A Checklist for Retrospective Database Studies—Report of
the ISPOR Task Force on Retrospective Databases
The citation for this report is:
Motheral B, Brooks J, Clark MA, et al. A checklist for retroactive
database studies -Report of the ISPOR Task Force on Retrospective
Databases.
Value in Health 2003;6:90-7
Task Force Chair
Brenda Motheral MBA, PhD, Vice
President, Express Scripts, Maryland Heights, MO, USA
Leadership Group
John Brooks PhD, Assistant Professor,
College of Pharmacy, University of Iowa, Iowa, City, IA, USA
Mary Ann Clark MHA, Manager Outcomes
Analytic, Boston Scientific Corporation, Natick, MA, USA
William Crown PhD, Vice President,
outcomes Research, The Medstat Group, Cambridge, MA, USA
Peter Davey MD, FRCP, head of
Pharmacoeconomics, Department of Clinical Pharmacology, University of
Dundee, Dundee, UK
Dave Hutchins MBA, MHSA, Researcher,
Advanced PCS Health Systems, Inc., Scottsdale, AZ, USA
Bradley C. Martin PharmD, PhD, Associate
Professor, College of Pharmacy, University of Georgia, Athens, GA, USA
Paul Stang PhD, Vice President, Galt
Associates, Inc., Blue Bell, PA
Reviewer Group
Frederick Berggen, PhD, Scientific
Advisor, AstraZeneca R&D, Lund Sweden
James Chan, PharmD, Pharmacy Operator,
Kaiser Foundation, Oakland, CA USA
Suellen Curkendall, PhD, Director of
Research, The Degge Group, Arlington, VA, USA
William Edell, PhD, Plano, TX, USA
Shelah Leader, PhD, Director, Medimmune,
Gaithersburg, MD, USA
Marianne McCollum, RPH, PhD, Assistant
Professor, University of Colorado, Denver, CO, USA
Newell McElwee, PharmD, MSPH, Senior
Director, Pfizer, Inc., New York, NY, USA
John Walt, MBA, Manager, Allergan, Inc.,
Irvine, CA, USA |
ABSTRACT
INTRODUCTION: Health-related retrospective databases, in particular claims
databases, continue to be an important data source for outcomes research.
However, retrospective databases present a pose a series of methodological
challenges, some of which are unique to this data source.
METHODS: In an effort to assist decision-makers in evaluating the quality
of published studies that use health-related retrospective databases, a
checklist was developed that focuses on issues, which are unique to
database studies or are particularly problematic in database research.
This checklist was developed primarily for the commonly used medical
claims or encounter-based databases but could potentially be used to
assess retrospective studies that employ other types of databases, such as
disease registries and national survey data.
RESULTS: Written in the form of 27 questions, the checklist can be used to
guide decision-makers as they consider the database, the study
methodology, and the study conclusions. Checklist questions cover a wide
range of issues, including relevance, reliability and validity, data
linkages, eligibility determination, research design, treatment effects,
sample selection, censoring, variable definitions, resource valuation,
statistical analysis, generalizability, and data interpretation.
CONCLUSIONS: For many of the questions, key references are provided as a
resource for those who want to further examine a particular issue.
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