Faculty Bibliography

OBJECTIVE:To assess the fulfilment of authors' and editors' individual disclosure of potential conflicts of interest in a group of highly influential medicine journals across a variety of specialties. DESIGN/METHODS:Cross-sectional analysis. SETTING AND PARTICIPANTS/METHODS:Top-ranked five journals as per 2017 Journal Citation Report impact factor of 26 medical, surgery and imaging specialties. INTERVENTIONS/METHODS:Observational analysis. PRIMARY AND SECONDARY OUTCOME MEASURES/UNASSIGNED:Percentage of journals requiring disclosure of authors' and editors' individual potential conflicts of interest (CoI). Journals that were listed as followers of the International Committee of Medical Journal Editors (ICMJE) Recommendations, members of the Committee on Publication Ethics (COPE) and linked to a third party (ie, college, professional association/society, public institution). RESULTS:Although 99% (129/130) of journals required author's CoI disclosure, only 12% (16/130) reported individual editors' potential CoIs. Forty-five per cent (58/130) of journals were followers of the ICMJE Recommendations, and 73% (95/130) were COPE members. Most (69%; 90/130) were linked to a college, professional society/association or public institution. Only one journal did not have policies on individual authors' and editors' CoI disclosure. CONCLUSION/CONCLUSIONS:Very few high-impact medical journals disclosed their editorial teams' individual potential CoIs-conversely, almost all required disclosure of authors' individual CoIs. Journal followers of the ICMJE Recommendations should regularly disclose the editors' individual CoIs, as this is the only legitimate way to ask the same transparency of authors.

Facial transplantation is emerging as a therapeutic option for self-inflicted gunshot wounds. The self-inflicted nature of this injury raises questions about the appropriate role of self-harm in determining patient eligibility. Potential candidates for facial transplantation undergo extensive psychosocial screening. The presence of a self-inflicted gunshot wound warrants special attention to ensure that a patient is prepared to undergo a demanding procedure that poses significant risk, as well as stringent lifelong management. Herein, we explore the ethics of considering mechanism of injury in the patient selection process, referring to the precedent set forth in solid organ transplantation. We also consider the available evidence regarding outcomes of individuals transplanted for self-inflicted mechanisms of injury in both solid organ and facial transplantation. We conclude that while the presence of a self-inflicted gunshot wound is significant in the overall evaluation of the candidate, it does not on its own warrant exclusion from consideration for a facial transplantation.

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 transplant 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.

Background/UNASSIGNED:Facial transplantation (FT) experience has grown but success in this innovative and complex field has yet to be defined. The purpose of this study is to determine attitudes regarding the failures in FT and the appropriate management of these failures. Methods/UNASSIGNED:An anonymous, 20-question survey elicited opinions regarding FT failure management. This survey was administered to attendees of 2 FT-focused national meetings. Demographics included sex, age, and personal/institutional FT experience. Attitudes related to FT recipient education, definition of FT failure, and management of complications were gathered. Results/UNASSIGNED:Eighty of 271 attendees completed the survey (29.5%). Respondents were predominantly male (81.3%) and 50 years of age or younger (80.5%). Thirty-eight percentage previously performed an FT and 53.8% were a part of an institution with a vascularized composite allotransplantation (VCA)-related Institutional Review Board (IRB). Respondents almost unanimously agreed it was "absolutely essential" to discuss possibility of FT failure (93.8%), mortality (91.1%), and treatment for chronic rejection (78.8%). However, uncertainty of failure rate existed, with 56.4% citing failure rate as unknown, 25.6% citing <25% and 18.0% citing >25%. 51.2% of those with direct FT experience lacked clear criteria for defining FT success or an institutional protocol for managing chronic rejection. 78.8% believed failed FT patients should be considered for retransplantation, but only about 25% cited functional concerns or esthetic dissatisfaction as appropriate indications. Conclusion/UNASSIGNED:There is a lack of consensus regarding definition of FT failure and rates mortality amongst experts. Even institutions with FT experience lack protocols for managing chronic rejection. Expert consensus and institutional regulations surrounding these issues are warranted.

BACKGROUND:U.S. physicians may treat a patient with an investigational drug outside of a clinical trial by using the expanded access (EA) pathway or the recently created federal right to try (RTT) pathway. The EA pathway requires physicians to get prior permission from the U.S. Food and Drug Administration (FDA) and, except in emergency cases, institutional review board (IRB) approval. The perspectives of IRB professionals on the review of single-patient EA requests have not been empirically studied. METHODS:We used a cross-sectional online survey to ascertain IRB professionals' perspectives on IRB experiences with and preparedness for review of single-patient EA requests, as well as their attitudes about the importance of IRB review of such requests. Email invitations were sent to 234 IRB professionals connected to the SMART IRB platform. Approximately half of the survey questions used a Likert scale to assess respondents' agreement with specific statements. RESULTS:Eighty-three respondents completed the survey (36.4% response rate, with 228 deliverable e-mail invitations). Of the respondents, 73.5% were affiliated with an academic medical institution; 78.3% of respondents agreed that it is important for a designated member of an IRB to review single-patient EA requests before investigational drugs are used by patients. The majority indicated that local review of the EA request was important and that a single designated reviewer was sufficient (rather than full board). Further, 86.6% felt that their IRBs were prepared to review these requests, and 9.2% indicated that not all the single-patient EA requests reviewed by their IRBs in 2017 were approved. CONCLUSIONS:A large majority of IRB professionals affiliated with the SMART IRB platform who responded to this survey felt IRB review of single-patient EA requests is important and that their IRBs were prepared to handle such requests.