Say GRACE! Principles for Observational Studies
Research critics often point to methodological weaknesses inherent in observational studies, coupled with the lack of standard principles to assess their quality, as practical limitations to their effective use in evidence development. In an effort to reduce bias in observational studies, a number of researchers have joined together to develop rigorous, generally agreed upon methods and standards known as the GRACE Principles (Good ReseArch for Comparative Effectiveness).
Research critics often point to methodological weaknesses inherent in observational studies, coupled with the lack of standard principles to assess their quality, as practical limitations to their effective use in evidence development. In an effort to reduce bias in observational studies, a number of researchers have joined together to develop rigorous, generally agreed upon methods and standards known as the GRACE Principles (Good ReseArch for Comparative Effectiveness).
GRACE collaborators recognized that a well-defined and consensus-driven set of principles could serve to guide good practice for observational studies of comparative effectiveness, both for those who conduct these studies and for those who need to understand how such studies can be used appropriately to support decision-making regarding therapeutic alternatives. These principles address the design, conduct, analysis, and reporting of observational studies of comparative effectiveness research (CER).
Additionally, GRACE collaborators have developed a GRACE checklist to "provide a validated tool for the assessment of observational CER quality and usefulness for decision-making." The checklist is "based on existing literature and guidance from experts with extensive experience in the conduct and utilization of observational CER." The GRACE principles, along with the checklist, should help to alleviate some of the concerns associated with observational studies.
Dr. Nancy Dreyer, Chief of Scientific Affairs and Senior Vice President at Outcome, a Quintiles Company, outlined how GRACE can help to ensure higher quality observational studies.
RCTs, observational studies and related topics will be discussed on April 25-26 at an Institute of Medicine (IOM) workshop, "Observational Studies in a Learning Health System."