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Comments on “sensitivity of estimands in clinical trials with imperfect compliance” by Chen and Heitjan

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Veröffentlicht/Copyright: 29. Juli 2024

Abstract

Chen and Heitjan (Sensitivity of estimands in clinical trials with imperfect compliance. Int J Biostat. 2023) used linear extrapolation to estimate the population average causal effect (PACE) from the complier average causal effect (CACE) in multiple randomized trials with all-or-none compliance. For extrapolating from CACE to PACE in this setting and in the paired availability design involving different availabilities of treatment among before-and-after studies, we recommend the sensitivity analysis in Baker and Lindeman (J Causal Inference, 2013) because it is not restricted to a linear model, as it involves various random effect and trend models.


Corresponding author: Stuart G. Baker, National Cancer Institute, Bethesda, MD, 20892-9789, USA, E-mail: 

Disclaimer: The opinions expressed by the authors are their own and this material should not be interpreted as representing the official viewpoint of the U.S. Department of Health and Human Services, the National Institutes of Health, or the National Cancer Institute.


  1. Research ethics: Not applicable.

  2. Author contributions: The authors have accepted responsibility for the entire content of this manuscript and approved its submission.

  3. Competing interests: The authors state no conflict of interest.

  4. Research funding: None declared.

  5. Data availability: Not applicable.

References

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4. Baker, SG, Kramer, BS, Lindeman, KL. Latent class instrumental variables. A clinical and biostatistical perspective. Stat Med 2016;35:147–60. Correction 2019; 38: 901. https://doi.org/10.1002/sim.6612.Suche in Google Scholar PubMed PubMed Central

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6. Sheng, E, Li, W, Zhou, XH. Estimating causal effects of treatment in RCTs with provider and subject noncompliance. Stat Med 2019;38:738–50. https://doi.org/10.1002/sim.8012.Suche in Google Scholar PubMed

7. Swanson, SA, Hernán, MA, Miller, M, Robins, JM, Richardson, T. Partial identification of the average treatment effect using instrumental variables: review of methods for binary instruments, treatments, and outcomes. J Am Stat Assoc 2018;113:933–47. https://doi.org/10.1080/01621459.2018.1434530.Suche in Google Scholar PubMed PubMed Central

8. Frangakis, CE, Rubin, DB. Principal stratification in causal inference. Biometrics 2002;58:21–9. https://doi.org/10.1111/j.0006-341x.2002.00021.x.Suche in Google Scholar PubMed PubMed Central

9. Angrist, JD, Imbens, GW, Rubin, DB. Identification of causal effects using instrumental variables. J Am Stat Assoc 1996;92:444–55. https://doi.org/10.2307/2291629.Suche in Google Scholar

10. Chen, H, Heitjan, DF. Sensitivity of estimands in clinical trials with imperfect compliance. Int J Biostat 2023;20:57–67. https://doi.org/10.1515/ijb-2022-0105.Suche in Google Scholar PubMed

11. Baker, SG, Lindeman, KS, Kramer, BS. Clarifying the role of principal stratification in the paired availability design. Int J Biostat 2011;7:25. https://doi.org/10.2202/1557-4679.1338.Suche in Google Scholar PubMed PubMed Central

12. Baker, SG, Lindeman, KS. Revisiting a discrepant result: a propensity score analysis, the paired availability design for historical controls, and a meta-analysis of randomized trials. J Causal Inference 2013;1:51–82. Correction 2014;1:113. https://doi.org/10.1515/jci-2013-0005.Suche in Google Scholar

Received: 2023-11-08
Accepted: 2024-02-27
Published Online: 2024-07-29

© 2024 Walter de Gruyter GmbH, Berlin/Boston

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