THE STATISTICAL PROPERTIES OF DIMENSION CALCULATIONS USING SMALL DATA SETS: SOME ECONOMIC APPLICATIONS

economic theory ; statistics

Treatment of Older Patients With Head and Neck Cancer: A Review

The incidence of head and neck cancer (HNC) in the elderly is increasing. The treatment of HNC often includes multimodality therapy that can be quite morbid. Older patients (herein, defined as ≥65 years) with HNC often have significant comorbidity and impaired functional status that may hinder their ability to receive and tolerate combined modality therapy. They have often been excluded from clinical trials that have defined standards of care. Therefore, tailoring cancer therapy for older patients with HNC can be quite challenging. In this paper, we performed a comprehensive literature review to better understand and discuss issues related to therapeutic recommendations that are particular to patients 65 years and older. Evidence suggests that older patients have similar survival outcomes compared with their younger peers; however, they may experience worse toxicity, especially with treatment intensification. Similarly, older patients may require more supportive care throughout the treatment process. Future studies incorporating geriatric tools for predictive and interventional purposes will potentially allow for improved patient selection and tolerance to intensive treatment

Toward a better understanding of task demands, workload, and performance during physician-computer interactions

OBJECTIVE: To assess the relationship between (1) task demands and workload, (2) task demands and performance, and (3) workload and performance, all during physician-computer interactions in a simulated environment. METHODS: Two experiments were performed in 2 different electronic medical record (EMR) environments: WebCIS (n = 12) and Epic (n = 17). Each participant was instructed to complete a set of prespecified tasks on 3 routine clinical EMR-based scenarios: urinary tract infection (UTI), pneumonia (PN), and heart failure (HF). Task demands were quantified using behavioral responses (click and time analysis). At the end of each scenario, subjective workload was measured using the NASA-Task-Load Index (NASA-TLX). Physiological workload was measured using pupillary dilation and electroencephalography (EEG) data collected throughout the scenarios. Performance was quantified based on the maximum severity of omission errors. RESULTS: Data analysis indicated that the PN and HF scenarios were significantly more demanding than the UTI scenario for participants using WebCIS (P < .01), and that the PN scenario was significantly more demanding than the UTI and HF scenarios for participants using Epic (P < .01). In both experiments, the regression analysis indicated a significant relationship only between task demands and performance (P < .01). DISCUSSION: Results suggest that task demands as experienced by participants are related to participants' performance. Future work may support the notion that task demands could be used as a quality metric that is likely representative of performance, and perhaps patient outcomes. CONCLUSION: The present study is a reasonable next step in a systematic assessment of how task demands and workload are related to performance in EMR-evolving environments

Comparison of Patient- and Practitioner-Reported Toxic Effects Associated With Chemoradiotherapy for Head and Neck Cancer

Agreement between patient- and practitioner-reported toxic effects during chemoradiotherapy for head and neck cancer is unknown. To compare patient-reported symptom severity and practitioner-reported toxic effects among patients receiving chemoradiotherapy for head and neck cancer. Forty-four patients participating in a phase 2 trial of deintensified chemoradiotherapy for oropharyngeal carcinoma were included in the present study (conducted from February 8, 2012, to March 2, 2015). Most treatment (radiotherapy, 60 Gy, with concurrent weekly administration of cisplatin, 30 mg/m2) was administered at academic medical centers. Included patients had no prior head and neck cancers, were 18 years or older, and had a smoking history of 10 pack-years or less or more than 10 pack-years but 30 pack-years or less and abstinent for the past 5 years. Cancer status was untreated human papillomavirus or p16-positive squamous cell carcinoma of the oropharynx or unknown head and neck primary site; and cancer staging was category T0 to T3, category N0 to N2c, M0, and Eastern Cooperative Oncology Group performance status 0 to 1. Baseline, weekly, and posttreatment toxic effects were assessed by physicians or nurse practitioners using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 4.0. Patient-reported symptom severity was measured using the Patient-Reported Outcomes version of the CTCAE (PRO-CTCAE). Descriptive statistics were used to characterize raw agreement between CTCAE grades and PRO-CTCAE severity ratings. Baseline, weekly, and posttreatment toxic effects assessed using CTCAE, version 4.0, and PRO-CTCAE. Raw agreement indices between patient-reported toxic effects, including symptom frequency, severity, and interference with daily activities (score range, 0 [none] to 4 [very severe]), and practitioner-measured toxic effects, including swallowing, oral pain, and hoarseness (score range, 1 [mild] to 5 [death]). Of the 44 patients included in the analysis (39 men, 5 women; mean [SD] age, 61 [8.4] years), there were 327 analyzable pairs of CTCAE and PRO-CTCAE symptom surveys and no treatment delays due to toxic effects. Patient-reported and practitioner-reported symptom severity agreement was high at baseline when most symptoms were absent but declined throughout treatment as toxic effects increased. Most disagreement was due to lower severity of toxic effects reported by practitioners (eg, from 45% agreement at baseline to 27% at the final week of treatment for pain). This was particularly noted for domains that are not easily evaluated by physical examination, such as anxiety and fatigue (eg, severity of fatigue decreased from 43% at baseline to 12% in the final week of treatment). Practitioner-reported toxic effects are lower than patient self-reports during head and neck chemoradiotherapy. The inclusion of patient-reported symptomatic toxic effects provides information that can potentially enhance clinical management and improve data quality in clinical trials

Improving Patient Safety in Clinical Oncology: Applying Lessons From Normal Accident Theory

Concerns for patient safety persist in clinical oncology. Within several nonmedical areas (eg, aviation, nuclear power), concepts from Normal Accident Theory (NAT), a framework for analyzing failure potential within and between systems, have been successfully applied to better understand system performance and improve system safety. Clinical oncology practice is interprofessional and interdisciplinary, and our therapies often have narrow therapeutic windows. Thus, many of our processes are, in NAT terms, interactively complex and tightly coupled within and across systems and are therefore prone to unexpected behaviors that can result in substantial patient harm. To improve safety at the University of North Carolina, we have applied the concepts of NAT to our practice to better understand our systems' behavior and adopted strategies to reduce complexity and coupling. Furthermore, recognizing that we cannot eliminate all risks, we have stressed safety mindfulness among our staff to further promote safety. Many specific examples are provided herein. The lessons from NAT are translatable to clinical oncology and may help to promote safety

Geriatric Assessment as a Predictor of Tolerance, Quality of Life, and Outcomes in Older Patients With Head and Neck Cancers and Lung Cancers Receiving Radiation Therapy

Purpose To evaluate the association between functional status based on a geriatric assessment (GA) and outcomes of tolerance to treatment in patients with lung or head and neck cancer receiving radiation therapy (RT) or chemoradiation (CRT). Methods and Materials A prospective cohort study was conducted in patients aged ≥65 years with head and neck cancer or lung cancer undergoing curative intent RT or CRT. Pretreatment GA, health-related quality of life (HRQoL), and patient-reported outcomes (PRO) were obtained. Questionnaires were repeated biweekly during RT and at 6 weeks after treatment. Dysfunction was defined as scores 3-day treatment delay, change in RT or CRT regimen, or death. Associations of dysfunction with tolerance to radiation therapy, HRQoL changes, and PRO ratings were evaluated. Results Of the 50 patients accrued, 46 had evaluable data. Mean age was 72.5 years (range, 65-92 years). At baseline, 37% had dysfunction. Poor tolerance to RT or CRT occurred in 39%. There was no association between dysfunction and tolerance. Patients with dysfunction had lower baseline HRQoL scores. From baseline to end of RT, those with baseline dysfunction had less of a decline in Role Functioning (P=.01) and Global Health Score (P=.04) domains. However, from end of RT to 6-week follow-up, those with dysfunction were more likely to continue to drop in the Physical, Role Functioning, and Social domains (all P<.01). Dysfunction at baseline was also associated with higher severity of certain PROs. Conclusions Pretreatment dysfunction was associated with continued decline and lack of recovery of HRQoL in this patient population. Larger studies could further elucidate the GA's predictive value

Recommended Patient-Reported Core Set of Symptoms to Measure in Head and Neck Cancer Treatment Trials

We identified a standard core set of patient-reported symptoms and health-related quality-of-life (HRQOL) domains to be assessed in head and neck (H&N) cancer clinical trials. The core symptom and HRQOL domain scores were used to guide recommendations by a working group of experts as part of a National Cancer Institute Symptom Management and HRQOL Clinical Trials Planning Meeting. A PubMed search was conducted using the search terms of “health-related quality of life” and “head & neck cancer,” limited to publications from January 1, 2000, to December 31, 2010. Fifty-four articles were used to guide the choice of recommendations. Twenty-nine symptoms and nine domains were identified, from which 12 H&N-specific core symptoms and HRQOL domains were recommended: swallowing, oral pain, skin changes, dry mouth, dental health, opening mouth/trismus, taste, excess/thick mucous/saliva, shoulder disability/motion, voice/hoarseness, social domain, and functional domain. This core set of 12 H&N-specific, patient-reported symptoms and HRQOL domains should be assessed in future H&N cancer clinical trials

Use of mobile device technology to continuously collect patient-reported symptoms during radiation therapy for head and neck cancer: A prospective feasibility study

AbstractPurposeAccurate assessment of toxicity allows for timely delivery of supportive measures during radiation therapy for head and neck cancer. The current paradigm requires weekly evaluation of patients by a provider. The purpose of this study is to evaluate the feasibility of monitoring patient reported symptoms via mobile devices.Methods and materialsWe developed a mobile application for patients to report symptoms in 5 domains using validated questions. Patients were asked to report symptoms using a mobile device once daily during treatment or more often as needed. Clinicians reviewed patient-reported symptoms during weekly symptom management visits and patients completed surveys regarding perceptions of the utility of the mobile application. The primary outcome measure was patient compliance with mobile device reporting. Compliance is defined as number of days with a symptom report divided by number of days on study.ResultsThere were 921 symptom reports collected from 22 patients during treatment. Median reporting compliance was 71% (interquartile range, 45%-80%). Median number of reports submitted per patient was 34 (interquartile range, 21-53). Median number of reports submitted by patients per week was similar throughout radiation therapy and there was significant reporting during nonclinic hours. Patients reported high satisfaction with the use of mobile devices to report symptoms.ConclusionsA substantial percentage of patients used mobile devices to continuously report symptoms throughout a course of radiation therapy for head and neck cancer. Future studies should evaluate the impact of mobile device symptom reporting on improving patient outcomes

PIK3CA mutation in HPV-associated OPSCC patients receiving deintensified chemoradiation

PIK3CA is the most frequently mutated gene in human papillomavirus (HPV)-associated oropharyngeal squamous cell carcinoma (OPSCC). Prognostic implications of such mutations remain unknown. We sought to elucidate the clinical significance of PIK3CA mutations in HPV-associated OPSCC patients treated with definitive chemoradiation (CRT). Seventyseven patients with HPV-associated OPSCC were enrolled on two phase II clinical trials of deintensified CRT (60 Gy intensitymodulated radiotherapy with concurrent weekly cisplatin). Targeted next-generation sequencing was performed. Of the 77 patients, nine had disease recurrence (two regional, four distant, three regional and distant). Thirty-four patients had mutation( s) identified; 16 had PIK3CA mutations. Patients with wild-type-PIK3CA had statistically significantly higher 3-year disease-free survival than PIK3CA-mutant patients (93.4%, 95% confidence interval [CI] = 85.0% to 99.9% vs 68.8%, 95% CI = 26.7% to 89.8%; P=.004). On multivariate analysis, PIK3CA mutation was the only variable statistically significantly associated with disease recurrence (hazard ratio = 5.71, 95% CI = 1.53 to 21.3; P=.01). PIK3CA mutation is associated with worse diseasefree survival in a prospective cohort of newly diagnosed HPV-associated OPSCC patients treated with deintensified CRT