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Enhanced precision in the analysis of randomized trials with ordinal outcomes

Author

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  • Iván Díaz
  • Elizabeth Colantuoni
  • Michael Rosenblum

Abstract

type="main" xml:lang="en"> We present a general method for estimating the effect of a treatment on an ordinal outcome in randomized trials. The method is robust in that it does not rely on the proportional odds assumption. Our estimator leverages information in prognostic baseline variables, and has all of the following properties: (i) it is consistent; (ii) it is locally efficient; (iii) it is guaranteed to have equal or better asymptotic precision than both the inverse probability-weighted and the unadjusted estimators. To the best of our knowledge, this is the first estimator of the causal relation between a treatment and an ordinal outcome to satisfy these properties. We demonstrate the estimator in simulations based on resampling from a completed randomized clinical trial of a new treatment for stroke; we show potential gains of up to 39% in relative efficiency compared to the unadjusted estimator. The proposed estimator could be a useful tool for analyzing randomized trials with ordinal outcomes, since existing methods either rely on model assumptions that are untenable in many practical applications, or lack the efficiency properties of the proposed estimator. We provide R code implementing the estimator.

Suggested Citation

  • Iván Díaz & Elizabeth Colantuoni & Michael Rosenblum, 2016. "Enhanced precision in the analysis of randomized trials with ordinal outcomes," Biometrics, The International Biometric Society, vol. 72(2), pages 422-431, June.
    • Handle: RePEc:bla:biomet:v:72:y:2016:i:2:p:422-431
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    Citations

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    Cited by:

    1. David Benkeser & Iván Díaz & Alex Luedtke & Jodi Segal & Daniel Scharfstein & Michael Rosenblum, 2021. "Improving precision and power in randomized trials for COVID‐19 treatments using covariate adjustment, for binary, ordinal, and time‐to‐event outcomes," Biometrics, The International Biometric Society, vol. 77(4), pages 1467-1481, December.
    2. Lu, Jiannan, 2018. "On the partial identification of a new causal measure for ordinal outcomes," Statistics & Probability Letters, Elsevier, vol. 137(C), pages 1-7.
    3. Nicholas Williams & Michael Rosenblum & Iván Díaz, 2022. "Optimising precision and power by machine learning in randomised trials with ordinal and time‐to‐event outcomes with an application to COVID‐19," Journal of the Royal Statistical Society Series A, Royal Statistical Society, vol. 185(4), pages 2156-2178, October.
    4. Jiannan Lu & Peng Ding & Tirthankar Dasgupta, 2018. "Treatment Effects on Ordinal Outcomes: Causal Estimands and Sharp Bounds," Journal of Educational and Behavioral Statistics, , vol. 43(5), pages 540-567, October.

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