HT-1: State the goals of HTE analyses, including hypotheses and the supporting evidence base
State the inferential goal of each HTE analysis, and explain how it is related to the topic of the research. Specify whether the HTE analysis is hypothesis-driven (sometimes denoted as confirmatory), or hypothesis-generating (sometimes denoted as exploratory). Hypothesis-driven HTE analyses should be pre-specified, based on prior evidence (described clearly in the study protocol and published paper), and supported by a clear statement of the hypotheses the study will evaluate, including how subgroups will be defined (e.g., by multivariate score or stratification), outcome measures, and the direction of the expected treatment effects.
Public comments
Public Comments - Methodology Standards
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5: Standards for Heterogeneity of Treatment Effects
HT-1: State the goals of HTE analyses, including hypotheses and the supporting evidence base
State the inferential goal of each HTE analysis, and explain how it is related to the topic of the research. Specify whether the HTE analysis is hypothesis-driven (sometimes denoted as confirmatory), or hypothesis-generating (sometimes denoted as exploratory). Hypothesis-driven HTE analyses should be pre-specified, based on prior evidence (described clearly in the study protocol and published paper), and supported by a clear statement of the hypotheses the study will evaluate, including how subgroups will be defined (e.g., by multivariate score or stratification), outcome measures, and the direction of the expected treatment effects.
Public comments