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Biomedical subjects

Hugh Tilson

Publications and source records attributed to Hugh Tilson.

15 recordsLinked to original sources
PubMed2007

Assessment of birth defects according to maternal therapy among infants in the Women and Infants Transmission Study.

BACKGROUND: To evaluate rate and types of birth defects according to timing of antiretroviral exposure among babies born to HIV-infected women. METHODS: Anomalies identified during the prenatal, neonatal, or follow-up period were classified using criteria of the Antiretroviral Pregnancy Registry. Antiretroviral use was classified as none, second or third trimester only, or first trimester. RESULTS: From January 1, 1990 through June 30, 2004, 2527 live births (LBs) occurred to 2353 women. Defects were identified in 90 babies for a rate of 3.56 defects per 100 LBs. The rate of defects was 3.19 per 100 LBs (24 of 752 LBs) with first-trimester antiretroviral exposure, 3.54 per 100 LBs (41 of 1158 LBs) with exposure later in pregnancy, and 4.05 of 100 LBs (25 of 617 LBs) with no antiretroviral use. Only genital abnormalities, specifically hypospadias, were significantly increased among babies born to women with first-trimester exposure to antiretrovirals (7 of 382 male LBs) compared with the 2 other groups (2 of 892 male LBs; P = 0.007). On logistic regression, use of zidovudine in the first trimester was associated with hypospadias (adjusted odds ratio = 10.68, 95% confidence interval: 2.11 to 54.13; P = 0.004). CONCLUSIONS: In general, data were reassuring, although the frequency of exposure to newer agents was limited. The increased risk of hypospadias after first-trimester exposure must be explored, because this association has not been detected previously.

Abnormalities, Drug-Induced↗
PubMed2006

Public health systems research: setting a national agenda.

The Institute of Medicine has recommended that policy decisions about improvement of national public health systems be guided by sound scientific evidence. However, to date there is no national research agenda to help guide public health systems. The Centers for Disease Control and Prevention was called upon to lead a collaborative consensus-based process to define key research questions and establish a framework to create opportunities to better coordinate, leverage, and identify public health resources, which are increasingly scarce. The public health systems research agenda that emerged from this process has 14 over-arching priority research themes. This national agenda should stimulate and guide research to meet the urgent need to improve the nation's public health systems.

Centers for Disease Control and Prevention, U.S.↗
PubMed2005

Creating a new structure for research on health care effectiveness.

Effectiveness research (a term we use in preference to the more confining and difficult health services or outcomes research) evaluates the clinical setting and the health care system on which it depends. It uses a variety of health care assessment techniques and the practical clinical trial to inform clinical practice, quality interventions, and health policy decisions. Effectiveness research had not had sufficient public or private funding to produce the information needed to facilitate evidence-based health care improvement. However, recent trends, such as the likelihood for continued substantial increases in health care costs and concern regarding the quality and safety of the US health care system, are among the important arguments for increasing its funding and capacity. We propose a new entity, a public-private consortium to expand and offer new capability and resources in this area. The consortium would consist of all relevant public and private entities. It would be organized into an executive committee, which would identify research priorities and panels to design requests for proposals. Competitive peer-reviewed proposals, transparency and balance of forces in choice of topics, conduct of research, and interpretation of results would be important features. Metrics for success would be use of the data derived from consortium projects in medical decision making and benefit design. The consortium would provide balance and potential mediation of conflicting or competing interests in which all stakeholders will be present to establish the rules. Broad representation of all interests would serve to avoid the economic, policy, and political issues that have bedeviled past efforts. Models for the consortium include the Health Effectiveness Institute, the Centers for Education and Research on Therapeutics, and the Transportation Research Board.

Clinical Competence↗
PubMed2004

Clinical research in the United States at a crossroads: proposal for a novel public-private partnership to establish a national clinical research enterprise.

The clinical research infrastructure of the United States is currently at a critical crossroads. To leverage the enormous biomedical research gains made in the past century efficiently, a drastic need exists to reengineer this system into a coordinated, safe, and more efficient and effective enterprise. To accomplish this task, clinical research must be transformed from its current state as a cottage industry to an enterprise-wide health care pipeline whose function is to bring the novel research from both government and private entities to the US public. We propose the establishment of a unique public-private partnership termed the National Clinical Research Enterprise (NCRE). Its agenda should consist of informed public participation, supportive information technologies, a skilled workforce, and adequate funding in clinical research. Devoting only 0.25% of the budgets from all health care stakeholders to support the NCRE would permit adequate funding to build the infrastructure required to address these problems in an enterprise fashion. All participants in the US health care delivery system must come together to focus on system-wide improvements that will benefit the public.

Academic Medical Centers↗
PubMed2004

Assessing teratogenicity of antiretroviral drugs: monitoring and analysis plan of the Antiretroviral Pregnancy Registry.

This paper describes the Antiretroviral Pregnancy Registry's (APR) monitoring and analysis plan. APR is overseen by a committee of experts in obstetrics, pediatrics, teratology, infectious diseases, epidemiology and biostatistics from academia, government and the pharmaceutical industry. APR uses a prospective exposure-registration cohort design. Clinicians voluntarily register pregnant women with prenatal exposures to any antiretroviral therapy and provide fetal/neonatal outcomes. A birth defect is any birth outcome > or = 20 weeks gestation with a structural or chromosomal abnormality as determined by a geneticist. The prevalence is calculated by dividing the number of defects by the total number of live births and is compared to the prevalence in the CDC's population-based surveillance system. Additionally, first trimester exposures, in which organogenesis occurs, are compared with second/third trimester exposures. Statistical inference is based on exact methods for binomial proportions. Overall, a cohort of 200 exposed newborns is required to detect a doubling of risk, with 80% power and a Type I error rate of 5%. APR uses the Rule of Three: immediate review occurs once three specific defects are reported for a specific exposure. The likelihood of finding three specific defects in a cohort of < or = 600 by chance alone is less than 5% for all but the most common defects. To enhance the assurance of prompt, responsible, and appropriate action in the event of a potential signal, APR employs the strategy of 'threshold'. The threshold for action is determined by the extent of certainty about the cases, driven by statistical considerations and tempered by the specifics of the cases.

Abnormalities, Drug-Induced↗
PubMed2004

Assessing the risk of birth defects associated with antiretroviral exposure during pregnancy.

OBJECTIVE: The purpose of this study was to examine teratogenic risk of antiretroviral (ARV) drugs. STUDY DESIGN: The Antiretroviral Pregnancy Registry (APR) monitors prenatal exposures to ARV drugs and pregnancy outcome through a prospective exposure-registration cohort. Statistical inference uses exact methods for binomial proportions. RESULTS: Through July 2003, APR has monitored 3583 live births exposed to ARV. Among 1391 first trimester exposures, there were 38 birth defects, prevalence of 2.7% (95% CI 1.9-3.7), not significantly higher than the CDC's population surveillance rate, 3.1 per 100 live births (95% CI 3.1-3.2). For lamivudine, nelfinavir, nevirapine, stavudine, and zidovudine, sufficient numbers of live births (>200) following first-trimester exposures have been monitored to allow detection of a 2-fold increase in risk of birth defects overall; no increases have been detected. CONCLUSION: APR data demonstrate no increase in prevalence of birth defects overall or among women exposed to lamivudine, nelfinavir, nevirapine, stavudine, and zidovudine.

Abnormalities, Drug-Induced↗
PubMed2004

The public health workforce.

The development of a fully-competent public health workforce as a key component of the nation's public health infrastructure has become the focus of increasing attention. The subject is included in one, and is the major topic of a second, report from the Institute of Medicine published late in 2002. Workforce issues have stimulated the convening of the majority of public health-related associations in a range of collaborations on the subjects of defining, enumerating, credentialing, educating, and studying the workforce. The authors review the major questions confronting the field and introduce key components of current thinking about approaches to improvement.

Disaster Planning↗
PubMed2003

Central challenges facing the national clinical research enterprise.

Medical scientists and public health policy makers are increasingly concerned that the scientific discoveries of the past generation are failing to be translated efficiently into tangible human benefit. This concern has generated several initiatives, including the Clinical Research Roundtable at the Institute of Medicine, which first convened in June 2000. Representatives from a diverse group of stakeholders in the nation's clinical research enterprise have collaborated to address the issues it faces. The context of clinical research is increasingly encumbered by high costs, slow results, lack of funding, regulatory burdens, fragmented infrastructure, incompatible databases, and a shortage of qualified investigators and willing participants. These factors have contributed to 2 major obstacles, or translational blocks: impeding the translation of basic science discoveries into clinical studies and of clinical studies into medical practice and health decision making in systems of care. Considering data from across the entire health care system, it has become clear that these 2 translational blocks can be removed only by the collaborative efforts of multiple system stakeholders. The goal of this article is to articulate the 4 central challenges facing clinical research at present--public participation, information systems, workforce training, and funding; to make recommendations about how they might be addressed by particular stakeholders; and to invite a broader, participatory dialogue with a view to improving the overall performance of the US clinical research enterprise.

Biomedical Research↗
PubMed2003

Improving the US health care system: action plan to enhance efficiency, reduce errors, and improve quality.

The decisions made by stakeholders in the nation's health care system that affect the quality of care experienced by patients are too often made without the benefit of scientific evidence. A multidisciplinary set of investigators conducting health services research have traditionally filled this gap between research findings and clinical decision making, but several barriers are hindering this work. This article offers several recommendations-restructuring organizations, ensuring funding, developing infrastructure, strengthening the community of researchers, and forging new links among stakeholders-to promote high-quality information for health decision makers.

Biomedical Research↗
PubMed2002

Birth defect classification by organ system: a novel approach to heighten teratogenic signalling in a pregnancy registry.

The Antiretroviral Pregnancy Registry (APR) is an ongoing international prospective exposure-registration cohort study that monitors outcomes of pregnancies exposed to marketed antiretroviral medications. The population of women exposed to antiretrovirals remains relatively small, which limits the power of the registry. In order to maximize identification of a teratogenic signal, a special birth defect classification system was devised. Birth defects were organized based upon organ system and embryology, using the Metropolitan Atlanta Congenital Defects Program as a model. Grouping defects that share embryology and pathogenesis increases the likelihood that a teratogenic effect will be apparent. The result is a three-tiered system: organ system, preferred defect term, and reported defect term. This system is text based, which eliminates the need to memorize codes and allows use by anyone familiar with medical terminology. Once established, the new APR Organ System Classification retains enough flexibility that categories may be collapsed or expanded as experience grows. Standardized nomenclature also minimizes variation introduced by collecting defect reports from many different sources.

Abnormalities, Drug-Induced↗
PubMedDate not supplied

Regulatory issues for health-related quality of life--PhRMA Health Outcomes Committee workshop, 1999.

INTRODUCTION: Health-related quality-of-life (HRQL) can be defined as the impact of disease and treatment across the physical, psychological, social and somatic domains of functioning and well-being. Health-related quality-of-life measures are included in clinical trials of drug treatment to assess the impact of therapy on the patient's functioning. HRQL guidance could allow for use of this data in drug labeling and promotion. OBJECTIVES: The aim of our study was to provide recommendations with respect to regulatory issues important to the development of guidelines for HRQL research. METHODS: The HRQL workshop was planned jointly by members of the Pharmaceutical Research and Manufacturers of America Health Outcomes Committee and the Division of Drug Marketing, Advertising, and Communications of the Food and Drug Administration. The workshop was limited to six regulatory issues related to HRQL research in clinical trials of pharmaceutical therapies. These six issues were: instrument selection and validation, study design, data analysis, HRQL and safety, clinical meaning, and promotional use. Before the meeting, a consensus was reached that HRQL does not measure, nor should it be used to measure, safety. Therefore, five work groups discussed HRQL issues and made recommendations. RESULTS: Overall, the workshop recommended that HRQL measures be treated as any other clinical end point. The workshop recognized that research in HRQL methods is ongoing and that any guidance should be flexible to allow for changes in this developing research area. CONCLUSIONS: HRQL provides a patient perspective on the impact of disease and therapy on patients' daily life and functioning. Including HRQL information in promotion could be beneficial to decision making on the use of therapies. HRQL is a measure of effectiveness, not safety, and should be treated as any other clinical end point.

Clinical Trials as Topic↗
PubMedDate not supplied

A research agenda for public health workforce development.

In the past decades, public health research has focused on categorical rather than cross-cutting or systems issues. Little research has been carried out on the infrastructure required to support public health programs. This article describes the results of an interactive process to develop a research agenda for public health workforce development to inform all those with stakes in the public health system. This research is defined as a multidisciplinary field of inquiry, both basic and applied, that examines the workforce in terms of costs, quality, accessibility, delivery, organization, financing, and outcomes of public health services to increase knowledge and understanding of the relationships among workforce and structure, processes, and effects of public health services. A logic model and five priority research areas resulted from meetings of expert panels during 2000 to 2003. Innovative public and private partnerships will be required to advance cross-cutting and systems-focused research.

Health Services Research↗
PubMedDate not supplied

The public health enterprise: examining our twenty-first-century policy challenges.

This paper examines the public health enterprise and its policy challenges in the twenty-first century. Among the many challenges public health faces, we include here collaboration across a broad range of stakeholders, the public health infrastructure, agreement on public health's essential services, preparedness, accountability and measurement, workforce, and a research agenda. Two Institute of Medicine reports on the future of public health have set the context for a more in-depth review of the public health workforce and infrastructure. Policy advocates must ask, however, why, if the way and the means are so clear, the public health system is still in disarray.

Community Health Planning↗