smdi: an R package to perform structural missing data investigations on partially observed confounders in real-world evidence studies

Author:

Weberpals Janick1ORCID,Raman Sudha R2,Shaw Pamela A3,Lee Hana4,Hammill Bradley G2,Toh Sengwee5,Connolly John G5,Dandreo Kimberly J5,Tian Fang6,Liu Wei6,Li Jie6,Hernández-Muñoz José J6ORCID,Glynn Robert J1,Desai Rishi J1

Affiliation:

1. Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School , Boston, MA 02120, United States

2. Department of Population Health Sciences, Duke University School of Medicine , Durham, NC 27701, United States

3. Biostatistics Division, Kaiser Permanente Washington Health Research Institute , Seattle, WA 98101, United States

4. Office of Biostatistics, Center for Drug Evaluation and Research, United States Food and Drug Administration , Silver Spring, MD 20993, United States

5. Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute , Boston, MA 02215, United States

6. Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, United States Food and Drug Administration , Silver Spring, MD 20993, United States

Abstract

Abstract Objectives Partially observed confounder data pose a major challenge in statistical analyses aimed to inform causal inference using electronic health records (EHRs). While analytic approaches such as imputation are available, assumptions on underlying missingness patterns and mechanisms must be verified. We aimed to develop a toolkit to streamline missing data diagnostics to guide choice of analytic approaches based on meeting necessary assumptions. Materials and methods We developed the smdi (structural missing data investigations) R package based on results of a previous simulation study which considered structural assumptions of common missing data mechanisms in EHR. Results smdi enables users to run principled missing data investigations on partially observed confounders and implement functions to visualize, describe, and infer potential missingness patterns and mechanisms based on observed data. Conclusions The smdi R package is freely available on CRAN and can provide valuable insights into underlying missingness patterns and mechanisms and thereby help improve the robustness of real-world evidence studies.

Funder

US Food and Drug Administration

Publisher

Oxford University Press (OUP)

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