Religion, Spirituality, and HIV Clinical Outcomes: A Systematic Review of the Literature.

This systematic review evaluates the association between religion, spirituality and clinical outcomes in HIV-infected individuals. A systematic literature review was conducted for all English language articles published between 1980 and 2016 in relevant databases. Six hundred fourteen studies were evaluated. 15 met inclusion criteria. Ten (67%) studies reported a positive association between religion or spirituality and a clinical HIV outcome. Two (13%) studies failed to detect such an association; and two (13%) demonstrated a negative association. One study (7%) identified features of religiosity and spirituality that had both negative and positive associations with HIV clinical outcomes. Recognizing the religious or spiritual commitments of patients may serve as an important component of patient care. Further longitudinal studies and interventions might be required to further clarify the potential impact of religion and spirituality on HIV clinical outcomes.

Risk of End-Stage Renal Disease in HIV-Positive Potential Live Kidney Donors.

New federal regulations allow HIV-positive individuals to be live kidney donors; however, potential candidacy for donation is poorly understood given the increased risk of end-stage renal disease (ESRD) associated with HIV infection. To better understand this risk, we compared the incidence of ESRD among 41 968 HIV-positive participants of North America AIDS Cohort Collaboration on Research and Design followed for a median of 5 years with the incidence of ESRD among comparable HIV-negative participants of National Health and Nutrition Examination III followed for a median of 14 years. We used risk associations from multivariable Cox proportional hazards regression to derive cumulative incidence estimates for selected HIV-positive scenarios (no history of diabetes, hypertension, AIDS, or hepatitis C virus coinfection) and compared these estimates with those from similarly selected HIV-negative scenarios. For 40-year-old HIV-positive individuals with health characteristics that were similar to those of age-matched kidney donors, viral load <400 copies/mL, and CD4+ count ≥500 cells/µL, the 9-year cumulative incidence of ESRD was higher than that of their HIV-negative peers, yet still low: 2.5 versus 1.1 per 10 000 among white women, 3.0 versus 1.3 per 10 000 among white men, 13.2 versus 3.6 per 10 000 among black women, and 15.8 versus 4.4 per 10 000 among black men. HIV-positive individuals with no comorbidities and well-controlled disease may be considered low-risk kidney donor candidates.

The impact of prescribed opioids on CD4 cell count recovery among HIV-infected patients newly initiating antiretroviral therapy.

OBJECTIVES: Certain prescribed opioids have immunosuppressive properties, yet their impact on clinically relevant outcomes, including antiretroviral therapy (ART) response among HIV-infected patients, remains understudied. METHODS: Using the Veterans Aging Cohort Study data, we conducted a longitudinal analysis of 4358 HIV-infected patients initiating ART between 2002 and 2010 and then followed them for 24 months. The primary independent variable was prescribed opioid duration, categorized using pharmacy data as none prescribed, short-term (< 90 days) and long-term (≥ 90 days). Outcomes included CD4 cell count over time. Analyses adjusted for demographics, comorbid conditions, ART type and year of initiation, and overall disease severity [ascertained with the Veterans Aging Cohort Study (VACS) Index]. Sensitivity analyses examined whether effects varied according to baseline CD4 cell count, achievement of viral load suppression, and opioid properties (i.e. dose and known immunosuppressive properties). RESULTS: Compared to those with none, patients with short-term opioids had a similar increase in CD4 cell count (mean rise per year: 74 vs. 68 cells/µL; P = 0.11), as did those with long-term prescribed opioids (mean rise per year: 74 vs. 75 cells/µL; P = 0.98). In sensitivity analysis, compared with no opioids, the effects of short-term prescribed opioids were statistically significant among those with a baseline CD4 cell count ≥ 500 cells/µL (mean rise per year: 52 cells/µL for no opioids vs. 20 cells/µL for short-term opioids; P = 0.04); findings were otherwise unchanged. CONCLUSIONS: Despite immunosuppressive properties intrinsic to opioids, prescribed opioids appeared to have no effect on CD4 cell counts over 24 months among HIV-infected patients initiating ART.

Comparing clinical outcomes in HIV-infected and uninfected older men hospitalized with community-acquired pneumonia.

OBJECTIVES: Outcomes of community-acquired pneumonia (CAP) among HIV-infected older adults are unclear. METHODS: Associations between HIV infection and three CAP outcomes (30-day mortality, readmission within 30 days post-discharge, and hospital length of stay [LOS]) were examined in the Veterans Aging Cohort Study (VACS) of male Veterans, age ≥ 50 years, hospitalized for CAP from 10/1/2002 through 08/31/2010. Associations between the VACS Index and CAP outcomes were assessed in multivariable models. RESULTS: Among 117 557 Veterans (36 922 HIV-infected and 80 635 uninfected), 1203 met our eligibility criteria. The 30-day mortality rate was 5.3%, the mean LOS was 7.3 days, and 13.2% were readmitted within 30 days of discharge. In unadjusted analyses, there were no significant differences between HIV-infected and uninfected participants regarding the three CAP outcomes (P > 0.2). A higher VACS Index was associated with increased 30-day mortality, readmission, and LOS in both HIV-infected and uninfected groups. Generic organ system components of the VACS Index were associated with adverse CAP outcomes; HIV-specific components were not. Among HIV-infected participants, those not on antiretroviral therapy (ART) had a higher 30-day mortality (HR 2.94 [95% CI 1.51, 5.72]; P = 0.002) and a longer LOS (slope 2.69 days [95% CI 0.65, 4.73]; P = 0.008), after accounting for VACS Index. Readmission was not associated with ART use (OR 1.12 [95% CI 0.62, 2.00] P = 0.714). CONCLUSION: Among HIV-infected and uninfected older adults hospitalized for CAP, organ system components of the VACS Index were associated with adverse CAP outcomes. Among HIV-infected individuals, ART was associated with decreased 30-day mortality and LOS.

Impact of defined clinical population and missing data on temporal trends in HIV viral load estimation within a health care system.

OBJECTIVES: Community viral load (CVL) estimates vary based on analytic methods. We extended the CVL concept and used data from the Veterans Health Administration (VA) to determine trends in the health care system viral load (HSVL) and its sensitivity to varying definitions of the clinical population and assumptions regarding missing data. METHODS: We included HIV-infected patients in the Veterans Aging Cohort Study, 2000-2010, with at least one documented CD4 count, HIV-1 RNA or antiretroviral prescription (n = 37 318). We created 6-month intervals including patients with at least one visit in the past 2 years. We assessed temporal trends in clinical population size, patient clinical status and mean HSVL and explored the impact of varying definitions of the clinical population and assumptions about missing viral load. RESULTS: The clinical population size varied by definition, increasing from 16 000-19 000 patients in 2000 to 23 000-26 000 in 2010. The proportion of patients with suppressed HIV-1 RNA increased over time. Over 20% of patients had no viral load measured in a given interval or the past 2 years. Among patients with a current HIV-1 RNA, mean HSVL decreased from 97 800 HIV-1 RNA copies/mL in 2000 to 2000 copies/mL in 2010. When current HIV-1 RNA data were unavailable and the HSVL was recalculated using the last available HIV-1 RNA, HSVL decreased from 322 300 to 9900 copies/mL. HSVL was underestimated when using only current data in each interval. CONCLUSIONS: The CVL concept can be applied to a health care system, providing a measure of health care quality. Like CVL, HSVL estimates depend on definitions of the clinical population and assumptions about missing data.

Virologic response and haematologic toxicity of boceprevir- and telaprevir-containing regimens in actual clinical settings.

Effectiveness, safety and tolerability of boceprevir (BOC) and telaprevir (TPV) in actual clinical settings remain unknown. We determined rates of sustained virologic response (SVR) and haematologic adverse effects among persons treated with BOC- or TPV-containing regimens, compared with pegylated interferon/ribavirin (PEG/RBV). Using an established cohort of hepatitis C virus (HCV)-infected persons, Electronically Retrieved Cohort of HCV Infected Veterans (ERCHIVES), we identified those treated with a BOC- or TPV-containing regimen and HCV genotype 1-infected controls treated with PEG/RBV. We excluded those with HIV coinfection and missing HCV RNA values to determine SVR. Primary endpoints were SVR (undetectable HCV RNA ≥12 weeks after treatment completion) and haematologic toxicity (grade 3/4 anaemia, neutropenia and thrombocytopenia). We evaluated 2288 persons on BOC-, 409 on TPV-containing regimen and 6308 on PEG/RBV. Among these groups, respectively, 31%, 43% and 9% were treatment-experienced; 17%, 37% and 14% had baseline cirrhosis; 63%, 54% and 48% were genotype 1a. SVR rates among noncirrhotics were as follows: treatment naïve: 65% (BOC), 67% (TPV) and 31% (PEG/RBV); treatment experienced: 57% (BOC), 54% (TPV) and 13% (PEG/RBV); (P-value not significant for BOC vs TPV; P < 0.0001 for BOC or TPV vs PEG/RBV). Haematologic toxicities among BOC-, TPV- and PEG/RBV-treated groups were as follows: grade 3/4 anaemia 7%, 11% and 3%; grade 4 thrombocytopenia 2.2%, 5.4% and 1.7%; grade 4 neutropenia 8.2%, 5.6% and 3.4%. SVR rates are higher and closer to those reported in pivotal clinical trials among BOC- and TPV-treated persons compared with PEG/RBV-treated persons. Haematologic adverse events are frequent, but severe toxicity is uncommon.

Sexual partner notification of HIV infection among a National United States-based sample of HIV-infected men.

Limited data exist on whether sexual partner notification practices among HIV-infected men, particularly those who have sex with men (MSM), vary by HIV viral load. We examined factors associated with complete (all partners) versus incomplete partner notification in 760 HIV-infected individuals across the United States, 49 % of whom were MSM. Thirty-four percent reported incomplete partner notification. Incomplete partner notification was more likely among black men, MSM, and those reporting casual partners and non-condom use. Partner notification practices did not vary by HIV viral load except among those with casual partners in whom a detectable viral load was associated with incomplete partner notification. Increased sexual partner notification among HIV-infected men, especially MSM, is needed.

Patient and provider-reported symptoms in the post-cART era.

Prior research has consistently demonstrated that providers often under recognize symptoms. However, this research was limited by the different ways in which patients and providers were asked about the symptoms patients experience. We sought to (1) describe the prevalence of patient-reported symptoms in the post-cART era; (2) identify those patient-reported symptoms which are most strongly associated with health-related quality of life (HRQoL), hospitalization and mortality; and (3) determine whether primary providers recognize symptoms associated with HRQoL, hospitalization and mortality. We conducted a secondary analysis using baseline survey data from the Veterans Aging Cohort Study and determined which patient-reported symptoms correlated with clinical outcomes using regression analyses. Kappa scores were then calculated. HIV-infected patients suffer from a high burden of symptoms in the post-cART era. Nine out of 20 symptoms correlated with clinical outcomes. Providers universally under recognized symptoms and demonstrated poor agreement beyond chance when patient-report was used as the gold standard.

All-cause mortality among males living with and without HIV initiating long-term opioid therapy, and its association with opioid dose, opioid interruption and other factors.

BACKGROUND: While the relationship between long-term opioid therapy (LTOT) dose and overdose is well-established, LTOT's association with all-cause mortality is less understood, especially among people living with HIV (PLWH). There is also limited information regarding the association of LTOT cessation or interruption with mortality. METHODS: Among PLWH and matched uninfected male veterans in care, we identified those who initiated LTOT. Using time-updated cox regression, we examined the association between all-cause mortality, unnatural death, and overdose, and opioid use categorized as 1-20 (reference group), 21-50, 51-90, and ≥ 91 mg morphine equivalent daily dose (MEDD). RESULTS: There were 22,996 patients on LTOT, 6,578 (29 %) PLWH and 16,418 (71 %) uninfected. Among 5,222 (23 %) deaths, 12 % were unnatural deaths and 6 % overdoses. MEDD was associated with risk of all 3 outcomes; compared to patients on 1-20 mg MEDD, adjusted risk for all-cause mortality monotonically increased (Hazard Ratios (HR) [95 % CI] for 21-50 mg MEDD = 1.36 [1.21, 1.52], 51-90 mg MEDD = 2.06 [1.82, 2.35], and ≥ 91 mg MEDD = 3.03 [2.71, 3.39]). Similar results were seen in models stratified by HIV. LTOT interruption was also associated with all-cause, unnatural, and overdose mortality (HR [95 % CI] 2.30 [2.09, 2.53], 1.47 [1.13, 1.91] and 1.52 [1.04, 2.23], respectively). CONCLUSIONS: Among PLWH and uninfected patients on LTOT we observed a strong dose-response relationship with all 3 mortality outcomes. Opioid risk mitigation approaches should be expanded to address the potential effects of higher dose on all-cause mortality in addition to unnatural and overdose fatalities.

Rates and predictors of hepatitis C virus treatment in HCV-HIV-coinfected subjects.

BACKGROUND: True treatment rates and the impact of comorbidities on treatment rates for hepatitis C virus in the HCV-HIV-coinfected subjects are unknown. AIM: To quantify the rates of treatment prescription and the effect of comorbidities on hepatitis C virus treatment rates in HCV-HIV-coinfected veterans. METHODS: The Veterans Affairs National Patient Care Database was used to identify all hepatitis C virus-infected subjects between 1999 and 2003 using ICD-9 codes. Demographics, comorbidities and pharmacy data were retrieved. We used logistic regression to compare the predictors of hepatitis C virus treatment in hepatitis C virus-monoinfected and HCV-HIV-coinfected subjects. FINDINGS: We identified 120 507 hepatitis C virus-infected subjects, of which 6502 were HIV coinfected. 12% of the hepatitis C virus-monoinfected and 7% of the -coinfected subjects were prescribed hepatitis C virus treatment (P < 0.0001). Those not prescribed treatment were older (48.6 years vs. 47.7 years, P = 0.007) and more likely to be black (52% vs. 32%, P < 0.0001). HIV coinfected was less likely to be prescribed hepatitis C virus treatment (OR 0.74, 95% CI: 0.67-0.82). Among the coinfected subjects, the following were associated with non-treatment (OR, 95% CI): black race (0.45, 0.35-0.57); Hispanic race (0.56, 0.38-0.82); drug use (0.68, 0.53-0.88); anaemia (0.17, 0.11-0.26); bipolar disorder (0.63, 0.40-0.99); major depression (0.72, 0.53-0.99); mild depression (0.47, 0.35-0.62). CONCLUSIONS: A small number of HCV-HIV-coinfected veterans are prescribed treatment for hepatitis C virus. Non-treatment is associated with increasing age, minority race, drug use and psychiatric illness. Further studies are needed to determine the eligibility for treatment and reasons for non-treatment for hepatitis C virus.

Characteristics of HIV infected patients cared for at "academic model for the prevention and treatment of HIV/AIDS" clinics in western Kenya.

BACKGROUND: With the new initiatives to treat large numbers of HIV infected individuals in sub-Saharan Africa, policy makers require accurate estimates of the numbers and characteristics of patients likely to seek treatment in these countries. OBJECTIVE: To describe characteristics of adults receiving care in two Kenyan public HIV clinics. DESIGN: Cross-sectional cohort analysis of data extracted from an electronic medical records system. SETTING: Academic Model for the Prevention and Treatment of HIV/AIDS (AMPATH) HIV clinics in Kenya's second national referral (urban) hospital and a nearby rural health center. SUBJECTS: Adult patients presenting for care at HIV clinics. MAIN OUTCOME MEASURES: Gender and inter-clinic stratified comparisons of demographic, clinical, and treatment data. RESULTS: In the first nineteen months, 790 adults visited the urban clinic and 294 the rural clinic. Mean age was 36 +/- 9 (SD) years. Two-thirds were women; a quarter had spouses who had died of acquired immune deficiency syndrome (AIDS). HIV/AIDS behavioural risk factors (multiple sexual partners, rare condom use) and constitutional symptoms (fatigue, weight loss, cough, fever, chills) were common. Rural patients had more symptoms and less prior and current tuberculosis. Men more commonly presented with symptoms than women. The cohort CD4 count was low (223 +/- 197 mm3), with men having significantly lower CD4 count than women (185 +/- 175 vs. 242 +/- 205 p = 0.0007). Eighteen percent had an infiltrate on chest radiograph. Five percent (most often men) had received prior antiretroviral drug therapy, (7% in urban and 1% in rural patients, p = 0.0006). Overall, 393 (36%) received antiretroviral drugs, 89% the combination of lamivudine, stavudine, and nevirapine. Half received prophylaxis for tuberculosis and Pneumocystis jirovecii. Men were sicker and more often received antiretroviral drugs. CONCLUSIONS: Patients presenting to two Kenyan HIV clinics were predominantly female, ill and naive to retroviral therapy with substantial differences by clinic site and gender. Behavioural risk factors for HIV/AIDS were common. A thorough understanding of clinical and behavioural characteristics can help target prevention and treatment strategies.

Management of incidental pituitary microadenomas: a cost-effectiveness analysis.

The objective of this study was to compare the cost-effectiveness of four management strategies for a patient with an incidentally discovered asymptomatic pituitary microadenoma. A decision analytic Markov model was used to determine the incremental cost-effectiveness of four clinical management strategies: 1) expectant management, 2) PRL screening, 3) an endocrine screening panel (PRL, insulin-like growth factor I, and 1-mg dexamethasone suppression test), and 4) magnetic resonance imaging (MRI) follow-up. The model incorporated the natural history of incidental microadenomas, test characteristics, pharmacological and surgical treatment outcomes, patient's quality of life, discounting, and the costs of hormone testing, bromocriptine, MRIs, hospitalization for surgery, and physician services. PRL screening, endocrine screening panel, and MRI follow-up all provided slightly greater quality-adjusted survival than expectant management, but the costs increased disproportionately more than the benefits. The incremental cost per quality-adjusted life year for PRL screening is $1,428, and that for the endocrine screening panel is $69,495. These results are most sensitive to patient anxiety about the microadenoma; increased anxiety shifts the recommended strategy to the endocrine screening panel. We conclude that in patients with an incidental asymptomatic pituitary microadenoma, a single PRL test may be the most cost-effective management strategy.

Enzyme-linked immunosorbent assay spot detection of interferon-gamma and interleukin 5-producing cells as a predictive marker for renal allograft failure.

BACKGROUND: Despite improvements in the short-term survival of renal transplants, many allografts fail over the 5-10 years after transplantation. We sought to identify an immunologic assay that could identify those patients at high risk for future allograft failure. METHODS: Blood samples were obtained from 23 renal allograft recipients with acute and/or chronic graft dysfunction and from 22 controls. Isolated peripheral blood lymphocytes (PBLs) were tested for interferon (IFN)-gamma and interleukin (IL)-5 production using an enzyme-linked immunosorbent spot assay. IFN-gamma:IL-5 ratios were calculated and compared between groups. Among the 23 patients with graft dysfunction, the ratios were also compared with graft function at 6 months. RESULTS: IFN-gamma:IL-5 ratios of > or = 15 were associated with allograft rejection episodes in 8 of 12 cases, whereas 10 of 11 episodes of graft dysfunction from other causes (infection, drug toxicity, obstruction) were associated with values <15. All normal controls had values <15 (22/22). Among the graft recipients with acute renal failure, all patients with IFN-gamma:IL-5 ratios <15 exhibited improved renal function at 6-month follow-up (14/14), whereas 8 of 9 patients with IFN-gamma:IL-5 ratios > or = 15 developed allograft failure at 6 months (sensitivity 100%, specificity 93.3%). CONCLUSION: In renal transplant recipients with acute allograft dysfunction, mitogen-induced peripheral blood lymphocyte IFN-gamma:IL-5 ratios > or = 15 were highly predictive of allograft failure within 6 months of the assay. This test may be a useful prognostic marker for identification of transplant recipients with acute graft dysfunction who are at high risk for future graft loss and thus allow targeted therapeutic interventions to prolong graft survival.

Veterans Aging Cohort Study (VACS) meeting summary.

The Veterans Aging Cohort Study (VACS) planning meeting was the first of a series of organizational meetings and VA-sponsored conference calls designed to build the scientific foundation and methodological infrastructure for a multisite, longitudinal study of HIV and chronic disease outcomes among aging veterans. More specifically, it served as a consensus conference to determine scientific priorities, develop hypotheses, and to assemble working groups and committees to outline the specific methodological approaches needed. Scientists, physicians from 20 VA clinical facilities in the United States, community members, and experts in the fields of immunology, cancer, sociology, aging, cognition, psychiatry and mental health, epidemiology, large database analysis, and health services research gathered for an intense, 2-day meeting held in Pittsburgh, PA, November 8-9, 2000.

General medical and psychiatric comorbidity among HIV-infected veterans in the post-HAART era.

We examined the prevalence of HIV, general medical, and psychiatric comorbidities by age based on a recent multisite cohort of HIV infected veterans receiving care: the Veterans with HIV/AIDS 3 Site Study (VACS 3). VACS 3 includes 881 adult patients with HIV infection enrolled between June 1999 and July 2000. Providers reported their patients' CDC-defined HIV comorbidities, general medical comorbidities (based on Duke and Charlson comorbidity scales), and psychiatric comorbidity. Mean age of participants was 49 years and 54% were African-American. The most common HIV comorbidities were oral candidiasis (21%), peripheral neuropathy (16%), and herpes zoster (16%). The most common general medical comorbidities included chemical hepatitis (53%), hypertension (24%), and hyperlipidemia (17%). The mean number of HIV and general medical comorbidities experienced by patients were respectively 1.1 and 1.4 (P < .001). Older (> or = 50 years) HIV-infected patients experienced a greater number of general medical comorbidities than those < 50 years (respectively 1.7 versus 1.2, P < .001). There was no significant difference in mean HIV comorbidity number by age. Based on patient report, 46% had significant depressive symptoms (> or = 10 on 10-item CES-D) and 21% reported at-risk drinking (> or = 8 on AUDIT). Providers reported 32% of patients had anxiety, 4% mania, 4% schizophrenia, and 11% cognitive impairment/dementia. General medical and psychiatric comorbidities constituted a higher disease burden for HIV-infected veterans than HIV comorbidities. Whether these comorbidities are due to antiretroviral drug toxicity or are age or lifestyle-associated conditions, the substantial prevalence of these "non-HIV" comorbidities suggest an important role for general medical and psychiatric management of HIV-infected patients.

Veterans aging cohort three-site study (VACS 3): overview and description.

Outcomes for middle-aged and older individuals with HIV infection are poor, and are likely to be mediated by age-related differences in risks and resources (access to care, relationship with the provider, comorbid conditions, health habits, and changes brought about by aging). The goal of the Veterans Aging Cohort Three-Site Study (VACS 3) is to study the influence of age and mediating factors on outcomes with HIV in order to identify mutable mediators of poorer outcomes. VACS 3 is an observational, longitudinal study. Data sources include patient and provider surveys and electronic medical data collected at baseline and 12-month follow-up from the Infections Disease Clinics at three Veterans Affairs Medical Centers (Cleveland, OH, Houston, TX, and Manhattan, NY). Trained Survey Coordinators at each site determined which patients are HIV infected, obtained consent, and asked the patient to complete a questionnaire. The primary provider also completed a questionnaire. Twelve-month follow-up will be completed July 2001. Of all veterans with HIV seen in these clinics 85% (881) have consented and enrolled. Of the 881 corresponding provider surveys, 92% were completed. Mean age is 49; 55% are African-American; 38% of the sample were men who have sex with men; and less than 2% are women. Almost a third (32%) have been without a permanent address. Complimentary or alternative therapies are common as are the use of cigarettes, alcohol, and illicit drugs. The majority (87%) of the patients are taking multiple antiretroviral medications. The median CD4 count is 331 mm(3), and the median viral load was 714 copies/ml. There is substantial variation by site. Veterans with HIV infection have characteristics that will likely become more prevalent among HIV-infected persons in the United States: they are older, commonly suffer comorbid disease, and are members of minority populations. VACS 3 may help inform the design of future clinical interventions to improve outcomes for people aging with HIV.

Patient- and provider-reported adherence: toward a clinically useful approach to measuring antiretroviral adherence.

We seek to develop a clinically useful measure of antiretroviral medication adherence. Because there is no gold standard for adherence, we will assess the clinical validity of patient- and provider-reported adherence by the strength of their expected associations with current viral load, depressive symptoms, alcohol and illicit drug use, and homelessness. The Veterans Aging Cohort 3 Site Study (VACS 3) is a multisite study of 881 patients at Cleveland, Houston, and Manhattan Veterans Affairs health care systems. Data was collected on adherence using patient report and provider assessment; depressive symptoms using the Center for Epidemiological Studies Depression (CESD) and provider assessment; alcohol use using the Alcohol Use Disorders Identification Test (AUDIT) and provider assessment; and homelessness using patient report only. Viral load was collected from electronic laboratory data. Although agreement between providers and patients about the patient's adherence was not better than chance (61%; weighted kappa =.07), both patient and provider-reported adherence were related to viral load (P <.001), current alcohol use (P <.01), current drug use (P <.01), and depressive symptoms (P <.001). Patient-reported adherence was also associated with homelessness (P <.05). In multivariate regression models, provider assessment of adherence demonstrated independent associations with viral load (P <.001), current alcohol use (P <.001), current drug use (P <.001), and depressive symptoms (P <.001) after adjustment for the patient's report of adherence (also significantly associated). The consistent and largely independent association between patient and provider reported adherence and a range of variables previously shown to be associated with adherence suggests that patient- and provider-reported adherence independently measure actual adherence. Future work will explore how patient- and provider-reported adherence might best be combined, and whether the measure may be further enhanced with pharmacy refill data.

The role of functional status in predicting inpatient mortality with AIDS: a comparison with current predictors.

To assess the independent prognostic role of functional status, as reflected by a measure of an inpatient's global requirement for nursing assistance with basic activities of daily living (Global ADL), we compared Global ADL with three validated AIDS mortality predictors: the Clinical AIDS Prognostic Staging (CAPS); the Severity Classification System for AIDS Hospitalization--version 2 (SCAH-2); and CD4 cell count. Our study sample consisted of 1392 patients with AIDS and a hospital stay of 3 or more days at one of 20 hospitals in 11 U.S. cities with high AIDS incidence. Data were collected from September 1990 through December 1991. Two percent of patients refused participation, and 26% were eliminated due to incomplete data collection, leaving an analytic sample of 1003 patients. Only 30% of patients had a CD4 count measured at any time during hospitalization. Cox regression was used to measure the hazard of inpatient mortality adjusted for length of stay. Overall mortality was 12%. Mortality rates for patients in Global ADL stages I-IV were 3%, 8%, 19%, and 51%, respectively (p < 0.0001). Global ADL more effectively discriminated mortality than CAPS (p < 0.001), SCAH-2 (p < 0.001), or CD4 count (p < 0.001). Global ADL also added independent information in analyses adjusted for both CAPS and SCAH-2: a single stage increase of Global ADL demonstrated a 1.9-fold increased hazard of death (CI: 1.6, 2.3). SCAH-2, assigned at discharge, was not strongly correlated with admission predictors (Global ADL: r = 0.17; CI: 0.11, 0.23 or CAPS: r = 0.03, CI: 0.02, 0.17). We conclude that Global ADL, alone or in tandem with other severity systems, provides an excellent severity adjustment for inpatient mortality with AIDS. Finally, CD4 cell counts were not routinely available and were not as predictive as Global ADL in the patients for whom both were available.

Justification for a new cohort study of people aging with and without HIV infection.

This supplement contains a series of papers supporting the justification, design, and implementation of a longitudinal cohort study of an aging HIV-positive and HIV-negative veteran population called the Veterans Aging Cohort Study (VACS). Although the papers cover a wide range of topics and several papers address methodologic issues not unique to a study of aging veterans, all are motivated by a unifying set of assumptions. Specifically: (a) HIV/AIDS is a chronic disease in an aging population; (b) conditions among HIV-positive and -negative patients in care have overlapping etiologies; (c) individuals with pre-existing organ injury are at increased risk for iatrogenic injury; (d) cohort studies are uniquely suited to the study of chronic disease complicated by aging, comorbid conditions, drug toxicities, and substance use/abuse; (e) VACS is well positioned to study HIV as a chronic disease in an aging population.

Development and validation of a self-completed HIV symptom index.

Traditional, open-ended provider questions regarding patient symptoms are insensitive. Better methods are needed to measure symptoms for clinical management, patient-oriented research, and adverse drug-event reporting. Our objective was to develop and initially validate a brief, self-reported HIV symptom index tailored to patients exposed to multidrug antiretroviral therapies and protease inhibitors, and to compare the new index to existing symptom measures. The research design was a multistage design including quantitative review of existing literature, qualitative and quantitative analyses of pilot data, and quantitative analyses of a prospective sample. Statistical analyses include frequencies, chi-square tests for significance, linear and logistic regression. The subjects were from a multisite convenience sample (n = 73) within the AIDS Clinical Trials Group and a prospective sample from the Cleveland Veterans Affairs Medical Center (n = 115). Measures were patient-reported symptoms and health-related quality of life, physician-assessed disease severity, CD4 cell count, and HIV-1 RNA viral quantification. A 20-item, self-completed HIV symptom index was developed based upon prior reports of symptom frequency and bother and expert opinion. When compared with prior measures the index included more frequent and bothersome symptoms, yet was easier to use (self-report rather than provider interview). The index required less than 5 minutes to complete, achieved excellent completion rates, and was thought comprehensive and comprehensible in a convenience sample. It was further tested in a prospective sample of patients and demonstrated strong associations with physical and mental health summary scores and with disease severity. These associations were independent of CD4 cell count and HIV-1 RNA viral quantification. This 20-item HIV symptom index has demonstrated construct validity, and offers a simple and rational approach to measuring HIV symptoms for clinical management, patient-oriented research, and adverse drug reporting.