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Update to VCA Transplant Outcomes Data Collection

Proposal Overview

Status: Public Comment

Sponsoring Committee: Vascularized Composite Allograft (VCA) Transplantation

Strategic Goal: Improve waitlisted patient, living donor, and transplant recipient outcomes

Read the proposal (PDF; 01/2020)

Contact: Tina Rhoades

Submit a comment

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eye iconAt a glance

What is current policy and why change it?

OPTN data submission requirements for Vascular Composite Allograft transplant (VCA) recipients were implemented September 2015. A review of data reported to the OPTN since that time noted opportunities to refine the data collection to further capture recipient outcomes. This proposal will modify data reported to the OPTN on VCA transplants.

What’s the proposal?

  • Modify existing Transplant Recipient Registration (TRR) and Transplant Recipient Follow-up (TRF) instruments used to collect data on head and neck, and upper limb transplant recipients.
  • Add new data elements for uterus on TRR and TRF instruments.
  • Request feedback on the data elements to collect for VCA types such as larynx, abdominal wall and penis.

What’s the anticipated impact of this change?

  • What it’s expected to do
    • Create consistent data elements across VCA types that are developed by consensus in the field.
    • Develop VCA outcomes data that can be used for future policy decision making.
  • What it won’t do
    • Change data reporting policy requirements, e.g., when forms are due, for OPTN members.

Themes to consider

  • Additional data submitted on uterus transplant recipients.
  • What data elements should be collected for other VCA types, including abdominal wall, larynx, musculoskeletal graft segments and penis? The feedback received from the transplant community will inform a future data collection proposal requiring data collection on the above VCA types other than upper limb, head and neck and uterus.
  • Which is the most appropriate psychosocial assessment to be included on the Transplant Recipient Follow-up (TRF) instrument for all VCA types?

Terms you need to know

  • Transplant Recipient Registration (TRR): The form completed and submitted by the transplant center when a patient is transplanted. The form contains patient status, pre-transplant clinical measures, transplant procedure, post-transplant clinical measures, graft status, treatment and immunosuppression.
  • Transplant Recipient Follow-up (TRF): The form completed and submitted by the transplant center containing recipient information at six months post-transplant (all but thoracic) and annually thereafter. The form contains patient status, clinical measures at follow-up, graft status, viral detection, treatment and immunosuppression.
  • Click here to search the OPTN glossary.

Comments

Baylor University Medical Center | 02/03/2020

We appreciate the opportunity to comment on plans to enhance VCA Transplant Outcomes Data Collection. Our center’s experience with uterus transplant for the past several years puts us in a unique position to inform this work. We wholeheartedly agree with removing data fields that are not pertinent to the general VCA and uterus specific instruments. Additions to the Uterus TRF instrument may provide valuable information. It is important to recognize that follow up in this population is challenging. Commercialization of this type of VCA transplantation may impact recipient inclination for long term, intrusive, follow up. In our experience, healthy uterus transplant recipients, after delivery and transplanted organ removed, are prefer to forgo long term follow up with a transplant center to provide information about themselves and their child(ren) in favor of moving with family life. Our research trial includes follow up for 5 years and we have encountered challenges in achieving this long term follow-up. Recipient follow up for 2 years or until the transplanted organ is removed, is realistic. Likewise, follow up of children delivered after uterus transplantation for 2 years, including only information gathered at routine pediatric visits, seems reasonable. We do not support the addition of an assessment of psychosocial status after uterus transplantation. Other type of VCA recipients may benefit from this type of assessment. Uterus transplant candidates are healthy women desiring a healthy baby and have limited willingness to undergo such an evaluation after transplant. In addition, the value of gathering this information from uterine transplant recipients will not outweigh the costs. We recognize the importance of monitoring of this novel type of VCA transplantation and look forwarding to continued collaboration with UNOS/ OPTN and other VCA programs.

Region 4 | 02/20/2020

Strongly support (11), Support (9), Neutral/Abstain (2), Oppose (0), Strongly Oppose (0)

Region 8 | 02/20/2020

8 Strongly Support, 10 Support, 2 Neutral/Abstain, 0 Oppose, 0 Strongly Oppose

Region 6 | 02/21/2020

Strongly support (8), Support (9), Neutral/Abstain (0), Oppose (0), Strongly Oppose (0)

Region 5 | 02/21/2020

Strongly support (13), Support (8), Neutral/Abstain (1), Oppose (0), Strongly Oppose (0)