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PubMed2000

Childhood risk factors for criminal justice involvement in a sample of homeless people with serious mental illness.

It has been suggested that criminal justice involvement among the homeless, particularly those with mental illness, is largely situational. The objective of this study was to assess, in a sample of homeless seriously mentally ill people, the prevalence of childhood conduct disorder behaviors as a risk factor for adult criminal activity as well as the extent and types of adult criminal justice contact. Data were taken from the national ACCESS program, which conducted extensive baseline interviews with 7,222 homeless seriously mentally ill adults. The interview assessed demographics, childhood risk factors for criminal activity such as conduct disorder behaviors, foster care, and parental abuse, as well as current illness severity and recent criminal justice contact. The 2-month arrest rate in this sample was much higher than national rates (11% compared with 1% annually in the general population). Although most arrests were for minor crimes (10.8%), there were also substantial rates of arrest for major (2.7%) and substance-related charges (2.0%). The prevalence of a history of conduct disorder behavior was also substantial (55% in male subjects, 40% in female subjects), and conduct disorder was a strong predictor of recent criminal justice involvement, even after controlling for other predictors of arrest (odds ratio = 1.76 for major crimes, 1.49 for minor crimes, and 1.98 for substance-related crimes). Recent literature has criticized a trend to criminalize homeless mentally ill persons for attempting to get needed food, shelter, or medical attention. However, these data indicate that at least some proportion of arrests in this population are of people who have been exhibiting antisocial behavior since early adolescence, and that early antisocial behavior is a strong predictor of all types of recent arrests in this population.

Adult↗
PubMed2001

Does cisapride influence cardiac rhythm? Results of a United States multicenter, double-blind, placebo-controlled pediatric study.

BACKGROUND: Major concerns about serious cardiac side effects underlie the recent decision by the FDA and Janssen Pharmaceutica (Titusville, NJ) to make cisapride available only through a limited access program. Concerns have grown despite the fact that most instances of prolonged QTc and other ventricular arrhythmias occurred while the drug was used concomitantly with contraindicated drugs. This study sought to analyze electrocardiograms (ECGs) from a multicenter pediatric study and to identify abnormalities in QTc interval associated with cisapride use. METHODS: Children between 6 months and 4 years of age were enrolled if they manifested symptoms of gastroesophageal reflux not responding to medical therapy for at least 6 weeks. In 49 subjects, ECGs obtained before and after randomization to receive 0.2 mg/kg dose three times daily or placebo were reviewed independently and blindly by two pediatric cardiologists. Placebo and active drug groups were compared for QTc and for change in QTc from baseline values after 3 to 8 weeks of treatment. RESULTS: Mean QTc among patients taking the drug was 408+/-18 ms. None was higher than 450 ms. Change between baseline and subsequent QTc at 3 to 8 weeks of treatment was 2+/-20 ms. CONCLUSIONS: In our study group of children without underlying cardiac disease or electrolyte imbalance, cisapride was found to have no significant effect on cardiac electrical function compared with placebo. These results are consistent with the drug's record of exceedingly infrequent cardiac events. Because the availability of this prokinetic is threatened, its safety and the safety and efficacy of alternative treatment options (including surgery) should be studied further.

Arrhythmias, Cardiac↗
PubMed1999

Street outreach for homeless persons with serious mental illness: is it effective?

OBJECTIVES: This study examined data on case management clients who are homeless and have a severe mental illness to determine how those contacted through street outreach differ in their socio-demographic characteristics, service needs, and outcomes from those clients contacted in shelters and other health and social service agencies. METHODS: As part of the Center for Mental Health Services' Access to Community Care and Effective Services and Supports (ACCESS) program, data were obtained from potential clients over the first 3 years of the program at the time of the first outreach contact (n = 11,857), at the time of enrollment in the case management program (n = 5,431), and 3 months after enrollment (n = 4,587). RESULTS: Clients contacted at outreach on the street, as opposed to being contacted in shelters and service agencies, were generally worse off. They were more likely to be male, to be older, to spend more nights literally homeless before the contact, to have psychotic disorders, and took longer to engage in case management. They expressed less interest in treatment and were less likely to enroll in the case management phase of the project. Subjects contacted on the street who did enroll were more impaired than their street counterparts who did not enroll. Three month outcome data showed that enrolled clients contacted through street outreach showed improvement that was equivalent to those enrolled clients contacted in shelters and other service agencies on nearly all outcome measures. CONCLUSION: Street outreach to homeless persons with serious mental illness is justified as these clients are more severely impaired, have more basic service needs, are less motivated to seek treatment, and take longer to engage than those contacted in other settings. Street outreach is further justified as it engages the most severely impaired among the street population. Street outreach also appears to be effective as the clients reached in this way showed improvement equal to that of other clients in most outcome domains when baseline differences were taken into account.

Adult↗
PubMedDate not supplied

Changes in exercise capacity and lipids after clinic versus home-based aerobic training in coronary artery bypass graft surgery patients.

PURPOSE: Despite the documented benefits of participating in rehabilitation programs, access to cardiac rehabilitation is limited for a large number of people with coronary artery disease (CAD). There is potential to increase participation in exercise training if home-based exercise were a viable option. METHODS: We conducted a retrospective database review of 1,042 patients who took part in exercise rehabilitation following coronary artery bypass graft surgery (CABGS) between 1992 and 1998. Of these, 713 patients took part in supervised exercise, and 329 were in an unsupervised, home-based group. All exercise protocols were based upon American College of Sports Medicine guidelines, and patients in both groups received exercise prescriptions that were similar in intensity, frequency, and duration. RESULTS: There were no differences between groups at baseline. Following 6 months of exercise training, there were substantial improvements in peak VO2, peak workload, and peak MET levels in both the supervised and unsupervised groups (P < 0.0001). Patients in the supervised group had significant improvements in both LDL and HDL-cholesterol, whereas the home-based group showed improvement in HDL-cholesterol only. When analyzed by sex, men performed better than women for all measures of exercise capacity; however, women in both groups showed approximate 20% improvements (P < 0.05) in exercise capacity as well as improvements in HDL-cholesterol. CONCLUSION: Stable post CABGS patients who receive a detailed exercise prescription to follow at home do as well as those in supervised rehabilitation.

Aged↗
PubMed2000

Efavirenz- and adefovir dipivoxil-based salvage therapy in highly treatment-experienced patients: clinical and genotypic predictors of virologic response.

OBJECTIVE: To determine the impact of prior nonnucleoside reverse transcriptase inhibitor (NNRTI) therapy, genotypic resistance, and other variables on response to efavirenz (EFV)- and adefovir dipivoxil (ADV)-based salvage therapy. DESIGN: Retrospective clinical cohort study. SETTING: One university and one community-based HIV clinic. STUDY SUBJECTS: All 33 patients who were coenrolled in both the EFV and ADV expanded access programs. INTERVENTIONS: Patients received EFV 600 mg/day and ADV 120 mg/day in addition to other antiretroviral agents. OUTCOME MEASURE: HIV viral load (<500 copies/ml) at 12 and 24 weeks. RESULTS: 10 of 33 (30%) patients at 12 weeks and 8 of 33 (24%) patients at 24 weeks had viral loads <500 copies/ml. Prior NNRTI use and a history of any NNRTI-associated mutations predicted failure. Patients with Y181C or G190A single mutations had an initial greater magnitude of viral load suppression than those with K103N, but this advantage was short lived. No one with any NNRTI mutations responded with a viral load <500 copies/ml at 12 or 24 weeks. CONCLUSIONS: EFV/ADV-based salvage yielded viral load suppression at 24 weeks in 42% (8 of 19) of patients who were highly NRTI and protease inhibitor experienced but NNRTI naive. NNRTI-experienced study subjects had a poor response regardless of the specific NNRTI resistance mutation they harbored.

Adenine↗
PubMedDate not supplied

Bosentan.

Bosentan is the first endothelin (ET) receptor antagonist approved by the Food and Drug Administration for the management of pulmonary arterial hypertension (PAH). In patients with World Health Organization Class III and IV PAH, bosentan has demonstrated improvement in dyspnea and exercise tolerance. ET also plays an important role in the pathophysiology of different vascular diseases. Therefore, bosentan also may have the potential to alter the outcome of many other diseases, such as heart failure, hypertension, ischemic heart disease, and renal disease, as well as cerebrovascular disorders. Because of the rarity and the poor prognosis of patients with PAH, as well as the requirement of close monitoring of bosentan (due to its potential of causing liver dysfunction and its teratogenic effects), bosentan is currently available only through a special access program and is distributed by certain selected pharmacies. Patients who are receiving bosentan should be taught to recognize early signs and symptoms of liver dysfunction and possible pregnancy. In addition, bosentan is not only a substrate but also an inducer of CYP3A4 and CYP2C9. Therefore, it is anticipated that numerous drug interactions may occur. Patients should be advised to consult their physicians or pharmacists should they need to consume other prescription or nonprescription medications.

Antihypertensive Agents↗
PubMed2005

Incorporating economic evaluations into decision-making: the Ontario experience.

The Drug Quality and Therapeutics Committee (DQTC) and the Canadian Expert Drug Assessment Committee (CEDAC) make reimbursement recommendations to publicly funded outpatient drug plans in Ontario and Canada respectively. In this article, the organization and decision-making processes of these committees are described. Issues associated with these committees such as potential biases associated with pharmaceutical company submissions, transparency, restricted access programs, conditional listing, and price negotiation are discussed.

Cost-Benefit Analysis↗
PubMed2007

A database on treating drug addiction with traditional Chinese medicine.

AIMS: Traditional Chinese medicine (TCM) has been used to treat drug addiction for more than 160 years and valuable experiences have been accumulated with regard to patients' detoxification and rehabilitation. The aims of this project were (1) to establish a computerized, bilingual (Chinese-English) database on TCM for drug addiction; (2) to analyse the literature published in this field; and (3) to identify those Chinese herbs commonly used for drug addiction treatment. DESIGN: (1) Paper collection: related papers were collected through electronic databases and hand-searched materials; (2) data computerization: the Microsoft Access program and Delphi language were used as the major data management systems; (3) paper analysis: annual publications from 1989 to 2003 were classified and calculated; and (4) herbal analysis: the frequency of herbs used and herbal function categories were analysed. FINDINGS: (1) A special bilingual database that contained 340 works of professional literature, including 85 patent files on TCM for drug addiction, was established, in which more than 90% of the publications originated from mainland China; (2) the literature classification showed a significant increase in the number of publications on clinical and laboratory researches in this field over the past decade; (3) five functional categorizations of Chinese herbs and the 10 most frequently used Chinese herbs as well as three toxic herbs were identified from more than 200 herbs reported in 150 original research articles and 85 patent files. CONCLUSIONS: For the first time, the published data on TCM in the treatment of drug addiction were analysed systematically by using a new database. The results are invaluable for further laboratory and clinical studies to obtain more direct evidence.

Databases as Topic↗
PubMedDate not supplied

Arteriovenous fistula surgery: an American perspective from Italy.

Hemodialysis depends on durable, long-term vascular access for the patient. In the United States, arteriovenous fistula (AVF) creation rates are lower than they are in Europe. Excess morbidity and mortality has been attributed to reliance on catheters and prosthetic grafts. In Italy, there is a high rate of fistula creation, and they are predominantly created by nephrologists. As American interventional nephrologists become more involved in the procedural aspects of renal care, consideration should be given to replicating the Italian model of dialysis access creation. Specific aspects of the surgical technique, comparison to available literature, and potential reasons for higher fistula creation rates are explored from the vantage point of an American nephrologist visiting Italy. The pertinence to American dialysis access programs is discussed, as is the opportunity for interventional nephrologists in the United States to further expand and improve upon the successes of the Italian experience.

Arteriovenous Shunt, Surgical↗
PubMed1993

Use of health care services in two rural communities in Tanzania.

This study was undertaken to investigate the pattern of utilization of medical and dental health care services in rural Tanzania. Two hundred adults, 91 men and 109 women aged 20 or over, were interviewed. Nearly all subjects reported using modern dental and medical health care services. Home remedy was the only indigenous method of treatment used for dental problems while for medical problems a traditional healer was the most commonly used indigenous alternative. The use of both indigenous and modern health care services was significantly lower for dental than for medical problems (P < 0.05). It seems that the pattern of utilization of health care services differs for medical and dental problems. This should be taken into account when planning comprehensive health care services for rural African societies.

Adult↗
PubMed2003

Connecting our resources: Louisiana's approach to community health network development.

Louisiana's rural community health systems are in crisis because of pressures fueled by the rising costs of health care, sustained poor health status, state budget shortfalls and changes in priorities, and a sliding rural economy. The development of community health networks is providing new infrastructure and capacity for communities to reprioritize, formulate innovative partnerships, and leverage new resources. Successful elements of Louisiana's network development experience include community commitment to engage in study and action; the availability of capable and motivated technical assistance; an approach that involves open-engagement, community-driven decision-making; and data-driven problem definition, prioritization, and solutions. Louisiana's experiences illustrate the benefits of developing networks along with, or as a result of, a community health plan. When a community owns its health improvement plan, it is more likely to support the new network as a structure for implementation. Broad-scale participation is also a principle of success. When social service agencies are included along with health agencies, more comprehensive strategies result, and they bring additional resources, resulting in more holistic solutions. The cases of 2 networks are presented as illustrations. One involves the facilitation of a community planning process for an existing network. The plan helped to expand the network's community connections and support and provided the content for a successful application for a Health Resources and Services Administration Community Access Program grant. In the second case, a new network was developed, and it leveraged federal funds from the federal Office of Rural Health Policy's Network Development Grant Program.

Community Health Planning↗
PubMed2006

Three immunoproteasome-associated subunits cooperatively generate a cytotoxic T-lymphocyte epitope of Epstein-Barr virus LMP2A by overcoming specific structures resistant to epitope liberation.

The precise roles of gamma interferon-inducible immunoproteasome-associated molecules in generation of cytotoxic T-lymphocyte (CTL) epitopes have yet to be fully elucidated. We describe here a unique epitope derived from the Epstein-Barr virus (EBV) latent membrane protein 2A (LMP2A) presented by HLA-A*2402 molecules. Generation of the epitope, designated LMP2A(222-230), from the full-length protein requires the immunoproteasome subunit low-molecular-weight protein 7 (ip-LMP7) and the proteasome activator 28-alpha subunit and is accelerated by ip-LMP2, as revealed by gene expression experiments using an LMP2A(222-230)-specific CTL clone as a responder in enzyme-linked immunospot assays. The unequivocal involvement of all three components was confirmed by RNA interference gene silencing. Interestingly, the LMP2A(222-230) epitope could be efficiently generated from incomplete EBV-LMP2A fragments that were produced by puromycin treatment or gene-engineered shortened EBV-LMP2A lacking some of its hydrophobic domains. In addition, epitope generation was increased by a single amino acid substitution from leucine to alanine immediately flanking the C terminus, this being predicted by a web-accessible program to increase the cleavage strength. Taken together, the data indicate that the generation of LMP2A(222-230) is influenced not only by extrinsic factors such as immunoproteasomes but also by intrinsic factors such as the length of the EBV-LMP2A protein and proteasomal cleavage strength at specific positions in the source antigen.

Alanine↗
PubMed1993

Hope for Haiti?

Haiti, one of the world's five poorest nations, gets international attention because of the number of refugees who leave by boat in search of a better future. The 80,000 inhabitants of Ile de la Gonave are neglected, even in Haiti--there is no government medical post, and facilities in the health posts run by missions are minimal. Typhoid and cholera epidemics threaten the island. Médecins Sans Frontières plans to send staff and supplies and train local health workers.

Haiti↗
PubMed2004

United States Food and Drug Administration Drug Approval summary: Gefitinib (ZD1839; Iressa) tablets.

On May 5, 2003, gefitinib (Iressa; ZD1839) 250-mg tablets (AstraZeneca Inc.) received accelerated approval by the United States Food and Drug Administration as monotherapy for patients with locally advanced or metastatic non-small cell lung cancer after failure of both platinum-based and docetaxel chemotherapies. Information provided in this summary includes chemistry manufacturing and controls, clinical pharmacology, and clinical trial efficacy and safety results. Gefitinib is an anilinoquinazoline compound with the chemical name 4-quinazolinamine,N-(3-chloro-4-flurophenyl)-7-methoxy-6-[3-(4-morpholinyl)propoxy]. It has the molecular formula C(22)H(24)ClFN(4)O(3). Gefitinib is often referred to as a "specific" or "selective" inhibitor of epidermal growth factor receptor. Studies demonstrate, however, that gefitinib inhibits the activity of other intracellular transmembrane tyrosine-specific protein kinases at concentrations similar to those at which it inhibits the epidermal growth factor signal. Maximum plasma concentrations resulting from clinically relevant doses are 0.5-1 microM or more, well within the IC(50) values of several tyrosine kinases. No clinical studies have been performed that demonstrate a correlation between epidermal growth factor receptor expression and response to gefitinib. Gefitinib is 60% available after oral administration and is widely distributed throughout the body. Gefitinib is extensively metabolized in the liver by cytochrome P450 3A4 enzyme. Over a 10-day period, approximately 86% of an orally administered radioactive dose is recovered in the feces, with <4% of the dose in the urine. After daily oral administration, steady-state plasma levels are reached in 10 days and are 2-fold higher than those achieved after single doses. Gefitinib effectiveness was demonstrated in a randomized, double-blind, Phase II, multicenter trial comparing two oral doses of gefitinib (250 versus 500 mg/day). A total of 216 patients were enrolled. The 142 patients who were refractory to or intolerant of a platinum and docetaxel comprised the evaluable population for the efficacy analysis. A partial tumor response occurred in 14% (9 of 66) of patients receiving 250 mg/day gefitinib and in 8% (6 of 76) of patients receiving 500 mg/day gefitinib. The overall objective response rate (RR) for both doses combined was 10.6% (15 of 142 patients; 95% confidence interval, 6.0-16.8%). Responses were more frequent in females and in nonsmokers. The median duration of response was 7.0 months (range, 4.6-18.6+ months). Other submitted data included the results of two large trials conducted in chemotherapy-naive, stage III and IV non-small cell lung cancer patients. Patients were randomized to receive gefitinib (250 or 500 mg daily) or placebo, in combination with either gemcitabine plus cisplatin (n = 1093) or carboplatin plus paclitaxel (n = 1037). Results from this study showed no benefit (RR, time to progression, or survival) from adding gefitinib to chemotherapy. Consequently, gefinitib is only recommended for use as monotherapy. Common adverse events associated with gefitinib treatment included diarrhea, rash, acne, dry skin, nausea, and vomiting. Interstitial lung disease has been observed in patients receiving gefitinib. Worldwide, the incidence of interstitial lung disease was about 1% (2% in the Japanese post-marketing experience and about 0.3% in a United States expanded access program). Approximately one-third of the cases have been fatal. Gefitinib was approved under accelerated approval regulations on the basis of a surrogate end point, RR. No controlled gefitinib trials, to date, demonstrate a clinical benefit, such as improvement in disease-related symptoms or increased survival. Accelerated approval regulations require the sponsor to conduct additional studies to verify that gefitinib therapy produces such benefit.

Adolescent↗
PubMed2005

Predictors of the response to gefitinib in refractory non-small cell lung cancer.

Gefitinib, an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, has a response rate of 10% to 20% in refractory non-small cell lung carcinoma. Although female gender, adenocarcinoma, and never having smoked are possible markers of a favorable response, mutations of the EGFR gene have also been reported to be highly significant predictors of response. Seventy patients with relapsed non-small cell lung carcinoma were enrolled in the Expanded Access Program. After the drug became available commercially, 28 more patients were treated with gefitinib. Response evaluations were feasible in 80 patients. Twenty-seven tumor specimens (8 responders and 19 nonresponders) were available for the sequence analysis of the EGFR gene. The response rate was 25% (20/80) and the disease control rate (remission + stable disease) was 47.5% (38/80). The response rate was significantly higher for adenocarcinoma (41.0%) versus non-adenocarcinoma (9.8%, P = 0.001), in those who never smoked (58.8%) versus smokers (15.9%, P < 0.001), and in females (42.1%) versus males (19.7%, P = 0.049). A deletion or mutation of the EGFR gene was found in six of eight responders. Remission was noted in all patients with a mutation, whereas the response rate was 9.5% (2/21) in patients without a mutation (P < 0.001). The predictors of response showed significant correlations with survival and time to progression. In a multivariate logistic analysis, the independent predictors of response were smoking history and adenocarcinoma. Given that 9.5% of smokers and 6.7% of those with non-adenocarcinoma showed a mutation of the EGFR gene, the genetic profile may replace those variables as an independent predictor of a response.

Adenocarcinoma↗
PubMed2000

The case management relationship and outcomes of homeless persons with serious mental illness.

OBJECTIVE: The effect of the case management relationship on clinical outcomes was examined among homeless persons with serious mental illness. METHODS: The sample consisted of the first two cohorts that entered the Access to Community Care and Effective Services and Supports (ACCESS) program, a five-year demonstration program for mentally ill homeless persons funded by the Center for Mental Health Services in 1994. At baseline, three months, and 12 months, clients were characterized as not having a relationship with their case manager or as having a low or high therapeutic alliance with their case manager. Analyses were conducted to test the association between the case manager relationship at baseline, three months, and 12 months and clinical outcomes at 12 months. RESULTS: Multivariate analyses of covariance were conducted for 2,798 clients who had outcome data at 12 months. No significant associations were found between the relationship with the case manager at baseline and outcomes at 12 months. At three months, clients who had formed an alliance with their case manager had significantly fewer days of homelessness at 12 months. Clients who reported a high alliance with their case manager at 12 months had significantly fewer days of homelessness at 12 months than those with a low alliance, and those with a low alliance at 12 months had fewer days of homelessness than clients who reported no relationship with their case manager. Clients with a higher alliance at both three and 12 months reported greater general life satisfaction at 12 months. CONCLUSIONS: The study found that clients' relationship with their case manager was significantly associated with homelessness and modestly associated with general life satisfaction.

Adult↗