Assessment in progress of newly identified death data
Published on: Wednesday, July 13, 2022
The OPTN, the SRTR and HRSA continue to evaluate the scope and potential impact of the bolus of newly identified additional deaths among transplant candidates and recipients recently affecting transplant registry files (STAR, SAF) released to researchers by the OPTN and SRTR. We are mindful of the questions and concerns raised by some in the transplant community, and we are committed to addressing these issues in a transparent and thorough manner.
The actual impact should be negligible for analyses such as program-specific reports or policy simulation models involving outcomes within the last five years, or for analyses conducted prior to 2015. This is because:
- Of the newly identified recipient deaths, 97 percent occurred longer than five years post-transplant.
- Of the newly identified waitlist deaths, 97 percent occurred longer than a year after removal from the waitlist.
- All newly identified deaths occurred after 2014.
We are studying the potential impacts on other types of analyses and the availability of data to support transplant research broadly. That process of seeking context and determining next steps is already underway. Shorter-term efforts in progress include the following:
- The OPTN Data Advisory Committee requested additional data analyses to better understand the distribution of these newly identified deaths by organ type, time period, candidate/recipient demographics, and other factors. The committee began reviewing the data at its July 11 meeting and will continue to discuss it. The committee will evaluate whether follow-up actions or communications are needed to address the interest of OPTN members, transplant patients, public health researchers and the public.
- The OPTN and SRTR are also developing sensitivity analyses in concert with HRSA to review this recent discovery and provide greater insight on the issues involved. Such analyses would be helpful to evaluate the broader implications for outcomes monitoring and research to improve transplant care.
Additional communications on the results of these analyses and the processes used to incorporate external sources of information such as death records into the transplant database are being planned.
In the longer term, but already in progress, the OPTN and SRTR are engaging with HRSA and other relevant federal agencies to identify process improvements to ensure we collect these data in a timely and complete manner, and to leverage external sources as effectively as possible to augment the registry. We all share the interest of ensuring that complete, timely and accurate data is routinely available to assess and improve transplant outcomes for all candidates and recipients.