GRACE Principles

The GRACE Principles provide high-level guidance to decision-makers to help them evaluate the quality of observational studies comparing the effectiveness of various medical products and services. Three questions represent the GRACE Principles for evaluating non-randomized studies of comparative effectiveness:

• Were the study plans, including research questions, main comparisons, outcome, etc. specified in advance of conducting the study?
• Was the study conducted and analyzed in a manner consistent with good practices, and reported in enough details for evaluation and replication?
• How valid is the interpretation of comparative effectiveness for the population of interest, assuming sound methodology and appropriate follow-up?

Detailed explanation and elaboration of these questions can be found in the full version of the GRACE Principles.

The April 2010 version of the Principles, which was formally endorsed by ISPE, is available here as a PDF.

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