Entrustable Professional Activities in Oral and Maxillofacial Surgery Education: A Faculty Development Construct.

The formative and summative evaluations of oral and maxillofacial surgery residents have commonly involved the six core competencies of the Accreditation Council for Graduate Medical Education. Unfortunately, the assessment of a resident's competencies in these six core areas is often subjective such that the written feedback might not be supportive of the resident's learning and continuous professional development. Compounding this problem is that faculty are infrequently trained in providing feedback in these core competencies, thereby adding to the inadequacy of this exercise. Entrustable professional activities (EPAs) represent a unit of professional practice, defined as tasks or responsibilities to be entrusted to the unsupervised execution by a trainee once he or she has attained sufficient specific competence. It is the purpose of this article to review the concept of EPAs that represent a hopeful solution to the theoretical and abstract nature of exclusive competency-based training assessments in resident education. EPAs are specifically proposed for oral and maxillofacial surgery resident education while discussing their serving as a faculty development construct.

Mandible Reconstruction in a Rural Population: Comparison of Radial Forearm and Free Fibula Flap Outcomes.

Comparison of microsurgical reconstructive options after mandible resection is limited in the literature. Fibula free flaps (FFFs) can be costly and have timing limitations, but dental restoration can be performed, with varied reported rates of completion. The radial forearm free flap (RFFF) with mandible plating may be an alternative in select populations. The purpose of this study was to determine if the RFFF has similar outcomes to the FFF for mandible reconstruction in a rural population. A retrospective review of patients who underwent mandibulectomy from 2017 to 2021 at a single tertiary-care academic institution was performed. Those with FFF or RFFF reconstruction were included. Mandible defects were classified using the Jewer-Boyd H-C-L system. Sixty-eight patients were included with 53 undergoing FFF and 15 undergoing RFFF. Immediate reconstruction was significantly more common with RFFF than FFF (100% versus 64.2%; P =0.01). Lateral mandible defects were most common among both groups (52.9% FFF versus 73.3% RFFF; P =0.04). Osseous defect length was similar (9.5 cm FFF versus 7.7 cm RFFF; P =0.07), but soft tissue defect size was significantly larger in the RFFF group (28.6 cm 2 versus 15.3 cm 2 ; P =0.01). Complication rates (47.1% FFF versus 46.7% RFFF; P =0.98) and disease-free status at last follow-up (96.2% FFF versus 80.0% RFFF; P =0.06) were similar. Dental restoration occurred in 21.3% of patients undergoing FFF. Patients undergoing RFFF or FFF reconstruction after mandibulectomy had similar surgical and disease outcomes, with a low rate of completed dental restoration after FFF. Our findings suggest RFFF is a reasonable alternative to FFF for mandible reconstruction in select patients.

American Association of Oral and Maxillofacial Surgeon's Position Paper on Oral Mucosal Dysplasia.

Oral potentially malignant disorders (OPMDs) of the oral mucosa include leukoplakia, erythroplakia, erythroleukoplakia, lichen planus, and oral lichenoid lesions, each with varying incidences of dysplastic disease at the time of presentation and each with observed incidences of malignant transformation over time. The primary goal of the management of dysplasia, therefore, includes their early detection and treatment prior to malignant transformation. The recognition and management of these OPMDs and an understanding of their potential progression to oral squamous cell carcinoma will reduce the morbidity and mortality associated with these lesions with expedient and properly executed treatment strategies that will have a positive effect on patient survival. It is the purpose of this position paper to discuss oral mucosal dysplasia in terms of its nomenclature, epidemiology, types, natural history, and treatment to acquaint clinicians regarding the timing of biopsy, type of biopsy, and follow-up of patients with these lesions of the oral mucosa. This position paper represents a synthesis of existing literature on this topic with the intention of closing gaps in our understanding of oral mucosal dysplasia while also stimulating new thinking to guide clinicians in the proper diagnosis and management of OPMDs. The fifth edition of the World Health Organization classification of head and neck tumors published in 2022 represents new information regarding this topic and a construct for this position paper.

American Association of Oral and Maxillofacial Surgeons' Position Paper on Medication-Related Osteonecrosis of the Jaws-2022 Update.

Strategies for management of patients with, or at risk for, medication-related osteonecrosis of the jaws (MRONJ) - formerly referred to as bisphosphonate-related osteonecrosis of the jaws (BRONJ)-were set forth in the American Association of Oral and Maxillofacial Surgeons (AAOMS) position papers in 2007, 2009 and 2014. The position papers were developed by a committee appointed by the AAOMS Board of Trustees and comprising clinicians with extensive experience in caring for these patients, as well as clinical and basic science researchers. The knowledge base and experience in addressing MRONJ continues to evolve and expand, necessitating modifications and refinements to the previous position papers. Three members of the AAOMS Committee on Oral, Head, and Neck Oncologic and Reconstructive Surgery (COHNORS) and three authors of the 2014 position paper were appointed to serve as a working group to analyze the current literature and revise the guidance as indicated to reflect current knowledge in this field. This update contains revisions to diagnosis and management strategies and highlights the current research status. AAOMS maintains that it is vitally important for this information to be disseminated to other relevant healthcare professionals and organizations.

Are Throat Pain and Otalgia Predictive of Perineural Invasion in Squamous Cell Carcinoma of the Oropharynx?

PURPOSE: Head and neck cancer is often associated with pain and perineural invasion (PNI). The purpose of this study was to determine the association of pain complaints and the microscopic identification of PNI in patients with oropharyngeal squamous cell carcinoma (OPSCC). PATIENTS AND METHODS: A retrospective cohort study was performed including patients diagnosed with OPSCC from 2010 to 2019. Patients diagnosed and operated on with curative intent at 2 institutions were included. The primary predictor variable was pain (measured as no pain, ear pain, throat pain, or simultaneous pain). Other variables were patient demographics, p16 status, and TNM staging. The primary outcome variable was the histologic presence of PNI. Chi-square analysis was performed to test for any significant associations between pain, T stage, overall stage, and p16 status in relation to PNI outcome. Multivariate logistic regression analysis was used to control for cancer staging variables when testing the association between pain and PNI. RESULTS: The final sample was composed of 157 subjects of whom 126 were men. The mean age was 59.7 years. Seventy-seven (49.0%) presented with no pain, while 35 (22.3%), 39 (24.8%), and 6 (3.8%) presented with both throat/ear pain, throat pain only, and ear pain only, respectively. Patients with simultaneous pain had 3.41 times higher odds of PNI compared to the no pain group (P = .02), although only pathologic T stage 4 and a diagnosis on the base of the tongue were independent postoperative predictors of PNI (P < .05). CONCLUSIONS: Our study demonstrates that otalgia is a preoperative predictor of PNI in OPSCC and also demonstrates a trend of increasing pain complaints with PNI.

Academic Relative Value Units: A Proposal for Faculty Development in Oral and Maxillofacial Surgery.

PURPOSE: The Resource-based Relative Value Scale (RBRVS) designates quantitative values to clinical health care services to identify the relative work and cost of these services. Each clinical service translates to relative value units (RVUs). Clinical RVUs describe clinician work effort to guide employed clinician salaries in academic medical centers. The development of an academic RVU (aRVU) system also seems reasonable to establish and assess the quantity and quality of academic effort of members of our specialty that supports resident and student achievement. MATERIALS AND METHODS: The 1998 Association of American Medical Colleges (AAMC) Mission-based Management (MBM) Program was assessed and adapted in creating an aRVU system. This aRVU system is hypothesized to guide oral and maxillofacial surgery faculty in advancing their missions of didactic and interactive teaching, production and dissemination of scholarly activity, performance of basic science and translational research, and participation in administrative service to academic medical centers. RESULTS: A logic model was constructed to create and support the aRVU equation as a proposal for faculty development in oral and maxillofacial surgery. Numerous potential barriers exist to the implementation of this proposal, including those related to legacy and generational issues in academic medical centers. CONCLUSION: The proposed aRVU system provides quantitative metrics for recognition of faculty development in oral and maxillofacial surgery. This system is based on strategic planning and allocation of effort sessions, and therefore, reflects mutually agreed upon faculty/department chair interests and goals. Annual performance evaluations of oral and maxillofacial surgery faculty can be based on aRVU accumulation.

Tracheotomies in COVID-19 Patients: Protocols and Outcomes.

PURPOSE: Approximately 3-15% of COVID-19 patients will require prolonged mechanical ventilation thereby requiring consideration for tracheotomy. Guidelines for tracheotomy in this cohort of patients are therefore required with assessed outcomes of tracheotomies. PATIENTS AND METHODS: A retrospective chart review was performed of COVID-19 patients undergoing tracheotomy. Inclusion criteria were the performance of a tracheotomy in COVID-19 positive patients between March 11 and December 31, 2020. Exclusion criteria were lack of consent, extubation prior to the performance of a tracheotomy, death prior to the performance of the tracheotomy, and COVID-19 patients undergoing tracheotomy who tested negative twice after medical treatment. The primary predictor variable was the performance of a tracheotomy in COVID-19 positive patients and the primary outcome variable was the time to cessation of mechanical ventilation with the institution of supplemental oxygen via trach mask. RESULTS: Seventeen tracheotomies were performed between 4-25 days following intubation (mean = 17 days). Seven patients died between 4 and 16 days (mean = 8.7 days) following tracheotomy and 10 living patients realized cessation of mechanical ventilation from 4 hours to 61 days following tracheotomy (mean = 19.3 days). These patients underwent tracheotomy between 4 and 22 days following intubation (mean = 14 days). The 7 patients who died following tracheotomy underwent the procedure between 7 and 25 days following intubation (mean = 18.2 days). Seven patients underwent tracheotomy on or after 20 days of intubation and 3 survived (43%). Ten patients underwent tracheotomy before 20 days of intubation and 7 patients survived (70%). Significant differences between the mortality groups were detected for age (P = .006), and for P/F ratio at time of consult (P = .047) and the time of tracheotomy (P = .03). CONCLUSIONS: Tracheotomies are safely performed in COVID-19 patients with a standardized protocol. The timing of tracheotomy in COVID-19 patients is based on ventilator parameters, P/F ratio, patient prognosis, patient advanced directives, and family wishes.

Assessment of Intraoperative Time for Head and Neck Cancer Surgeries Compared With Medicare Work Time.

PURPOSE: Surgeon reimbursement is dictated in part by the operative time necessary to complete a procedure. The purpose of this study is to compare insurer-set time to true intraoperative time for common head and neck cancer procedures. METHODS: This retrospective cohort study compares intraoperative times between the 2019 Center for Medicare and Medicaid Services (CMS) work-time estimates and the 2017 to 2018 American College of Surgeons National Surgical Quality Improvement Program (NSQIP) data sets for 10 commonly billed head and neck cancer procedures. The primary predictor variable was common head and neck oncologic and reconstructive procedures with corresponding Current Procedural Terminology (CPT) code. The primary outcome variable includes the computed difference between CMS and NSQIP times. Additional variables collected include patient demographics (gender, age, race, and inpatient/outpatient) and work relative value unit (wRVU) per CPT code. Analysis of variance was used to evaluate differences in intraoperative times across CPT codes. Linear regression using standardized coefficients were calculated between CMS time and NSQIP time; CMS time and wRVUs; and NSQIP time and wRVUs. RESULTS: There were 8,330 subjects (44% female, 57.7% inpatient) across 10 CPT codes. Analysis of variance revealed intercode variability in median intraoperative times between CMS and NSQIP (P < .001). CMS underestimated the time necessary to complete excision of malignant tumor mandible (CPT 21045) by 315 minutes. CMS overestimated the time necessary for excision of tongue lesion (CPT 41112) by 5 minutes. Overall, CMS intraoperative time estimates were neither invariably longer nor consistently shorter than NSQIP procedural times (ß, 0.85; 95% confidence interval, 0.43 to 1.26). CONCLUSIONS: CMS estimates of time needed to complete head and neck cancer surgeries varies from national intraoperative times. No consistent trend in underestimation or overestimation of procedure time was found. Improving the accuracy of CMS time estimates used in determining surgeon reimbursement for head and neck cancer procedures may be warranted.

Comparing the Surgical Response of Bisphosphonate-Related Versus Denosumab-Related Osteonecrosis of the Jaws.

PURPOSE: The pathophysiology and treatment of medication-related osteonecrosis of the jaws (MRONJ) remain unclear after nearly two decades of recorded observation and discussion. The purpose of this study was to assess outcomes of surgical resection of MRONJ in patients exposed to denosumab. MATERIALS AND METHODS: A literature review was performed in conjunction with experts at the University of Illinois at Chicago Library. The primary outcome of interest was surgical success defined by maintenance of complete mucosal closure without bone exposure and infection after surgical resection. Secondary interests included demographics, MRONJ stage, location of the focus of osteonecrosis, and the primary underlying disease necessitating antiresorptive treatment. Statistical analysis was performed by χ2, analysis of variance, or t test (P < .05 and b = 0.2 or a power of 0.8). RESULTS: A total of 70 articles were identified and 14 met inclusion criteria. Twenty patients were included (13 women; 7 men); age 61.8 years ± 12.9 (range 19 to 77); and MRONJ stage I (40.0%), II (35.0%), and III (25.0%). Most cases occurred in the mandible (65.0%), followed by the maxilla (30.0%). The success rate of surgical intervention for MRONJ secondary to denosumab was in 16 of 20 (80.0%) patients. Stage I MRONJ lesions achieved mucosal closure in 100% of patients, stage II in 71.4%, and stage III in 60.0%. The surgical success rate was 83.3% in the maxilla and 76.9% in the mandible. CONCLUSIONS: The surgical success rate for MRONJ secondary to denosumab was 80.0%, similar to that reported in bisphosphonates of 85 to 95%; however, more evidence must be reported and analyzed.

Preoperative Serum Albumin Predicts Wound Dehiscence but Not Infection After Surgery for Oral Squamous Cell Carcinoma.

PURPOSE: Inadequate nutrition is common in individuals diagnosed with cancer. The present study evaluated the association between preoperative albumin and postoperative complications in otherwise healthy patients presenting with newly diagnosed squamous cell carcinoma of the oral cavity primarily managed with ablative surgery. PATIENTS AND METHODS: A retrospective cohort study of patients with newly diagnosed oral squamous cell carcinoma from 2005 to 2019 was performed. Patients referred to and managed by a single surgeon (ERC) and who had not received any nutritional support in the preoperative period were included in the study. The primary predictor variable was preoperative albumin level. Other studied variables were patient demographic data and TNM stage. Complications related to primary ablative surgery represented the primary outcome variable. χ2 analysis was completed to assess for significant associations between independent albumin groups (4+, 3.5 to 3.9, and 3.0 to 3.4 g/dL) in relation to postoperative complications. Multivariate logistic regression analysis was completed to control for clinical variables and medical comorbidities when testing the association between albumin and dehiscence. RESULTS: The patient cohort included 268 individuals; of whom, 154 were men. The average age of the patients at surgery was 63 years. When controlling for all other variables, albumin was the only statistically significant predictor of postoperative dehiscence, P = .005. Patients with albumin of 3.5 to 3.9 g/dL had 3.24 times higher odds of dehiscence (95% confidence interval 1.42 to 7.38) in comparison with participants in the 4+ g/dL group. There was no difference of odds between the 3.0 to 3.4 group and the 4+ reference group. CONCLUSIONS: Our study demonstrated that among those individuals meeting the inclusion criteria, there is a statistically significant association between lower albumin levels and postoperative complication rates, specifically dehiscence.

Are Oral Pain and Otalgia Predictive of Perineural Invasion in Squamous Cell Carcinoma of the Oral Tongue?

PURPOSE: Tongue cancer is often associated with pain and perineural invasion. The purpose of the present study was to determine the association between tongue pain and otalgia and the microscopic identification of perineural invasion (PNI) in patients with squamous cell carcinoma of the tongue (SCCOT). PATIENTS AND METHODS: A retrospective cohort study was performed of patients with a diagnosis of SCCOT from January 2013 through June 2019. Patients without a history of head and neck cancer, who had SCCOT diagnosed and treated surgically by a single surgeon, were included in the present study. The primary predictor variables were tongue pain and otalgia (presence vs absence of both). Other variables included patient demographic data and TNM stage. The primary outcome variable was the histologic presence of PNI. A χ2 analysis was performed to test for any significant associations between pain, T stage, and overall stage in relation to PNI outcome. Multivariate logistic regression analysis was used to control for cancer staging variables when testing the association between pain and PNI. RESULTS: The sample included 128 subjects, of whom 76 were men. Their mean age was 60 years. Most patients (n = 97; 75.8%) complained of tongue pain and a few (n = 50; 39.1%) complained of otalgia. The patients with otalgia had a 3.15 times greater odds of PNI when controlling for T stage (P = .016) and 3.68 times greater odds of PNI when controlling for overall stage (P = .007). Increasing T stage and overall stage-with the exception of stage II-were also significantly associated with PNI (P ≤ .05). CONCLUSIONS: Our study has demonstrated a statistically significant association between preoperative otalgia and PNI in a consecutive group of patients presenting with newly diagnosed SCCOT.

Are Tracheotomies Required for Patients Undergoing Composite Mandibular Resections for Oral Cancer?

PURPOSE: Prophylactic tracheotomy has traditionally been performed during composite mandibular resection of oral cavity cancer to avoid postoperative airway compromise. The purpose of the present study was to measure the frequency and identify the factors associated with an increased or a decreased risk of an adverse airway event (AAE) within 30 days postoperatively. PATIENTS AND METHODS: A retrospective cohort study of patients who had undergone composite mandibular resection for oral cancer from 2006 to 2018 was conducted at the University of Tennessee Medical Center. The primary predictor variable was composite resection with or without immediate flap reconstruction. The primary outcome variable was realization of a 30-day AAE, defined as the requirement for tracheotomy for any reason, emergent endotracheal reintubation at any time during the postoperative admission, or prolonged (>48 hours) postoperative endotracheal intubation. The secondary outcome variable was the inpatient length of stay. Descriptive and bivariate statistics were used to compare the patients with and without an AAE for demographic, confounding, and clinical characteristics. RESULTS: A total of 114 patients were identified through retrospective medical record review. The prevalence of AAEs in the sample was 8.8% (10 of 114). None of the 49 patients without immediate flap reconstruction developed an AAE. Of the 65 patients who had undergone flap reconstruction, 10 (15.4%) developed an AAE. The χ2 analysis revealed a significantly greater rate of AAEs when flap reconstruction was implemented (P < .05). Also, a significantly greater rate of AAEs was found in the group requiring resection of the floor of the mouth with bilateral neck dissections and immediate flap reconstruction compared with all other flap reconstruction groups (P < .05). CONCLUSIONS: A composite resection involving the floor of the mouth with bilateral neck dissection and flap reconstruction should receive strong consideration for prophylactic tracheotomy to avoid an AAE.

Lifelong Learning: A Higher Order of Consciousness and a Construct for Faculty Development.

Learning is an element of human personal and professional development that occurs throughout life in a variety of informal and formal contexts. Meaning making, a process in which people construct the meaning of events and experiences that are part of and shape our existence, represents an informal context of learning in that thinking and reflection is all that is required to accomplish this type of learning. Our meaning making equates to informal learning that develops through a lens in which we create the meaning of our experiences. Informal adult education, or casual opportunities to learn in adult life, is represented by the flexibility of the process, the experiential nature of the learning process, and the enthusiasm and dedication of the participants. Lifelong learning is an overarching experience that involves formal educational experiences. Lifelong learning is motivated internally, including the ability to establish favorable change in one's career trajectory. As such, it can be argued that lifelong learners ascribe to a higher order of consciousness, specifically, self-authoring or self-transforming minds. The support, stimulation, and encouragement of lifelong learning, therefore, represents a construct for effective faculty development in graduate medical education.

What Is the Role of Elective Neck Dissection in the Management of Patients With Buccal Squamous Cell Carcinoma and Clinically Negative Neck?

PURPOSE: Buccal squamous cell carcinoma (BSCC) is rare in the United States. Given its location, few anatomic barriers to spread exist and it has been found to have a high locoregional recurrence rate. The role of elective neck dissection (END) in patients with clinically negative neck (N0) is not clear. This study aims to answer the following research question: Among patients with N0 BSCC, does END improve locoregional control rates, distant metastasis rates, and 2- and 5-year survival rates? MATERIALS AND METHODS: A retrospective cohort study was conducted. The sample included patients who received a diagnosis of BSCC. The primary predictor variable was END status (yes or no). Five institutions participated between June 2001 and June 2011: University of Washington, University of Michigan, University of Tennessee, North Memorial Oral and Maxillofacial Surgery in Minnesota, and Head and Neck Surgical Associates (Portland, OR). The primary outcome variable was locoregional recurrence. Secondary outcome variables were distant metastasis and 2- and 5-year survival rates. Other variables collected were demographic characteristics, initial operation, adjuvant therapy, clinical and pathologic data, and staging. Kaplan-Meier and Cox proportional hazards statistics were computed. RESULTS: The sample was composed of 98 patients with clinical N0 BSCC. The mean age was 66 years (range, 30-88 years), and 54% were men. Of the patients, 74 (76%) underwent END. The locoregional recurrence-free rate was 61% for END versus 38% for no END (P = .042). The distant metastasis rate was 4% for END versus 9% for no END. The 2- and 5-year disease-free survival rates were 91% and 75% (P = .042), respectively, for END and 85% and 63% (P = .019), respectively, for no END. CONCLUSIONS: END had a therapeutic effect, as evidenced by a lower locoregional recurrence rate, lower distant metastasis rate, and improved 2- and 5-year survival rates.

Surgical Landmarks to Locating the Main Trunk of the Facial Nerve in Parotid Surgery: A Systematic Review.

PURPOSE: The purpose of this study was to describe distances from commonly used anatomic landmarks to the main trunk of the facial nerve during parotid surgery. MATERIALS AND METHODS: A systematic search of the published literature was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. All studies from January 1, 1990 to January 1, 2017 that measured distances to the main trunk of the facial nerve from common anatomic landmarks were eligible. Inclusion criteria were English-language articles with distances measured from the main trunk of the facial nerve to anatomic landmarks. The primary outcome variable was the distance from the respective anatomic landmarks. Other variables included surgical approach, year, and existential status of subject (cadaveric or living). RESULTS: The search yielded 1,412 studies (1,397 by PubMed, 15 by reference searching), with 10 studies meeting the inclusion criteria. Within the 10 studies, there were 30 reported means and 375 dissected cadavers. The most common incision was the standard preauricular incision; the mean distances to the facial trunk from landmarks were 13.6 ± 11.0 mm (n = 6 reported means) for the tragal pointer, 8.79 ± 3.99 mm (n = 7 reported means) for the posterior belly of the digastric muscle, 10.5 ± 1.4 mm (n = 4 reported means) for the tip of the mastoid process, 14.99 ± 1.68 mm (n = 3 means) for the transverse process of C1, 3.79 ± 2.92 mm (n = 6 means) for the tympanomastoid fissure, 9.80 ± 0 mm (n = 1 mean) for the styloid process, and 11.77 ± 1.42 mm (n = 3 means) for the external auditory meatus. Formal assessment of inter-study variability could not be assessed because of the small number of studies and measurements. CONCLUSION: There are substantial variations in measurements from anatomic landmarks to the main trunk of the facial nerve in the literature. Therefore, multiple landmarks can be used to identify the main trunk of the facial nerve during parotid surgery. The distances reported in this study can guide surgeons during parotid surgery to decrease the risk of facial nerve damage.

The Double Mandibular Osteotomy for Vascular and Tumor Surgery of the Parapharyngeal Space.

PURPOSE: The purposes of this study are to describe our experience using a double mandibular osteotomy for access to the parapharyngeal space in vascular and tumor surgery and to report on the outcomes and complications of this procedure. PATIENTS AND METHODS: We designed and implemented a case series to review the medical records of all patients treated with a double mandibular osteotomy for parapharyngeal space access from 1994 to 2016. Patient demographic characteristics, indications for the procedure, outcomes, and complications were recorded. RESULTS: A total of 17 patients underwent a double mandibular osteotomy procedure for access to the parapharyngeal space during the study period. There were 7 men (41%) and 10 women (59%) comprising the cohort. The average age was 57 years (range, 29 to 75 years). The follow-up period ranged from 6 to 98 months (mean, 40 months), and 7 patients (41%) were tobacco users at the time of surgery. The most common indication was high internal carotid artery stenosis (n = 6) followed by carotid body paraganglioma (n = 3). Average blood loss was 186 mL, and there were no deaths during the study period. Eight postoperative complications were noted in 7 patients (41%). No procedures were aborted or compromised because of inadequate parapharyngeal space access. All patients showed clinical and radiographic signs of healing of the osteotomy sites. CONCLUSION: The double mandibular osteotomy provides adequate access to the parapharyngeal space for effective tumor removal and high carotid surgical intervention with acceptable patient morbidity and complications.