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<p>The ICH E9(R1) <i>Addendum on Estimands and Sensitivity Analysis</i> provides a framework for defining the treatment effect a trial intends to estimate—the estimand. The addendum is widely adopted in pharmaceutical research. However, it remains underutilized in trials investigating internet-based interventions (IBIs). This manuscript introduces the addendum to IBI researchers. It concludes that estimands are essential to improve the interpretability, relevance, and validity of effect estimates derived in IBI trials.</p>

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Using the ICH estimand framework to improve the interpretation of treatment effects in internet interventions

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年8月20日

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  • Manuel Heinrich,
  • Pavle Zagorscak,
  • Johannes Bohn,
  • Christine Knaevelsrud,
  • Lars Schulze

摘要

The ICH E9(R1) Addendum on Estimands and Sensitivity Analysis provides a framework for defining the treatment effect a trial intends to estimate—the estimand. The addendum is widely adopted in pharmaceutical research. However, it remains underutilized in trials investigating internet-based interventions (IBIs). This manuscript introduces the addendum to IBI researchers. It concludes that estimands are essential to improve the interpretability, relevance, and validity of effect estimates derived in IBI trials.