participated in the conceptualization of this project, drafted portions of the manuscript, and contributed feedback to subsequent drafts; Dr Bluebond-Langner participated in the conceptualization of this project and contributed feedback to subsequent drafts; and all authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work.
Background.
Despite early skepticism, the field of vascularized composite allotransplantation (VCA) has demonstrated feasibility. The ethics of VCA have moved past doubts about the morality of attempting such transplants to how to conduct them ethically.
Methods.
Leaders of each program performing and/or evaluating VCA in the United States were invited to participate in a working group to assess the state and future of VCA ethics and policy. Four meetings were held over the course of 1 year to describe key challenges and potential solutions.
Results.
Working group participants concluded that VCA holds great promise as treatment for patients with particular injuries or deficits, but the field faces unique challenges to adoption as standard of care, which can only be overcome by data sharing and standardization of evaluation and outcome metrics.
Conclusions.
Adequate attention must be given to concerns including managing the uniquely intense physician-patient relationship, ethical patient selection, ensuring patients have adequate representation, informing and earning the trust of the public for donation, standardizing metrics for success, and fostering an environment of data sharing. These steps are critical to transitioning VCA from research to standard of care and to its insurance coverage inclusion.
Educational interventions hold much promise for increasing the general public's awareness of facial transplantation and willingness to participate in donation of facial allografts.
Guidelines should be developed to address penile transplantation and must cover the donation of tissue, consent, subject selection, qualifications of the surgical team, and management of both failure and patient dissatisfaction. Unless guidelines are established and disseminated, penile transplants should not be undertaken. The preliminary recommendations suggested in this article may help to inform development of guidelines.
Policy makers, payers, and the general public are increasingly focused on health care quality improvement. Measuring quality requires robust data systems that collect data over time, can be integrated with other systems, and can be analyzed easily for trends. The goal of this project was to study effective tools and strategies in the design and use of clinical registries with the potential to facilitate quality improvement, value-based purchasing, and public reporting on the quality of care. The research team worked with an expert panel to define characteristics of effectiveness, and studied examples of effective registries in cancer, cardiovascular care, maternity, and joint replacement. The research team found that effective registries were successful in 1 or more of 6 key areas: data standardization, transparency, accuracy/completeness of data, participation by providers, financial sustainability, and/or providing feedback to providers. The findings from this work can assist registry designers, sponsors, and researchers in implementing strategies to increase the use of clinical registries to improve patient care and outcomes.
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