Table 1Considerations for Study Design

ConstructRelevant questions
Research questionWhat are the clinical and/or public health questions of interest?
ResourcesWhat resources, in terms of funding, sites, clinicians, and patients, are available for the study?
Exposures and outcomesHow do the clinical questions of interest translate into measurable exposures and outcomes?
Data sourcesWhere can the necessary data be found?
Study designWhat types of design can be used to answer the questions or fulfill the purpose?
Study populationWhat types of patients are needed for study? Is a comparison group needed? How should patients be selected for study?
SamplingHow should the study population be sampled, taking into account the target populations and study design?
Study size and durationFor how long should data be collected, and for how many patients?
Internal and external validityWhat are the potential biases?
What are the concerns about generalizability of the results (external validity)?

From: Chapter 3, Registry Design

Cover of Registries for Evaluating Patient Outcomes: A User's Guide
Registries for Evaluating Patient Outcomes: A User's Guide. 2nd edition.
Gliklich RE, Dreyer NA, editors.

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