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Purpose: To describe the demographic and clinical factors associated with the importance of religiousness and spirituality among patients with human immunodeficiency virus (HIV) infection in the United States. Methods: Longitudinal study of a nationally representative cohort of 2266 patients receiving care for HIV infection surveyed in 1996 and again in 1998. Measures included 12 items assessing religious affiliation and attendance, the importance of religion and spirituality in life, and religious and spiritual practices. Multi-item religiousness and spirituality scales were constructed. Results: Eighty percent of respondents reported a religious affiliation. Sixty-five percent affirmed that religion and 85% that spirituality was "somewhat" or "very" important in their lives. A majority indicated that they "sometimes" or "often" rely on religious or spiritual means when making decisions (72%) or confronting problems (65%). Women, nonwhites, and older patients were more religious and spiritual. Residents of regions other than the western United States reported higher religiousness. High school graduates were more religious and spiritual than those with less education. Patients who did not report one of the risk factors assessed for HIV infection had higher religiousness scores than injection drug users (IDUs). Women, nonwhites other than Hispanics, patients older than 45 years of age compared to those between 18 and 34 years of age, and more educated patients reported higher spirituality. Clinical stage was not associated with religiousness or spirituality. Conclusions: A large majority of HIV-infected patients in the United States affirm the importance of religiousness and spirituality. These findings support a comprehensive, humanistic approach to the care of HIV-infected patients. [ABSTRACT FROM AUTHOR]

Background: Although case management has been advocated as a method for improving the care of chronically ill persons, its effectiveness is poorly understood.Objective: To assess the effect of case managers on unmet need for supportive services and utilization of medical care and medications among HIV-infected persons.Design: Baseline and follow-up interview of a national probability sample.Setting: Inpatient and outpatient medical facilities in the United States.Participants: 2437 HIV-infected adults representing 217 081 patients receiving medical care.Measurements: Outcomes measured at follow-up were unmet need for supportive services, medical care utilization (ambulatory visits, emergency department visits, and hospitalizations), and use of HIV medication (receipt of antiretroviral therapy and prophylaxis against Pneumocystis carinii pneumonia and toxoplasmosis).Results: At baseline, 56.5% of the sample had contact with a case manager in the previous 6 months. In multiple logistic regression analyses that adjusted for potential confounders, contact with a case manager at baseline was associated with decreased unmet need for income assistance (odds ratio [OR], 0.57 [95% CI, 0.36 to 0.91]), health insurance (OR, 0.54 [CI, 0.33 to 0.89]), home health care (OR, 0.29 [CI, 0.15 to 0.56]), and emotional counseling (OR, 0.62 [CI, 0.41 to 0.94]) at follow-up. Contact with case managers was not significantly associated with utilization of ambulatory care (OR, 0.77 [CI, 0.57 to 1.04]), hospitalization (OR, 1.13 [CI, 0.84 to 1.54]), or emergency department visits (OR, 1.30 [CI, 0.97 to 1.73]) but was associated with higher utilization of two-drug (OR, 1.58 [CI, 1.23 to 2.03]) and three-drug (OR, 1.34 [CI, 1.00 to 1.80]) antiretroviral regimens and of treatment with protease inhibitors or non-nucleoside reverse transcriptase inhibitors (OR, 1.29 [CI, 1.02 to 1.64]) at follow-up.Conclusions: Case management appears to be associated with fewer unmet needs and higher use of HIV medications in patients receiving HIV treatment. [ABSTRACT FROM AUTHOR]

Objective: To distinguish the effects of drug abuse, mental disorders, and problem drinking on antiretroviral therapy (ART) and highly active ART (HAART) use.Design: Prospective population-based probability sample of 2,267 (representing 213,308) HIV-infected persons in care in the United States in early 1996.Measurements: Self-reported ART from first (January 1997-July 1997) to second (August 1997-January 1998) follow-up interviews. Drug abuse/dependence, severity of abuse, alcohol use, and probable mental disorders assessed in the first follow-up interview. Adjusted odds ratios (AORs) and 95% confidence intervals (CIs) estimated from weighted models for 1) receipt of any ART, and 2) receipt of HAART among those on ART.Results: Of our study population, ART was reported by 90% and HAART by 61%. Over one third had a probable mental disorder and nearly half had abused any drugs, but drug dependence (9%) or severe abuse (10%) was infrequent. Any ART was less likely for persons with dysthymia (AOR, 0.74; CI, 0.58 to 0.95) but only before adjustment for drug abuse. After full adjustment with mental health and drug abuse variables, any ART was less likely for drug dependence (AOR, 0.58; CI, 0.34 to 0.97), severe drug abuse (AOR, 0.52; CI, 0.32 to 0.87), and HIV risk from injection drug use (AOR, 0.55; CI, 0.39 to 0.79). Among drug users on ART, only mental health treatment was associated with HAART (AOR, 1.57; CI, 1.11 to 2.08).Conclusions: Drug abuse-related factors were greater barriers to ART use in this national sample than mental disorders but once on ART, these factors were unrelated to type of therapy. [ABSTRACT FROM AUTHOR]

Background: Health-related quality of life refers to how well people are able to perform daily activities (functioning) and how they feel about their lives (well-being). The relationship between symptoms and health-related quality of life has not been fully explored.Objective: To estimate the association of HIV symptoms with health-related quality of life and with disability days.Design: Prospective cohort study.Setting: HIV providers in 28 urban and 24 rural randomly selected sites throughout the United States.Patients: Nationally representative sample of 2267 adults with known HIV infection who were interviewed in 1996 and again between 1997 and 1998.Measurements: Symptoms, two single-item global measures of health-related quality of life (perceived health and perceived quality of life), and disability days.Results: White patches in the mouth; nausea or loss of appetite; persistent cough, difficulty breathing, or difficulty catching one's breath; and weight loss were associated with more disability days and worse scores on both health-related quality-of-life measures. Headache; pain in the mouth, lips, or gums; dry mouth; and sinus infection, pain, or discharge were associated with worse perceived health. Pain in the mouth, lips, or gums; trouble with eyes; pain, numbness, or tingling of hands or feet; and diarrhea or loose or watery stools were associated with worse perceived quality of life. Headache and fever, sweats, or chills were associated with more disability days.Conclusions: Several symptoms are associated with worse health-related quality of life and more disability days in persons with HIV infection. In such patients, targeting specific symptoms may improve health-related quality of life and reduce disability. [ABSTRACT FROM AUTHOR]

There is substantial variation in the generosity of public assistance programs that affect HIV+ patients, and these differences should affect the economic outcomes associated with HIV infection. This article uses data from a nationally representative sample of HIV+ patients to assess how differences across states in Medicaid and AIDS Drug Assistance Programs (ADAP) affect costs and labor market outcomes for HIV+ patients in care in that state. Making ADAP programs more generous in terms of drug coverage would reduce per patient total monthly costs, mainly through a reduction in hospitalization costs. In contrast, expanding ADAP eligibility by increasing the income threshold would increase the total cost of care. Expanding eligibility for Medicaid through the medically needy program would increase per patient total costs, but full-time employment would increase and so would monthly earnings. The authors conclude that more generous state policies toward HIV+ patients--especially those designed to provide access to efficacious treatment--could improve the economic outcomes associated with HIV. [ABSTRACT FROM AUTHOR]

Objective: To assess the propensity of HIV-infected adults to seek care for common symptoms, and to determine whether they would seek care in the emergency department (ED) or with their primary care provider.Design: Cross-sectional interview study.Setting: Patients in care in the 48 contiguous United States.Participants: A nationally representative group of HIV- infected adults selected using multistage probability sampling.Measurements: Subjects were interviewed between January 1996 and April 1997. Patients with advanced disease (past AIDS diagnosis and/or CD4 cell count <200/microL) and early disease were asked how they would seek care for key HIV-associated symptom complexes. Three advanced disease and 3 early disease symptom scenarios were used.Main Results: Most advanced disease patients (78% to 87%) would seek care right away from the ED or primary care provider for the symptoms asked. Most early disease patients (82%) would seek care right away for new respiratory symptoms; fewer would do so for headache (46%) or oral white patches (62%). In a multivariate model, independent predictors of propensity to use the ED for advanced disease symptoms included African-American ethnicity (adjusted odds ratio [OR], 2.5; 95% confidence interval [95% CI], 1.8 to 3.4); less education (adjusted OR, 1.4; 95% CI, 1.1 to 1.7); drug dependence (adjusted OR, 1.4; 95% CI, 1.1 to 1.7); annual income less than $5,000 (adjusted OR, 1.5; 95% CI, 1.0 to 2.3); and lower psychological well-being (adjusted OR, 0.9; 95% CI, 0.9 to 1.0). In early disease, the following independently predicted ED use: African American (adjusted OR, 4.7; 95% CI, 3.1 to 7.1) or Hispanic ethnicity (adjusted OR 2.4; 95% CI, 1.4 to 4.3), female gender (adjusted OR, 1.6; 95% CI, 1.2 to 2.2), annual income less than $5,000 (adjusted OR, 1.8; 95% CI, 1.1 to 3. 0), and lower psychological well-being (adjusted OR, 0.9; 95% CI, 0. 8 to 1.0).Conclusions: Many patients would use the ED instead of same-day primary care for several common symptoms of HIV disease. African Americans, the poor, and patients with psychological symptoms had a higher propensity to use the ED. [ABSTRACT FROM AUTHOR]

Although increasing attention has been paid to the use of dental care by HIV patients, the existing studies do not use probability samples, and no accurate population estimates of use can be made from this work. The intent of the present study was to establish accurate population estimates of the use of dental services by patients under medical care. The study, part of the HIV Cost and Services Utilization Study (HCSUS), created a representative national probability sample, the first of its kind, of HIV-infected adults in medical care. Both bivariate and logistic regressions were conducted, with use of dental care in the preceding 6 months as the dependent variable and demographic, social, behavioral, and disease characteristics as independent variables. Forty-two percent of the sample had seen a dental health professional in the preceding 6 months. The bivariate logits for use of dental care show that African-Americans, those whose exposure to HIV was caused by hemophilia or blood transfusions, persons with less education, and those who were employed were less likely to use dental care (p < 0.05). Sixty-five percent of those with a usual source of care had used dental care in the preceding 6 months. Use was greatest among those obtaining dental care from an AIDS clinic (74%) and lowest among those without a usual source of dental care (12%). We conclude that, in spite of the high rate of oral disease in persons with HIV, many do not use dental care regularly, and that use varies by patient characteristics and availability of a regular source of dental care. [ABSTRACT FROM AUTHOR]

Context: Studies of selected populations suggest that not all persons infected with human immunodeficiency virus (HIV) receive adequate care.Objective: To examine variations in the care received by a national sample representative of the adult US population infected with HIV.Design: Cohort study that consisted of 3 interviews from January 1996 to January 1998 conducted by the HIV Cost and Services Utilization Consortium.Patients and Setting: Multistage probability sample of 2864 respondents (68% of those targeted for sampling), who represent the 231400 persons at least 18 years old, with known HIV infection receiving medical care in the 48 contiguous United States in early 1996 in facilities other than emergency departments, the military, or prisons. The first follow-up consisted of 2466 respondents and the second had 2267 (65% of all surviving sampled subjects).Main Outcome Measures: Service utilization (<2 ambulatory visits, at least 1 emergency department visit that did not lead to hospitalization, at least 1 hospitalization) and medication utilization (receipt of antiretroviral therapy and prophylaxis against Pneumocystis carinii pneumonia).Results: Inadequate HIV care was commonly reported at the time of interviews conducted from early 1996 to early 1997 but declined to varying degrees by late 1997. Twenty-three percent of patients initially and 15% of patients subsequently had emergency department visits that did not lead to hospitalization, 30% initially and 26% subsequently of those who had CD4 cell counts below 0.20 x 10(9)/L did not receive P carinii pneumonia prophylaxis, and 41% initially and 15% subsequently of those who had CD4 cell counts below 0.50 x 10(9)/L did not receive antiretroviral therapy (protease inhibitor or nonnucleoside reverse transcriptase inhibitor). Inferior patterns of care were seen for many of these measures in blacks and Latinos compared with whites, the uninsured and Medicaid-insured compared with the privately insured, women compared with men, and other risk and/or exposure groups compared with men who had sex with men even after CD4 cell count adjustment. With multivariate adjustment, many differences remained statistically significant. Even by early 1998, fewer blacks, women, and uninsured and Medicaid-insured persons had started taking antiretroviral medication (CD4 cell count adjusted P values <.001 to <.005).Conclusions: Access to care improved from 1996 to 1998 but remained suboptimal. Blacks, Latinos, women, the uninsured, and Medicaid-insured all had less desirable patterns of care. Strategies to ensure optimal care for patients with HIV requires identifying the causes of deficiency and addressing these important shortcomings in care. [ABSTRACT FROM AUTHOR]

To evaluate the extent of the problem of scientific misconduct in investigational drug trials, we reviewed data from 1955 routine audits conducted by the US Food and Drug Administration (FDA) from June 1977 to April 1988. Serious deficiencies were detected in 12% of audits prior to October 1985, but in only 7% since that date. At the same time, there was no evidence of a decline over time in the rate of detection of many categories of deficiencies, and some investigators were able to continue to participate in drug trials after flagrant violations of recognized norms of research. The data auditing program should be continued, but additional measures are needed to regulate misconduct. These must be tailored to the variety of causes of misconduct, ranging from negligence to fraud. Possible additional approaches could include certifying the competence of potential investigators; peer-reviewed, competitive application for the opportunity to conduct FDA-authorized clinical trials; limiting an investigator's level of participation in clinical trials; penalizing manufacturers who fail to detect their investigators' misconduct; and permitting the FDA to suspend investigators prior to a hearing. Measures taken should maximize public utility at the least economic cost to society and should be evaluated thoroughly. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the educational strategies and experiences of residency programs regarding the training of primary care providers in the care of patients who have AIDS.Design: Cross-sectional, self-administered questionnaire survey.Setting: Survey conducted November 1988-April 1989.Participants: All 771 non-military U.S. internal medicine and family medicine program directors were surveyed; 80% responded.Interventions: None.Measurements and Main Results: While 91% of the directors felt that primary care of AIDS patients was an important educational experience and 94% reported that their programs usually had AIDS inpatients, only 16% reported that the majority of trainees cared for AIDS patients in their continuity clinics. Even at programs that typically had six or more AIDS inpatients, only 26% of directors reported that most residents had cared for an AIDS patient in their continuity clinics. Among the 57% who did not believe or were unsure whether their residents were adequately trained in AIDS ambulatory care, only 38% reported improving resident education in this area to be a high priority. Among the 39% who did not encourage residents' assumption of primary care, 60% had at least one of the following concerns: AIDS care too stressful for residents (24%), AIDS care too complicated for generalists (31%), or clinic faculty not qualified to supervise residents' caring for AIDS patients (39%).Conclusion: Although program directors view education in AIDS ambulatory care as important, most do not believe that residents are adequately trained, many do not encourage residents' assumption of primary care of AIDS patients, and residents usually have not provided such care in their programs. Strategies to augment residents' ambulatory experience in AIDS care are needed. [ABSTRACT FROM AUTHOR]

Funding for medical care research in the interrelated fields of health services research, clinical decision-making, clinical epidemiology, the medical humanities and social sciences, and medical education has been unstable, and relatively little is available in the form of investigator-initiated grants. Stable funding for these fields is important to society and critical to the healthy development of academic general internal medicine. Strategies to augment funding can include political interventions to increase support for the National Center for Health Services Research and Health Care Technology Assessment and to secure designated funds within the National Institutes of Health. Public funding is also needed for career development awards in these fields. Research support also could be enhanced by establishing a consortium of foundations interested in funding investigator-initiated grants through open competition, by developing a mechanism for reviewing proposals from small foundations, by developing consortia in the private sector to support focused research, and by developing endowments to support research. [ABSTRACT FROM AUTHOR]