» Articles » PMID: 28913963

Reporting to Improve Reproducibility and Facilitate Validity Assessment for Healthcare Database Studies V1.0

Abstract

Purpose: Defining a study population and creating an analytic dataset from longitudinal healthcare databases involves many decisions. Our objective was to catalogue scientific decisions underpinning study execution that should be reported to facilitate replication and enable assessment of validity of studies conducted in large healthcare databases.

Methods: We reviewed key investigator decisions required to operate a sample of macros and software tools designed to create and analyze analytic cohorts from longitudinal streams of healthcare data. A panel of academic, regulatory, and industry experts in healthcare database analytics discussed and added to this list.

Conclusion: Evidence generated from large healthcare encounter and reimbursement databases is increasingly being sought by decision-makers. Varied terminology is used around the world for the same concepts. Agreeing on terminology and which parameters from a large catalogue are the most essential to report for replicable research would improve transparency and facilitate assessment of validity. At a minimum, reporting for a database study should provide clarity regarding operational definitions for key temporal anchors and their relation to each other when creating the analytic dataset, accompanied by an attrition table and a design diagram. A substantial improvement in reproducibility, rigor and confidence in real world evidence generated from healthcare databases could be achieved with greater transparency about operational study parameters used to create analytic datasets from longitudinal healthcare databases.

Citing Articles

Real-world data to support post-market safety and performance of embolization coils: evidence generation from a medical device manufacturer and data institute partnership.

Hochreiter-Hufford A, Gatz J, Griggs A, Schoch R, Birmingham K, Frederick C BMC Med Inform Decis Mak. 2024; 24(1):263.

PMID: 39300415 PMC: 11414114. DOI: 10.1186/s12911-024-02659-0.


OpenSAFELY: A platform for analysing electronic health records designed for reproducible research.

Nab L, Schaffer A, Hulme W, DeVito N, Dillingham I, Wiedemann M Pharmacoepidemiol Drug Saf. 2024; 33(6):e5815.

PMID: 38783412 PMC: 7616137. DOI: 10.1002/pds.5815.


Antipsychotics and Risks of Cardiovascular and Cerebrovascular Diseases and Mortality in Dwelling Community Older Adults.

Perreault S, Boivin Proulx L, Brouillette J, Jarry S, Dorais M Pharmaceuticals (Basel). 2024; 17(2).

PMID: 38399393 PMC: 10892683. DOI: 10.3390/ph17020178.


The Coming of Age of AI/ML in Drug Discovery, Development, Clinical Testing, and Manufacturing: The FDA Perspectives.

Niazi S Drug Des Devel Ther. 2023; 17:2691-2725.

PMID: 37701048 PMC: 10493153. DOI: 10.2147/DDDT.S424991.


Association between cardiovascular diseases and dementia among various age groups: a population-based cohort study in older adults.

Boivin-Proulx L, Brouillette J, Dorais M, Perreault S Sci Rep. 2023; 13(1):14881.

PMID: 37689801 PMC: 10492794. DOI: 10.1038/s41598-023-42071-8.


References
1.
Suissa S . Immortal time bias in pharmaco-epidemiology. Am J Epidemiol. 2007; 167(4):492-9. DOI: 10.1093/aje/kwm324. View

2.
Schuemie M, Gini R, Coloma P, Straatman H, Herings R, Pedersen L . Replication of the OMOP experiment in Europe: evaluating methods for risk identification in electronic health record databases. Drug Saf. 2013; 36 Suppl 1:S159-69. DOI: 10.1007/s40264-013-0109-8. View

3.
Berger M, Sox H, Willke R, Brixner D, Eichler H, Goettsch W . Good practices for real-world data studies of treatment and/or comparative effectiveness: Recommendations from the joint ISPOR-ISPE Special Task Force on real-world evidence in health care decision making. Pharmacoepidemiol Drug Saf. 2017; 26(9):1033-1039. PMC: 5639372. DOI: 10.1002/pds.4297. View

4.
Jick H, Kaye J, Vasilakis-Scaramozza C, Jick S . Risk of venous thromboembolism among users of third generation oral contraceptives compared with users of oral contraceptives with levonorgestrel before and after 1995: cohort and case-control analysis. BMJ. 2000; 321(7270):1190-5. PMC: 27524. DOI: 10.1136/bmj.321.7270.1190. View

5.
Ray W . Evaluating medication effects outside of clinical trials: new-user designs. Am J Epidemiol. 2003; 158(9):915-20. DOI: 10.1093/aje/kwg231. View