The Efficacy of Liposomal Bupivacaine for Opioid and Pain Reduction: A Systematic Review of Randomized Clinical Trials.

Background The opioid crisis has prompted surgeons to search for alternative postoperative methods of analgesia. Liposomal bupivacaine is a long-acting local anesthetic formulation used for pain, potentially reducing opioid use. Evaluation of liposomal bupivacaine as a viable alternative for pain management is needed. The objective was to assess the efficacy of randomized clinical trials (RCTs) of liposomal bupivacaine in postoperative pain management and opioid consumption. Material and Methods The authors extracted RCTs comparing liposomal bupivacaine versus placebo or active comparators for postoperative pain or opioid reduction from PubMED/MEDLINE, Cochrane Library, and ClinicalTrials.gov. Exclusion criteria included nonhuman studies, non-RCTs, pooled studies, and inability to access full text. The following variables were abstracted: surgical specialty, number of subjects, pain and opioid outcomes, and authors' financial conflicts of interest. Results We identified 77 published RCTs, of which 63 studies with a total of 6770 subjects met inclusion criteria. Liposomal bupivacaine did not demonstrate significant pain relief compared to placebo or active agents in 74.58% of RCTs. Of the studies evaluating narcotic use, liposomal bupivacaine did not show a reduction in opioid consumption in 85.71% of RCTs. Liposomal bupivacaine, when compared to standard bupivacaine or another active agent, yielded no reduction in opioid use in 83.33% and 100.00% of studies, respectively. Clinical trials with a financial conflict of interest relating to the manufacturer of liposomal bupivacaine were significantly more likely to show pain relief (OR: 14.31 [95% CI, 2.8, 73.10], P = 0.0001) and decreased opioid consumption (OR: 12.35 [95% CI 1.40, 109.07], P = 0.0237). Of the 265 unpublished RCTs on ClinicalTrials.gov, 47.54% were withdrawn, terminated, suspended, or completed without study results available. Conclusions The efficacy of liposomal bupivacaine for providing superior postoperative pain control relative to placebo or another active agent is not supported by a majority of RCTs. Underreporting of trial results and bias due to underlying financial relationships amongst authors are two major concerns that should be considered when evaluating the available evidence.

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.

Do Speakers Fully Disclose Potential Conflicts of Interest in Oral and Maxillofacial Surgery?

PURPOSE: The complete disclosure of conflicts of interest is critical to providing objective and ethical continuing education. The purpose of this study was to determine the accuracy of the disclosed financial relationships by speakers at an annual oral and maxillofacial surgery conference. MATERIALS AND METHODS: This retrospective cross-sectional study compared speakers' disclosures on the American Association of Oral and Maxillofacial Surgery Dental Implant Conference 2018 website to the payments reported on the Center for Medicare and Medicaid Services Open Payments Database. The predictor variable was the number of companies reported by the speakers. The outcome variable was the number of relevant companies discovered on the Open Payments Database. Other variables evaluated included total dollar sum transferred and the type of speaker (oral and maxillofacial surgeon (OMS) vs non-OMS). Companies providing payments to speakers on the Open Payments Database were deemed relevant if they had provided goods or services relevant to dental implants. Descriptive statistics were computed, and the Student t test was performed, with P < .05 considered to indicate statistical significance. RESULTS: A total of 43 speakers were included (32 OMSs; 74.4%). We found that 35 of the 43 speakers (81.4%) had received payments relating to dental implants on the Open Payments Database that had not been disclosed on the conference website. On average, the speakers disclosed 0.65 ± 1.04 companies; however, 2.51 ± 1.32 relevant companies per speaker were reported on the Open Payments Database (P < .0001). The OMS speakersdisclosed 0.47 ± 0.95 company on the conference site but had 2.47 ± 1.32 companies reporting payments on the Open Payments Database (P < .0001). Non-OMS speakers disclosed 1.18 ± 1.17 companies, with 2.64 ± 1.36 companies listed on the Open Payments Database (P = .0044). CONCLUSIONS: Continuing education conferences offer an avenue of knowledge transfer; however, the objectivity of the information presented could be affected by undisclosed conflicts of interest. The results from the present study have demonstrated that most speakers at an annual oral and maxillofacial surgery conference have underreported payments from companies relevant to the conference topic.

Characteristics of National Malpractice Claims in Oral and Maxillofacial Surgery.

PURPOSE: Insight into the causes and outcomes of malpractice claims against surgeons will help inform practitioners and may support better patient care. The purpose of this study was to characterize national malpractice claims against oral and maxillofacial surgeons (OMSs). MATERIALS AND METHODS: A comprehensive review of all claims against OMSs from 2000 to August 2018 in the National Practitioner Data Bank was performed. Primary outcomes were claims against OMSs, payment amount, claim duration, and percentage of anesthesia-related claims. Other variables of interest included demographic characteristics, nature of allegations, clinical outcome of injury, outcome of claim, and number of payments of $1 million or greater ("catastrophic payments"). Student t tests and Wilcoxon rank-sum test were performed, and P < .05 was considered significant. RESULTS: This was a retrospective cohort study of malpractice claims against OMSs. There were 2,643 claims against OMSs during the study period. The average age of the claimant was 35.5 ± 18.4 years, and 47.6% were female patients. Most claims (94.7%) were settled out of court for a mean of $130,824 ± $402,633.8. Court-adjudicated claims had significantly higher payments with a mean of $247,554.69 ± $414,655.51 (P < .0001). The average duration from time of event to conclusion of claim was significantly shorter for settled claims (3.5 ± 2.3 years) than for claims that were court adjudicated (5.2 ± 2.7 years) (P < .0001). Anesthesia-related claims made up 3.63% of the total, and 0.56% of claims were pediatric anesthesia related. Anesthesia-related payments were significantly higher than other claims (P < .0001). The most common type of allegation was "surgery-related" injuries (63.1%), followed by "treatment-related" injuries (22.2%). The most common clinical outcome was minor permanent injury (34.6%). CONCLUSIONS: Most claims against OMSs were settled. Only a small portion of claims were associated with anesthesia complications, but payment amounts for these were significantly higher than for other claims. Settlements were made more quickly and for significantly lower rewards compared with judgments. Claims against OMSs during the past 2 decades were most commonly associated with minor permanent injuries occurring in the outpatient setting.

Shining Sunlight on Industry Payments in Oral and Maxillofacial Surgery: The Sunshine Act.

PURPOSE: To characterize industry payments to oral and maxillofacial surgeons (OMSs) and to determine the accuracy of the Centers for Medicare and Medicaid Services (CMS) Open Payments Databases. MATERIALS AND METHODS: This was a cross-sectional study of the CMS General and Research Payments Databases in 2016 for clinicians categorized as OMSs. General payments include consulting fees, honoraria, gifts, entertainment, food and beverage, travel and education, and others. Research payments include payments associated with research. Variables collected included number of OMSs who received payments, type of and number of payments, total amount paid, geographic distribution, and proportion of funding allotted to research. The accuracy of payee categorization was determined by verifying a random selection of 5% of those categorized as "OMS" in the database with publicly available data. To assess impact on research productivity, the h-index of research payment recipients was calculated. RESULTS: A total of 6,720 OMSs received industry compensation in 2016. Accuracy was 88% in the General Payments Database and 50% in the Research Payments Database. OMSs received 28,456 general payments totaling $5,971,800.79. The average number of payments and the average amount per payment were 4.27 and $1,597.60, respectively. The CMS reported total research payments of $23,592.17. The 4 verified OMSs received a total of $18,500 in research payments and had an average h-index of 3.25 (range, 0 to 8). The most common payments made were for food and beverage (80.2%), travel and lodging (5.83%), education (3.91%), compensation for services other than consulting (3.1%), and gifts (3.03%). Research accounted for 0.07% of all payments. CONCLUSION: Although industry payments to OMSs were common, research funding was negligible. Most industry value transfers were related to food and beverage or travel and lodging. Clinicians were accurately classified in the CMS General Payments Database but not in the Research Payments Database.

Medicare in Oral and Maxillofacial Surgery Part 2: Academic Surgeons and Cancer Surgeons Are Reimbursed Less.

PURPOSE: The purpose was to evaluate predictors of reimbursement of oral and maxillofacial surgery services in the Medicare population. MATERIALS AND METHODS: This was a cross-sectional study of Medicare Physician and Other Supplier Aggregate Data from 2015. Clinicians were included if they were confirmed to be oral and maxillofacial surgeons (OMSs) by National Provider Identifier data. The primary outcome variable of this study was the proportion reimbursed (actual payment amount divided by charge amount). Predictor variables included type of practice (private vs academic), scope (cancer vs non-cancer), number of Medicare beneficiaries seen, number of unique Current Procedural Terminology (CPT) codes billed, and total amount charged. Descriptive statistics and regression analyses were calculated, with P < .05 considered significant. RESULTS: The initial search revealed 952 providers categorized as performing maxillofacial surgery, with 894 confirmed to be OMSs (144 academic and 750 private practice). Of 894 OMSs, 39 were cancer surgeons and 855 were non-cancer surgeons. Academic OMSs saw more complex patients than OMSs in private practice (P < .0001). Academic surgeons (n = 144) charged an average of $116,876.92 to Medicare, with a mean payment amount of $22,219.62. Private practice surgeons (n = 750) submitted an average charge of $27,812.56, with average reimbursement of $9,472.76. Multiple linear regression showed that academia, cancer surgeons, number of unique CPT codes, higher Hierarchal Condition Category scores, and total submitted charge amount were negative predictors of the proportion of reimbursement. CONCLUSIONS: Roughly 10% of OMSs participate in and bill for Medicare. Factors associated with a lower reimbursement proportion include being in academia, treating head and neck cancer, billing more unique CPT codes, seeing sicker patients, and having larger total submitted charges. As third-party private insurers often follow fee schedules and rates set by the Centers for Medicare & Medicaid Services, this observed effect also should be evaluated in claims data of other insurers.

Residency Interview Experiences in Oral and Maxillofacial Surgery Differ by Gender and Affect Residency Ranking.

PURPOSE: Resident interview experiences are crucial for applicants when ranking programs. The purpose of the present study was to evaluate the interview experience among current oral and maxillofacial surgery (OMS) residents to determine the factors that influenced their selection and ranking of training programs and whether these experiences differed between women and men. MATERIALS AND METHODS: We conducted a cross-sectional survey of OMS residents in 2018. The 12-question survey included demographics, reasons for selecting an interview and ranking programs, and positive and negative experiences during the interviews. Logistic regression models were constructed to evaluate the predictors of unprofessional or negative experiences. RESULTS: A total of 1134 surveys were emailed, with 165 completed questionnaires (14.6%) returned by 35 women (21.2%) and 130 men (78.8%). Their average age was 30.8 years (range, 25 to 42). The racial/ethnic distribution was as follows: white, 75.8%; Asian, 15.8%; and other, 8.4%. Of the 165 respondents, 52% were in MD and 48% in non-MD programs. The top factors in selecting an institution at which to interview were clinical scope and volume, and the reason for ranking a program high was resident friendliness, which was similar among the female and male respondents. Unprofessional behavior or negative experiences were reported by 62 respondents (38%) and occurred by both faculty and residents and during both interviews and social events. Demeaning behavior toward the applicant, residents, and colleagues was the most common negative experience overall, with the women experiencing more gender-specific inappropriate behavior. Female respondents and those who were in dual-degree programs were 2.4 and 2.1 times more likely to experience unprofessional conduct than their peers, respectively (P = .03). CONCLUSIONS: Female and male residents were influenced by the same factors when selecting interviews and ranking residency programs. Unprofessional and inappropriate conduct was reported by 38% of the respondents. Women and dual-degree respondents were 2.4 and 2.1 times more likely to experience unprofessionalism during interviews, respectively. This might have contributed to the low number of current female OMS residents.

Conflicts of Interest in Clinical Guidelines: Lack of Authors and Disclosures in the AAOMS White Papers.

PURPOSE: The purpose of this study was to evaluate current state of authorship, financial disclosures, and conflicts of interest in position papers published by the American Association of Oral and Maxillofacial Surgeons (AAOMS). MATERIALS AND METHODS: This is a cross-sectional review of the position papers published by the AAOMS from 2013 to 2017. Primary outcome variables include position papers published by the AAOMS. Secondary outcome variables include declaration of authorship, financial disclosures, and financial payments. The Open Payments Database for financial disclosures was reviewed for the year the position paper was published and the immediate preceding year. RESULTS: Ten position papers were published by the AAOMS from 2013 to 2017. Of the 10 papers, authorship was listed in 3, and none explicitly addressed the presence or absence of financial disclosures or conflicts of interest. Contributors to 3 of the 3 authored papers were found at review of the Open Payments Database to have received industry funding in the year the position paper was published and the immediate preceding year. The remuneration ranged from less than $1,000 to $554,006.02. CONCLUSION: Position papers published by the AAOMS lack standardization for authorship and statements on potential financial disclosure. The authors suggest full disclosures of authorship and authors' conflicts of interest should be stated on all position papers to provide transparency to the process.

Value in Oral and Maxillofacial Surgery: A Systematic Review of Economic Analyses.

PURPOSE: The purpose of this study is to describe the state of economic analyses in the field of oral and maxillofacial surgery (OMS). MATERIALS AND METHODS: A systematic search of published literature up to 2016 was performed. The inclusion criteria were as follows: English-language articles on economic analyses pertaining to OMS including anesthesia and pain management; dentoalveolar surgery; orthognathic, cleft, and/or obstructive sleep apnea treatment; pathology; reconstruction; temporomandibular disorders; trauma; and other. The exclusion criteria were as follows: opinion or perspective articles, studies unrelated to OMS, nonhuman research, and implant-related studies. Cost-effectiveness analyses (CEAs), cost-utility analyses, and cost-minimization analyses (CMAs) were evaluated with the original Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklist or a modified CHEERS checklist. RESULTS: The search yielded 798 articles, 77 of which met the inclusion criteria (published from 1980 to 2016, 48 from the United States). There were an increasing number of studies over time (P for trend < .01). There were 7 economic studies on anesthesia and pain management (9.1%); 16 studies on dentoalveolar surgery (20.7%); 15 studies on orthognathic, cleft, and/or obstructive sleep apnea treatment (19.4%); 1 study on pathology (1.3%); 6 studies on reconstruction (7.8%); no studies on temporomandibular joint disorders and/or facial pain (0%); 20 studies on trauma (25.9%); and 12 studies categorized as other (15.5%). CEAs made up 11.7% of studies, and CMAs comprised 58.4%. Of the 9 CEAs, 55.6% were published in 2010 or later. Of the 45 CMAs, 88.6% were published in 2000 or later and 61.4% in 2010 or later. CEAs met 56.0% (range, 29.2 to 87.5%) of the CHEERS criteria, whereas CMA studies met 45.1% (range, 23.9 to 76.1%) of the modified CHEERS criteria. Only 1 study succeeded in estimating costs and health outcomes (value) of an OMS procedure. CONCLUSIONS: There is an increasing trend in the number of economic studies in the field of OMS. More high-quality economic evaluations are needed to demonstrate the value of OMS procedures. To determine value, future studies should compare both costs and health-related outcomes.

What Is Important for Confirming Negative Margins When Resecting Mandibular Ameloblastomas?

PURPOSE: The purpose of this study was to assess the utility of intraoperative radiographs and frozen sections in achieving negative margins and preventing recurrence of mandibular ameloblastomas. MATERIALS AND METHODS: This was a retrospective cohort study of patients who underwent resection (≥1 cm) of mandibular ameloblastomas from 2005 through 2015. Patients were included if they had at least 1-year follow-up and complete records. Demographic variables included age, gender, and type of resection (segmental vs marginal). Predictor variables were type of margin assessment: 1) frozen section, 2) intraoperative ex vivo specimen radiograph, 3) both, or 4) none. The outcome variables were final margin status and recurrence rate. Accuracy of intraoperative radiographic margins was determined by comparison with histologic margin distance. Descriptive statistics were conducted with the Fisher exact test. RESULTS: The study sample consisted of 35 patients (47.5 ± 20.4 yr old; 16 men) who underwent 25 segmental and 10 marginal resections. Ten had frozen sections only, 3 had ex vivo specimen radiographs only, 10 had no intraoperative measurements, and 12 had both. There were no positive frozen sections. One patient had a positive posterior bony margin at final pathology despite negative frozen section histology. There was no difference in recurrence rate at latest follow-up among cohorts. The anterior radiographic margin was 11.8 ± 5.9 mm compared with 11.5 ± 7.5 mm by histology (P = .124). The posterior radiographic margin was 12.3 ± 5.3 mm compared with 9.8 ± 6.5 mm histologically (P = .546). Margin distances that were at least 5 mm when measured with specimen radiographs had histologic margin distances of at least 5 mm in 25 of 30 resection margins (83.3%). CONCLUSION: Resection of ameloblastoma with planned margins of at least 1 cm is sufficient to prevent recurrence of ameloblastoma. Achieving a radiographic margin of at least 5 mm provided a histologic margin of at least 5 mm 83.3% of the time.