Hidden Otolaryngology Malpractice Claims: An Internal Review From 2000 to 2020.

OBJECTIVE: To report key characteristics and patterns of captive insurance claims not publicly reported in otolaryngology across a large tertiary-level academic health system over the previous 2 decades. STUDY DESIGN: Case series. SETTING: The tertiary care health system. METHODS: The internal captive insurance database at a tertiary level healthcare system was queried to identify otolaryngology-related malpractice claims regardless of final disposition (settled or dismissed) filed from 2000 to 2020. The date of the incident, date of claim, error type, patient outcome, provider subspecialty, total expenses, disposition, and final reward amount were recorded. RESULTS: Twenty-eight claims were identified. There were 11 (39.3%) claims from 2000 to 2010 and 17 (60.7%) claims from 2011 to 2020. Head and neck surgery was the most frequently implicated subspecialty (n = 9, 32.1% of all cases), followed by general otolaryngology (n = 7, 25.0%), pediatrics (n = 5, 17.9%), skull base/rhinology (n = 4, 14.3%), and laryngology (n = 1, 3.6%). Improper surgical performance was cited in 35.7% of cases (n = 10), followed by failure to diagnose (n = 8, 28.6%), to treat (n = 4, 14.3%), and to obtain informed consent (n = 3, 10.7%). While 2 cases are ongoing, a total of 17/26 (65.4%) cases were settled and 20/26 (76.9%) dismissed some or all parties. Dismissed claims had significantly higher expenses (p = .022) and duration from incident to disposition (p = .013) compared to settled claims. CONCLUSION: This study expands the malpractice landscape in otolaryngology by including data not readily available through public sources and compares it to national trends. These findings encourage otolaryngologists to better gauge current quality and safety measures that best protect patients from harm.

Association of Routine Preoperative Frailty Assessment With 1-Year Postoperative Mortality.

Importance: Patient frailty is a known risk factor for adverse outcomes following surgery, but data are limited regarding whether systemwide interventions related to frailty are associated with improved patient outcomes. Objective: To evaluate whether a frailty screening initiative (FSI) is associated with reduced late-term mortality after elective surgery. Design, Setting, and Participants: This quality improvement study with an interrupted time series analysis used data from a longitudinal cohort of patients in a multihospital, integrated health care system in the US. Beginning in July 2016, surgeons were incentivized to measure frailty with the Risk Analysis Index (RAI) for all patients considering elective surgery. Implementation of the BPA occurred in February 2018. The cutoff for data collection was May 31, 2019. Analyses were conducted between January and September 2022. Exposures: The exposure of interest was an Epic Best Practice Alert (BPA) used to identify patients with frailty (RAI ≥42) and prompt surgeons to document a frailty-informed shared decision-making process and consider additional evaluation by a multidisciplinary presurgical care clinic or the primary care physician. Main Outcomes and Measures: The primary outcome was 365-day mortality after the elective surgical procedure. Secondary outcomes included 30-day and 180-day mortality as well as the proportion of patients referred for additional evaluation based on documented frailty. Results: A total of 50 463 patients with at least 1 year of postsurgical follow-up (22 722 before intervention implementation and 27 741 after) were included (mean [SD] age, 56.7 [16.0] y; 57.6% women). Demographic characteristics, RAI score, and operative case mix, as defined by Operative Stress Score, were similar between time periods. After BPA implementation, the proportion of frail patients referred to a primary care physician and presurgical care clinic increased significantly (9.8% vs 24.6% and 1.3% vs 11.4%, respectively; both P < .001). Multivariable regression analysis demonstrated an 18% reduction in the odds of 1-year mortality (0.82; 95% CI, 0.72-0.92; P < .001). Interrupted time series models demonstrated a significant slope change in the rate of 365-day mortality from 0.12% in the preintervention period to -0.04% in the postintervention period. Among patients triggering the BPA, estimated 1-year mortality changed by -4.2% (95% CI, -6.0% to -2.4%). Conclusions and Relevance: This quality improvement study found that implementation of an RAI-based FSI was associated with increased referrals of frail patients for enhanced presurgical evaluation. These referrals translated to a survival advantage among frail patients of similar magnitude to those observed in a Veterans Affairs health care setting, providing further evidence for both the effectiveness and generalizability of FSIs incorporating the RAI.

Potential impact of the COVID-19 pandemic on financial toxicity in cancer survivors.

BACKGROUND: In the context of COVID-19, cancer survivors represent a particularly vulnerable population that may be "doubly hit" by both costs of cancer treatment and financial strain imposed by the pandemic. METHODS: We performed a review of the literature pertaining to cancer, financial toxicity, and economic challenges. RESULTS: Multiple societies have put forth recommendations to modify delivery of cancer care in order to minimize patient exposure to the virus. Cancer survivors, especially patients with head and neck cancer, have been disproportionately affected by rising unemployment levels and economic recessions in the past, both of which are linked to higher cancer mortality. Patients who rely on employer-provided insurance and do not qualify for Medicaid may lose access to life-saving treatments. CONCLUSIONS: It is essential to implement interventions and policy changes in order to mitigate the effects of this pandemic but also to ensure this becomes a nonissue during the next one.

Understanding financial toxicity in head and neck cancer survivors.

OBJECTIVES: (1) Describe financial toxicity (FT) in head and neck cancer (HNC) survivors and assess its association with personal/health characteristics and health-related quality of life (HRQOL); (2) examine financial coping mechanisms (savings/loans); (3) assess relationship between COmprehensive Score for financial Toxicity (COST) and Financial Distress Questionnaire (FDQ). PATIENTS AND METHODS: Cross-sectional survey from January - April 2018 of insured patients at a tertiary multidisciplinary HNC survivorship clinic who completed primary treatment for squamous cell carcinoma of the oral cavity, oropharynx, or larynx/hypopharynx. RESULTS: Of 104 survivors, 30 (40.5%) demonstrated high FT. Patients with worse FT were more likely (1) not married (COST, 25.33 ±â€¯1.87 vs. 30.61 ±â€¯1.34, p = 0.008); (2) of lower education levels (COST, 26.12 ±â€¯1.47 vs. 34.14 ±â€¯1.47, p < 0.001); and (3) with larynx/hypopharynx primaries (COST, 22.86 ±â€¯2.28 vs. 30.27 ±â€¯1.50 vs. 32.72 ±â€¯1.98, p = 0.005). Younger age (4.23, 95%CI 2.20 to 6.26, p < 0.001), lower earnings at diagnosis (1.17, 95%CI 0.76 to 1.58, p < 0.001), and loss in earnings (-1.80, 95%CI -2.43 to -1.16, p < 0.001) were associated with worse FT. COST was associated with HRQOL (0.08, p = 0.03). Most survivors (63/102, 60%) reported using savings and/or loans. Worse FT was associated with increased likelihood of using more mechanisms (COST, OR1.06, 95%CI 1.02 to 1.10, p = 0.004). Similar results were found with FDQ. CONCLUSIONS: We found differences in FT by primary site, with worst FT in larynx/hypopharynx patients. This finding illuminates potential site-specific factors, e.g. workplace discrimination or inability to return to work, that may contribute to increased risk. FDQ correlates strongly with COST, encouraging further exploration as a clinically-meaningful screening tool.

Teach the teacher: Training otolaryngology fellows to become academic educators.

OBJECTIVES/HYPOTHESIS: Fellowship is the capstone of academic training and serves as preparation for an academic career. Fellows are expected to educate medical students and residents during and long after fellowship. However, little time is typically spent teaching fellows to become effective educators. We investigate a formal curriculum addressing teaching skills among fellows in otolaryngology-head and neck surgery (OHNS). STUDY DESIGN: E-mail survey. METHODS: We developed and implemented an educational program called Teach the Teacher to build skills as educators for fellows in OHNS. We conducted a survey of fellows from 2014 to 2017 in OHNS who participated in the course. The survey evaluated demographics, teaching experiences, and teaching limitations structured as yes/no and Likert-style questions (1 = strongly disagree, 5 = strongly agree). RESULTS: Thirty fellows were surveyed with a response rate was 80%. Fellowship was rated highly as an experience that will make fellows a better academic educator (mean ± standard deviation: 4.54 ± 0.64). The most important components of teaching during fellowship were role modeling (4.67 ± 0.62), followed by teaching psychomotor skills in the operating room (4.29 ± 0.89), diagnostic reasoning (4.25 ± 0.66), and evidence-based medicine (4.25 ± 0.83). The Teach the Teacher course specifically was rated as a helpful experience (4.00 ± 0.90). The primary limitations to developing teaching skills during fellowship identified were lack of time, patient safety, and inexperience with hospital culture. CONCLUSIONS: Fellowship is a key time to improve skills as academic educators. Fellows value formal efforts to teach academic skills. LEVEL OF EVIDENCE: NA. Laryngoscope, 128:2034-2048, 2018.

Postoperative Swallowing Assessment After Lung Transplantation.

BACKGROUND: Dysphagia, aspiration, and potential pneumonia represent a major source of morbidity in patients undergoing lung transplantation. Conditions that potentiate dysphagia and aspiration include frailty and prolonged intubation. Our group of speech-language pathologists has been actively involved in performance of a bedside evaluation of swallowing, and instrumental evaluation of swallowing with modified barium swallow, and postoperative management in patients undergoing lung transplantation. METHODS: All lung transplant patients from April 2009 to September 2012 were evaluated retrospectively. A clinical bedside examination was performed by the speech-language pathology team, followed by a modified barium swallow or fiberoptic endoscopic evaluation of swallowing. RESULTS: A total of 321 patients were referred for evaluation. Twenty-four patients were unable to complete the evaluation. Clinical signs of aspiration were apparent in 160 patients (54%). Deep laryngeal penetration or aspiration were identified in 198 (67%) patients during instrumental testing. A group of 81 patients (27%) had an entirely normal clinical examination, but were found to have either deep penetration or aspiration. CONCLUSIONS: The majority of patients aspirate after lung transplantation. Clinical bedside examination is not sensitive enough and will fail to identify patients with silent aspiration. A standard of practice following lung transplantation has been established that helps avoid postoperative aspiration associated with complications.

Transoral Robotic Surgery and the Unknown Primary: A Cost-Effectiveness Analysis.

OBJECTIVE: To evaluate the cost-effectiveness of transoral robotic surgery (TORS) for the diagnosis and treatment of cervical unknown primary squamous cell carcinoma (CUP). STUDY DESIGN: Case series with chart review. SETTING: Tertiary academic hospital. SUBJECTS AND METHODS: A retrospective chart review was performed on patients with new occult primary squamous cell carcinoma of the head and neck with nondiagnostic imaging and/or endoscopy who were treated with TORS at a tertiary hospital between 2009 and 2012. Direct costs were obtained from the hospital's billing system, and national data were used for inpatient hospital costs and physician fees. The proportion of tumors found in 3 strategies was used as effectiveness to calculate the incremental cost-effectiveness ratio. RESULTS: In total, 206 head and neck robotic cases were performed at our institution between December 2009 and December 2012. Three surgeons performed TORS on 22 patients for occult primary squamous cell carcinoma. The primary tumor was located in 19 of 22 patients (86.4%). The incremental cost-effectiveness ratio for sequential and simultaneous examination under anesthesia with tonsillectomy (EUA) and TORS base of tongue resection was $8619 and $5774 per additional primary identified, respectively. CONCLUSION: Sequential EUA followed by TORS is associated with an incremental cost-effectiveness ratio of $8619 compared with traditional EUA alone. Bilateral base of tongue resection should be considered in the workup of these patients, particularly if the palatine tonsils have already been removed.

Effect of weight loss on short-term outcomes and costs of care after head and neck cancer surgery.

OBJECTIVES: Patients with head and neck cancer (HNC) frequently present with weight loss secondary to dysphagia and malnutrition. We sought to determine the relationship between weight loss and in-hospital mortality, complications, length of hospitalization, and costs in HNC surgery. METHODS: We analyzed discharge data from the Nationwide Inpatient Sample for 93,663 patients who underwent an ablative procedure for malignant oral cavity, laryngeal, hypopharyngeal, or oropharyngeal neoplasms between 2003 and 2008. RESULTS: Weight loss was significantly associated with dysphagia (relative risk ratio [RRR] = 3.0; p < 0.001), alcohol abuse (RRR = 2.0; p < 0.001), advanced comorbidity (RRR = 1.8; p < 0.001), Medicaid payor status (RRR = 1.6; p = 0.002), urgent or emergent admission (RRR = 1.7; p = 0.015), and major surgical procedures (RRR = 2.3; p < 0.001). Patients with weight loss had increased risks of acute cardiac events, pneumonia, renal failure, sepsis, pulmonary failure (RRR = 2.6; p < 0.001), and postoperative wound healing complications, including fistula, dehiscence, and surgical site infection (RRR = 2.0; p < 0.001). After we controlled for all other variables, weight loss was associated with significantly increased length of hospitalization and hospital-related costs. CONCLUSIONS: Weight loss is associated with increases in medical complications, surgical complications, length of hospitalization, and hospital-related costs in HNC surgical patients. Aggressive preoperative identification and treatment of underlying dysphagia and malnutrition may reduce the medical and surgical morbidity in this high-risk population.

A cost-effectiveness analysis of positron emission tomography-computed tomography surveillance versus up-front neck dissection for management of the neck for N2 disease after chemoradiotherapy.

OBJECTIVES/HYPOTHESIS: To study the cost effectiveness of positron emission tomography-computerized tomography (PET-CT) scanning in the management of the neck after chemoradiotherapy (CRT). STUDY DESIGN: Cost effectiveness and decision analysis model. METHODS: A cost-effectiveness analysis comparing up-front neck dissection to serial PET-CT imaging in a hypothetical clinical scenario of debate. A patient with an oropharygeal cancer with pretreatment N2 disease having a complete response was considered. Standardized costs were obtained using national databases. A literature review in PubMed was performed to obtain information on incidence, probabilities, and range for various clinical events in the algorithm. RESULTS: PET-CT strategy costs an average of $14,492 per patient. Neck dissection had a 0.6% greater efficacy in controlling neck disease with a $22,433 incremental cost. CONCLUSIONS: Our results strongly support the use of PET-CT imaging as the more cost-effective strategy for surveillance of neck after completion of definitive CRT compared to up-front neck dissection.

Cost-identification analysis of total laryngectomy: an itemized approach to hospital costs.

OBJECTIVES: To understand the contribution of intraoperative and postoperative hospital costs to total hospital costs, examine the costs associated with specific hospital services in the postoperative period, and recognize the impact of patient factors on hospital costs. STUDY DESIGN: Case series with chart review. SETTING: Large tertiary care teaching hospital system. SUBJECTS AND METHODS: Using the Pittsburgh Head and Neck Organ-Specific Database, 119 patients were identified as having total laryngectomy with bilateral selective neck dissection and primary closure from 1999 to 2009. Cost data were obtained for 112 patients. Costs include fixed and variable costs, adjusted to 2010 US dollars using the Consumer Price Index. RESULTS: Mean total hospital costs were $29,563 (range, $10,915 to $120,345). Operating room costs averaged 24% of total hospital costs, whereas room charges, respiratory therapy, laboratory, pharmacy, and radiology accounted for 38%, 14%, 8%, 7%, and 3%, respectively. Median length of stay was 9 days (range, 6-43), and median Charlson comorbidity index score was 8 (2-16). Patients with ≥1 day in the intensive care unit had significantly higher hospital costs ($46,831 vs $24,601, P < .01). The authors found no significant cost differences with stratification based on previous radiation therapy ($27,598 vs $29,915 with no prior radiation, P = .62) or hospital readmission within 30 days ($29,483 vs $29,609 without readmission, P = .97). CONCLUSION: This is one of few studies in surgery and the first in otolaryngology to analyze hospital costs for a relatively standardized procedure. Further work will include cost analysis from multiple centers with investigation of global cost drivers.

The cost-effectiveness of community-based screening for oral cancer in high-risk males in the United States: a Markov decision analysis approach.

OBJECTIVE: The 2004 US Preventative Services Task Force (USPSTF) guidelines do not recommend routinely screening adults for oral cancer given no proven mortality reduction. A large cluster-randomized controlled screening trial in Kerala, India, in 2005, however, reported a significant reduction in mortality for screened male tobacco and/or alcohol users. In the United States, office-based screening efforts targeting males of high risk (regular use of tobacco and/or alcohol) have been unsuccessful due to poor attendance. Given the newfound screening mortality benefit to this high-risk subpopulation, we sought to ascertain the cost-effectiveness threshold of a yearly, community outreach screening program for males more than 40 years regularly using tobacco and/or alcohol. STUDY DESIGN: Markov decision analysis model; societal perspective. METHODS: A literature search was performed to determine event probabilities, health utilities, and cost parameters to serve as model inputs. Screen versus No-Screen strategies were modeled using assumptions and published data. The primary outcome was the difference in costs and quality-adjusted life-years (QALYs) between the two cohorts, representing the potential budget for a screening program. One-way sensitivity analysis was performed for several key parameters. RESULTS: The No-Screen arm was dominated with an incremental cost of $258 and an incremental effectiveness of -0.0414 QALYs. Using the $75,000/QALY metric, the maximum allowable budget for a screening program equals $3,363 ($258 + $3,105) per screened person over a 40-year time course. CONCLUSION: Given the significant health benefits and financial savings via early detection in the screened cohort, a community-based screening program targeting high-risk males is likely to be cost-effective.

Protecting medical record information: start your research registries today.

OBJECTIVE: The Health Insurance Portability and Accountability Act (HIPAA) of 1996 was enacted with the long-term goal of improving the efficiency and effectiveness of health care. It has created sweeping changes for clinical medicine and research. Generally, the standards for privacy of individual, identifiable health information (the privacy rule) require patient consent before their protected health information (PHI) can be employed in clinical research. This rule requires that all patients sign an IRB approved informed consent before their identifiable clinical information can be aggregated with the information from other patients. This rule has been applied to ensure the privacy of health care data accrued previously. Accordingly, investigators have been blocked from using the aggregate data from prior clinical records and registries until consent is obtained from living, former patients. At the University of Pittsburgh Department of Otolaryngology, a clinical tumor registry was established in 1982. These data have served as the basis for over 200 publications reflecting practice-based learning. The present study quantifies the cost of HIPAA compliance to maintain access to our faculty's career-long clinical activities and to stress to all physicians the importance of research registries as a means of protecting their own career's work. RESULTS/CONCLUSIONS: Compliance with the privacy rule required that written, informed consents be mailed to 14,330 former patients. This resulted in direct costs of more than $30,888. The practical and financial impact of HIPAA on clinical research and our departmental solutions to these challenges are discussed.

Quality of life, functional outcome, and costs of early glottic cancer.

OBJECTIVE: To analyze quality of life, functional outcome, and hidden costs by primary treatment with surgery or radiation therapy in patients with early glottic cancer. STUDY DESIGN: Retrospective study in a tertiary care facility. METHODS: A group of 101 patients with carcinoma in situ and T1 invasive squamous cell carcinoma treated primarily with either surgery or radiation, between January 1990 and December 2000, were identified from searching our tumor registry. Patients completed two previously validated questionnaires and one local questionnaire. Statistical significance was assessed with the rank sum test, chi2 test, or Fisher's Exact test. RESULTS: Questionnaires were completed in 59% (44 of 74) of the surgical cohort and 41% (11 of 27) of the radiation therapy cohort. The primary surgical treatments were endoscopic excision (86%), hemilaryngectomy (12%), and total laryngectomy (1%). Patient-reported problems with swallowing, chewing, speech, taste, saliva, pain, activity, recreation, and appearance showed no difference between the endoscopic excision or radiation therapy cohorts. Comparing endoscopic excision versus radiation therapy, respectively, median number of treatments (2 vs. 35), total median travel distance (150 vs. 660 miles), total median travel time (180 vs. 1440 min), and total median number of hours of work missed (76 vs. 24) all differed significantly (P <.01). CONCLUSIONS: Almost all patients with early glottic cancer, whether treated with surgery or radiation therapy, reported excellent quality of life outcomes and functional results. In addition to actual costs, the hidden costs for radiation therapy versus endoscopic excision were all greater in terms of total number of hours of work missed, total travel time, and total travel distance.