A randomized, double-blind, placebo-controlled pilot study of naltrexone in outpatients with bipolar disorder and alcohol dependence.

BACKGROUND: Alcohol dependence is extremely common in patients with bipolar disorder and is associated with unfavorable outcomes including treatment nonadherence, violence, increased hospitalization, and decreased quality of life. While naltrexone is a standard treatment for alcohol dependence, no controlled trials have examined its use in patients with co-morbid bipolar disorder and alcohol dependence. In this pilot study, the efficacy of naltrexone in reducing alcohol use and on mood symptoms was assessed in bipolar disorder and alcohol dependence. METHODS: Fifty adult outpatients with bipolar I or II disorders and current alcohol dependence with active alcohol use were randomized to 12 weeks of naltrexone (50 mg/d) add-on therapy or placebo. Both groups received manual-driven cognitive behavioral therapy designed for patients with bipolar disorder and substance-use disorders. Drinking days and heavy drinking days, alcohol craving, liver enzymes, and manic and depressed mood symptoms were assessed. RESULTS: The 2 groups were similar in baseline and demographic characteristics. Naltrexone showed trends (p < 0.10) toward a greater decrease in drinking days (binary outcome), alcohol craving, and some liver enzyme levels than placebo. Side effects were similar in the 2 groups. Response to naltrexone was significantly related to medication adherence. CONCLUSIONS: Results suggest the potential value and acceptable tolerability of naltrexone for alcohol dependence in bipolar disorder patients. A larger trial is needed to establish efficacy.

Exploring the use of pharmaceutical patient assistance programs as an option to improve access to and affordability of prescription drugs

Background. Pharmaceutical-sponsored patient assistance programs (PAPs) are charity programs that provide free or reduced-priced medications to eligible patients. PAPs have the potential to improve prescription drug accessibility for patients but currently there is limited information about their use and effectiveness. ^ Objectives and methods. This dissertation described the use of PAPs in the U.S. through the conduct of two studies: (1) a systematic review of primary studies of PAPs from commercially-published and “grey” literature sources; and (2) a retrospective, cross-sectional study of cancer patients' use of PAPs at a tertiary care cancer outpatient center. ^ Results. (1) The systematic review identified 33 studies: 15 evaluated the impact of PAP enrollment assistance programs on patient healthcare outcomes; 7 assessed institutional costs of providing enrollment assistance; 7 surveyed stakeholders; 4 examined other aspects. Standardized mean differences calculated for disease indicator outcomes (most of which were single group, pre-posttest designs) showed significant decreases in glycemic and lipid control, and inconsistent results for blood pressure. Grey literature abstracts reported insufficient statistics for calculations. Study heterogeneity made weighted summary estimates inappropriate. Economic analyses indicated positive financial benefits to institutions providing enrollment assistance (cost) compared to the wholesale value of the medications provided (benefit); analyses did not value health outcomes. Mean quality of reporting scores were higher for observational studies in commercially-published articles versus full text, grey literature reports. (2) The cross-sectional study found that PAP outpatients were significantly more likely to be uninsured, indigent, and < 65 years old than non-PAP patients. Nearly all non-PAP and PAP prescriptions were for non-cancer conditions, either for co-morbidities (e.g., hypertension) or the management of treatment side effects (e.g., pain). Oral chemotherapies from PAPs were significantly more likely to be for breast versus other cancers, and be a newer, targeted versus traditional chemotherapy.^ Conclusions. In outpatient settings, PAP enrollment assistance plus additional medication services (e.g., counseling, reminders, and free samples) is associated with improved disease indicators for patients. Healthcare institutions, including cancer centers, can offset financial losses from uncompensated drug costs and recoup costs invested in enrollment assistance programs by procuring free PAP medications. Cancer patients who are indigent and uninsured may be able to access more outpatient medications for their supportive care needs through PAPs, than for cancer treatment options like oral chemotherapies. Because of the selective availability of drugs through PAPs, there may be more options for newer, oral, targeted chemotherapies for the treatment breast cancer versus other for other cancers.^

Racial differences in heart failure with preserved ejection fraction in the ambulatory heart failure population

Racial differences in heart failure with preserved ejection fraction (HFpEF) have rarely been studied in an ambulatory, financially "equal access" cohort, although the majority of such patients are treated as outpatients. ^ Retrospective data was collected from 2,526 patients (2,240 Whites, 286 African American) with HFpEF treated at 153 VA clinics, as part of the VA External Peer Review Program (EPRP) between October 2000 and September 2002. Kaplan Meier curves (stratified by race) were created for time to first heart failure (HF) hospitalization, all cause hospitalization and death and Cox proportional multivariate regression models were constructed to evaluate the effect of race on these outcomes. ^ African American patients were younger (67.7 ± 11.3 vs. 71.2 ± 9.8 years; p < 0.001), had lower prevalence of atrial fibrillation (24.5 % vs. 37%; p <0.001), chronic obstructive pulmonary disease (23.4 % vs. 36.9%, p <0.001), but had higher blood pressure (systolic blood pressure > 120 mm Hg 77.6% vs. 67.8%; p < 0.01), glomerular filtration rate (67.9 ± 31.0 vs. 61.6 ± 22.6 mL/min/1.73 m2; p < 0.001), anemia (56.6% vs. 41.7%; p <0.001) as compared to whites. African Americans were found to have higher risk adjusted rate of HF hospitalization (HR 1.52, 95% CI 1.1 - 2.11; p = 0.01), with no difference in risk-adjusted all cause hospitalization (p = 0.80) and death (p= 0.21). ^ In a financially "equal access" setting of the VA, among ambulatory patients with HFpEF, African Americans have similar rates of mortality and all cause hospitalization but have an increased risk of HF hospitalizations compared to whites.^

Epidemiological trends of influenza A positive patients hospitalized at St. Luke's Episcopal Hospital, Houston, Texas September, 2009--January, 2010

This study was a descriptive analysis of 437 influenza A positive inpatients and outpatients during the five month period between September, 2009 and January, 2010. The objective of the study was to describe the epidemiological trends of the total influenza A positive population and more specifically the clinical features of patients hospitalized with influenza A at St. Luke's Episcopal Hospital in Houston, Texas from September 2009 through January 2010. Eligible cases were included if they tested positive for influenza A test using the rapid antigen test and/or rRT-PCR. Hospitalized cases were included based on the laboratory confirmation of influenza A as well as hospital admission for at least 24 hours. Data was collected from medical record abstraction and included patient demographics, clinical history and history of chronic disease. Clinical findings in the differential diagnosis that led to laboratory-confirmation of influenza A as well as course of treatment during the hospital admission were summarized. Finally, co-morbid conditions charted during the hospital visit were reviewed and evaluated for associations with influenza A complications. During the study period, forty-eight patients were included in the study of which 27 tested positive for the H1N1 subtype. Females were more likely to be hospitalized than men. The median age of all patients admitted to St. Luke's Episcopal Hospital with influenza A was 42. The distribution for admitted cases was 15 White, 15 Black, and 18 Hispanic. Patients with co-morbid disease constituted 81% of the admissions for Influenza A. The presence of an underlying medical condition remains a risk factor for both seasonal and H1N1 influenza. Although respiratory conditions such as asthma and COPD are commonly associated with complications of seasonal influenza, patients with metabolic disorders such as kidney disease and/or diabetes were admitted more frequently (58%) during the study period. The patients in the study also of a much younger age than the age that is usually associated with complications of influenza infection, i.e. no patients greater than 65 years of age were admitted with a diagnosis of influenza A. Lower infection rates among elderly populations were similarly reported in other studies of influenza during the same time period. Older patient populations may benefit from antibodies to previous H1N1 strains that have circulated during the twentieth century, whereas younger age groups lack these exposures.^

MEDICAL CARE UTILIZATION IN TIME AMONG ELDERLY MEDICARE ENROLLEES IN AN HMO

Investigation into the medical care utilization of elderly Medicare enrollees in an HMO (Kaiser - Portland, Oregon): The specific research topics are: (1) The utilization of medical care by selected determinants such as: place of service, type of service, type of appointment, physician status, physician specialty and number of associated morbidities. (2) The attended prevalence of 3 chronic diseases: hypertension, diabetes and arthritis in addition to pneumonias as an example of acute diseases. The selection of these examples was based on their importance in morbidity/or mortality results among the elderly. The share of these diseases in outpatient and inpatient contacts was examined as an example of the relation between morbidity and medical care utilization. (3) The tendency of individual utilization patterns to persist in subsequent time periods. The concept of contagion or proneness was studied in a period of 2 years. Fitting the negative binomial and the Poisson distributions was applied to the utilization in the 2nd year conditional on that in the 1st year as regards outpatient and inpatient contacts.^ The present research is based on a longitudinal study of 20% random sample of elderly Medicare enrollees. The sample size is 1683 individuals during the period from August 1980-December 1982.^ The results of the research were: (1) The distribution of contacts by selected determinants did not reveal a consistent pattern between sexes and age groups. (2) The attended prevalence of hypertension and arthritis showed excess prevalence among females. For diabetes and pneumonias no female excess was noticed. Consistent increased prevalence with increasing age was not detected.^ There were important findings pertaining to the relatively big share of the combined 3 chronic diseases in utilization. They accounted for 20% of male outpatient contacts vs. 25% of female outpatients. For inpatient contacts, they consumed 20% in case of males vs. 24% in case of females. (3) Finding that the negative binomial distribution fit the utilization experience supported the research hypothesis concerning the concept of contagion in utilization. This important finding can be helpful in estimating liability functions needed for forecasting future utilization according to previous experience. Such information has its relevance to organization, administration and planning for medical care in general. (Abstract shortened with permission of author.) ^

TECHNOLOGY ASSESSMENT: SMALL-VOLUME INFUSION PUMPS

"Technology assessment is a comprehensive form of policy research that examines the short- and long-term social consequences of the application or use of technology" (US Congress 1967).^ This study explored a research methodology appropriate for technology assessment (TA) within the health industry. The case studied was utilization of external Small-Volume Infusion Pumps (SVIP) at a cancer treatment and research center. Primary and secondary data were collected in three project phases. In Phase I, hospital prescription records (N = 14,979) represented SVIP adoption and utilization for the years 1982-1984. The Candidate Adoption-Use (CA-U) diffusion paradigm developed for this study was germane. Compared to classic and unorthodox curves, CA-U more accurately simulated empiric experience. The hospital SVIP 1983-1984 trends denoted assurance in prescribing chemotherapy and concomitant balloon SVIP efficacy and efficiency. Abandonment of battery pumps was predicted while exponential demand for balloon SVIP was forecast for 1985-1987. In Phase II, patients using SVIP (N = 117) were prospectively surveyed from July to October 1984; the data represented a single episode of therapy. The questionnaire and indices, specifically designed to measure the impact of SVIP, evinced face validity. Compeer group data were from pre-SVIP case reviews rather than from an inpatient sample. Statistically significant results indicated that outpatients using SVIP interacted socially more than inpatients using the alternative technology. Additionally, the hospital's education program effectively taught clients to discriminate between self care and professional SVIP services. In these contexts, there was sufficient evidence that the alternative technology restricted patients activity whereas SVIP permitted patients to function more independently and in a social lifestyle, thus adding quality to life. In Phase III, diffusion forecast and patient survey findings were combined with direct observation of clinic services to profile some economic dimensions of SVIP. These three project phases provide a foundation for executing: (1) cost effectiveness analysis of external versus internal infusors, (2) institutional resource allocation, and (3) technology deployment to epidemiology-significant communities. The models and methods tested in this research of clinical technology assessment are innovative and do assess biotechnology. ^

The role of serotonin in depression and clotting in the coronary artery disease population

Background: The mechanisms underlying the relationship between depression and acute coronary syndrome (ACS) remain unclear. Platelet serotonin has been associated with both depression and coronary artery disease in stable outpatients. Understanding the association between depression and platelet serotonin, during ACS, may explain some of the acute cardiovascular events seen in some individuals with depression. ^ Objectives: This study was designed to evaluate whether levels of platelet serotonin, during ACS, differ between individuals who screen positive for depression and individuals who screen negative for depression and to determine if a dose-response relationship exists between depressive symptoms and platelet serotonin levels. ^ Methods: In this cross-sectional study, data was collected on 51 patients hospitalized for ACS. Multiple linear regression models were used to determine if a relationship exists between depression and platelet serotonin levels. ^ Results: Of the 51 ACS patients, 24 screened positive for depression and 27 screened negative for depression. Platelet serotonin levels were not significantly different between the depressed group (942.10 ± 461.3) and the non-depressed group (1192.41 ± 764.3) (p= .293 and β= -4.093) and a dose-response relationship between depressive symptoms and platelet serotonin levels was not found (p= .250 and β= -.254). ^ Discussion: In this study, a relationship between depression and platelet serotonin levels was not found. Future research should focus on gaining a better understanding of the variables that may influence platelet serotonin levels in the ACS population. ^

Differences in performance for quality of care indicators for acute myocardial infarction (AMI) across various hospital categories in Texas

The study analyzed Hospital Compare data for Medicare Fee-for-service patients at least 65 years of age to determine whether hospital performance for AMI outcome and processes of care measures differ amongst Texas hospitals with respect to ownership status (for profit vs. not-for-profit), academic status (teaching vs. non-teaching) and geographical setting (rural vs. urban). ^ The study found a statistically significant difference between for-profit and not-for-profit hospitals in four process-of-care measures (aspirin at discharge, P=0.028; ACE or ARB inhibitor for LSVD, P=0.048; Smoking cessation advice: P=0.034; outpatients who got aspirin with 24 hours of arrival in the ED, P=0.044). No significant difference in performance was found between COTH-member teaching and non-teaching hospitals for any of the eight process-of-care measures or the two outcome measures for AMI. The study was unable to compare performance based on geographic setting of hospitals due to lack of sufficient data for rural hospitals. ^ The results of the study suggest that for-profit Texas hospitals might be slightly better than not-for –profit hospitals at providing possible heart attack patients with certain processes of care.^