International guidelines for the diagnosis and management of hereditary haemorrhagic telangiectasia.

BACKGROUND: HHT is an autosomal dominant disease with an estimated prevalence of at least 1/5000 which can frequently be complicated by the presence of clinically significant arteriovenous malformations in the brain, lung, gastrointestinal tract and liver. HHT is under-diagnosed and families may be unaware of the available screening and treatment, leading to unnecessary stroke and life-threatening hemorrhage in children and adults. OBJECTIVE: The goal of this international HHT guidelines process was to develop evidence-informed consensus guidelines regarding the diagnosis of HHT and the prevention of HHT-related complications and treatment of symptomatic disease. METHODS: The overall guidelines process was developed using the AGREE framework, using a systematic search strategy and literature retrieval with incorporation of expert evidence in a structured consensus process where published literature was lacking. The Guidelines Working Group included experts (clinical and genetic) from eleven countries, in all aspects of HHT, guidelines methodologists, health care workers, health care administrators, HHT clinic staff, medical trainees, patient advocacy representatives and patients with HHT. The Working Group determined clinically relevant questions during the pre-conference process. The literature search was conducted using the OVID MEDLINE database, from 1966 to October 2006. The Working Group subsequently convened at the Guidelines Conference to partake in a structured consensus process using the evidence tables generated from the systematic searches. RESULTS: The outcome of the conference was the generation of 33 recommendations for the diagnosis and management of HHT, with at least 80% agreement amongst the expert panel for 30 of the 33 recommendations.

[Quality of life in patients with chronic rhinosinusitis: validation of the Sino-Nasal Outcome Test-20 German Adapted Version]. / Lebensqualität bei Patienten mit chronischer Rhinosinusitis: Validierung des Sino-Nasal Outcome Test-20 German Adapted Version.

BACKGROUND: No validated German instrument for measuring health-related quality of life (QOL) in patients with chronic rhinosinusitis (CRS) has been available to date. METHODS: The Sino-Nasal Outcome Test-20 German Adapted Version (SNOT-20 GAV) is a translated and adapted version of SNOT-20. To validate this instrument, we evaluated its reliability, validity and sensitivity. SNOT-20 GAV was completed by 163, 123, and 82 patients at the initial visit and at 3 months and 1 year after treatment commencement, respectively. RESULTS: Cronbach's alpha indicated good internal consistency. Test-retest scores in 38 patients were highly correlated. Discrimination validity was demonstrated by a comparison with healthy controls. Sensitivity to change showed medium to large effects. CONCLUSIONS: SNOT-20 GAV is the first reliable, validated and sensitive German instrument for measuring health-related QOL in patients with CRS.

Chromosome 8 allelic loss and the outcome of patients with squamous cell carcinoma of the supraglottic larynx.

BACKGROUND: Loss of genetic heterogeneity (allelic loss or loss of heterozygosity) on chromosome arm 8p is frequent in squamous cell carcinomas of the head and neck and has been associated with poor prognosis. We have previously demonstrated that there are three minimal regions of allelic loss on this chromosome arm. The location of each region is marked by a microsatellite locus: D8S264 (8p23), D8S552 (8p23-p22), and D8S133 (8p21). These findings imply the existence of at least three putative tumor suppressor genes on this chromosome arm that may become inactivated during the progression of squamous cell carcinoma. PURPOSE: We used allelic loss data from these three loci to determine if inactivation of these putative suppressors is associated with poor prognosis for patients with squamous cell carcinoma of the supraglottic larynx. We also used multivariate statistics to compare the prognostic power of allelic loss at these genetic markers with that of demographic, clinical, and histopathologic parameters. METHODS: We examined the D8S264, D8S552, and D8S133 microsatellites in tumors from a retrospective population of 59 patients. All patients had histologically confirmed squamous cell carcinoma of the supraglottic larynx and had been treated surgically. DNA was extracted from matched sets of normal and microdissected tumor tissue and used for polymerase chain reaction amplification of the microsatellite markers. Reaction products were separated by denaturing gel electrophoresis and visualized by autoradiography. Patient data were obtained from the original pathology report and from the tumor registry of the Department of Otolaryngology-Head and Neck Surgery, Washington University School of Medicine, St. Louis, MO. Histopathologic data were obtained by reviewing the portion of the resection specimen used for DNA extraction. Parameters whose association with reduced disease-free interval and reduced disease-specific survival was statistically significant were identified by use of the Kaplan-Meier method and the logrank statistic. Multivariate Cox proportional hazards models were used to identify independent predictors of poor prognosis. All statistical tests were two-sided. RESULTS: In this patient population, allelic loss at the D8S264 locus was associated with both shorter disease-free interval (logrank P = .028) and reduced disease-specific survival (logrank P = .004). Allelic loss at the next most centromeric locus, D8S552, had a statistically significant association with only reduced disease-specific survival (logrank P = .034), whereas allelic loss at the most centromeric region, D8S133, showed no statistically significant association with reductions in either interval. Multivariate Cox models suggested that D8S264 was the only 8p marker of the three microsatellites with a statistically significant and independent association with shortened disease-free interval (relative risk [RR] = 3.38; P = .0107) and reduced disease-specific survival (RR = 3.41; P = .0105). CONCLUSIONS: Allelic loss in the p23 region of chromosome 8 appears to be a statistically significant, independent predictor of poor prognosis in patients with supraglottic squamous cell carcinoma.

Pathology-based staging for HPV-positive squamous carcinoma of the oropharynx.

OBJECTIVE: The rapid worldwide rise in incidence of human papillomavirus (HPV)-positive oropharyngeal squamous cell carcinoma (OPSCC) has generated studies confirming this disease as an entity distinct from traditional OPSCC. Based on pathology, surgical studies have revealed prognosticators specific to HPV-positive OPSCC. The current AJCC/UICC staging and pathologic nodal (pN)-classification do not differentiate for survival, demonstrating the need for new, HPV-specific OPSCC staging. The objective of this study was to define a pathologic staging system specific to HPV-positive OPSCC. METHODS: Data were assembled from a surgically-managed, p16-positive OPSCC cohort (any T, any N, M0) of 704 patients from five cancer centers. Analysis was performed for (a) the AJCC/UICC pathologic staging, (b) newly published clinical staging for non-surgically managed HPV-positive OPSCC, and (c) a novel, pathology-based, "HPVpath" staging system that combines features of the primary tumor and nodal metastases. RESULTS: A combination of AJCC/UICC pT-classification and pathology-confirmed metastatic node count (⩽4 versus ⩾5) yielded three groups: stages I (pT1-T2, ⩽4 nodes), II (pT1-T2, ⩾5 nodes; pT3-T4, ⩽4 nodes), and III (pT3-T4, ⩾5 nodes), with incrementally worse prognosis (Kaplan-Meier overall survival of 90%, 84% and 48% respectively). Existing AJCC/UICC pathologic staging lacked prognostic definition. Newly published HPV-specific clinical stagings from non-surgically managed patients, although prognostic, showed lower precision for this surgically managed cohort. CONCLUSIONS: Three loco-regional "HPVpath" stages are identifiable for HPV-positive OPSCC, based on a combination of AJCC/UICC primary tumor pT-classification and metastatic node count. A workable, pathologic staging system is feasible to establish prognosis and guide adjuvant therapy decisions in surgically-managed HPV-positive OPSCC.

Methodological and statistical problems in sleep apnea research: the literature on uvulopalatopharyngoplasty.

A comprehensive review of the literature on the surgical treatment of sleep apnea found 37 appropriate papers (total n = 992) on uvulopalatopharyngoplasty (UPPP). Methodological and statistical problems in these papers included the following: 1) There were no randomized studies and few (n = 4) with control groups. 2) Median sample size was only 21.5; thus statistical power was low and clinically important associations were routinely classified as "not statistically significant". 3) Only one paper presented the confidence bounds that might distinguish between statistical and clinical significance. 4) Because of short follow-up time and infrequent repeat follow-ups, little is known about whether UPPP results deteriorate with time. 5) In at least 15 papers, bias caused by retrospective designs and nonrandom loss to follow-up raised questions about the generalizability of results. 6) Few papers associated polysomnographic data with patient-based quality of life measures. 7) Missing data and missing and inconsistent definitions were common. 8) Baseline measures were often biased because the same assessment was inappropriately but routinely used for both screening and baseline. We conclude that because of these and other problems, there is much that is needlessly unknown about UPPP. It is the responsibility of the research and professional communities to define training, editorial and review procedures that will raise the methodological and statistical quality of published research.

The efficacy of surgical modifications of the upper airway in adults with obstructive sleep apnea syndrome.

This paper, which has been reviewed and approved by the Board of Directors of the American Sleep Disorders Association, provides the background for the Standards of Practice Committee's parameters for the practice of sleep medicine in North America. The intent of this paper is to provide an overview of the surgical treatment of obstructive sleep apnea syndrome, to provide the basis for the American Sleep Disorders Association's practice parameters on this subject and to share our findings of metanalysis of previously published studies regarding uvulopalatopharyngoplasty. We searched MEDLINE from January 1966 through April 1993, with an update in February 1995, to provide a review of the application of surgical modifications of the upper airway to treat adults with obstructive sleep apnea syndrome. Operations to treat obstructive sleep apnea syndrome include nasal septal reconstruction; uvulopalatopharyngoplasty; uvulopalatopharyngoglossoplasty; laser midline glossectomy; lingualplasty; inferior sagittal mandibular osteotomy and genioglossal advancement, with hyoid myotomy and suspension (the entire process is referred to as GAHM); maxillomandibular osteotomy and advancement, and tracheotomy. Papers included in metanalysis provided preoperative and postoperative polysomnographic data on at least nine patients treated with uvulopalatopharyngoplasty for their obstructive sleep apnea. Analysis of the uvulopalatopharyngoplasty papers revealed that this procedure is, at best, effective in treating less than 50% of patients with obstructive sleep apnea syndrome. The site of pharyngeal narrowing or collapse, although identified by different and unvalidated methods, has a marked effect on the probability of success of uvulopalatopharyngoplasty. Patients who achieve a favorable response with uvulopalatopharyngoplasty tend to have less severe obstructive sleep apnea than those who do not. For patients who demonstrate retrolingual narrowing or collapse, other surgical modifications have been described, such as lingualplasty, GAHM, and maxillomandibular osteotomy and advancement. The studies to support the use of the surgical treatment of obstructive sleep apnea syndrome contain biases related to small sample size, limited follow-up and patient selection.

Inclusion of comorbidity in a staging system for head and neck cancer.

The widespread use of the TNM staging system has helped standardize the classification of cancers. Despite its excellence in describing a tumor's size and extent of anatomic spread, the TNM system does not account for the clinical biology of the cancer. Clinical factors, such as symptom severity, performance status, and comorbidity, which are important for classification, prognostication, and evaluation of treatment effectiveness, remain excluded from this system. In several studies of cancer prognosis, the presence of severe comorbidity was found to dramatically influence survival statistics and the evaluation of treatment effectiveness. A statistical technique known as conjunctive consolidation was used to incorporate comorbidity into the TNM staging system and maintain the four category system. Utilizing this technique, comorbidity was added to the TNM system for laryngeal cancer to create a composite staging system. Quantitative evaluation of the new system showed that the addition of comorbidity provides improved prognostic precision over TNM stage alone.

Decision analysis of treatment options in pyriform sinus carcinoma.

Decision analysis was used to evaluate the current treatment options for stage III squamous cell carcinoma of the pyriform sinus (surgery, radiation therapy, and combined surgery/radiation therapy). Using published data, a decision tree was constructed based on quality-adjusted weeks of survival. With this model the combination of surgery and postoperative radiation therapy is preferred over either primary surgery or the combination of preoperative irradiation and surgery; primary radiation therapy is least favored. The decision is quite sensitive to the augmentation in survival that postoperative radiation therapy seems to provide over primary surgery. The decision is somewhat sensitive to the operative mortality rate and to the probability of disease-free survival following surgery. Quality of life issues emerge as important variables which need to be considered when planning treatment for patients with stage III pyriform sinus carcinoma.

Outcomes research and obstructive sleep apnea.

Sleep disorders in general and obstructive sleep apnea syndrome in particular are prevalent health problems. This report describe the methodology and findings from a prospective multicenter outcomes research study on obstructive sleep apnea syndrome that was conducted by the American Academy of Otolaryngology-Head and Neck Surgery. Other outcome measures available for outcomes research in obstructive sleep apnea syndrome are also summarized.

Importance of comorbidity in head and neck cancer.

OBJECTIVES/HYPOTHESIS: Patients with head and neck cancer are staged according to the morphology of the tumor with little or no attention given to the importance of the other diseases, illnesses, or conditions. These other conditions are generally referred to as comorbidities. Although not a feature of the cancer itself, comorbidity is an important attribute of the patient with cancer. Comorbidity has direct impact on the care of patients, selection of initial treatment, and evaluation of treatment effectiveness. The objective of this thesis is to demonstrate the importance of comorbidity in head and neck cancer. Specifically, the aims are 1) to demonstrate the burden of comorbidity among head and neck cancer patients by comparing the incidence of none, mild, moderate, and severe comorbidity among patients with head and neck cancer to patients with cancers of the colorectum, lung, breast, gynecological sites, or prostate, 2) to demonstrate the independent impact of comorbidity on overall survival, and 3) to demonstrate the importance of comorbidity in the assessment of initial treatment effectiveness. STUDY DESIGN: This was a prospective cohort study of the impact of comorbidity on head and neck cancer patients presenting for treatment between January 1995 and December 1996. METHODS: In 1994, the author trained cancer registrars at an academic teaching hospital to code comorbidity from the medical record of new patients using a standard comorbidity index. Standard statistical techniques, including multivariable analysis, were used to compare and contrast the burden of comorbidity for patients with different cancers. Life survival techniques and multivariable logistic regression analysis were used to assess the independent prognostic impact of comorbidity. Further, the technique of conjunctive consolidation was used to augment the TNM system with comorbidity information, to more completely assess the impact of different initial treatments for patients with head and neck cancers. RESULTS: The cohort consisted of 3,378 patients with cancers of the head and neck (341), colorectum (307), lung (655), breast (483), gynecological sites (482), and prostate (1,110). The percentage of head and neck cancer patients with moderate to severe comorbidity was 21%; this degree of comorbidity burden was second only to patients with lung (40%) and colorectal (25%) cancer. There was a significant relationship between severity of comorbidity and overall survival (log-rank test, chi2 = 15.75; P < .0013). For cancers of the head and neck, lung, breast, and prostate the prognostic significance of comorbidity remained even after controlling for other factors, such as age and TNM stage. CONCLUSIONS: The results of this study show that comorbidity is an important feature of patients with head and neck cancer. Valid instruments exist to measure and classify the overall severity of comorbidity. The scientific evaluation of treatment and the care of patients are impeded by a rigid adherence to a staging system based solely on morphological descriptions of the cancer while ignoring suitable descriptions of the patient. The author believes that the addition of comorbidity information will improve the value of cancer statistics and the care of cancer patients.

Ciprofloxacin for the treatment of chronic ear disease.

The treatment of chronic ear disease is often difficult and frustrating. Patients typically present with a history of chronic, persistent otorrhea that has failed to respond to multiple topical and oral antibiotics. Organisms that are resistant to multiple antibiotics are common. Ciprofloxacin has been shown to be effective against a wide range of gram-negative and gram-positive organisms. To evaluate the role of ciprofloxacin in the treatment of chronic ear disease, 21 patients who failed routine therapy for chronic ear disease were prospectively treated with oral ciprofloxacin. Prior to therapy, all ear cultures grew Pseudomonas aeruginosa, Staphylococcus aureus or other gram-negative organisms. Ninety-five percent of patients completing therapy showed either improvement or cure. Only one patient failed to improve. Ciprofloxacin has been shown to be effective in the management of chronic ear disease.

Indications for sinus surgery: how appropriate are the guidelines?

Sinusitis is the most commonly reported chronic disorder in America. More than 75,000 sinus surgical procedures were performed in 1993. Evaluating the appropriateness of procedures is a major focus of health care reform. The American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) collaborated with Value Health Sciences, Inc. (VHS) to develop guidelines for the use of sinus surgery. The clinical utility of these guidelines is presented. Patients undergoing sinus surgery at Barnes Hospital in St. Louis, Missouri, between November 1994 and July 1995 were eligible. Relevant patient information was used to prospectively rate surgery on the nine-point VHS appropriateness scale (1 to 3, inappropriate; 4 to 6, equivocal; 7 to 9, appropriate). Of 55 patients, 37 (67%) had chronic sinusitis, 10 (18%) recurrent sinusitis, five (9%) chronic sinusitis with nasal polyps, and three (6%) sinusitis with moderate to severe asthma; 27 (49%) had previous sinus surgery. Appropriateness ratings ranged from 1 to 9, with nine (16%) procedures rated as inappropriate, 22 (40%) uncertain, and 24 (44%) appropriate. There were no significant differences in the ratings of appropriateness between the group of patients who had undergone previous sinus surgery and the group of patients who had not. Overall, the guidelines were easily applied and clinically pertinent.

Chemoradiation for metastatic SCCA: role of comorbidity.

OBJECTIVES: A previous study of 371 patients with extracapsular spread (ECS) of cervical metastases from squamous cell carcinoma (SCCA) of the head and neck revealed a survival advantage for patients treated with adjuvant chemoradiation, compared with those treated with surgery and radiation or surgery alone. While all patients in the study were offered adjuvant chemotherapy, only 35% selected this option. Comorbidity was identified as a reason for declining chemotherapy. Recently, Piccirillo demonstrated that the Modified Medical Comorbidity Index (MMCI) is a valid instrument to classify and quantify severity of comorbidity. We applied this instrument to previously reported patients with ECS to determine 1) how comorbidity affected treatment selection, 2) whether the survival advantage of adjuvant chemoradiation persisted after controlling for comorbidity, and 3) the impact of comorbidity on outcome. STUDY DESIGN: This was a nonrandomized, retrospective study. METHODS: Patients in the initial study underwent resection of the primary tumor and neck dissection. Eligible patients elected to receive chemoradiation, radiation, or no further treatment. Comorbidity scores were assigned according to the MMCI. Data were analyzed according to disease-specific survival and overall survival. RESULTS: The study population consisted of 330 patients. More severe comorbidity was related to higher overall mortality rates after controlling for treatment. Adjuvant chemoradiation resulted in improved disease-specific and overall survival compared with adjuvant radiation after adjusting for severity of comorbidity. CONCLUSIONS: These results substantiate the benefits of adjuvant chemoradiation for patients with SCCA of the head and neck. Furthermore, these results reinforce the importance of comorbidity as a prognostic indicator for this population of patients.

The use of patient satisfaction data to assess the impact of continuous quality improvement efforts.

OBJECTIVE: To quantitatively compare patient satisfaction with the visit to an academic otolaryngology office before and after quality improvement efforts. DESIGN: Survey research of convenience sample of new patients. SETTING: Outpatients offices of the Department of Otolaryngology at Washington University School of Medicine, St Louis, Mo. PATIENTS: New patients seen between November 1993 and March 1994 (phase 1) and November 1995 and February 1996 (phase 2). INTERVENTION: Numerous department-wide quality improvements efforts were begun between phase 1 and phase 2. The Visit Rating Questionnaire, a 9-item patient-based questionnaire, was used to measure patient satisfaction. MAIN OUTCOME MEASURE: The percentage of patients who rated their visit overall as excellent. RESULTS: Overall, 973 patients participated. The percentage of patients who rated their overall visit as excellent was 570 (58%) of 1067, while it was 200 (41%) of 491 for phase 1 and 370 (64%) of 576 for phase 2 (chi 2 = 63.8; P < .001). Using a process control chart for the percentage of patients who rated the visit as excellent demonstrated special cause variation, indicating that the continuous quality improvement efforts had made an impact on patient satisfaction. CONCLUSIONS: The impact of continuous quality improvement efforts can be documented with patient satisfaction measures. The techniques of statistical process control, including the use of control charts, can transform the data from these measures into information that allows for the evaluation of the effectiveness of continuous quality improvement efforts.

Purposes, problems, and proposals for progress in cancer staging.

OBJECTIVE: To learn the opinions of selected members of the American Society for Head and Neck Surgery about the purpose of cancer staging and the problems with the current system, and to use these opinions to suggest improvements. DESIGN: Questionnaire survey. PARTICIPANTS: One hundred one physicians, based on their prominence in the field of head and neck cancer, selected from the society membership directory. OUTCOME MEASUREMENT: Responses to the six questions and other comments provided by the responding physicians. RESULTS: Sixty-six physicians returned the questionnaire. Of the six purposes of cancer staging, comparing end results was rated most important. Considerable variation existed among the respondents in the rank order of importance of the six purposes. The TNM strengths were its simplicity, low cost, relative accuracy, objectivity, universal acceptance, and lack of need for special technology. Weaknesses included inconsistencies, inaccuracies, observer variability, and problems with various T, N, and M classification criteria. Most believed that the TNM system should be expanded to include host factors, such as functional status, severity of comorbidity, immunocompetence, and symptom severity. CONCLUSIONS: These results suggest a wide range of opinion about the purpose of cancer staging. Several problems with the present TNM system, such as the exclusion of additional prognostic factors, limit the usefulness of the system. Progress in cancer staging will occur when the current system is augmented by these prognostic factors.

Histiocytic necrotizing lymphadenitis (Kikuchi's disease).

Histiocytic necrotizing lymphandenitis (HNL), or Kikuchi's disease, is a newly recognized disease of unknown origin that causes cervical lymphadenitis, usually in young women. Initially described in Japan, cases of HNL are being reported in the United States and other western countries with increasing frequency. Symptoms of HNL include tender cervical adenopathy, fever, weight loss, and night sweats. Laboratory studies reveal leukopenia with relative granulocytopenia and lymphocytosis. Lymph node biopsy reveals areas with frank cellular necrosis, karyorrhexis, and absence of plasma cells. The histologic features of HNL are distinctive but can be confused with those of lymphoma. We describe two cases of HNL and present recommendations for diagnosis and treatment.

Conscious sedation: a new approach for peritonsillar abscess drainage in the pediatric population.

OBJECTIVE: To assess the safety and efficacy of conscious sedation (CS) in children undergoing emergency department incision and drainage (I&D) of peritonsillar abscesses (PTAs). DESIGN: A 33-month retrospective chart review of all children presenting to the emergency department with the diagnosis of a PTA or peritonsillar cellulitis. Children who underwent CS prior to I&D were compared with children without CS for complications and efficacy. SETTING: St Louis Children's Hospital, an academic tertiary care pediatric hospital. PATIENTS: Fifty-two children were enrolled; 30 PTAs were drained with CS in 27 children (3 underwent I&D twice), and 25 PTAs were drained in 25 children without CS. INTERVENTIONS: The CS team included an otolaryngologist, a pediatric emergency department physician, and a registered nurse. A standardized CS protocol assessing vital signs and level of consciousness was employed during each procedure. A combination of midazolam, ketamine hydrochloride, and glycopyrrolate was used in appropriately weighted calculated doses. Patients were assessed for major and minor airway complications. MAIN OUTCOME MEASURES: Airway complications related to CS were reviewed. Patients who underwent I&D with and without CS were compared with regard to purulent drainage. RESULTS: There were no major airway complications in patients undergoing I&D with CS. There was 1 minor complication in this group, oxygen desaturation to 88%, which resolved with stimulation. Of the 55 procedures, 45 (82%) yielded purulence: 29 (97%) of 30 in the CS group and 16 (64%) of 25 in the non-CS group (chi2 = 9.8; P = .002). Of those children undergoing CS, 3 (10%) of 30 were admitted to the hospital from the emergency department as compared with 6 (24%) of 25 without CS (chi2 = 1.95; P = .16). In the CS group, PTAs had a low recurrence rate of 1 (3.3%) of 30 compared with 2 (8%) of 25 in the non-CS group (chi2 = 0.57; P = .45). No one in the CS group required a secondary procedure under general anesthesia. CONCLUSIONS: This preliminary study demonstrates CS to be a potentially safe and efficacious approach to drainage of PTAs in children. Given its efficacy and its associated lower levels of anxiety and pain for the patient, CS seems to be a promising new approach to caring for children with PTAs.

Clinical-severity staging system for oropharyngeal cancer: five-year survival rates.

OBJECTIVE: To improve the classification and survival estimates for patients with oropharyngeal cancer by combining cancer symptom severity and comorbidity with the current TNM cancer staging system. DESIGN: Retrospective medical record review using explicit coding criteria. SETTING: University medical center. PATIENTS AND METHODS: Two hundred ninety-six patients receiving initial treatment from January 1, 1980, to December 31, 1989. Multivariate analysis identified patient factors that had a significant impact on 5-year survival. These patient factors, symptom severity and comorbidity, were combined with cancer stage to create a composite clinical-severity staging system. MAIN OUTCOME MEASURE: Five-year survival. RESULTS: The overall 5-year survival rate was 38% (111/ 296). Survival by TNM cancer stage was 67% (18/27) for stage I, 46% (24/52) for stage II, 31% (26/85) for stage III, and 32% (43/132) for stage IV (chi2=10.84; P=.001). When patients were grouped according to the clinical-severity staging system, survival rates were 70% (16 of 23) for stage A, 47% (71 of 152) for stage B, 27% (18 of 67) for stage C, and 11% (6 of 54) for stage D (chi2=34.49; P=.001). CONCLUSIONS: Survival estimates can be improved by adding carefully studied and suitably defined patient variables to the TNM cancer stage. The current TNM cancer staging system for oropharyngeal cancer is based solely on the morphologic description of the tumor and disregards the clinical condition of the patient. Cancer symptom severity and comorbidity have a significant impact on survival. Continued exclusion of patient factors leads to imprecision in prognostic estimates and hinders interpretation of clinical studies.

Outcomes research and otolaryngology.

Outcomes research studies the effects of diverse therapies on patient outcome and is increasingly recognized by physicians, third-party payers, and the federal government as crucial for the demonstration of treatment effectiveness and the establishment of patient treatment guidelines. Outcomes research began in the 1970s when researchers studied the geographic variation in the rates and appropriateness of various surgical procedures, including tonsillectomies. Outcomes research is different from traditional clinical research because it addresses a wide variety of issues pertaining to health care delivery, strategy, and policy. To address these issues, outcomes research uses two principal methodologic approaches: (1) nonrandomized research methods and (2) expanded descriptions of patient outcomes. The methodologic requirements for outcomes research include (1) establishment of the diagnostic criteria for the disease under study, (2) creation of clinical-severity index for prognostic stratification, (3) identification and measurement of cogent comorbid conditions, and (4) establishment of outcomes that include descriptions of health status, quality of life, satisfaction with care, and medical costs. Many diseases within otolaryngology seem appropriate for outcomes research. Because prospective outcomes research is conducted with patients treated in the community, great opportunity exists for community-based physicians to become involved in this type of research.