Early stroke post-heart transplant is associated with decreased survival in children.

BACKGROUND: Major neurologic events (MNEs) after heart transplantation (HTx) and their effect on survival have not been well described in children. In this study we aimed to characterize early MNEs (stroke, isolated seizures not from stroke and posterior reversible leukoencephalopathy [PRES] within 1 year after primary pediatric HTx) and evaluate their impact on 1-year post-HTx survival. We hypothesized that early an MNE after HTx is associated with decreased 1-year patient survival. METHODS: We performed a pediatric, single-center, retrospective analysis of 345 consecutive patients aged 0 to 22 years who underwent primary HTx during the period from November 1, 1994 to October 31, 2015. Characteristics were compared between patients with and without early MNEs. RESULTS: Nineteen percent (65 of 345) of patients had an MNE within 1 year after HTx (median 9 days, interquartile range [IQR] 4 to 23 days). Freedom from early MNE was 97%, 85% and 80% at 1, 6 and 12 months, respectively. Of the total 65 events, stroke comprised 55.4% (n = 36), isolated seizure 29.2% (n = 19) and PRES 15.4% (n = 10). With multiple logistic regression, previous neurologic disease, infection requiring intravenous antibiotic therapy and post-operative drug-treated hypertension were found to be significant risk factors for early MNEs. Stroke (hazard ratio 4.1, IQR 2.3 to 7.6, p < 0.0001), but not seizures and PRES, was associated with decreased 1-year patient survival. CONCLUSIONS: Major neurologic events are common after pediatric HTx and usually occur within the first few weeks. Early stroke was associated with decreased 1-year survival. Potentially modifiable factors, including prior neurologic event, drug-treated hypertension and infection, were associated with increased risk of developing early MNEs.

Effects of a behavioural intervention to reduce acquisition of HIV infection among men who have sex with men: the EXPLORE randomised controlled study.

BACKGROUND: Effective interventions are needed to prevent acquisition of HIV infection in men who have sex with men. To date, no behavioural interventions specifically for this risk group have been tested with HIV infection as the primary outcome. METHODS: This multisite two-group randomised controlled phase IIb trial tested the efficacy of a behavioural intervention in preventing HIV infection among 4295 men who have sex with men. The experimental intervention consisted of ten one-on-one counselling sessions followed by maintenance sessions every 3 months. The standard condition was twice-yearly Project RESPECT individual counselling. Twice-yearly follow-up visits included testing for HIV antibody and assessment of behavioural outcomes. FINDINGS: The rate of acquisition of HIV infection was 18.2% (95% CI -4.7 to 36.0) lower in the intervention group than the standard group. Adjustment for baseline covariates attenuated the intervention effect to 15.7% (-8.4 to 34.4). The effect was more favourable in the first 12-18 months of follow-up. The occurrence of unprotected receptive anal intercourse with HIV-positive and unknown-status partners was 20.5% (10.9 to 29.0) lower in the intervention than in the standard group. INTERPRETATION: The results from the primary analyses allow us to rule out that the experimental intervention is associated with a 35% lower rate of HIV acquisition than in the standard group. The overall estimate of a difference of 18.2%, more favourable estimates of effect in the first 12-18 months, and similar effects on risk behaviours suggest that prevention of HIV infection among men who have sex with men by a behavioural intervention is feasible. Further work should be done to develop more effective interventions.

See one, do one, teach one? House staff experience discussing do-not-resuscitate orders.

BACKGROUND: Medical residents commonly discuss resuscitation decisions with hospitalized patients. Previous studies suggest that the quality of these discussions is poor. OBJECTIVE: To learn about residents' experience with do-not-resuscitate (DNR) discussions and their attitudes toward them. METHODS: Medical house officers on the wards of three teaching hospitals were eligible to participate. A subset had previously audiotaped actual DNR discussions as part of a study that described the quality of discussions. In a self-administered questionnaire, house officers rated their performance conducting a recent DNR discussion, stated their attitudes, and described their experience learning to talk to patients about these issues. RESULTS: One hundred one (88%) of 115 residents responded to the survey. Eighty-six (90%) of 96 stated they had done a good job with the discussion and 78 (77%) of 101 reported feeling comfortable discussing the topic with patients. Ninety-four (94%) of 100 residents said they discuss code status with all seriously ill patients and while on the medical wards they conduct a median of one DNR discussion per week. On average, they had observed four discussions conducted by more senior clinicians. One third of the residents had never been observed talking to patients about DNR decisions and 71% had been observed two or fewer times. CONCLUSIONS: These findings help explain the observations about the quality of DNR discussions. House staff "see" and "do" these discussions, but are not taught through observation and feedback. We recommend that communication about end-of-life treatment decisions be treated as a medical skill to be taught with the same rigor as other clinical procedures.

Depressive affect and survival among gay and bisexual men infected with HIV.

BACKGROUND: Although depression has been related to chronic disease processes and outcomes, studies examining the relationship between depression and disease progression in persons with human immunodeficiency virus (HIV) infection have produced inconsistent results. OBJECTIVE: To investigate whether depressive affect is associated with HIV mortality. METHODS: This was a prospective cohort study (San Francisco Men's Health Study) using a population based probability sample of single men living in areas of San Francisco, Calif, with high case rates of acquired immunodeficiency syndrome. Data collection was at 6-month intervals with up to 15 waves of follow-up. Subjects included all 402 homosexual or bisexual men who in July 1984 had serologic evidence of HIV infection and who survived a minimum of 1 wave after baseline. Depressive affect was measured at each wave with the affective subscale of the Center for Epidemiologic Studies-Depression Scale. Laboratory markers, World Health Organization staging, antiretroviral use, and hospitalizations were also used as predictor variables. The primary outcome measure was survival. RESULTS: In a Cox proportional hazards model, a time-dependent measure of depressive affect was associated with greater mortality (adjusted risk ratio, 1.67; 95% confidence interval, 1.01-2.78). CONCLUSIONS: Depressive affect was associated with mortality risk, highlighting the importance of diagnosis and treatment of depression among HIV-infected gay and bisexual men. Replication of this effect in incident cohorts with well-characterized dates of HIV infection is needed and, if replicated, an exploration of mediating pathways suggested.

The impact of diuretic therapy on reported sexual function.

BACKGROUND: --Thiazide diuretics are the most commonly prescribed antihypertensive agent in the treatment of hypertension. No studies to date have isolated conclusively the effect of diuretic therapy on patient quality of life, and particularly on sexual dysfunction. METHODS: --We carried out a randomized placebo-controlled trial of the effect of thiazide diuretics on quality of life in mildly hypertensive men between the ages of 35 and 70 years. After a 1-month washout period off diuretic therapy, the men were randomized to a 2-month trial of a thiazide treatment or placebo. At the end of the trial, 176 men completed a confidential self-administered questionnaire assessing aspects of social performance, general well-being, and emotional and physiologic states. RESULTS: --Patients taking diuretics reported significantly greater sexual dysfunction than control subjects, including decreased libido, difficulty in gaining and maintaining an erection, and difficulty with ejaculation. Multivariate analysis suggested that the findings were not mediated by low serum potassium levels or by low blood pressure. Sexual dysfunction was noted more often in the confidential self-report questionnaire than in response to direct questions from clinicians. We found no differences between diuretic and placebo groups in measures of mood, general sense of well-being, ability to work, alertness, and social/recreational activities. CONCLUSIONS: --Thiazide diuretic use is associated with male sexual dysfunction but does not appear to adversely affect other aspects of quality of life.

Informal caregivers and the intention to hasten AIDS-related death.

OBJECTIVES: To determine the extent to which homosexual men dying of the acquired immunodeficiency syndrome (AIDS) receive medication intended to hasten death. To assess the impact on caregivers of administering medications intended to hasten death. METHODS: In a prospective study of caregiving partners of men with AIDS (n = 140), characteristics of the ill partner, the caregiver, and the relationship were assessed at baseline and 1 month before the ill partner's death. Three months after the death, caregivers were asked if they had increased their partner's narcotic and/or sedative-hypnotic medication dose and if so, what had been the objective of the increase, and their comfort with their medication decisions. RESULTS: Of 140 ill partners who died of AIDS, 17 (12.1%) received an increase in the use of medications immediately before death intended to hasten death. Diagnoses and care needs of ill partners who received increases in the use of medications to hasten death did not differ from those of ill partners receiving medication for symptoms. Fourteen increases (10%) in use of medications were administered by caregivers. These caregivers did not differ from those administering medication for symptom control in level of distress, caregiving burden, relationship characteristics, or comfort with the medication decision, but they reported more social support and positive meaning in caregiving. CONCLUSION: The decision to hasten death is not a rare event in this group of men. There is no evidence that it is the result of caregiver distress, poor relationship quality, or intolerable caregiving burden; and it does not cause excessive discomfort in the surviving partner. This study, although small, has implications for the policy debate on assisted suicide.

Adherence to isoniazid prophylaxis in the homeless: a randomized controlled trial.

OBJECTIVES: To test 2 interventions to improve adherence to isoniazid preventive therapy for tuberculosis in homeless adults. We compared (1) biweekly directly observed preventive therapy using a $5 monetary incentive and (2) biweekly directly observed preventive therapy using a peer health adviser, with (3) usual care at the tuberculosis clinic. METHODS: Randomized controlled trial in tuberculosis-infected homeless adults. Outcomes were completion of 6 months of isoniazid treatment and number of months of isoniazid dispensed. RESULTS: A total of 118 subjects were randomized to the 3 arms of the study. Completion in the monetary incentive arm was significantly better than in the peer health adviser arm (P = .01) and the usual care arm (P = .04), by log-rank test. Overall, 19 subjects (44%) in the monetary incentive arm completed preventive therapy compared with 7 (19%) in the peer health adviser arm (P = .02) and 10 (26%) in the usual care arm (P = .11). The median number of months of isoniazid dispensed was 5 in the monetary incentive arm vs 2 months in the peer health adviser arm (P = .005) and 2 months in the usual care arm (P = .04). In multivariate analysis, independent predictors of completion were being in the monetary incentive arm (odds ratio, 2.57; 95% CI, 1.11-5.94) and residence in a hotel or other stable housing at entry into the study vs residence on the street or in a shelter at entry (odds ratio, 2.33; 95% CI, 1.00-5.47). CONCLUSIONS: A $5 biweekly cash incentive improved adherence to tuberculosis preventive therapy compared with a peer intervention or usual care. Living in a hotel or apartment at the start of treatment also predicted the completion of therapy.

Limited patient adherence to highly active antiretroviral therapy for HIV-1 infection in an observational cohort study.

BACKGROUND: Adherence to highly active antiretroviral therapy (HAART) for human immunodeficiency syndrome type 1 (HIV-1) infection is essential to sustain viral suppression and prevent drug resistance. We investigated adherence to HAART among patients in a clinical cohort study. METHODS: Patients receiving HAART had their plasma concentrations of protease inhibitors or nevirapine measured and completed a questionnaire on adherence. We determined the percentage of patients who reported taking all antiretroviral medication on time and according to dietary instructions in the past week. Drug exposure was compared between patients reporting deviation from their regimen and fully adherent patients. Among patients who received HAART for at least 24 weeks, we assessed the association between adherence and virologic outcome. RESULTS: A total of 224 of 261 eligible patients completed a questionnaire. Forty-seven percent reported taking all antiretroviral medication on time and according to dietary instructions. Patients who reported deviation from their regimen showed lower drug exposure compared with fully adherent patients (median concentration ratio, 0.81 vs 1.07; P =.001). Among those receiving HAART for at least 24 weeks, patients reporting deviation from their regimen were less likely to have plasma HIV-1 RNA levels below 500 copies/mL (adjusted odds ratio, 4.0; 95% confidence interval, 1.4-11.6) compared with fully adherent patients. CONCLUSIONS: Only half of the patients took all antiretroviral medication in accordance with time and dietary instructions in the preceding week. Deviation from the antiretroviral regimen was associated with decreased drug exposure and a decreased likelihood of having suppressed plasma HIV-1 RNA loads. Patient adherence should remain a prime concern in the management of HIV-1 infection.

Effectiveness of psychosocial interventions in preventing HIV risk behaviour in injecting drug users.

OBJECTIVE: To consider evidence for the effectiveness of psychosocial interventions in reducing the risk of infection with HIV of injecting drug users. METHOD: We reviewed 19 published studies of the effectiveness of individual counselling, HIV testing, group interventions, street outreach, and a 'social' intervention designed to change norms for safer behaviours. RESULTS: Eight of 15 studies that examined behavioural outcomes provided evidence of the effectiveness of an experimental intervention, compared with a control or comparison group. In four of these studies, however, serious design limitations made results difficult to interpret. In the other four studies without design limitations, the success of the experimental interventions may have been due to their greater length and intensity as well as to having been conducted with stable and well-motivated populations. Nine of the 15 studies showed evidence of marked behaviorial changes in both experimental and comparison group(s), with the changes in many cases being sustained for upwards of 12 months. CONCLUSIONS: A close examination of the evidence and competing hypotheses for the pattern of results suggests that participating in evaluation research may itself be a valuable intervention. Implications for the development of interventions include the potential efficacy of health risk assessment. Implications for evaluation of interventions include the need for developing unobtrusive measures and for assessing the impact of behavioural assessments. Despite the large behavioural changes reported in most of the studies, a substantial proportion of subjects receiving interventions reported unacceptably high levels of risk behaviours. New, more potent interventions are needed, such as those designed to change the norms of entire communities of drug users concerning safer injection and safer sex.

Adherence: a necessity for successful HIV combination therapy.

Patient adherence to combination therapy is a critical component of successful treatment outcomes. While combination therapy is known to be effective in slowing disease progression, the long-term benefit of these therapies can only be sustained if resistant strains of HIV do not emerge. Among factors that can result in the emergence of resistance, non-adherence is perhaps the most amenable to intervention. To maximize intervention efforts, a program of research on adherence is needed. A prerequisite for progress in adherence research is a focused effort on developing reliable and valid methods for measuring adherence that are feasible for patients living with HIV/AIDS. If new adherence assessment procedures cannot be developed, it would be helpful if a consensus on measurement approaches could be achieved. This consensus might propose strategies for matching measurement approaches with research questions and recommendations for the use of multiple measures where appropriate. It is important that research continue to identify psychological, physiological, socio-cultural and environmental factors that are associated with non-adherence in various populations both in the developed and the developing world. Intervention programs that address these risk factors and promote adherence need to be developed and evaluated in controlled clinical trials. These programs will need to be tailored to different populations and cultural groups, and tested in both developed and developing countries where HIV therapies are being prescribed. The results of this research would significantly contribute to efforts to prevent virus breakthrough and, by doing so, assist persons living with HIV/AIDS in achieving the health benefits that the combination therapies offer.

Does HIV reporting by name deter testing? MESH Study Group.

OBJECTIVE: Name-based HIV reporting is controversial in the United States because of concerns that it may deter high-risk persons from being tested. We sought to determine whether persons at risk of HIV infection knew their state's HIV reporting policy and whether they had delayed or avoided testing because of it. DESIGN: A cross-sectional anonymous survey. METHODS: We interviewed 2404 participants in one of three high-risk groups: men who have sex with men (MSM), heterosexuals attending a sexually transmitted disease (STD) clinic, and street-recruited injection drug users (IDU). Participants were asked standardized questions about their knowledge of reporting policies and reasons for having delayed or avoided testing. We recruited in eight US states: four with name-based reporting and four without; all offered anonymous testing at certain sites. RESULTS: Fewer than 25% correctly identified their state's HIV reporting policy. Over 50% stated they did not know whether their state used name-based reporting. Of the total, 480 participants (20%) had never been tested. Of these, 17% from states with name-based reporting selected concern about reporting as a reason for not testing compared with 14% from states without name-based reporting (P = 0.5). Comparing previously tested participants from states with name-based reporting to those from states without, concern about HIV reporting was given as a reason for delaying testing by 26% compared with 13% of IDU (P < 0.001), and for 26% compared with 19% of MSM (P = 0.06). CONCLUSION: Most participants did not know their state's HIV reporting policy. Name-based reporting policies were not associated with avoiding HIV testing because of worry about reporting, although they may have contributed to delays in testing among some IDU.

Home collection for frequent HIV testing: acceptability of oral fluids, dried blood spots and telephone results. HIV Early Detection Study Group.

OBJECTIVE: To assess the feasibility and acceptability of bimonthly home oral fluid (OF) and dried blood spot (DBS) collection for HIV testing among high-risk individuals. DESIGN: A total of 241 participants [including men who have sex with men (MSM), injecting drug users (IDU), and women at heterosexual risk] were recruited from a randomly selected subset of study participants enrolled at four sites in the HIV Network for Prevention Trials (HIVNET) cohort, and assigned at random to bimonthly home collection of OF or DBS specimens over a 6 month interval. Participants could select telephone calls or clinic visits to receive HIV test results. METHODS: Bimonthly specimens were tracked for adherence to the schedule, were evaluated for adequacy for testing, and tested using antibody assays and polymerase chain reaction (PCR) for DBS. The acceptability of bimonthly home OF and DBS collection and telephone counseling was assessed in an end-of-study questionnaire. RESULTS: The laboratory received 96 and 90% of expected OF and DBS specimens, respectively; 99% of each specimen type was adequate for testing. Almost all (95%) participants chose results disclosure by telephone. The majority of participants (85%) reported that bimonthly testing did not make them worry more about HIV, and almost all (98%) judged that with bimonthly testing their risk behavior remained the same (77%) or became less risky (21%). CONCLUSION: Bimonthly home specimen collection of both OF and DBS with telephone counseling is acceptable and feasible among study participants at high risk. These methods will be useful for the early detection of HIV infection and remote follow-up of research cohort participants in HIV vaccine and prevention trials.

Adherence to protease inhibitors, HIV-1 viral load, and development of drug resistance in an indigent population.

OBJECTIVE: To examine the relationship between adherence, viral suppression and antiretroviral resistance in HIV-infected homeless and marginally housed people on protease inhibitor (PI) therapy. DESIGN AND SETTING: A cross-sectional analysis of subjects in an observational prospective cohort systematically sampled from free meal lines, homeless shelters and low-income, single-room occupancy (SRO) hotels. PARTICIPANTS: Thirty-four HIV-infected people with a median of 12 months of PI therapy. MAIN OUTCOMES: Adherence measured by periodic unannounced pill counts, electronic medication monitoring, and self-report; HIV RNA viral load; and HIV-1 genotypic changes associated with drug resistance. RESULTS: Median adherence was 89, 73, and 67% by self-report, pill count, and electronic medication monitor, respectively. Thirty-eight per cent of the population had over 90% adherence by pill count. Depending on the measure, adherence explained 36-65% of the variation in concurrent HIV RNA levels. The three adherence measures were closely related. Of 20 genotyped patients who received a new reverse transcriptase inhibitor (RTI) when starting a PI, three had primary protease gene substitutions. Of 12 genotyped patients who received a PI without a new RTI, six had primary protease gene substitutions (P < 0.03). CONCLUSION: A substantial proportion of homeless and marginally housed individuals had good adherence to PI therapy. A strong relationship was found between independent methods of measuring adherence and concurrent viral suppression. PI resistance was more closely related to the failure to change RTI when starting a PI than to the level of adherence.

Association of high resting end tidal CO2 with carotid artery thickness in women, but not men.

BACKGROUND: A previous study found high resting end tidal CO2 (PetCO2) to be an independent determinant of systolic blood pressure in women, but not men. The present study investigates the association of PetCO2 with the common carotid artery intima-media thickness (IMT) and wall-to-lumen (W/L) ratio in a sample of normotensive men and women. DESIGN AND METHODS: Resting PetCO2 of 188 healthy volunteers, including 88 men and 100 women, in the Baltimore Longitudinal Study on Aging was monitored continuously for 25 min via a respiratory gas monitor. At another session, carotid artery IMT was determined via high-resolution B-mode carotid ultrasonography. The ratio of IMT to carotid artery diameter was calculated as W/L ratio. Resting blood pressure was determined oscillometrically every 5 min for 20 min during each session. RESULTS: Univariate associations of PetCO2 with systolic blood pressure (SBP) (P< 001), IMT (P< 001) and W/L ratio (P< 001) were significant in women, but not men. Multiple regression analyses showed that high resting PetCO2 was a predictor of SBP (P < 01), IMT (P< 01) and W/L ratio (P< 01) in women, independent of age, body mass index and SBP. For men, age (P < 001) and SBP (P < 01) were independent predictors of carotid IMT, while age (P< 001) was the only independent predictor of W/L ratio in men. CONCLUSIONS: This study indicates that PetCO2 can play a role in cardiovascular structure, as well as function, in women, and that the relationship is independent of the association of PetCO2 with blood pressure.

Perseverance pays off: health care providers' impact on HIV testing decisions by adolescent females.

BACKGROUND AND OBJECTIVE: Although HIV counseling and testing of adolescents has increased rapidly in recent years due to increasing HIV seroprevalence rates, little is known about adolescents' use of HIV testing services. The aims of this study were to determine what proportion of high risk adolescent girls would use confidential HIV testing services linked to primary care and to explore the characteristics, beliefs, and experiences that distinguish those teenage girls who obtain HIV testing in this setting from those who do not. DESIGN: Prospective cohort study. SETTING: General pediatrics clinic with adolescent-specific appointments at a large urban HMO. PARTICIPANTS: Convenience sample of 124 adolescent girls engaging in risky behaviors identified by chart review before regularly scheduled clinic appointments. INTERVENTION: Subjects completed a self-report questionnaire assessing HIV-related knowledge, attitudes, beliefs, and behaviors before the medical visit. During their provider visit, teens were counseled about their risk behaviors and the availability of HIV testing services at the clinic. Subjects were also given the opportunity to view an educational video about HIV testing designed for adolescents. MAIN OUTCOME MEASURES: Use of HIV counseling and testing services at the clinic and HIV test results. RESULTS: Forty-one percent of these adolescent girls obtained HIV testing at the clinic on the day of their scheduled appointment. Univariate analysis revealed that adolescents who obtained testing had initiated sexual intercourse at a younger age (mean age 13.8 vs 14.4 years, P = .02) and were more likely to have had a prior discussion about HIV testing with a health care provider [RR = 2.02, 95% CIs (1.22, 3.36)]. Those who did not view the video were less likely to test [RR = 0.20, 95% CIs (0.07, 0.58)]. Multiple logistic regression modeling revealed that a prior discussion with a health care provider was the only independent predictor of obtaining an HIV test [OR = 3.47 95% CIs (1.26, 9.52)]. CONCLUSIONS: A significant proportion of adolescent girls engaging in risky behaviors will use confidential HIV counseling and testing services that are linked to primary care. Health care providers play an important role in helping teens address their risk for and concerns about HIV infection by engaging adolescents in repeated discussions about HIV testing.

Effects of anger on left ventricular ejection fraction in coronary artery disease.

This study examined the comparative potency of several psychological stressors and exercise in eliciting myocardial ischemia as measured by left ventricular (LV) ejection fraction (EF) changes using radionuclide ventriculography. Twenty-seven subjects underwent both exercise (bicycle) and psychological stressors (mental arithmetic, recall of an incident that elicited anger, giving a short speech defending oneself against a charge of shoplifting) during which EF, blood pressure, heart rate and ST segment were measured. Eighteen subjects had 1-vessel coronary artery disease (CAD), defined by greater than 50% diameter stenosis in 1 artery as assessed by arteriography. Nine subjects served as healthy control subjects. Anger recall reduced EF more than exercise and the other psychological stressors (overall F [3.51] = 2.87, p = .05). Respective changes in EF for the CAD patients were -5% during anger recall, +2% during exercise, 0% during mental arithmetic and 0% during the speech stressor. More patients with CAD had significant reduction in EF (greater than or equal to 7%) during anger (7 of 18) than during exercise (4 of 18). The difference in EF change between patients with CAD and healthy control subjects was significant for both anger (t25 = 2.23, p = 0.04) and exercise (t25 = 2.63, p = 0.01) stressors. In this group of patients with CAD, anger appeared to be a particularly potent psychological stressor.

Television viewing and cardiovascular risk factors in young adults: the CARDIA study.

Cross-sectional associations between self-reported hours of television (TV) viewing per day and cardiovascular risk factors were assessed in a biracial (black and white) study population of 4280 men and women, ages 23 to 35 years, undergoing the year-5 follow-up examination for the Cardiovascular Risk Development in Young Adults (CARDIA) study in 1990 to 1991. Number of hours of TV viewing per day was higher in blacks than in whites and was inversely associated with education and income. Relative to "light" TV viewers (0 to 1 h/d), "heavy" TV viewers (> or = 4 h/d) had a higher prevalence (P < 0.05) of obesity, smoking, and high hostility score in all race/gender groups, and of physical inactivity in all groups except black men. Among whites, "heavy" TV viewers had higher depression scores, and among blacks, reported more alcohol use. TV viewing was not associated with hypertension and lipid abnormalities. Heavy TV viewing is a modifiable behavior that is associated with increased prevalence of several cardiovascular risk factors.

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.

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.

Lack of independent relationships between left ventricular mass and cardiovascular reactivity to physical and psychological stress in the Coronary Artery Risk Development in Young Adults (CARDIA) Study.

The objective of this study was to determine whether exaggerated blood pressure (BP) reactivity to stress and psychosocial characteristics are related to left ventricular mass (LVM) in a large cohort of young adults. Analyses were conducted with 3,742 participants of the CARDIA study (945 white men, 1,024 white women, 781 black men, and 992 black women), evaluated in 1990 to 1091 with echocardiographic measurement of LVM. Analyses were stratified by gender and race. The relationships of LVM/height2.7 and cardiovascular reactivity to physical and psychological stressors (treadmill exercise, cold pressor, video game, and star-tracing tasks), were examined in both univariate and multivariate analyses adjusting for baseline BP, weight, and other relevant biobehavioral variables. The relationships between LVM and several psychosocial characteristics (hostility, anger suppression, anxiety, depressive symptoms, and education) were also assessed. Systolic blood pressure (SBP) reactivity to exercise was significantly related to LVM in black and white men; LVM was 10% greater among white men with exaggerated (upper quintile) peak exercise SBP than among other white men. SBP reactivity to the cold pressor test was related to LVM in all race/gender groups, although the relationship remained significant only among white men and women in the multivariate analysis. Diastolic blood pressure (DBP) reactivity to the video game was related to LVM only among black men in adjusted analyses. After adjusting for resting BP, weight, and other covariates in linear multiple regression models, SBP reactivity to exercise explained only 3% of the variance in LVM among white men. Otherwise, reactivity to other stressors or psychosocial variables accounted for no more than 1% of the variance in LVM. It was concluded that among a cohort of young adults, blood pressure reactivity to physical and mental stressors did not add substantially to the prediction of LVM when resting BP, weight, and other covariates were taken into account.