Eliciting patient preferences for hormonal therapy options in the treatment of metastatic prostate cancer.

Treatment choices for metastatic prostate cancer are complex and can involve men balancing survival versus quality of life. The present study aims to elicit patient preferences with respect to the attributes of treatments for metastatic prostate cancer through a discrete choice experiment (DCE) questionnaire. Men with recently diagnosed localized prostate cancer were asked to envisage that they had metastatic disease when completing a survey. As expected, men with prostate cancer placed considerable importance on gains in survival; however, avoiding side effects of treatment was also clearly important. Survival gains should be considered alongside side effects when discussing treatment options in metastatic disease.

Psychometric evaluation of the fatigue severity scale for use in chronic hepatitis C.

Evidence exists demonstrating that infection with hepatitis C virus impairs health-related quality of life, but less is known about the effect of fatigue, a common symptom, on everyday life. The psychometric properties of the fatigue severity scale (FSS) were explored to determine suitability as an outcome measure in clinical trials. The FSS includes nine items developed to measure disabling fatigue and a visual analog scale (VAS) to measure overall fatigue. Using baseline data from three clinical trials (n = 1225) involving chronic hepatitis C patients, scaling and psychometric characteristics of the FSS were assessed. The SF-36 was also used in the trials. Item response theory analysis demonstrated that the FSS items can be placed along a single homogenous domain, fatigue. Internal consistency reliability was 0.94. Test-retest reliability was 0.82 for the total score and 0.80 for the VAS. The total score and the VAS were significantly correlated with the SF-36 vitality subscale (r = -0.76 and r = -0.76 respectively). Correlations with other SF-36 subscales were moderate (r = -0.46 to r = -0.67, all p < 0.0001). In summary, the FSS possesses good psychometric properties.

Psychometric validation of a constipation symptom assessment questionnaire.

BACKGROUND: Clinical management of constipation is complicated by the lack of a gold standard for evaluation of symptoms. A constipation symptom assessment instrument, the PAC-SYM, was developed to address the patient perspective on the disorder. Instrument content was based on literature review and results of focus groups. METHODS: Two hundred and sixteen patients at nine sites participated in a 6-week psychometric evaluation of the PAC-SYM. The final instrument contained 12 items assigned to 3 subscales: stool symptoms, rectal symptoms, and abdominal symptoms. The psychometric properties of this final instrument were assessed. RESULTS: Internal consistency and test-retest reliability of the final instrument was high (Cronbach's alpha = 0.89; intraclass correlation = 0.75). Concurrent validity was supported by the correlation with both subject and investigator constipation severity ratings (r= 0.68 and 0.72, respectively; P < 0.0001). Scores were moderately correlated with instruments measuring quality of life. Comparison of treatment responders with nonresponders showed the ability of the instrument to differentiate between groups on the basis of clinical severity (t = -6.12, P < 0.0001 ). Scores changed significantly over time among responders, indicating instrument responsiveness. CONCLUSIONS: The PAC-SYM is internally consistent, reproducible under stable conditions, valid, and responsive to change and provides a comprehensive means to assess the effectiveness of treatment for constipation.

Improving the quality of care for children in health systems.

OBJECTIVE: To summarize the state of the art in quality improvement, review its application to care for children, and define the information that will be needed so that care for children can be further improved. PRINCIPAL FINDINGS: Health services for children exhibit numerous deficiencies in quality of care. The deficiencies cross all major domains of pediatric care--preventive services, acute care, and chronic care--and provide the opportunity for creative application of improvement strategies with a potential to benefit the health and well-being of children. Approaches to quality improvement have changed over the past two decades from those emphasizing the inspection of structural aspects of care and the imposition of sanctions to more dynamic strategies that emphasize measurement and comparison to motivate change; the use of evidence to specify aims for improvement; and the adoption of a variety of management strategies adapted from business and the social sciences to achieve these aims. These modern approaches to quality improvement have rarely been subjected to rigorous testing of their effectiveness. Moreover, their application in pediatrics has been less widespread than in adult healthcare. For children, several aspects about health services, such as the relative rarity of chronic illness, the important effects of social factors on health, and the limited cost, make some of these approaches even more challenging and may require new approaches or meaningful modifications. RECOMMENDATIONS: Research to understand better the general process of improvement will benefit improvement efforts for children. Research that builds the base of knowledge about best practices for children--effectiveness research--will also result in an enhanced capacity for improvement of those systems that care for children's health. Quality of care for children would be enhanced by targeted research examining ways both to foster improvement across segments of society, and to make recommendations for care more sensitive to children's development and environmental context. Research that supports incorporating the child's perspective into care is both uniquely challenging to perform and central to improving pediatric care.

Homing in on the homeless: assessing the physical health of homeless adults in Los Angeles County using an original method to obtain physical examination data in a survey.

OBJECTIVE: Public policy that decreases the finding for social services may combine with the ascendancy of corporate managed care to increase the health care deficit. Assessing the health impact of these policy changes on various populations is a fundamental challenge for health services research. Disadvantaged populations, such as the homeless, are likely to be affected disproportionately. Research quality data on the physical health of such populations are difficult and expensive to obtain. In particular, physical examination data have not been available and self-reports are insufficient. Our objective: to develop and utilize a structured physical exam system enabling lay survey researchers to report reliably physical findings related to six tracer conditions in a disadvantaged population. STUDY SETTING: A field survey of homeless adults in Los Angeles County, California. Respondents were 363 homeless adults representing a subsample of a probability sample of the county's homeless adult population. STUDY DESIGN: We integrated existing measures with expert clinical opinion and original means of data collection into a structured physical exam enabling lay interviewers to identify the prevalence of vision problems, significant skin disorders, peripheral vascular disease of the lower extremities, selected podiatric disorders, hypertension, and tuberculosis in a sample of homeless adults. PRINCIPAL MEASURES: We describe lay interviewer performance in terms of mastery of the necessary material based on written and practical exams and in terms of the number of respondents successfully followed. We base our description of the instrument on the time necessary to complete it, and on the proportion of each component successfully completed during the field survey, as well as on interrater reliability. We report the prevalence of the various clinical conditions according to self-report and according to the structured limited physical exam, as well as the marginal proportion of respondents who were identified by the physical exam and not by self-report. PRINCIPAL FINDINGS: Interviewers performed the exam successfully under field conditions. Respondent acceptance of the instrument was high. Interrater agreement was 100 percent regarding the need for referral on the basis of blood pressure and vision. Kappa statistics for skin, foot, and edema findings were .67,.71, and .81, respectively. Adjusted for sampling weights, 60 percent of this population required referral for at least one of the specified conditions. For those portions of the survey for which both self-report and physical exam data were available, lay interviewers made significant percentages of referrals on the basis of physical findings alone. CONCLUSIONS: High blood pressure, poor vision, peripheral vascular diseases of the feet and legs, and significant skin conditions are prevalent among the homeless in Los Angeles County. Without physical exam data, estimates of the prevalence of these conditions will be incorrect. Researchers can use laypersons to collect reliable and valid physical exam data on disadvantaged populations. This represents a new tool for assessing and monitoring the health of these populations.

The medical appropriateness of tympanostomy tubes proposed for children younger than 16 years in the United States.

OBJECTIVE: To describe the clinical reasons tympanostomy tubes are proposed for children and to assess their appropriateness. DESIGN: Analysis of data previously collected prospectively by a national utilization review (UR) firm during a two-step UR process to assess the medical appropriateness of tympanostomy tube placement. Nurses interviewed otolaryngologists' and primary care physicians' office staff to collect clinical data. For a randomly selected subsample of cases found inappropriate, we reviewed subsequent interviews of the otolaryngologists by physician reviewers, who looked for possible extenuating clinical circumstances or additional clinical data that might have changed the appropriateness category. SETTING: Otolaryngologists' practices from 49 states and the District of Columbia. PATIENTS: All 6611 children younger than 16 years who were insured by three clients of the UR firm and whose proposal to receive tympanostomy tubes were reviewed by this system from January 1, 1990, through July 31, 1991. The insurance companies in the study insured 5.6 million Americans at the time of the study. MAIN OUTCOME MEASURE: The medical appropriateness of tympanostomy tube surgery according to explicit criteria developed by an expert panel using the RAND/University of California-Los Angeles modified Delphi method. RESULTS: A total of 6429 (97%) of the cases were proposed for recurrent acute otitis media, otitis media with effusion, or both. Making generous clinical assumptions, 41% of the proposals for these reasons had appropriate indications, 32% had equivocal indications, and 27% had inappropriate ones. Considering the additional information available from the subsample review, the proportion appropriate was 42%, equivocal 35%, and inappropriate 23%. CONCLUSION: About one quarter of tympanostomy tube insertions for children in this study were proposed for inappropriate indications and another third for equivocal ones.

Pharmaceutical assessment of amygdalin (Laetrile) products.

The National Cancer Institute (NCI) recently acquired a large supply of formulated products of amygdalin manufactured by Cyto Pharma of Mexico, for possible use in a clinical trial in the US. Tablets for oral administration and ampules of the injectable produce were obtained. Both forms were extensively analyzed and evaluated by several analytic and pharmaceutical laboratories under contract with the NCI. Analytic test procedures were developed to determine the chemical integrity and quantitative composition of the formulated products. Routine physical and biologic tests were also performed to evaluate the manufacturing quality of both dosage forms. The results indicate that both the oral and injectable forms of amygdalin were substandard by US criteria for manufactured pharmaceutical products. All samples were determined to be chemically subpotent, mislabeled, and of poor manufacturing quality. More than 20 samples of the ampules were found by visual inspection to contain microbial contamination. Other samples were found to be pyrogenic. Based on the results of the testing performed, both tablet and ampule forms of amygdalin manufactured by Cyto Pharma of Mexico are considered unfit for use in man.