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Related Experiment Videos

Assessing placebo response using Bayesian hierarchical survival models

D K Stangl1, J B Greenhouse

  • 1Institute of Statistics and Decision Sciences, Duke University, USA. dalene@stat.duke.edu

Lifetime Data Analysis
|May 6, 1998
PubMed
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This study investigated variations in placebo effects across different centers for recurrent unipolar affective disorders. Bayesian models revealed significant heterogeneity in these placebo responses, impacting treatment outcome predictions.

Area of Science:

  • Biostatistics
  • Psychiatry
  • Clinical Trials

Background:

  • The National Institute of Mental Health (NIMH) Collaborative Study examined long-term drug therapy for recurrent affective illness.
  • A key observation was significant heterogeneity in placebo group outcomes across study centers.
  • Understanding this variability is crucial for interpreting clinical trial results in unipolar affective disorders.

Purpose of the Study:

  • To employ Bayesian hierarchical survival models to quantify and explore center-specific heterogeneity in placebo effects.
  • To investigate the impact of this heterogeneity on the prediction of depressive episode recurrence.
  • To assess the sensitivity of these models to different survival distribution assumptions and prior distributions.

Main Methods:

Related Experiment Videos

  • Utilized Bayesian hierarchical survival models to analyze data from the NIMH Collaborative Study.
  • Employed the Gibbs sampling algorithm for approximating posterior and predictive distributions.
  • Compared results from exponential, exponential mixture, and exponential changepoint models to assess sensitivity to hazard distribution assumptions.

    • Main Results:

    • Bayesian analysis confirmed substantial heterogeneity in placebo effects across different centers.
    • The models provided insights into the marginal posterior distributions of key parameters and predictive distributions for future observations.
    • Sensitivity analyses indicated the robustness of findings to variations in model assumptions regarding survival distributions and prior specifications.

    Conclusions:

    • Heterogeneity in placebo responses is a significant factor in multicenter trials for recurrent unipolar affective disorders.
    • Bayesian hierarchical models offer a robust framework for investigating and accounting for such variability.
    • These findings have implications for the interpretation of treatment efficacy and the design of future clinical studies in affective disorders.