Allogeneic transplant programs in the U.S. are required to submit corrective action plans to FACT when they do not meet the expected range of one-year survival in the CIBMTR Transplant Center-Specific Survival Report. To adequately assess lower-than-expected one-year survival, it is necessary to fully understand how the report is generated.
CIBMTR explains the report methodology in the document titled, Methodology Employed for Annual Report on Hematopoietic Cell Transplant Center-Specific Survival Rates. The document provides technical information on statistics, but offers the following summary: “A censored data logistic regression model is fitted to survival data for first unrelated and related donor hematopoietic cell transplants at U.S. centers. The model is adjusted for recipient age; recipient race/ethnicity; Karnofsky/Lansky score; coexisting disease (Sorror HCT-CI); recipient CMV status; disease/status; interval from diagnosis to transplant (ALL and AML only); NHL subtype; resistant disease (NHL and HL only); CLL and other chronic leukemia stage; prior autologous transplant; year of transplant; donor type/graft type/HLA matching; donor/recipient gender match (bone marrow or PBSC only); and donor age (unrelated donor bone marrow or PBSC only). The report on transplant center-specific survival rates helps to identify centers that may have performed above or below confidence limits compared to the overall network of transplant centers . . .”
CIBMTR also explains the report, and its tools and resources to help Clinical Programs use their data, in the FACT webinar recording titled, Using CIBMTR Data to Determine and Evaluate Clinical Outcomes, presented by Stephen Spellman, MBS. This recording gives an overview of how CIBMTR data is used to determine outcomes and how Clinical Programs can use additional data to further evaluate outcomes and improve.
The following are common points Clinical Programs make about the CIBMTR report, and how they can be evaluated in the context of creating corrective action plans to address lower-than-expected one-year survival:
- High-risk patients: Some corrective action plans stated the root cause of death to be transplants for high-risk patients. As outlined above, the CIBMTR report is risk-adjusted. High-risk patients should be accounted for within the report. The FACT committee expects corrective actions that specifically address the causes of death. Broad refusal to transplant patients with high risk is not the intent of FACT requirements. As transplants are often the last hope for patients, careful attention to trends in causes of death is particularly important for these patients to improve their outcomes. For example, some programs have determined myeloablative therapy was not necessary or beneficial for a group of frail patients; another adjusted its protocol for preparative regimens.
- Small programs: It is difficult to identify trends among a small number of transplants, but FACT will look for a good-faith effort of the program to review data and determine if a trend can be found. One small program found that its patients had a high rate of CNS disease, and is educating its network of referring physicians.
- Confidence interval: A common worry is that Clinical Programs will have one-year survival lower than the expected range, through no fault of their own, because of the 95% confidence interval. It is important to realize that each program has its own confidence interval. A defined number does not have to drop out of the curve. Therefore, it is possible for each program to meet expected one-year survival. Small programs typically have a wider range of expected outcomes.
- Delay in reporting: Due to the inherent timeframe of “one-year” survival, the CIBMTR report is delayed by two years because the transplant has to have occurred a year prior, and an additional year is needed to analyze the data. Furthermore, the report uses three years’ worth of data. For example, data analysis may show that a Clinical Program had a particularly bad year in 2012 that resulted in lower-than-expected one-year survival in the 2015 report. However, it is still necessary to review the causes of death and their root causes for the timeframe of the report. If survival is showing an upward trajectory since that year, include that information in the corrective action plan for consideration.
- Overall one-year survival: The CIBMTR report only provides overall one-year survival; however, drilling down into specific diseases will help Clinical Programs determine root causes and which corrective actions may help. This is the same for treatment-related mortality or disease relapse. This type of drill-down has helped programs identify root causes.
- Data errors: Some Clinical Programs have noted that errors in the data submitted to the CIBMTR were the true root of low one-year survival. Indeed, this can affect results of the algorithm. If data errors are a problem, FACT will want to see corrective actions related to accurate data management and reporting.