A Methodology for Determining Standard of Care Status for a New Surgical Procedure: Hand Transplantation.

BACKGROUND: Hand allotransplantation was initially criticized as unethical and unlikely to succeed. The results proved to be better than anticipated, now raising the issue of whether hand transplantation is the standard of care. The purpose of this article is to outline a reasonable methodology for determining whether a surgical procedure is the standard of care, and then to apply that methodology to hand transplantation.
METHODS: Publications on ethics and definitions of medical (not legal) standard of care were reviewed. All hand transplantations completed in the United States were evaluated regarding their status as experimental, standard of care, or both. Then, the stakeholders, physicians, public insurers, and regulators were examined to determine whether they accepted hand transplantation as the standard of care. Utility and incremental cost-utility ratio were determined. Hand transplantation was considered the standard of care when stakeholders were using, insuring, and regulating the procedure.
RESULTS: The public expresses a desire for hand transplantation. A minority of surgeons consider the procedure the standard of care. Ethical committees, institutional review boards, and scholarly articles deem the procedure ethical. A series of institutions have carried out the procedure with a record of successes. Some institutions perform the surgical procedure as the standard of care. Scholarly work demonstrates beneficial outcomes. Some commercial and federal government insurers are willing to cover the cost of the procedure. Utility determination justifies the procedure. There are no incremental cost-utility ratio analysis studies that justify the procedure.
CONCLUSION: Hand transplantation is moving from acceptance as an ethical surgical experiment to the standard of care.