Faculty Bibliography

BACKGROUND:Spin-reporting that distorts the interpretation of results-is not unusual within scientific literature. OBJECTIVE:To appraise strategies of spin among placebo-controlled double-blind clinical trials of topical treatments for photoaged skin. METHODS:A systematic review of literature was performed to identify placebo-controlled double-blind clinical trials of topical treatments for photoaged skin. A survey of spin strategies was developed and applied to the cohort of identified studies. RESULTS:Systematic review identified 20 studies, all of which employed various spin strategies, broadly classified as either inappropriate statistical analysis or inappropriate interpretation of results. Most commonly used strategies included use of multiple primary outcomes (95%), inappropriate extrapolation of the results from specific outcome to global improvement (95%), focus on within-group comparison (75%), and focus on interim analyses to give more weight to nonsignificant findings (65%). LIMITATIONS/CONCLUSIONS:Classification of spin strategies is subjective and may not encompass all methods used by studies in the published literature. CONCLUSIONS:Findings in this study may inform efforts to reduce spin in the dermatologic literature.

Transgender and gender-nonconforming (TGNC) youth who suffer from gender dysphoria are at a substantially elevated risk of numerous adverse physical and psychosocial outcomes compared with their cisgender peers. Innovative treatment options used to support and affirm an individual's preferred gender identity can help resolve gender dysphoria and avoid many negative sequelae of nontreatment. Yet, despite advances in these relatively novel treatment options, which appear to be highly effective in addressing gender dysphoria and mitigating associated adverse outcomes, ethical challenges abound in ensuring that young patients receive appropriate, safe, affordable treatment and that access to this treatment is fair and equitable. Ethical considerations in gender-affirming care for TGNC youth span concerns about meeting the obligations to maximize treatment benefit to patients (beneficence), minimizing harm (nonmaleficence), supporting autonomy for pediatric patients during a time of rapid development, and addressing justice, including equitable access to care for TGNC youth. Moreover, although available data describing the use of gender-affirming treatment options are encouraging, and the risks of not treating TGNC youth with gender dysphoria are evident, little is known about the long-term effects of both hormonal and surgical interventions in this population. To support ethical decision-making about treatment options, we encourage the development of a comprehensive registry in the United States to track long-term patient outcomes. In the meantime, providers who work with TGNC youth and their families should endeavor to offer ethically sound, patient-centered, gender-affirming care based on the best currently available evidence.

Promising aesthetic and functional outcomes in facial transplantation have fueled the interest of patients and providers alike. However, there are currently only 11 active face transplant centers in the United States, and only five have accumulated operative experience to date, resulting in an extremely unbalanced geographical distribution of providers. Since face transplant recipients must receive life-long follow-up, this presents unique challenges for face transplant candidates and provider teams, as long-distance travel may add considerable difficulty to pre- and post-transplant care. Furthermore, by compromising follow-up, this burden of travel may impact the ability of experienced face transplant centers to collect data, share knowledge as these patients are followed, and continue to advance the field. This article highlights the unique logistical and ethical implications of the highly probable long-distance nature of face transplant care in the United States, a challenging aspect of management that has not been previously discussed in the literature. Furthermore, we review current strategies in the long-distance management of solid organ transplantation (SOT) recipients, and propose several possibilities to help address these challenges in facial transplantation based on SOT experience.

Facial transplantation (FT) has attracted the interest of individuals with facial disfigurement as a path to social reintegration. The perception among face transplant recipients and the reconstructive surgery community appears to be that superior functional and esthetic outcomes can be obtained with FT compared to autologous reconstruction (AR). Although lifelong immunosuppression adds well-known risks to FT, its benefits have proven difficult to quantify, especially because of its non-life-saving nature. Evidence that the general public perceives facial allograft recipients as less disfigured than AR patients may dramatically alter the currently accepted risk/benefit ratio of this novel procedure. A survey containing independent images of individuals in nondisfigured (ND), autologous facial reconstruction, and FT groups was administered to the general public in an urban environment. Participants assigned a disfigurement score to each photograph using the Observer-Rated Facial Disfigurement Scale, a validated instrument used to rate facial disfigurement among head and neck cancer patients. One-way analysis of variance was used to calculate differences in mean level of perceived facial disfigurement among the 3 groups. A total of 250 participants completed the survey. Mean perceived disfigurement scores assigned to the ND, FT, and AR groups were 1.2 ± 0.4, 4.9 ± 1.3, and 8.5 ± 0.6, respectively. A significant difference in disfigurement score was observed between all 3 groups (P < 0.001). This pilot study suggests that the general public perceives the esthetic outcome of FT to be superior to those obtained with AR in patients with severe facial defects.

BACKGROUND:Despite the growing success of facial transplantation, organ donor shortages remain challenging. Educational health campaigns can effectively inform the general public and institute behavioral modifications. A brief educational introduction to facial transplantation may positively influence the public's position on facial donation. METHODS:The authors anonymously surveyed 300 participants, gathering basic demographic information, donor registration status, awareness of facial transplantation, and willingness to donate solid organs and facial allografts. Two-hundred of these participants were presented an educational video and subsequently resurveyed on facial donation. Factorial parametric analyses were performed to compare exposure responses before and after watching video exposure. RESULTS:Among participants completing the survey alone (control group), 49 percent were registered donors, 78 percent reported willingness to donate solid organs, and 52 percent reported willingness to donate facial allograft. Of participants who watched the video (video group) 52 percent were registered; 69 and 51 percent were willing to donate solid organs and face, respectively. Following educational intervention, 69 percent of participants in the video group reported willingness to donate facial tissue, an 18 percent increase (p < 0.05), that equated to those willing to donate solid organs. The greatest increase was observed among younger participants (23 percent); women (22 percent); Jewish (22 percent), Catholic (22 percent), and black/African American (25 percent) participants; and respondents holding a higher degree. No significant differences according to gender or ethnicity were observed. CONCLUSION/CONCLUSIONS:Educational interventions hold much promise for increasing the general public's awareness of facial transplantation and willingness to participate in donation of facial allografts.

BACKGROUND:Patients who are seriously ill and have run out of available treatment options may seek access to investigational agents that have not yet been fully vetted by regulatory agencies for safety and efficacy and approved for use in human subjects. Over time, a variety of terms have evolved internationally to denote mechanisms for providing access to such unapproved investigational agents. The lack of consistency in terminology used to describe this process is confusing at best and, at worst, possibly even detrimental to patients. METHODS:To highlight variation around the globe in terminology denoting pre-approval access to investigational agents, we conducted extensive Internet searches to locate specific legislation, guidance, or policy documents describing access mechanisms in numerous countries. We created a table of results intended to convey a sampling of international terminological diversity. RESULTS:The profusion of terms used internationally to indicate pre-approval access to investigational agents is evident. We recommend a shift toward the use of "pre-approval access" as an umbrella term encompassing all forms of access to unapproved agents. We also recommend use of the phrases "individual/named patient regulatory routes for pre-approval access" and "group/cohort regulatory routes for pre-approval access" to differentiate between pre-approval access programs designed for single patients, versus those designed for groups of patients. CONCLUSIONS:There is a pressing need to revisit and better align pre-approval access terminology at the international level. Adopting the umbrella term "pre-approval access" may be a useful strategy for initiating and promoting harmonization of terms to reduce potential confusion by patients and health care decision makers regarding experimental treatment options.

BACKGROUND: For men with significant genitourinary injury, penile transplantation is being considered as an option when reconstruction is not feasible or proves unacceptable to the injured patient. METHODS: A review of the literature was conducted to assess the current state of penile reconstruction and transplantation options, as well as to evaluate scholarly research addressing the ethical dimensions of penile transplantation. RESULTS: The state of penile transplantation is elementary. If reconstruction is not a possibility, proceeding ethically with research on penile vascularized composite allotransplantation will require the articulation of guidelines. To date, very little has been published in the scholarly literature assessing the ethics of penile transplantation. CONCLUSIONS: 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.