Revising the National Ambient Air Quality Standards: The integration of science and policy

Under the Clean Air Act, Congress granted discretionary decision making authority to the Administrator of the Environmental Protection Agency (EPA). This discretionary authority involves setting standards to protect the public's health with an "adequate margin of safety" based on current scientific knowledge. The Administrator of the EPA is usually not a scientist, and for the National Ambient Air Quality Standard (NAAQS) for particulate matter (PM), the Administrator faced the task of revising a standard when several scientific factors were ambiguous. These factors included: (1) no identifiable threshold below which health effects are not manifested, (2) no biological basis to explain the reported associations between particulate matter and adverse health effects, and (3) no consensus among the members of the Clean Air Scientific Advisory Committee (CASAC) as to what an appropriate PM indicator, averaging period, or value would be for the revised standard. ^ This project recommends and demonstrates a tool, integrated assessment (IA), to aid the Administrator in making a public health policy decision in the face of ambiguous scientific factors. IA is an interdisciplinary approach to decision making that has been used to deal with complex issues involving many uncertainties, particularly climate change analyses. Two IA approaches are presented; a rough set analysis by which the expertise of CASAC members can be better utilized, and a flag model for incorporating the views of stakeholders into the standard setting process. ^ The rough set analysis can describe minimal and maximal conditions about the current science pertaining to PM and health effects. Similarly, a flag model can evaluate agreement or lack of agreement by various stakeholder groups to the proposed standard in the PM review process. ^ The use of these IA tools will enable the Administrator to (1) complete the NAAQS review in a manner that is in closer compliance with the Clean Air Act, (2) expand the input from CASAC, (3) take into consideration the views of the stakeholders, and (4) retain discretionary decision making authority. ^

Perinatal mortality and quality of care at the National Institute of Perinatology: A 3-year analysis

Quality of medical care has been indirectly assessed through the collection of negative outcomes. A preventable death is one that could have been avoided if optimum care had been offered. The general objective of the present project was to analyze the perinatal mortality at the National Institute of Perinatology (located in Mexico City) by social, biological and some available components of quality of care such as avoidability, provider responsibility, and structure and process deficiencies in the delivery of medical care. A Perinatal Mortality Committee data base was utilized. The study population consisted of all singleton perinatal deaths occurring between January 1, 1988 and June 30, 1991 (n = 522). A proportionate study was designed.^ The population studied mostly corresponded to married young adult mothers, who were residents of urban areas, with an educational level of junior high school or more, two to three pregnancies, and intermediate prenatal care. The mean gestational age at birth was 33.4 $\pm$ 3.9 completed weeks and the mean birthweight at birth was 1,791.9 $\pm$ 853.1 grams.^ Thirty-five percent of perinatal deaths were categorized as avoidable. Postnatal infection and premature rupture of membranes were the most frequent primary causes of avoidable perinatal death. The avoidable perinatal mortality rate was 8.7 per 1000 and significantly declined during the study period (p $<$.05). Preventable perinatal mortality aggregated data suggested that at least part of the mortality decline for amenable conditions was due to better medical care.^ Structure deficiencies were present in 35% of avoidable deaths and process deficiencies were present in 79%. Structure deficiencies remained constant over time. Process deficiencies consisted of diagnosis failures (45.8%) and treatment failures (87.3%), they also remained constant through the years. Party responsibility was as follows: Obstetric (35.4%), pediatric (41.4%), institutional (26.5%), and patient (6.6%). Obstetric responsibility significantly increased during the study period (p $<$.05). Pediatric responsibility declined only for newborns less than 1500 g (p $<$.05). Institutional responsibility remained constant.^ Process deficiencies increased the risk for an avoidable death eightfold (confidence interval 1.7-41.4, p $<$.01) and provider responsibility ninety-fivefold (confidence interval 14.8-612.1, p $<$.001), after adjustment for several confounding variables. Perinatal mortality due to prematurity, barotrauma and nosocomial infection, was highly preventable, but not that due to transpartum asphyxia. Once specific deficiencies in the quality of care have been identified, quality assurance actions should begin. ^

Cataract surgery in cancer patients and its impact on quality of life as measured by the National Eye Institute Visual Functioning Questionnaire - 25 (NEI-VFQ-25)

Purpose. The measurement of quality of life has become an important topic in healthcare and in the allocation of limited healthcare resources. Improving the quality of life (QOL) in cancer patients is paramount. Cataract removal and lens implantation appears to improve patient well-being of cancer patients, though a formal measurement has never been published in the US literature. In this current study, National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25), a validated vision quality of life metric, was used to study the change in vision-related quality of life in cancer patients who underwent cataract extraction with intraocular lens implantation. ^ Methods. Under an IRB approved protocol, cancer patients who underwent cataract surgery with intraocular lens implantation (by a single surgeon) from December 2008 to March 2011, and who had completed a pre- and postoperative NEI-VFQ-25 were retrospectively reviewed. Post-operative data was collected at their routine 4-6 week post-op visit. Patients' demographics, cancer history, their pre and postoperative ocular examinations, visual acuities, and NEI-VFQ-25 with twelve components were included in the evaluation. The responses were evaluated using the Student t test, Spearman correlation and Wilcoxon signed rank test. ^ Results. 63 cases of cataract surgery (from 54 patients) from the MD Anderson Cancer Center were included in the study. Cancer patients had a significant improvement in the visual acuity (P<0.0001) postoperatively, along with a significant increase in vision-related quality of life (P<0.0001). Patients also had a statistically significant improvement in ten of the twelve subcategories which are addressed in the NEI-VFQ-25. ^ Conclusions. In our study, cataract extraction and intraocular implantation showed a significant impact on the vision-related quality of life in cancer patients. Although this study includes a small sample size, it serves as a positive pilot study to evaluate and quantify the impact of a surgical intervention on QOL in cancer patients and may help to design a larger study to measure vision related QOL per dollar spent for health care cost in cancer patients.^

BENCHMARKING AND IMPLEMENTATION OF A NEW INDEPENDENT MONTE CARLO DOSE CALCULATION QUALITY ASSURANCE AUDIT TOOL FOR CLINICAL TRIALS

Introduction Commercial treatment planning systems employ a variety of dose calculation algorithms to plan and predict the dose distributions a patient receives during external beam radiation therapy. Traditionally, the Radiological Physics Center has relied on measurements to assure that institutions participating in the National Cancer Institute sponsored clinical trials administer radiation in doses that are clinically comparable to those of other participating institutions. To complement the effort of the RPC, an independent dose calculation tool needs to be developed that will enable a generic method to determine patient dose distributions in three dimensions and to perform retrospective analysis of radiation delivered to patients who enrolled in past clinical trials. Methods A multi-source model representing output for Varian 6 MV and 10 MV photon beams was developed and evaluated. The Monte Carlo algorithm, know as the Dose Planning Method (DPM), was used to perform the dose calculations. The dose calculations were compared to measurements made in a water phantom and in anthropomorphic phantoms. Intensity modulated radiation therapy and stereotactic body radiation therapy techniques were used with the anthropomorphic phantoms. Finally, past patient treatment plans were selected and recalculated using DPM and contrasted against a commercial dose calculation algorithm. Results The multi-source model was validated for the Varian 6 MV and 10 MV photon beams. The benchmark evaluations demonstrated the ability of the model to accurately calculate dose for the Varian 6 MV and the Varian 10 MV source models. The patient calculations proved that the model was reproducible in determining dose under similar conditions described by the benchmark tests. Conclusions The dose calculation tool that relied on a multi-source model approach and used the DPM code to calculate dose was developed, validated, and benchmarked for the Varian 6 MV and 10 MV photon beams. Several patient dose distributions were contrasted against a commercial algorithm to provide a proof of principal to use as an application in monitoring clinical trial activity.

Content of prenatal care and spontaneous preterm birth: Findings from the 1988 National Maternal and Infant Health Survey

The purposes of this study were to examine (1) the relationship between selected components of the content of prenatal care and spontaneous preterm birth; and (2) the degree of comparability between maternal and caregivers' responses regarding the number of prenatal care visits, selected components of the content of prenatal care, and gestational age, based on analyses of the 1988 National Maternal and Infant Health Survey conducted by the National Centers for Health Statistics. Spontaneous preterm birth was subcategorized into very preterm and moderately preterm births, with term birth as the controls. The study population was limited to non-Hispanic Anglo- and African-American mothers. The racial differences in terms of birth outcomes were also compared.^ This study concluded that: (1) there was not a high degree of comparability (less than 80%) between maternal and prenatal care provider's responses regarding the number of prenatal care visits and the content of prenatal care; (2) there was a low degree of comparability (less than 50%) between maternal and infant's hospital of delivery responses regarding gestational age at birth; (3) there were differences in selected components of the content of prenatal care between the cases and controls, overall and stratified by ethnicity (i.e., hemoglobin/hematocrit test, weight measurement, and breast-feeding counseling), but they were confounded with missing values and associated preterm delivery bias; (4) there were differences in selected components of the content of prenatal care between Anglo- and African-American cases (i.e., vitamin/mineral supplement advice, weight measurement, smoking cessation and drug abuse counseling), but they, too, were difficult to interpret definitively due to item nonresponse and preterm delivery biases; (5) no significant predictive association between selected components of the content of prenatal care and spontaneous preterm birth was found; and (6) inadequate/intermediate prenatal care and birth out of wedlock were found to be associated with moderately preterm birth.^ Future research is needed to examine the validity of maternal and prenatal care providers' responses and identify the sources of disagreement between their responses. In addition, further studies are needed to examine the relationship between the quality of prenatal care and preterm birth. Finally, the completeness and quality of patient and provider data on the utilization and content of prenatal care needs to be strengthened in subsequent studies. ^

Determinants of quality of advanced cancer care in Latin America. A look at five countries: Argentina, Brazil, Cuba, Mexico and Peru

The World Health Organization reports that nearly half a million people died of cancer in Latin America in 2001. As a growing public health problem, cancer is now either the first or second leading cause of death among adults in most Latin American nations. Despite these trends, information on the quality of care people with advanced cancer in Latin America receive has been limited. This study assessed the quality of advanced cancer care in diverse Latin American countries and institutions by surveying cancer care providers from: Argentina; Brazil; Cuba; Mexico; and Peru. This study also identified the most salient factors that influence the quality of this care at the national and institutional levels and compared these factors across countries. This study was based on the secondary analyses of data collected by the University of Texas M. D. Anderson's WHO/PAHO Collaborating Center in Supportive Cancer Care from March 2000 to November 2002. The sample for this survey was a convenience sample of physicians and nurses who treat cancer patients in these regions. Strategies for the dissemination of this survey included: mass mailings; distribution at professional meetings/conferences; collaboration with regional institutions, professional organizations and PAHO; and the posting of online surveys. The strongest predictor of providers' assessments of the quality of advanced cancer care was their ratings of access to care. This major finding reflects a shared equitable notion of quality care among providers from diverse countries and medical institutions that is highly interrelated with providing accessible care to those with advanced cancer. Higher ratings of the affordability of care, an increased reported availability of end-of-life services and opioid analgesics, practicing in either a private hospital or specialized cancer center, and practicing in Cuba were also associated with higher provider ratings of the quality of advanced cancer care. The findings of this study contribute towards the much needed body of knowledge that may guide the formulation of policies and interventions aimed at improving the care for people with advanced cancer in Latin America. ^

Hazardous air pollutants and childhood lymphohematopoietic cancer in Southeast Texas, 1995--2004

Southeast Texas, including Houston, has a large presence of industrial facilities and has been documented to have poorer air quality and significantly higher cancer rates than the remainder of Texas. Given citizens’ concerns in this 4th largest city in the U.S., Mayor Bill White recently partnered with the UT School of Public Health to determine methods to evaluate the health risks of hazardous air pollutants (HAPs). Sexton et al. (2007) published a report that strongly encouraged analytic studies linking these pollutants with health outcomes. In response, we set out to complete the following aims: 1. determine the optimal exposure assessment strategy to assess the association between childhood cancer rates and increased ambient levels of benzene and 1,3-butadiene (in an ecologic setting) and 2. evaluate whether census tracts with the highest levels of benzene or 1,3-butadiene have higher incidence of childhood lymphohematopoietic cancer compared with census tracts with the lowest levels of benzene or 1,3-butadiene, using Poisson regression. The first aim was achieved by evaluating the usefulness of four data sources: geographic information systems (GIS) to identify proximity to point sources of industrial air pollution, industrial emission data from the U.S. EPA’s Toxic Release Inventory (TRI), routine monitoring data from the U.S. EPA Air Quality System (AQS) from 1999-2000 and modeled ambient air levels from the U.S. EPA’s 1999 National Air Toxic Assessment Project (NATA) ASPEN model. Further, once these four data sources were evaluated, we narrowed them down to two: the routine monitoring data from the AQS for the years 1998-2000 and the 1999 U.S. EPA NATA ASPEN modeled data. We applied kriging (spatial interpolation) methodology to the monitoring data and compared the kriged values to the ASPEN modeled data. Our results indicated poor agreement between the two methods. Relative to the U.S. EPA ASPEN modeled estimates, relying on kriging to classify census tracts into exposure groups would have caused a great deal of misclassification. To address the second aim, we additionally obtained childhood lymphohematopoietic cancer data for 1995-2004 from the Texas Cancer Registry. The U.S. EPA ASPEN modeled data were used to estimate ambient levels of benzene and 1,3-butadiene in separate Poisson regression analyses. All data were analyzed at the census tract level. We found that census tracts with the highest benzene levels had elevated rates of all leukemia (rate ratio (RR) = 1.37; 95% confidence interval (CI), 1.05-1.78). Among census tracts with the highest 1,3-butadiene levels, we observed RRs of 1.40 (95% CI, 1.07-1.81) for all leukemia. We detected no associations between benzene or 1,3-butadiene levels and childhood lymphoma incidence. This study is the first to examine this association in Harris and surrounding counties in Texas and is among the first to correlate monitored levels of HAPs with childhood lymphohematopoietic cancer incidence, evaluating several analytic methods in an effort to determine the most appropriate approach to test this association. Despite recognized weakness of ecologic analyses, our analysis suggests an association between childhood leukemia and hazardous air pollution.^

Probiotics and the prevention of necrotizing enterocolitis in preterm infants: A systematic review of the literature

Necrotizing enterocolitis is a common gastrointestinal disease associated with high mortality and morbidity among preterm infants. This was a systematic literature review that evaluated whether the administration of probiotic supplements is of benefit in the prevention of NEC. The search was narrowed to randomized clinical trials identified through The Cochrane Central Register of Controlled Trials, U.S. National Institute of Health clinical trials registry database, Pub Med and OVID MEDLINE databases. Inclusion criteria were: prospective, randomized clinical trials that administered probiotics as a preventive measure against NEC for infants of early gestational age (<35 wks) and/or low birth weight (<1500g), maintained NEC as the primary measured outcome, used Bell’s classification for NEC diagnosis with reports of stage 2 NEC or higher, and began probiotic administration within 10 days of life. Trials were excluded if participant enrollment was fewer than 100 infants, published before the year 2000, or probiotic supplementation was discontinued after less than seven consecutive days. Based on specific study characteristics, each resulting article was then judged by two authors for study quality. The search was further narrowed to studies of either high or moderate quality, which were then summarized in a set of tables based on study characteristics and results. From an initial set of 20 identified studies, five clinical trials met all criteria; each was discussed thoroughly based on trial limitations, strengths and comparisons to other included publications. Based on this review, the weight of evidence appears to support the use of probiotic supplementation in preterm infants as a preventive measure against NEC. Recommendations for future research were also provided.^

Can accreditation work as a tool for quality improvement in public health? A critical review

Public health departments play an important role in promoting and preserving the health of communities. The lack of a system to ensure their quality and accountability led to the development of a national voluntary accreditation program by Public Health Accreditation Board (PHAB). The concept that accreditation will lead to quality improvement in public health which will ultimately lead to healthy communities seems intuitive but lacks a robust body of evidence. A critical review of literature was conducted to explore if accreditation can lead to quality improvement in public health. The articles were selected from publically available databases using a specific set of criteria for inclusion, exclusion, and appraisal. To understand the relationship between accreditation and quality improvement, the potential strengths and limitations of accreditation process were evaluated. Recommendations for best practices are suggested so that public health accreditation can yield maximum benefits. A logic model framework to help depict the impact of accreditation on various levels of public health outcomes is also discussed in this thesis. The literature review shows that existing accreditation programs in other industries show limited but encouraging evidence that accreditation will improve quality and strengthen the delivery of public health services. While progress in introducing accreditation in public health can be informed by other accredited industries, the public health field has its own set of challenges. Providing incentives, creating financing strategies, and having a strong leadership will allow greater access to accreditation by all public health departments. The suggested recommendations include that continuous evaluation, public participation, systems approach, clear vision, and dynamic standards should become hallmarks of the accreditation process. Understanding the link between accreditation, quality improvement, and health outcomes will influence the successful adoption and implementation of the public health accreditation program. This review of literature suggests that accreditation is an important step in improving the quality of public health departments and in ultimately improving the health of communities. However, accreditation should be considered in an integrated system of tools and approaches to improve the public health practice. Hence, it is a means to an end - not an end unto itself.^

The impact of traditional psychiatric services and case management services on the functioning of people with schizophrenia: A cross-national study in Nova Scotia and Texas

The purpose of this study was to determine the impact of traditional psychiatric services with case management services on the functioning of people with schizophrenia. Traditional services were defined as routine clinic services consisting of medication follow-along, psychotherapy, and support services. Case management consisted of activities involved in linking, planning, and monitoring services for the outpatient client who has schizophrenia. The target population was adult schizophrenics who had been receiving outpatient clinic services for a minimum of six months. Structured interviews were conducted using standardized scales (e.g., Quality of Life, Self-Efficacy, and Brief Symptom Inventory) with 78 outpatient client volunteers from two sites: Nova Scotia (Canada) and Texas (USA). The researcher tested for differences in psychiatric symptomatology, recidivism, and quality of life for persons with schizophrenia receiving traditional psychiatric services in Nova Scotia and traditional plus case management services in Texas. Data were collected from the structured interviews and medical records review forms. Types of services were blocked into low and high levels of Intensity (frequency x minutes) and compared to determine the relative contribution of each. Finally, the role of clients' self-efficacy was tested as an intervening variable. Although the findings did not support the hypotheses in the direction anticipated, there were some interesting and useful results. From the Nova Scotia site, clients who received low levels of services were hospitalized less compared to the Texas site. The more psychotic a patient was the higher their involvement in medication follow-along and the more monitoring they received. The more psychotherapy received, the lower the reported satisfaction with social relationships. Of particular interest is the role that self-efficacy played in improved client outcomes. Although self-efficacy scores were related to improved functioning, the mechanism for this still needs to be clarified through subsequent research. ^

The role of a nursing home administrator's education in influencing quality of care in US nursing homes

Nursing home literature links poor management practices to poor quality of care and resident outcomes. Since Nursing Home Administrators (NHAs) require an array of skills to perform their role, it is important to explore what makes a NHA effective. This research fills a gap in the literature and provides a possible option to improve the quality of care in nursing homes. Purpose of the study. The study examines whether NHAs with advanced education (defined as a Masters degree or more) are associated with better quality of care in licensed nursing homes (NHs). Design and Methods. Data was derived from the CDC’s 2004 National Nursing Home Survey, which is a representative sample of NHs across the US. A Donabedian- inspired structure-process-outcomes study model was created to explain how education relates to quality of care. Quality of care was defined as onsite oral care, employee influenza vaccination rates and staff recognition programs. Statistical analyses included multivariate logistic regression; covariates included facility-level variables used in similar peer-reviewed research but also included select measures from the Area Resource File to control for county-level factors. Results. Descriptive and analytical analyses confirm that NHAs with a Bachelor’s degree, Associate degree or high school diploma perform less well than NHAs with a Masters degree or more. NHAs with advanced education are more likely to have onsite dental care and recognition programs for staff than NHAs with a Bachelor’s degree (or less). Also NHAs with less than graduate education are more likely to provide off-site dental care. Employee vaccination rates are not impacted by education. Adding certification, tenure or years of experience to a NHA with advanced education gives them an advantage. In fact, certification and experience alone do not have a positive relationship to care indicators; however adding these to advanced education produces a significant result. Implications. This research provides preliminary evidence that advanced education for the NHA is associated with better quality of care. If future research can confirm these findings, there is merit in revisiting the qualifications. Education can be a legitimate option to support quality improvement efforts in US nursing homes. ^

Long Term Follow-up of Morbidity and Quality of Life Associated with Isolated Gastroschisis

Gastroschisis is a birth defect in which an opening in the abdominal wall allows herniation of the viscera. Prenatal counseling regarding gastroschisis typically discusses that, although these infants often endure a difficult neonatal course, they experience few long-term complications. However, information regarding long-term outcomes is based on limited studies that lack specificity. Therefore, we aimed to study the long-term morbidity and quality of life in children born with gastroschisis in a large and diverse population drawn from the Texas Birth Defects Registry (TBDR). Study packets with informed consent, a questionnaire, and the Pediatric Quality of Life Inventory Generic Core Scale 4.0 (PedsQL 4.0) in English and Spanish were mailed to 1,112 parents of children born with isolated gastroschisis in Texas between 1999 and 2008 via the TBDR. Information was abstracted from the TBDR for 58 mothers of children with gastroschisis who returned study materials. Three hundred fifty five packets were returned to sender, giving a response rate of 7.7%. Children born with gastroschisis had quality of life scores that were not significantly different than expected (p = 0.981). However, factors such as having a learning disability (p = 0.001) and missing school due to gastrointestinal issues (p = 0.020) were found to significantly decrease quality of life. Overall, children with gastroschisis had a significantly increased risk for learning disabilities regardless of whether they were preterm (p = 0.021) or full term (p = 0.021). Additionally, there appeared to be an increased risk for auditory impairment in Caucasian children (p < 0.0005). Therefore, while overall long-term quality of life is not significantly altered for children born with gastroschisis, the previously unreported increased risk for learning disabilities and possible association with hearing impairment are important findings that should be conveyed to prospective parents.

Prevalence and risk factors of asthma and work -related asthma among U.S. adults: Data from the Third National Health and Nutrition Examination Survey, 1988--1994

This cross-sectional analysis of the data from the Third National Health and Nutrition Examination Survey was conducted to determine the prevalence and determinants of asthma and wheezing among US adults, and to identify the occupations and industries at high risk of developing work-related asthma and work-related wheezing. Separate logistic models were developed for physician-diagnosed asthma (MD asthma), wheezing in the previous 12 months (wheezing), work-related asthma and work-related wheezing. Major risk factors including demographic, socioeconomic, indoor air quality, allergy, and other characteristics were analyzed. The prevalence of lifetime MD asthma was 7.7% and the prevalence of wheezing was 17.2%. Mexican-Americans exhibited the lowest prevalence of MD asthma (4.8%; 95% confidence interval (CI): 4.2, 5.4) when compared to other race-ethnic groups. The prevalence of MD asthma or wheezing did not vary by gender. Multiple logistic regression analysis showed that Mexican-Americans were less likely to develop MD asthma (adjusted odds ratio (ORa) = 0.64, 95%CI: 0.45, 0.90) and wheezing (ORa = 0.55, 95%CI: 0.44, 0.69) when compared to non-Hispanic whites. Low education level, current and past smoking status, pet ownership, lifetime diagnosis of physician-diagnosed hay fever and obesity were all significantly associated with MD asthma and wheezing. No significant effect of indoor air pollutants on asthma and wheezing was observed in this study. The prevalence of work-related asthma was 3.70% (95%CI: 2.88, 4.52) and the prevalence of work-related wheezing was 11.46% (95%CI: 9.87, 13.05). The major occupations identified at risk of developing work-related asthma and wheezing were cleaners; farm and agriculture related occupations; entertainment related occupations; protective service occupations; construction; mechanics and repairers; textile; fabricators and assemblers; other transportation and material moving occupations; freight, stock and material movers; motor vehicle operators; and equipment cleaners. The population attributable risk for work-related asthma and wheeze were 26% and 27% respectively. The major industries identified at risk of work-related asthma and wheeze include entertainment related industry; agriculture, forestry and fishing; construction; electrical machinery; repair services; and lodging places. The population attributable risk for work-related asthma was 36.5% and work-related wheezing was 28.5% for industries. Asthma remains an important public health issue in the US and in the other regions of the world. ^