Ethical Principles in Plastic Surgery Research.

Research is an integral part of medical progress that leads to better understanding of disease processes and the development of therapies to improve patient care. The medical community has an obligation and societal responsibility to review its practices and advance its knowledge to optimize care for those who entrust it with their health and well-being. While ultimately intended to benefit patients specifically and society as a whole, every laboratory and clinical investigation inherently carries an element of uncertainty and has attendant risks. These can have unintended and, at times, harmful consequences that cannot justify the knowledge gained. In order to mitigate these risks and protect human subjects involved in clinical research studies, a basic framework of ethical principles has been developed to guide responsible experimental design, execution, and data dissemination. This article provides a review of these principles and the historical context from which they were derived and explores the persistent challenges and cognitive biases that can increase susceptibility to unethical research practices.

Surgical Regret and Intraoperative Decision-Making: A Living Donor Kidney Case.

Surgical regret often experienced at times of a great loss may cause a surgeon to reflect on their practice and intraoperative decision-making. It is inevitable that in the surgical profession, both in training and practice, a surgeon's decisions will be questioned by themselves, peers, and possibly patients. Here, we explore a case of living donor kidney donation in which the surgeon chooses to discontinue the operation for an incidental finding. Ultimately, this is against the patient's wishes and a decision over which both the surgeon and patient experience moral hazard and regret. This article explores surgical regret from the lens of an altruistic donor case and a surgeon's inaction, discussing the ethics of the operative decision-making and surgeon's viewpoint intra- and post-operatively.

"Longitudinal Experience Using Pedicled Buccal Fat Pad Flaps in Cleft Palatoplasty: Mitigating Velopharyngeal Insufficiency Risk and Severity".

BACKGROUND: Cleft palatoplasty commonly results in denuded maxillary bone in the lateral gutter(s) and a posterior void between oral and nasal closures. Bony exposure of the anterior palate subjects the maxilla to scarring and growth restriction, while scar contracture of the posterior void may result in velopharyngeal insufficiency (VPI) and fistula formation. Utilization of the buccal fat pad flap (BFPF) at the time of palatoplasty provides vascularized tissue over these critical areas, thereby reducing the rate of secondary surgery for speech and fistula revision. METHODS: A single-center, retrospective review identified patients who underwent palatoplasty with or without BFPF between 1995-2015. Data collected included cleft type, surgical technique, follow-up duration, and complications. Outcomes included rate of speech surgery and palatal fistula development. Veau phenotype index was computed on a scale of 2-4 as a weighted mean to reflect the frequency of cleft type (Veau II-IV) in BFPF and non-BFPF groups. RESULTS: Charts of 866 patients were reviewed; 212 met inclusion criteria. Of these, 101 received a BFPF. Mean follow-up duration was 11.4 years. Despite a selection bias for more severe clefts, the BFPF group had lower incidence of speech surgery (9.9% vs. 36.9%, p=0.0072). The BFPF group had more mild cases treatable with fat injection (7.9% vs. 2.7%, p=0.0346) and developed fewer fistulas (6.9% vs. 18.0%, p=0.0280). CONCLUSION: Despite the presence of more severe clefts, the BFPF group had a significantly lower rate of speech surgery. The BFPF is a valuable adjunct in primary palatoplasty, reducing VPI and fistula formation.

Reasons for Removal of Rigid Internal Fixation Devices in Craniofacial Surgery: A 20-year Update.

The hardware utilized for rigid internal fixation of the craniofacial skeleton has evolved over time. Thus, the reasons for the unplanned removal of hardware continue to change. The purpose of this study is to compare past (1989-1995) and present (2000-2020) patient cohorts to establish trends related to unplanned removal of craniofacial hardware. A retrospective review study was designed. Data from our institution's original publication describing the unplanned removal of craniofacial hardware (1989-1995) was obtained. Data related to patients who underwent unplanned removal of hardware from 2000 to 2020 was collected from the electronic medical record. A descriptive statistical analysis was performed to compare demographics, reasons for hardware placement, and reasons for unplanned hardware removal between cohorts. This study includes 55 patients treated from 1989 to 1995 and 184 patients treated from 2000 to 2020. The average age at hardware placement decreased from 32 years (1989-1995) to 28 years (2000-2020). The most common reason for hardware placement changed from motor vehicle accident (1989-1995) to congenital deformity (2000-2020). The length of time with hardware in situ increased from 13 months (1989-1995) to 25 months (2000-2020). The most common reason for hardware removal changed from prominent hardware (1989-1995) to hardware exposure (2000-2020). In summary, patients who underwent rigid internal fixation of the craniofacial skeleton from 2000 to 2020 retained their hardware 2 times longer than patients treated from 1989 to 1995. Factors potentially contributing to increased retention include improved surgical technique, decreased profile of hardware, and increased surgeon experience. Further studies are warranted to define preoperative risk factors for unplanned hardware removal.

Trust-building: Why Virtual Formats Threaten the Moral Ends of Surgical Informed Consent.

The coronavirus disease 2019 pandemic forced a wide range of medical practices to virtual formats, including the preoperative informed consent practice. However, virtual informed consent persists despite the pandemic being largely considered resolved. The continued use of virtual formats relies on a problematic "information transfer" model of informed consent. We suggest a "trust-building" model of consent as a better conceptualization of what is occurring during the consent process. Highlighting how virtual formats might fail to fulfill this fuller understanding of consent on both interpersonal and systemic levels, we offer an ethical structure for physicians to navigate this novel virtual space.

Understanding Factors Associated with Paid Malpractice Claims in Plastic Surgery.

BACKGROUND: Few studies have investigated malpractice broadly in the field of plastic surgery. The purpose of this analysis was to characterize plastic surgery malpractice cases and examine factors influencing malpractice case outcomes, thereby identifying areas of patient safety concern. METHODS: The Candello database, which catalogs approximately 30% of all paid and unpaid malpractice claims in the United States, was used to obtain cases involving plastic surgery closed between 2009 and 2018. A total of 2674 cases were identified. A multivariable regression model was developed to analyze factors associated with a malpractice case closing with indemnity payment. RESULTS: A total of 716 claims (26.8%) resulted in an indemnity payment. The clinical severity was determined to be high in 229 cases (8.6%). Emotional trauma [ n = 558 (20.9%)] was the most frequently cited injury category. Major differences between procedure groups were not observed, with consistent severity of injury across categories. Poor surgical technique, problems with communication among providers, inadequate informed consent, and deficient documentation were significant factors predictive of malpractice cases closing with payment. Issues with technical performance resulting in a known complication and patient factors were protective against paid claims. CONCLUSIONS: The financial and clinical severity of malpractice claims in plastic surgery were relatively low overall. Multiple factors were found to be associated with a case closing with an indemnity payment. These data highlight the importance of the informed consent process and managing expectations in the clinical care of surgical patients.

Parents' Perceptions of Social Media Use by Pediatric Plastic Surgeons.

BACKGROUND: Pediatric craniofacial surgeons face specific ethical and professional concerns regarding the growth of social media use in plastic surgery. The authors sought to elucidate parents' views on social media use by pediatric craniofacial surgeons. In addition, the study examines issues of consent, assent, and exploitation. METHODS: An anonymous, 51-question, multiple-choice survey investigating parents' views of pediatric plastic surgeons' social media use was crowdsourced through Prolific.Co. RESULTS: A total of 681 parents responded to the survey. Of the 656 included respondents, 88% to 93% believe that surgeons need to obtain consent from the parents to post pictures of the pediatric patient on social media, regardless of age. Respectively, 84.5% and 75% of respondents believe the surgeon needs to document assent from the 12- and 10-year-old patient. Parents who follow plastic surgeons on social media are more likely to agree that assent needs to be documented from all pediatric patients, regardless of age, before posting pictures on social media. The mean age at which respondents believe physicians should be required to elicit assent from the pediatric patient to post pictures was 9.65 years. Approximately 40% of respondents felt that patients portrayed in pictures on social media were being exploited, irrespective of the child's stated age. CONCLUSIONS: Plastic surgeons need to recognize parents' perceptions regarding social media use when considering posting pictures of pediatric patients on social media. The data suggest that surgeons should elicit assent from patients as young as 9 years before posting pictures on social media.

A 9-Year Review of Ethics Complaints to the American Society of Plastic Surgeons.

PURPOSE: The American Society of Plastic Surgeons (ASPS) provides an avenue for filing formal complaints regarding unethical behavior of Members. These complaints are investigated by the Ethics Committee and referred to the Judicial Council if a violation may have occurred. METHODS: A review of complaints filed with the ASPS from 2013-2021 was performed. Data surrounding both complaints and complainant type were reviewed, as well as region of complaint origin. Categories of violations resulting formal investigations and Judicial Council referrals were also reviewed. RESULTS: A total of 584 complaints were filed with the ASPS Ethics Committee from 2013-2021, which was nearly 100 fewer than from a prior review of 2004-2008. Twenty-one percent of complaints were formally investigated by the Ethics Committee, and 26% of these were referred to the Judicial Council. The most common complaint investigated was related to advertising/misleading communications, whereas the most common complaint referred to the Judicial Council was regarding expert testimony. Most complaints were filed by ASPS members. CONCLUSIONS: The total number of complaints filed decreased significantly, the reasons for which are unclear. Evolution of culture and thought likely impacted not only specific behaviors, but also the likelihood of reporting those behaviors. It remains incumbent on plastic surgeons to utilize the self-regulating mechanisms available in order to maintain the autonomy we enjoy as a profession.

Conscientious Objection to Gender-Affirming Surgery: Institutional Experience and Recommendations.

SUMMARY: As more academic institutions with surgical residency training programs begin to offer gender-affirming surgery, issues of trainee conscientious objection related to participation in these patient encounters may arise. In this article, the authors discuss their institutional experience with residents' conscientious objection to involvement in gender-affirming surgery. Although there are ethical arguments for and against conscientious objection, current U.S. federal policy grants all health care workers conscientious objector status upon their request. Recommendations are offered for other institutions that may experience similar situations regarding conscientious objection to gender-affirming care or to other aspects of plastic and reconstructive surgery.

Managing Resident Mental Health: Prevention is Better than Cure.

OBJECTIVE: There is a high prevalance of burnout and mental health illness among trainees. Through structured meetings, Program Directors (PDs) have an opportunity to screen and aid residents that may be affected by mental health concerns. However, barriers to this process exist. This study sought to evaluate the perspectives of PDs regarding mental health screening for trainees. DESIGN: A 13-item survey-based study. SETTING: Electronic distribution of the survey was performed via three individualized requests sent via e-mail to PDs. PARTICIPANTS: PDs of 5 ACGME specialties, including Internal Medicine, Pediatrics, Emergency Medicine, General Surgery, and Psychiatry were invited to participate. RESULTS: In total, 595 PDs responded to the survey (response rate = 40.0%) In general, PDs expressed dissatisfaction with the management of burnout and mental health. Most PDs supported periodic screening of residents for burnout (87.0%) and mental health (73.9%). For a resident that could screen positive for mental illness, most PDs were concerned about the possibility of harm to a patient (70.7%) and implications for future licensing (65.7%). Only 30.2% of PDs currently use some form of standardized screening to identify residents struggling with mental health and burnout concerns. CONCLUSION: The majority of PDs across 5 ACGME specialties support the use of periodic screening of residents for burnout and mental health. However, concerns exist regarding such screening such as the implications for future licensing. Additional work needs to be done to address PD concerns and destigmatizate mental health wellbeing and care among trainees.

Understanding motivations behind medical student involvement in COVID-19 pandemic relief efforts.

BACKGROUND: Although students were removed from patient-facing settings at the beginning of the COVID-19 pandemic due to concerns of burdening teaching physicians and depleting personal protective equipment, some leaders suggest students can be effectively utilized when personnel resources may be scarce. There have been narrative discussions surrounding medical student involvement, but no studies exploring the attitudes of these students. The authors aim to quantify the degree to which factors influenced a medical student's decision to or to not volunteer during the pandemic and to characterize medical students' attitudes towards medical professionals' duty to serve in a pandemic. METHODS: The authors developed and tested a secure web-based survey before distribution to students at 23 different US allopathic medical schools that did not graduate medical students early to aid in pandemic efforts between April and June 2020. Of the 599 students who completed the survey, 65.5% self-identified as female and were on average 25.94 years old (SD = 2.5). Multiple comparisons were made based on volunteer status. Ordinal scale questions were compared with the Mann Whitney U test, and the Chi-Squared test was used for categorical variables using R version 3.62. RESULTS: 67.6% of students volunteered in pandemic relief activities and a majority of those students volunteered in non-patient-facing roles. Community service, new skills, and time commitment were top 3 influencing factors for students who volunteered, while risk to other, time commitment, and risk to self were top 3 influencing factors for students who chose not to volunteer. Compared to other specialties, students interested in primary care specialties agreed to a greater degree that physicians have a duty to serve in pandemic relief efforts. CONCLUSIONS: Medical students who volunteered cited self-serving factors and altruistic values as significant motivators. Students who did not volunteer were significantly more concerned with risks of COVID-19 exposure. However, medical students in general agreed that students should be allowed to volunteer in COVID-19 related relief efforts. As large areas of the United States continue to experience increases in COVID-19 cases, institutions should involve medical students in balancing the level of acceptable risk with the educational benefits.

Institutional Trends in Opioid Prescribing and Utilization after Primary Cleft Lip and Palate Repair.

BACKGROUND: Outpatient prescriptions for postoperative pain play an important role in the opioid epidemic. Prescribing guidelines are an effective target for intervention but require procedure-specific data to be successful. The aim of this study was to examine opioid prescribing patterns and pain control after primary cleft lip and palate repair at a large academic center. METHODS: Children undergoing cleft lip and palate repair from April of 2018 to July of 2019 were included in a prospective cohort study. Data on discharge prescriptions, refills, and emergency room visits were obtained from the medical record. Caregivers were surveyed 7 to 21 days after surgery regarding pain control, opioid use, education exposure, storage, and disposal. Chi-square tests and one-way analysis of variance were used to examine predictors of pain control, opioid consumption, safe storage, and disposal. RESULTS: After screening, 59 children were included in the study. Patients were 55.8 percent male with a median age of 12 months (interquartile range, 5 to 15). Ninety percent of patients received an opioid prescription at discharge with a mean quantity of 10 doses (interquartile range, 5 to 15). Ninety-seven percent of caregivers used adjunct medication. Opioids were given for a median of 3 days (interquartile range, 2 to 6.5). Seventy-six percent of caregivers gave less opioid than prescribed. There was no association between pain control and opioid quantity ( p = 0.68). Twenty-four percent of caregivers used locked storage. Thirty-four percent of respondents with leftover medication reported disposal. CONCLUSIONS: Opioids are often overprescribed after cleft lip and palate repair. Providers should consider limiting prescriptions to a 3-day supply to help reduce the quantity of opioids available in the community.

Resident Mental Health and Burnout: Current Practices and Perspectives of Urology Program Directors.

OBJECTIVE: To understand perspectives of urology program directors (PDs) regarding the management and screening of resident mental health and burnout. METHODS: After piloting and survey validation, an IRB-exempt 14 question survey was distributed to PDs of all 145 ACGME accredited urology residency programs. Statistical significance was determined using an alpha value of 0.05 and response plurality was determined by non-overlapping 95% confidence intervals. RESULTS: A total of 72 PDs completed the survey (response rate = 49.6%). The majority of PDs (59.7%) do not use standardized screening for resident burnout or mental health. A statistically significant proportion of PDs agreed to implementing periodic mental health (75.0%, 95% CI [65.0%-75.0%]) and burnout (87.6%, 95% CI [79.9%-95.1%]) screening. Female PDs were more likely to agree to implementing mental health screening compared to male PDs (female=94.4% vs male=68.5%; P =.03). If mental health screening was implemented and a resident tested positive, PDs were most concerned about harm to a patient (72.2%, 95% CI [61.9-82.6]) and implications of a positive screen on future licensing and practice (55.6%, 95% CI [44.1-67.0]). CONCLUSION: Although the majority of urology PDs believe residents should be periodically screened for burnout and mental health, most do not currently screen their trainees. If mental health screening was implemented, PDs expressed concern about patient harm and challenges associated with future licensing. Our survey results suggest opportunities for improving management of resident burnout and mental health.

Two-Stage Dual-Nerve Facial Reanimation: Outcomes and Complications in a Series of Pediatric Patients.

BACKGROUND: In facial reanimation via microneurovascular muscle transfer, dual-nerve reinnervation of the muscle capitalizes on the synergistic effects of spontaneous motion from cross facial nerve grafting (CFNG) and increased excursion from masseteric nerve transfer. Two-stage approaches that delay masseteric nerve transfer until the time of the muscle flap increase spontaneity by maximizing muscle reinnervation from the CFNG. While this 2-stage, dual-nerve approach has been described in adults, we present a series of pediatric patients who underwent this reconstructive technique. METHODS: We retrospectively reviewed all pediatric patients who underwent 2-stage, dual-nerve reconstruction with CFNG and ipsilateral masseteric nerve transfers. Procedures were performed between 2004 and 2016 by 2 surgeons at a single centre. Degree of facial paralysis before and after surgical intervention was measured using House-Brackmann scores. RESULTS: Nine patients with a mean age of 8.6 (range: 5-15 years) years at time of surgery underwent 2-stage, dual-nerve reconstruction. Average time between CFNG and transfer of the free gracilis with masseteric nerve transfer was 13.3 (SD 2.4) months. Mean follow-up was 27.3 months (SD 25.7). Patients demonstrated initiation of voluntary movement on paralyzed side by 3.6 months (SD 0.6) on average, with 3 patients demonstrating spontaneous movement at 3 months. CONCLUSION: The 2-stage, dual innervation technique using CFNG and delayed ipsilateral masseteric nerve transfer with a free gracilis is a promising reconstructive option to maximize spontaneous expression in pediatric patients. Validated, objective scoring systems for excursion are needed before meaningful comparisons can be made to other reconstructive strategies.

HISTORIQUE: Lors de la réanimation faciale par transfert du muscle microneurovasculaire, la réinnervation de deux nerfs du muscle tire profit des effets synergétiques du mouvement spontané à partir de la greffe de nerf transfacial (GNTF) et améliore l'excursion du transfert de nerf massétérin. Une intervention en deux étapes qui reporte le transfert du nerf massétérin jusqu'à ce que le lambeau musculaire améliore la spontanéité par une maximisation de la réinnervation musculaire à partir de la GNTF. Cette intervention sur deux nerfs en deux étapes a été décrite chez les adultes, mais les chercheurs présentent les résultats de cette technique chez une série de patients d'âge pédiatrique. MÉTHODOLOGIE: Les chercheurs ont procédé à l'analyse rétrospective de tous les patients pédiatriques qui avaient subi une reconstruction de deux nerfs en deux étapes par transferts de la GNTF et du nerf massétérin ipsilatéral. Deux chirurgiens d'un même centre ont effectué les interventions entre 2004 et 2016. Les chercheurs ont mesuré le degré de paralysie faciale avant et après l'intervention chirurgicale au moyen des scores de House-Brackmann. RÉSULTATS: Neuf patients, d'un âge moyen de 8,6 ans (plage de cinq à 15 ans) au moment de l'opération ont subi une reconstruction de deux nerfs en deux étapes. La période moyenne entre la GNTF et le transfert du muscle gracile libre avec le transfert du nerf massétérin était de 13,3 mois (ÉT 2,4). Le suivi moyen était d'une durée de 27,3 mois (ÉT 25,7). Les patients avaient commencé à faire des mouvements volontaires du côté paralysé au bout d'une moyenne de 3,6 mois (ÉT 0,6), et trois patients faisaient des mouvements spontanés au bout de trois mois. CONCLUSION: La technique d'innervation double en deux étapes à l'aide de la GNTF et du transfert tardif du nerf massétérin ipsilatéral avec le muscle gracile libre est une méthode de reconstruction prometteuse pour maximiser l'expression spontanée chez les patients d'âge pédiatrique. Il faudra établir des systèmes objectifs de scores d'excursion avant de faire des comparaisons significatives avec d'autres stratégies de reconstruction.