Quality indicators for depression care in HIV patients.

HIV patients are at increased risk for depression. However, a comprehensive set of quality of care indicators for depression in the context of HIV does not exist. We report the results of a recent expert panel convened to develop a comprehensive set of HIV depression quality indicators. We systematically reviewed the depression and HIV depression literature to provide the evidence for the quality indicators. The HIV depression quality indicators were divided into six chapters: general, bereavement, substance abuse, viral hepatitis, cognitive impairment and drug interactions. A modified Delphi expert panel method was used to evaluate the validity and feasibility of the candidate quality indicators. The expert panel included HIV physicians, psychiatrists and a pharmacist, all with experience with HIV depression. The in-person eleven-member panel rated 80 candidate HIV-depression quality indicators. Indicators were evaluated using main and sensitivity analysis criteria for validity and feasibility. Seventy-four percent (59/80) of the quality indicators met a priori main analysis criteria for validity and feasibility and 61% met sensitivity analysis criteria. Approved indicators that are more specific to HIV depression include: depression screening frequency; depression screening and treatment in the context of hepatitis C; optimizing depression and HIV treatment in the context of cognitive impairment; and starting antidepressants at lower doses but advancing to doses typical for the general population. Most adverse medication interaction indicators did not meet main analysis validity criteria. The quality indicators identified in this study provide a useful tool for measuring and informing the quality of HIV-depression care.

Factors in AIDS dementia complex trial design: results and lessons from the abacavir trial.

OBJECTIVES: To determine the efficacy of adding abacavir (Ziagen, ABC) to optimal stable background antiretroviral therapy (SBG) to AIDS dementia complex (ADC) patients and address trial design. DESIGN: Phase III randomized, double-blind placebo-controlled trial. SETTING: Tertiary outpatient clinics. PARTICIPANTS: ADC patients on SBG for > or = 8 wk. INTERVENTIONS: Participants were randomized to ABC or matched placebo for 12 wk. OUTCOME MEASURES: The primary outcome measure was the change in the summary neuropsychological Z score (NPZ). Secondary measures were HIV RNA and the immune activation markers beta-2 microglobulin, soluble tumor necrosis factor (TNF) receptor 2, and quinolinic acid. RESULTS: 105 participants were enrolled. The median change in NPZ at week 12 was +0.76 for the ABC + SBG and +0.63 for the SBG groups (p = 0.735). The lack of efficacy was unlikely related to possible limited antiviral efficacy of ABC: at week 12 more ABC than placebo participants had plasma HIV RNA < or = 400 copies/mL (p = 0.002). There were, however, other factors. Two thirds of patients were subsequently found to have had baseline resistance to ABC. Second, there was an unanticipated beneficial effect of SBG that extended beyond 8 wk to 5 mo, thereby rendering some of the patients at baseline unstable. Third, there was an unexpectedly large variability in neuropsychological performance that underpowered the study. Fourth, there was a relative lack of activity of ADC: 56% of all patients had baseline cerebrospinal fluid (CSF) HIV-1 RNA < 100 copies/mL and 83% had CSF beta-2 microglobulin < 3 nmol/L at baseline. CONCLUSIONS: The addition of ABC to SBG for ADC patients was not efficacious, possibly because of the inefficacy of ABC per se, baseline drug resistance, prolonged benefit from existing therapy, difficulties with sample size calculations, and lack of disease activity. Assessment of these trial design factors is critical in the design of future ADC trials.