Statistical primer: individual patient data meta-analysis and meta-analytic approaches in case of non-proportional hazards

Author:

An Kevin R12ORCID,Di Franco Antonino1ORCID,Rahouma Mohamed1ORCID,Biondi-Zoccai Giuseppe34ORCID,Redfors Björn567ORCID,Gaudino Mario1ORCID

Affiliation:

1. Department of Cardiothoracic Surgery, Weill Cornell Medicine , New York, NY, USA

2. Division of Cardiac Surgery, Department of Surgery, University of Toronto , Toronto, ON, Canada

3. Department of Medical-Surgical Sciences and Biotechnologies, Sapienza University of Rome , Latina, Italy

4. Mediterranea Cardiocentro , Napoli, Italy

5. Department of Molecular and Clinical Medicine, Institute of Medicine, Gothenburg University , Gothenburg, Sweden

6. Department of Cardiology, Sahlgrenska University Hospital , Gothenburg, Sweden

7. Department of Population Health Sciences, Weill Cornell Medicine , New York, NY, USA

Abstract

Abstract Individual patient data (IPD) meta-analyses build upon traditional (aggregate data) meta-analyses by collecting IPD from the individual studies rather than using aggregated summary data. Although both traditional and IPD meta-analyses produce a summary effect estimate, IPD meta-analyses allow for the analysis of data to be performed as a single dataset. This allows for standardization of exposure, outcomes, and analytic methods across individual studies. IPD meta-analyses also allow the utilization of statistical methods typically used in cohort studies, such as multivariable regression, survival analysis, propensity score matching, uniform subgroup and sensitivity analyses, better management of missing data, and incorporation of unpublished data. However, they are more time-intensive, costly, and subject to participation bias. A separate issue relates to the meta-analytic challenges when the proportional hazards assumption is violated. In these instances, alternative methods of reporting time-to-event estimates, such as restricted mean survival time should be used. This statistical primer summarizes key concepts in both scenarios and provides pertinent examples.

Funder

European Union—NextGenerationEU

Italian Ministry of University and Research

Publisher

Oxford University Press (OUP)

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