Clinical Decision Support Systems in Otolaryngology-Head and Neck Surgery: A State of the Art Review.

OBJECTIVE: To offer practical, evidence-informed knowledge on clinical decision support systems (CDSSs) and their utility in improving care and reducing costs in otolaryngology-head and neck surgery. This primer on CDSSs introduces clinicians to both the capabilities and the limitations of this technology, reviews the literature on current state, and seeks to spur further progress in this area. DATA SOURCES: PubMed/MEDLINE, Embase, and Web of Science. REVIEW METHODS: Scoping review of CDSS literature applicable to otolaryngology clinical practice. Investigators identified articles that incorporated knowledge-based computerized CDSSs to aid clinicians in decision making and workflow. Data extraction included level of evidence, Osheroff classification of CDSS intervention type, otolaryngology subspecialty or domain, and impact on provider performance or patient outcomes. CONCLUSIONS: Of 3191 studies retrieved, 11 articles met formal inclusion criteria. CDSS interventions included guideline or protocols support (n = 8), forms and templates (n = 5), data presentation aids (n = 2), and reactive alerts, reference information, or order sets (all n = 1); 4 studies had multiple interventions. CDSS studies demonstrated effectiveness across diverse domains, including antibiotic stewardship, cancer survivorship, guideline adherence, data capture, cost reduction, and workflow. Implementing CDSSs often involved collaboration with health information technologists. IMPLICATIONS FOR PRACTICE: While the published literature on CDSSs in otolaryngology is finite, CDSS interventions are proliferating in clinical practice, with roles in preventing medical errors, streamlining workflows, and improving adherence to best practices for head and neck disorders. Clinicians may collaborate with information technologists and health systems scientists to develop, implement, and investigate the impact of CDSSs in otolaryngology.

Does Quitting Smoking Make a Difference Among Newly Diagnosed Head and Neck Cancer Patients?

INTRODUCTION: To determine if smoking after a cancer diagnosis makes a difference in mortality among newly diagnosed head and neck cancer patients. METHODS: Longitudinal data were collected from newly diagnosed head and neck cancer patients with a median follow-up time of 1627 days (N = 590). Mortality was censored at 8 years or September 1, 2011, whichever came first. Based on smoking status, all patients were categorized into four groups: continuing smokers, quitters, former smokers, or never-smokers. A broad range of covariates were included in the analyses. Kaplan-Meier curves, bivariate and multivariate Cox proportional hazards models were constructed. RESULTS: Eight-year overall mortality and cancer-specific mortality were 40.5% (239/590) and 25.4% (150/590), respectively. Smoking status after a cancer diagnosis predicted overall mortality and cancer-specific mortality. Compared to never-smokers, continuing smokers had the highest hazard ratio (HR) of dying from all causes (HR = 2.71, 95% confidence interval [CI] = 1.48-4.98). Those who smoked at diagnosis, but quit and did not relapse-quitters-had an improved hazard ratio of dying (HR = 2.38, 95% CI = 1.29-4.36) and former smokers at diagnosis with no relapse after diagnosis-former smokers-had the lowest hazard ratio of dying from all causes (HR = 1.68, 95% CI = 1.12-2.56). Similarly, quitters had a slightly higher hazard ratio of dying from cancer-specific reasons (HR = 2.38, 95% CI = 1.13-5.01) than never-smokers, which was similar to current smokers (HR = 2.07, 95% CI = 0.96-4.47), followed by former smokers (HR = 1.70, 95% CI = 1.00-2.89). CONCLUSIONS: Compared to never-smokers, continuing smokers have the highest HR of overall mortality followed by quitters and former smokers, which indicates that smoking cessation, even after a cancer diagnosis, may improve overall mortality among newly diagnosed head and neck cancer patients. Health care providers should consider incorporating smoking cessation interventions into standard cancer treatment to improve survival among this population. IMPLICATIONS: Using prospective observational longitudinal data from 590 head and neck cancer patients, this study showed that continuing smokers have the highest overall mortality relative to never-smokers, which indicates that smoking cessation, even after a cancer diagnosis, may have beneficial effects on long-term overall mortality. Health care providers should consider incorporating smoking cessation interventions into standard cancer treatment to improve survival among this population.

Socioeconomic and Other Demographic Disparities Predicting Survival among Head and Neck Cancer Patients.

BACKGROUND: The Institute of Medicine (IOM) report, "Unequal Treatment," which defines disparities as racially based, indicates that disparities in cancer diagnosis and treatment are less clear. While a number of studies have acknowledged cancer disparities, they have limitations of retrospective nature, small sample sizes, inability to control for covariates, and measurement errors. OBJECTIVE: The purpose of this study was to examine disparities as predictors of survival among newly diagnosed head and neck cancer patients recruited from 3 hospitals in Michigan, USA, while controlling for a number of covariates (health behaviors, medical comorbidities, and treatment modality). METHODS: Longitudinal data were collected from newly diagnosed head and neck cancer patients (N = 634). The independent variables were median household income, education, race, age, sex, and marital status. The outcome variables were overall, cancer-specific, and disease-free survival censored at 5 years. Kaplan-Meier curves and univariate and multivariate Cox proportional hazards models were performed to examine demographic disparities in relation to survival. RESULTS: Five-year overall, cancer-specific, and disease-free survival were 65.4% (407/622), 76.4% (487/622), and 67.0% (427/622), respectively. Lower income (HR, 1.5; 95% CI, 1.1-2.0 for overall survival; HR, 1.4; 95% CI, 1.0-1.9 for cancer-specific survival), high school education or less (HR, 1.4; 95% CI, 1.1-1.9 for overall survival; HR, 1.4; 95% CI, 1.1-1.9 for cancer-specific survival), and older age in decades (HR, 1.4; 95% CI, 1.2-1.7 for overall survival; HR, 1.2; 95% CI, 1.1-1.4 for cancer-specific survival) decreased both overall and disease-free survival rates. A high school education or less (HR, 1.4; 95% CI, 1.0-2.1) and advanced age (HR, 1.3; 95% CI, 1.1-1.6) were significant independent predictors of poor cancer-specific survival. CONCLUSION: Low income, low education, and advanced age predicted poor survival while controlling for a number of covariates (health behaviors, medical comorbidities, and treatment modality). Recommendations from the Institute of Medicine's Report to reduce disparities need to be implemented in treating head and neck cancer patients.

Factors associated with smoking among operating engineers.

Although disparities in smoking prevalence between white collar workers and blue collar workers have been documented, reasons for these disparities have not been well studied. The objective of this study was to determine variables associated with smoking among Operating Engineers, using the Health Promotion Model as a guide. With cross-sectional data from a convenience sample of 498 Operating Engineers, logistic regression was used to determine personal and health behaviors associated with smoking. Approximately 29% of Operating Engineers currently smoked cigarettes. Multivariate analyses showed that younger age, unmarried, problem drinking, physical inactivity, and a lower body mass index were associated with smoking. Operating Engineers were at high risk of smoking, and smokers were more likely to engage in other risky health behaviors, which supports bundled health behavior interventions.

Factors associated with sleep quality among operating engineers.

Blue collar workers generally report high job stress and are exposed to loud noises at work and engage in many of risky health behavioral factors, all of which have been associated with poor sleep quality. However, sleep quality of blue collar workers has not been studied extensively, and no studies have focused Operating Engineers (heavy equipment operators) among whom daytime fatigue would place them at high risk for accidents. Therefore, the purpose of this study was to determine variables associated with sleep quality among Operating Engineers. This was a cross-sectional survey design with a dependent variable of sleep quality and independent variables of personal and related health behavioral factors. A convenience sample of 498 Operating Engineers was recruited from approximately 16,000 Operating Engineers from entire State of Michigan in 2008. Linear regression was used to determine personal and related health behavior factors associated with sleep quality. Multivariate analyses showed that personal factors related to poor sleep quality were younger age, female sex, higher pain, more medical comorbidities and depressive symptoms and behavioral factors related to poor sleep quality were nicotine dependence. While sleep scores were similar to population norms, approximately 34 % (n = 143) showed interest in health services for sleep problems. While many personal factors are not changeable, interventions to improve sleep hygiene as well as interventions to treat pain, depression and smoking may improve sleep quality resulting in less absenteeism, fatal work accidents, use of sick leave, work disability, medical comorbidities, as well as subsequent mortality.

Comprehensive analysis of DNA methylation in head and neck squamous cell carcinoma indicates differences by survival and clinicopathologic characteristics.

Head and neck squamous cell carcinoma (HNSCC) is the eighth most commonly diagnosed cancer in the United States. The risk of developing HNSCC increases with exposure to tobacco, alcohol and infection with human papilloma virus (HPV). HPV-associated HNSCCs have a distinct risk profile and improved prognosis compared to cancers associated with tobacco and alcohol exposure. Epigenetic changes are an important mechanism in carcinogenic progression, but how these changes differ between viral- and chemical-induced cancers remains unknown. CpG methylation at 1505 CpG sites across 807 genes in 68 well-annotated HNSCC tumor samples from the University of Michigan Head and Neck SPORE patient population were quantified using the Illumina Goldengate Methylation Cancer Panel. Unsupervised hierarchical clustering based on methylation identified 6 distinct tumor clusters, which significantly differed by age, HPV status, and three year survival. Weighted linear modeling was used to identify differentially methylated genes based on epidemiological characteristics. Consistent with previous in vitro findings by our group, methylation of sites in the CCNA1 promoter was found to be higher in HPV(+) tumors, which was validated in an additional sample set of 128 tumors. After adjusting for cancer site, stage, age, gender, alcohol consumption, and smoking status, HPV status was found to be a significant predictor for DNA methylation at an additional 11 genes, including CASP8 and SYBL1. These findings provide insight into the epigenetic regulation of viral vs. chemical carcinogenesis and could provide novel targets for development of individualized therapeutic and prevention regimens based on environmental exposures.

Health behaviors predict higher interleukin-6 levels among patients newly diagnosed with head and neck squamous cell carcinoma.

BACKGROUND: Health behaviors have been shown to be associated with recurrence risk and survival rates in patients with cancer and are also associated with interleukin-6 (IL-6) levels, but few epidemiologic studies have investigated the relationship of health behaviors and IL-6 among cancer populations. The purpose of the study is to look at the relationship between five health behaviors, viz.: smoking, alcohol problems, body mass index (BMI; a marker of nutritional status), physical activity, and sleep and pretreatment IL-6 levels in persons with head and neck cancer. METHODS: Patients (N = 409) were recruited in otolaryngology clinic waiting rooms and invited to complete written surveys. A medical record audit was also conducted. Descriptive statistics and multivariate analyses were conducted to determine which health behaviors were associated with higher IL-6 levels controlling for demographic and clinical variables among patients with newly diagnosed head and neck cancer. RESULTS: While smoking, alcohol problems, BMI, physical activity, and sleep were associated with IL-6 levels in bivariate analysis, only smoking (current and former) and decreased sleep were independent predictors of higher IL-6 levels in multivariate regression analysis. Covariates associated with higher IL-6 levels were age and higher tumor stage, whereas comorbidities were marginally significant. CONCLUSION: Health behaviors, particularly smoking and sleep disturbances, are associated with higher IL-6 levels among patients with head and neck cancer. IMPACT: Treating health behavior problems, especially smoking and sleep disturbances, may be beneficial to decreasing IL-6 levels, which could have a beneficial effect on overall cancer treatment outcomes.

Pretreatment dietary patterns, weight status, and head and neck squamous cell carcinoma prognosis.

BACKGROUND: Few studies have evaluated the association of diet and weight status with head and neck cancer outcomes. OBJECTIVE: The purpose of this study was to determine whether pretreatment dietary patterns and weight status are associated with head and neck cancer prognosis. DESIGN: This was a longitudinal study of 542 patients with newly diagnosed head and neck cancer who completed food-frequency questionnaires and health surveys before treatment. Clinical data were abstracted from medical records and the Social Security Death Index. Dietary patterns were identified by using principal component analysis. Cox proportional hazard models were used to examine the association of derived dietary patterns (fit by quintiles of exposure) and weight status with time to recurrence and survival, with control for covariates. RESULTS: During the study period, there were 229 deaths and 184 recurrences. Two dietary patterns were identified: a whole-foods pattern (characterized by high intakes of vegetables, fruit, fish, poultry, and whole grains) and a Western pattern (characterized by high intakes of red and processed meats, refined grains, potatoes, and French fries). In multivariable analyses, significantly fewer deaths were observed in subjects most adherent to the whole-foods pattern (HR: 0.56; 95% CI: 0.34, 0.92; P-trend = 0.01). Subjects classified as overweight or obese had significantly fewer deaths (HR: 0.65; 95% CI: 0.49, 0.85; P = 0.001) and recurrences (HR: 0.70; 95% CI: 0.52, 0.95; P = 0.02) than did normal-weight or underweight subjects. CONCLUSION: Consumption of a diet rich in vegetables, fruit, fish, poultry, and whole grains and being overweight before diagnosis with head and neck cancer are associated with a better prognosis.

Predictors of pain among patients with head and neck cancer.

OBJECTIVE To determine predictors of pain 1 year after the diagnosis of head and neck cancer. DESIGN Prospective, multisite cohort study. SETTING Three academically affiliated medical centers. PATIENTS The study population comprised 374 previously untreated patients with carcinoma of the upper aerodigestive tract. MAIN OUTCOME MEASURES Participants were surveyed before treatment and 1 year thereafter. Multivariate analyses were conducted to determine predictors of the 36-Item Short-Form Instrument (SF-36) bodily pain score 1 year after diagnosis. RESULTS The mean SF-36 bodily pain score at 1 year was 65, compared with 61 at the time of diagnosis (P = .004), and 75, the population norm (lower scores indicate worse pain). Variables independently associated with pain included pretreatment pain score (P < .001), less education (P = .02), neck dissection (P = .001), feeding tube (P = .05), xerostomia (P < .001), depressive symptoms (P < .001), taking more pain medication (P < .001), less physical activity (P = .02), and poor sleep quality (P = .006). The association between head and neck cancer pain and current smoking and problem drinking did not reach significance (P = .07 and P = .08, respectively). CONCLUSIONS Aggressive pain management may be indicated for patients with head and neck cancer who undergo neck dissections, complain of xerostomia, require feeding tubes, and have medical comorbidities. Treatment of modifiable risk factors such as depression, poor sleep quality, tobacco use, and alcohol abuse may also reduce pain and improve quality of life among patients with head and neck cancer.

Factors associated with health-related quality of life among operating engineers.

BACKGROUND: Because health-related quality of life among blue-collar workers has not been well studied, the purpose of this study was to determine factors associated with health-related quality of life among Operating Engineers. METHODS: With cross-sectional data from a convenience sample of 498 Operating Engineers, personal and health behavioral factors associated with health-related quality of life were examined. RESULTS: Multivariate linear regression analysis revealed that personal factors (older age, being married, more medical comorbidities, and depression) and behavioral factors (smoking, low fruit and vegetable intake, low physical activity, high body mass index, and low sleep quality) were associated with poor health-related quality of life. CONCLUSIONS: Operating Engineers are at risk for poor health-related quality of life. Underlying medical comorbidities and depression should be well managed. Worksite wellness programs addressing poor health behaviors may be beneficial.

Higher micronutrient intake is associated with human papillomavirus-positive head and neck cancer: a case-only analysis.

No studies have investigated dietary differences between head and neck squamous cell carcinoma (HNSCC) patients with human papillomavirus (HPV)-positive tumors and patients with HPV-negative tumors. This study was designed to investigate the relationship between diet and HPV status in HNSCC patients. Cases of HNSCC were recruited from 2 clinical centers participating in the University of Michigan Head and Neck Specialized Program of Research Excellence (SPORE). HPV tissue genotyping was performed, and epidemiological and dietary data collected. Multivariable logistic regression tested whether pretreatment consumption of 12 selected micronutrients was significantly associated with HPV-positive status in 143 patients newly diagnosed with cancer of the oral cavity or pharynx. After controlling for age, sex, body mass index, tumor site, cancer stage, problem drinking, smoking, and energy intake, significant and positive associations were observed between vitamin A, vitamin E, iron, ß-carotene, and folate intake and HPV-positive status (P(trend) < 0.05), suggesting that diet may be a factor in the improved prognosis documented in those with HPV-positive HNSCC. Dietary differences by HPV status should be considered in prognostic studies to better understand the influence of diet on HNSCC survival.

Predictors of poor sleep quality among head and neck cancer patients.

OBJECTIVES/HYPOTHESIS: The objective of this study was to determine the predictors of sleep quality among head and neck cancer patients 1 year after diagnosis. STUDY DESIGN: This was a prospective, multisite cohort study of head and neck cancer patients (N = 457). METHODS: Patients were surveyed at baseline and 1 year after diagnosis. Chart audits were also conducted. The dependent variable was a self-assessed sleep score 1 year after diagnosis. The independent variables were a 1 year pain score, xerostomia, treatment received (radiation, chemotherapy, and/or surgery), presence of a feeding tube and/or tracheotomy, tumor site and stage, comorbidities, depression, smoking, problem drinking, age, and sex. RESULTS: Both baseline (67.1) and 1-year postdiagnosis (69.3) sleep scores were slightly lower than population means (72). Multivariate analyses showed that pain, xerostomia, depression, presence of a tracheotomy tube, comorbidities, and younger age were statistically significant predictors of poor sleep 1 year after diagnosis of head and neck cancer (P < .05). Smoking, problem drinking, and female sex were marginally significant (P < .09). Type of treatment (surgery, radiation and/or chemotherapy), primary tumor site, and cancer stage were not significantly associated with 1-year sleep scores. CONCLUSIONS: Many factors adversely affecting sleep in head and neck cancer patients are potentially modifiable and appear to contribute to decreased quality of life. Strategies to reduce pain, xerostomia, depression, smoking, and problem drinking may be warranted, not only for their own inherent value, but also for improvement of sleep and the enhancement of quality of life.

Perceived difficulty quitting predicts enrollment in a smoking-cessation program for patients with head and neck cancer.

PURPOSE/OBJECTIVES: To determine the predictors of participation in a smoking-cessation program among patients with head and neck cancer. DESIGN: This cross-sectional study is a substudy of a larger, randomized trial of patients with head and neck cancer that determined the predictors of smokers' participation in a cessation intervention. SETTING: Otolaryngology clinics at three Veterans Affairs medical centers (Ann Arbor, MI, Gainesville, FL, and Dallas, TX), and the University of Michigan Hospital in Ann Arbor. SAMPLE: 286 patients who had smoked within six months of the screening survey were eligible for a smoking-cessation intervention. METHODS: Descriptive statistics and bivariate and multivariate logistic regression were used to determine the independent predictors of smokers' participation in an intervention study. MAIN RESEARCH VARIABLES: Perceived difficulty quitting (as a construct of self-efficacy), health behaviors (i.e., smoking and problem drinking), clinical characteristics (i.e., depression and cancer site and stage), and demographic variables. FINDINGS: Forty-eight percent of those eligible participated. High perceived difficulty quitting was the only statistically significant predictor of participation, whereas problem drinking, lower depressive symptoms, and laryngeal cancer site approached significance. CONCLUSIONS: Special outreach may be needed to reach patients with head and neck cancer who are overly confident in quitting, problem drinkers, and patients with laryngeal cancer. IMPLICATIONS FOR NURSING: Oncology nurses are in an opportune position to assess patients' perceived difficulty quitting smoking and motivate them to enroll in cessation programs, ultimately improving quality of life, reducing risk of recurrence, and increasing survival for this population.

Validation of the Sino-Nasal Outcome Test 20 (SNOT-20) domains in nonsurgical patients.

BACKGROUND: The objectives of this study were, first, to confirm the presence of multiple domains within the Sino-Nasal Outcome Test 20 (SNOT-20) using a medically treated population, and, second, to reanalyze data from this population to reveal incremental information. A prospective, randomized controlled trial was performed. METHODS: One hundred twenty-seven adults with chronic rhinitis or rhinosinusitis symptoms were treated with nasal saline irrigation or spray. Treatment outcome was quality of life measured with SNOT-20 scores, which were reanalyzed for this study with a factor analysis. Differences in change scores were compared. RESULTS: Factor analysis confirmed the presence of four domains: psychological function, sleep function, rhinological symptoms, and ear and/or facial symptoms. At 8 weeks after randomization, saline irrigation had significant effects on the rhinological symptom (p = 0.01) and sleep (p = 0.01) compared with saline spray, but no between-group difference was seen in psychological function or ear and/or facial symptom domains. CONCLUSION: Subscales identified differences in the impact of two medical interventions on chronic sinonasal symptoms. Reporting subscale scores might improve the precision of the SNOT-20 instrument, allowing discrimination between various treatments and their differential impact on sinonasal quality of life.

Pretreatment health behaviors predict survival among patients with head and neck squamous cell carcinoma.

PURPOSE: Our prior work has shown that the health behaviors of head and neck cancer patients are interrelated and are associated with quality of life; however, other than smoking, the relationship between health behaviors and survival is unclear. PATIENTS AND METHODS: A prospective cohort study was conducted to determine the relationship between five pretreatment health behaviors (smoking, alcohol, diet, physical activity, and sleep) and all-cause survival among 504 head and neck cancer patients. RESULTS: Smoking status was the strongest predictor of survival, with both current smokers (hazard ratio [HR] = 2.4; 95% CI, 1.3 to 4.4) and former smokers (HR = 2.0; 95% CI, 1.2 to 3.5) showing significant associations with poor survival. Problem drinking was associated with survival in the univariate analysis (HR = 1.4; 95% CI, 1.0 to 2.0) but lost significance when controlling for other factors. Low fruit intake was negatively associated with survival in the univariate analysis only (HR = 1.6; 95% CI, 1.1 to 2.1), whereas vegetable intake was not significant in either univariate or multivariate analyses. Although physical activity was associated with survival in the univariate analysis (HR = 0.95; 95% CI, 0.93 to 0.97), it was not significant in the multivariate model. Sleep was not significantly associated with survival in either univariate or multivariate analysis. Control variables that were also independently associated with survival in the multivariate analysis were age, education, tumor site, cancer stage, and surgical treatment. CONCLUSION: Variation in selected pretreatment health behaviors (eg, smoking, fruit intake, and physical activity) in this population is associated with variation in survival.

Probiotics as adjunctive treatment for chronic rhinosinusitis: a randomized controlled trial.

OBJECTIVE: To determine if oral probiotics as adjunctive treatment are more effective than placebo in improving quality of life in patients with chronic inflammatory rhinosinusitis. DESIGN: Prospective, randomized, double-blind, placebo-controlled trial. METHODS: A total of 77 patients with chronic inflammatory rhinosinusitis were randomly assigned to receive oral probiotic Lactobacillus rhamnosus R0011 strain (500 million active cells/tablet twice daily) (n = 39) or oral placebo treatment (n = 38) for 4 weeks. RESULTS: In the probiotic group, the mean change from baseline in the SNOT-20 scores was significant at 4 weeks (P = 0.002) but not at 8 weeks (P = 0.37). Rhinological domain improved by 9.3 percent (P = 0.004) in probiotics group but returned to baseline level at 8 weeks. No significant differences were found between the probiotic and placebo groups in mean changes from baseline to 4 weeks (P = 0.79) or from baseline to 8 weeks (P = 0.23). No changes in symptom frequency were noted, either within each group or between treatment groups at 4 and 8 weeks. There was no difference in medication use or side effects between the two study groups. CONCLUSION: Oral use of the probiotic strain L rhamnosus R0011 did not improve sinonasal quality-of-life scores in patients with chronic inflammatory rhinosinusitis compared with placebo.

The effect of neck dissection on quality of life after chemoradiation.

OBJECTIVE: To determine differences in quality of life (QOL) between patients with head and neck cancer who receive chemoradiation versus chemoradiation and neck dissection. METHODS: A prospective cohort study was conducted at two tertiary otolaryngology clinics and a Veterans Administration hospital. SAMPLE: 103 oropharyngeal patients with Stage IV squamous cell carcinoma treated via chemoradiation +/- neck dissection. INTERVENTION: self-administered health survey to collect health, demographic, and QOL information pretreatment and 1 year later. MAIN OUTCOME MEASURES: QOL via SF-36 and HNQoL. Descriptive statistics were calculated for health/clinical characteristics, demographics, and QOL scores. t tests evaluated changes in QOL over time. RESULTS: Sixty-five patients underwent chemoradiation and 38 patients underwent chemoradiation and neck dissection. Only the pain index of the SF-36 showed a significant difference between groups (P < 0.05) with the neck dissection group reporting greater pain. CONCLUSIONS: After post-treatment neck dissection, patients experience statistically significant decrement in bodily pain domain scores, but other QOL scores are similar to those of patients who underwent chemoradiation alone.

Interleukin-6 predicts recurrence and survival among head and neck cancer patients.

BACKGROUND: Increased pretreatment serum interleukin (IL)-6 levels among patients with head and neck squamous cell carcinoma (HNSCC) have been shown to correlate with poor prognosis, but sample sizes in prior studies have been small and thus unable to control for other known prognostic variables. METHODS: A longitudinal, prospective cohort study determined the correlation between pretreatment serum IL-6 levels, and tumor recurrence and all-cause survival in a large population (N = 444) of previously untreated HNSCC patients. Control variables included age, sex, smoking, cancer site and stage, and comorbidities. Kaplan-Meier plots and univariate and multivariate Cox proportional hazards models were used to study the association between IL-6 levels, control variables, and time to recurrence and survival. RESULTS: The median serum IL-6 level was 13 pg/mL (range, 0-453). The 2-year recurrence rate was 35.2% (standard error, 2.67%). The 2-year death rate was 26.5% (standard error, 2.26%). Multivariate analyses showed that serum IL-6 levels independently predicted recurrence at significant levels [hazard ratio (HR) = 1.32; 95% confidence interval (CI), 1.11 to 1.58; P = .002] as did cancer site (oral/sinus). Serum IL-6 level was also a significant independent predictor of poor survival (HR = 1.22; 95% CI, 1.02 to 1.46; P = .03), as were older age, smoking, cancer site (oral/sinus), higher cancer stage, and comorbidities. CONCLUSIONS: Pretreatment serum IL-6 could be a valuable biomarker for predicting recurrence and overall survival among HNSCC patients. Using IL-6 as a biomarker for recurrence and survival may allow for earlier identification and treatment of disease relapse.

Quality of life scores predict survival among patients with head and neck cancer.

PURPOSE: The purpose of this study was to examine whether quality of life (QOL) scores predict survival among patients with head and neck cancer, controlling for demographic, health behavior, and clinical variables. PATIENTS AND METHODS: A self-administered questionnaire was given to 495 patients being treated for head and neck cancer while they were waiting to be seen for a clinic appointment. Data collected from the survey included demographics, health behaviors, and QOL as measured by Short Form-36 (SF-36) physical and mental component scores and the Head and Neck QOL scores. Clinical measures were collected by chart abstraction. Kaplan-Meier plots and univariate and multivariate Cox proportional hazards models were used to determine the association between QOL scores and survival time. RESULTS: After controlling for age, time since diagnosis, marital status, education, tumor site and stage, comorbidities, and smoking, the SF-36 physical component score and three of the four Head and Neck QOL scales (pain, eating, and speech domains) were associated with survival. Controlling for the same variables, the SF-36 mental component score and the emotional domain of the Head and Neck QOL were not associated with survival. CONCLUSION: QOL instruments may be valuable screening tools to identify patients who are at high risk for poor survival. Those with low QOL scores could be followed more closely, with the potential to identify recurrence earlier and perform salvage treatments, thereby possibly improving survival for this group of patients.

Changes in quality of life over 1 year in patients with head and neck cancer.

OBJECTIVES: To characterize and compare quality of life (QOL) in patients with head and neck cancer shortly before initial treatment and 1 year later and to study the predictors of changes in QOL over 1 year. DESIGN: Prospective cohort study. SETTING: Three otolaryngology clinics. PATIENTS: Three hundred sixteen patients having newly diagnosed squamous cell head and neck cancer. MAIN OUTCOME MEASURE: Health-related QOL was assessed using the 36-item Short-Form Health Survey and a head and neck cancer-specific QOL scale. RESULTS: Over 1 year, QOL decreased for physical functioning measures and eating but improved for mental health QOL. Depression and smoking were major predictors of poor QOL at baseline. Major predictors of change in QOL from baseline to 1 year were treatment factors, especially feeding tube placement (9 scales), chemotherapy (3 scales), and radiation therapy (3 scales). Baseline smoking and depressive symptoms also remained significant predictors of several QOL scales at 1 year. CONCLUSIONS: Health-related physical QOL tended to decline over 1 year and mental health QOL improved. The major predictors of change in QOL were treatment factors, smoking, and depressive symptoms. Physicians should alert patients to the relative effects on QOL one may experience with different treatments.