Psychometric testing of two new patient-reported outcome instruments for the evaluation of treatment for hypogonadism.

AIM: The aim of this study was to perform psychometric testing and estimate minimal important change (MIC) of two new patient-reported outcome (PRO) instruments - Sexual Arousal, Interest and Drive Scale (SAID) and Hypogonadism Energy Diary (HED). METHODS: New PRO instruments were administered immediately after screening (Time 1, test-retest subset only) and immediately prior to both randomisation (Time 2) and end-point (Time 3) to men participating in a randomised clinical trial comparing the effect of testosterone solution 2% (TS) and placebo on serum total testosterone. Psychometric analyses included reliability, validity and responsiveness. Total scores for both PRO instruments were transformed to a 0-100 scale. RESULTS: Study participants (n = 694) were 80% age ≤ 65 years, 79% White, with mean baseline testosterone = 202 ng/dl. Clinicians identified 86% subjects as having low sex drive, 86% with low energy and 76% with both symptoms. Reliability analyses for SAID and HED yielded reliability coefficients > 0.70. SAID scores discriminated between men having low sex drive (n = 553) and those who did not (n = 80) (34.5 vs. 42.8, p < 0.001). HED scores discriminated between men having low energy (n = 541) and those who did not (n = 64) (48.9 vs. 60.2, p < 0.001). In the men randomised to TS (vs. placebo), SAID and HED detected effect sizes of 0.61 (vs. 0.39) and 0.68 (vs. 0.48), respectively. MIC estimates for SAID and HED were approximately 10 and 8, respectively. CONCLUSIONS: This study provided evidence of the reliability, validity and responsiveness of SAID and HED as measures of sex drive and energy, respectively, making them potentially useful for evaluation of hypogonadal treatment.

Establishing the content validity of the Sexual Arousal, Interest, and Drive Scale and the Hypogonadism Energy Diary.

AIM: The aim of this qualitative analysis was to establish the content validity of two new patient-reported outcome (PRO) measures: Sexual Arousal, Interest, and Drive Scale (SAID) and Hypogonadism Energy Diary (HED). METHODS: Four separate qualitative studies were conducted with 125 men with hypogonadism (mean age: 53 years, 85% adult onset). Study 1 used focus groups/interviews to identify important and relevant concepts related to the experience of hypogonadism and its treatment in men primarily with adult-onset hypogonadism. Study 2 tested items generated for assessments of low sex drive and low energy. Study 3 used interviews to confirm in men with early-onset hypogonadism that low sex drive and low energy were also important and relevant symptoms. Study 4 tested final versions of the two PROs and determined equivalency of paper-based and electronic versions of the two PROs. RESULTS: Of the concepts emerging in Studies 1 and 3, low sex drive and low energy were the symptoms most often spontaneously mentioned. Coding of transcripts from Studies 1 and 3 led to the generation of items for the SAID and HED. After item testing (Studies 2 and 4), the final SAID included five items pertaining to arousal, interest in sex and sex drive with a 7-day recall period and the final HED included two items (energy, tired/exhausted) to be administered three times per day. CONCLUSION: The SAID and HED have content validity established according to regulatory guidance and, therefore, the potential to provide the patient perspective of treatments for hypogonadism.

Pneumocystis carinii infection of the small intestine.

Extrapulmonary Pneumocystis carinii infections are rare in comparison to other opportunistic infections in patients with acquired immunodeficiency syndrome (AIDS). In recent years, however, the number of reported cases of extrapulmonary pneumocystosis has increased. It is therefore important for physicians to recognize the various presentations of extrapulmonary P carinii infection. This article reports a case in which the initial clinically detected AIDS-related infection was extrapulmonary P carinii infection of the small intestine diagnosed after perforation of the jejunum.

African-American physicians' views on health reform: results of a survey.

Little is known about African-American physicians' health system experience or their opinions on health reform. In an attempt to obtain socioculturally relevant data quantifying these experiences and opinions, the National Medical Association administered a 38-question, 80-item survey instrument in August 1993. The questionnaire was completed by 236 physicians. The results indicate that African-American physicians feel health care is a right and that the health system needs fundamental change. Although there was no consensus on the type of health reform needed, approximately 35% cited availability and access to care to be the greatest problem facing the system with high costs of care (18.2%) ranking second. Unique findings in the survey indicated respondents felt that the needs and concerns of most African Americans will not be fairly addressed in the reform of the health-care system, that African-African physicians are not included in the formation of health-care policies, and that African-American physicians are facing high levels of professional and healthcare system racial discrimination. More than 99% of African-American physicians reported some degree of racial discrimination in the practice of medicine including peer review, obtaining practice privileges at hospitals, hospital staff promotions, Medicaid and Medicare reimbursements, malpractice suits, private insurance oversight and reimbursements, and referral practices of white colleagues. These findings have profound health policy, health financing, and health service delivery implications and should be included in debates and deliberations on health reform.

A layman's guide to the U.S. health care system.

This article provides an overview of the U.S. health care system and recent proposals for health system reform. Prepared for a 15-nation comparative study for the Organization for Economic Cooperation and Development (OECD), the article summarizes descriptive data on the financing, utilization, access, and supply of U.S. health services; analyzes health system cost growth and trends; reviews health reforms adopted in the 1980s; and discusses proposals in the current health system reform debate.

Hypertension management in health care for the homeless clinics: results from a survey.

BACKGROUND: With the exception of alcohol abuse, hypertension is the most common chronic physical health problem encountered among homeless persons. The material conditions of homelessness greatly complicate the management of this disorder. Some of the complications and their solutions are discussed here, based on the experiences of health clinics for the homeless in large US cities. METHODS: In 1988, the Stewart B. McKinney Homeless Assistance Act established health care clinics for homeless persons in 108 cities. We surveyed medical directors in these clinics, asking about the management of hypertension in this difficult-to-treat population; 65 responded. RESULTS: Comparisons between our survey data and those obtained in two recent surveys of clinicians in "normal" clinical practice provide interesting lessons in how medical practice is adapted to respond to the unique needs and problems of the urban homeless. Although therapeutic goals are similar, the means chosen to achieve them often are not. CONCLUSIONS: The treatment of homeless hypertensives illustrates the problems inherent in strict biomedical models of disease and its alleviation. Preferred treatments, course of disease, and success of intervention are powerfully affected by social factors.