Reporting to Improve Reproducibility and Facilitate Validity Assessment for Healthcare Database Studies V1.0
Top Cited Papers
Open Access
- 15 September 2017
- journal article
- research article
- Published by Wiley in Pharmacoepidemiology and Drug Safety
- Vol. 26 (9), 1018-1032
- https://doi.org/10.1002/pds.4295
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.Keywords
This publication has 47 references indexed in Scilit:
- 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 makingPharmacoepidemiology and Drug Safety, 2017
- Drug Regulation and Pricing — Can Regulators Influence Affordability?The New England Journal of Medicine, 2016
- Transparency and Reproducibility of Observational Cohort Studies Using Large Healthcare Databases.Clinical Pharmacology & Therapeutics, 2015
- PCORnet: turning a dream into realityJournal of the American Medical Informatics Association, 2014
- Replication of the OMOP Experiment in Europe: Evaluating Methods for Risk Identification in Electronic Health Record DatabasesDrug Safety, 2013
- A systematic review finds prediction models for chronic kidney disease were poorly reported and often developed using inappropriate methodsJournal of Clinical Epidemiology, 2013
- Immortal Time Bias in PharmacoepidemiologyAmerican Journal of Epidemiology, 2007
- Indications for Propensity Scores and Review of their Use in PharmacoepidemiologyBasic & Clinical Pharmacology & Toxicology, 2006
- Evaluating Medication Effects Outside of Clinical Trials: New-User DesignsAmerican Journal of Epidemiology, 2003
- 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 analysisBMJ, 2000