Overlapping Surgery Verbiage in Informed Consent Documents.

OBJECTIVE: To assess informed consent documents from United States (US) institutions for verbiage regarding overlapping surgery. SUMMARY BACKGROUND DATA: Overlapping surgery remains a controversial practice. Recent guidance from the Senate Finance Committee and American College of Surgeons emphasizes transparency with patients regarding this practice through the informed consent process, but it remains unclear how many institutions adopted their recommendations. METHODS: Informed consent documents were collected from a national sample of 104 institutions and assessed for verbiage regarding overlapping surgery and/or attending absence during a surgical case. The verbiage of these forms was further analyzed for inclusion of key terms (e.g., "overlapping surgery," "critical portions") as well as transparency regarding surgeon absence. RESULTS: Thirty (29%) forms included verbiage regarding overlapping surgery and/or surgeon absence during a case. Most of these 30 utilized the terms "overlapping surgery" or "critical portions" (18 [60%] and 25 [83%], respectively), although only 3 (10%) explicitly stated that portions of the procedure that may be performed in the absence of the attending surgeon. Six forms (20%) specifically stated who may perform the procedure without the attending present, and 3 forms (10%) had patients acknowledge this section of the consent form with an additional signature or initial. Only 2 of the forms (7%) fulfilled all of the criteria set forth by the SFC. CONCLUSION: Detailed information regarding overlapping surgery is infrequently included in hospitals' procedure informed consent documents. Forms that include this information rarely provide explicit statements of attending presence and trainee participation, raising concerns regarding surgeon-patient transparency.

Impact of comorbidities on immediate post-operative complications in oral cavity free flap patients.

PURPOSE: To examine the relationship between comorbidities and the development of immediate post-operative complications in patients undergoing oral cavity composite resection (OCCR) with free flap (FF) reconstruction. MATERIALS AND METHODS: Retrospective analysis was completed on all consecutive OCCRs with FF reconstruction performed at a single quaternary care facility between 1999 and 2020. Comorbidities, immediate post-operative complications, patient demographics, and tumor characteristics were collected. Odds ratios (OR) with 95 % confidence intervals were calculated for associations between comorbidities and immediate post-operative complications. RESULTS: 320 patients who underwent OCCR with FF reconstruction were included. One hundred twenty-one (37.8 %) patients developed a post-operative complication during their initial hospital admission. The most common complications were non-pneumonia cardiopulmonary events (14.1 %), pneumonia (9.4 %), and wound infection (8.4 %). Other complications included flap compromise, bleeding, and fistula. On multivariate analysis, patients without comorbid conditions were less likely to develop a post-operative complication (OR 0.64; 0.41-0.98). Atrial fibrillation (OR 2.94; 1.17-7.39) and cerebrovascular disease (OR 2.28; 1.08-4.84) were associated with increased odds of developing any complications. Furthermore, cerebrovascular disease (OR: 2.33; 1.04-5.39) and peripheral vascular disease (OR: 2.7; 1.2-6.08) were independently associated with pneumonia. CONCLUSION: In this retrospective review of patients undergoing OCCR with FF reconstruction for oral cavity SCC, lack of identifiable comorbidities appeared to be protective for post-operative complications while atrial fibrillation and cerebrovascular disease were associated with increased odds of any complication. Pre-existing vascular disease was also associated with an increased risk of pneumonia.

Ethical and Legal Considerations for Recording in the Operating Room: A Systematic Review.

INTRODUCTION: The integration of high-resolution video into surgical practice has fostered widespread interest in capturing surgical video recordings for the purposes of patient care, medical training, quality improvement, and documentation. The capture, analysis, and storing of such recordings inherently impact operating room (OR) activities and introduce potential harms to patients as well as members of the surgical team, which can be analyzed from both ethical and legal perspectives. METHODS: Following Preferred Reporting Items for Systematic Reviews and Meta Analyses (PRISMA) guidelines, a systematic literature search of PubMed was conducted. The citations of included articles were then reviewed to find any articles not captured by our initial search. RESULTS: 62 Articles were included in the review (52 from PubMed search and 10 from citation review). Prevalent key issues in the literature at present include privacy, consent, ownership, legal use and discoverability, editing, data security, and recording's impact on the surgical team. CONCLUSIONS: This review aims to spark proactive discussions of the ethical and legal implications of recording in the OR, which will guide transformation as the medical field adapts to new and innovative technologies without compromising its ideals or patient care.

Talking with Patients about Surgical Trainees.

AbstractTraining of resident physicians is essential for the care of future patients. While surgical trainee involvement is necessary, its disclosure to patients can often be omitted or underplayed by surgeons. The informed consent process and the underlying ethical principles make evident that patients should be informed of trainee involvement. In this review we explore the importance of disclosure, current themes in practice, and the optimal discussion for which we should strive.

Working Definitions of "Critical Portions": Results from Qualitative Interviews with 51 Academic Surgeons.

OBJECTIVE: Identify the considerations academic surgeons use when determining which portions of a procedure are "critical" and necessitate their presence. BACKGROUND: Teaching physicians are required to be present for the "critical portion" of surgical procedures, but the definition of what constitutes a critical portion remains elusive. Current guidelines defer to surgeons' expert judgment in identifying critical portion(s) of a procedure; little is known about what concepts surgeons apply when deciding what parts of a procedure are critical. METHODS: Qualitative analysis of interviews with 51 practicing surgeons from a range of specialties regarding their working definition of critical portions. RESULTS: Surgeons identified 4 common themes that they use in practice to define the critical portions of procedures: portions that require their first-hand observation of events, those involving challenging anatomy or structures that cannot be repaired if injured, and portions where an error would result in severe consequences for the patient. Surgeons also recognized contextual factors regarding the patient, trainee, surgeon, and team that might alter determinations for individual cases. CONCLUSIONS: Although critical portion definitions are largely treated as subjective, surgeons across multiple specialties identified consistent themes defining "critical portions'', suggesting that setting a minimum standard for criticality is feasible for specific procedures. Surgeons also recognized contextual factors that support the need for case-specific judgement beyond minimum standard. This framework of procedure features and contextual factors may be used as a guide for surgeons making day-to-day decisions and in future work to formally define critical portions for a given procedure.

Patient Perceptions of Audio and Video Recording in the Operating Room.

OBJECTIVE: The goal of this study was to determine surgical patients' perceptions of hypothetical continuous audio-video OR recording (ORR). SUMMARY OF BACKGROUND DATA: Continuous audio-video recording of the operating room (OR), akin to the aviation industry's black box, has been proposed as a means to enhance training, supplement the medical record, and allow large-scale analysis of surgical performance and safety. These recordings would include patients' bodies; yet, understanding of patient perceptions regarding such technology is limited. METHODS: Semi-structured interviews were conducted during elective surgery preoperative appointments during a 2-week period in August 2018 at a quaternary care center. Deidentified transcripts were analyzed using thematic analysis. RESULTS: Forty-nine subjects were interviewed. Subjects recognized the potential for recording to improve surgical quality, safety and training. Subjects also desired access to an objective record of their own surgery, for the purposes of future care, medical-legal evidence, and to satisfy their own curiosity and understanding. Subjects had mixed perceptions regarding OR decorum and thus, differing views on the potential effect of ORR on OR behavior; some imagined that ORR would discourage bad behavior and others worried that it would cause unnecessary anxiety to the surgical team. CONCLUSIONS: Patients have a diverse set of views about the potential benefits, risks, and uses for OR data and consider themselves to be important stakeholders. Our study identifies pathways and potential challenges to implementation of continuous audio/video recording in ORs.

Impact of COVID-19 on presentation, staging, and treatment of head and neck mucosal squamous cell carcinoma.

OBJECTIVES: During the COVID-19 pandemic, maintenance of safe and timely oncologic care has been challenging. The goal of this study is to compare presenting symptoms, staging, and treatment of head and neck mucosal squamous cell carcinoma during the pandemic with an analogous timeframe one year prior. MATERIALS AND METHODS: Retrospective cohort study at a single tertiary academic center of new adult patients evaluated in a head and neck surgical oncology clinic from March -July 2019 (pre-pandemic control) and March - July 2020 (COVID-19 pandemic). RESULTS: During the pandemic, the proportion of patients with newly diagnosed malignancies increased by 5%, while the overall number of new patients decreased (n = 575) compared to the control year (n = 776). For patients with mucosal squamous cell carcinoma (SCC), median time from referral to initial clinic visit decreased from 11 days (2019) to 8 days (2020) (p = 0.0031). There was no significant difference in total number (p = 0.914) or duration (p = 0.872) of symptoms. During the pandemic, patients were more likely to present with regional nodal metastases (adjusted odds ratio (OR) 2.846, 95% CI 1.072-3.219, p = 0.028) and more advanced clinical nodal (N) staging (p = 0.011). No significant difference was seen for clinical tumor (T) (p = 0.502) or metastasis (M) staging (p = 0.278). No significant difference in pathologic T (p = 0.665), or N staging (p = 0.907) was found between the two periods. CONCLUSION: Head and neck mucosal SCC patients presented with more advanced clinical nodal disease during the early months of the COVID-19 pandemic despite no change in presenting symptoms.

Surgeon Perspectives on Benefits and Downsides of Overlapping Surgery: In-depth, Qualitative Interviews.

OBJECTIVE: The aim of the study was to characterize surgeon perspectives regarding the benefits and downsides of conducting overlapping surgery. BACKGROUND: Although surgeons are key stakeholders in current discussions surrounding overlapping surgery, little has been published regarding their opinions on the practice. Further characterization of surgeon perspectives is needed to guide future studies and policy development regarding overlapping surgery. METHODS: Study information was sent to all members of 3 professional surgical societies. Interested individuals were eligible to participate if they identified as attending surgeons in an academic setting who work with trainees. Purposive selection was used to diversify surgeons interviewed across multiple dimensions, including subspecialty and opinion regarding appropriateness of overlapping surgery. In-depth, qualitative interviews were conducted with participants regarding their opinions on overlapping surgery. RESULTS: The 51 surgeons interviewed identified a wide array of potential benefits and disadvantages of overlapping surgery, some of which have not previously been measured, including downsides to surgeon wellness and patient experience, less surgeon control over procedures, and difficulty in scheduling cases. Interviewees often disagreed as to whether overlapping surgery negatively or positively affects each dimension discussed, particularly regarding the impact on resident training. CONCLUSIONS: The utilization of the novel perspectives presented here will allow for targeted assessment of physician perspectives in future quantitative studies and increase the likelihood that variables measured encompass the range of factors that surgeons find meaningful and relevant. Priority areas of future research should include examining effects of overlapping surgery on surgical training and surgeon wellness.

Diagnostic approaches to carcinoma of unknown primary of the head and neck.

Squamous cell carcinoma in cervical lymph nodes arising from an undetected primary tumour, termed carcinoma of unknown primary (SCCUP), is a well-recognized clinical presentation within head and neck oncology. SCCUP is a common presentation for patients with human papillomavirus-mediated oropharyngeal cancer (HPV + OPSCC), as patients with HPV + OPSCC often present with smaller primary tumours and early nodal metastasis. Meticulous work-up of the SCCUP patient is central to the management of these patients as identification of the primary site improves overall survival and allows for definitive oncologic resection or more focused radiation when indicated. This review summarizes the comprehensive diagnostic approach to the SCCUP patient, including history and physical examination, methods of biopsy of the cervical lymph node, imaging modalities and intraoperative methods to localize the unknown primary. Novel techniques such as transcervical ultrasound of the oropharynx, narrow band imaging and diagnostic transoral robotic surgery are also discussed.

Neuroendocrine carcinomas of the head and neck: A small case series.

INTRODUCTION: Neuroendocrine tumors of the head and neck are rare and arise either from epithelial or neuronal origin. Debate continues over the classification systems and appropriate management of these pathologies. OBJECTIVE: By investigating a small set of cases of high grade epithelial-derived neuroendocrine tumors of the head and neck (neuroendocrine carcinomas or NEC) from one institution, we compare survival rates of NEC of the head and neck to pulmonary NEC. METHODS: We identified patients from pathology records with neuroendocrine carcinomas of the head and neck and retrospectively collected clinical data as well as immunohistochemical (IHC) staining data. RESULTS: We identified 14 patients with NEC, arising from the parotid (n = 5), nasal cavity (n = 4), larynx (n = 2), and other regions (n = 2). One additional patient had NEC arising in two sites simultaneously (parotid and nasal). Staining patterns using IHC were relatively consistent across specimens, showing reactivity to chromogranin and synaptophysin in 73% and 100% of specimens, respectively. Treatment courses varied across patients and included combinations of surgery, chemotherapy, and/or radiation. The overall survival rate at 1, 2, and 5 years of these patients was 56%, 56%, and 43% with a mean follow-up time of 2.12 years. CONCLUSION: Compared to NEC arising in the lung, this subset of patients had better survival rates, but worse survival rates than the more common squamous cell carcinoma of the head and neck.

Transcervical sonography and human papillomavirus 16 E6 antibodies are sensitive for the detection of oropharyngeal cancer.

BACKGROUND: Human papillomavirus 16 (HPV-16) E6 seropositivity is a promising early marker of human papillomavirus-driven oropharyngeal cancer (HPV-OPC), yet more sensitive imaging modalities are needed before screening is considered. The objective of this study was to determine the sensitivity of transcervical sonography (TCS) for detecting clinically apparent HPV-OPC in comparison with computed tomography (CT) and positron emission tomography (PET)/CT. METHODS: Fifty-one patients with known or suspected HPV-OPC without prior treatment underwent oropharyngeal TCS and blood collection (for HPV multiplex serology testing). Eight standard sonographic images were collected; primary-site tumors were measured in 3 dimensions if identified. Each patient underwent a full diagnostic workup as part of standard clinical care. The pathologic details, HPV status, final staging, and imaging findings were abstracted from the medical record. The sensitivity of each imaging modality was compared with the final clinical diagnosis (the gold standard). RESULTS: Twenty-four base of tongue cancers (47%), 22 tonsillar cancers (43%), and 2 unknown primary cancers (4%) were diagnosed; 3 patients (6%) had no tumors. All p16-tested patients were positive (n = 47). Primary-site tumors were correctly identified in 90.2% (95% confidence interval [CI], 78.6%-96.7%) with TCS, in 69.4% (95% CI, 54.6%-81.7%) with CT, and in 83.3% (95% CI, 68.6%-93.0%) with PET/CT. TCS identified tumors in 10 of 14 cases missed by CT and recognized the absence of tumors in 3 cases for which CT or PET/CT was falsely positive. The smallest sonographically identified primary-site tumor was 0.5 cm in its greatest dimension; the average size was 2.3 cm. Among p16-positive patients, 76.1% (95% CI, 61.2%-87.4%) were seropositive for HPV-16 E6. CONCLUSIONS: TCS and HPV-16 E6 antibodies are sensitive for the diagnosis of HPV-OPC.

The Value of the Surgeon Informatician.

Clinical informatics is an interdisciplinary specialty that leverages big data, health information technologies, and the science of biomedical informatics within clinical environments to improve quality and outcomes in the increasingly complex and often siloed health care systems. Core competencies of clinical informatics primarily focus on clinical decision making and care process improvement, health information systems, and leadership and change management. Although the broad relevance of clinical informatics is apparent, this review focuses on its application and pertinence to the discipline of surgery, which is less well defined. In doing so, we hope to highlight the importance of the surgeon informatician. Topics covered include electronic health records, clinical decision support systems, computerized order entry, data analytics, clinical documentation, information architectures, implementation science, quality improvement, simulation, education, and telemedicine. The formal pathway for surgeons to become clinical informaticians is also discussed.

Embedding Ethics Education in Clinical Clerkships by Identifying Clinical Ethics Competencies: The Vanderbilt Experience.

The clinical clerkships in medical school are the first formal opportunity for trainees to apply bioethics concepts to clinical encounters. These clerkships are also typically trainees' first sustained exposure to the "reality" of working in clinical teams and the full force of the challenges and ethical tensions of clinical care. We have developed a specialized, embedded ethics curriculum for Vanderbilt University medical students during their second (clerkship) year to address the unique experience of trainees' first exposure to clinical care. Our embedded curriculum is centered around core "ethics competencies" specific to the clerkship: for Medicine, advanced planning and end-of-life discussions; for Surgery, informed consent; for Pediatrics, the patient-family-provider triad; for Obstetrics and Gynecology, women's autonomy, unborn child's interests, and partner's rights; and for Neurology/Psychiatry, decision-making capacity. In this paper, we present the rationale for these competencies, how we integrated them into the clerkships, and how we assessed these competencies. We also review the additional ethical issues that have been identified by rotating students in each clerkship and discuss our strategies for continued evolution of our ethics curriculum.

Fibula osteofascial flap with proximal skin paddle for intraoral reconstruction.

BACKGROUND: the fibula free flap has become a workhorse in intraoral reconstruction. However, its skin paddle has multiple drawbacks. The aim of this report is to establish the applicability of the fibula osteofascial flap in intraoral reconstruction. METHODS: prospectively maintained database was performed in 15 patients who underwent fibula osteofascial flap for intraoral reconstruction. Mandibular reconstruction was the main location (13 patients). Ten flaps were done following tumor resection, three due to osteoradionecrosis and two following mandible fracture/bone loss. A standard fibula flap dissection performing an anterior approach was done, adding a distal fascial flap isolated on the distal perforators (for intraoral reconstruction) and a proximal skin paddle (for external soft tissue reconstruction). RESULTS: One flap was lost due to hypercoagulable state. Fourteen flaps survived with complete oral mucosalization, resembling physiological intraoral bone coverage by 7 weeks (range: 6-8 weeks). One patient presented with delayed donor-site wound healing. The mean follow-up was 14.4 months (range: 2-33 months). Thirteen patients (87%) were without tracheotomy at last follow-up, and 14 patients (93%) were taking at least some nutrition by mouth. CONCLUSION: Fibula osteofascial flap can be safely used for intraoral reconstruction. This flap provides a stable, thin, and vascularized fascia over the fibula with minimal donor-site complications. © 2016 Wiley Periodicals, Inc. Microsurgery, 2016. © 2016 Wiley Periodicals, Inc. Microsurgery 37:276-281, 2017.

Standardization of Disposable Instruments in Microvascular Breast Reconstruction: A Case Study in Cost Reduction.

Background A key avoidable expense in the surgical setting is the wastage of disposable surgical items, which are discarded after cases even if they go unused. A major contributor to wastage of these items is the inaccuracy of surgeon preference cards, which are rarely examined or updated. The authors report the application of a novel technique called cost heatmapping to facilitate standardization of preference cards for microvascular breast reconstruction. Methods Preference card data were obtained for all surgeons performing microvascular breast reconstruction at the authors' institution. These data were visualized using the heatmap.2 function in the gplot package for R. The resulting cost heatmaps were shown to all surgeons performing microvascular breast reconstruction at our institution; each surgeon was asked to classify the items on the heatmap as "always needed," "sometimes needed," or "never needed." This feedback was used to generate a lean standardized preference card for all surgeons. This card was validated by all surgeons performing the case and by nursing leadership familiar with the supply needs of microvascular breast reconstruction before implementation. Cost savings associated with implementation were calculated. Results Implementation of the preference card changes will lead to an estimated per annum savings of $17,981.20 and a per annum reduction in individual items listed on preference cards of 1,693 items. Conclusion Cost heatmapping is a powerful tool for increasing surgeon awareness of cost and for facilitating comparison and standardization of surgeon preference cards.

TCR gene-modified T cells can efficiently treat established hepatitis C-associated hepatocellular carcinoma tumors.

The success in recent clinical trials using T cell receptor (TCR)-genetically engineered T cells to treat melanoma has encouraged the use of this approach toward other malignancies and viral infections. Although hepatitis C virus (HCV) infection is being treated with a new set of successful direct anti-viral agents, potential for virologic breakthrough or relapse by immune escape variants remains. Additionally, many HCV+ patients have HCV-associated disease, including hepatocellular carcinoma (HCC), which does not respond to these novel drugs. Further exploration of other approaches to address HCV infection and its associated disease are highly warranted. Here, we demonstrate the therapeutic potential of PBL-derived T cells genetically engineered with a high-affinity, HLA-A2-restricted, HCV NS3:1406-1415-reactive TCR. HCV1406 TCR-transduced T cells can recognize naturally processed antigen and elicit CD8-independent recognition of both peptide-loaded targets and HCV+ human HCC cell lines. Furthermore, these cells can mediate regression of established HCV+ HCC in vivo. Our results suggest that HCV TCR-engineered antigen-reactive T cells may be a plausible immunotherapy option to treat HCV-associated malignancies, such as HCC.

Efficiency improvement in the operating room.

BACKGROUND: In the changing health care environment, health systems, hospitals, and health care providers must focus on improving efficiency to meet an increasing demand for high-quality, low-cost health care. Much has been written about strategies and efforts to improve efficiency in the perioperative periods, yet the time when the patient is in the operating room-the intraoperative period-has received less attention. Yet, this is the period in which surgeons may have the most influence. METHODS: Systematically review published efforts to improve intraoperative efficiency; assess the outcomes of these efforts, and propose standardized reporting of future studies. RESULTS: A total of 39 studies were identified that met inclusion criteria. These divided naturally into small (single operative team), medium (multi-operative team), and large (institutional) interventions. Most studies used time or money as their metric for efficiency, though others were used as well. CONCLUSIONS: There is substantial opportunity to enhance operating room efficiency during the intraoperative period. Surgeons may have a particular role in procedural efficiency, which has been relatively unstudied. Common themes were standardizing tasks, collecting and using actionable data, and maintaining effective team communication.

Quality of neck dissection operative reports.

PURPOSE: The operative report is the official documentation of an operation and a key form of surgical communication. The objective of this study is to assess completeness of operative reports for neck dissections. METHODS: This is a retrospective review of narrative operative reports for neck dissections for head and neck squamous cell carcinoma. Forty-nine operative reports were provided by ten surgeons from seven academic institutions. Operative report completeness was expressed as a percentage of variables from a standardized checklist created by an expert panel. RESULTS: For level 1 dissections, most reports identified critical structures, such as the marginal mandibular nerve (84%) and the submandibular gland (84%). Of the cases that involved submandibular gland excision, reports were deficient in identification of the lingual nerve (74%), hypoglossal nerve (58%) and submandibular duct (22%). For neck dissections involving levels 2, 3 and 4, most described identifying spinal accessory nerve (92%) and internal jugular vein (98%), whereas fewer described identification of carotid artery or vagus nerve (67%), ansa cervicalis (31%), or cervical rootlets (48%). For level 5 dissections, only 75% of reports reported identification of spinal accessory nerve. Sixty percent of reports provided some description of the removed lymph nodes, but there was no consistency in terminology or definitions. Overall completeness of all NORs was 64% (40%-79%, SD 9%). CONCLUSIONS: There is heterogeneity and incompleteness in neck dissection operative reports across surgeons and institutions, despite being a crucial record of head and neck cancer treatment.