A Call to Accountability: Reporting Outcomes in Vascularized Composite Allotransplantation. Issue 6 (14th June 2019)

• Record Type: Journal Article
• Authors: Benedict, James L.; Robbins, Nicholas L.; Kaplan, Bruce; Breidenbach, Warren C.
• Is Part Of: Plastic and reconstructive surgery. Volume 7:Issue 6(2019)
• Page Start: e2266
• Publication Date: 2019-06-14
• Subjects: Surgery, Plastic -- Periodicals; Surgery, Plastic -- Periodicals; Reconstructive Surgical Procedures -- Periodicals; 617.95205
• DOI: 10.1097/GOX.0000000000002266
• Languages: English
• ISSNs: 2169-7574

Abstract

Abstract : Summary: Because nearly all the vascularized composite allotransplants performed in the United States have been proposed and carried out as research, the ethical duty to report outcomes pertains. This duty is set forth in several international statements, including the World Health Organization's Statement on Public Disclosure of Clinical Trial Results, the 2013 Helsinki Declaration, and the Singapore Statement on Research Integrity. These international statements call for the reporting of negative and inconclusive outcomes as well as positive outcomes, and for the reporting of results from previously unreported past research. In 2014, the Organ Procurement and Transplant Network vascularized composite allotransplant committee proposed mandatory data collection and submission requirements for transplants, but only for those which took place in September 2015 or later. Reporting of data for the allotransplants which took place before September 2015 was regarded as optional, even though the pre-September 2015 transplants represent the majority of vascularized composite allotransplants in the United States and all the long-term outcome data. We encourage the American Society of Reconstructive Transplantation and the Organ Procurement and Transplant Network committee to embrace the international ethical standards and to hold all vascularized composite allotransplant programs in the United States accountable for reporting data on outcomes of pre-September 2015 transplants.