Assessing and Reporting Heterogeneity in Treatment Effects in Clinical Trials¶
Kent, D. M., Rothwell, P. M., Ioannidis, J. P., Altman, D. G., & Hayward, R. A. (2010). Assessing and Reporting Heterogeneity in Treatment Effects in Clinical Trials: A Proposal. Trials, 11.
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Primes¶
- Outlier Leverage
- And in multi-site clinical trials, a handful of strong responders can drive a positive mean treatment effect even when the median patient is unaffected
This sourceTrial summary results reflect the arithmetic mean and can be unrepresentative of the typical (median) patient, so a positive mean effect can be driven by a high-risk/high-response subgroup while the median patient is largely unaffected — motivating subgroup/influence sensitivity analysis.
- And in multi-site clinical trials, a handful of strong responders can drive a positive mean treatment effect even when the median patient is unaffected
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