Ira B. Wilson

Better physician-patient relationships are associated with higher reported adherence to antiretroviral therapy in patients with HIV infection

AbstractBACKGROUND: There is little evidence to support the widely accepted assertion that better physician-patient relationships result in higher rates of adherence with recommended therapies. OBJECTIVE: To determine whether and which aspects of a better physician-patient relationship are associated with higher rates of adherence with antiretroviral therapies for persons with HIV infection. DESIGN: Cross-sectional analysis. SETTING: Twenty-two outpatient HIV practices in a metropolitan area. PARTICIPANTS: Five hundred fifty-four patients with HIV infection taking antiretroviral medications. MEASUREMENTS: We measured adherence using a 4-item self-report scale (α=0.75). We measured core aspects of physician-patient relationships using 6 previously tested scales (general communication, HIV-specific information, participatory decision making, overall satisfaction, willingness to recommend physician, and physician trust; α>0.70 for all) and 1 new scale, adherence dialogue (α=0.92). For adherence dialogue, patients rated their physician at understanding and solving problems with antiretroviral therapy regimens. RESULTS: Mean patient age was 42 years, 15% were female, 73% were white, and 57% reported gay or bisexual sexual contact as their primary HIV risk factor. In multivariable models that accounted for the clustering of patients within physicians’ practices, 6 of the 7 physician-patient relationship quality variables were significantly (P<.05) associated with adherence. In all 7 models worse adherence was independently associated (P<.05) with lower age, not believing in the importance of antiretroviral therapy, and worse mental health. CONCLUSIONS: This study showed that multiple, mutable dimensions of the physician-patient relationship were associated with medication adherence in persons with HIV infection, suggesting that physician-patient relationship quality is a potentially important point of intervention to improve patients’ medication adherence. In addition, our data suggest that it is critical to investigate and incorporate patients’ belief systems about antiretroviral therapy into adherence discussions, and to identify and treat mental disorders.

Health-related quality of life in patients with human immunodeficiency virus infection in the United States: results from the HIV cost and services utilization study

PURPOSE To measure health-related quality of life among adult patients with human immunodeficiency virus (HIV) disease; to compare the health-related quality of life of adults with HIV with that of the general population and with patients with other chronic conditions; and to determine the associations of demographic variables and disease severity with health-related quality of life. SUBJECTS AND METHODS We studied 2,864 HIV-infected adults participating in the HIV Cost and Services Utilization Study, a probability sample of adults with HIV receiving health care in the contiguous United States (excluding military hospitals, prisons, or emergency rooms). A battery of 28 items covering eight domains of health (physical functioning, emotional well-being, role functioning, pain, general health perceptions, social functioning, energy, disability days) was administered. The eight domains were combined into physical and mental health summary scores. SF-36 physical functioning and emotional well-being scales were compared with the US general population and patients with other chronic diseases on a 0 to 100 scale. RESULTS Physical functioning was about the same for adults with asymptomatic HIV disease as for the US population [mean (+/- SD) of 92+/-16 versus 90+/-17) but was much worse for those with symptomatic HIV disease (76+/-28) or who met criteria for the acquired immunodeficiency syndrome (AIDS; 58+/-31). Patients with AIDS had worse physical functioning than those with other chronic diseases (epilepsy, gastroesophageal reflux disease, clinically localized prostate cancer, clinical depression, diabetes) for which comparable data were available. Emotional well-being was comparable among patients with various stages of HIV disease (asymptomatic, 62+/-9; symptomatic, 59+/-11; AIDS, 59+/-11), but was significantly worse than the general population and patients with other chronic diseases except depression. In multivariate analyses, HIV-related symptoms were strongly associated with physical and mental health, whereas race, sex, health insurance status, disease stage, and CD4 count were at most weakly associated with physical and mental health. CONCLUSIONS There is substantial morbidity associated with HIV disease in adults. The variability in health-related quality of life according to disease progression is relevant for health policy and allocation of resources, and merits the attention of clinicians who treat patients with HIV disease.

Optimal Recall Period and Response Task for Self-Reported HIV Medication Adherence

Self-reported measures of antiretroviral adherence vary greatly in recall time periods and response tasks. To determine which time frame is most accurate, we compared 3-, 7-day, and 1-month self-reports with data from medication event monitoring system (MEMS). To determine which response task is most accurate we compared three different 1-month self-report tasks (frequency, percent, and rating) to MEMS. We analyzed 643 study visits made by 156 participants. Over-reporting (self-report minus MEMS) was significantly less for the 1-month recall period (9%) than for the 3 (17%) or 7-day (14%) periods. Over-reporting was significantly less for the 1-month rating task (3%) than for the 1-month frequency and percent tasks (both 12%). We conclude that 1-month recall periods may be more accurate than 3- or 7-day periods, and that items that ask respondents to rate their adherence may be more accurate than those that ask about frequencies or percents.

Adjusting for patient characteristics when analyzing reports from patients about hospital care.

Objectives.To determine which patient characteristics are associated with reports and ratings of hospital care, and to evaluate how adjusting reports and ratings for hospital differences in such variables affects comparisons among hospitals. Design.A telephone survey of a sample of patients hospitalized in 22 hospitals in a single city and a statewide mail survey of hospitalized patients. Measures.The surveys assessed: respect for patients’ preferences, coordination of care, information exchange between patient and providers, physical care, emotional support, involvement of family and friends, and transition and continuity. The surveys also asked patients to rate their doctors, nurses, and other hospital staff. Results.The variables with the strongest and most consistent associations with patient-reported problems were age and reported health status. Patient gender and education level also sometimes predicted reports and/or ratings. Models including these variables explained only between 3% and 8% of the variation in reports and ratings. Conclusions.The impact of adjusting for patient characteristics on hospital rankings was small, although a larger impact would be expected when comparing hospitals with more variability in types of patients. Nevertheless, we recommend adjusting at least for the most important predictors, such as age and health status. Such adjustment helps alleviate concerns about bias. It also may be useful to present data for certain groups of patients (ie, medical, surgical, obstetric) separately to facilitate interpretation and quality improvement efforts.

HEALTH-RELATED QUALITY OF LIFE IN PERSONS WITH ACQUIRED IMMUNE DEFICIENCY SYNDROME

Assessing health-related quality of life in persons infected with human immunodeficiency virus (HIV) is extremely important, but most available scales are too long, contain items that are not relevant for such persons, or do not assess important signs and symptoms of HIV infection. This study presents a new set of scales for assessing the symptoms and functioning of persons infected with HIV and reports data on their reliability and validity collected in face-to-face interviews with 189 patients receiving primary care. This study also assesses the associations among systems, functional impairment, and global health assessments. The scales are easy to administer, are reliable, and serve as valid measures of quality of life. Fatigue, functional status, and average severity of all symptoms were the best predictors of overall perceived health status. Psychological well-being and perceived health status were the best predictors of overall perceived health status. Psychological well-being and perceived health status were the strongest correlates of life satisfaction. When assessing the health-related quality of life of persons infected with HIV, this study recommends utilizing a comprehensive set of measures that allows one to examine both discrete symptoms and the more diffuse impact of illness on functioning, mental health, and quality of life.

Effects of a Quality Improvement Collaborative on the Outcome of Care of Patients with HIV Infection: The EQHIV Study

Context Multi-institutional quality improvement collaboratives are popular, but are they effective? Contribution This controlled study evaluated an HIV care Breakthrough Series program that emphasized provider teams, sessions on quality improvement theory and techniques, and report backs about implementing quality improvement. A review of the medical records of 9986 HIV-infected patients showed no important differences in quality of care (viral load suppression, pneumocystitis prophylaxis, and screening for tuberculosis and hepatitis) between the 44 intervention clinics and the 25 control clinics. Cautions Patient adherence and satisfaction were not measured, and some control clinics may have used quality improvement techniques similar to those recommended by the collaborative program. The Editors In the pastdecade, tremendous improvements have occurred in measuring and monitoring the quality of medical care in the United States. Despite these advances, striking problems with quality persist (1, 2). The quality of care for patients with HIV infection is of particular concern. Substantial evidence shows that obtaining medical services and treatment for patients with HIV infection may lead to longer survival and better quality of life (3, 4), yet serious quality-of-care problems and striking disparities in quality by race and social class have been documented (4-6). In the 1980s, continuous quality improvement techniques were introduced into health care (7, 8). These strategies emphasize that most quality problems are a result of system failings rather than problems with individual practitioners (9). In 1995, the Institute for Healthcare Improvement introduced the concept of the Breakthrough Series, which brings together health care organizations dedicated to improving the quality of care in particular clinical areas through the application of continuous quality improvement techniques (10). These techniques (known as Plan/Do/Study/Act or PDSA cycles; Figure 1) first identify deficiencies in quality, next repeatedly implement small-scale interventions and measure changes, and then refine and expand interventions to improve processes of care (11, 12). Typically, each Breakthrough Series collaborative is composed of 20 to 40 participating health care organizations and a faculty with expertise in the clinical area and quality improvement methods (13). To date, the Institute for Healthcare Improvement has conducted collaboratives with more than 700 teams working on 23 clinical conditions or treatment processes, including improving asthma care and reducing medication errors. Although some evaluations of quality before and after a collaborative support the validity of this approach, only a few limited controlled trials have been conducted (14, 15). Figure 1. Theoretical construct of continuous quality improvement. An important source of funding for HIV care is the Ryan White Comprehensive AIDS Resources Emergency (CARE) Act, which is administered by the HIV/AIDS Bureau of the Health Resources and Services Administration. Title III of the CARE Act supports comprehensive primary health care for HIV-infected individuals and currently supports primary care services for more than 150000 patients receiving care in more than 200 community health centers, hospital-based clinics, and city or county health services (16). In 1999, the Health Resources and Services Administration required all clinical sites that were newly awarded funding under Title III of the CARE Act to participate in a quality improvement collaborative conducted by the Institute for Healthcare Improvement. Other sites already receiving Title III funding were also invited to participate. This study evaluates the impact of the collaborative by examining pre- and postimplementation quality-of-care information on samples of patients from both participating and matched nonparticipating clinics. Methods Study Site Selection and Controls Of the 200 Title III sites in the continental United States in May 2000, we excluded 16 that reported caseloads of fewer than 100 cases per year, 12 that were initially slated to participate in the Breakthrough collaborative but elected not to do so, and 1 that lost its CARE Act funding shortly before the collaborative began. Of the remaining 171 sites, 62 participated in the collaborative. Among these sites, 54 agreed to participate in the study and 44 (including 11 mandatory participants and 33 voluntary participants; 71% of collaborative participants) provided chart review data. Of the 109 nonparticipating sites eligible to be selected as control sites, 65 provided information needed for matching. The potential control sites were matched with intervention sites on the basis of the type of site (community health center, community-based organization, health department, hospital, or university medical center), location (rural or urban), number of locations delivering care, region, and number of patients with active HIV infection. When these criteria were used, 40 sites were selected as potential controls and 37 of them (93%) agreed to participate in the study. Of these, 25 (63% of potential control sites) participated in the chart review portion of the study. The Committee on Human Studies of Harvard Medical School approved the study protocol. Quality Improvement Intervention Each participating clinic selected a team, usually consisting of at least one administrator and one or more clinicians, and a population of focus on which the teams interventions would be tested. Usually, the population of focus consisted of all HIV-infected patients in a particular site, but participants sometimes chose to focus on a subset of patients, such as those under the care of a particular group of clinicians. Originally, the design of the collaborative extended for 12 months and included a kickoff meeting and 2 subsequent 2-day meetings called learning sessions. The kickoff learning session included instruction in the theory and practice of quality improvement by identifying problems in HIV care and then introducing the techniques of continuously implementing, measuring, and refining changes (the Plan/Do/Study/Act cycles) (11, 12) to improve the care of HIV-infected patients. Each learning session included additional instruction in quality improvement techniques and breakout sessions that focused on improving specific aspects of care, developing an information infrastructure to track progress, and specific aspects of quality improvement theory. In addition, teams exchanged ideas and presented storyboards of their progress to date. At each session, teams reported on activities, methods, and results. Toward the end of the 12-month period, the Health Resources and Services Administration decided to extend the collaborative by 4 months and add a third learning session. Between the sessions (action periods), team members implemented concepts and ideas. Each site had access to a collaborative listserve, participated in monthly conference calls with the collaborative faculty, and submitted monthly reports of its improvements, which included charts that tracked the sites improvements to date in the required key quality measures described in the next section. Detailed descriptions of the Breakthrough Series collaboratives are available elsewhere (10, 17-19). Quality-of-Care Monitors We selected quality-of-care measures (Table 1) to coincide with required and optional quality measures selected by the collaborative faculty as areas for improvement. These measures were selected by the faculty after reviewing the literature to identify areas of quality deficiency in the delivery of HIV care, particularly for underserved populations targeted by the CARE Act. Because of the paramount importance of antiretroviral therapy to the treatment of HIV infection, the faculty focused on measures related to antiretroviral treatment, including the percentage of patients receiving highly active antiretroviral therapy, the percentage of patients with a controlled viral load, and the percentage of patients who received adherence counseling, as required key measures for the collaborative. Measures were then developed on the basis of consensus guidelines appropriate for the period of care (20). Our primary measures were rates of highly active antiretroviral therapy use and control of HIV viral load for appropriate patients. Patients eligible for highly active antiretroviral therapy included those with CD4+cell counts less than 0.350 109 cells/L, those with CD4+counts between 0.350 and 0.500 109 cells/L and a viral load greater than 5000 copies/mL, all patients with a viral load greater than 30000 copies/mL, and patients already receiving highly active antiretroviral therapy, as per the guidelines. We also assessed the use of highly active antiretroviral therapy for those with CD4+counts less than 0.350 109 cells/L to reflect recommendations that were published after the end of the collaborative (21). Because of the variability in viral load assays available at the time, viral load was considered controlled if it was undetectable or if the total viral load was less than 400 copies/mL. We also assessed the use of screening and prophylaxis, as well as access to care. The only key measure followed by the collaborative that we could not assess was related to adherence counseling because this information is not reliably available from medical records. Table 1. Quality of Care Indicators* Quality-of-Care Data Collection To identify pre- and postintervention samples of patients, we requested lists of all HIV-infected patients in care at each of the sites during the 2 time periods (Figure 2). For the first sample, sites were asked to provide encrypted lists of all HIV-infected patients age 18 years or older as of June 2000 seen at the site between 1 January and 30 June 2000. For the second sample, sites were asked to provide a similar list of active patients age 18 years or older as of Dec

The effect of protease inhibitors on weight and body composition in HIV-infected patients

Objectives:To determine the nutritional changes that occur in HIV-infected patients receiving protease inhibitor (PI) therapy and to determine the effects of PI treatment on physical functioning and health perceptions in patients with HIV infection. Design:Longitudinal data analysis of 38 patients from a large Nutrition and HIV cohort. Methods:Patients were included if they had started PI therapy after enrollment in the cohort, if they had taken the drug for at least 4 months without interruption and if data on weight, body composition and viral loads were available. Results:Mean person-months of follow-up was 8.1 months before and 12.2 months after PI treatment. Weight (1.54 kg, P < 0.0001), body mass index (0.50 kg/m2, P < 0.0001), physical functioning (8.52 points, P = 0.0006) and current health perception (6.7 points, P = 0.01) increased significantly, and the daily caloric intake increase was close to significance (915.5 kJ/day, P = 0.06), after treatment with PI. Lean body mass did not change. Patients who responded to PI therapy with decreased viral load (n = 28) had significantly greater weight gain per month than non-responders. Conclusions:PI therapy of HIV infection is associated with weight gain and improvement in quality of life indices. The weight gain is mainly in fat mass, with no change in lean body mass (skeletal muscle). Optimal therapy of HIV-infected patients with weight loss may require highly active antiretroviral therapy combined with an anabolic stimulus such as exercise, anabolic steroids or human growth hormone.

Clinical understanding and clinical implications of response shift

The purpose of this paper is to provide clinical understanding and clinical context for the concept of response shift. First, the paper describes a variety of target constructs or dimensions of health-related quality of life that are important in clinical medicine, including biological and physiological measures, symptoms, functioning, general health perceptions and overall quality of life. It is argued that insight into response shift can be gained by assessing the ways in which measures on these different dimensions change relative to each other. Second, somatization and hypochondriasis are presented as examples of clinical circumstances in which appropriate and adaptive response shifts do not occur. Third, placebo effects are defined and it is argued that response shift is one subtype of placebo effect. Finally, the role of response shift in routine clinical care and its implication for the physician-patient relationship are discussed. Although it cannot and should not replace careful attention to and appropriate treatment of abnormal biological and physiological processes, there are times when explicit attempts to produce response shifts may complement these biomedical therapies. Producing response shift probably involves understanding the psychological, social and cultural context of the illness; may be mediated by the physician-patient relationship and may facilitate coping processes in ways that improve health-related quality of life.

International AIDS Society global scientific strategy: towards an HIV cure 2016

Antiretroviral therapy is not curative. Given the challenges in providing lifelong therapy to a global population of more than 35 million people living with HIV, there is intense interest in developing a cure for HIV infection. The International AIDS Society convened a group of international experts to develop a scientific strategy for research towards an HIV cure. This Perspective summarizes the groups strategy.

The relationship of post-traumatic stress disorder and depression to antiretroviral medication adherence in persons with HIV.

In HIV/AIDS, symptoms of depression or post-traumatic stress may interfere with important self-care behaviors such as the ability to adhere to ones medical treatment regimen. However, these problems may frequently go undetected in HIV care settings. The present study used brief self-report screening measures of depression and post-traumatic stress disorder (PTSD) in the HIV/AIDS care settings to examine (1) frequency of positive screens for these diagnoses; (2) the degree to which those with a positive screen were prescribed antidepressant treatment; and (3) the association of continuous PTSD and depression symptom scores, and categorical (screening positive or negative) PTSD and depression screening status, to each other and to ART adherence as assessed by the Medication Event Monitoring System, regardless of antidepressant treatment. Participants were 164 HIV-infected individuals who took part in a multisite adherence intervention study in HIV treatment settings in Massachusetts. Available data from 5 time points was used, yielding 444 data points. Participants screened positive for PTSD at 20% of visits, and depression at 22% of visits. At visits when participants screened positive for both depression and PTSD, 53.6% of the time they were on an antidepressant. Those who screened positive for PTSD were more likely to also screen positive for depression. In multiple regression analyses that included both continuous and dichotomous PTSD and depression and controlled for shared variance due to clustering of multiple observations, only depression contributed significant unique variance, suggesting the primary role of depression and the secondary role of PTSD in poor adherence in individuals with HIV.