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Objective:We undertook this study of free flap reconstruction of the head and neck to stratify patients and procedures, to determine how donor site preference changed over time, to assess medical and surgical outcomes, and to identify variables associated with complications. Methods:We analyzed computerized medical records from 236 patients who underwent a total of 241 reconstructions at a tertiary academic medical center in St. Louis between 1989 and 1998. We created a more detailed retrospective database of 141 of those patients by using 48 perioperative variables and 7 adverse outcome measures. Multivariate statistical models were used to analyze associations between variables and outcomes. Results:The fibula became the preferred donor site for mandibular reconstruction, and the radial forearm became the preferred donor site for pharyngoesophageal reconstruction. For the 241 procedures, the mortality rate was 2.1%, the median length of stay was 11 days, and the flap survival rate was 95%. Administration of more than 7 L of crystalloid during surgery and age over 55 were associated with major medical complications. Blood transfusion, prognostic comorbidity, and number of surgeons correlated with length of stay. Cigarette smoking and receipt of more than 7 L of crystalloid during surgery were associated with overall flap complications, and weight loss of more than 10% before surgery, more than one operating surgeon, and cigarette smoking were associated with major flap complications. Conclusions:Risk to patients and transferred tissue is low in free flap head and neck reconstruction. Age, smoking history, and weight loss should be considered during patient selection. Fluid balance should be considered during and after surgery. Division of labor for patient care should be carefully delineated among surgeons in a teaching setting. (Otolaryngol Head Neck Surg 2001;125:10-7.)

Frequent allelic loss at a genetically polymorphic locus in tumors is an established marker for the presence of a tumor suppressor gene in the neighboring chromosomal region. This technique can be used to identify novel tumor suppressor genes and to monitor their status before the cloning of the gene itself. We have used the polymerase chain reaction and microsatellite loci on all 39 nonacrocentric autosomal chromosomal arms to identify sites of frequent allelic loss in squamous cell carcinomas of the supraglottic larynx. Our allelotype identified seven chromosomal arms (3p, 5q, 8p, 9p, 9q, 13q, and 17p) likely to contain tumor suppressor genes frequently inactivated during squamous tumorigenesis in the larynx. We tested for associations between allelic losses on these chromosomal arms and the clinical and histopathologic features of these tumors. There were no correlations with either T or N classifications. Allelic loss on chromosomal arm 13q is significantly associated with a number of histopathologic features characteristic of poorly differentiated or histologically aggressive tumors. Allelic loss on this arm also exhibits statistical trends toward association with early tumor recurrence and poor survival. The association with survival was substantiated by a multivariate Cox proportional hazards model.

To assess the feasibility of multisite community‐based outcomes research. Prospective observational study of variations in treating acute external otitis by otolaryngologists and primary care practitioners. Community‐based independent otolaryngology practices. Patients with external otitis treated by otolaryngologists in Project Solo, a nonprofit, grassroots organization of independent physicians united for quality, patient advocacy, and cost containment. Confidential (bar‐coded), disease‐specific outcomes questionnaires completed by patients (12 items) and by participating physicians (15 items). Response to treatment was measured with a follow‐up patient questionnaire (3 items). Nine patients were recruited from 5 of 29 enrolled otolaryngologists. Primary care practitioners were more likely to prescribe oral antimicrobials than otolaryngologists (100% vs. 44%, p = 0.03), but less likely to insert a wick in the external auditory canal (11 % vs. 78%, p = 0.02). Poor recruitment was caused by an overly long and complex survey, data collection at multiple time points, lack of time during office hours, cumbersome data collection requirements, inadequate ongoing communication, and a lack of enthusiasm for the project. Future efforts at implementing a multisite outcomes study will require shorter questionnaires, smoother integration of the survey process with regular office flow, simplified procedures for data exchange, frequent communication with data collection sites, and motivational programs for participating physicians and their office staff.

Approximately 40 million Americans have chronic sleep disorders, the most serious of which is obstructive sleep apnea. The goals of this research were to serve as a demonstration project for a multicenter treatment outcomes research project for patients with obstructive sleep apnea. A clinical-severity staging system was created to control for important differences in the severity of sleep apnea among the enrolled patients. A disease-specific quality-of-life measure was used in this project to measure, from the patient's perspective, important pretreatment and posttreatment physical, functional, and emotional aspects of obstructive sleep apnea. Adults with apnea indexes greater than 5 who had not previously undergone uvulopalatoplasty were eligible. In total 142 patients were enrolled from eight otolaryngology practices. The mean age was 48 years, 112 were men, and 114 were white. The mean pretreatment apnea index was 40.0, and the mean respiratory distress index was 60.5. Seventy-one patients received continuous positive airway pressure, and 48 patients received surgery. Outcomes were assessed from scores on patient-based general and disease-specific health status measures 4 months after enrollment. The short duration of follow-up and limited number of patients undergoing posttreatment polysomnograms prohibit any analysis of treatment effectiveness. Nevertheless, this research represents a step forward for the support of future outcomes research projects by organized otolaryngology. (Otolaryngol Head Neck Surg 1998;118:833–44.)

Approximately 40 million Americans have chronic sleep disorders, the most serious of which is obstructive sleep apnea. The goals of this research were to serve as a demonstration project for a multicenter treatment outcomes research project for patients with obstructive sleep apnea. A clinical‐severity staging system was created to control for important differences in the severity of sleep apnea among the enrolled patients. A disease‐specific quality‐of‐life measure was used in this project to measure, from the patient's perspective, important pretreatment and posttreatment physical, functional, and emotional aspects of obstructive sleep apnea. Adults with apnea indexes greater than 5 who had not previously undergone uvulopalatoplasty were eligible. In total 142 patients were enrolled from eight otolaryngology practices. The mean age was 48 years, 112 were men, and 114 were white. The mean pretreatment apnea index was 40.0, and the mean respiratory distress index was 60.5. Seventy‐one patients received continuous positive airway pressure, and 48 patients received surgery. Outcomes were assessed from scores on patient‐based general and disease‐specific health status measures 4 months after enrollment. The short duration of follow‐up and limited number of patients undergoing posttreatment polysomnograms prohibit any analysis of treatment effectiveness. Nevertheless, this research represents a step forward for the support of future outcomes research projects by organized otolaryngology. (Otolaryngol Head Neck Surg 1998;118:833–44.)

Educational objectives: To understand the historical development and goals of outcomes research and the methodologic differences among the three different types of outcomes research.