#TBT: Need Evidence to Inform Health Decisions? Do it GRACEfully with our Checklist

As part of our “Throwback Thursday” blog series, we’re taking a look at a research topic that’s currently in the news and tagging it with previous research, videos or commentaries in a relevant way. As the saying goes, “what’s old is new again” – and we hope you enjoy our wonky twist on #TBT.

In recent weeks, we’ve heard a lot about the Patient-Centered Outcomes Research Institute’s interest in conducting different types of research studies, such as pragmatic clinical trials, head-to-head comparisons and observational studies. We’ve also heard a lot about “big data” and how it’s being mined to provide real-world information that can be useful to researchers as well as decision-makers such as payers, who use this and other information to make coverage decisions.

And these decision-makers agree that good research has the potential to inform better health care decisions. But how do we identify "good research?" Although randomized controlled trials (RCTs) have long been considered the gold standard of scientific studies, observational studies also can play a central role in answering certain types of questions, particularly regarding real-world behavior. However, some stakeholders are reluctant to utilize observational studies because of their limitations (see our infographic).

To help stakeholders evaluate the quality of an observational study, Quintiles and the National Pharmaceutical Council worked together to test the Good ReseArch for Comparative Effectiveness (GRACE) checklist. The results were published as a study, “The GRACE Checklist for Rating the Quality of Observational Studies of Comparative Effectiveness: A Tale of Hope and Caution,” in the Journal of Managed Care & Specialty Pharmacy.  

So what exactly is the GRACE checklist? The GRACE checklist contains 11 items about data and research methods that can be used as an initial screening tool to separate observational studies that meet baseline quality criteria from those that do not. The GRACE checklist is “based on existing literature and guidance from experts with extensive experience in the conduct and utilization of observational comparative effectiveness research,” and is meant to help determine which observational studies should be considered to support decision-making. This checklist is an outgrowth from the GRACE Principles, an initiative kicked off in 2008 to develop a set of high-level questions that lay out the elements of good practice for the design, conduct, analysis and reporting of observational CER studies.

To explain more about the checklist, we pulled from our video archives an interview with Dr. Nancy Dreyer, global chief of scientific affairs and SVP at Quintiles and the Initiative’s leader, at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 17th Annual International Meeting in 2012. Check out our video below as Dr. Dreyer discusses the work that went into developing the GRACE checklist and how stakeholders can use it.