Application of Time-Driven Activity-Based Costing for Head and Neck Microvascular Free Flap Reconstruction.

OBJECTIVE: Traditional hospital accounting fails to provide an accurate cost of complex surgical care. Here we describe the application of time-driven activity-based costing (TDABC) to characterize costs of head and neck oncologic procedures involving free tissue transfer. STUDY DESIGN: Retrospective cohort study. SETTING: Single tertiary academic medical center. METHODS: An analysis of head and neck oncologic procedures involving microvascular free flap reconstruction from 2018 to 2020 (n = 485) was performed using TDABC methodology to measure cost across operative case and postoperative admission, using quantity of time and cost per unit of each resource to characterize resource utilization. Univariate and generalized linear mixed models were used to examine associations between patient and hospital characteristics and cost of care delivery. RESULTS: The total cost of care delivery was $41,905.77 ± 21,870.27 with operating room (OR) supplies accounting for only 10% of the total cost. Multivariable analyses identified significant cost drivers including operative time, postoperative length of stay, number of return trips to the OR, postoperative complication, number of free flaps performed, and patient transfer from another hospital or via emergency department admission (P < .05). CONCLUSION: Operative time and postoperative length of stay, but not operative supplies, were primary drivers of cost of care for head and neck oncology cases involving free tissue transfer. TDABC offers granular cost characterization to inform cost optimization through unused capacity identification and postoperative admission efficiencies.

Inter-hospital Transfer Decision-making During the COVID-19 Pandemic: a Qualitative Study.

BACKGROUND: Inter-hospital patient transfers to hospitals with greater resource availability and expertise may improve clinical outcomes. However, there is little guidance regarding how patient transfer requests should be prioritized when hospital resources become scarce. OBJECTIVE: To understand the experiences of healthcare workers involved in the process of accepting inter-hospital patient transfers during a pandemic surge and determine factors impacting inter-hospital patient transfer decision-making. DESIGN: We conducted a qualitative study consisting of semi-structured interviews between October 2021 and February 2022. PARTICIPANTS: Eligible participants were physicians, nurses, and non-clinician administrators involved in the process of accepting inter-hospital patient transfers. Participants were recruited using maximum variation sampling. APPROACH: Semi-structured interviews were conducted with healthcare workers across Michigan. KEY RESULTS: Twenty-one participants from 15 hospitals were interviewed (45.5% of eligible hospitals). About half (52.4%) of participants were physicians, 38.1% were nurses, and 9.5% were non-clinician administrators. Three domains of themes impacting patient transfer decision-making emerged: decision-maker, patient, and environmental factors. Decision-makers described a lack of guidance for transfer decision-making. Patient factors included severity of illness, predicted chance of survival, need for specialized care, and patient preferences for medical care. Decision-making occurred within the context of environmental factors including scarce resources at accepting and requesting hospitals, organizational changes to transfer processes, and alternatives to patient transfer including use of virtual care. Participants described substantial moral distress related to transfer triaging. CONCLUSIONS: A lack of guidance in transfer processes may result in considerable variation in the patients who are accepted for inter-hospital transfer and in substantial moral distress among decision-makers involved in the transfer process. Our findings identify potential organizational changes to improve the inter-hospital transfer process and alleviate the moral distress experienced by decision-makers.

Characteristics and outcomes associated with anxiety and depression in a head and neck cancer survivorship cohort.

PURPOSE: To assess the prevalence and predictors of mental health disorders (MDHs) among head and neck squamous cell carcinoma (HNSCC) survivors, and the association with health-related quality of life (HRQOL), pain, and survival outcomes. MATERIALS AND METHODS: This was a retrospective, cross-sectional study of HNSCC survivors surveyed at an outpatient oncology clinic from May 2012 through July 2016. RESULTS: Among 198 HNSCC survivors, 21% reported a MHD. Female sex (OR 6.60, 95% CI 2.08 to 20.98; p = 0.001) and Medicare insurance status (OR 4.95, 95% CI 1.52 to 16.11; p = 0.008) were significant predictors of reporting a MHD in the fully adjusted model. Patients reporting a MHD reported significantly worse pain (p < 0001) and worse HRQOL on the PROMIS Physical (p < 0.001), PROMIS Mental (p < 0.001), and FACT-GP (p < 0.026) questionnaires. Diagnosis of a MHD was not correlated with 5-year OS (74% vs. 84%; p = 0.087). CONCLUSION: Initiatives for early identification and intervention of MHDs as part of survivorship initiatives may engender clinically meaningful outcomes in head and neck cancer.

The Value of Diversity, Equity, and Inclusion in Otolaryngology.

Diversity impacts performance of our teams, fosters innovation, and improves outcomes of our patients in otolaryngology head and neck surgery. In addition to the moral imperative, increasing the otolaryngology diversity workforce will decrease health care disparities while equity and justice can increase the culture humility to take care of an increasingly diverse patient population. To move toward justice, otolaryngology departments need to end biases in faculty hiring, development, research evaluations, and publication practices. The more intentional our efforts, the more benefit to our patients, providers, staff, learners, and society.

Development and Assessment of a Model for Predicting Individualized Outcomes in Patients With Oropharyngeal Cancer.

Importance: Recent insights into the biologic characteristics and treatment of oropharyngeal cancer may help inform improvements in prognostic modeling. A bayesian multistate model incorporates sophisticated statistical techniques to provide individualized predictions of survival and recurrence outcomes for patients with newly diagnosed oropharyngeal cancer. Objective: To develop a model for individualized survival, locoregional recurrence, and distant metastasis prognostication for patients with newly diagnosed oropharyngeal cancer, incorporating clinical, oncologic, and imaging data. Design, Setting, and Participants: In this prognostic study, a data set was used comprising 840 patients with newly diagnosed oropharyngeal cancer treated at a National Cancer Institute-designated center between January 2003 and August 2016; analysis was performed between January 2019 and June 2020. Using these data, a bayesian multistate model was developed that can be used to obtain individualized predictions. The prognostic performance of the model was validated using data from 447 patients treated for oropharyngeal cancer at Erasmus Medical Center in the Netherlands. Exposures: Clinical/oncologic factors and imaging biomarkers collected at or before initiation of first-line therapy. Main Outcomes and Measures: Overall survival, locoregional recurrence, and distant metastasis after first-line cancer treatment. Results: Of the 840 patients included in the National Cancer Institute-designated center, 715 (85.1%) were men and 268 (31.9%) were current smokers. The Erasmus Medical Center cohort comprised 300 (67.1%) men, with 350 (78.3%) current smokers. Model predictions for 5-year overall survival demonstrated good discrimination, with area under the curve values of 0.81 for the model with and 0.78 for the model without imaging variables. Application of the model without imaging data in the independent Dutch validation cohort resulted in an area under the curve of 0.75. This model possesses good calibration and stratifies patients well in terms of likely outcomes among many competing events. Conclusions and Relevance: In this prognostic study, a multistate model of oropharyngeal cancer incorporating imaging biomarkers appeared to estimate and discriminate locoregional recurrence from distant metastases. Providing personalized predictions of multiple outcomes increases the information available for patients and clinicians. The web-based application designed in this study may serve as a useful tool for generating predictions and visualizing likely outcomes for a specific patient.

A Pre-Doctoral Clinical Ethics Fellowship for Medical Students.

INTRODUCTION: Despite the need for trained physician ethicists, fellowships in clinical ethics are limited and primarily offered to those who have completed a graduate degree. The standardization of credentialing for clinical ethics consultants (CECs) and the restructuring of undergraduate medical education allow innovative models to train CECs that can provide an expanded opportunity for formal ethics training at an earlier stage. METHODS: At the University of Michigan Medical School we developed, implemented, and evaluated a pre-doctoral clinical ethics fellowship program from 2017 to 2019 for senior medical students, designed to meet established competencies for CECs. Consultation notes from the beginning and end of the fellowship program were randomly selected for each fellow and independently rated by two faculty ethicists who used the validated Ethics Consultation Quality Assessment Tool (ECQAT). Inter rater reliability and trends in scores over time were calculated. RESULTS: Three students successfully completed the fellowship at the University of Michigan Medical School, conducted at least 50 formal ethics consultations, and spent approximately 40 hours a week on service for a minimum of six months. All students finished the fellowship with teaching and policy development experience, first-authored peer-reviewed manuscripts, and national presentations. The fellows demonstrated improvement in their ECQAT overall holistic rating score; all ended their fellowship with a holistic score of adequate or above. There was 92 percent agreement between raters with respect to the acceptability of the fellows' ethics consult notes. Two fellows have taken and passed the Healthcare Ethics Consultant-Certification (HEC-C) exam offered by the American Society for Bioethics and Humanities (ASBH). CONCLUSIONS: Integration of a pre-doctoral fellowship model that meets professional certification standards for clinical ethics consultation creates an opportunity for medical students to become trained CECs early in their career.

Drug shortage management: A qualitative assessment of a collaborative approach.

Drug shortages frequently and persistently affect healthcare institutions, posing formidable financial, logistical, and ethical challenges. Despite plentiful evidence characterizing the impact of drug shortages, there is a remarkable dearth of data describing current shortage management practices. Hospitals within the same state or region may not only take different approaches to shortages but may be unaware of shortages proximate facilities are facing. Our goal is to explore how hospitals in Michigan handle drug shortages to assess potential need for comprehensive drug shortage management resources. We conducted semi-structured interviews with diverse stakeholders throughout the state to describe experiences managing drug shortages, approaches to recent shortages, openness to inter-institutional engagement, ideas for a shared resource, and potential obstacles to implementation. To solicit additional feedback on ideas for a shared resource gathered from the interviews, we held focus groups with pharmacists, physicians, ethicists, and community representatives. Among participants representing a heterogeneous sample of institutions, three themes were consistent: (1) numerous drug shortage strategies occurring simultaneously; (2) inadequate resources and lead time to proactively manage shortages; and (3) interest in, but varied attitudes toward, a collaborative approach. These data provide insight to help develop and test a shared drug shortage management resource for enhancing fair allocation of scarce drugs. A shared resource may help institutions adopt accepted best practices and more efficiently access or share finite resources in times of shortage.

Needs assessment for a decision support tool in oral cancer requiring major resection and reconstruction: a mixed-methods study protocol.

INTRODUCTION: Advanced oral cancer and its ensuing treatment engenders significant morbidity and mortality. Patients are often elderly with significant comorbidities. Toxicities associated with surgical resection can be devastating and they are often highlighted by patients as impactful. Given the potential for suboptimal oncological and functional outcomes in this vulnerable patient population, promotion and performance of shared decision making (SDM) is crucial.Decision aids (DAs) are useful instruments for facilitating the SDM process by presenting patients with up-to-date evidence regarding risks, benefits and the possible postoperative course. Importantly, DAs also help elicit and clarify patient values and preferences. The use of DAs in cancer treatment has been shown to reduce decisional conflict and increase SDM. No DAs for oral cavity cancer have yet been developed.This study endeavours to answer the question: Is there a patient or surgeon driven need for development and implementation of a DA for adult patients considering major surgery for oral cancer? METHODS AND ANALYSIS: This study is the first step in a multiphase investigation of SDM during major head and neck surgery. It is a multi-institutional convergent parallel mixed-methods needs assessment study. Patients and surgeon dyads will be recruited to complete questionnaires related to their perception of the SDM process (nine-item Shared Decision-Making Questionnaire, SDM-Q-9 and SDM-Q-Doc) and to take part in semistructured interviews. Patients will also complete questionnaires examining decisional self-efficacy (Ottawa Decision Self-Efficacy Scale) and decisional conflict (Decisional Conflict Scale). Questionnaires will be completed at time of recruitment and will be used to assess the current level of SDM, self-efficacy and conflict in this setting. Thematic analysis will be used to analyse transcripts of interviews. Quantitative and qualitative components of the study will be integrated through triangulation, with matrix developed to promote visualisation of the data. ETHICS AND DISSEMINATION: This study has been approved by the research ethics boards of the Nova Scotia Health Authority (Halifax, Nova Scotia) and the University Health Network (Toronto, Ontario). Dissemination to clinicians will be through traditional approaches and creation of a head and neck cancer SDM website. Dissemination to patients will include a section within the website, patient advocacy groups and postings within clinical environments.

Disparities and ethical considerations for children with tracheostomies during the COVID-19 pandemic.

The COVID-19 pandemic is exacerbating longstanding challenges facing children with tracheostomies and their families. Myriad ethical concerns arising in the long-term care of children with tracheostomies during the COVID-19 pandemic revolve around inadequate access to care, healthcare resources, and rehabilitation services. Marginalized communities such as those from Black and Hispanic origins face disproportionate chronic illness because of racial and other underlying disparities. In this paper, we describe how these disparities also present challenges to children who are technology-dependent, such as those with tracheostomies and discuss the emerging ethical discourse regarding healthcare and resource access for this population during the pandemic.

Patient-reported financial toxicity and adverse medical consequences in head and neck cancer.

OBJECTIVES: Financial toxicity (FT) is a significant barrier to high-quality cancer care, and patients with head and neck cancer (HNCA) are particularly vulnerable given their need for intensive support, daily radiotherapy (RT), and management of long-term physical, functional, and psychosocial morbidities following treatment. We aim to identify predictors of FT and adverse consequences in HNCA following RT. MATERIALS AND METHODS: We performed a prospective survey study of patients with HNCA seen in follow-up at an academic comprehensive cancer center (CCC) or Veterans Affairs hospital between 05/2016 and 06/2018. Surveys included validated patient-reported functional outcomes and the COST measure, a validated instrument for measuring FT. RESULTS: The response rate was 86% (n = 63). Younger age and lower median household income by county were associated with lower COST scores (i.e., worse FT) on multivariable analysis (p = .045 and p = .016, respectively). Patients with worse FT were more likely to skip clinic visits (RR (95% CI) 2.13 (1.23-3.67), p = .007), be noncompliant with recommended supplements or medications (1.24 (1.03-1.48), p = .02), and require supportive infusions (1.10 (1.02-1.20), p = .02). At the CCC, patients with worse FT were more likely to require feeding tubes (1.62 (1.14-2.31), p = .007). Overall, 36% reported that costs were higher than expected, 48% were worried about paying for treatment, and 33% reported at least a moderate financial burden from treatment. CONCLUSION: HNCA patients experience substantial FT from their diagnosis and/or therapy, with potential implications for medical compliance, QOL, and survivorship care.

How Should We Determine the Value of CAR T-Cell Therapy?

In 2017, the US Food and Drug Administration approved the first chimeric antigen receptor (CAR) T-cell therapies for patients with relapsed or refractory B-cell leukemia and selected B-cell lymphomas. This novel form of cellular immunotherapy creates a "living drug" that effectively reprograms a patient's T cells to target specific antigens on the surface of a tumor. The therapy has high response rates in patients with refractory disease, although a single infusion of CAR T cells costs hundreds of thousands of dollars. A value analysis is required to determine whether and how to offer patients these expensive, customized drugs.

Assessment of Intraoperative Nerve Monitoring Parameters Associated With Facial Nerve Outcome in Parotidectomy for Benign Disease.

Importance: Prior studies suggest that the use of facial nerve monitoring decreases the rate of immediate postoperative facial nerve weakness in parotid surgery, but published data are lacking on normative values for these parameters or cutoff values to prognosticate facial nerve outcomes. Objective: To identify intraoperative facial nerve monitoring parameters associated with postoperative weakness and to evaluate cutoff values for these parameters under which normal nerve function is more likely. Design, Setting, and Participants: This retrospective case series of 222 adult patients undergoing parotid surgery for benign disease performed with intraoperative nerve monitoring was conducted at an academic medical institution from September 13, 2004, to October 30, 2014. The data analysis was conducted from May 2018 to January 2019. Main Outcomes and Measures: The main outcome measure was facial nerve weakness. Receiver operating characteristic curves were generated to define optimal cut point to maximize the sensitivity and specificity of the stimulation threshold, mechanical events, and spasm events associated with facial nerve weakness. Results: Of 222 participants, 121 were women and 101 were men, with a mean (SD) age of 51 (16) years. The rate of temporary facial nerve paresis of any nerve branch was 45%, and the rate of permanent paralysis was 1.3%. The mean predissection threshold was 0.22 milliamperes (mA) (range, 0.1-0.6 mA) and the mean postdissection threshold was 0.24 mA (range, 0.08-1.0 mA). The average number of mechanical events was 9 (range, 0-66), and mean number of spontaneous spasm events was 1 (range, 0-12). Both the postdissection threshold (area under the curve [AUC], 0.69; 95% CI, 0.62-0.77) and the number of mechanical events (AUC, 0.58; 95% CI, 0.50-0.66) were associated with early postoperative facial nerve outcome. The number of spasm events was not associated with facial nerve outcome. The optimal cutoff value for the threshold was 0.25 mA, and the optimal cutoff for number of mechanical events was 8. If a threshold of greater than 0.25 mA was paired with more than 8 mechanical events, there was a 77% chance of postoperative nerve weakness. Conversely, if a threshold was 0.25 mA or less and there were 8 mechanical events or less, there was 69% chance of normal postoperative nerve function. No parameters were associated with permanent facial nerve injury. Conclusions and Relevance: Postdissection threshold and the number of mechanical events are associated with immediate postoperative facial nerve function. Accurate prediction of facial nerve function may provide anticipatory guidance to patients and may provide surgeons with intraoperative feedback allowing adjustment in operative techniques and perioperative management.

Biospecimens, Research Consent, and Distinguishing Cell Line Research.

Newly revised regulations for human research affecting translational oncology will become effective in January 2019. A substantial component of the debate leading to this revision was how to regulate biospecimen research; specifically, whether all biospecimens should be considered inherently "identifiable," thereby necessitating informed consent for use in research. The famous cases seminal to this discussion involve cancer cell lines, but the unique features of this kind of biospecimen research were largely missing from the regulatory deliberation. However, special aspects of cell line research-at the stages of procurement, generation, evolution, and sharing-alter how society should balance participant interests against the goals of research. Recommendations are offered to cancer researchers and policymakers going forward to enable ethically appropriate regulation of biospecimen research across its diverse spectrum.

Implementation of an Intramural Competitive Resident Research Grant.

Experience with procurement of research funding and grantsmanship is an essential skill and one that is rarely taught in a manner that adequately prepares trainees for the magnitude of this professional requirement. The aims of the program described in this article are (1) to provide a mentored experience in grantsmanship through designing and concisely outlining an individual research study and (2) to supplement extramural funding mechanisms for clinical trainees to produce meaningful and substantive clinical and/or basic science research. A total of $10,000 of departmental chair discretionary funds is allocated for resident research annually. The first 2 cycles have successfully allocated the allotted funding through a competitive, scored grant evaluation process. Awardees have already produced meaningful data that have been nationally presented, submitted for publication, and integrated into an National Institutes of Health grant submission. The feasibility of implementing an intramural competitive resident research grant may have broad application within varied training environments.

Comprehensive Hearing Aid Intervention at a Free Subspecialty Clinic.

Importance: Providing a model of a comprehensive free audiologic program may assist other health care professionals in developing their own similar program. Objective: To describe the structure, feasibility, and outcomes of a free subspecialty clinic providing hearing aids to develop a paradigm for other programs interested in implementing similar projects. Design, Setting, and Participants: A retrospective case series was conducted from September 1, 2013, through March 31, 2016. In a partnership between a free independent clinic for indigent patients and an academic medical center, 54 indigent patients were referred to the clinic for audiograms. A total of 50 of these patients had results of audiograms available for review and were therefore included in the study; 34 of these 50 patients were determined to be eligible for hearing aid fitting based on audiometric results. Exposures: Free audiometric testing, hearing aid fitting, and hearing aid donation. Main Outcomes and Measures: The number of hearing aids donated, number of eligible patients identified, number of patients fitted with hearing aids, and work effort (hours) and start-up costs associated with implementation of this program were quantified. Results: A total of 54 patients (31 women [57.4%] and 23 men [42.6%]; median age, 61 years; range, 33-85 years) had audiograms performed, and 84 hearing aids were donated to the program. The patients were provided with free audiograms, hearing aid molds, and hearing aid programming, as well as follow-up appointments to ensure continued proper functioning of their hearing aids. Since 2013, a total of 34 patients have been determined to be eligible for the free program and were offered hearing aid services. Of these, 20 patients (59%) have been fitted or are being fitted with free hearing aids. The value of services provided is estimated to be $2260 per patient. Conclusions and Relevance: It is feasible to provide free, comprehensive audiologic care, including hearing aids and fitting, in a well-established, free clinic model. The opportunity for indigent patients to use hearing aids at minimal personal cost is a major step forward in improving access to high-quality care.

Accuracy of administrative and clinical registry data in reporting postoperative complications after surgery for oral cavity squamous cell carcinoma.

BACKGROUND: The purpose of this study was to describe and compare how postoperative complications after oral cavity squamous cell carcinoma (SCC) surgery are reported in medical records, institutional billing claims, and national clinical registries. METHODS: The medical records of 355 previously untreated patients who underwent surgery for oral cavity SCC at our institution were retrospectively reviewed for postoperative complications. Information was compared with claims and National Surgical Quality Improvement Program (NSQIP) data. RESULTS: We identified 219 patients (62%) experiencing 544 complications (10% major). Billing claims identified 29% of these patients, 36% of overall complications, and 98% of major complications. Of overlapping patients, NSQIP identified 27% of patients, 33% of overall complications, and 100% of major complications noted on chart abstraction. CONCLUSION: The incidence of minor postoperative complications after oral cavity SCC surgery is relatively high. Both claims data and NSQIP accurately recorded major complications, but were suboptimal compared to chart abstraction in capturing minor complications.

Patching the safety net: establishing a free specialty care clinic in an academic medical center.

We describe the collaboration between an academic medical center and a free primary care clinic that provides multi-specialty services to indigent community members. Complementary components of both institutions have engendered a system in which they broaden the array of available services, providing a prototype for other institutions to collaborate similarly.