Drug Safety

, Volume 36, Supplement 1, pp 15–25 | Cite as

Variation in Choice of Study Design: Findings from the Epidemiology Design Decision Inventory and Evaluation (EDDIE) Survey

  • Paul E. Stang
  • Patrick B. Ryan
  • J. Marc Overhage
  • Martijn J. Schuemie
  • Abraham G. Hartzema
  • Emily Welebob
Original Research Article



Researchers using observational data to understand drug effects must make a number of analytic design choices that suit the characteristics of the data and the subject of the study. Review of the published literature suggests that there is a lack of consistency even when addressing the same research question in the same database.


To characterize the degree of similarity or difference in the method and analysis choices made by observational database research experts when presented with research study scenarios.

Research Design

On-line survey using research scenarios on drug-effect studies to capture method selection and analysis choices that follow a dependency branching based on response to key questions.


Voluntary participants experienced in epidemiological study design solicited for participation through registration on the Observational Medical Outcomes Partnership website, membership in particular professional organizations, or links in relevant newsletters.


Description (proportion) of respondents selecting particular methods and making specific analysis choices based on individual drug-outcome scenario pairs. The number of questions/decisions differed based on stem questions of study design, time-at-risk, outcome definition, and comparator.


There is little consistency across scenarios, by drug or by outcome of interest, in the decisions made for design and analyses in scenarios using large healthcare databases. The most consistent choice was the cohort study design but variability in the other critical decisions was common.


There is great variation among epidemiologists in the design and analytical choices that they make when implementing analyses in observational healthcare databases. These findings confirm that it will be important to generate empiric evidence to inform these decisions and to promote a better understanding of the impact of standardization on research implementation.


Acute Myocardial Infarction Propensity Score Acute Liver Injury Health Information Exchange Analysis Choice 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.



The Observational Medical Outcomes Partnership is funded by the Foundation for the National Institutes of Health (FNIH) through generous contributions from the following: Abbott, Amgen Inc., AstraZeneca, Bayer Healthcare Pharmaceuticals, Inc., Bioden Idec, Bristol-Myers Squibb, Eli Lilly & Company, GlaxoSmithKline, Janssen Research and Development, Lundbeck, Inc., Merck & Co., Inc., Novartis Pharmaceuticals Corporation, Pfizer Inc, Pharmaceutical Research Manufacturers of America (PhRMA), Roche, Sanofi-aventis, Schering-Plough Corporation, and Takeda. Drs. Stang, Schuemie and Ryan are employees of Janssen Research and Development. Dr. Schuemie received a fellowship from the Office of Medical Policy, Center for Drug Evaluation and Research, Food and Drug Administration and has become an employee of Janssen Research & Development since completing this research.

Drs. Schuemie and Madigan have received a grant previously from FNIH. J. Marc Overhage, Abraham G. Hartzema, and Emily Welebob have no conflicts of interest to declare.

This article was published in a supplement sponsored by the Foundation for the National Institutes of Health (FNIH). The supplement was guest edited by Stephen J.W. Evans. It was peer reviewed by Olaf H. Klungel who received a small honorarium to cover out-of-pocket expenses. S.J.W.E has received travel funding from the FNIH to travel to the OMOP symposium and received a fee from FNIH for the review of a protocol for OMOP. O.H.K has received funding for the IMI–PROTECT project.from the Innovative Medicines Initiative Joint Undertaking ( under Grant Agreement no 115004, resources of which are composed of financial contribution from the European Union’s Seventh Framework Programme (FP7/2007–2013) and EFPIA companies’ in kind contribution.

Supplementary material

40264_2013_103_MOESM1_ESM.pdf (67 kb)
Supplementary material 1 (PDF 66 kb)


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Copyright information

© Springer International Publishing Switzerland 2013

Authors and Affiliations

  • Paul E. Stang
    • 1
    • 2
    • 6
  • Patrick B. Ryan
    • 1
    • 6
  • J. Marc Overhage
    • 3
    • 6
  • Martijn J. Schuemie
    • 4
    • 6
  • Abraham G. Hartzema
    • 5
    • 5
  • Emily Welebob
    • 6
  1. 1.Janssen Research and Development LLCTitusvilleUSA
  2. 2.TitusvilleUSA
  3. 3.Siemens Health ServicesMalvernUSA
  4. 4.Department of Medical InformaticsErasmus University Medical Center RotterdamRotterdamThe Netherlands
  5. 5.College of PharmacyUniversity of FloridaGainesvilleUSA
  6. 6.Observational Medical Outcomes PartnershipFoundation for the National Institutes of HealthBethesdaUSA

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