Swahili translation and validation of the Patient Health Questionnaire-9 depression scale in the Kenyan head and neck cancer patient population.

BACKGROUND: Depression is an important predictor of post therapy quality of life (QOL) in head and neck (H&N) cancer patients. In addition, depression rates may vary among cultures. OBJECTIVE: As part of a larger cross cultural study on post therapy QOL differences in H&N cancer patients, the goal of this project was to translate a well-validated English language depression scale into Swahili, and then validate this scale in Kenyan H&N cancer patients. METHODS, SETTINGS AND SUBJECTS: In Part 1 of the study, we translated the Patient Health Questionnaire-9 (PHQ-9) into Swahili, adhering to established International Quality of Life Association (IQOLA) guidelines. In Part 2, we psychometrically validated the newly translated scale using a prospective study of 48 patients at the Kenyatta National Hospital ENT clinic in Nairobi, Kenya. RESULTS: The Swahili PHQ-9 had good test retest reliability (Intraclass correlation coefficient, 0.71) and internal consistency (Cronbach's alpha = 0.80). It also had good construct validity, as scores correlated strongly with TNM stage (Chi square = 123, p < 0.05), and with the compositeand global scores of an H&N cancer specific QOL scale (UW-QOL, r = -0.87, p < 0.05). CONCLUSION: The Swahili version of the PHQ-9 is a reliable scale in Kenyan H&N cancer patients, and is a valuable tool in screening for and monitoring of depression as a function of QOL in this population.

Analysis of the performance characteristics of the University of Washington Quality of Life instrument and its modification (UW-QOL-R).

BACKGROUND: During a 5-year period, we analyzed 3 patient subsets from the University of Washington Quality of Life (UW-QOL) Registry and published the results. In each instance, editorial review has raised legitimate concerns regarding the UW-QOL instrument that deserve public comment. We present our response to these criticisms. Since our original publication (1993), we have added domains to the original UW-QOL instrument. These additions reflected our concern that we might be missing important elements in the spectrum of disease-specific response to treatment. Using the data we have accumulated in the last 5 years, we present an analysis of the internal consistency of the UW-QOL. We have identified those domains that are responsive (or not responsive) to treatment effect and have revised the UW-QOL accordingly to create the UW-QOL-R, which is recommended for future use. DESIGN: The project began January 1, 1993, after approval by the UW Human Subjects Committee. Critical comments offered by external review were collated and responded to. Internal consistency was evaluated by interitem correlation matrix (Cronbach alpha) testing. SUBJECTS: All new patients presenting to the UW Medical Center (Seattle) with a diagnosis of head and neck cancer were asked to participate in a prospective analysis of QOL changes during and after treatment. INTERVENTION: Patients completed the pretreatment QOL questionnaire on the day of their initial workup. The format for the pretreatment test was an interviewer-supervised self-administered test; the subsequent tests were self-administered and were completed at 3, 6, 12, 24, and 36 months. Other data entered for each patient included site, stage, treatment, histologic classification, reconstruction, and current status. A QOL registrar was responsible for patient follow-up, data collection, and collation. All data were entered into the departmental relational database. RESULTS: Criticisms by external review included the following: "it is improper to call it [UW-QOL] a measure of quality of life"; "the summary scale is problematic because it implies that each of the subscales are weighted or 'valued' equally"; "some domain questions relate to surgery specific issues. while others are specific to radiation"; "we were confused by the scoring"; and "the UW-QOL index does not specifically address the psychological impact of the disease and its treatment." After evaluation of internal consistency, the UW-QOL was modified by removing 2 domains that correlated poorly with the others. This resulted in a 10-item instrument (UW-QOL-R) with an overall internal consistency score of 0.85. CONCLUSIONS: The UW-QOL can be effectively and accurately used to compare treatment effects in the management of head and neck cancer. With this revised instrument, the 10 items appear to measure the domains of overall QOL in a highly consistent and reliable fashion over time.

Quality of life in patients with head and neck cancer: lessons learned from 549 prospectively evaluated patients.

OBJECTIVES: To summarize our quality-of-life (QOL) research findings for patients with head and neck cancer, to suggest areas for future productive QOL research, and to discuss how to undertake QOL studies in a cost-effective manner. DESIGN: Review of previously published analyses of advanced larynx cancer, advanced oropharynx cancer, and neck-dissection cases and current data from the complete set of patients. PATIENTS: From January 1, 1993, through December 31, 1998, data on 549 patients were entered in our head and neck database. Of these patients, 364 met additional criteria for histologic findings (squamous cell carcinoma) and the restriction of their cancer to 4 major anatomical sites (oral, oropharynx, hypopharynx, or larynx). Of these, 339 patients were more than 1 year beyond initial treatment. Complete baseline TNM staging and QOL data were obtained for 260 of these patients, of whom 210 presented with an untreated first primary tumor (index cases) to the University of Washington, Seattle. INTERVENTION: Pretreatment QOL was assessed with an interviewer-supervised self-administered questionnaire. Subsequent self-administered tests were completed at 3, 6, 12, 24, and 36 months. Other data collected on each patient included cancer site, stage, treatment, histologic findings, type of surgical reconstruction, and current disease and vital status. RESULTS/CONCLUSIONS: It is difficult to achieve "statistically significant" results in a single-institution setting. The "composite" QOL score may not be a sufficiently sensitive tool. Analysis of separate domains may be more effective.

Quality of life in head and neck cancer.

Because treatments for patients with cancer of the head and neck can have major impact on physical, social, and psychological function, the collection of quality of life (QOL) data in this group of patients is critical for our specialty. The University of Washington Quality of Life data have been collected and analyzed on three subsets of cancer patients. Information learned from these patients is summarized and strategies for future projects are outlined.

Clinimetric evaluation of the Sinonasal Outcome Test-16. Student Research Award 1998.

This study describes the reliability, validity, and responsiveness of the Sinonasal Outcome Test-16 (SNOT-16), a rhinosinusitis-specific health-related quality-of-life instrument, in the University of Washington Department of Otolaryngology-Head and Neck Surgery patient population. The SNOT-16 was completed by 47, 24, and 22 patients at weeks 0, 6, and 12, respectively. In addition, all 47 patients completed the Short-form 36-item Health Survey (SF-36) at week 0. Furthermore, an additional cohort of patients from the otology clinic who denied symptoms of rhinosinusitis or previous physician diagnoses of rhinosinusitis were asked to complete the SNOT-16. These scores were subsequently used to determine discriminant validity of the instrument. Cronbach's alpha was 0.89, indicating a high degree of homogeneity of the test items. The SNOT-16 demonstrated excellent discriminant validity, and mean total SNOT-16 scores were significantly correlated with patient-reported overall health, overall bother, and 7 of the 8 SF-36 subscales. The standardized response mean calculated between weeks 0 and 6 was 0.69, indicating moderate sensitivity to change. We conclude that the SNOT-16 is a reliable, valid, and responsive instrument for measuring rhinosinusitis-specific health-related quality of life.

Quality-of-life outcomes after osteoplastic frontal sinus obliteration.

Frontal sinusitis and its treatment remain controversial. Although several authors have evaluated the results of traditional endoscopic sinus surgery, few have assessed patient outcomes and quality of life after osteoplastic frontal sinus obliteration. This retrospective study evaluates these outcomes in a postoperative review and questionnaire of 39 patients treated at the University of Washington from 1991 to 1994. Most patients were satisfied with the results of this procedure, had significant improvements in their Chronic Sinusitis Survey scores, and reported decreased clinic visits and antibiotic use. However, approximately half thought nonsurgical treatments were more effective and continued to require other medical therapy; 30% required additional surgical intervention. Such outcomes may reflect the ineffectiveness of frontal sinus obliteration to treat the chronic symptoms of patients affected by the refractory underlying disease process of chronic sinusitis; however, despite these mixed results, we found a significant decrease in annual days of lost work or activity in this study group after osteoplastic obliteration.

Impact of neck dissection on quality of life.

OBJECTIVES: For decades, the gold standard for treatment of cervical metastasis was radical neck dissection (RND). Current oncologic philosophy allows for treatment of appropriately staged neck disease with modified radical neck dissection (MRND) or selective neck dissection (SND). The purposes of this study were to determine the impact of various forms of neck dissection on patients' quality of life (QOL) and to evaluate the responsiveness of the University of Washington (UW) QOL shoulder domain. STUDY DESIGN: Prospective accumulation of QOL data from patients treated for head and neck cancer at UW. METHODS: Eighty-four patients were identified from the UW QOL registry who had undergone neck dissection and had completed pretreatment and posttreatment QOL questionnaires at 6 and 12 months. RESULTS: Compared with pretreatment scores, the MRND and RND groups reported worse shoulder function at 6 and 12 months (P<.0005). The MRND group reported greater shoulder disability at 6 months compared with the SND group (P = .002), but by 12 months, there was no difference between the two groups. Shoulder function for the RND group was worse than the SND group at 6 and 12 months (P = .004). There was a trend toward decreased pain after treatment in the SND and MRND groups. There were no significant differences in subjective appearance, activity, recreation, chewing, swallowing, or speech in the three groups after treatment. CONCLUSIONS: Consistent with findings of published functional studies, this study confirmed that the three forms of neck dissection affect patients' QOL differently. This study demonstrates that the UW QOL shoulder domain is a responsive instrument in assessing the effect of neck dissection on shoulder function.

Endoscopic treatment of juvenile nasopharyngeal angiofibroma.

Traditional treatment of juvenile nasopharyngeal angiofibromas (JNAs) has included open surgical approaches for the majority of tumors. At the University of Washington Medical Center (UWMC), endoscopic techniques have been used for the removal of some small JNAs. This report describes the institutional experience in treating these tumors. The medical records of 15 patients at UWMC treated over a 15-year period for JNA were reviewed. Three patients were treated only by an endoscopic approach, and one patient had a combined endoscopic and open procedure. All three of the patients treated only by the endoscopic approach were disease free with a minimum of 24 months follow up. The one patient treated with a combined endoscopic and open approach had recurrence of disease. Endoscopic removal after embolization effectively treated three patients with early stage JNAs. Indications for this procedure are discussed.

Quality of life after laryngectomy: are functional disabilities important?

BACKGROUND: The purpose of this study was to determine the functional disabilities and overall quality of life (QOL) of patients successfully treated (ie, without evidence of disease at two years) for laryngeal or hypopharyngeal cancer by a total laryngectomy. METHODS: The University of Washington QOL questionnaire was administered to 10 patients prior to laryngectomy, at one year postlaryngectomy, and at two years postlaryngectomy. RESULTS: Postlaryngectomy QOL scores were not significantly different from prelaryngectomy scores. In all QOL domains the severity of functional disability was not significantly correlated with its importance. Ninety percent of patients (9/10) reported that compared with one year prior to the diagnosis of cancer their general health was the same or better at two years postlaryngectomy. Seventy percent of patients (7/10) reported having a good to excellent overall QOL. CONCLUSIONS: Though the loss of voice is disabling, the functional limitations caused by a laryngectomy do not necessarily translate into a worse overall QOL. Future research is needed to determine whether the importance of individual QOL domains changes as patients adjust to the experience of having and surviving cancer.

Propofol versus isoflurane for endoscopic sinus surgery.

PURPOSE: A previous retrospective study reported that propofol anesthesia decreased bleeding during endoscopic sinus surgery compared with isoflurane. We performed a prospective study to compare the effects of propofol versus isoflurane on measured blood loss and the surgeon's subjective assessment of operating conditions during endoscopic sinus surgery. PATIENTS AND METHODS: After receiving institutional review board approval and written informed consent, 56 patients undergoing endoscopic sinus surgery were randomly assigned to receive propofol (n = 30) or isoflurane (n = 26) supplemented with nitrous oxide-oxygen and alfentanil. Blood loss was calculated from the hemoglobin concentration in suction canisters. One surgeon, who was blinded to the anesthetic agent, performed every procedure and assessed bleeding as follows: 1, no bleeding; 2, modest bleeding; 3, bleeding interfering with operating conditions and cause for an agent switch; and 4, intolerable bleeding requiring a change in surgical plan. Results were compared in the two anesthetic groups using chi-squared test, unpaired t-test, Mann-Whitney Utest, and a permutation test. A P of .05 was considered significant. RESULTS: Mean bleeding scores were less over time (P = .02) with propofol anesthesia, particularly in surgery in the ethmoid and sphenoid sinuses (P = .03), and the proportion of patients with a mean score >2 was less in the propofol group (30% v 54%; P = .033). Time until discharge to home or to a limited stay in a hospital bed was also less in the propofol group (183 v 243 minutes; P = .019). CONCLUSION: In our study, surgical blood loss was the same for both anesthetic agents overall, but propofol appeared to offer an advantage in terms of subjective improvement in operating conditions, particularly in the ethmoid and sphenoid sinuses.

Percutaneous tracheostomy: a comprehensive evaluation.

Percutaneous tracheostomy (PT) is an ancient procedure that has recently attracted increasing interest. While there are numerous publications in the literature, there remains confusion due to the large variety of techniques and instruments with which it has been performed and the wide disparity in clinical outcome. This study evaluates the international literature on over 1,500 cases, classifies the techniques that have been used, analyzes the safety of each method, and reports a prospective outcome and cost analysis of 130 cases undergoing what we determined to be the safest method. We found that PT performed with the correct instruments and technique under bronchoscopic surveillance has a lower incidence of complications than open tracheostomy (OT). Cost estimation demonstrated that PT may be significantly more expensive than bedside OT. While we recommend PT as a relatively safe and expedient method of tracheostomy for selected intubated patients in an intensive care unit, it does not offer an advantage for patients who must be taken to the operating room, and should not deprive house officers of necessary experience in OT in this setting.

Clinical staging and operative reporting for multi-institutional trials in head and neck squamous cell carcinoma.

BACKGROUND: A Strategic Planning Conference (jointly supported by NCI and NIDCD) was convened to consider potential improvements in surgical patient data for multi-institutional trials. The thesis underlying this project is that inadequacies in staging, pretreatment patient stratification, and the details of surgical resection may have obscured the detection of treatment effect. The goals of this project were multiple: (1) to consider the utility of new clinical stratification variables, (2) to increase the precision of tumor staging, and (3) to improve operative reporting for multi-institutional trials in head and neck cancer. CONCLUSIONS: The conference attendees came to a number of important conclusions: (1) TNM status is inadequate for describing head and neck cancer in a multi-institutional trial setting. A detailed anatomic reporting scheme is proposed; (2) comorbidity measures should be included as patient descriptors, especially those that meet the criteria "definitely important and easy to obtain"; (3) surgical reporting in multi-institutional trials should use a format that is compatible with computer analysis and use the same items as the revised (anatomic) staging system; (4) the surgeon should be personally responsible for data coding and should interact directly with the pathologist in marking the surgical specimen; (5) pathologic reporting should use an anatomic template identical to the staging and operative reporting formats.

Geographic variation in the utilization of esophagoscopy and bronchoscopy in head and neck cancer.

OBJECTIVE: To determine the extent to which esophagoscopy and bronchoscopy are being used in various regions of the United States in the initial examination of patients with head and neck cancer. DESIGN: Population-based study derived from Medicare claims data and information from the National Cancer Institute's Surveillance, Epidemiology, and End Results (SEER) Program. SETTING: Five SEER areas (San Francisco, Calif; Connecticut; Seattle, Wash; Iowa; and Detroit, Mich). PARTICIPANTS: The cohort included 1410 Medicare patients with squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx diagnosed between March 1, 1991, and December 31, 1993, in the 5 SEER areas. MAIN OUTCOME MEASURE: Rates of esophagoscopy and bronchoscopy according to SEER area. RESULTS: The proportion of patients who underwent esophagoscopy ranged from 12.9% (San Francisco) to 39.8% (Detroit) for patients with local cancer and from 22.2% (San Francisco) to 59.7% (Detroit) for patients with regional cancer. The proportion of patients who underwent bronchoscopy ranged from 6.9% (San Francisco) to 32.6% (Detroit) for patients with local cancer and from 12.8% (San Francisco) to 50.7% (Detroit) for patients with regional cancer. After controlling for differences in age, sex, race, tumor site, tumor grade, comorbidity, and socioeconomic status, SEER area remained independently associated with esophagoscopy and bronchoscopy (both P < .001). CONCLUSIONS: There is substantial geographic variation in the use of esophagoscopy and bronchoscopy as part of the initial examination of patients diagnosed as having head and neck cancer that cannot be explained by differences in patient or tumor characteristics. This variation likely underscores uncertainty and disagreement about the value of endoscopic screening for synchronous tumors. Additional research is required to determine whether routine endoscopic screening increases survival rates or improves quality of life.

Quality of life of disease-free survivors of advanced (stage III or IV) oropharyngeal cancer.

BACKGROUND: This study assessed the quality of life (QOL) of patients with advanced oropharyngeal cancer (stage III or IV) who were disease-free at 1 year posttreatment. METHODS: Between 1993 and 1994, 13 consecutive cases were identified from the University of Washington QOL registry. Patients were divided into two groups, depending on treatment: surgical group, 6 patients treated with surgical resection and postoperative radiotherapy; and nonsurgical group, 7 patients treated with definitive radiotherapy. RESULTS: Composite pretreatment and posttreatment QOL scores were similar for the two treatment groups. Subset analysis of QOL domains revealed that both treatment groups generally reported a worsening of chewing and swallowing. A worsening of appearance and of speech was more frequently reported by the surgical group. Sixty-seven percent of the surgically treated patients reported pain relief, as opposed to only 29% of the nonsurgical group. CONCLUSION: Composite QOL-score sensitivity may be compromised by inverse changes in individual QOL domains. Treatment-specific QOL domains may be more sensitive measures of outcome.

Head and neck osteosarcoma at the University of Washington.

BACKGROUND: Head and neck osteosarcoma is a comparatively rare and aggressive malignancy. Our goal was to examine the experience of head and neck osteosarcoma patients seen over a 15-year period at the University of Washington Medical Center and compare this with the published experience of other centers in terms of demographics, histology, treatment, and survival rate. METHODS: We reviewed surgical pathology slides and clinical treatment records of 13 patients who were treated at the University of Washington Medical Center between 1981 and 1996. A total of 17 cases from 13 patients (13 primary tumors and 4 recurrences) were studied. RESULTS: There was a slight male predominance, with a male:female ratio of 1.6:1, and median age at diagnosis of 40.9 years (range 22 to 75 years), both slightly higher than has been generally reported. Three of 13 patients had recognized risk factors for the development of osteosarcoma: 2 with a history of prior radiotherapy and 1 with Paget's disease. All surgical pathology specimens were examined independently by two pathologists for histologic grading and typing. At initial presentation, 9/13 (69%) cases had conventional (osteoblastic) histology; 2/13 (15%) were fibroblastic, 1 chondroblastic (8%) and 1 parosteal (8%). Eight of 13 (62%) cases were high grade at initial presentation. Four of 13 (30%) of the primary tumors were low grade 2, of which did not recur over a median follow-up period of 24 months. The other 2 low-grade tumors later recurred locally, as high-grade osteosarcomas, after disease-free intervals of 1 year and 14 years, respectively. One patient had an intermediate-grade tumor which has not recurred as of last follow-up. Combined-modality treatment, including surgery with or without radiotherapy and/or chemotherapy, was given depending on the histologic grade, surgical margins, and recurrence. Some patients with low-grade tumors had surgery only. There were 5 local recurrences, 1 of these following a disease-free interval of 14 years. One patient had 3 separate recurrences at the same site. Ten of 13 (77%) are alive and disease-free. Of the 3 deaths, 1 was related to radiation-induced brain necrosis, without evidence of recurrent tumor. The project 5-year overall survival in this series is 72%, with a mean follow-up of 58 months (median, 36 months). Of those receiving neoadjuvant chemotherapy, 6/7 have survived to the present. CONCLUSION: Given the limitations of a small patient population, our data suggest that neoadjuvant chemotherapy may provide benefit in terms of survival. Longer follow-up will be necessary to support this conclusion. Our data also show that our population has a higher-than-average age of onset, low presence of risk factors, and better survival rate in comparison with the published series from other institutions.

Risk factors for pulmonary complications in the postoperative head and neck surgery patient.

BACKGROUND: Pulmonary complications are a primary source of increased cost and morbidity in surgically treated head and neck cancer patients. This study investigates potential risk factors related to postoperative pulmonary complications (pneumonia, adult respiratory distress syndrome (ARDS), and prolonged mechanical ventilation) in head and neck cancer patients. METHODS: Data from 144 major head and neck procedures performed at the University of Washington between 1985 and 1991 were retrospectively reviewed. Univariate and multivariate analysis were used to evaluate preoperative and perioperative variables identified as potential risk factors for postoperative pulmonary complications. RESULTS: Fifteen percent of patients had a postoperative pulmonary complication, (n = 21: 18 postoperative pneumonia; 2 ARDS; and 4 prolonged ventilation). The most common pneumonia pathogen was Staphylococcus aureus (62%). Univariate analysis identified smoking and weight loss as significant factors associated with pulmonary complications. The variables preoperative blood urea nitrogen, white blood cell count, and operative chest flap closure all approached but did not reach significance. Multivariate analysis of a subgroup of patients identified smoking history and perioperative antibiotic choice as the only independently significant variables. CONCLUSIONS: Patient smoking history was the primary variable related to postoperative pulmonary problems, with evidence of increasing risk with increased exposure. Other variables added only limited additional risk association information after multivariate analysis.

Comparison of cost and function in reconstruction of the posterior oral cavity and oropharynx. Free vs pedicled soft tissue transfer.

OBJECTIVE: To compare the cost and functional results of free and pedicled soft tissue reconstruction after posterior oral cavity and oropharyngeal extirpation. DESIGN: Retrospective study of 53 consecutive patients undergoing extirpation with primary soft tissue reconstruction from January 1, 1991, to December 31, 1995. Median follow-up was 298 days. SETTING: Academic tertiary care medical center. INTERVENTION: Twenty-four patients underwent reconstruction with a pedicled pectoralis major myocutaneous flap (PMMF); 29 patients, with a fasciocutaneous free flap (FF) (27 radial forearm, 1 lateral arm, and 1 scapular). MAIN OUTCOME MEASURES: Direct (inpatient hospital resources used and monetary costs) and intangible (post-operative complications and function) costs. RESULTS: Operative time was longer for FF reconstructions (P = .003), but both patient groups had similar intensive care unit and hospital stays. Treatment cost for FF reconstructions was $41,122, compared with $37,160 for PMMF reconstructions (P = .003). This difference was due to increased professional fees for FF reconstruction (P < .001) which was offset by intangible cost differences. The PMMF group tended toward an increased rate of flap-related complications, compared with the FF group. At last follow-up, 4 patients in the FF group (15%) and 3 in the PMMF group (15%) had their tracheotomy. In contrast, 17 (85%) patients in the PMMF group and 11 (39%) patients in the FF group required enteral tube feedings (P = .002). Also, 18 (64%) patients in the FF group were eating at least a soft diet compared with 6 (30%) patients in the PMMF group (P = .02). CONCLUSIONS: Comparison of direct costs reveals only a modest difference in reconstruction costs that is outweighed by the intangible costs of PMMF reconstruction. The functional benefits of FF reconstruction appear to justify its slight increased expense and its use rather than PMMF reconstruction after extirpation in the posterior oral cavity and oropharynx.