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Biomedical subjects

H V Fineberg

Publications and source records attributed to H V Fineberg.

At least 19 recordsLinked to original sources

The efficacy of bacillus Calmette-Guérin vaccination of newborns and infants in the prevention of tuberculosis: meta-analyses of the published literature.

OBJECTIVE: To quantify the efficacy of vaccination of infants with bacillus Calmette-Guérin (BCG) against tuberculosis. DATA SOURCES: MEDLINE with index terms BCG vaccine, tuberculosis, and human; lists of all known studies provided by experts at the Centers for Disease Control and Prevention, the World Health Organization, and other organizations. STUDY SELECTION: A total of 1264 articles and abstracts were reviewed for details on BCG vaccination, the availability of concurrent vaccinated and unvaccinated groups, and a tuberculosis outcome. Seventy articles were reviewed in depth for method of vaccine allocation used to create comparable groups, age at vaccination of study participants, comparability of surveillance and follow-up of recipient and concurrent control groups in trials, an appropriately defined control group in case-control studies, and outcome measures (tuberculosis cases and/or deaths). Five prospective trials and eleven case-control studies of vaccination during infancy were included in the present analyses. DATA EXTRACTION: We recorded study design, age range of study population, number of patients enrolled, efficacy of vaccine, location of the study, and a series of items to assess the potential for bias in study design, follow-up, and diagnosis. We extracted or computed vaccine efficacy by years since vaccination wherever possible. At least two readers independently extracted data and evaluated data validity. DATA SYNTHESIS: The relative risk (RR) or odds ratio (OR) for tuberculosis in vaccinated versus unvaccinated infants was the measure of vaccine efficacy analyzed. A random-effects method estimated a weighted average RR or OR from data extracted from the trials and case-control studies. The protective effect was then computed by 1-RR or 1-OR. Overall, the protective effect of vaccination against cases of tuberculosis was 0.74 (95% confidence interval [95% CI], 0.62 to 0.83) when estimated from four randomized controlled trials, and 0.52 (95% CI, 0.38 to 0.64) when estimated from nine case-control studies. Five trials reporting deaths from tuberculosis showed a BCG protective effect of 0.65 (95% CI, 0.12 to 0.86), five studies reporting on meningitis showed a protective effect of 0.64 (95% CI, 0.30 to 0.82), and three studies of disseminated tuberculosis showed a protective effect of 0.78 (95% CI, 0.58 to 0.88). Three case-control studies included separate results for laboratory-confirmed cases of tuberculosis. These studies documented a protective effect of 0.83 (95% CI, 0.58 to 0.93). In a random-effects regression model of the nine case-control studies, study validity score explained 15% of the heterogeneity among study-estimated protective effects, suggesting that better studies reported greater efficacy. Three trials and six case-control studies provided some age-specific information that allowed us to examine the duration of BCG efficacy. Most of this evidence suggested that BCG efficacy may persist through 10 years after infant vaccination. CONCLUSION: BCG vaccination of newborns and infants significantly reduces the risk of tuberculosis--by over 50%, on average. Protection has been observed across many populations, study designs, and forms of tuberculosis. Rates of protection against cases that are confirmed by laboratory tests, reflecting reduced error in disease classification and consequently more accurate estimates of BCG efficacy, are highest at 83%.

BCG Vaccine

Adverse events following pertussis and rubella vaccines. Summary of a report of the Institute of Medicine.

In August 1991, the Institute of Medicine released a report entitled Adverse Effects of Pertussis and Rubella Vaccines, which examined 18 adverse events in relation to diphtheria-tetanus-pertussis (DTP) vaccine and four adverse events in relation to the currently used rubella vaccine strain, RA 27/3. The committee spent 20 months reviewing a wide range of information sources, including case series and individual case reports, both published and unpublished, epidemiologic studies, studies in animals, and other laboratory studies. The committee found that the evidence indicates a causal relation between DTP vaccine and anaphylaxis and between the pertussis component of DTP vaccine and extended periods of inconsolable crying or screaming. The committee also reported that the evidence indicates a causal relation between the rubella vaccine and acute arthritis in adult women. The committee found the available evidence weaker but still consistent with a causal relation between DTP vaccine and two conditions--acute encephalopathy and hypotonic, hyporesponsive episodes--and between rubella vaccine and chronic arthritis in adult women. Estimated incidence rates of these adverse events following vaccination are provided, where possible. The committee found that the evidence does not indicate a causal relation between the DTP vaccine and infantile spasms, hypsarrhythmia, Reye's syndrome, and sudden infant death syndrome. The committee found insufficient evidence to indicate either the presence or absence of a causal relation between DTP vaccine and chronic neurologic damage, aseptic meningitis, erythema multiforme or other rash, Guillain-Barré syndrome, hemolytic anemia, juvenile diabetes, learning disabilities and attention-deficit disorder, peripheral mononeuropathy, or thrombocytopenia, and between rubella vaccine and radiculoneuritis and other neuropathies or thrombocytopenic purpura. The committee's evaluative methods are briefly described and a summary of research needs is provided.

Acute Disease

Chronic arthritis after rubella vaccination.

In August 1991 the Institute of Medicine released a report entitled "Adverse Effects of Pertussis and Rubella Vaccines" that examined, among other relations, the relation between immunization with the RA 27/3 rubella vaccine strain and chronic arthritis. The committee spent 20 months reviewing a wide range of information sources including case series and individual case reports published in peer-reviewed journals and reported by vaccine manufacturers; unpublished case reports from physicians, parents, and other concerned persons; epidemiological studies; and laboratory studies. There were no animal studies available. The committee found that the evidence is consistent with a causal relation between the RA 27/3 rubella vaccine strain and chronic arthritis in adult women, although the evidence is limited in scope. Proving that rubella vaccination can cause chronic arthritis will require a better understanding of pathogenetic mechanisms and additional well-designed studies. We briefly describe the committee's evaluative methods and present the evidence underlying its conclusion.

Adult

Infections in HIV-infected travelers: risks and prevention.

OBJECTIVE: To review risks for infection and to outline strategies to protect the health of travelers infected with human immunodeficiency virus (HIV). DATA SOURCES: Original reports and summaries of the geographic distribution and frequency of infections as well as of special risks these infections impose on HIV-infected persons. The recommendations incorporate guidelines published by the Centers for Disease Control (CDC) and the World Health Organization. STUDY SELECTION: Sources containing the most recent, pertinent information. DATA SYNTHESIS: Infections of the gastrointestinal tract are common in all travelers to developing countries and are likely to be more frequent, severe, and difficult to treat in HIV-infected persons. Prominent among the respiratory tract infections that pose special risks to HIV-infected travelers are influenza, measles, and fungal infections with geographically focal distributions. The most common vector-borne infection, malaria, appears to present relatively little, if any, incremental risk to the HIV-infected traveler. Persons with HIV infection respond less vigorously to vaccines and have a higher frequency of adverse reactions to antimicrobial agents. Nevertheless, immunizations and chemoprophylaxis can reduce the risk for many travel-related infections. Additionally, there are protective measures that travelers can take to minimize exposure to pathogens. CONCLUSIONS: By understanding the risks for disease in different destinations, assessing patients' HIV status, counseling patients about travel plans and personal protective measures, appropriately using vaccines and chemoprophylaxis, as well as instituting early treatment of infection, physicians can help HIV-infected patients to preserve their health during travel.

Gastrointestinal Diseases

Bleach programs for preventing AIDS among i.v. drug users: modeling the impact of HIV prevalence.

BACKGROUND: The growing importance of drug use as a mode of HIV transmission has led to increased attention to AIDS prevention among intravenous drug users (IVDUs). This analysis examines the effectiveness of bleach distribution, a program to prevent HIV transmission via shared needles. METHODS: We used a Markov model to assess the role of the initial HIV prevalence among drug users in determining the effectiveness of bleach programs. The model incorporates survey data on risk behaviors and published information describing HIV incubation and mortality. It predicts life expectancy for cohorts of IVDUs with and without a bleach program to estimate program effectiveness. RESULTS: We found that bleach programs can produce the greatest life-year savings in areas of low HIV prevalence. In the lowest prevalence scenario (0.02 initial prevalence), initiation of the program resulted in a projected savings of 2.3 life years per HIV-negative drug user, compared with 1.7 and 1.3 years under medium (0.25) and high (0.60) prevalence, respectively. CONCLUSIONS: While bleach programs are beneficial in all groups of IVDUs, these results highlight the advantages of introducing bleach programs early, when prevalence is still comparatively low in a drug-user population.

Acquired Immunodeficiency Syndrome

Paying the medical cost of the HIV epidemic: a review of policy options.

The complex health care needs of people with HIV infection highlight inadequacies in our health care financing system and raise the question of how best to pay for care. AIDS requires a broad continuum of care to maintain high quality and reasonable costs. A simultaneous need is to assure access to care for patients with HIV infection who lack insurance or entitlement to health care benefits. We suggest new and practical payment mechanisms that can encourage the availability of comprehensive care for people with HIV infection. We suggest changes in state and federal payment policies that would make the cost of providing AIDS care more of a collective, community responsibility. We recommend mandated workplace insurance, extension of Medicaid eligibility to all with incomes below the federal poverty level, an opportunity for individuals with incomes to 200% of the poverty level to purchase Medicaid coverage, mechanisms to encourage public and private agencies to pay for continued health insurance after loss of employment, and a shortened waiting period for Medicare disability.

Acquired Immunodeficiency Syndrome

Estimating prevalence of HIV infection: considerations in the design and analysis of a national seroprevalence survey.

A national survey to estimate prevalence of HIV infection would provide a useful addition to available information about the current status and future prospects of the AIDS epidemic in the United States. Both design and interpretation of a prevalence study should make use of existing information about the biology and epidemiology of AIDS. In conjunction with such information, a survey would help increase the accuracy of prevalence estimates and aid in making projections, despite the possibility that participation rates will differ in infected and uninfected individuals.

Acquired Immunodeficiency Syndrome

Education to prevent AIDS: prospects and obstacles.

A number of obstacles thwart effective education to prevent AIDS in the United States. These include the biological basis and social complexity of the behaviors that must be changed, disagreement about the propriety of educational messages to prevent AIDS, uncertainty about the degree of risk to the majority of Americans, and dual messages of reassurance and alarm from responsible officials. Long-term protection of an individual from infection requires extreme changes in risk-taking behavior. Partial shifts toward safer practices may be epidemiologically important in retarding the rate and extent of spread of infection. Though some striking changes in behavior have occurred, especially in homosexual populations in areas with high prevalence of AIDS, educational efforts to date have succeeded more in raising awareness and knowledge about AIDS than in producing sufficient changes in behavior. The United States has yet to mount a nationwide comprehensive, intensive, and targeted education program to prevent AIDS.

Acquired Immunodeficiency Syndrome

Compulsory premarital screening for the human immunodeficiency virus. Technical and public health considerations.

The effectiveness of a mandatory premarital screening program was examined as a means of curtailing the spread of the human immunodeficiency virus (HIV) infection in the United States. The epidemiology of the HIV, the technical characteristics of tests for antibodies to HIV, and the logistic, economic, and legal implications of such a program were considered. In one year, universal premarital screening in the United States currently would detect fewer than one tenth of 1% of HIV-infected individuals at a cost of substantially more than +100 million. More than 100 infected individuals would be told that they were probably not infected, and there would likely be more than 350 false-positive results. Public education, counseling of individuals, and discretionary testing can be important tools in reducing the spread of HIV infection, but mandatory premarital screening in a population with a low prevalence of infection is a relatively ineffective and inefficient use of resources.

Acquired Immunodeficiency Syndrome

A cost-effectiveness model for coronary thrombolysis/reperfusion therapy.

A model was designed to examine the relations between incremental costs and benefits of coronary thrombolysis/reperfusion therapy. The model allows for the study of intravenous and intracoronary streptokinase, intravenous tissue plasminogen activator and primary angioplasty. Three strategies for the management of reocclusion are also compared. It was found that each of the following four variables can be responsible for a 2- to 15-fold variation in the costs per additional survivor: 1) the quantity of jeopardized myocardium, 2) the duration of coronary occlusion before the onset of therapy, 3) the time required from the onset of therapy until reperfusion is achieved, and 4) the reocclusion management strategy. Therapeutic strategies involving intravenous administration of thrombolytic agents were found to be consistently more cost effective than were strategies involving intracoronary administration of thrombolytic agents and primary angioplasty. In patients with a large or moderate-sized infarct, proper selection of intravenous protocols and reocclusion management strategies leads to costs of $7,000 to $100,000/additional survivor, costs that are similar to those of many generally accepted medical practices. Substantially higher costs per additional survivor are incurred with the routine use of thrombolytic therapy in patients with a small infarct or the routine use of coronary artery bypass surgery to reduce the risk of reocclusion after successful thrombolytic therapy. Decisions regarding which patients should receive thrombolysis/reperfusion therapy depend on society's willingness to pay for its incremental benefits.

Angioplasty, Balloon

Clinical evaluation: how does it influence medical practice?

This paper reviews reports of the effects of clinical evaluations on physician awareness and behavior. Among the reviewed papers, there are 28 studies of the effect of specific randomized clinical trials (RCTs) on 19 different medical practices. After analyzing these 28 papers, there remain two (7%) where the RCT has clear implications for practice, where the pattern of practice reported quantitatively over time conforms fully to the RCT findings, where the RCT preceded the change in the pattern of practice, and where findings from the RCT differ from the results of other forms of evaluation. The majority of the reviewed papers do not support an inference that RCTs have a strong, direct influence in changing established clinical practices. Clinical evaluation is one among many factors bearing on changes in medical practices. Improving the care of patients requires both improved methods of evaluation and more effective translation of the results of evaluation into practice. Evaluations are likely to exert a greater impact on medical practices if they are buttressed by attention to other controllable factors, like channels of communication and environmental constraints and incentives, that affect the adoption and abandonment of medical practices.

Awareness