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Semiparametric recurrent event vs time-to-first-event analyses in randomized trials: Estimands and model misspecification

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dc.contributor.authorZhong, Yujie
dc.contributor.authorCook, Richard
dc.date.accessioned2022-08-08T14:12:54Z
dc.date.available2022-08-08T14:12:54Z
dc.date.issued2021-04-20
dc.descriptionThis is the peer reviewed version of the following article: “Zhong Y and Cook RJ (2021), Semiparametric recurrent event vs time-to-first-event analyses in randomized trials: Estimands and model misspecification, Statistics in Medicine, 40 (16): 3823–3842” which has been published in final form at https://doi.org/10.1002/sim.9002.en
dc.description.abstractInsights regarding the merits of recurrent event and time-to-first-event analyses are needed to provide guidance on strategies for analyzing intervention effects in randomized trials involving recurrent event responses. Using established asymptotic results we introduce a framework for studying the large sample properties of estimators arising from semiparametric proportional rate function models and Cox regression undermodel misspecification. The asymptotic biases and power implications are investigated for different data generating models, and we study the impact of dependent censoring on these findings. Illustrative applications are given involving data from a cystic fibrosis trial and a carcinogenicity experiment, following which we summarize findings and discuss implications for clinical trial design.en
dc.description.sponsorshipNational Natural Science Foundation of China, NSFC-11901376 (to YZ) || Shanghai Pujiang Program, 2019PJC051 (to YZ) || SUFE Innovation Funding, 2019110051 (to YZ) || Discovery Grant and Supplement Award from the Natural Science and Engineering Research Council of Canada, RGPIN 155849 and RGPIN 04207 (to RJC) || Canadian Institutes for Health Research, FRN 13887 (to RJC)en
dc.identifier.urihttps://doi.org/10.1002/sim.9002
dc.identifier.urihttp://hdl.handle.net/10012/18490
dc.language.isoenen
dc.publisherJohn Wiley & Sons Ltd.en
dc.subjectCox regression, estimands, multiplicative rate functions, power, recurrent events, robustnessen
dc.titleSemiparametric recurrent event vs time-to-first-event analyses in randomized trials: Estimands and model misspecificationen
dc.typeArticleen
uws.contributor.affiliation1Faculty of Mathematicsen
uws.contributor.affiliation2Statistics and Actuarial Scienceen
uws.peerReviewStatusRevieweden
uws.scholarLevelFacultyen
uws.typeOfResourceTexten

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