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Should responder analyses be conducted on continuous outcomes?

Robert Abugov1, Jennifer Clark1, Laura Higginbotham2

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Dichotomizing continuous outcomes in clinical trials can distort results. The "responder effect" may misleadingly suggest significance, while the "continuous treatment effect" offers a more reliable measure of clinical benefit.

Keywords:
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Area of Science:

  • Biostatistics
  • Clinical Trial Design
  • Pharmacometrics

Background:

  • Continuous outcomes are frequently dichotomized into responder/non-responder categories.
  • This practice defines the
  • responder effect
  • as the difference in response rates between treatment and control groups.

Purpose of the Study:

  • To caution against the dichotomization of continuous interval outcomes in clinical research.
  • To propose and analyze the
  • continuous treatment effect
  • as a more appropriate measure of clinical benefit.

Main Methods:

  • Examined normally distributed continuous outcomes differing only in location.
  • Analyzed the relationship between dichotomization thresholds and responder effects.
  • Compared responder effects with continuous treatment effects.

Main Results:

  • Dichotomization thresholds do not guarantee clinically relevant responder effects.
  • Increasing thresholds can paradoxically increase calculated responder effects.
  • Responder effects can be misleading, especially when standard deviations are small or thresholds are suboptimal.

Conclusions:

  • Dichotomizing continuous outcomes presents interpretational challenges for assessing treatment effects.
  • The continuous treatment effect is a more robust measure for evaluating clinical benefit or harm.
  • Relying solely on responder effects can lead to inaccurate conclusions about drug efficacy and risk.