Healthcare stakeholders are “buzzing” about the QUALITY of healthcare – rightfully so. As in other arenas, excellence is easily recognized and can be magnificent but is difficult to achieve. A central issue in the ongoing discussion is how to measure and describe points along the Quality spectrum with sufficient accuracy for patients, payers and providers themselves to make decisions based on the results. How do we deliver care? When do we deliver care (is it timely?)? Are the outcomes of care are what they should be? Even whether end of life care was compassionate and competent are some of the questions being asked. In the field of transplantation, even the most basic outcome measure – Patient Survival 1 Year Following Transplantation – already in use by United Network for Organ Sharing (UNOS) and Center for Medicare and Medicaid Services (CMS) (and virtually all healthcare payers) to determine whether or not transplant centers meet regulatory expectations, has multiple imperfections as a quality measure.
Let’s examine why use of the 1 Year Patient Survival measure to assess the quality of care at a specific transplant center is so tricky. If an imaginary center called the “Chimera Center” has a 1 Year Patient Survival for liver transplants of 100%, it would appear to be doing an excellent job, right? In fact, to achieve that rate, the Chimera team may have turned down patients that were quite sick and, they feared, had too high a likelihood of not surviving the transplant. But, at least some of these patients would likely have been considered acceptable candidates at other transplant centers, and were therefore being denied access to transplantation. Similarly, the Chimera team may have been too “selective” about which organs they accepted for transplantation – again denying patients adequate access to transplantation.
The (mythical) Chimera team that appears to deliver outstanding quality liver transplantation might also be loathe to participate in clinical trials of new drugs or therapies for their patients because of potential adverse impact on their center’s patient survival rates. So, unfortunately, the regulatory focus on patient survival rates tends to impede clinical research that may offer advances in transplantation.
If the Chimera Center‘s most recent 1 Year Patient Survival rate was significantly below the expected rate, any of the factors discussed above may have been responsible. However, it is also possible that the transplants were not well performed, the care during the first post-transplant year was sub-optimal, or there was a combination of both issues. Regardless, changes would be required within the Center‘s approaches. But, now the Center will have difficulty persuading payers to allow subsequent transplants to be performed at Chimera. This negative selection bias will drive away the best quality patients (however that is measured) and tend to leave the sickest patients for transplantation at Chimera. The Center will therefore be facing a major uphill battle to re-establish a good 1 Year Patient Survival Rate even if all of the appropriate changes have been implemented. Local patients will still have limited access to transplantation because of the challenges of traveling to remote centers and the issues facing Chimera.
This issue of clinical data measurement is front and center in the field of clinical transplantation. The annual American Transplant Congress is about to begin in Seattle, Washington. Stay tuned for updates on this and other topics in subsequent posts.