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dc.contributor.authorYang, Song
dc.contributor.authorAmbrosius, Walter T
dc.contributor.authorFine, Lawrence J
dc.contributor.authorBress, Adam P
dc.contributor.authorCushman, William C
dc.contributor.authorRaj, Dominic S
dc.contributor.authorRehman, Shakaib
dc.contributor.authorTamariz, Leonardo
dc.date.accessioned2018-09-14T22:06:26Z
dc.date.available2018-09-14T22:06:26Z
dc.date.issued2018-06
dc.identifier.citationYang, S., Ambrosius, W. T., Fine, L. J., Bress, A. P., Cushman, W. C., Raj, D. S., ... & Tamariz, L. (2018). A new modeling and inference approach for the Systolic Blood Pressure Intervention Trial outcomes. Clinical Trials, 15(3), 305-312. https://doi.org/10.1177/1740774518769865en_US
dc.identifier.issn1740-7745
dc.identifier.issn1740-7753
dc.identifier.pmid29671345
dc.identifier.doi10.1177/1740774518769865
dc.identifier.urihttp://hdl.handle.net/10150/629127
dc.description.abstractBackground/aims In clinical trials with time-to-event outcomes, usually the significance tests and confidence intervals are based on a proportional hazards model. Thus, the temporal pattern of the treatment effect is not directly considered. This could be problematic if the proportional hazards assumption is violated, as such violation could impact both interim and final estimates of the treatment effect. Methods We describe the application of inference procedures developed recently in the literature for time-to-event outcomes when the treatment effect may or may not be time-dependent. The inference procedures are based on a new model which contains the proportional hazards model as a sub-model. The temporal pattern of the treatment effect can then be expressed and displayed. The average hazard ratio is used as the summary measure of the treatment effect. The test of the null hypothesis uses adaptive weights that often lead to improvement in power over the log-rank test. Results Without needing to assume proportional hazards, the new approach yields results consistent with previously published findings in the Systolic Blood Pressure Intervention Trial. It provides a visual display of the time course of the treatment effect. At four of the five scheduled interim looks, the new approach yields smaller p values than the log-rank test. The average hazard ratio and its confidence interval indicates a treatment effect nearly a year earlier than a restricted mean survival time-based approach. Conclusion When the hazards are proportional between the comparison groups, the new methods yield results very close to the traditional approaches. When the proportional hazards assumption is violated, the new methods continue to be applicable and can potentially be more sensitive to departure from the null hypothesis.en_US
dc.description.sponsorshipNational Institutes of Health [HHSN268200900040C]; CWRU [UL1TR000439]; OSU [UL1RR025755]; U Penn [UL1RR024134, UL1TR000 003]; U Boston [UL1RR025771]; U Stanford [UL1TR000093]; U Tufts [UL1RR025752, UL1TR000073, UL1TR001064]; University of Illinois [UL1TR000050]; University of Pittsburgh [UL1TR 000005]; UT Southwestern [9U54TR00 0017-06]; University of Utah [UL1TR000105-05]; Vanderbilt University [UL1 TR000445]; George Washington University [UL1TR000075]; UC Davis [UL1 TR000002]; University of Florida [UL1 TR000064]; University of Michigan [UL1TR000433]; Tulane University COBRE Award NIGMS [P30GM103337]; Wake Forest University [UL1TR 001420]; National Heart, Lung, and Blood Institute [HHSN268200900040C]en_US
dc.language.isoenen_US
dc.publisherSAGE PUBLICATIONS LTDen_US
dc.relation.urlhttp://journals.sagepub.com/doi/10.1177/1740774518769865en_US
dc.rightsCopyright © 2018, © SAGE Publicationsen_US
dc.subjectAdaptively weighted log-rank testen_US
dc.subjectaverage hazard ratioen_US
dc.subjectnon-proportional hazardsen_US
dc.subjecttime-to-event outcomesen_US
dc.titleA new modeling and inference approach for the Systolic Blood Pressure Intervention Trial outcomesen_US
dc.typeArticleen_US
dc.contributor.departmentUniv Arizona, Coll Meden_US
dc.identifier.journalCLINICAL TRIALSen_US
dc.description.collectioninformationThis item from the UA Faculty Publications collection is made available by the University of Arizona with support from the University of Arizona Libraries. If you have questions, please contact us at repository@u.library.arizona.edu.en_US
dc.eprint.versionFinal accepted manuscripten_US
dc.source.journaltitleClinical Trials
dc.source.volume15
dc.source.issue3
dc.source.beginpage305
dc.source.endpage312
refterms.dateFOA2018-09-14T22:06:27Z


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