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

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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.

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Most cited references 30

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Launching PCORnet, a national patient-centered clinical research network

Rachael L Fleurence, Lesley H. Curtis, Robert Califf … (2014)

The Patient-Centered Outcomes Research Institute (PCORI) has launched PCORnet, a major initiative to support an effective, sustainable national research infrastructure that will advance the use of electronic health data in comparative effectiveness research (CER) and other types of research. In December 2013, PCORI's board of governors funded 11 clinical data research networks (CDRNs) and 18 patient-powered research networks (PPRNs) for a period of 18 months. CDRNs are based on the electronic health records and other electronic sources of very large populations receiving healthcare within integrated or networked delivery systems. PPRNs are built primarily by communities of motivated patients, forming partnerships with researchers. These patients intend to participate in clinical research, by generating questions, sharing data, volunteering for interventional trials, and interpreting and disseminating results. Rapidly building a new national resource to facilitate a large-scale, patient-centered CER is associated with a number of technical, regulatory, and organizational challenges, which are described here.

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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

Marc Berger, Harold Sox, Richard J Willke … (2017)

Abstract Purpose Real‐world evidence (RWE) includes data from retrospective or prospective observational studies and observational registries and provides insights beyond those addressed by randomized controlled trials. RWE studies aim to improve health care decision making. Methods The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the International Society for Pharmacoepidemiology (ISPE) created a task force to make recommendations regarding good procedural practices that would enhance decision makers' confidence in evidence derived from RWD studies. Peer review by ISPOR/ISPE members and task force participants provided a consensus‐building iterative process for the topics and framing of recommendations. Results The ISPOR/ISPE Task Force recommendations cover seven topics such as study registration, replicability, and stakeholder involvement in RWE studies. These recommendations, in concert with earlier recommendations about study methodology, provide a trustworthy foundation for the expanded use of RWE in health care decision making. Conclusion The focus of these recommendations is good procedural practices for studies that test a specific hypothesis in a specific population. We recognize that some of the recommendations in this report may not be widely adopted without appropriate incentives from decision makers, journal editors, and other key stakeholders.

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Reproducible Research Practices and Transparency across the Biomedical Literature

Shareen Iqbal, Joshua D Wallach, Muin Khoury … (2016)

There is a growing movement to encourage reproducibility and transparency practices in the scientific community, including public access to raw data and protocols, the conduct of replication studies, systematic integration of evidence in systematic reviews, and the documentation of funding and potential conflicts of interest. In this survey, we assessed the current status of reproducibility and transparency addressing these indicators in a random sample of 441 biomedical journal articles published in 2000–2014. Only one study provided a full protocol and none made all raw data directly available. Replication studies were rare (n = 4), and only 16 studies had their data included in a subsequent systematic review or meta-analysis. The majority of studies did not mention anything about funding or conflicts of interest. The percentage of articles with no statement of conflict decreased substantially between 2000 and 2014 (94.4% in 2000 to 34.6% in 2014); the percentage of articles reporting statements of conflicts (0% in 2000, 15.4% in 2014) or no conflicts (5.6% in 2000, 50.0% in 2014) increased. Articles published in journals in the clinical medicine category versus other fields were almost twice as likely to not include any information on funding and to have private funding. This study provides baseline data to compare future progress in improving these indicators in the scientific literature.

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Author and article information

Contributors

Shirley V. Wang:

ORCID: http://orcid.org/0000-0001-7761-7090

swang1@bwh.harvard.edu

Journal

Journal ID (nlm-ta): Pharmacoepidemiol Drug Saf

Journal ID (iso-abbrev): Pharmacoepidemiol Drug Saf

Journal ID (doi): 10.1002/(ISSN)1099-1557

Journal ID (publisher-id): PDS

Title: Pharmacoepidemiology and Drug Safety

Publisher: John Wiley and Sons Inc. (Hoboken )

ISSN (Print): 1053-8569

ISSN (Electronic): 1099-1557

Publication date (Electronic): 15 September 2017

Publication date (Print): September 2017

Volume: 26

Issue: 9 ( doiID: 10.1002/pds.v26.9 )

Pages: 1018-1032

Affiliations

[ ¹ ] Division of Pharmacoepidemiology and Pharmacoeconomics Brigham and Women's Hospital MA USA

[ ² ] Department of Medicine Harvard Medical School MA USA

[ ³ ] Pfizer NY USA

[ ⁴ ] Department of Population Medicine Harvard Medical School MA USA

[ ⁵ ] Department of Clinical Pharmacy Maastricht UMC+ The Netherlands

[ ⁶ ] London School of Hygiene and Tropical Medicine England UK

[ ⁷ ] Agenzia regionale di sanità della Toscana Florence Italy

[ ⁸ ] Division of Pharmacoepidemiology & Clinical Pharmacology Utrecht University Utrecht Netherlands

[ ⁹ ] Pharmaceutical Health Services Research Department University of Maryland School of Pharmacy MA USA

[ ¹⁰ ] FDA Center for Drug Evaluation and Research USA

[ ¹¹ ] Aetion, Inc. NY USA

[ ¹² ] Erasmus University Medical Center Rotterdam Netherlands

Author notes

[*] [* ] Correspondence

S. V. Wang, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital and Harvard Medical School, United States.

Email: swang1@ 123456bwh.harvard.edu

Contributors to the joint ISPE‐ISPOR Special Task Force on Real World Evidence in Health Care Decision Making paper co‐led by Shirley V. Wang and Sebastian Schneeweiss. The writing group contributors are the following: Marc L. Berger, Jeffrey Brown, Frank de Vries, Ian Douglas, Joshua J. Gagne, Rosa Gini, Olaf Klungel, C. Daniel Mullins, Michael D. Nguyen, Jeremy A. Rassen, Liam Smeeth and Miriam Sturkenboom. The contributors who participated in small group discussion and/or provided substantial feedback prior to ISPE/ISPOR membership review are the following: Andrew Bate, Alison Bourke, Suzanne Cadarette, Tobias Gerhard, Robert Glynn, Krista Huybrechts, Kiyoshi Kubota, Amr Makady, Fredrik Nyberg, Mary E Ritchey, Ken Rothman and Sengwee Toh. Additional information is listed in Appendix.

Author information

Shirley V. Wang http://orcid.org/0000-0001-7761-7090

Joshua J. Gagne http://orcid.org/0000-0001-5428-9733

Article

Publisher ID: PDS4295 Other ID: PDS-17-0312.R2

DOI: 10.1002/pds.4295

PMC ID: 5639362

PubMed ID: 28913963

SO-VID: 7b1ed887-eb40-46ab-a894-934b9d6ab41e

License:

This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

History

Date received : 21 July 2017

Date revision received : 25 July 2017

Date accepted : 25 July 2017

Page count

Figures: 2, Tables: 3, Pages: 15, Words: 6216

Custom metadata

source-schema-version-number 2.0

component-id pds4295

cover-date September 2017

details-of-publishers-convertor Converter:WILEY_ML3GV2_TO_NLMPMC version:5.2.1 mode:remove_FC converted:13.10.2017

ScienceOpen disciplines: Pharmacology & Pharmaceutical medicine

Keywords: transparency,reproducibility,replication,healthcare databases,pharmacoepidemiology,methods,longitudinal data

Data availability:

ScienceOpen disciplines: Pharmacology & Pharmaceutical medicine

Keywords: transparency, reproducibility, replication, healthcare databases, pharmacoepidemiology, methods, longitudinal data

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

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Abstract

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Acta Materia Medica

Most cited references 30

Launching PCORnet, a national patient-centered clinical research network

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

Reproducible Research Practices and Transparency across the Biomedical Literature

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Author notes

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