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

被引：120

作者：

Wang, Shirley V. ^{[1
,2
]}

Schneeweiss, Sebastian ^{[1
,2
]}

Berger, Marc L. ^{[3
]}

Brown, Jeffrey ^{[4
]}

de Vries, Frank ^{[5
]}

Douglas, Ian ^{[6
]}

Gagne, Joshua J. ^{[1
,2
]}

Gini, Rosa ^{[7
]}

Klungel, Olaf ^{[8
]}

Mullins, C. Daniel ^{[9
]}

Nguyen, Michael D. ^{[10
]}

Rassen, Jeremy A. ^{[11
]}

Smeeth, Liam ^{[6
]}

Sturkenboom, Miriam ^{[12
]}

机构：

[1] Brigham & Womens Hosp, Div Pharmacoepidemiol & Pharmacoecon, Boston, MA 02115 USA

[2] Harvard Med Sch, Dept Med, Boston, MA USA

[3] Pfizer, New York, NY USA

[4] Harvard Med Sch, Dept Populat Med, Boston, MA USA

[5] Maastricht UMC, Dept Clin Pharm, Maastricht, Netherlands

[6] London Sch Hyg & Trop Med, London, England

[7] Agenzia Reg Sanita Toscana, Florence, Italy

[8] Univ Utrecht, Div Pharmacoepidemiol & Clin Pharmacol, Utrecht, Netherlands

[9] Univ Maryland, Sch Pharm, Pharmaceut Hlth Serv Res Dept, College Pk, MD 20742 USA

[10] FDA Ctr Drug Evaluat & Res, Greenbelt, MD USA

[11] Aetion Inc, New York, NY USA

[12] Erasmus MC, Rotterdam, Netherlands

来源：

PHARMACOEPIDEMIOLOGY AND DRUG SAFETY | 2017年 / 26卷 / 09期

关键词：

Transparency; reproducibility; replication; healthcare databases; pharmacoepidemiology; methods; longitudinal data; REAL-WORLD DATA; SAFETY; DRUG; GUIDELINES; PCORNET; DESIGN; COHORT; RISK;

D O I：

10.1002/pds.4295

中图分类号：

R1 [预防医学、卫生学];

学科分类号：

1004 ; 120402 ;

摘要：

PurposeDefining 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. MethodsWe 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. ConclusionEvidence 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.

引用

页码：1018 / 1032

页数：15

共 59 条

[41] Promoting an open research culture [J].

Nosek, B. A. ;

Alter, G. ;

Banks, G. C. ;

Borsboom, D. ;

Bowman, S. D. ;

Breckler, S. J. ;

Buck, S. ;

Chambers, C. D. ;

Chin, G. ;

Christensen, G. ;

Contestabile, M. ;

Dafoe, A. ;

Eich, E. ;

Freese, J. ;

Glennerster, R. ;

Goroff, D. ;

Green, D. P. ;

Hesse, B. ;

Humphreys, M. ;

Ishiyama, J. ;

Karlan, D. ;

Kraut, A. ;

Lupia, A. ;

Mabry, P. ;

Madon, T. A. ;

Malhotra, N. ;

Mayo-Wilson, E. ;

McNutt, M. ;

Miguel, E. ;

Paluck, E. Levy ;

Simonsohn, U. ;

Soderberg, C. ;

Spellman, B. A. ;

Turitto, J. ;

VandenBos, G. ;

Vazire, S. ;

Wagenmakers, E. J. ;

Wilson, R. ;

Yarkoni, T. .

SCIENCE, 2015, 348 (6242) :1422-1425

[42] Reproducibility in Cancer Biology: Making sense of replications [J].

Nosek, Brian A. ;

Errington, Timothy M. .

ELIFE, 2017, 6

[43] The EU-ADR Web Platform: delivering advanced pharmacovigilance tools [J].

Oliveira, Jose Luis ;

Lopes, Pedro ;

Nunes, Tiago ;

Campos, David ;

Boyer, Scott ;

Ahlberg, Ernst ;

van Mulligen, Erik M. ;

Kors, Jan A. ;

Singh, Bharat ;

Furlong, Laura I. ;

Sanz, Ferran ;

Bauer-Mehren, Anna ;

Carrascosa, Maria C. ;

Mestres, Jordi ;

Avillach, Paul ;

Diallo, Gayo ;

Diaz Acedo, Carlos ;

van der Lei, Johan .

PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, 2013, 22 (05) :459-467

[44] Mini-Sentinel and Regulatory Science - Big Data Rendered Fit and Functional [J].

Psaty, Bruce M. ;

Breckenridge, Alasdair M. .

NEW ENGLAND JOURNAL OF MEDICINE, 2014, 370 (23) :2165-2167

[45] Evaluating medication effects outside of clinical trials: New-user designs [J].

Ray, WA .

AMERICAN JOURNAL OF EPIDEMIOLOGY, 2003, 158 (09) :915-920

[46] INDUCTION AND LATENT PERIODS [J].

ROTHMAN, KJ .

AMERICAN JOURNAL OF EPIDEMIOLOGY, 1981, 114 (02) :253-259

[47] A review of uses of health care utilization databases for epidemiologic research on therapeutics [J].

Schneeweiss, S ;

Avorn, J .

JOURNAL OF CLINICAL EPIDEMIOLOGY, 2005, 58 (04) :323-337

[48] DECISION-MAKING ALIGNED WITH RAPID-CYCLE EVALUATION IN HEALTH CARE [J].

Schneeweiss, Sebastian ;

Shrank, William H. ;

Ruhl, Michael ;

Maclure, Malcolm .

INTERNATIONAL JOURNAL OF TECHNOLOGY ASSESSMENT IN HEALTH CARE, 2015, 31 (04) :214-222

[49] Replication of the OMOP Experiment in Europe: Evaluating Methods for Risk Identification in Electronic Health Record Databases [J].

Schuemie, Martijn J. ;

Gini, Rosa ;

Coloma, Preciosa M. ;

Straatman, Huub ;

Herings, Ron M. C. ;

Pedersen, Lars ;

Innocenti, Francesco ;

Mazzaglia, Giampiero ;

Picelli, Gino ;

van der Lei, Johan ;

Sturkenboom, Miriam C. J. M. .

DRUG SAFETY, 2013, 36 :S159-S169

[50]

Science CfO, TRANSPR OP PROM TOP

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