Observational, database studies provide a powerful QI supplement
Explore this issue:November 2011
The proposed rules by the Centers for Medicare & Medicaid Services (CMS), which will allow access to patient-protected Medicare data, will provide for greater transparency and for data that could be utilized toward comparative-effectiveness research (CER). Thus, these rules have the potential to improve the quality of healthcare and impact patient safety.
The Institute of Medicine in December 1999 issued its now-famous article “To Err is Human,” which reported that medical errors cause up to 98,000 deaths and more than 1 million injuries each year in the U.S.6 However, the evidence shows minimal impact on improving patient safety in the past 10 years.
A retrospective study of 10 North Carolina hospitals reported in the New England Journal of Medicine by Landrigan and colleagues found that harms resulting from medical care remained extremely common, with little evidence for improvement.7 It also is estimated that it takes 17 years on average for clinical research to become incorporated into the majority of clinical practices.8 Although the randomized control trial (RCT) is unquestionably the best research tool to explore simple components of clinical care (i.e. tests, drugs, and procedures), its translation into daily clinical practice remains difficult.
Improving the process of care leading to quality remains an extremely difficult proposition based on such sociological issues as resistance to change, the need for interdisciplinary teamwork, level of support staff, economic factors, information retrieval inadequacies, and, most important, the complexity of patients with multiple comorbidities that do not fit the parameters of the RCT.
Don Berwick, MD, the lead author in the landmark IOM report and currently CMS administrator, has stated “in such complex terrain, the RCT is an impoverished way to learn.”9 Factors that cause this chasm include:10
- Too narrowly focused RCT;
- More required resources, including financial and personnel support with RCT, compared with usually clinical practices;
- Lack of collaboration between academic medical center researchers and community clinicians; and
- Lack of expertise and experience to undertake quality improvement in healthcare.
CER has received a $1.1 billion investment with the passage of the American Recovery and Reinvestment Act to provide evidence on the effectiveness, benefits, and harms of various treatment options.11 As part of this research to improve IOM’s goals to improve healthcare, better evidence is desperately needed to cross the translational gap between clinical research and the bedside.12 Observational outcome studies based on registries or databases derived primarily from clinical care can provide a powerful supplement to quality improvement.13