Abstract
Days alive and out of hospital is recommended as a patient-centered outcome in perioperative clinical studies. It is defined as the number of days, out of the first M postoperative days, that the patient has been discharged from hospital, or zero if the patient dies within M days of surgery. This composite measure presents statistical challenges in its unusual distributional shape, and its inability to distinguish between the qualitatively different outcomes of death, and a hospital stay longer than M days. We propose a mixed binary-continuous model that overcomes these difficulties, and illustrate its use on a clinical trial of a drug administered in cardiac surgery.
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Heller, G., Forbes, A., Heritier, S. (2024). Statistical Models for Patient-Centered Outcomes in Clinical Studies. In: Einbeck, J., Maeng, H., Ogundimu, E., Perrakis, K. (eds) Developments in Statistical Modelling. IWSM 2024. Contributions to Statistics. Springer, Cham. https://doi.org/10.1007/978-3-031-65723-8_8
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DOI: https://doi.org/10.1007/978-3-031-65723-8_8
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