Published Mar 2003
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
Introduction: Health-related retrospective databases, in
particular claims databases, continue to be an important
data source for outcomes research. However, retrospective
databases 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 healthrelated
retrospective databases, a checklist was developed
that focuses on issues that 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.
Keywords: claims databases, outcomes research, research design, statistics.