Probe-based fluorescence dosimetry of an antibody-dye conjugate to identify head and neck cancer as a first step to fluorescence-guided tissue preselection for pathological assessment.

BACKGROUND: Despite the rapid growth of fluorescence imaging, accurate sampling of tissue sections remains challenging. Development of novel technologies to improve intraoperative assessment of tissue is needed. METHODS: A novel contact probe-based fluorescence dosimeter device, optimized for IRDye800CW quantification, was developed. After evaluation of the device in a phantom setup, its clinical value was defined ex vivo in patients with head and neck squamous cell carcinoma who received panitumumab-IRDye800CW. RESULTS: Ten patients were enrolled with a total of 216 data points obtained. Final histopathology showed tumor in 119 spots and normal tissue in 97 spots. Fluorescence-to-excitation ratios in tumor tissue were more than three times higher than those in normal tissue. The area under the curve was 0.86 (95% CI: 0.81-0.91) for tumor detection. CONCLUSIONS: Fluorescence-guided tissue preselection using a fluorescence dosimeter could have substantial impact on tissue sampling for frozen section analysis and potentially reduce sampling errors.

End-of-Life Costs and Hospice Utilization in Patients with Head and Neck Cancer.

The Quality Oncology Practice Initiative has several metrics related to end-of life (EOL) care, including hospice enrollment ≤3 days, with lower scores signaling better performance. Of privately insured patients with head and neck cancer, 3.5% were enrolled in hospice prior to death and 21.3% spent ≤3 days in hospice, indicating aggressive EOL care. Patients with late hospice enrollment had higher spending in the last 30 days of life (DOL). Patients in hospice ≤3 days spent $37,426, while those in hospice >3 days spent $24,418 (P = .002). The largest portion of this difference was attributable to inpatient services. Patients in hospice ≤3 days spent $22,089 on inpatient services in the last 30 DOL, while those in hospice >3 days spent $8361 (P < .001). Further research is needed to determine if more high-value care can be provided with earlier hospice enrollment and to ensure that goal concordance is included in defining high-value care.

Cost-effectiveness of ibrutinib as first-line therapy for chronic lymphocytic leukemia in older adults without deletion 17p.

Ibrutinib is a novel oral therapy that has shown significant efficacy as initial treatment of chronic lymphocytic leukemia (CLL). It is a high-cost continuous therapy differing from other regimens that are given for much shorter courses. Our objective was to evaluate the cost-effectiveness of ibrutinib for first-line treatment of CLL in patients older than age 65 years without a 17p deletion. We developed a semi-Markov model to analyze the cost-effectiveness of ibrutinib vs a comparator therapy from a US Medicare perspective. No direct comparison between ibrutinib and the best available treatment alternative, obinutuzumab plus chlorambucil (chemoimmunotherapy), exists. Therefore, we compared ibrutinib to a theoretical treatment alternative, which was modeled to confer the effectiveness of an inferior treatment (chlorambucil alone) and the costs and adverse events of chemoimmunotherapy, which would provide ibrutinib with the best chance of being cost-effective. Even so, the incremental cost-effectiveness ratio of ibrutinib vs the modeled comparator was $189 000 per quality-adjusted life-year (QALY) gained. To reach a willingness-to-pay threshold (WTP) of $150 000 per QALY, the monthly cost of ibrutinib would have to be at most $6800, $1700 less than the modeled cost of $8500 per month (a reduction of $20 400 per year). When the comparator efficacy is increased to more closely match that seen in trials evaluating chemoimmunotherapy, ibrutinib costs more than $262 000 per QALY gained, and the monthly cost of ibrutinib would need to be lowered to less than $5000 per month to be cost-effective. Ibrutinib is not cost-effective as initial therapy at a WTP threshold of $150 000 per QALY gained.

Predictors of readmissions after head and neck cancer surgery: A national perspective.

OBJECTIVES: Surgical oncology patients have multiple comorbidities and are at high risk of readmission. Prior studies are limited in their ability to capture readmissions outside of the index hospital that performed the surgery. Our goal is to evaluate risk factors for readmission for head and neck cancer patients on a national scale. MATERIAL AND METHODS: A retrospective cohort study of head and neck cancer patients in the Nationwide Readmissions Database (2013). Our main outcome was 30-day readmission. Statistical analysis included 2-sided t tests, χ2, and multivariate logistic regression analysis. RESULTS: Within 30days, 16.1% of 11,832 patients were readmitted and 20% of readmissions were at non-index hospitals, costing $31million. Hypopharyngeal cancer patients had the highest readmission rate (29.6%), followed by laryngeal (21.8%), oropharyngeal (18.2%), and oral cavity (11.6%) cancers (P<0.001). Half of readmissions occurred within 10days and were often associated with infections (27%) or wound complications (12%). Patients from lower household income areas were more likely to be readmitted (odds ratio [OR], 1.54; 95% confidence interval [CI], 1.16-2.05). Patients with valvular disease (OR, 2.07; 95% CI, 1.16-3.69), rheumatoid arthritis/collagen vascular disease (OR, 2.05; 95% CI, 1.27-3.31), liver disease (OR, 2.02, 95% CI, 1.37-2.99), and hypothyroidism (OR 1.30; 95% CI, 1.02-1.66) were at highest risk of readmission. CONCLUSION: The true rate of 30-day readmissions after head and neck cancer surgery is 16%, capturing non-index hospital readmissions which make up 20% of readmissions. Readmissions after head and neck cancer surgery are most commonly associated with infections and wound complications.

Improving Care With a Portfolio of Physician-Led Cancer Quality Measures at an Academic Center.

PURPOSE: Development and implementation of robust reporting processes to systematically provide quality data to care teams in a timely manner is challenging. National cancer quality measures are useful, but the manual data collection required is resource intensive, and reporting is delayed. We designed a largely automated measurement system with our multidisciplinary cancer care programs (CCPs) to identify, measure, and improve quality metrics that were meaningful to the care teams and their patients. METHODS: Each CCP physician leader collaborated with the cancer quality team to identify metrics, abiding by established guiding principles. Financial incentive was provided to the CCPs if performance at the end of the study period met predetermined targets. Reports were developed and provided to the CCP physician leaders on a monthly or quarterly basis, for dissemination to their CCP teams. RESULTS: A total of 15 distinct quality measures were collected in depth for the first time at this cancer center. Metrics spanned the patient care continuum, from diagnosis through end of life or survivorship care. All metrics improved over the study period, met their targets, and earned a financial incentive for their CCP. CONCLUSION: Our quality program had three essential elements that led to its success: (1) engaging physicians in choosing the quality measures and prespecifying goals, (2) using automated extraction methods for rapid and timely feedback on improvement and progress toward achieving goals, and (3) offering a financial team-based incentive if prespecified goals were met.

Quality Measures in Breast Reconstruction: A Systematic Review.

BACKGROUND: The importance of providing quality care over quantity of care, and its positive effects on health care expenditure and health, has motivated a transition toward value-based payments. The Centers for Medicare and Medicaid Services and private payers are establishing programs linking financial incentives and penalties to adherence to quality measures. As payment models based on quality measures are transitioned into practice, it is beneficial to identify current quality measures that address breast reconstruction surgery as well as understand gaps to inform future quality measure development. METHODS: We performed a systematic review of quality measures for breast reconstruction surgery by searching quality measure databases, professional society clinical practice guidelines, and the literature. Measures were categorized as structure, process, or outcome according to the Donabedian domains of quality. RESULTS: We identified a total of 27 measures applicable to breast reconstruction: 5 candidate quality measures specifically for breast reconstruction surgery and 22 quality measures that relate broadly to surgery. Of the breast reconstruction candidate measures, 3 addressed processes and 2 addressed outcomes. Seventeen of the general quality measures were process measures and 5 were outcome measures. We did not identify any structural measures. CONCLUSIONS: Currently, an overrepresentation of process measures exists, which addresses breast reconstruction surgery. There is a limited number of candidate measures that specifically address breast reconstruction. Quality measure development efforts on underrepresented domains, such as structure and outcome, and stewarding the measure development process for candidate quality measures can ensure breast reconstruction surgery is appropriately evaluated in value-based payment models.

Geographic variation in Medicare treatment costs and outcomes for advanced head and neck cancer.

BACKGROUND: Advanced head and neck cancer (HNC) is a complex group of diseases that requires the input and coordination of multiple providers. While there are general guidelines for treatment, there is also considerable variation in how patients are treated, and how long they survive after treatment. It is unclear how the treatment variations relate to treatment costs and survival. METHODS: We identified 3678 Medicare patients with advanced HNC treated in 12 US regions between 2004 and 2009 using the linked database containing Medicare and Surveillance Epidemiology and End Results (SEER) data. We calculated average cost per patient during the period three months before to 12months after diagnosis for each region. Costs included inpatient hospital, outpatient, physician, and durable medical equipment charges. We also calculated three-year overall survival for each of the regions. RESULTS: The mean cost-per-patient varied substantially among the regions, ranging from $51,857 for Utah to $82,181 for Detroit. Utah incurred the lowest total costs within one year of advanced HNC diagnosis ($51,857 per patient, 95% CI $42,285-$61,429), whereas Detroit had the highest costs ($82,181 per patient, 95% CI $74,752-$89,610). Overall survival also varied among the regions, ranging from 45months in Kentucky to 58months in Washington. There was little correlation between expenditures and length of survival, with correlation coefficient of 0.0088. CONCLUSION: Despite significant variation in both expenditures and survival among the regions, we found no correlation between costs and mean survival time, suggesting that more costly care did not lead to improved outcomes.

Third party assessment of resection margin status in head and neck cancer.

BACKGROUND: Definitive assessment of primary site margin status following resection of head and neck cancer is necessary for prognostication, treatment determination and qualification for clinical trials. This retrospective analysis determined how often an independent reviewer can assess primary tumor margin status of head and neck cancer resections based on review of the pathology report, surgical operative report, and first follow-up note alone. METHODS: We extracted from the electronic medical record pathology reports, operative reports, and follow-up notes from head and neck cancer resections performed at Stanford Hospital. We classified margin status as definitive or not. We labeled any pathology report clearly indicating a positive, negative, or close (<5mm) margin as definitive. For each non-definitive pathology report, we reviewed the operative report and then the first follow-up note in an attempt to clarify margin status. We also looked for associations between non-definitive status and surgeon, year, and primary site. RESULTS: 743 unique cases of head and neck cancer resection were extracted. We discarded 255 as non-head and neck cancer cases, or cases that did not involve a definitive resection of a primary tumor site. We could not definitively establish margin status in 20% of resections by independent review of the medical record. There was no correlation between margin determination and surgeon, site, or year of surgery. CONCLUSION: A substantial fraction (20%) of primary site surgical margins could not be definitively determined via independent EMR review. This could have implications for subsequent patient care decisions and clinical trial options.

Consultation via telemedicine and access to operative care for patients with head and neck cancer in a Veterans Health Administration population.

BACKGROUND: The purpose of this study was to evaluate a telemedicine model that utilizes an audiovisual teleconference as a preoperative visit. METHODS: Veterans Health Administration (VHA) patients with head and neck cancer at 2 remote locations were provided access to the Palo Alto Veterans Affairs (PAVA) Health Care System otolaryngology department via the telemedicine protocol: tissue diagnosis and imaging at the patient site; data review at PAVA; and a preoperative teleconference connecting the patient to PAVA. Operative care occurred at PAVA. Follow-up care was provided remotely via teleconference. RESULTS: Fifteen patients were evaluated. Eleven underwent surgery, 4 with high-grade neoplasms (carcinoma). Average time from referral to operation was 28 days (range, 17-36 days) and 72 (range, 31-108 days), respectively, for high-grade and low-grade groups. The average patient was spared 28 hours traveling time and $900/patient was saved on travel-related costs. CONCLUSION: A telemedicine model enables timely access to surgical care and permits considerable savings among select VHA patients with head and neck cancer. © 2016 Wiley Periodicals, Inc. Head Neck 38: 925-929, 2016.

A prospective study of electronic quality of life assessment using tablet devices during and after treatment of head and neck cancers.

OBJECTIVES: Electronic data collection is increasingly used for quality of life (QOL) assessments in the field of oncology. It is important to assess the feasibility of these new data capture technologies. MATERIALS AND METHODS: Patients at our institution who were 18 years or older with a pathological diagnosis of head and neck cancer were prospectively enrolled. Each patient completed two questionnaires [EORTC-QLQ-C30 and EORTC-QLQ-H&N35] administered on a touch-screen tablet device (iPad) at initial consult, during treatment, at the completion of treatment and at each subsequent follow up visit for one year after treatment. RESULTS: A total of 50 patients were included in this study. Although all patients completed the surveys at the initial consult, 86% of initially enrolled patients completed surveys at the end of radiation treatment, and 48% of initially enrolled patients completed surveys by the fourth follow-up visit. Average time to complete the survey for all patients over all time points was 9.8 min (standard deviation 6.1). Age as a continuous variable was significantly associated with time for survey completion (p<0.001), with older age associated with longer survey completion times. CONCLUSION: QOL assessment using tablet devices in head and neck cancer patients is feasible, but may be more challenging in elderly patients. Patients ⩾70 years old may benefit from more assistance with electronic forms and should be allotted more time for completing tablet-based QOL surveys.