The evolution and assessment of pharmaceutical care: Structure, processes, and outcomes

The evolution of pharmaceutical care is identified through a complete review of the literature published in the American Journal of Health-System Pharmacy, the sole comprehensive publication of institutional pharmacy practice. The evolution is categorized according to characteristics of structure (organizational structure, the role of the pharmacist), process (drug delivery systems, formulary management, acquiring drug products, methods to impact drug therapy decisions), and outcomes (cost of drug delivery, cost of drug acquisition and use, improved safety, improved health outcomes) recorded from the 1950s through the 1990s. While significant progress has been made in implementing basic drug distribution systems, levels of pharmacy involvement with direct patient care is still limited.^ A new practice framework suggests enhanced direct patient care involvement through increase in the efficiency and effectiveness of traditional pharmacy services. Recommendations advance internal and external organizational structure relationships that position pharmacists to fully use their unique skills and knowledge to impact drug therapy decisions and outcomes. Specific strategies facilitate expansion of the breadth and scope of each process component in order to expand the depth of integration of pharmacy and pharmaceutical care within the broad healthcare environment. Economic evaluation methods formally evaluate the impact of both operational and clinical interventions.^ Outcome measurements include specific recommendations and methods to increase efficiency of drug acquisition, emphasizing pharmacists' roles that impact physician prescribing decisions. Effectiveness measures include those that improve safety of drug distribution systems, decrease the potential of adverse drug therapy events, and demonstrate that pharmaceutical care can significantly contribute to improvement in overall health status.^ The implementation of the new framework is modeled on a case study at the M.D. Anderson Cancer Center. The implementation of several new drug distribution methods facilitated the redeployment of personnel from distributive functions to direct patient care activities with significant personnel and drug cost reduction. A cost-benefit analysis illustrates that framework process enhancements produced a benefit-to-cost ratio of 7.9. In addition, measures of effectiveness demonstrated significant levels of safety and enhanced drug therapy outcomes. ^

The epidemiology of left ventricular outflow tract obstruction defects in Texas, 2002-2008: An update and assessment of effect heterogeneity

Left ventricular outflow tract (LVOT) defects are an important group of congenital heart defects (CHDs) because of their associated mortality and long-term complications. LVOT defects include aortic valve stenosis (AVS), coarctation of aorta (CoA), and hypoplastic left heart syndrome (HLHS). Despite their clinical significance, their etiology is not completely understood. Even though the individual component phenotypes (AVS, CoA, and HLHS) may have different etiologies, they are often "lumped" together in epidemiological studies. Though "lumping" of component phenotypes may improve the power to detect associations, it may also lead to ambiguous findings if these defects are etiologically distinct. This is due to potential for effect heterogeneity across component phenotypes. ^ This study had two aims: (1) to identify the association between various risk factors and both the component (i.e., split) and composite (i.e., lumped) LVOT phenotypes, and (2) to assess the effect heterogeneity of risk factors across component phenotypes of LVOT defects. ^ This study was a secondary data analysis. Primary data were obtained from the Texas Birth Defect Registry (TBDR). TBDR uses an active surveillance method to ascertain birth defects in Texas. All cases of non complex LVOT defects which met our inclusion criteria during the period of 2002–2008 were included in the study. The comparison groups included all unaffected live births for the same period (2002–2008). Data from vital statistics were used to evaluate associations. Statistical associations between selected risk factors and LVOT defects was determined by calculating crude and adjusted prevalence ratio using Poisson regression analysis. Effect heterogeneity was evaluated using polytomous logistic regression. ^ There were a total of 2,353 cases of LVOT defects among 2,730,035 live births during the study period. There were a total of 1,311 definite cases of non-complex LVOT defects for analysis after excluding "complex" cardiac cases and cases associated with syndromes (n=168). Among infant characteristics, males were at a significantly higher risk of developing LVOT defects compared to females. Among maternal characteristics, significant associations were seen with maternal age > 40 years (compared to maternal age 20–24 years) and maternal residence in Texas-Mexico border (compared to non-border residence). Among birth characteristics, significant associations were seen with preterm birth and small for gestation age LVOT defects. ^ When evaluating effect heterogeneity, the following variables had significantly different effects among the component LVOT defect phenotypes: infant sex, plurality, maternal age, maternal race/ethnicity, and Texas-Mexico border residence. ^ This study found significant associations between various demographic factors and LVOT defects. While many findings from this study were consistent with results from previous studies, we also identified new factors associated with LVOT defects. Additionally, this study was the first to assess effect heterogeneity across LVOT defect component phenotypes. These findings contribute to a growing body of literature on characteristics associated with LVOT defects. ^

A methodologic study of pain assessment in Anglo and Hispanic children with cancer

There is growing clinical evidence that even young children experience pain and accompanying anxiety. Few instruments have been validated to assess pain characteristics in children. The study of related demographic, illness, psychologic and parental factors in children has also been limited. This study examines the reliability and validity of pain assessment tools in an outpatient pediatric cancer population. A total of 78 children from three to fifteen years of age were observed and interviewed about the pain of invasive procedures. The effect of cultural factors and the stress of acculturation were examined by comparing data from two cultural groups, Anglo and Hispanic.^ Spielberger State-Trait Anxiety Scales were administered to children and parents prior to an invasive procedure. The Procedure Behavioral Checklist (PBCL) was used for observation of the child's response during the procedure. The Children's Procedural Interview (CPI) which contains items on the PBCL and visual analogues (scales of faces indicating varying degrees of pain and anxiety) was administered following the procedure.^ Reliability coefficients for Anglos were.78 on the PBCL,.79 on the CPI and.85 on the visual analogue scales. For Hispanics, the reliability for the PBCL was.54, while the CPI had a reliability of.72 and the visual analogue scales,.87. Construct validity was demonstrated by high correlations between the PBCL and CPI scores for both ethnic groups (.66 for Anglos and.64 for Hispanics) and by the significant correlation of State anxiety scores with both PBCL and CPI scores. Age was inversely correlated with PBCL and CPI scores for both ethnic groups. Hispanic parents' anxiety scores were higher than Anglo parents, but were not highly correlated with their child's PBCL, CPI or State-Trait anxiety scores. Caregivers' ratings were correlated with the PBCL scores for Anglos but not for Hispanics.^ The findings of this study indicate that pain responses may be reliably assessed using both observational and self-report methods in children, though differences in Anglo and Hispanic cultures exist. Differences in pain symptomatology and assessment in the two cultural groups warrant further study. ^

Tracking of plasma lipids and lipoproteins, within-person and year-to-year variability in plasma cholesterol levels among participants from age 8 to 18 in Project HeartBeat!

Coronary heart disease remains the leading cause of death in the United States and increased blood cholesterol level has been found to be a major risk factor with roots in childhood. Tracking of cholesterol, i.e., the tendency to maintain a particular cholesterol level relative to the rest of the population, and variability in blood lipid levels with increase in age have implications for cholesterol screening and assessment of lipid levels in children for possible prevention of further rise to prevent adulthood heart disease. In this study the pattern of change in plasma lipids, over time, and their tracking were investigated. Also, within-person variance and retest reliability defined as the square root of within-person variance for plasma total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglycerides and their relation to age, sex and body mass index among participants from age 8 to 18 years were investigated. ^ In Project HeartBeat!, 678 healthy children aged 8, 11 and 14 years at baseline were enrolled and examined at 4-monthly intervals for up to 4 years. We examined the relationship between repeated observations by Pearson's correlations. Age- and sex-specific quintiles were calculated and the probability of participants to remain in the uppermost quintile of their respective distribution was evaluated with life table methods. Plasma total cholesterol, HDL-C and LDL-C at baseline were strongly and significantly correlated with measurements at subsequent visits across the sex and age groups. Plasma triglyceride at baseline was also significantly correlated with subsequent measurements but less strongly than was the case for other plasma lipids. The probability to remain in the upper quintile was also high (60 to 70%) for plasma total cholesterol, HDL-C and LDL-C. ^ We used a mixed longitudinal, or synthetic cohort design with continuous observations from age 8 to 18 years to estimate within person variance of plasma total cholesterol, HDL-C, LDL-C and triglycerides. A total of 5809 measurements were available for both cholesterol and triglycerides. A multilevel linear model was used. Within-person variance among repeated measures over up to four years of follow-up was estimated for total cholesterol, HDL-C, LDL-C and triglycerides separately. The relationship of within-person and inter-individual variance with age, sex, and body mass index was evaluated. Likelihood ratio tests were conducted by calculating the deviation of −2log (likelihood) within the basic model and alternative models. The square root of within-person variance provided the retest reliability (within person standard deviation) for plasma total cholesterol, HDL-C, LDL-C and triglycerides. We found 13.6 percent retest reliability for plasma cholesterol, 6.1 percent for HDL-cholesterol, 11.9 percent for LDL-cholesterol and 32.4 percent for triglycerides. Retest reliability of plasma lipids was significantly related with age and body mass index. It increased with increase in body mass index and age. These findings have implications for screening guidelines, as participants in the uppermost quintile tended to maintain their status in each of the age groups during a four-year follow-up. The magnitude of within-person variability of plasma lipids influences the ability to classify children into risk categories recommended by the National Cholesterol Education Program. ^

Airliner cabin air quality exposure assessment

The airliner cabin environment and its effects on occupant health have not been fully characterized. This dissertation is: (1) A review of airliner environmental control systems (ECSs) that modulate the ventilation, temperature, relative humidity (RH), and barometric pressure (PB) of the cabin environment---variables related to occupant comfort and health. (2) A review and assessment of the methods and findings of key cabin air quality (CAQ) investigations. Several significant deficiencies impede the drawing of inferences about CAQ, e.g., lack of detail about investigative methods, differences in methods between investigations, limited assessment of CAQ variables, small sample sizes, and technological deficiencies of data collection. (3) A comprehensive evaluation of the methods used in the subsequent NIOSH-FAA Airliner CAQ Exposure Assessment Feasibility Study (STUDY) in which this author participated. A number of problems were identified which limit the usefulness of the data. (4) An analysis of the reliable 10-flight STUDY data. Univariate and multivariate methods applied to CO2 (a surrogate for air contaminants), temperature, RH, and PB, in association with percent passenger load, ventilation system, flight duration, airliner body type, and measurement location within the cabin, revealed neither the measured values nor their variability exceeded established health-based exposure limits. Regression analyses suggest CO2, temperature, and RH were affected by percent passenger load. In-flight measurements of CO2 and RH were relatively independent of ventilation system type or flight duration. Cabin temperature was associated with percent passenger load, ventilation system type, and flight duration. (5) A synthesis of the implications of the airliner ECS and cabin O2 environment on occupant health. A model was developed to predict consequences of the airliner cabin pressure altitude 8,000 ft limit and resulting model-estimated PO2 on cardiopulmonary status. Based on the PB, altitude, and environmental data derived from the 10 STUDY flights, the predicted PaO2 of adults with COPD, or elderly adults with or without COPD, breathing ambient cabin air could be < 55 mm Hg (SaO2 < 88%). Reduction in cabin PB found in the STUDY flights could aggravate various medical conditions and require the use of in-flight supplemental O2. ^

Lessons learned from nationwide vaccine programs: Comparing human papillomavirus, poliomyelitis vaccine, and swine flu

This assessment compares the human papillomavirus (HPV) nationwide vaccine to the poliomyelitis vaccine and the swine flu vaccine with the purpose of finding parallels and lessons in the controversies faced by the development and use of the vaccines. There are a number of great barriers that are facing the HPV vaccine to date. These controversies lie in dealing with the risk involved in taking the vaccine, how much control the government should have in administering the vaccine, how to communicate the risk to the public, and the cost-effectiveness of the vaccine versus treatment for cervical cancer. The lessons for the HPV vaccine that were learned after comparison and assessment of the controversies were: (1) plan ahead of time on how to inform the public if a risk develops from taking the HPV vaccination and it may be better to provide some information while the event is occurring, always being as truthful as possible, and later dispensing more information once all of the facts are known, (2) the human papillomavirus is not something that will become a pandemic in a short amount of time because the virus takes a long time to develop into cervical cancer, so if a major risk begins to show after continuing to develop and administer the vaccine for an amount of time, it may be better to take it off the market for a while and possibly reconfigure it to help eliminate some of the risks, (3) if side reactions and risks do develop and the government assumes liability for these reactions, the cost-effectiveness can be greatly affected, so it is important to be constantly checking to see if all the monetary and health benefits of the vaccine are outweighing any of the negative costs of the vaccine, and lastly, (4) the public must feel that every aspect of the vaccine, both good and bad, has been thought over and the benefits of taking the vaccine prevail over the negatives and that politics and commercial interests have nothing to do with the production and administration of the vaccine. ^

Report on the practice based culminating experience as teaching assistant for "Pathology and Public Health" class taught at University of Texas School of Public Health, Houston

Objectives. The objectives of this report were to describe current best standards in online education, class competencies, class objectives, class activities and to compare the class competencies, objectives and activities undertaken with the current best practices in online teaching and to provide a list of recommendations based on the most efficacious practices. ^ Methods. Utilizing the key words- online teaching, national standards, quality, online courses, I: (1) conducted a search on Google to find the best standard for quality online courses; the search yielded National Standards for Quality Online Teaching as the gold standard in online course quality; (2) specified class objectives and competencies as well as major activities undertaken as a part of the class. Utilizing the Southern Regional Education Board evaluation checklist for online courses, I: (1) performed an analysis comparing the class activities, objectives, and competencies with the current best standards; (2) utilized the information obtained from the analysis and class experiences to develop recommendations for the most efficacious online teaching practices. ^ Results. The class met the criteria set by the Southern Regional Education Board for evaluating online classes completely in 75%, partially in 16% and did not meet the criteria in 9% cases. The majority of the parameters in which the class did not meet the standards (4 of 5) were due to technological reasons beyond the scope of the class instructor, teaching assistant and instructional design. ^ Discussion. Successful online teaching requires awareness of technology, good communication, methods, collaboration, reflection and flexibility. Creation of an online community, engaging online learners and utilizing different learning styles and assessment methods promote learning. My report proposes that online teaching should actively engage the students and teachers with multiple interactive strategies as evidenced from current best standards of online education and my “hands-on” work experience. ^ Conclusion. The report and the ideas presented are intended to create a foundation for efficacious practice on the online teaching platform. By following many of the efficacious online practices described in the report and adding from their own experiences, online instructors and teaching assistants can contribute to effective online learning. ^

Perceptions of chief executives of Texas Catholic health care institutions regarding the poor and the provision of Catholic health care

Perceptions of chief executive officers (CEOs) of Texas Catholic health care institutions regarding the poor and the provision of Catholic health care were the focus for this study. A total of 40 health care administrators were asked to participate in a survey. Thirty-seven CEOs responded, including seven religious superiors, six health system CEOs and 24 hospital CEOs. Survey items concerning Catholic health for the poor centered on obligations and responsibilities of Catholic hospitals, means of achieving those obligations, and assessment of whether hospitals' objectives were being met. In addition, respondents' attitudes and beliefs about poor people in general were examined. Independent variables were CEO type, gender, religious preference, member of a religious order, and educational preparation. For purposes of analysis, most survey items were classified by level of consensus exhibited by respondents. The respondents to this survey agreed on most issues concerning poor people and the provision of Catholic health care. However, there were areas of disagreement particularly in Part I of the survey which dealt with responsibility/obligation, means/methods, and assessment of health care delivery for the poor. ^

THE EFFECT OF PERSON-ENVIRONMENT INTERACTION ON ANXIETY, DEPRESSION, AND SUBJECTIVE DISTRESS OF OPTOMETRY STUDENTS

The purpose of this study was to investigate whether an incongruence between personality characteristics of individuals and concomitant charcteristics of health professional training environments on salient dimensions contributes to aspects of mental health. The dimensions examined were practical-theoretical orientation and the degree of structure-unstructure. They were selected for study as they are particularly important attributes of students and of learning environments. It was proposed that when the demand of the environment is disparate from the proclivities of the individual, strain arises. This strain was hypothesized to contribute to anxiety, depression, and subjective distress.^ Select subscales on the Omnibus Personality Inventory (OPI) were the operationalized measures for the personality component of the dimensions studied. An environmental index was developed to assess students' perceptions of the learning environment on these same dimensions. The Beck Depression Inventory, State-Trait Anxiety Inventory and General Well-Being schedule measured the outcome variables.^ A congruence model was employed to determine person-environment (P-E) interaction. Scores on the scales of the OPI and the environmental index were divided into high, medium, and low based on the range of scores. Congruence was defined as a match between the level of personality need and the complementary level of the perception of the environment. Alternatively, incongruence was defined as a mismatch between the person and the environment. The consistent category was compared to the inconsistent categories by an analysis of variance procedure. Furthermore, analyses of covariance were conducted with perceived supportiveness of the learning environment and life events external to the learning environment as the covariates. These factors were considered critical influences affecting the outcome measures.^ One hundred and eighty-five students (49% of the population) at the College of Optometry at the University of Houston participated in the study. Students in all four years of the program were equally represented in the study. However, the sample differed from the total population on representation by sex, marital status, and undergraduate major.^ The results of the study did not support the hypotheses. Further, after having adjusted for perceived supportiveness and life events external to the learning environment, there were no statistically significant differences between the congruent category and incongruent categories. Means indicated than the study sample experienced significantly lower depression and subjective distress than the normative samples.^ Results are interpreted in light of their utility for future study design in the investigation of the effects of P-E interaction. Emphasized is the question of the feasibility of testing a P-E interaction model with extant groups. Recommendations for subsequent research are proposed in light of the exploratory nature of the methodology. ^

Activation of c -Met contributes to growth and metastasis of human colorectal carcinoma

c-Met is the protein tyrosine kinase receptor for hepatocyte growth factor/scatter factor (HGF/SF) and mediates several normal cellular functions including proliferation, survival, and migration. Overexpression of c-Met correlates with progression and metastasis of human colorectal carcinoma (CRC). The goals of this study were to determine if overexpression of c-Met directly contributes to tumorigenicity and liver metastatic potential of colon cancer, and what are the critical pathways regulated by c-Met in this process. The studies used two colon tumor cell lines, KM12SM and KM20, which express high levels of constitutively active c-Met and are highly metastatic in nude mice. To examine the effects of c-Met overexpression, subclones of theses lines with reduced c-Met expression were obtained following transfection with a c-Met specific targeting ribozyme. Reduction of c-Met in KM12SM cells abolished liver metastases when cells were injected intrasplenically in an experimental metastasis assay. However, c-Met downregulation in theses clones was unstable. Three stable KM20 clones with a 25–35% reduction in c-Met protein levels but 60–90% reduction in basal c-Met autophosphorylation and kinase activity were obtained. While HGF increased c-Met kinase activity in the clones with reduced c-Met, the activity was less than that observed in parental or control transfected cells. Correlating with the reduction in c-Met kinase activity, subclones with reduced c-Met expression had significantly reduced in vitro growth rates, soft-agar colony forming abilities, and increased apoptosis. HGF/SF treatment did not affect anchorage-dependent growth or soft-agar colony forming abilities. Further, c-Met downregulation significantly impaired the ability of HGF/SF to induce migration. To examine the effects of reduced c-Met on tumor formation, parental and c-Met reduced KM20 cells were grown subcutaneously and intrahepatically in nude mice. c-Met downregulation delayed, but did not abolish growth at the subcutaneous site. When these cells were injected intrahepatically, both tumor incidences and size were significantly reduced. To further understand the molecular basis of c-Met in promoting tumor growth, the activation of several signaling intermediates that have been implicated in c-Met mediated growth, survival and migration were compared between KM20 parental cells and subclones with reduced c-Met expression levels. The expression and activity (as determined by phosphorylation) of AKT and Erk1/2 were unaltered. In contrast, Src kinase activity, as measured by immune complex kinase assay, was reduced 2–5 fold following c-Met downregulation. As Src has been implicated in growth, survival and migration, Src activation in c-Met overexpressing lines is likely contributing to the tumorigenic and metastatic capabilities of colon tumor cell lines that overexpress c-Met. Collectively, these results suggest that c-Met overexpression plays a causal role in the development of CRC liver metastases, and that c-Src and c-Met inhibitors may be of potential therapeutic benefit for late-stage colon cancer. ^