The growth in therapeutic choices for many health conditions has sparked interest in evaluating the comparative effectiveness of these treatment options. Randomized controlled trials frequently do not provide direct comparisons of different treatments and may not be representative of the patients and their co-morbidities. Non-randomized research, such as observational studies, has many benefits, but critics often point to methodological weaknesses of observational studies and the lack of standard principles to assess their quality, which limit their effectiveness in providing evidence-based information.
The Good ReseArch for Comparative Effectiveness (GRACE) Initiative addresses these concerns through the development and definition of a set of good practice principles to aid researchers and policymakers in identifying and assessing the quality of observational studies. As part of this effort, they have developed the GRACE Principles, which define the elements of good practice for the design, conduct, analysis and reporting of observational CER studies. The GRACE principles are endorsed by the International Society for Pharmacoepidemiology and supported by a number of professionals and organizations.
The GRACE Principles use three important questions when assessing a study:
- 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?
To help stakeholders evaluate observational studies of comparative and effectiveness in terms of their quality and usefulness for health care decision-making, the GRACE Initiative also developed a validated 11-item checklist. The checklist was developed from a review of published literature and tested by hundreds of volunteers from around the world.
The GRACE Initiative was spearheaded by Quintiles Real-World & Late Phase Research with seed funding from the National Pharmaceutical Council. GRACE contributors represent academic, government, and private sectors from around the world and represent many different perspectives on comparative effectiveness.