A critical assessment of the National Institutes of Health Consensus Development Program against the eras which shaped it

This research study offers a critical assessment of NIH's Consensus Development Program (CDP), focusing upon its historical and valuative bases and its institutionalization in response to social and political forces. The analysis encompasses systems-level, as well as interpersonal factors in the adoption of consensus as the mechanism for resolving scientific controversies in clinical practice application. Further, the evolution of the CDP is also considered from an ecological perspective as a reasoned adaptation by NIH to pressures from its supporters and clients for translating biomedical research into medical practice. The assessment examines federal science policy and institutional designs for the inclusion of the public interest and democratic deliberation.^ The study relies on three distinct approaches to social research. Conventional historical methods were utilized in the interpretation of social and political influences across eras on the evolution of the National Institutes of Health and its response to demands for accountability and relevance through its Consensus Development Program. An embedded single-case study was utilized for an empirical examination of the CDP mechanism through five exemplar conferences. Lastly, a sociohistorical approach was taken to the CDP in order to consider its responsiveness to the values of the eras which created and shaped it. An exploration of organizational behavior with considerations for institutional reform as a response to continuing political and social pressure, it is a study of organizational birth, growth, and response to demands from its environment. The study has explanatory import in its attempt to account for the creation, timing, and form of the CDP, relative to political, institutional, and cultural pressures, and predictive import thorough its historical view which provides a basis for informed speculation on the playing out of tensions between extramural and intermural scientists and the current demands for health care reform. ^

Addressing Obesity: Fear of Crime, Perceptions of Disorder and Disaparities in Child and Adolescent Use of Public Parks

Abstract The objectives of this study were: 1) To determine factors which inhibit and facilitate child and adolescent use of outdoor spaces for healthy physical activity by race and ethnicity in four Houston communities and 2) To propose guidelines for encouraging and maintaining child and adolescent outdoor physical activity. Using local health data and Houston Police Department crime statistics, four communities were identified for the study that had the highest concentration of crime and the racial/ ethnic groups of interest. The researchers then identified public parks in the communities. At least two parks were observed in each of the four communities from 2010 to 2011 during spring, summer, fall and winter. The parks were observed for use by children and adolescents and to describe the condition of the park spaces. The communities were Alief (Asian), Sunnyside (Black), Eldridge- West Oaks (White) and Northside- Northline (Hispanic). Observations were made at varying hours of both day and night, weekdays and weekends. Photographs were taken and the condition of the spaces noted in detail. One hundred and twenty persons, 18 years and over, using the spaces or otherwise in these communities were conveniently sampled and interviewed about their health and the extent to which they, or any children or adolescents under their care, used the outdoor spaces of interest. Data were analyzed qualitatively and with basic descriptive statistics. The photographs, journal notes and observation notes of all investigators and key personnel were analyzed. Interview data were also coded to identify patterns and themes in the responses. The findings indicate disparities in the quality and quantity of park equipment and the maintenance of the areas. Where perceptions of disorder were described, there was often visible evidence to support the perceptions. In many cases, residents' perceptions of crime were corroborated by police data. While interview reports did not seem to support the expectation that the condition of the parks was a significant deterrent to their use by children and adolescents, the condition of the parks might be said to limit the extent of that use. Specific reports of disorder that inhibited use included hearing gunfire, seeing drug dependent homeless persons and/or suspected prostitutes in an area.

Culture and the social context of health inequalities

There has been a great deal of interest and debate recently concerning the linkages between inequality and health cross-nationally. Exposures to social and health inequalities likely vary as a consequence of different cultural contexts. It is important to guide research by a theoretical perspective that includes cultural and social contexts cross-nationally. If inequality affects health only under specific cultural conditions, this could explain why some of the literature that compares different societies finds no evidence of a relationship between inequality and health in certain countries. A theoretical framework is presented that combines sociological theory with constructs from cultural psychology in order to identify pathways that might lead from cultural dimensions to health inequalities. Three analyses are carried out. The first analysis explores whether there is a relationship between cultural dimensions at the societal level and self-rated health at the individual level. The findings suggest that different cultural norms at the societal level can produce both social and health inequalities, but the effects on health may differ depending on the socio-cultural context. The second analysis tests the hypothesis that health is affected by the density of social networks in a society, levels of societal trust, and inequality. The results suggest that commonly used measures of social cohesion and inequality may have both contextual and compositional effects on health in a large number of countries, and that societal measures of social cohesion and inequality interact with individual measures of social participation, trust, and income, moderating their effects on health. The third analysis explores whether value systems associated with vertical individualist societies may lead to health disparities because of their stigmatizing effects. I test the hypothesis that, within vertical individualist societies, subjective well-being will be affected by a social context where competition and the Protestant work ethic are valued, mediated by inequality. The hypothesis was not supported by the available cross-national data, most likely because of inadequate measures, missing data, and the small sample of vertical individualist countries. The overall findings demonstrate that cultural differences are important contextual factors that should not be overlooked when examining the causes of health inequalities. ^

Racial disparities in CD4 counts at initial HIV-1 diagnosis: Analysis of the Adult Spectrum of HIV disease dataset and public health implications

Introduction. The HIV/AIDS disease burden disproportionately affects minority populations, specifically African Americans. While sexual risk behaviors play a role in the observed HIV burden, other factors including gender, age, socioeconomics, and barriers to healthcare access may also be contributory. The goal of this study was to determine how far down the HIV/AIDS disease process people of different ethnicities first present for healthcare. The study specifically analyzed the differences in CD4 cell counts at the initial HIV-1 diagnosis with respect to ethnicity. The study also analyzed racial differences in HIV/AIDS risk factors. ^ Methods. This is a retrospective study using data from the Adult Spectrum of HIV Disease (ASD), collected by the City of Houston Department of Health. The ASD database contains information on newly reported HIV cases in the Harris County District Hospitals between 1989 and 2000. Each patient had an initial and a follow-up report. The extracted variables of interest from the ASD data set were CD4 counts at the initial HIV diagnosis, race, gender, age at HIV diagnosis and behavioral risk factors. One-way ANOVA was used to examine differences in baseline CD4 counts at HIV diagnosis between racial/ethnic groups. Chi square was used to analyze racial differences in risk factors. ^ Results. The analyzed study sample was 4767. The study population was 47% Black, 37% White and 16% Hispanic [p<0.05]. The mean and median CD4 counts at diagnosis were 254 and 193 cells per ml, respectively. At the initial HIV diagnosis Blacks had the highest average CD4 counts (285), followed by Whites (233) and Hispanics (212) [p<0.001 ]. These statistical differences, however, were only observed with CD4 counts above 350 [p<0.001], even when adjusted for age at diagnosis and gender [p<0.05]. Looking at risk factors, Blacks were mostly affected by intravenous drug use (IVDU) and heterosexuality, whereas Whites and Hispanics were more affected by male homosexuality [ p<0.05]. ^ Conclusion. (1) There were statistical differences in CD4 counts with respect to ethnicity, but these differences only existed for CD4 counts above 350. These differences however do not appear to have clinical significance. Antithetically, Blacks had the highest CD4 counts followed by Whites and Hispanics. (2) 50% of this study group clinically had AIDS at their initial HIV diagnosis (median=193), irrespective of ethnicity. It was not clear from data analysis if these observations were due to failure of early HIV surveillance, HIV testing policies or healthcare access. More studies need to be done to address this question. (3) Homosexuality and bisexuality were the biggest risk factors for Whites and Hispanics, whereas for Blacks were mostly affected by heterosexuality and IVDU, implying a need for different public health intervention strategies for these racial groups. ^

A systematic review of economic evaluations for interventions of cardiovascular diseases

Background. Cardiovascular disease (CVD) exhibits the most striking public health significance due to its high prevalence and mortality as well as huge economic burdens all over the world, especially in industrialized countries. Major risk factors of CVDs have been the targets of population-wide prevention in the United States. Economic evaluations provide structured information in regard to the efficiency of resource utilization which can inform decisions of resource allocation. The main purpose of this review is to investigate the pattern of study design of economic evaluations for interventions of CVDs. ^ Methods. Primary journal articles published during 2003-2008 were systematically retrieved via relevant keywords from Medline, NHS Economic Evaluation Database (NHS EED) and EBSCO Academic Search Complete. Only full economic evaluations for narrowly defined CVD interventions were included for this review. The methodological data of interest were extracted from the eligible articles and reorganized in Microsoft Access database. Chi-square tests in SPSS were used to analyze the associations between pairs of categorical data. ^ Results. One hundred and twenty eligible articles were reviewed after two steps of literature selection with explicit inclusion and exclusion criteria. Descriptive statistics were reported regarding the evaluated interventions, outcome measures, unit costing and cost reports. The chi-square test of the association between prevention level of intervention and category of time horizon showed no statistical significance. The chi-square test showed that sponsor type was significantly associated with whether new or standard intervention being concluded as more cost effective. ^ Conclusions. Tertiary prevention and medication interventions are the major interests for economic evaluators. The majority of the evaluations were claimed from either a provider’s or a payer’s perspective. Almost all evaluations adopted gross costing strategy for unit cost data rather than micro costing. EQ-5D is the most commonly used instrument for subjective outcome measurement. More than half of the evaluations used decision analytic modeling techniques. The lack of consistency in study design standards in published evaluations appears in several aspects. Prevention level of intervention is not likely to be a factor for evaluators to decide whether to design an evaluation in a lifetime horizon or not. Published evaluations sponsored by industry are more likely to conclude that new intervention is more cost effective than standard intervention.^

Determinants of CD4 cell count decline after treatment interruption

Patients who had started HAART (Highly Active Anti-Retroviral Treatment) under previous aggressive DHHS guidelines (1997) underwent a life-long continuous HAART that was associated with many short term as well as long term complications. Many interventions attempted to reduce those complications including intermittent treatment also called pulse therapy. Many studies were done to study the determinants of rate of fall in CD4 count after interruption as this data would help guide treatment interruptions. The data set used here was a part of a cohort study taking place at the Johns Hopkins AIDS service since January 1984, in which the data were collected both prospectively and retrospectively. The patients in this data set consisted of 47 patients receiving via pulse therapy with the aim of reducing the long-term complications. ^ The aim of this project was to study the impact of virologic and immunologic factors on the rate of CD4 loss after treatment interruption. The exposure variables under investigation included CD4 cell count and viral load at treatment initiation. The rates of change of CD4 cell count after treatment interruption was estimated from observed data using advanced longitudinal data analysis methods (i.e., linear mixed model). Using random effects accounted for repeated measures of CD4 per person after treatment interruption. The regression coefficient estimates from the model was then used to produce subject specific rates of CD4 change accounting for group trends in change. The exposure variables of interest were age, race, and gender, CD4 cell counts and HIV RNA levels at HAART initiation. ^ The rate of fall of CD4 count did not depend on CD4 cell count or viral load at initiation of treatment. Thus these factors may not be used to determine who can have a chance of successful treatment interruption. CD4 and viral load were again studied by t-tests and ANOVA test after grouping based on medians and quartiles to see any difference in means of rate of CD4 fall after interruption. There was no significant difference between the groups suggesting that there was no association between rate of fall of CD4 after treatment interruption and above mentioned exposure variables. ^

Integrated pest management in multi-story public housing for the elderly in Houston, Texas

Integrated pest management is a viable alternative to traditional pest control methods. A paired sample design was utilized to measure the effect of IPM education on the number of cockroaches in a 200 unit, seven story public housing building for the elderly in Houston, TX. Glue traps were placed in 71 randomly selected apartments (5traps/unit) and left in place for two nights. Baseline cockroach counts were shared with the property manager, maintenance/janitorial staff, service coordinator, pest control professional and tenant representatives at the end of a one day “Integrated Pest Management in Multi-Family Housing” training course.^ There was a significant decrease in the average number of cockroaches after IPM education and implementation of IPM principles (P < 0.0003). Positive changes in behavior by members of the IPM team and changes in the housing authority operational plan were also found. Paired t-tests comparing the difference between mean cockroach counts at baseline and follow-up by location within the apartment all demonstrated a significant decrease in the number of cockroaches.^ Results supported the premise that IPM education and the implementation of IPM principles are effective measures to change pest control behaviors and control cockroaches. Cockroach infestations in multi-story housing are not solely determined by the actions of individual tenants. The actions of other residents, property managers and pest control professionals are also important factors in pest control.^ Findings support the implementation of IPM education and the adoption of IPM practices by public housing authorities. This study adds to existing evidence that clear communication of policies, a team approach and a commitment to ongoing inspection and monitoring of pests combined with corrective action to eliminate food, water and harborage and the judicial use of low risk pesticides have the potential to improve the living conditions of elderly residents living in public housing.^

Introduction to disaster epidemiology for public health personnel

There has been a renewed interest in disaster epidemiology after the World Trade Center and Pentagon terrorist attacks of 2001, the devastation of Hurricane Katrina and the overwhelming loss of life that resulted from the tsunami that originated in the Indian Ocean and struck Indonesia and other adjacent countries on December 26, 2004. Institutions that have accepted the challenge of training the next generation of public health professionals as well as to continue the education of the dedicated professionals already serving in public health fields have a responsibility to train practitioners in the basic principles of disaster epidemiology as well as in practical applications of these principles. This culminating experience project involved developing an on-line course complete with the background information as well as relevant case studies that can be used as a curriculum for an introductory course in disaster epidemiology. ^

Evaluation of a wellness program at a large private sector petrochemical company in Texas

The study purpose was to analyze the effects Integrated Health Solutions (IHS), an employee wellness program that has been implemented for one year on the corporate campus of a major private sector petrochemical company in Houston, TX, has on employee health. ^ Chronic diseases are the leading causes of morbidity and mortality in the United States and are the most preventable of all health problems. The costs of chronic diseases in the working-age adult population include not only health problems and a decrease in quality of life, but also an increase the cost of health care and costs to businesses and employers, both directly and indirectly. These emerging costs to employers as well as the fact that adults now spend the majority of waking hours at the office have increased the interest in worksite health promotion programs that address many of the behavioral factors that lead to chronic conditions. Therefore, implementing and evaluating programs that are aimed at promoting health and decreasing the prevalence of chronic diseases at worksites is very important. ^ Data came from existing data that were collected by IHS staff during employee biometric screenings at the company in 2010 and 2011. Data from employees who participated in screenings in both 2010 and 2011 were grouped into a cohort by IHS staff. ^ One-tailed t-tests were conducted to determine if there were significant improvements in the biometric measures of body fat percentage, BMI, waist circumference, systolic and diastolic blood pressures, total, HDL, and LDL cholesterol levels, triglycerides, blood glucose levels, and cardiac risk ratios. Sensitivity analysis was conducted to determine if there were differences in program outcomes when stratified by age, gender, job type, and time between screenings. ^ Mean differences for the variables from 2010 to 2011 were small and not always in the desired direction for health improvement indicators. Through conducting t-tests, it was found that there were significant improvements in HDL, cardiac risk ratio, and glucose levels. There were significant increases in cholesterol, LDL, and diastolic blood pressures. For the IHS program, it appears that gender, job type, and time between screenings were possible modifiers of program effectiveness. When program outcome measures were stratified by these factors, results suggest that corporate employees had better outcomes than field employees, males had better outcomes overall than females, and more positive program effects were seen for employees with less time between their two screenings. ^ Recommendations for the program based on the results include ensuring validity of instruments and initial and periodic training of measurement procedures and equipment handling, using normative data or benchmarks to decrease chances for biased estimates of program effectiveness, measuring behaviors as well as biometric and physiologic statuses and changes, and collecting level of engagement data.^

Patenting genes and gene sequences: Analysis of public health implications and the law

At issue is whether or not isolated DNA is patent eligible under the U.S. Patent Law and the implications of that determination on public health. The U.S. Patent and Trademark Office has issued patents on DNA since the 1980s, and scientists and researchers have proceeded under that milieu since that time. Today, genetic research and testing related to the human breast cancer genes BRCA1 and BRCA2 is conducted within the framework of seven patents that were issued to Myriad Genetics and the University of Utah Research Foundation between 1997 and 2000. In 2009, suit was filed on behalf of multiple researchers, professional associations and others to invalidate fifteen of the claims underlying those patents. The Court of Appeals for the Federal Circuit, which hears patent cases, has invalidated claims for analyzing and comparing isolated DNA but has upheld claims to isolated DNA. The specific issue of whether isolated DNA is patent eligible is now before the Supreme Court, which is expected to decide the case by year's end. In this work, a systematic review was performed to determine the effects of DNA patents on various stakeholders and, ultimately, on public health; and to provide a legal analysis of the patent eligibility of isolated DNA and the likely outcome of the Supreme Court's decision. ^ A literature review was conducted to: first, identify principle stakeholders with an interest in patent eligibility of the isolated DNA sequences BRCA1 and BRCA2; and second, determine the effect of the case on those stakeholders. Published reports that addressed gene patents, the Myriad litigation, and implications of gene patents on stakeholders were included. Next, an in-depth legal analysis of the patent eligibility of isolated DNA and methods for analyzing it was performed pursuant to accepted methods of legal research and analysis based on legal briefs, federal law and jurisprudence, scholarly works and standard practice legal analysis. ^ Biotechnology, biomedical and clinical research, access to health care, and personalized medicine were identified as the principle stakeholders and interests herein. Many experts believe that the patent eligibility of isolated DNA will not greatly affect the biotechnology industry insofar as genetic testing is concerned; unlike for therapeutics, genetic testing does not require tremendous resources or lead time. The actual impact on biomedical researchers is uncertain, with greater impact expected for researchers whose work is intended for commercial purposes (versus basic science). The impact on access to health care has been surprisingly difficult to assess; while invalidating gene patents might be expected to decrease the cost of genetic testing and improve access to more laboratories and physicians' offices that provide the test, a 2010 study on the actual impact was inconclusive. As for personalized medicine, many experts believe that the availability of personalized medicine is ultimately a public policy issue for Congress, not the courts. ^ Based on the legal analysis performed in this work, this writer believes the Supreme Court is likely to invalidate patents on isolated DNA whose sequences are found in nature, because these gene sequences are a basic tool of scientific and technologic work and patents on isolated DNA would unduly inhibit their future use. Patents on complementary DNA (cDNA) are expected to stand, however, based on the human intervention required to craft cDNA and the product's distinction from the DNA found in nature. ^ In the end, the solution as to how to address gene patents may lie not in jurisprudence but in a fundamental change in business practices to provide expanded licenses to better address the interests of the several stakeholders. ^