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The National Institutes of Health (NIH) recognizes that, despite HIV scientific advances, stigma and discrimination continue to be critical barriers to the uptake of evidence-based HIV interventions. Achieving the Ending the HIV Epidemic: A Plan for America (EHE) goals will require eliminating HIV-related stigma. NIH has a significant history of supporting HIV stigma research across its Institutes, Centers, and Offices (ICOs) as a research priority. This article provides an overview of NIH HIV stigma research efforts. Each ICO articulates how their mission shapes their interest in HIV stigma research and provides a summary of ICO-relevant scientific findings. Research gaps and/or future opportunities are identified throughout, with key research themes and approaches noted. Taken together, the collective actions on the part of the NIH, in tandem with a whole of government and whole of society approach, will contribute to achieving EHE's milestones.Los Institutos de Salud Nacional (NIH, siglas en inglés) reconocen que, a pesar de los avances en la prevención y el tratamiento, el estigma y la discriminación continúan siendo barreras críticas a la adopción de la prevención y el cuido basados en la evidencia. Las metas de Logrando el Fin de la Epidemia de VIH: Plan para América (EHE, siglas en inglés) requerirán la eliminación del estigma relacionado al VIH. Los NIH tienen una historia significativa apoyando la investigación del estigma relacionado al VIH a través de sus Institutos, Centros, y Oficinas (ICOs, siglas en inglés). Esta investigación es una prioridad fundamental y entrelazada para los ICOs. En este artículo, los autores de los NIH proveen una reseña sobre la investigación del estigma relacionado al VIH a través de los ICOs selectos. Cada ICO articula como su misión y prioridad dan forma a su interés en la investigación del estigma al VIH y provee una breve reseña de los hallazgos científicos pertinentes al ICO. Lagunas en la investigación relacionada a la misión, prioridades, y/o áreas de investigación futuras se identifican a través del artículo. También se apuntan en el resumen los temas de investigación claves y sus estrategias. En conjunto, las acciones colectivas de parte de los NIH, junto a la estrategia necesaria de parte del gobierno en su totalidad y de la sociedad en su totalidad, contribuirán al logro de las metas del EHE.

Findings from health services research highlight continuing health care disparities in the United States, especially in the areas of access to health care and quality of care. Although attention to health care disparities has increased, considerable knowledge gaps still exist. A better understanding of how cultural, behavioral, and health system factors converge and contribute to unequal access and differential care is needed. Research-informed approaches for reducing health care disparities that are feasible and capable of sustained implementation are needed to inform policymakers. More important, for health equity to be achieved, it is essential to create a health care system that provides access, removes barriers to care, and provides equally effective treatment to all persons living in the United States.

BACKGROUND: A series of six manuscripts with an introduction appeared in the Mayo Clinic Proceedings, based upon the collective effort of 30 individuals with an interest and expertise in assessing the clinical significance of quality of life (QOL) assessments. The series of manuscripts described the state of the science of QOL assessments in oncology clinical research and practice and included extensive literature and theoretical justification for the continued inclusion of QOL in oncology clinical research and practice. OBJECTIVES: The purpose of this paper is to produce a summary of these articles and to supplement these works with additional information that was gleaned from subsequent meetings and discussions of this material. The primary aim of this paper is to present a cogent and concise description for clinicians to facilitate the incorporation of QOL assessments into oncology clinical research and practice. The theoretical discussion is supplemented with an example of how the various ideas can be operationalized in an oncology clinical trial

Background The extent to which patient-based outcomes can be used to evaluate and communicate the effect of new drugs and devices is a subject of much debate. Criteria for evaluating the scientific quality of data to support health-related quality of life (HRQL) and other patient-based labeling and promotional claims in the United States and Europe have been proposed by various scientists and organizations. Since March 2000, a working group composed of members of the International Society for Quality of Life Research (ISOQOL), the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), the Pharmaceutical Manufacturer's Association Health Outcomes Committee (PhRMA-HOC), and the European Regulatory Issues on Quality of Life Assessment (ERIQA) met to discuss and coordinate the various recommendations by their respective groups and address the need to harmonize outcomes review criteria within and across United States and European regulatory agencies. Over time, the discussion expanded from HRQL outcomes to include any outcome based on data provided by the patient or patient proxy, that is, patient-reported outcomes (PROs). The working group therefore became known as the PRO Harmonization Group. Methods Working with a member of the US Food and Drug Administration (FDA), four key issues requiring clarification were identified: how PROs are defined and put into operation for research purposes; the added value of PROs in the drug review and evaluation process; selected questions related to the PRO measurement and research methodology; and the interest and demand for PRO information by decision makers. On February 15, 2001, all members of the PRO Harmonization Group attended a meeting in Rockville, Maryland, to discuss these four issues further, and on February 16, 2001, a formal presentation was made to representatives from various departments and reviewing divisions of the FDA. These presentations are summarized in this report. Results All participants agreed that PROs are important for understanding the impact of treatment on patient functioning and well-being. They also stressed the need to communicate PRO information to key decision makers, including regulatory agencies, clinicians, patients and their families, and payers. Finally, the meeting resulted in plans for continuing the dialogue on PRO measurement and interpretation. Summary The February 16, 2001, meeting represented an important step in harmonizing efforts across various organizations and in opening a dialogue with the FDA around major issues related to methodologic standards for measuring and interpreting PROs in the drug evaluation process.

Health-related quality of life (HRQL) outcomes evaluation is becoming an important component of clinical trials of new pharmaceuticals and medical devices. HRQL research provides patients, providers, and decision makers with important information on the impact of disease and treatment on physical, psychological, and social functioning and well-being. These outcomes are also useful to the pharmaceutical and device industries as they attempt to understand and communicate product value to physicians, patients, health insurers and others. HRQL labeling and promotional claims in the US are likely to increase over the next few years. The evidentiary requirements to make such a claim should be based on accepted scientific standards of HRQL evaluation and consistent with the regulatory requirements for clinical efficacy. This report outlines the scientific practices that should be considered in the evaluation of evidence for an HRQL claim, including the selection of appropriate domains, evidence to support the reliability and validity of HRQL measurement, considerations in research design and statistical analyses, and the issue of clinical significance. Representatives from the pharmaceutical and device industries, regulatory agencies, and the HRQL scientific community should work together to make certain the use of HRQL in labeling and promotion are based on sound scientific evidence, and that these messages are clearly and accurately reported to the consumers.

BACKGROUND: The US Presidents Emergency Plan for AIDS Relief (PEPFAR) has supported the extension of HIV care and treatment to 2.4 million individuals as of September 2009. With increasing resources targeted toward rapid scale-up it is important to understand the characteristics of current PEPFAR-supported HIV care and treatment sites. METHODS: Forty-five sites in Botswana Ethiopia Nigeria Uganda and Vietnam were sampled. Data were collected retrospectively from successive 6-month periods through reviews of facility records and interviews with site personnel between April 2006 and March 2007. Facility size and scale-up rate patient characteristics staffing models clinical and laboratory monitoring and intervention mix were compared. RESULTS: Sites added a median of 293 patients per quarter. By the evaluations end sites supported a median of 1649 HIV patients 922 of them receiving antiretroviral therapy. Patients were predominantly adult (97.4%) and the majority (96.5%) were receiving regimens based on nonnucleoside reverse transcriptase inhibitors. The ratios of physicians to patients dropped substantially as sites matured. Antiretroviral therapy patients were commonly seen monthly or quarterly for clinical and laboratory monitoring with CD4 counts being taken at 6-month intervals. One-third of sites provided viral load testing. Cotrimoxazole prophylaxis was the most prevalent supportive service. CONCLUSIONS: HIV treatment sites scaled up rapidly with the influx of resources and technical support through PEPFAR providing complex health services to progressively expanding patient cohorts. Human resources are stretched thin and delivery models and intervention mix differ widely between sites. Ongoing research is needed to identify best-practice service delivery models.

This is the sixth article in a series intended to summarize the state of the science for assessing the clinical significance of quality-of-life (QOL) assessments. The previous 5 articles dealt with specific methodological issues, whereas this article addresses practical considerations in implementing the methods and presenting the results to various audiences with differing perspectives. Proposals for how to interpret the "clinical significance" or "clinical meaningfulness" of changes in QOL scores were addressed in previous articles within this series. Within this article, 4 audiences—patients and physicians, clinical researchers, health policymakers, and private- and public-sector employees who work in health-related fields—are examined because each is a unique stakeholder with a distinct vantage point and each can interpret QOL outcomes differently. A clinician may attempt to explain to a patient potential treatment alternatives for his or her QOL; a health policymaker may try to describe to elected officials the financial impact on a patient population with reduced QOL; a researcher may try to obtain the vital messages from a clinical trial that included QOL end points; and a regulatory agency and/or pharmaceutical company may try to ascertain the appropriate level of evidence required for a successful research study. For each of the 4 audiences, concrete examples and practical guidelines are offered by which changes in QOL outcomes can be interpreted meaningfully. Ultimately, both determining and disseminating the meaning of clinical significance are functions of the outlook of the audience because the perspective of the audience determines its ability to comprehend, evaluate, and convey the context within which such outcomes appear meaningful. Among the audiences described within this article, a commonality of interests exist that mandates a careful exposition of the scientific rigor involved in describing the clinical significance of QOL assessments. Collectively, this series attempts to provide methods and means for making such determinations.

Clinical trials involving quality of life measurement published in the literature suffer from important weaknesses due to the lack of information on numerous topics. The psychometric properties of the instruments are often lacking as well as data on the number of patients treated and analyzed. The handling of missing data is rarely documented. In order to facilitate the reporting of trials and the evaluation of published results, this article proposes a set of general guidelines for the reporting of clinical trials which include a quality of life assessment. A checklist designed to assist authors is appended.

OBJECTIVES: To assess differences in the health care resource use of patients who received selective serotonin reuptake inhibitor (SSRI) antidepressants. METHODS: Retrospective analysis of administrative medical claims from 1/97–12/99 was conducted using Protocare Sciences' Managed Care Database. Patients were categorized as early discontinued or continued ( one agent). Total health care costs were compared across these categories. RESULTS: Under half (48%) of the 11,119 SSRI users studied continued antidepressant therapy for at least 6 months. Two-thirds of all patients received monotherapy; 19% switched agents (44% of switches were in the first three months of therapy); 15% used multiple agents. Eight percent of patients who discontinued early had switched agents within the specified 6 month period; 90% of these switches occurred in the first three months. For patients who continued therapy for 6 months, the average total health care charges per patient per month (PPPM) during the first three therapy months were $906 (switch by third month), $568 (switch by sixth month), $496 (switch by twelfth month) and $375 (switch after twelfth month). PPPM charges in the first six therapy months ranged from $452–$921 for discontinued patients and from $423–$483 for non-switched, continued patients. CONCLUSIONS: Patients who discontinued SSRI therapy early tended to have higher costs than patients who continued therapy. It is unclear whether these increased costs stem from treatment of medication side effects or increased utilization related to lack of efficacy of the initial antidepressant. Alternatively, early switchers may simply be more clinically complex patients.

Jeff A. Sloan, PhD,l Carol Moinpour, PhD,2 Rick Berzon, PhD,3 Monika Bullinger, PhD,4 Ivan Barofsky, PhD,* and Albert W. Wu, MD, MPH,6 for the Clinical Significance Consensus Meeting Group ‘Mayo Clinic and Mayo Foundation, Rochestel; Minnesota, 2Southwest Oncology Group Statistical Centel; Seattle, Washington, 3Boehringer Ingelheim Pharmaceuticals, Ridgefield, Connecticut, 4University of Hamburg, Hamburg, Germany, %&ality of l$e Institute, East Sandwich, Massachusetts, and 6The]ohns Hopkins University, Baltimore, Maryland