is a complex task that spans people, products, and practices in diverse settings. For years, the Healthcare Infection Control Practices Advisory Committee (HICPAC) has provided advice and guidance to the Centers for Disease Control and Prevention (CDC) on how best to prevent infections. ⋯ To address this gap, the CDC asked HICPAC to develop a process that would help inform committees considering product-related recommendations. This article describes the process to develop this approach and provides an outline of how the tool may be used when products with infection control claims are recommended in guidelines or recommendations for infection prevention.