Christa R. Nevin

Patient Reported Outcomes in Routine Care: Advancing Data Capture for HIV Cohort Research

INTRODUCTION Computerized collection of standardized measures of patient reported outcomes (PROs) provides a novel paradigm for data capture at the point of clinical care. Comparisons between data from PROs and Electronic Health Records (EHR) are lacking. We compare EHR and PRO for capture of depression and substance abuse and their relationship to adherence to antiretroviral therapy (ART). METHODS This retrospective study includes HIV-positive patients at an HIV clinic who completed an initial PRO assessment April 2008-July 2009. The questionnaire includes measures of depression (PHQ-9) and substance abuse (ASSIST). Self-reported ART adherence was modeled using separate logistic regression analyses (EHR vs PRO). RESULTS The study included 782 participants. EHR vs PRO diagnosis of current substance abuse was 13% (n = 99) vs 6% (n = 45) (P < .0001), and current depression was 41% (n = 317) vs 12% (n = 97) (P < .0001). In the EHR model, neither substance abuse (OR = 1.25; 95% CI = 0.70-2.21) nor depression (OR = 0.93; 95% CI = 0.62-1.40) was significantly associated with poor ART adherence. Conversely, in the PRO model, current substance abuse (OR = 2.78; 95% CI = 1.33-5.81) and current depression (OR = 1.93; 95% CI = 1.12-3.33) were associated with poor ART adherence. DISCUSSIONS The explanatory characteristics of the PRO model correlated best with factors known to be associated with poor ART adherence (substance abuse; depression). The computerized capture of PROs as a part of routine clinical care may prove to be a complementary and potentially transformative health informatics technology for research and patient care.

Antiretroviral Prescribing Patterns in Treatment-Naïve Patients in the United States

Numerous antiretroviral therapy (ART) regimens are recommended for first-line and subsequent HIV care, but regimen selection for clinical use may not represent the full range of options. We hypothesized that despite an increase in available antiretrovirals, clinical trial data on regimen efficacy and fixed-dose combination options have lead to uniformity in initial ART. We evaluated regimen selection for ART-naïve patients at the University of Alabama at Birmingham (UAB) 1917 Clinic between January 2000 and December 2007. The annual number of unique initial regimens was quantified. Initial regimen variability was expressed as regimens per 100 patients. Subsequent ART regimens were characterized for complexity via regimen sequence trees detailing the first three generations of regimens for patients starting the two most common initial combinations. Four hundred eighty-two ART-naïve patients were treated with 39 unique initial regimens (8.0 regimens per 100 patients). Variability in initial regimen selection was highest in the first 6 years (14.9-24.4 regimens per 100 patients). A sharp decline was observed in 2006 (16.1 regimens per 100 patients) and 2007 (6.5 regimens per 100 patients). The most dramatic shift in drug selection involved an increase in emtricitabine plus tenofovir plus efavirenz, from 0% in 2003 to 85% in 2007. During the study period, 205 of 482 (43%) patients required a change in initial therapy. Of these, 156 of 205 (76%) had a unique sequence of regimens. A shift toward homogeneity of initial ART was observed (85% of patients received the same first-line regimen in 2007). In contrast, regimen sequencing beyond the first regimen remained complex. These shifts in ART prescribing patterns may have implications for collaborative HIV care.

Closing the Feedback Loop: An Interactive Voice Response System to Provide Follow-up and Feedback in Primary Care Settings

In primary care settings, follow-up regarding the outcome of acute outpatient visits is largely absent. We sought to develop an automated interactive voice response system (IVRS) for patient follow-up with feedback to providers capable of interfacing with multiple pre-existing electronic medical records (EMRs). A system was designed to extract data from EMRs, integrate with the IVRS, call patients for follow-up, and provide a feedback report to providers. Challenges during the development process were analyzed and summarized. The components of the technological solution and details of its implementation are reported. Lessons learned include: (1) Modular utilization of system components is often needed to adapt to specific clinic workflow and patient population needs (2) Understanding the local telephony environment greatly impacts development and is critical to success, and (3) Ample time for development of the IVRS questionnaire (mapping all branching paths) and speech recognition tuning (sensitivity, use of barge-in tuning, use of “known voice”) is needed. With proper attention to design and development, modular follow-up and feedback systems can be integrated into existing EMR systems providing the benefits of IVRS follow-up to patients and providers across diverse practice settings.

Temporal Trends in Presentation for Outpatient HIV Medical Care 2000–2010: Implications for Short-term Mortality

BackgroundMany newly diagnosed patients present to outpatient care with advanced HIV infection. More timely HIV diagnosis and initiation of care has the potential to improve individual health outcomes and has public health implications.ObjectiveTo assess temporal trends in late presentation for outpatient HIV medial care as measured by CD4 count <200 cells/mm3 and the implications on short-term (1-year) mortality.DesignWe conducted a cohort study nested in a prospective HIV clinical cohort including patients establishing initial outpatient HIV treatment between 2000–2010. Time series regression analysis evaluated temporal trends in late presentation for care measured by the proportion of patients with a CD4 count <200 cells/mm3 or an opportunistic infection at enrollment, and also evaluated trends in short-term mortality.ParticipantsPatients establishing initial outpatient HIV treatment between 2000–2010 at an academic HIV clinic.Main MeasuresThe proportion of patients with a CD4 count <200 cells/mm3 or an opportunistic infection at initial presentation and short-term (1-year) mortality following clinic enrollment.Key ResultsAmong 1121 patients, 41% had an initial CD4 count <200 cells/mm3, 25% had an opportunistic infection and 2.4% died within 1-year of their initial visit. Time series regression analysis demonstrated significant reductions in late presentation for HIV care and decreases in short-term mortality with temporal improvement preceding updated CDC HIV testing recommendations.ConclusionWe observed a significant decline in the number of patients presenting for outpatient HIV care with advanced disease, particularly in 2006–2010. A significant trend in improved short-term survival among patients establishing HIV care was also observed, likely related to more timely presentation for outpatient care in more recent years.

Darunavir outcomes study: comparative effectiveness of virologic suppression, regimen durability, and discontinuation reasons for three-class experienced patients at 48 weeks.

Several new antiretroviral (ARV) agents for treatment experienced HIV-infected patients have been approved since June 2006, including darunavir (DRV) and raltegravir (RAL). While efficacious in clinical trials, the effectiveness, durability, and tolerability of these new ARVs remains understudied in the context of routine clinical care. The Darunavir Outcomes Study is a prospective cohort study of three-class ARV-experienced patients changing regimens at the 1917 Clinic after 1/7/2006. All treatment decisions were at the discretion of primary providers. Multivariate (MV) logistic regression for 48 week VL < 400c/ml and Cox models for regimen durability were completed. Propensity score methods controlled for sociodemographics. Among 108 patients, mean age of 46, 48% were white, 80% male, with prior exposure to a mean 10.5 ARVs. Overall, 64% of patients achieved 48-week VL < 400 c/ml. In MV modeling DRV/rll (OR = 5.77;95%CI = 1.62-20.58) and RAL (OR = 3.84;95%CI = 1.23-11.95) use increased odds of 48-week suppression. Use of these agents exhibited a trend towards prolonged regimen durability in Cox models. Among those highly ARV-experienced, regimens containing DRV/r and/or RAL were more likely to achieve 48-week VL < 400 c/ml and exhibited a trend towards prolonged durability. New agents have transformed the treatment landscape for ARV-experienced patients, with effectiveness in routine clinical care mirroring efficacy in clinical trials.

Underutilization of the AIDS Drug Assistance Program: associated factors and policy implications.

BACKGROUND The AIDS Drug Assistance Program (ADAP) provides antiretroviral medications to low-income individuals with HIV infection. METHODS A prospective cohort study of ADAP utilization, measured using medication possession ratio (MPR), was conducted during the 2008 calendar year at the University of Alabama at Birmingham 1917 HIV Clinic. Multivariable ordinal logistic regression evaluated factors associated with ADAP utilization. RESULTS Among 245 patients, MPR quartiles (Q) were the following: Q1<69 percent, Q2=69-83 percent, Q3=84-93 percent, Q4>93 percent. In ordinal logistic regression, younger age (OR=0.59 per 10 years; 95 percent CI=0.44-0.79), nonwhite males (2.18; 1.18-4.04), lower CD4 count (2.79 for <200 cells/mm(3) ; 1.44-5.43), and a history of alcohol abuse (2.11; 1.02-4.37) were associated with poor ADAP utilization. CONCLUSIONS One quarter of ADAP enrollees had MPR below 69 percent, a level well below that associated with optimal HIV treatment outcomes, indicating a need for programmatic interventions to improve ADAP utilization.

Cost ramifications of increased reporting of detectable plasma HIV-1 RNA levels by the Roche COBAS AmpliPrep/COBAS TaqMan HIV-1 version 1.0 viral load test.

To the Editors: HIV treatment guidelines state the goal of antiretroviral therapy (ART) is virologic suppression [plasma HIV viral load (VL) below 50 copies/mL] for patients on initial and subsequent regimens.[1] Assays measuring HIV-1 RNA VL levels have been a cornerstone in the evaluation of successful ART since 1996.[2, 3] Providers depend on serial VL measurements to gauge treatment success and to provide early evidence of failing ART. Over the past decade, a series of assays, each with increased ability to detect progressively lower VL levels, have been released.[4] In 2008, Roche Diagnostics released the COBAS Ampliprep/COBAS TaqMan HIV-1, v.1.0 assay (TaqMan). Due to ease of performance (more automated, requiring less manual intervention), a wider linear dynamic range (both lower and higher limits of detection: 48 to 1×107 copies/mL) and similar sensitivity and specificity to the previous VL assay [Roche COBAS HIV-1 Ampliprep Amplicor Monitor Test, v.1.5 (Amplicor)], the University of Alabama at Birmingham (UAB) clinical hospital laboratory transitioned to TaqMan as its primary VL assay on June 9, 2008. [5, 6] Following the transition to TaqMan, multiple HIV care providers at the UAB 1917 HIV/AIDS Clinic (1917 Clinic) reported an increase in the number of patients with HIV-1 VL>50 copies/mL who had previous long-term virologic suppression (VL<50 copies/mL). These anecdotes were supported by quarterly clinic quality control data as the year prior to TaqMan use, 60-63% of patients on ART achieved VL suppression, while after its introduction this percentage steadily decreased each quarter falling to a low of 49% (January-March 2009). In vitro evidence and reports from other sites have questioned the clinical implications of employing the TaqMan assay at the lower end of the dynamic range due to increased reports of detectable VL levels and viral load “blips” in previously well-controlled individuals. [7-10] In order to explore the impact of the change to the TaqMan assay on our clinic population, we sought to quantify the number of elevated VL readings in previously well-controlled patients during the first year of TaqMan use; and determine the costs associated with the increased frequency of these reported VL elevations. The UAB 1917 HIV/AIDS Clinic Cohort is an IRB approved protocol that has been previously described.[11] We conducted a retrospective study nested in the UAB 1917 Clinic Cohort among virologically suppressed patients on ART, at the time of implementation of the TaqMan assay. Patients meeting the following criteria were included: 1) Initiated ART prior to 9/10/07; (2) ≥ 1 VL measurement in the defined pre-TaqMan (9/10/07-6/8/08) and TaqMan (6/9/08-4/10/09) observation periods; (3) All reported VL values in the pre-TaqMan period 50 copies/mL) VL following implementation of the TaqMan assay. Bivariate analyses (chi-square, T-test) of patient characteristics, including age, sex, race, insurance status, place of residence, number of visits, HIV risk factor, and number of CD4 and VL measures in each time period were performed. The differences in frequency of VL and CD4 test ordering before and after TaqMan implementation were established. The total materials cost for the additional laboratory testing (VL, CD4, resistance tests) was calculated. The results of repeated VL tests in the TaqMan era detectable VL population are described. The number and outcomes of resistance tests ordered among patients with previously controlled VL after the transition to the TaqMan assay were quantified. All statistical analyses were performed using SAS software version 9.1.3. Among 434 patients meeting inclusion criteria, 236 (54%) maintained VL suppression following implementation of the TaqMan assay, whereas 198 (46%) had detectable viremia (>50 copies/mL). Male gender was more common in the TaqMan detectable group (p<0.03), but there were no other significant differences between groups across study variables. In the pre-TaqMan period, a mean 2.07±1.01 VL measures were ordered per patient. Patients with detectable VL measures following TaqMan implementation underwent more VL testing than those that remained undetectable (2.34±0.96 vs. 2.10±1.09 respectively, p<0.01). Compared to the pre-TaqMan era, the mean number of VL tests performed increased by 0.40±1.15 per patient in those with detectable viremia versus a decrease of 0.08±1.18 among those with sustained VL suppression (p<0.01). A statistically significant change (p<0.01) in CD4 test ordering was also seen in the TaqMan detectable group following TaqMan implementation (0.31±1.09 vs. -0.05±1.26 in the sustained VL suppression group). By multiplying the differences in frequency of test ordering before and after implementation of the TaqMan assay by the number of detectable patients (n=198) following assay release, we estimated an additional 79 VL and 61 CD4 tests were ordered. The estimated cost of these additional tests was US

From Access to Engagement: Measuring Retention in Outpatient HIV Clinical Care

22,358.00 (

Routine, Self-Administered, Touch-Screen, Computer- Based Suicidal Ideation Assessment Linked to Automated Response Team Notification in an HIV Primary Care Setting

172.00 per VL test,

Short Communication Routine HIV Testing in the Emergency Department: Assessment of Patient Perceptions

136.00 per CD4 test,