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Background: The aim of this study was to evaluate the effect airway management has on perioperative outcomes of patients undergoing oral cavity free flap reconstruction., Methods: A retrospective review was performed on patients receiving oral cavity free flap reconstruction between March 2006 and October 2007. Patient, tumor, and treatment variables were recorded. Patients were managed with nasotracheal intubation (NTI) or elective tracheotomy and different perioperative outcomes were measured., Results: Thirty-seven patients received NTI and 21 received tracheotomy. No patients in the NTI group required conversion to tracheotomy or reintubation. The mean total hospital stay was prolonged in the tracheotomy group (12.4 days vs 8.4 days), as was their likelihood of requiring a feeding tube at discharge (76% vs 19%). In multivariate analyses, placement of a tracheotomy was independently correlated with longer hospital stay and feeding tube dependence at discharge., Conclusions: NTI is a safe alternative to tracheotomy for select patients receiving oral cavity free flap reconstruction and may reduce hospital stay and feeding tube dependence at discharge., (2009 Wiley Periodicals, Inc. Head Neck, 2010.)

Objectives: Dysphagia-related sequelae are common after head and neck cancer treatment. Our aims were 1) to document overall and site-specific dysphagia, stricture, and pneumonia rates in a Medicare population, 2) to calculate treatment-specific rates and adjusted odds of developing these complications, and 3) to track changes in rates between 1992 and 1999., Methods: Head and neck cancer patients between 1992 and 1999 were identified in combined Surveillance Epidemiology and End Results (SEER) registry and Medicare databases. Multivariate analyses determined odds of dysphagia, stricture, and pneumonia based on modality., Results: Of 8,002 patients, 40% of experienced dysphagia, 7% stricture, and 10% pneumonia within 3 years of treatment. In adjusted analyses, patients treated with chemoradiation had more than 2.5-times-greater odds of dysphagia than did those treated with surgery alone. Combined therapy was associated with increased odds of stricture (p<0.05). The odds of pneumonia were increased in patients treated with radiation with or without chemotherapy. Temporally, the dysphagia rates increased 10% during this period (p<0.05)., Conclusions: Sequelae of head and neck cancer treatment are common and differ by treatment regimen. Those treated with chemoradiation had higher odds of experiencing dysphagia and pneumonia, whereas patients treated with any combined therapy more commonly experienced stricture. These sequelae represent major sources of morbidity and mortality in this population.

Objectives: To perform a factor analysis using the University of Washington Quality of Life Questionnaire version 4 (UW-QOLv4) to establish subscales; to report their normative values and variations for patients by age, sex, extent of disease, and time from treatment; and to estimate clinical effect sizes and potential for use in comparative treatment studies., Design: Retrospective cohort., Setting: Regional Maxillofacial Unit, University Hospital Aintree, Liverpool, England., Patients: Patients with primary oral and oropharyngeal cancer treated by surgery with or without adjuvant radiotherapy since 1992. A database accumulating since 1995 contains more than 2600 UW-QOLs completed by these patients. A data set of 372 patients without cancer attending 10 general dental practices provided normative data., Main Outcome Measures: UW-QOLv4., Results: Factor analysis indicated a 2-factor solution: (1) physical function, involving chewing, swallowing, speech, taste, saliva, and appearance, and (2) social-emotional function, involving anxiety, mood, pain, activity, recreation, and shoulder function. The best scores were for those with less advanced oral cancer tumors not requiring free-flap surgery or adjuvant radiotherapy. Older patients reported better scores, but associations were weak, and no sex differences were found. Significant differences were seen for T category, site, free-flap surgery, and adjuvant radiotherapy (P < .001). Preoperative scores were close to normative values. Patients regain social-emotional deficits by 1 year after surgery but continue with significant deficits in physical function. Comparative studies using these UW-QOL subscales as outcome measures should recruit at least 80 patients per treatment arm to detect moderately sized treatment effects., Conclusion: With the UW-QOLv4, it is appropriate to analyze and report outcomes using the 2 subscales of physical and social-emotional function.

Background: Based on the International Classification of Functioning (ICF)-Disability and Health, participants from different professional and cultural backgrounds were invited to achieve consensus on a first version of ICF Core Set for head and neck cancer (HNC). It was designed to set standards for the assessment of functioning in HNC., Methods: The ICF was adopted by the World Health Organization (WHO) in 2001 and was used as the frame of reference. Preselection of potential ICF categories was based on 4 different preparatory studies: patient interviews, health professional surveys, literature review, and multicenter study applying ICF-nomenclature. After training on the ICF, the results of preparatory studies were presented to 21 invited participants to vote in a formal consensus process on both the Brief and Comprehensive ICF Core Set for HNC. Participants came from all 6 WHO world regions, covering 12 different countries. Professional backgrounds included otorhinolaryngologists, maxillofacial surgeons, medical/radiation oncologists, psychologists, physiotherapists, nurses, and social workers., Results: The Comprehensive ICF Core Set for HNC included 112 categories (8% of entire ICF) and the Brief ICF Core Set for HNC included 19 categories (1% of ICF)., Conclusion: A first version of ICF Core Sets for HNC was defined. Further validation is in process., (Copyright 2009 Wiley Periodicals, Inc.)

Background: Hearing impairment is the most common body system disability in veterans. In 2008, nearly 520,000 veterans had a disability for hearing loss through the Department of Veterans Affairs (VA). Changes in eligibility for hearing aid services, along with the aging population, contributed to a greater than 300% increase in the number of hearing aids dispensed from 1996 to 2006. In 2006, the VA committed to having no wait times for patient visits while providing quality clinically-appropriate care. One approach to achieving this goal is the use of group visits as an alternative to individual visits. We sought to determine: 1) if group hearing aid fitting and follow-up visits were at least as effective as individual visits, and 2) whether group visits lead to cost savings through the six month period after the hearing aid fitting. We describe the rationale, design, and characteristics of the baseline cohort of the first randomized clinical trial to study the impact of group versus individual hearing aid fitting and follow-up visits., Methods: Participants were recruited from the VA Puget Sound Health Care System Audiology Clinic. Eligible patients had no previous hearing aid use and monaural or binaural air-conduction hearing aids were ordered at the evaluation visit. Participants were randomized to receive the hearing aid fitting and the hearing aid follow-up in an individual or group visit. The primary outcomes were hearing-related function, measured with the first module of the Effectiveness of Aural Rehabilitation (Inner EAR), and hearing aid adherence. We tracked the total cost of planned and unplanned audiology visits over the 6-month interval after the hearing aid fitting., Discussion: A cohort of 659 participants was randomized to receive group or individual hearing aid fitting and follow-up visits. Baseline demographic and self-reported health status and hearing-related measures were evenly distributed across the treatment arms.Outcomes after the 6-month follow-up period are needed to determine if group visits were as least as good as those for individual visits and will be reported in subsequent publication., Trial Registration: NCT00260663.

Objective: To examine the impact of clinical predictors (pretreatment variables) and other influences (treatment and posttreatment variables) on long-term quality of life (QOL) in patients treated for squamous cell carcinoma of the upper aerodigestive tract. We hypothesized that baseline QOL and comorbidity would be predictors of QOL 1 year after treatment., Design: Retrospective cohort study., Setting: Academic Medical Center in Seattle, Washington., Patients: Patients (N = 173) with baseline (pretreatment) and 1-year posttreatment QOL data., Main Outcome Measure: Head and neck-specific QOL scores at 1 year after treatment (as measured by the University of Washington Quality of Life [UW-QOL] scale)., Results: We identified strong relationships between 1-year UW-QOL scores and baseline UW-QOL scores (correlation coefficient [Pearson r] = 0.58; P < .001) and pretreatment comorbidity (as measured by the Adult Comorbidity Evaluation scale) (Spearman rho = 0.23; P < .001). T stage and N stage were also predictive. Although not a predictive variable, the presence of a gastrostomy tube at 1 year also strongly influenced 1-year UW-QOL scores. Patients with gastrostomy tubes had UW-QOL scores 11.5 points worse than those without (P < .001), when a 7-point difference is considered clinically significant. In predictive multivariate regression models, pretreatment QOL scores, comorbidity, and T stage had the strongest prognostic impact on 1-year UW-QOL scores., Conclusions: In bivariate analyses, the presence of a gastrostomy tube worsens UW-QOL scores at 1 year and requires further investigation. When considering predictive variables only, baseline QOL and comorbidity appear to have strong influences on posttreatment QOL and have greater impact than treatment modality. Greater attention to these baseline predictors should be given when counseling patients about long-term function after treatment.

Purpose: To determine if gene expression signature of invasive oral squamous cell carcinoma (OSCC) can subclassify OSCC based on survival., Experimental Design: We analyzed the expression of 131 genes in 119 OSCC, 35 normal, and 17 dysplastic mucosa to identify cluster-defined subgroups. Multivariate Cox regression was used to estimate the association between gene expression and survival. By stepwise Cox regression, the top predictive models of OSCC-specific survival were determined and compared by receiver operating characteristic analysis., Results: The 3-year overall mean+/-SE survival for a cluster of 45 OSCC patients was 38.7+/-0.09% compared with 69.1+/-0.08% for the remaining patients. Multivariate analysis adjusted for age, sex, and stage showed that the 45 OSCC patient cluster had worse overall and OSCC-specific survival (hazard ratio, 3.31; 95% confidence interval, 1.66-6.58 and hazard ratio, 5.43; 95% confidence interval, 2.32-12.73, respectively). Stepwise Cox regression on the 131 probe sets revealed that a model with a term for LAMC2 (laminin gamma2) gene expression best identified patients with worst OSCC-specific survival. We fit a Cox model with a term for a principal component analysis-derived risk score marker and two other models that combined stage with either LAMC2 or PCA. The area under the curve for models combining stage with either LAMC2 or PCA was 0.80 or 0.82, respectively, compared with 0.70 for stage alone (P=0.013 and 0.008, respectively)., Conclusions: Gene expression and stage combined predict survival of OSCC patients better than stage alone.

Oral squamous cell carcinoma (OSCC) is associated with substantial mortality and morbidity. To identify potential biomarkers for the early detection of invasive OSCC, we compared the gene expressions of incident primary OSCC, oral dysplasia, and clinically normal oral tissue from surgical patients without head and neck cancer or preneoplastic oral lesions (controls), using Affymetrix U133 2.0 Plus arrays. We identified 131 differentially expressed probe sets using a training set of 119 OSCC patients and 35 controls. Forward and stepwise logistic regression analyses identified 10 successive combinations of genes which expression differentiated OSCC from controls. The best model included LAMC2, encoding laminin-gamma2 chain, and COL4A1, encoding collagen, type IV alpha1 chain. Subsequent modeling without these two markers showed that COL1A1, encoding collagen, type I alpha1 chain, and PADI1, encoding peptidyl arginine deiminase, type 1, could also distinguish OSCC from controls. We validated these two models using an internal independent testing set of 48 invasive OSCC and 10 controls and an external testing set of 42 head and neck squamous cell carcinoma cases and 14 controls (GEO GSE6791), with sensitivity and specificity above 95%. These two models were also able to distinguish dysplasia (n = 17) from control (n = 35) tissue. Differential expression of these four genes was confirmed by quantitative reverse transcription-PCR. If confirmed in larger studies, the proposed models may hold promise for monitoring local recurrence at surgical margins and the development of second primary oral cancer in patients with OSCC.

Objective: To validate the DNA microarray results on a subset of genes that could potentially serve as biomarkers of oral squamous cell carcinoma (OSCC) by examining their expression with an alternate quantitative method and by assessing their protein levels., Design: Based on DNA microarray data from our laboratory and data reported in the literature, we identified 6 potential biomarkers of OSCC to investigate further. We used quantitative real-time polymerase chain reaction to examine expression changes of CDH11, MMP3, SPARC, POSTN, TNC, and TGM3 in OSCC and histologically normal control tissues. We further examined validated markers at the protein level by immunohistochemical analysis of OSCC tissue microarray sections., Results: Quantitative real-time polymerase chain reaction analysis revealed upregulation of CDH11, SPARC, POSTN, and TNC gene expression and decreased TGM3 expression in OSCC tissue compared with control tissue; MMP3 was not found to be differentially expressed. In tissue microarray immunohistochemical analyses, SPARC (secreted protein, acidic, rich in cysteine), periostin, and tenascin C exhibited increased protein expression in tumor tissue compared with control tissue, and their expression was primarily localized within tumor-associated stroma rather than tumor epithelium. Conversely, transglutaminase 3 protein expression was found only within keratinocytes in control tissue and was significantly downregulated in cancer cells., Conclusions: Of 6 potential gene markers of OSCC, initially identified by DNA microarray analyses, differential expression of CDH11, SPARC, POSTN, TNC, and TGM3 were validated by quantitative real-time polymerase chain reaction. Differential expression and localization of proteins encoded by SPARC, POSTN, TNC, and TGM3 were clearly shown by tissue microarray immunohistochemical analysis.

Purpose: Cyclooxygenase-2 (COX-2)-specific inhibition suppresses carcinogenesis in preclinical models and is a promising strategy for preventing oral cancer. In this pilot randomized phase II study, we evaluated the efficacy and safety of the COX-2 inhibitor celecoxib in patients with oral premalignant lesions (OPL)., Experimental Design: Patients were randomly assigned to placebo (n=18), celecoxib 100 mg twice daily (n=17), or celecoxib 200 mg twice daily (n=15) for 12 weeks. Six additional patients received celecoxib (400 mg twice daily) in an unblinded extension of the study. Biopsies were obtained at baseline and week 12. All patients entering the study were required to have at least one histologically confirmed early (atypical hyperplasia, atypical hyperkeratosis, or mild dysplasia) or advanced (moderate to severe dysplasia) OPL., Results: Forty-nine patients (46 of 50 randomized and 3 of 6 open label) were evaluable for efficacy analyses. There were no statistically significant differences between the response rates of the randomly assigned arms: placebo, 33.3% (6 of 18); celecoxib 100 mg twice daily, 41.2% (7 of 17); and celecoxib 200 mg twice daily, 20.0% (3 of 15). Two patients responded on celecoxib 400 mg twice daily. Celecoxib was generally well tolerated. Patients with higher baseline COX-2 mRNA levels had an increased risk of disease progression within 3 months., Conclusions: Celecoxib at 100 or 200 mg twice daily was ineffective in controlling OPLs in this randomized controlled trial. This result and cardiovascular toxicity results of other (large scale) randomized controlled trials of selective COX-2 inhibitors have discouraged the continued investigation of these agents in oral cancer chemoprevention. Better methods for identifying high-risk patients and more active interventions are needed for future oral cancer chemoprevention trials.

Objective: To describe changes in disease-specific and global quality of life (QOL) for adults with recurrent or chronic tonsillitis at 6 months and 1 year after tonsillectomy using two instruments: the Tonsil and Adenoid Health Status Instrument (TAHSI) and the SF-12 Health Survey (12-item short form of SF-36 Health Survey)., Study Design and Setting: Multicenter, prospective observational outcomes study., Results: Seventy-two adults, mean age 28.0 years (SD 7.2 years), were enrolled with follow-up available for 42 adults at 6 months and for 40 adults at 1 year. Patients showed significant improvements in all six subscales of the TAHSI: airway and breathing, infection, health care utilization, cost of care, eating and swallowing, and behavior (all P < 0.0001). Significant improvements were also found in the physical functioning subscale of the SF-12 at 1 year., Conclusion: After tonsillectomy for recurrent and chronic tonsillitis, we found large improvements in disease-specific and global QOL., Significance: Most prior studies on tonsillectomy for recurrent tonsillitis have assessed only the frequency of infections as an outcome measure. This study describes the changes in QOL measured in our cohort of reporting adults after tonsillectomy for chronic or recurrent tonsillitis. This study provides prospective evidence of the effectiveness of tonsillectomy on adult QOL.

Objective: To describe changes in disease-specific and global quality of life (QOL) for children with recurrent or chronic tonsillitis at 6 months and 1 year after tonsillectomy using two validated instruments, the Tonsil and Adenoid Health Status Instrument (TAHSI) and the Child Health Questionaire-PF28 (CHQ-PF28)., Study Design and Setting: A multicenter, prospective observational outcomes study., Results: Ninety-two children, mean age (SD) 10.6 (3.4) years, enrolled with follow-up available for 58 children at 6 months and 38 children at 1 year. The children showed significant improvements in all subscales of the TAHSI including airway and breathing, infection, health care utilization, cost of care, eating and swallowing (all P < 0.001), and behavior (P = 0.01). Significant improvements were also found on several subscales of the CHQ-PF28, such as general health perceptions, physical functioning, parental impact, and family activities (all P < 0.001)., Conclusion/significance: This uncontrolled study provides prospective evidence of improved disease-specific and global QOL in children after tonsillectomy.

Background: Effective screening programs should not merely detect presence of disease, but also lead to long-term benefit. We describe the rationale and design of the first randomized clinical trial to study the long-term effects of routine screening for hearing loss. We also describe the baseline characteristics of the randomized cohort., Methods: We randomized 2305 veterans age 50 years or older to a control arm without screening, or to screening with: physiologic testing (AudioScope), a self-administered questionnaire (Hearing Handicap Inventory for the Elderly-Screening version [HHIE-S]), or both tests. The primary outcome measure will be hearing aid use one year after screening. We will also study a number of secondary outcomes, including appointments made with and visits to an audiologist, cases of aidable hearing loss, hearing aids dispensed, self-rated communication ability, and hearing-related quality of life., Results: Baseline demographic and health status measures were evenly distributed across the screening arms. The percentage of patients who screened positive for hearing loss was 18.6%, 59.2%, and 63.6% for the AudioScope, HHIE-S, and combined screening arms, respectively., Implications: Long-term results are needed to gain insight into whether the AudioScope is associated with high rates of false negative screening, the HHIE-S is associated with high rates of false positive screening, or a combination of both. Identifying the best screening program will depend on determining which strategy leads to successful hearing aid use.

Background: The University of Washington Quality of Life (UW-QOL) questionnaire is an English-language survey instrument used worldwide to assess the quality of life of patients with head and neck cancer. To be used in other cultures, such instruments require careful translation and psychometric validation in other languages., Methods: The translation and cultural adaptation of the questionnaire were performed following accepted international guidelines. The psychometric validation was performed on a consecutive series of patients with at least 1 year of disease-free survival after treatment for squamous cell carcinoma of the upper aerodigestive tract, recruited from October 2004 to January 2005 from a tertiary cancer center hospital. Eligible subjects were invited to complete the Portuguese version of the UW-QOL questionnaire during routine clinical consultation and complete it again within 15 days. They also completed a validated Portuguese version of the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) and a questionnaire to evaluate anxiety and depression symptoms (Hospital Anxiety and Depression Scale [HADS])., Results: A Portuguese version of the questionnaire was developed in iterative fashion. In the psychometric validation process, a total of 109 patients were analyzed. Reliability was excellent, including both internal consistency (Cronbach's alpha [alpha] of 0.744) and test retest reliability (intraclass correlation coefficient [ICC] of 0.882). Construct validity was supported by statistically significant relationships between the SF-36 and HAD questionnaires and the translated UW-QOL questionnaire., Conclusions: The Brazilian-Portuguese version of the UW-QOL questionnaire appears to be culturally appropriate and psychometrically valid. This version is a valuable tool to evaluate accurately the quality of life of Brazilian patients with head and neck cancer.

Objective: To test the hypothesis that comorbidity, performance of concurrent sleep apnea procedures in addition to uvulopalatopharyngoplasty, body mass index, apnea-hypopnea index, and lowest oxygen saturation are risk factors for serious perioperative complications after uvulopalatopharyngoplasty., Design: Prospective cohort and nested case-control studies., Setting: United States Veterans Affairs medical centers., Patients: A prospective cohort of 3130 consecutive adult inpatients who underwent uvulopalatopharyngoplasty from 1991 to 2001 was retrospectively analyzed from the Veterans Affairs National Surgical Quality Improvement Program database to determine the relationship between perioperative complications and both concurrent procedures and medical comorbidity. A nested case-control analysis was conducted on 43 cases with complications and 212 controls without complications from the cohort. Controls were matched on age, sex, year of operation, and concurrent surgery; this case-control analysis enabled the study of body mass index, apnea-hypopnea index, and lowest oxygen saturation, which were not available in the cohort database. Multivariate logistic regression measured associations between risk factors and complications, adjusting or controlling for age, sex, race, smoking status, year of uvulopalatopharyngoplasty, and presence of any concurrent procedure., Main Outcome Measure: Sixteen specific serious perioperative complications, including 30-day mortality., Results: The cohort included 3130 veterans (97% were men aged 50+/-11 [mean+/-SD] years). In the cohort study, comorbidity was associated with serious complication: the adjusted risk ratio was 1.96 (95% confidence interval, 1.16-3.18) for each increase in American Society of Anesthesiologists class. Concurrent nonnasal procedures increased the risk of complication compared with no concurrent procedures (adjusted risk ratio, 4.94; 95% confidence interval, 2.34-10.4). In the case-control analyses, the apnea-hypopnea index, body mass index, and medical comorbidity were each associated with serious complication after adjustment for confounding variables, but this study had insufficient power to determine if these risk factors were independent of each other. Concurrent retrolingual procedures demonstrated an independent association with complication after adjustment for confounders. The lowest oxygen saturation was not associated with serious complication., Conclusions: Apnea-hypopnea index, body mass index, and medical comorbidity were each associated with serious complication; however, the low complication rate precluded demonstration of associations independent of each other. Concurrent retrolingual procedures were also associated with serious complication, but the cumulative risk of separate retrolingual procedures is unknown.

Background: Use of complementary and alternative medicine (CAM) is increasing in the United States. This study investigates whether the use of alternative medicine is associated with a delay of treatment in head and neck cancer., Methods: This study used the records obtained from a large trial involving ambulatory care US veterans. Subjects completed a CAM utilization questionnaire. The primary outcome variable was the time duration from cancer diagnosis to the time of cancer treatment., Results: Of veterans with head and neck cancer, 51% reported using some form of CAM, whereas 23% reported using a therapy classified as alternative medicine. Patients who used alternative medicine significantly delayed cancer treatment by 22 days compared with those who did not use alternative medicine (p = .05, 95% confidence interval [CI] = 0-44 days)., Conclusions: CAM use is common in veterans with head and neck cancer. Use of alternative medicine was associated with a significant delay in cancer treatment., ((c) 2006 Wiley Periodicals, Inc.)

Background: Utilization of vascularized bone grafts rigidly fixated with titanium reconstruction plates is the method of choice for reconstruction of segmental mandibular defects. We hypothesized that the use of the newer 2.0-mm locking reconstruction plate (LRP) is not associated with higher rates of complications when compared with larger, previously used plating systems., Methods: A retrospective case series of 184 patients undergoing 185 vascularized bone graft reconstruction procedures of the mandible was conducted., Results: There were 37 plate complications. There was no significant difference in complication rates for the 2 most used plate types (14.5% with the 2.0-mm LRP and 22.2% with the 2.4-mm LRP)., Conclusions: Use of the smaller 2.0-mm LRP was not associated with an increase in the complications of plate fracture, exposure, infection, or nonunion. Because of its lower profile and ease of application, the 2.0-mm LRP is our plate of choice for mandibular reconstruction., (Copyright 2006 Wiley Periodicals, Inc.)

Objective: To develop a new scale of hearing-related function and quality of life in patients with hearing aids that addresses overlooked concerns, such as hearing-aid comfort, convenience, and cosmetic appearance, that may influence hearing-aid adherence while maintaining brevity and sensitivity to clinical change., Design: Prospective, multicenter instrument validation., Setting: Four diverse sites in Washington State, including 2 private practices, 1 university setting, and 1 Veterans Affairs hospital., Patients: Seventy-eight patients with hearing aids., Interventions: We created 2 modules in the Effectiveness of Auditory Rehabilitation (EAR) scale. The first module (Inner EAR) covers intrinsic hearing issues such as hearing in quiet and hearing in noise and is administered both before and after treatment. The second module (Outer EAR) covers extrinsic (hearing-aid related) issues such as comfort, appearance, and convenience and is administered after hearing-aid fitting., Main Outcome Measures: Both scales were developed and validated in 3 stages. Stage 1 used a qualitative approach from multiple data sources to develop preliminary instruments. Stage 2 used approaches from classic test theory to reduce the number of items and psychometrically validate the instruments. Stage 3 examined the responsiveness or sensitivity to clinical change., Results: A 10-item Inner EAR module and a 10-item Outer EAR module were created and validated. Internal consistency of individual domains (Cronbach alpha = 0.85 and 0.72, respectively) and test-retest reliability (intraclass correlation coefficients = 0.76 and 0.81, respectively) were excellent. Evidence of construct validity included concurrent validity with other hearing scales and global visual analog scales, discriminant validity with dizziness handicap, correlation with hearing-aid adherence, and confirmatory factor analyses. Both scales had strong evidence of responsiveness (sensitivity to change), with higher effect sizes and Guyatt responsiveness statistics than the 2 widely used hearing scales in this study. The scales took an average of 5 minutes to complete., Conclusions: The EAR scale is a valid and reliable measure of the effectiveness of amplification in the treatment of sensorineural hearing loss. It addresses the range of issues that are of importance to hearing-aid patients. The scales have excellent psychometric properties, are more responsive than several widely used hearing scales, and are minimally burdensome for patients to complete. The EAR may be a valuable outcome measure in future studies of both existing hearing aids and newer hearing-aid technologies, such as bone-anchored aids or middle ear implants.

Background: The current Phase I/II study assessed induction docetaxel/carboplatin given weekly for 4 weeks, followed by weekly docetaxel/carboplatin and concomitant boost radiotherapy (CB-XRT) for locally advanced head and neck squamous cell carcinoma., Methods: Twenty patients with Stage III or IV (M0) disease of the oropharynx, supraglottic larynx, or hypopharynx were enrolled. Patients initially received docetaxel 20 mg/m2 and carboplatin area under the curve (AUC) 2 weekly x 4. Patients with stable (SD) or responding disease subsequently received dose-escalated docetaxel (10-20 mg/m2 in sequential patient cohorts) and carboplatin AUC 1 weekly x 5 with CB-XRT (1.8 gray [Gy] every day x 15 days, followed by 1.8/1.5 Gy twice per day x 13 days)., Results: All patients were evaluable, and 15 patients (5 patients with Stage III disease, 10 patients with Stage IV disease) completed all planned therapy. The target docetaxel dose level of 20 mg/m(2) weekly with radiotherapy was achieved with no dose-limiting toxicities. The most frequent maximum toxicities during chemoradiotherapy were Grade 3 mucositis, dysphagia, and/or pain. Primary site responses after induction included 4 patients with partial responses, 11 patients with SD, and 5 patients with disease progression. Fifteen patients (75%) continued to receive chemoradiotherapy, with 14 patients attaining a complete response (CR). Overall, a clinicopathologic neck CR after chemoradiotherapy was achieved in 9 of 10 patients. One patient had persistent primary disease and underwent salvage surgery, whereas another died of unrelated causes before neck assessment. Thirteen patients remain free of any disease event, with a median follow-up of 15 months (range, 3-29 months)., Conclusions: This regimen was feasible, safe, and particularly well tolerated. Early Phase II outcomes revealed promising activity in patients completing all treatment. Initial induction response results suggested that further investigation of this regimen with more aggressive induction therapy is warranted., (Copyright 2005 American Cancer Society.)

Background: 2-deoxy-2[(18)F]fluoro-D-glucose-positron emission tomography (FDG-PET) imaging can be registered with CT images and can potentially improve neck staging sensitivity and specificity in patients with head and neck squamous cell cancer. The intent of this study was to examine the use of registered FDG-PET/CT imaging to guide head and neck intensity modulated radiotherapy (IMRT) planning., Methods: Twenty patients with squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx underwent FDG-PET and contrast-enhanced CT imaging of the head and neck before neck dissection surgery. Combined FDG-PET/CT images were created by use of a nonrigid image registration algorithm. All IMRT plans were theoretical and were not used for treatment. We prescribed 66 Gy in 30 fractions to FDG-avid CT abnormalities and nodal zones directly involved with disease, without prophylactic coverage of uninvolved neck levels. Matched CT-guided IMRT plans designed according to the specifications of Radiation Therapy Oncology Group (RTOG) H-0022 were available for comparison. We investigated the feasibility of FDG-PET/CT-directed IMRT dose escalation in five patients with FDG-avid disease located away from critical normal structures. After 66 Gy, FDG-avid disease with 0.5-cm margins was boosted in 220 cGy increments until dose-limiting criteria were reached., Results: Elimination of prophylactic coverage to FDG-PET/CT-negative neck levels markedly reduced mean dose (Dmean) to the contralateral parotid gland (p < .001) and Dmean to the laryngeal cartilage (p = .001). No FDG-PET/CT-directed plan missed pathologically verified nodal disease. During the dose escalation exercise, we successfully increased the dose to 95% of the planning target volume (PTV95%) to a mean of 7490 cGy (range, 7153-8098 cGy)., Conclusions: We demonstrate early proof of the principle that FDG-PET/CT-guided IMRT planning can selectively target and intensify treatment of head and neck disease while reducing critical normal tissue doses. Routine clinical use of such planning should not be engaged until the accuracy of FDG-PET/CT is fully validated. Future directions, including refinement of treatment to gross disease and radiologically uninvolved neck nodal levels, are discussed., ((c) 2005 Wiley Periodicals, Inc.)

Objective: Outcomes for patients with otitis media were assessed in this prospective, multicenter study., Study Design and Setting: Thirty-one otolaryngologists enrolled 272 pediatric patients with otitis media; caregivers completed surveys at 3-month intervals, and clinical and treatment data was also collected. The Otitis Media 6 (OM-6) was the primary outcome measure., Results: One hundred seventy-seven patients (mean age 2.0 years) completed 3-month follow-up. One hundred thirty-seven patients underwent tympanostomy tube placement. Large improvements in disease-specific quality of life (QOL) were seen up to 9 months of follow-up. Baseline OM-6 score was the best predictor of clinical success in regression modeling., Conclusions: Patients referred to an otolaryngologist for treatment of otitis media see large improvements in disease-specific QOL regardless of treatment rendered., Significance: The study demonstrates the feasibility of multicenter outcomes studies and confirms appropriate triage of patients with otitis media into surgical versus medical interventions., Ebm Rating: C.

Background: Psychiatric disorders are associated with increased symptom burden when combined with chronic medical conditions. However, there are no reports of how psychiatric distress influences outcomes with surgical treatment for chronic rhinosinusitis (CRS). We hypothesized that subjects with psychiatric distress (somatization, anxiety, and depression) would report more severe long-term sinus symptoms and worse quality of life (QOL) than subjects without psychiatric distress., Methods: This is a community-based, prospective, observational cohort study of patients diagnosed with CRS presenting for surgery. Patients were interviewed before surgery; CT scans were reviewed, and questionnaires were completed about sinusitis-related symptoms (SNOT-16), general health status and QOL (SF-36), and psychiatric distress (BSI and PHQ). Outcomes were also assessed 1, 3, 6, and 12 months postoperatively., Results: Ninety-five patients had complete records for analysis. Psychiatric distress was prevalent, with 31% screening positive for somatization, 17% positive for anxiety, and 25% positive for depressive disorders. Subjects with somatization had significantly worse SNOT-16 scores at each time point compared with those without somatization ( P < 0.05). Subjects with depression reported more severe symptoms at 6 and 12 months after surgery than those without depression ( P < 0.05). The presence of somatization preoperatively was also independently associated with worse symptom severity 12-months after surgery, even after adjusting for prior sinus surgery, CT stage, Charlson Index, and deviated septum. In addition, subjects with psychiatric distress reported significantly worse SF-36 physical and mental component summary scores 12-months after surgery than subjects without psychiatric distress., Conclusions: Psychiatric distress is associated with worse reported sinus symptoms and lower QOL throughout surgical management of chronic rhinosinusitis. Despite this, subjects with psychiatric distress report a similar degree of improvement in sinus symptoms after surgery compared with those without distress., Clinical Significance: Psychiatric distress should be considered in patients with persistent symptoms after surgery. Psychiatric distress should also be considered in efforts to design a chronic sinusitis staging system.

Purpose: Image localization of head-and-neck squamous cell carcinoma lags behind current techniques to deliver a precise radiation dose with intensity-modulated radiotherapy. This pilot study prospectively examined the use of registered 18-F-fluorodeoxyglucose (FDG)-positron emission tomography (PET)/CT for preradiotherapy staging of the neck., Methods and Materials: Sixty-three patients with squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx were enrolled into an institutional FDG-PET imaging protocol between September 2000 and June 2003. Of these patients, 20 went on to immediate neck dissection surgery and were studied further. Of these 20, 17 (85%) had American Joint Committee on Cancer Stage III or IV disease. All patients underwent preoperative FDG-PET and contrast-enhanced CT of the head and neck. FDG-PET/CT images were created using a nonrigid image registration algorithm developed at the University of Washington. Alternate primary and nodal gross tumor volumes were contoured with radiotherapy treatment planning software, blinded to each other and to the pathology results. One set of volumes was designed with CT guidance alone and the other with the corresponding FDG-PET/CT images. Neck dissection specimens were subdivided into surgical nodal levels intraoperatively, and the histopathologic findings were correlated with the CT and FDG-PET/CT nodal level findings., Results: FDG-PET/CT detected 17 of 17 heminecks and 26 of 27 nodal zones histologically positive by dissection (100% and 96% sensitivity, respectively). The nodal level staging sensitivity and specificity for FDG-PET/CT was 96% (26 of 27) and 98.5% (68 of 69), respectively. FDG-PET/CT correctly detected nodal disease in 2 patients considered to have node-negative disease by CT alone. Agreement between the imaging results and pathology findings was stronger for FDG-PET/CT (kappa 0.95, 95% confidence interval 0.82-0.99) than for CT alone (kappa 0.81, 95% confidence interval 0.63-0.91; p = 0.06 by two-sided McNemar's testing)., Conclusion: These early findings suggest that FDG-PET/CT is superior to CT alone for geographic localization of diseased neck node levels. Confirmatory trials to substantiate the accuracy of FDG-PET/CT neck staging should be prioritized.

Objective: To perform a cost minimization analysis of total laryngectomy with postoperative radiotherapy vs induction chemotherapy with subsequent radiotherapy in patients with advanced (stage III or IV) squamous cell carcinoma of the larynx., Design: Decision-analysis model using data from peer-reviewed trials, case series, meta-analyses, and Medicare diagnosis related group reimbursement rates., Setting and Patients: A hypothetical cohort of patients with stage III or IV laryngeal cancer. The perspective is that of a health care payer., Interventions: The hypothetical patient cohort could receive (1) surgery (total laryngectomy) with postoperative radiotherapy or (2) induction chemotherapy (fluorouracil and cisplatin) with radiotherapy followed by salvage surgery for patients failing to respond to chemotherapy., Main Outcome Measure: Overall difference in direct medical costs in 2003 US dollars between the 2 treatment arms from initiation to completion of treatment., Results: In the baseline analysis, the direct medical costs for the surgical arm were 30,138 US dollars per patient. For the organ preservation arm, the direct medical costs were 33,052 US dollars per patient. The finding that the surgical arm costs were lower was robust to all sensitivity analyses except for the extreme low estimate for the cost of chemotherapy., Conclusions: Our results suggest that total laryngectomy with postoperative radiotherapy costs nearly 3000 US dollars less than organ preservation treatment for advanced laryngeal cancer. Given that survival appears equivalent between the 2 modalities, cost consideration and patient preference may be important factors in decision making for the treatment of advanced laryngeal cancer.

Objective: To confirm that high pretreatment uptake of 2-deoxy-2[(18)F]fluoro-d-glucose (FDG) detected by positron emission tomography (PET) measured at the primary head and neck squamous cell carcinoma (HNSCC) and at metastatic nodal disease predicts poor outcomes for HNSCC., Design and Patients: We enrolled 63 consecutive patients with a histological diagnosis of HNSCC (including tumors of the oral cavity, oropharynx, larynx, and hypopharynx) from September 2000 through June 2003, into a prospective institutional imaging trial. Fifty-four patients (86%) underwent a baseline FDG-PET scan before curative treatment and were eligible for analysis., Results: A primary tumor standardized uptake value (SUV) of greater than 9.0 predicted inferior local recurrence-free survival (P = .02) and disease-free survival (P = .03). Nodal SUV dichotomized according to the cohort median of 6.1 did not predict for either disease outcome (P = .71 and P = .98, respectively). On proportional hazards analysis, local recurrence and disease event hazard ratios for a primary tumor SUV of 9.0 or greater remained significant or at borderline significance when adjusted for nodal SUV or other clinical covariates., Conclusions: Our findings support an association between baseline primary tumor FDG SUV and HNSCC outcomes. In contrast, nodal FDG SUV was not predictive. Primary tumor FDG SUV is a promising prognostic factor and may establish the need for intensified locoregional therapy in individual patients. Multi-institutional imaging trials and further characterization of the biology responsible for elevated FDG uptake in HNSCC will be necessary to confirm the prognostic utility of FDG-labeled PET.

Objective: To evaluate the long-term quality of life of patients treated for head and neck cancer at a single institution in a developing country., Design: Cross-sectional analysis of a consecutive series of patients., Setting: Tertiary cancer center hospital in Brazil., Patients: Eligible subjects included patients treated between 1974 and 1999 for head and neck carcinoma who had a minimum disease-free survival of 2 years and who completed a Portuguese version of the University of Washington Quality of Life (UW-QOL) questionnaire., Main Outcome Measures: Descriptive analyses of the results and comparisons of the scores for each UW-QOL domain, stratified by tumor site, were performed using nonparametric tests., Results: Findings from 344 patients were analyzed. Of the study population, 140 (41%) had survived 2 to 5 years, 125 (36%) had survived 5 to 10 years, and 79 (23%) had survived more than 10 years since treatment. Primary tumor sites were in the oral cavity in 43.3% of cases, the oropharynx in 20.9%, the larynx in 32.0%, and the hypopharynx in 3.8%. In terms of treatment, 33.1% underwent surgery alone; 16.9%, radiotherapy alone; and 50% underwent combined treatment. Overall, 78.5% of the patients classified their own health as good or excellent. Stratified analysis showed that impairment in chewing and swallowing was more common in patients with oral and oropharyngeal tumors than in those with larynx and hypopharynx tumors, and speech impairment was more frequently related to patients with larynx and hypopharynx tumors than to those with oral and oropharynx tumors. In all tumor sites, the composite scores were significantly worse in advanced tumors than early stage tumors, but the use of combined treatment had the greatest negative impact on quality-of-life scores, after we adjusted for T and N stage with multivariable analyses (P<.001)., Conclusions: The Portuguese version of the UW-QOL questionnaire was an effective tool to evaluate quality of life in a Brazilian population. Although many patients reported some limitations, most reported a good to excellent long-term quality of life.

Objectives: To identify risk factors for and the rate of wound complications after laryngectomy in a large, prospectively collected national dataset, and to generate a predictive model. Study design We used the National Surgical Quality Improvement Program (NSQIP) registry created by the Department of Veterans Affairs (VA) to identify patients undergoing total laryngectomy from 1989 to 1999 (n = 2063). We linked these data to inpatient and outpatient VA administrative records to capture data for prior radiation. Over 20 preoperative and intraoperative risk factors were analyzed using bivariate techniques. Those significant at the P < 0.01 level were analyzed with logistic regression and conjunctive consolidation to identify independent predictors of wound complications., Results: The overall wound complication rate was 10.0%. In adjusted analyses, prolonged operative time (>10 hours, odds ratio = 2.10, 95% confidence interval: 1.32-3.36), exposure to prior radiation therapy (OR =1.63, 1.07-2.46), presence of diabetes (OR =1.78, 1.04-3.04), preoperative hypoalbuminemia (OR =1.90, 1.32-2.74), anemia (OR =1.59, 1.07-2.36), and thrombocytosis (OR =1.48, 1.04-2.10) were independently associated with postoperative wound complications. A prognostic model using three variables-prior radiation therapy, diabetes, and hypoalbuminemia-provided excellent risk stratification into three tiers (6.3%, 13.7%, 21.7%)., Conclusions: Preoperative radiation, prolonged operative time, low albumin, and diabetes were independently associated with postoperative wound infections. These results will help to identify patients at risk for wound complications, thus allowing for heightened surveillance and preventive measures where possible.

Objectives: Continuous positive airway pressure (CPAP) improves sleep apnea survival. We tested whether CPAP is associated with better survival than uvulopalatopharyngoplasty (UPPP)., Study Design and Methods: This retrospective cohort database study included all sleep apnea patients treated with CPAP or UPPP in Veteran Affairs facilities from October 1997 through September 2001. Treatment groups were compared with Cox regression, adjusting for age, gender, race, year treatment was initiated, and comorbidity. Sleep apnea severity and CPAP use data were not available., Results: By September 2002, 1339 (7.1%) of 18,754 CPAP patients and 71 (3.4%) of 2,072 UPPP patients were dead (P < 0.001). After adjustment, CPAP patients had 31% (95% confidence interval, 3% to 67%, P = 0.03) higher probability of being dead at any time, relative to UPPP patients [corrected]., Conclusions: UPPP confers a survival advantage over CPAP, after adjustment for age, gender, race, year of treatment, and comorbidity. However, we were unable to adjust for sleep apnea severity or CPAP use. Surgical treatment should be considered in sleep apnea patients who use CPAP inadequately.

Background: Because survival differences between surgical and nonsurgical treatment for head and neck cancer (HNC) are hard to detect, increasing focus has been placed on quality of life (QOL) differences after treatment. Utility assessment provides insight into QOL. Evidence suggests that a patient's comfort with numerical concepts ("numeracy") may influence utility measures. We hypothesize that patients who are nonnumerate provide inconsistent utility data in QOL studies., Methods: New HNC (n = 18) patients were recruited to participate. Patients completed a numeracy questionnaire, a utility assessment, and a global QOL questionnaire. Higher scores reflect better function. Interviewers rated the functional level of each patient. For both numerate and nonnumerate patients, utility scores were compared with global QOL (good vs poor) and observer-rated function., Results: Half of the patients were numerate. Numerate patients who rated their QOL as good had significantly higher utility scores than did patients with poor global QOL (0.95 vs 0.43, p =.03). In contrast, nonnumerate patients with good QOL had lower utility scores than did patients with poor QOL (0.45 vs 0.77, NS). Utility scores for numerate patients correlated well with observer-rated function (r = 0.41 to r = 0.57), whereas those of nonnumerate patients did not (r = -0.16 to r = 0.06)., Conclusions: QOL evaluation through utility assessment may provide inaccurate and contradictory data about patient functioning for nonnumerate patients. This may confound QOL assessment when interpreting utility data., (Copyright 2004 Wiley Periodicals, Inc. Head Neck 26: 401-407, 2004)

Objectives: To determine the impact of sinus computed tomography (CT) on treatment decisions by otolaryngologists and to explore the factors leading to choice of surgical treatment for patients suspected of having chronic sinusitis., Design: Prospective cohort study., Setting: A tertiary academic medical center., Patients: Questionnaires were administered to 3 otolaryngologists in a tertiary academic institution regarding diagnosis and treatment decisions in 27 patients suspected of having chronic sinusitis, before and after they reviewed sinus CT scans., Main Outcome Measures: The dichotomous decisions regarding surgical or nonsurgical treatment and the agreement of treatment decisions among surgeons were evaluated. The factors strongly influencing surgeons' treatment decisions regarding patients selected for surgery were also determined., Results: The dichotomous treatment decisions were changed in one third of patients (9 of 27) after the sinus CT scans were reviewed. The agreement of treatment decisions among the 3 surgeons was markedly improved after they reviewed sinus CT scans. The factors favorably influencing surgical treatment were obstruction of the ostiomeatal complex on CT and concordance of CT abnormality with a patient's symptoms. Lund-Mackay stage, symptoms, and corticosteroid or antibiotic use were not significant predictors., Conclusions: Despite the common belief that treatment decisions for chronic sinusitis should be solely based on clinical grounds, with sinus CT providing only anatomic detail before surgery, our study indicates that the decision to perform surgery was altered by CT in a substantial portion of the patients. In our preliminary study, CT increased the tendency to elect surgical treatment by all 3 surgeons.

Background: While obstructive sleep apnea syndrome is defined by both polysomnographic (PSG) abnormalities and symptoms, severity is quantified primarily by the apnea-hypopnea index (AHI) alone., Objective: To determine the correlation between standard PSG indices (AHI and others) and self-reported sleepiness, mental health status, and general health in patients with sleep apnea., Design: Cross-sectional study., Setting: University-affiliated outpatient sleep laboratory., Patients: Ninety-six consecutive patients with PSG-confirmed sleep apnea (AHI >or=5)., Measurements: Patients completed a questionnaire that included the Epworth Sleepiness Scale, Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) mental health domain, and self-rated health on the evening of diagnostic PSG. Spearman correlation coefficients were computed. This sample had 85% power to detect a correlation of 0.3 or greater. The associations between PSG indices and self-reported measures were further assessed with multivariable regression techniques, adjusting for age, sex, body mass index, comorbidity, and PSG type., Results: The PSG parameters correlated poorly with self-reported measures (15 correlations; range of magnitude, 0.004-0.24; mean, 0.09). AHI was not associated with self-reported sleepiness or general health, and it was associated with the SF-36 Health Status mental health domain only on multiple linear regression (P =.04) but not on multiple logistic regression (adjusted odds ratio, 1.02; 95% confidence interval, 1.00-1.04; P =.09)., Conclusions: In general, PSG measures, and AHI in particular, correlated poorly with self-reported measures in a clinical sleep laboratory sample. After adjustment for potentially confounding variables, weak associations were found between some PSG indices and selected self-reported measures. These findings suggest that sleep apnea disease burden should be quantified with both physiologic and subjective measures.

Objective: Our goal was to assess disease-specific quality of life outcomes after nasal septoplasty in adults with nasal obstruction., Design, Settings, and Patients: We conducted a prospective observational outcomes multicenter study with 14 sites and 16 investigators, including private practice and academic settings. Patients had had septal deviation and symptomatic nasal obstruction for at least 3 months, and medical management had failed., Methods: Patients with septal deviation completed a validated outcomes instrument (the Nasal Obstruction Septoplasty Effectiveness [NOSE] scale) before and 3 and 6 months after septoplasty, with or without partial turbinectomy., Results: Fifty-nine patients underwent surgery; there was a significant improvement in mean NOSE score at 3 months after septoplasty (67.5 versus 23.1, P < 0.0001), and this improvement was unchanged at 6 months. Patient satisfaction was very high, and patients used significantly fewer nasal medications., Conclusions: In patients with septal deformity, nasal septoplasty results in significant improvement in disease-specific quality of life, high patient satisfaction, and decreased medication use.

Objective: The study goal was to validate a disease-specific health status instrument for use in patients with nasal obstruction.Design, settings, and patients The study consisted of a prospective instrument validation conducted at 4 academic medical centers with 32 adults with nasal septal deformity., Methods: Prospective instrument validation occurred in 2 stages. Stage 1 was the development of a preliminary (alpha-version) instrument of potential items. Stage 2 was a test of the alpha-version for item performance, internal consistency, and test-retest reliability; construct, discriminant, criterion validity, and responsiveness; and creation of the final instrument., Results: Items with poor performance were eliminated from the alpha-version instrument. In testing the final instrument, test-retest reliability was adequate at 0.702; internal consistency reliability was also adequate at 0.785. Validity was confirmed using correlation and comparison analysis, and response sensitivity was excellent., Conclusions: The Nasal Obstruction Symptom Evaluation Scale is a valid, reliable, and responsive instrument that is brief and easy to complete and has potential use for outcomes studies in adults with nasal obstruction.

Introduction: Limited information is available regarding surveillance patterns after head and neck cancer radiotherapy. We cataloged follow-up for a specified patient cohort treated at three neighboring university, community, and Veterans Administration institutions., Methods: One hundred fifteen patients were treated with curative intent between 1994-1998 with definitive or postoperative radiotherapy for newly diagnosed squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx. One hundred patients had continuous follow-up at their treating institution and were included for analysis. Median follow-up until disease recurrence or censorship was 28.5 months., Results: Median follow-up frequency was 5.7 visits/year and was highly variable. Although visit frequency correlated with disease stage and the presence of high-risk disease features, this association was lost when patients with early recurrences were removed from analysis. Procedure and test utilization closely mirrored visit frequency, resulting in a wide range of estimated yearly charges (0-15,668 dollars/year; median, 1,772 dollars/year). Actuarial 3-year overall survival for the study group was 71%. Eighty-six percent (19 of 22) of potentially salvageable locoregional failures were discovered secondary to symptomatic complaint rather than by test results. Disease failure, whether detected by symptom or testing, predicted for poor survival (22% at 24 months after recurrence)., Conclusions: Postradiotherapy surveillance for head and neck cancer is inconsistently pursued. A proven correlation between intensive follow-up and improved patient survival is lacking. Surveillance directed by patient symptoms should be investigated as an alternative approach., (Copyright 2003 Wiley Periodicals, Inc. Head Neck 25: 000-000, 2003)

Background: Accurate baseline staging is necessary to appropriately treat head and neck squamous cell carcinoma. [F-18]-fluorodeoxyglucose positron emission tomography (FDG-PET) is valuable for locoregional staging of primary head and neck disease. The effectiveness of FDG-PET for the detection of distant metastatic or synchronous disease remains unproven., Objective: To investigate the utility of FDG-PET extended into the abdomen (extended-field FDG-PET) for wide-field staging of head and neck tumors., Methods: This is a prospective institutional study of 35 consecutive patients diagnosed with American Joint Committee on Cancer (AJCC)-defined stage II-IV squamous cell carcinoma of the oral cavity, oropharynx, or larynx between September 2000 and June 2002. Thirty-three patients (94%) were eligible for analysis. All patients were routinely staged with chest radiography, liver function tests, and extended-field FDG-PET. Chest or abdominal computed tomographic scans were used as corroborative studies and were obtained only when one of the above tests indicated distant disease., Results: Of 33 patients, 7 (21%) had evidence of distant disease by extend-field FDG-PET-4 with metastases and 3 with synchronous primary cancers of the aerodigestive tract. [F-18]-fluorodeoxyglucose PET detected hepatic, bone, gastrointestinal, and mediastinal disease not identified by chest radiography or liver function tests. Two of the 7 patients with FDG-avid distant disease had false-negative staging by all other tests, including computed tomography., Conclusions: Extended-field FDG-PET is feasible and may improve staging of primary head and neck squamous cell carcinoma. Use of staging FDG-PET must be explicitly described in reports from centers engaged in prospective research to facilitate comparison with historical results.

Sinusitis is a highly prevalent disease, with a significant impact on the health care economy. Sinus CT is the primary imaging modality for evaluation of acute and chronic sinusitis. The roles of CT for patients with sinusitis are to assist clinical diagnosis, to evaluate the extent of disease, and to provide detailed anatomy necessary for treatment planning. Although sinus CT has been criticized for lack of specificity and correlation with patients' clinical symptoms, sinus CT may provide pivotal objective information that affects treatment decisions for acute and chronic sinusitis. This article provides a clinical overview and reviews the role of imaging studies in diagnosis and treatment of sinusitis.

Context: Hearing loss is the third most prevalent chronic condition in older adults and has important effects on their physical and mental health. Despite these effects, most older patients are not assessed or treated for hearing loss., Objective: To review the evidence on screening and management of hearing loss of older adults in the primary care setting., Data Sources and Study Selection: We performed a search from 1985 to 2001 using MEDLINE, HealthSTAR, EMBASE, Ageline, and the National Guideline Clearinghouse for articles and practice guidelines about screening and management of hearing loss in older adults, as well as reviewed references in these articles and those suggested by experts in hearing impairment., Data Extraction: We reviewed articles for the most clinically important information, emphasizing randomized clinical trials, where available, and identified 1595 articles., Data Synthesis: Screening tests that reliably detect hearing loss are use of an audioscope, a hand-held combination otoscope and audiometer, and a self-administered questionnaire, the Hearing Handicap Inventory for the Elderly-Screening version. The value of routine screening for improving patient outcomes has not been evaluated in a randomized clinical trial. Screening is endorsed by most professional organizations, including the US Preventive Services Task Force. While most hearing loss in older adults is sensorineural and due to presbycusis, cerumen impaction and chronic otitis media may be present in up to 30% of elderly patients with hearing loss and can be treated by the primary care clinician. In randomized trials, hearing aids have been demonstrated to improve outcomes for patients with sensorineural hearing loss. Nonadherence to use of hearing aids is high. Prompt recognition of potentially reversible causes of hearing loss, such as sudden sensorineural hearing loss, is important to maximize the possibility of functional recovery., Conclusion: While untested in a clinical trial, older adults can be screened for hearing loss using simple methods, and effective treatments exist and are available for many forms of hearing loss.

Hearing loss is one of the most common chronic health conditions and has important implications for patient quality of life. However, hearing loss is substantially underdetected and undertreated. We present clinical cases to illustrate common situations in which primary care physicians may be called on to identify or to manage hearing loss. With the data reported in the companion scientific review as a guide, we present potential answers to important questions pertaining to hearing loss and suggest ways in which primary care physicians can improve the detection, evaluation, and treatment of hearing loss. The cases focus on screening for chronic hearing loss, evaluation of hearing loss, and treatment of patients with presbycusis.

Objective: To review surgical outcomes in the management of advanced mandibular osteoradionecrosis (ORN) with aggressive debridement and microvascular reconstruction., Design: Retrospective cohort study., Setting: Tertiary care referral center., Patients: Thirty patients with Marx stage III ORN of the mandible who underwent debridement with microvascular reconstruction. Two types of patients with stage III disease were included: those who had not received prior hyperbaric oxygen (HBO) therapy but who presented with a pathologic fracture, orocutaneous fistula, or bony resorption of the inferior border of the mandible (group 1, n = 9), and those who were classified as having stage III disease as a result of failure of previous debridement and HBO therapy (group 2, n = 21)., Main Outcome Measure: Clinical resolution of ORN as well as surgical perioperative complications., Interventions: Debridement and primary free flap reconstruction in all patients; Perioperative HBO therapy in 3 patients., Results: The overall complication rate was 43%, but 29 (97%) of 30 patients had clinical resolution of their ORN. There were no flap failures. After smoking status and use of perioperative HBO were adjusted for, patients with Marx stage III disease who had received prior HBO therapy (group 2) were significantly more likely to have postoperative wound infection (P =.01) and overall surgical complications (P =.04) than were patients with stage III disease who had never been treated with HBO (group 1). Perioperative HBO therapy was provided too infrequently to comment on its effectiveness., Conclusions: Microvascular reconstruction is effective in the treatment of patients with mandibular ORN. Management of mandibular ORN can be successfully achieved without the use of perioperative HBO therapy. Because only 3 patients received perioperative HBO therapy, we are unable to comment on its potential benefit. Patients in whom prior HBO therapy has failed are significantly more likely to have surgical complications than are other patients with Marx stage III disease, and further study is required to improve outcomes in this subgroup of patients.

Background: Critical pathways have been purported to decrease resource utilization in the management of head and neck cancer. Prior reports have documented shorter lengths of stay (LOS) for pathway patients than for historical cohorts., Objective: To critically evaluate the impact of critical pathways on LOS after laryngectomy., Design: Length-of-stay trends of 2 concurrent observational cohorts of laryngectomy patients (September 1992 to February 1999) were compared, 1 at each of 2 medical centers. One center instituted a critical pathway for laryngectomy patients in February 1997; the other never used such pathways. In addition, we examined the independent impact of the critical pathway at the pathway institution after controlling for date of laryngectomy (which reflected temporal trends) and other confounding variables., Results: Both centers experienced reductions in LOS after February 1997, but there was no statistically significant difference between the reductions (1.9 days at the pathway center vs 1.5 days at the nonpathway center; P>.05). Multivariable linear and linear spline regression models demonstrated that the use of critical pathways at the pathway institution had no statistically significant impact on LOS after controlling for the date of laryngectomy., Conclusions: Pathway implementation has a limited direct impact on LOS in relatively low-volume procedures such as laryngectomy. Although pathways may influence utilization trends, their impact is likely mediated by the development and educational process that accompanies pathway adoption rather than implementation of the pathway itself. The inclusion of temporal trends and contemporary cohorts provides substantial insight into the effectiveness of critical pathways.

Objective: Our goal was to measure the impact of chronic rhinosinusitis (CRS) on the use and cost of health care by adults in a health maintenance organization (HMO)., Setting and Subjects: In the setting of the Group Health Cooperative, an HMO in Washington State, we conducted a study of all 218,587 adults (>/=18 years) who used services during 1994. Using automated data, 20,175 adults were identified with one or more CRS diagnoses during 1994., Outcome Measures: We identified nonurgent outpatient visits, pharmacy fills, urgent visits, hospital days, and their associated costs (per adult per year)., Results: The marginal utilization associated with a diagnosis of CRS was 2.0 nonurgent outpatient visits, 5.1 pharmacy fills, 0.01 urgent visit, and -0.07 hospital day. The marginal total cost of CRS was $206., Conclusions: Adults with CRS had higher costs primarily because of increased nonurgent outpatient visit and pharmacy fill utilization. The overall direct cost of CRS in the United States in 1994 is estimated to have been $4.3 billion.

Background: The prognosis of patients with recurrent tumors of the head and neck generally is considered poor. Better prediction of outcomes can help physicians counsel patients about the merits of additional treatment. The TNM system, which was created for patients with primary tumors, may not provide optimal information. Anatomic staging systems traditionally have ignored symptom-based variables, such as weight loss, despite their known prognostic value. The objectives of this study were 1) to measure the prognostic impact of weight loss, 2) to evaluate the prognostic value of the TNM staging system, and 3) to create a practical staging system capable of predicting survival after patients develop recurrent tumors of the oral cavity and oropharynx., Methods: A retrospective chart review was used to identify an inception cohort of patients seeking treatment for recurrent, persistent, and second primary tumors of the oral cavity and oropharynx at the University of Washington. The primary outcome variable was 1-year survival., Results: The 1-year survival rate for the cohort (n = 97 patients) was 38%, with a median survival of 0.7 years. Multivariate analysis (Cox regression) identified weight loss, previous radiation to the head and neck, and TNM stage of the recurrent tumor as factors that had a substantial impact on mortality. A second multivariate technique called conjunctive consolidation was used to determine the relative quantitative impact of each variable on survival and to develop a clinical staging system. Weight loss and previous radiation had the greatest influence, and the use of just these two variables resulted in a three-tiered staging system with 1-year survival rates of 62% (16 of 26 patients), 44% (18 of 41 patients), and 10% (3 of 30 patients). In contrast, the TNM staging system produced survival rates of 60% (patients with Stage I disease), 67% (patients with Stage II disease), 32% (patients with Stage III disease), and 32% (patients with Stage IV disease)., Conclusions: The authors found substantial variation in survival after patients developed recurrent tumors of the oral cavity and oropharynx. Two readily available clinical variables--weight loss and previous radiation--were combined to create a clinically practical staging scheme with more prognostic power than the TNM staging system. Until molecular markers can reliably used be to predict outcomes, greater attention needs to be given to the utility of simple, inexpensive, and surprisingly powerful clinical variables., (Copyright 2002 American Cancer Society.)

Background: There are numerous head and neck specific quality of life questionnaires, each having its own merits and disadvantages. The University of Washington questionnaire has been widely used and is notable by the inclusion of a shoulder dysfunction domain, domain importance ratings, and patient free text. It is short, simple to process, and provides clinically relevant information. However, it has lacked any psychological dimension of quality of life. The aim of this study was to report the inclusion of two psychological domains (mood, anxiety) to the most recent refinement of the questionnaire (version 3)., Method: A cross-sectional survey was performed in April 2000. Questionnaires were sent to 183 patients alive and disease free after surgery for oral and oro-pharyngeal malignancy. Replies were received from 145 patients (79% response rate)., Results: The new domains (mood and anxiety) correlated significantly with the emotional functioning domains from the EORTC C30 and with the pain and appearance domains of UW-QOL. There were also significant correlations between the "global quality of life" item and the two new domains. Mood (p =.005) and anxiety (p <.001) scores were associated with patient age but with no other clinicodemographic variable., Conclusion: The addition of mood and anxiety domains makes the UW-QOL version 4 a single broad measure suitable for effective health-related quality of life evaluation in the routine clinical setting., (Copyright 2002 Wiley Periodicals, Inc.)

Resource allocation in health care is increasingly guided by financial considerations. The cost of care influences treatment decisions not only for health care organizations but also for patients, especially in the fee-for-service marketplace that typifies cosmetic surgery. The purposes of this article are to improve the facial plastic surgeon's understanding of cost analyses and to facilitate critical reading of the literature. We describe basic concepts in economic analyses, such as perspective of analysis, the difference between costs and charges, and the importance of discounting. We also introduce the importance of assessing treatment effectiveness and quality of care. In a review of existing cost-based studies in facial plastic surgery, we found a paucity of rigorous treatment analyses. There are numerous opportunities to pursue economic analysis in facial plastic surgery. We discuss potentially rewarding directions for future research.

In order to optimize the delivery of multidisciplinary cancer care to veterans, our institution has developed a regional cancer center with a telemedical outreach program. The objectives of this report are to describe the organization and function of the telemedical cancer center and to report our early clinical results. The Veterans Affairs Health Care System is organized into a series of integrated service networks that serve veterans within different areas throughout the United States. Within Veterans Integrated Service Network 20 (Washington, Alaska, Idaho, Oregon) we have developed a regional cancer center with telemedicine links to four outlying facilities within the service area. The telemedical outreach effort functions through the use of a multidisciplinary telemedicine tumor board. The tumor board serves patients in outlying facilities by providing comprehensive, multidisciplinary consultation for the complete range of malignancies. For individuals who do require referral to the cancer center, the tumor board serves to coordinate the logistical and clinical details of the referral process. This program has been in existence for 1 year. During that time 85 patients have been evaluated in the telemedicine tumor board. Sixty-two percent of the patients were treated at their closest facility; 38% were referred to the cancer center for treatment and/or additional diagnostic studies. The patients' diagnoses included the entire clinical spectrum of malignant disease. Preliminary clinical results demonstrate the program is feasible and it improves access to multidisciplinary cancer care. Potential benefits include improved referral coordination and minimization of patient travel and treatment delays.