Lisa R. Hirschhorn

Better Tests, Better Care: Improved Diagnostics for Infectious Diseases

Abstract In this IDSA policy paper, we review the current diagnostic landscape, including unmet needs and emerging technologies, and assess the challenges to the development and clinical integration of improved tests. To fulfill the promise of emerging diagnostics, IDSA presents recommendations that address a host of identified barriers. Achieving these goals will require the engagement and coordination of a number of stakeholders, including Congress, funding and regulatory bodies, public health agencies, the diagnostics industry, healthcare systems, professional societies, and individual clinicians.

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

Estimating health workforce needs for antiretroviral therapy in resource-limited settings

BackgroundEfforts to increase access to life-saving treatment, including antiretroviral therapy (ART), for people living with HIV/AIDS in resource-limited settings has been the growing focus of international efforts. One of the greatest challenges to scaling up will be the limited supply of adequately trained human resources for health, including doctors, nurses, pharmacists and other skilled providers. As national treatment programmes are planned, better estimates of human resource needs and improved approaches to assessing the impact of different staffing models are critically needed. However there have been few systematic assessments of staffing patterns in existing programmes or of the estimates being used in planning larger programmes.MethodsWe reviewed the published literature and selected plans and scaling-up proposals, interviewed experts and collected data on staffing patterns at existing treatment sites through a structured survey and site visits.ResultsWe found a wide range of staffing patterns and patient-provider ratios in existing and planned treatment programmes. Many factors influenced health workforce needs, including task assignments, delivery models, other staff responsibilities and programme size. Overall, the number of health care workers required to provide ART to 1000 patients included 1–2 physicians, 2–7 nurses, <1 to 3 pharmacy staff, and a much wider range of counsellors and treatment supporters. We estimate from these data that the equivalent of 20 000 to 100 000 physicians, nurses, pharmacists and other core clinical staff will be needed to meet the WHO target of treating 3 million people by the end of 2005. The total number of staff, including counsellors, administrators and other cadres, could be substantially higher.DiscussionThese data are consistent with other estimates of human resource requirements for antiretroviral therapy, but highlight the considerable variability of current staffing models and the importance of a broad range of factors in determining personnel needs. Few outcome or cost data are currently available to assess the effectiveness and efficiency of different staffing models, and it will be important to develop improved methods for gathering this information as treatment programmes are scaled up.

HIV/AIDS patients’ perspectives on adhering to regimens containing protease inhibitors

AbstractOBJECTIVE: To gather qualitative data regarding HIV/AIDS patients’ perspectives about HIV-1 protease inhibitors (PIs), and about their experiences taking and adhering to regimens containing PIs. DESIGN: Six focus groups of persons under care for HIV were conducted between September and November 1996 regarding participants’ knowledge, awareness, experiences when taking, and adherence to antiretroviral regimens containing PIs. An identical discussion guide was used to facilitate all six groups. Focus group proceedings were audiotaped, transcribed, coded for themes, and analyzed qualitatively. SETTING: HIV/AIDS practices of three teaching hospitals and two community health centers. PATIENTS/PARTICIPANTS: Fifty-six patients with HIV disease: 28 men and 28 women. MEASUREMENTS AND MAIN RESULTS: Knowledge and positive impressions of PIs were prevalent among this diverse group of persons with HIV, and did not differ by race/ethnicity or gender. Most knew that these were new, potent medications for treating HIV/AIDS. Networks of persons with HIV and medical providers were the most important information sources. Those taking PIs were aware that adherence to the regimen is important, and most were using special strategies to maximize their own adherence, but expressed considerable frustration about the central role these medication regimens had assumed in their life. A subset who did not believe they would adhere to these regimens had declined treatment with them. Motivating factors for taking and adhering to these complex regimens were improving CD4 counts and viral loads and the patient-provider relationship. CONCLUSIONS: Among those with HIV/AIDS, awareness of PIs and their effectiveness is substantial, owing to the impact of informal networks and medical providers. This early positive “reputation” of PIs may enhance motivation for adherence. Those who are taking PIs invest substantial effort adhering to these complex regimens, but resent the need to make medications the focus of their lives.

Comprehensive and integrated district health systems strengthening: the Rwanda Population Health Implementation and Training (PHIT) Partnership

BackgroundNationally, health in Rwanda has been improving since 2000, with considerable improvement since 2005. Despite improvements, rural areas continue to lag behind urban sectors with regard to key health outcomes. Partners In Health (PIH) has been supporting the Rwanda Ministry of Health (MOH) in two rural districts in Rwanda since 2005. Since 2009, the MOH and PIH have spearheaded a health systems strengthening (HSS) intervention in these districts as part of the Rwanda Population Health Implementation and Training (PHIT) Partnership. The partnership is guided by the belief that HSS interventions should be comprehensive, integrated, responsive to local conditions, and address health care access, cost, and quality. The PHIT Partnership represents a collaboration between the MOH and PIH, with support from the National University of Rwanda School of Public Health, the National Institute of Statistics, Harvard Medical School, and Brigham and Women’s Hospital.Description of interventionThe PHIT Partnership’s health systems support aligns with the World Health Organization’s six health systems building blocks. HSS activities focus across all levels of the health system — community, health center, hospital, and district leadership — to improve health care access, quality, delivery, and health outcomes. Interventions are concentrated on three main areas: targeted support for health facilities, quality improvement initiatives, and a strengthened network of community health workers.Evaluation designThe impact of activities will be assessed using population-level outcomes data collected through oversampling of the demographic and health survey (DHS) in the intervention districts. The overall impact evaluation is complemented by an analysis of trends in facility health care utilization. A comprehensive costing project captures the total expenditures and financial inputs of the health care system to determine the cost of systems improvement. Targeted evaluations and operational research pieces focus on specific programmatic components, supported by partnership-supported work to build in-country research capacity.DiscussionBuilding on early successes, the work of the Rwanda PHIT Partnership approach to HSS has already seen noticeable increases in facility capacity and quality of care. The rigorous planned evaluation of the Partnership’s HSS activities will contribute to global knowledge about intervention methodology, cost, and population health impact.

The CASE adherence index: A novel method for measuring adherence to antiretroviral therapy

Abstract The Center for Adherence Support Evaluation (CASE) Adherence Index, a simple composite measure of self-reported antiretroviral therapy (ART) adherence, was compared to a standard three-day self-reported adherence measure among participants in a longitudinal, prospective cross-site evaluation of 12 adherence programs throughout the United States. The CASE Adherence Index, consisting of three unique adherence questions developed for the cross-site study, along with a three-day adherence self-report were administered by interviews every three months over a one-year period. Data from the three cross-site adherence questions (individually and in combination) were compared to three -day self-report data and HIV RNA and CD4 outcomes in cross-sectional analyses. The CASE Adherence Index correlated strongly with the three-day self-reported adherence data (p<0.001) and was more strongly associated with HIV outcomes, including a 1-log decline in HIV RNA level (maximum OR = 2.34; p<0.05), HIV RNA < 400 copies/ml (maximum OR = 2.33; p<0.05) and performed as well as the three-day self-report when predicting CD4 count status. Participants with a CASE Index score >10 achieved a 98 cell mean increase in CD4 count over 12 months, compared to a 41 cell increase for those with scores ≤10 (p<0.05). The CASE Adherence Index is an easy to administer instrument that provides an alternative method for assessing ART adherence in clinical settings.

Electronic surveillance of antibiotic exposure and coded discharge diagnoses as indicators of postoperative infection and other quality assurance measures.

OBJECTIVES To assess postoperative exposure to parenteral antibiotics and coded discharge diagnoses of infection as markers of nosocomial infection, postoperative morbidity, and potentially inappropriate antibiotic use after cesarean section. DESIGN Retrospective cohort study to compare automated markers with the criterion of record review. SETTING Tertiary care hospital. PATIENTS Women admitted to a large teaching hospital after April 15, 1987, and discharged before October 1, 1989, who underwent a nonrepeat, nonelective cesarean section and had received prophylaxis with a cephalosporin. METHODS Antibiotic exposure and discharge diagnosis codes were obtained from a large electronic hospital data base. A sample of charts was reviewed to determine the presence of infection, other postoperative complications, and postoperative antibiotic exposure. RESULTS A total of 2,197 women who had undergone a nonrepeat nonelective cesarean section were included in the study cohort. These women were assigned to 6 subgroups based on postoperative antibiotic exposure status and discharge codes suggesting endometritis, other postoperative infection, or no infection. Review of 457 records indicated that the overall infection rate was 9%. Eight percent of all the patients had a coded diagnosis for infection, and 16% received some parenteral antibiotics after the first postoperative day. Exposure to at least 2 days of parenteral postoperative antibiotics was the best marker by which to discriminate between infected and uninfected patients, with a sensitivity of 81%, a specificity of 95%, and a positive predictive value of 61% for detecting infection. The corresponding figures for coded diagnoses for infection had rates of 65%, 97%, and 74%, respectively. The combination of discharge codes and exposure to parenteral postoperative antibiotics resulted in a more accurate but less sensitive marker for nosocomial infections, with a positive predictive value of 94% and a sensitivity of 59%. The groups with discordant parenteral postoperative antibiotics exposure and discharge codes for infection were enriched for errors in coding, noninfectious morbidity, and unexplained antibiotic use. Less than 1% of the entire cohort had > or = to 2 days of parenteral postoperative antibiotics without any reason apparent in the medical record. CONCLUSIONS Parenteral postoperative antibiotic exposure determined from automated pharmacy records correlated with the results of the more labor-intensive manual review of medical records for the identification of nosocomial infection. In addition, information on antibiotic exposure combined with coded discharge diagnoses provided a rapid screen to identify subgroups of patients with higher rates of infectious and noninfectious morbidity, unexplained antibiotic use, and errors in discharge coding. Information derived from electronic data bases created for administrative purposes may be useful as a marker for infectious complications, inappropriate antibiotic prescribing, and other issues related to total quality hospital monitoring.

Cost-effectiveness of an intervention to improve adherence to antiretroviral therapy in HIV-infected patients.

Summary:Adherence to antiretroviral medications has been shown to be an important factor in predicting viral suppression and clinical outcomes. The objective of this analysis was to assess the cost-effectiveness of a nursing intervention on antiretroviral adherence using data from a randomized controlled clinical trial as input to a computer-based simulation model of HIV disease. For a cohort of HIV-infected patients similar to those in the clinical trial (mean initial CD4 count of 319 cells/mm3), implementing the nursing intervention in addition to standard care yielded a 63% increase in virologic suppression at 48 weeks. This produced increases in expected survival (from 94.5 to 100.9 quality-adjusted life months) and estimated discounted direct lifetime medical costs (

Approaches to ensuring and improving quality in the context of health system strengthening: a cross-site analysis of the five African Health Initiative Partnership programs

253,800 to

Research for change: using implementation research to strengthen HIV care and treatment scale-up in resource-limited settings.

261,300). The incremental cost-effectiveness ratio for the intervention was