Validation of the University of Washington quality of life questionnaires for head and neck cancer patients in India.

UNLABELLED: Quality of life (QOL) is a multidimensional construct capturing the subjective wellbeing of patients in physical, emotional, functional and social domains. Available work on post treatment QOL have only been made in western literature and less in Indian literature. AIMS: To translate the UW-QOL into both Hindi and Marathi and psychometrically validate the translation in HandN cancer patients in Indian population. SETTINGS AND DESIGN: A prospective study was done at the Tata Memorial Hospital for patients who were treated for H and N cancers. MATERIALS AND METHODS: 147 patients were enrolled from January to April 2005. The study was carried out in two phases. Patients were given translated versions of the UW-QOL and EORTC QOL questionnaires pre-operatively, 15 days post-operatively and then three months post-operatively. RESULTS: Both the Hindi and Marathi translations had strong internal consistency (Cronbach's alpha=0.7971 and 0.7839). UW-QOL composite scores correlated well with the global questions on overall QOL in both the Hindi (r=0.69) and Marathi (r=0.66) translations and also with T-stage. QOL scores were worse three months post-operatively than pre-operatively and for patients undergoing surgery that violated the mucosa. A strong correlations was observed (r>0.50) between all similar domains on the UW-QOL and EORTC HandN35 except the saliva item on the Marathi translation, where r< 0.50, but P-values were significant. CONCLUSIONS: The Marathi and Hindi versions of the UW-QOL appear to be valid and reliable instruments for assessing the QOL in Indian population and will be a vital tool for achieving greater insight into the short- and the long term QOL.

Abstruse comparisons: the problems of numerical contrasts of two groups.

The most common quantitative comparison in medical literature is a contrast of two numbers, such as two means or two rates. The two numbers, A and B, can be compared as a direct increment (A-B), ratio (A/B), relative change ([A-B]/B), or other index of contrast. To appreciate the quantitative distinction, a reader must know the "setting" reflected by the basic values of A and B. For example, a ratio of 2.0 does not distinguish comparisons between rates of 60% versus 30% and 0.006% versus 0.003%. Despite the frequency of published comparisons, they can be expressed with two types of abstrusity: quantitatives, if the basic values for A and B are not readily evident; and qualitative, if the component underlying variables are unfamiliar and not suitably explained. Among the published articles during the first six months of 1995 for JAMA and New England Journal of Medicine, 57 that satisfied inclusion criteria were reviewed for compliance with standards for avoiding the two types of abstrusity. The standards for quantitative abstrusity were applied to the published abstract-summary, because it is often the only "sound bite" that is read and remembered by most readers. The standards for qualitative abstrusity, however, could be fulfilled in the text, not just in the abstract-summaries of each article. Among the 57 abstract-summaries, 30% were abstruse quantitatively, and 11 (48%) of 23 pertinent papers were qualitatively abstruse. Abstrusity can be eliminated if authors and editors insist that quantitative contrasts cite the basic numbers being compared and the meaning of the associated variables and their rating scales.

Implantation of the lateral cochlear wall for auditory nerve stimulation.

Although cochlear implants now regularly achieve gratifying results, traditional intrascalar implants have certain limitations. Extraluminal implants may offset some of these problems by accessing neurons subserving a wider tonotopic range, avoiding intracochlear insertion trauma, and offering alternatives when cochlear obliteration is present. We have investigated the utility of a lateral cochlear wall implant in a normal-hearing cat model with implants at the middle and basal turns, and found successful activation of the auditory nerve at thresholds of 28.1 and 40.6 microA, respectively. No adventitial stimulation of the facial nerve was noted within the dynamic range. Maximum responsiveness was observed with implants of the middle turn of the cochlea, an area that is not reliably approached with current intrascalar implants. These observations support and extend prior observations of the feasibility of extraluminal stimulation of the auditory nerve.

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.

Quality-of-life outcomes in the evaluation of head and neck cancer treatments.

OBJECTIVES: To review the published literature to evaluate the design, use of terminology, and interpretation of results in studies using quality-of-life (QOL) instruments to measure differences between head and neck cancer treatments at a point in time or to report changes over time in one or more treatment groups. DATA SOURCE: MEDLINE search for subject headings "head and neck neoplasms" (as a main topic) and "quality of life" or "health status" restricted to English-language sources and a 10-year period from 1989 to 1999. STUDY SELECTION: Four hundred forty-five abstracts were reviewed to find articles using an instrument to compare head and neck cancer therapy groups with a QOL outcome (13.7% included). DATA EXTRACTION: Two readers reviewed each article to determine how terminology was used, if a scientific study design was used, and if differences or changes in scores were clinically interpreted. RESULTS: Sixty-one articles were reviewed. Forty different instruments were used. Terminology was used inconsistently in 21 (34.4%) of the 61 articles. A scientific study design was used in only 11 (18.0%) of the 61 articles (P<.001). A clinical interpretation of results was given in 16 (26.2%) of the 61 articles (P<.001). CONCLUSIONS: While QOL outcomes show promise for assisting with treatment decisions in head and neck cancer therapy, few studies using instruments to measure QOL outcomes are hypothesis driven and clinical interpretations of results are not commonly provided. We recommend that future studies identify the construct to be measured, specify comparator groups and hypotheses a priori, and provide clinical interpretations of results.

Prognostic staging system for recurrent, persistent, and second primary cancers of the oral cavity and oropharynx.

OBJECTIVE: To develop a practical staging system for predicting mortality of patients with recurrent squamous cell tumors of the oral cavity and oropharyngeal mucosa. DESIGN AND SETTING: An inception cohort at an academic medical center. PATIENTS: A total of 308 patients who had evidence of recurrent, persistent, or second primary tumors of the oral cavity and oropharynx between January 1, 1980, and December 31, 1991, of whom 162 (52.6%) met inclusion criteria. MAIN OUTCOME MEASURE: One-year mortality. RESULTS: The median survival time was 10 months. In bivariate analysis, the TNM stage of the recurrent tumor, invasion of pharyngeal constrictors and the floor-of-mouth muscles, weight loss, local and systemic symptoms, and eating function had significant effects on mortality. Multivariable analysis (done by conjunctive consolidation and Cox regression) identified constrictor invasion, the TNM stage of the recurrence, and weight loss as having a substantial effect on mortality. A composite 4-stage system using these 3 variables demarcated 1-year survival rates of 88.2% (30/34), 71.9% (23/32), 32.6% (16/49), and 4.2% (2/47). CONCLUSIONS: The TNM status of recurrent tumors predicts mortality, but constrictor muscle invasion and weight loss also have major prognostic importance. The consolidation of these variables into a composite staging system successfully stratifies patients with widely divergent mortality rates. Improved staging of recurrent head and neck tumors can lead to more effective decisions about the comparisons and merits of additional treatment.

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.

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.

Randomized trial of amplification strategies.

BACKGROUND: Little is known about quality of life after the use of specific types of hearing aids, so it is difficult to determine whether technologies such as programmable circuits and directional microphones are worth the added expense. OBJECTIVE: To compare the effectiveness of an assistive listening device, a nonprogrammable nondirectional microphone hearing aid, with that of a programmable directional microphone hearing aid against the absence of amplification. DESIGN: Randomized controlled trial. SETTING: Audiology clinic at the VA Puget Sound Health Care System, Seattle, Wash. PATIENTS: Sixty veterans with bilateral moderate to severe sensorineural hearing loss completed the trial. Half the veterans (n = 30) had hearing loss that the Veterans Affairs clinic determined was rated as "service connected," which meant that they were eligible for Veterans Affairs-issued hearing aids. INTERVENTION: Veterans with non-service-connected hearing loss, who were ineligible for Veterans Affairs-issued hearing aids, were randomly assigned to no amplification (control arm) or to receive an assistive listening device. Veterans with service-connected loss were randomly assigned to receive either the nonprogrammable hearing aid that is routinely issued ("conventional") or a programmable aid with a directional microphone ("programmable"). MAIN OUTCOME MEASURES: Hearing-related quality of life, self-rated communication ability, adherence to use, and willingness to pay for the amplification devices (measured 3 months after fitting). RESULTS: Clear distinctions were observed between all 4 arms. The mean improvement in hearing-related quality of life (Hearing Handicap Inventory for the Elderly) scores was small for control patients (2.2 points) and patients who received an assistive listening device (4.4 points), excellent for patients who received a conventional device (17.4 points), and substantial for patients who received a programmable device (31.1 points) (P<.001 by the analysis of variance test). Qualitative analyses of free-text diary entries, self-reported communication ability (Abbreviated Profile of Hearing Aid Benefit) scores, adherence to hearing aid use, and willingness to pay for replacement devices showed similar trends. CONCLUSIONS: A programmable hearing aid with a directional microphone had the highest level of effectiveness in the veteran population. A nonprogrammable hearing aid with an omnidirectional microphone was also effective compared with an assistive listening device or no amplification.

Accuracy of terminology and methodology in economic analyses in otolaryngology.

OBJECTIVE: Economic studies increasingly guide health care resource allocation decisions. Because rigorous adherence to accepted definitions and research techniques is critical to ensure accuracy, we evaluated the terminology and methods of otolaryngology economic analyses. STUDY DESIGN: A total of 71 articles published from 1990 to 1999 in 6 peer-reviewed otolaryngology journals with terms such as "cost-effective" in their title or representing economic analyses were reviewed for terminology and use of established methodology guidelines. RESULTS: Over half (35 of 66) of terms such as "cost-effective" were used incorrectly, and 60% of articles (39 of 64) confused "charge" and "cost" data. Eleven percent (7 of 64) of papers specified the perspective of their analysis. About half (17 of 30) reported a summary measure such as a cost-effectiveness ratio. Only one third (23 of 63) performed sensitivity analyses. CONCLUSION: Adherence to accepted definitions and research methods is inconsistent, although we did note moderate improvements in making the distinction between costs and charges, defining of study perspective, and performing sensitivity analysis. SIGNIFICANCE: Greater attention to both terminology and methodology can enhance the quality of economic analyses and ultimately improve certain resource allocation decisions.

Cost and cost-effectiveness of universal screening for hearing loss in newborns.

OBJECTIVE: To estimate the cost and cost-effectiveness of universal newborn hearing screening. STUDY DESIGN AND SETTING: Decision analysis model utilizing the hospital perspective. This model evaluated 4 distinct protocols for screening a fixed and defined hypothetical cohort of newborn infants. OUTCOME MEASURES: Cost of screening and the number of infants with hearing loss identified through universal screening. RESULTS: Otoacoustic emissions testing at birth followed by repeat testing at follow up demonstrated the lowest cost ($13 per infant) and had the lowest cost-effectiveness ratio ($5100 per infant with hearing loss identified). Screening auditory brainstem evoked response testing at birth with no screening test at follow-up was the only protocol with greater effectiveness, but it also demonstrated the highest cost ($25 per infant) and highest cost-effectiveness ratio ($9500 per infant with hearing loss identified). These findings were robust to sensitivity analysis, including best-case and worst-case estimation. The prevalence of hearing loss and the fraction of infants returned for follow-up testing had a large impact on the absolute level, but not relative level of protocol cost and cost-effectiveness. CONCLUSION: The otoacoustic emissions testing protocol should be selected by screening programs concerned with cost and cost-effectiveness, although there are certain caveats to consider. SIGNIFICANCE: The most significant barriers to implementation of universal newborn hearing screening programs have been financial, and this study compares the most common protocols currently in use. This study can assist program directors not only in the decision to initiate universal screening but also in their choice of screening protocol.

Human papillomavirus infection and survival in oral squamous cell cancer: a population-based study.

OBJECTIVE: To determine whether human papillomavirus (HPV) type 16 affects survival in oral squamous cell carcinoma. STUDY DESIGN: Two hundred fifty-four patients diagnosed with primary oral cancer were studied for survival in relation to tumor HPV type 16 status. Kaplan-Meier analysis and Cox proportional hazard models were used to assess survival and estimate hazard ratios adjusted for potential confounders. RESULTS: HPV type 16 DNA was detected in 15.1% of tumors. HPV 16 positive patients had significantly reduced all-cause mortality (hazard ratio [HR] estimates = 0.34, 95% CI = 0.14, 0.83) and disease-specific mortality (HR = 0.17, 95% CI = 0.04, 0.76) compared with HPV 16 negative patients after adjustment for age, stage, treatment, smoking, alcohol, education, and comorbid disease. CONCLUSIONS: The presence of HPV type 16 DNA is independently associated with a favorable prognosis in patients with oral squamous cell carcinoma. CLINICAL SIGNIFICANCE: Although HPV genotyping is currently not widely available, it may provide important prognostic information.

Fitting hearing aids with the Articulation Index: impact on hearing aid effectiveness.

Although most clinical tests focus on how much a particular hearing aid improves speech audibility under controlled conditions, it is unclear how these measures relate to hearing aid effectiveness, or the benefit perceived by the patient under everyday conditions. In this study, the relationship between audibility and hearing aid effectiveness was examined in a cohort of patients who obtained hearing aids through the Veteran's Administration. The measure of audibility was the Articulation Index, a common index of speech audibility. Measures of effectiveness included two hearing-specific surveys and self-reported ratings of global satisfaction and hearing aid use adherence. Results indicated that there were no systematic relationships between measurements of improved audibility and patient ratings of communication ability. Additionally, improved audibility was not related to overall satisfaction with the amplification characteristics of the hearing aid (fitting). However, improved audibility is related to hearing aid use adherence, with patients who achieve better audibility reporting that they use their hearing aids more frequently.

Shortfalls in international, multidisciplinary outcome data collection following head and neck cancer: does the ICF Core Set for HNC provide a common solution?

This article summarizes different experiences from research groups working in the field of outcome research in head and neck cancer (HNC). It presents information that has been gathered over a number of years, and emphasizes areas where further research is needed. In this context, the importance of interdisciplinary and multi-institutional collaboration is emphasized. There is a substantial need for a standardized description tool to provide a common basic language for outcome research in HNC. The International Classification of Functioning, Disability and Health (ICF), as adopted by the World Health Organization (WHO), and disease-specific ICF Core Sets for HNC are introduced to describe functioning in HNC. Applications of the ICF Core Set for HNC for further research are discussed.

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.