Will CER Really Deliver Better Patient Outcomes?
With billions of public dollars directed to comparative effectiveness research (CER) through the 2009 stimulus package and the subsequent passage of the Affordable Care Act (ACA), there is an unprecedented amount of research in the pipeline to inform patient and provider health care decision-making. But what impact can we expect CER to have in improving care?
New research published in the June issue of the American Journal of Managed Care suggests that changes are needed to enable more consistent translation of research findings into clinical practice.
With billions of public dollars directed to comparative effectiveness research (CER) through the 2009 stimulus package and the subsequent passage of the Affordable Care Act (ACA), there is an unprecedented amount of research in the pipeline to inform patient and provider health care decision-making. But what impact can we expect CER to have in improving care?
New research published in the June issue of the American Journal of Managed Care suggests that changes are needed to enable more consistent translation of research findings into clinical practice.
The study, “Real-World Impact of Comparative Effectiveness Research Findings on Clinical Practice,” was authored by researchers from Truven Health Analytics, the National Pharmaceutical Council, Harvard Medical School and the University of Michigan. Its authors evaluated real-world utilization trends before and after the publication of CER findings and the release of relevant clinical practice guidelines (CPGs) from four high-profile CER case studies published within the last decade.
Analysis revealed no clear pattern of utilization in the first four quarters after publication. Even when research was included in revised or updated CPGs, researchers were not able to consistently find changes in utilization or clinical practice. Here is what they found:
- PROVE-IT (2004). The PROVE-IT study compared standard and intensive cholesterol-lowering therapies and their impact on multiple cardiovascular-related outcomes. Study results showing a lower risk of death or cardiovascular events for those on intensive than on standard therapy were captured in accompanying CPGs, which would have led to predictions of a consequent increased use of intensive statin therapy and decreased use of standard statin therapy. In clinical practice, use of intensive therapy remained flat in the three years after study publication, prior to a decline in the use of standard therapy.
- MAMMOGRAPHY WITH MAGNETIC RESONANCE IMAGING (MRI) (2004). The MRI -study compared the effectiveness of mammography, ultrasound, magnetic resonance imaging (MRI) and clinical breast exam in detecting tumors among carriers of BRCA1 or BRCA2 mutations. Strong study results favoring the use of MRI led to new CPGs. In clinical practice, while the use of MRI did increase prior to and after the result of findings and new guidelines, MRI utilization was far less than the utilization of ultrasound or mammography, which also increased or remained steady.
- SPORT (2006). The Spine Patient Outcomes Research Trial (SPORT) compared whether surgery (standard open discectomy) was more effective than non-operative treatment for people with herniated disks. While the research results and CPGs that followed would have suggested an increase in the use of surgery, in clinical practice surgical rates over time remained steady.
- COURAGE (2007). The COURAGE trial assessed whether adding percutaneous coronary intervention (PCI) to optimal medical therapy (OMT) for people with coronary artery disease improved outcomes. The research would have suggested either steady or decreased use of PCI, yet in clinical practice usage oscillated in the two years following research publication and updated CPGs.
These findings echo the recent NPC survey of health care stakeholders. While there is continued optimism for the use of CER as a tool for improving health care decision-making, its impact has not yet been seen. These sentiments support previous studies, which have shown that it can take several years for CER findings to actually be translated into clinical practice.
Conclusions from the CER and clinical practice study suggest areas where continued effort is needed to effectively translate and disseminate CER results to improve application of CER in clinical practice.
- Improve stakeholder engagement in research design and development. Progress can be seen in efforts to date by organizations like the Patient-Centered Outcomes Research Institute (PCORI), which has already yielded greater involvement from patients in determining which research questions need to be asked and answered.
- Identify where multiple confirmatory studies are needed. Accumulating research can be particularly important when evidence is conflicting with current practice, or when the science is less mature
- Fund studies to confirm or shape clinical opinion or current practices. Fostering a learning health system can streamline efforts to identify where multiple confirmatory studies should result in changes to clinical practice
- Align financial incentives with evidence. As an example, as an alternative to rewarding volume of treatments, procedures and services, there is promising work being done with value-based insurance design (V-BID), shared savings models, and bundled, severity-adjusted payments
- Improve understanding of how to translate knowledge to different stakeholders. Growing research in the area of study referred to as ‘knowledge translation’ will help isolate the factors that move research into practice at the point of decision-making
- Coordinate dissemination and policy efforts. Clinical practice guidelines are a necessary first step to synthesize evidence and can serve as a catalyst for uptake, other dissemination efforts, such as media campaigns, targeted outreach and others, may be important components of evidence dissemination
Looking ahead, the return on investment of CER will be measured by if, and how quickly, results from the research are used in decision-making and translated into clinical practice and will almost surely impact the duration of the nation’s investment in CER. Efforts to date by organizations such as the PCORI have already resulted in greater stakeholder engagement, and the movement toward value-based insurance design is encouraging in terms of the alignment of financial incentives with evidence. This study emphasizes the need for funding to extend beyond simply creating more CER or evidence and for it to also help ensure that research is translated and used by patients and their providers in practice.