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

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

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Title: Reporting to Improve Reproducibility and Facilitate Validity Assessment for Healthcare Database Studies V1.0
Author: Wang, Shirley V.; Schneeweiss, Sebastian; Berger, Marc L.; Brown, Jeffrey; de Vries, Frank; Douglas, Ian; Gagne, Joshua J.; Gini, Rosa; Klungel, Olaf; Mullins, C. Daniel; Nguyen, Michael D.; Rassen, Jeremy A.; Smeeth, Liam; Sturkenboom, Miriam

Note: Order does not necessarily reflect citation order of authors.

Citation: Wang, S. V., S. Schneeweiss, M. L. Berger, J. Brown, F. de Vries, I. Douglas, J. J. Gagne, et al. 2017. “Reporting to Improve Reproducibility and Facilitate Validity Assessment for Healthcare Database Studies V1.0.” Pharmacoepidemiology and Drug Safety 26 (9): 1018-1032. doi:10.1002/pds.4295. http://dx.doi.org/10.1002/pds.4295.
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Abstract: 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.
Published Version: doi:10.1002/pds.4295
Other Sources: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5639362/pdf/
Terms of Use: This article is made available under the terms and conditions applicable to Other Posted Material, as set forth at http://nrs.harvard.edu/urn-3:HUL.InstRepos:dash.current.terms-of-use#LAA
Citable link to this page: http://nrs.harvard.edu/urn-3:HUL.InstRepos:34492402
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