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At least 307 records · Page 17Linked to original sources
PubMed1997

Impact of representative payees on substance use by homeless persons with serious mental illness.

OBJECTIVE: Assignment of representative payees, third parties responsible for managing clients' funds, has been proposed to counter potential use of public support payments for abused substances by people with severe mental illness and substance use disorders. This study examines substance use outcomes in a sample of homeless persons with serious mental illness and substance use disorders, some of whom were assigned representative payees. METHODS: The subjects were participating in the Access to Community Care and Effective Services and Supports (ACCESS) program, a federally funded demonstration program on integrating service systems. Clients were assessed at baseline and three months after case management services were initiated. Factorial repeated-measures analysis of covariance was used to examine substance use among four client subgroups, two of which had payees and two of which did not. RESULTS: Clients in this sample (N = 1,348) showed significant improvement on all measures of substance use over the first three months in the program. Those with payees showed no greater improvement in substance abuse than those without payees, although they did have fewer days of homelessness. CONCLUSIONS: This study failed to find evidence that merely adding external money management services to existing services improves substance abuse outcomes among clients who had dual diagnoses and were homeless. Besides assigning a payee, structured behavioral interventions may be needed to produce additional clinical benefits.

Adult↗
PubMed1996

Pediatric enteral access center: a multidisciplinary approach.

The need for enteral access and gastrostomy placement in children has increased dramatically over the past several years. In the following article, we present a case report of a typical patient undergoing evaluation for enteral nutrition and enteral access. Following the case report, we describe our newly formed Pediatric Enteral Access Program including patient selection, the method of gastrostomy placement, risks and benefits, cost analysis, and follow-up of this ever-increasing population of children.

Child Nutrition Disorders↗
PubMed1992

Didanosine.

OBJECTIVE: To review the chemistry, intracellular metabolism, pharmacokinetics, and clinical experience with didanosine (2',3'-dideoxyinosine [ddI]). DATA SOURCES: English-language articles and conference proceedings (indexing terms were didanosine, 2',3'-dideoxyinosine, and ddI). STUDY SELECTION: Available Phase I studies and abstracts determined to have clinical significance were included. DATA EXTRACTION: Clinical experience with ddI is limited to uncontrolled Phase I studies and a large "expanded-access" program. The primary outcome parameters used to evaluate ddI were the HIV surrogate markers: CD4+ lymphocytes and p24 antigen. Thus, the clinical data reviewed here must be evaluated critically and be considered preliminary until the results of studies comparing ddI with zidovudine (ZDV) and combination studies are available. DATA SYNTHESIS: Didanosine has been approved for the treatment of HIV infection in patients who are unable to tolerate ZDV because of adverse effects (e.g., anemia and neutropenia) or who experience clinical or immunologic deterioration while receiving ZDV. Compared with ZDV, ddI has a long intracellular half-life and negligible bone-marrow toxicity. It also has in vitro activity against ZDV-resistant strains of HIV. Phase I studies indicate that ddI has a beneficial effect on the CD4+ cell counts and HIV p24 antigen concentrations. As a result of the acid-labile nature of ddI, oral formulations are buffered or must be mixed with antacid to neutralize gastric pH. Bioavailability then averages 20-40 percent, depending on the dose and formulation given. The plasma half-life, total body clearance, and volume of distribution of ddI are one to two hours, 0.7-1 L/kg/h, and 0.8-1 L/kg, respectively. Painful peripheral neuropathy and pancreatitis (dose-limiting toxicities of ddI) occurred in 34 and 9 percent of patients in Phase I studies, respectively. CONCLUSIONS: Didanosine has demonstrated preliminary efficacy in the treatment of late-stage HIV infection; however, its effect on patient survival, its efficacy relative to ZDV, and its utility in combination with other agents are still under evaluation.

Acquired Immunodeficiency Syndrome↗
PubMed1993

Zalcitabine.

OBJECTIVE: To review the chemistry, intracellular metabolism, pharmacokinetics, and clinical trials of zalcitabine (2'3'-dideoxycytidine, ddC). DATA SOURCES: English-language articles and conference procedings. The indexing terms used were zalcitabine, 2'3'-dideoxycytidine, and ddC. STUDY SELECTION: In addition to the manufacturer's package insert, available Phase I and Phase I/II studies were reviewed. DATA EXTRACTION: Clinical experience with ddC has been limited to uncontrolled studies and an expanded-access program. Efficacy was evaluated solely on surrogate markers of HIV disease: CD4+ lymphocyte counts and p24 antigen determinations. Clinical endpoints, such as disease progression and survival rates, must be provided to the Food and Drug Administration (FDA) for continued approval. DATA SYNTHESIS: The FDA has approved use of ddC in combination with zidovudine (ZDV) as therapy of HIV infection for patients with CD4+ lymphocyte counts < or = 300 cells/mm3 who have experienced significant clinical or immunologic deterioration. Although ddC has the same mechanism of action as other nucleoside analogs, it is more potent on a molar basis. The drug is stable in gastric pH and has good bioavailability (approximately 70-90 percent), but is rapidly cleared from plasma (half life approximately 1-3 h). Intracellular concentrations of ddC triphosphate, the active form, are probably related to plasma concentrations, yet may persist in cells longer than the parent drug persists in plasma. When used as primary therapy in patients with CD4+ < or = 300 cells/mm3, ddC/ZDV increased CD4+ lymphocyte counts and reduced plasma p24 antigen concentrations. In comparison to ZDV monotherapy data taken from other studies, ddC/ZDV appeared to demonstrate a more pronounced and sustained increase in CD4+ cell counts; however, this observation cannot be confirmed until the results of ZDV-controlled comparisons are available. Overall, 17-31 percent of the patients receiving the currently recommended initial dosage of ddC experience peripheral neuropathy. CONCLUSIONS: In combination with ZDV, ddC appears to augment the CD4+ cell response of ZDV monotherapy in the treatment of HIV infection for ZDV-naive patients, although controlled studies and rigorous statistical analyses are lacking at present. The efficacy of ddC/ZDV in patients who received prior treatment with ZDV monotherapy is unclear at the present.

Adolescent↗
PubMed1993

High perinatal and neonatal mortality in rural India.

A prospective study conducted in rural India on pregnant women showed poor utilization of primary health services and very poor maternal care receptivity especially in terms of antenatal care. A very high perinatal mortality rate of 81.3/1000 live births and a neonatal mortality rate of 63.7/1000 live births was observed in the present study. Out of 204 live births, 72.05% of newborn developed complications within 6 weeks of the delivery. Most of the complications were of a minor nature and could be attributed to poor environmental conditions, lack of personal hygiene and ignorance. The study highlights the need for training of grass root level workers for the improvement of perinatal and neonatal care in rural India.

Female↗
PubMed2004

Advances in endovascular techniques to treat failing and failed hemodialysis access.

During the decade since JEVT was inaugurated, we have witnessed the growing application of endovascular techniques for arteriovenous (AV) access in parallel with the evolution of endovascular therapy for arterial pathology. To date, few if any technologies have compared with balloon angioplasty for treating venous anastomotic stenosis, the most common cause of access failure. Only one device, which incorporates the principles of access graft design and self-expanding stent technology, has been uniquely conceived for this pathology. The encapsulated polytetrafluoroethylene stent-graft has achieved reasonable preliminary results, but randomized data is forthcoming. Technology to clear the clot from a thrombosed graft continues to evolve, but will never be as cost-effective as simple balloon thrombectomy. However, the pressure placed on providers to perform all percutaneous interventions and move away from open techniques continues to fuel interest in this component of treatment. Finally, the pursuit of a completely percutaneous AV access continues. As with endovascular procedures in general, whether or not the procedure is cost-effective or time-consuming seems to take a back seat to the all-percutaneous approach that so many seem to converge upon. Moreover, as most autogenous fistulas and AV grafts can be created with minimal incisions under local anesthesia, the pursuit of a completely percutaneous access system seems more like an academic exercise than a practical application of technology. We must try and avoid the tendency to "minimize invasiveness" with technology that is maximally intensive (and expensive), such as limiting ourselves to only percutaneous methods. Given the increasing pressure to have an all autogenous access program, current techniques that apply well in prosthetic grafts will need to be modified to accommodate the different biology of a native fistula. Clearly, the enlarging end-stage renal disease population will continue to provide endovascular specialists with clinically challenging problems requiring new and revolutionary technology.

Angioplasty, Balloon↗
PubMed2005

GASH: an improved algorithm for maximizing the number of equivalent residues between two protein structures.

BACKGROUND: We introduce GASH, a new, publicly accessible program for structural alignment and superposition. Alignments are scored by the Number of Equivalent Residues (NER), a quantitative measure of structural similarity that can be applied to any structural alignment method. Multiple alignments are optimized by conjugate gradient maximization of the NER score within the genetic algorithm framework. Initial alignments are generated by the program Local ASH, and can be supplemented by alignments from any other program. RESULTS: We compare GASH to DaliLite, CE, and to our earlier program Global ASH on a difficult test set consisting of 3,102 structure pairs, as well as a smaller set derived from the Fischer-Eisenberg set. The extent of alignment crossover, as well as the completeness of the initial set of alignments are examined. The quality of the superpositions is evaluated both by NER and by the number of aligned residues under three different RMSD cutoffs (2,4, and 6A). In addition to the numerical assessment, the alignments for several biologically related structural pairs are discussed in detail. CONCLUSION: Regardless of which criteria is used to judge the superposition accuracy, GASH achieves the best overall performance, followed by DaliLite, Global ASH, and CE. In terms of CPU usage, DaliLite CE and GASH perform similarly for query proteins under 500 residues, but for larger proteins DaliLite is faster than GASH or CE. Both an http interface and a simple object application protocol (SOAP) interface to the GASH program are available at http://www.pdbj.org/GASH/.

Algorithms↗
PubMed2004

Recent developments in national Aboriginal and Torres Strait Islander health strategy.

In this paper I will describe some of the sentinel events in Aboriginal and Torres Strait Islander health policy and strategy during 2003 and the early part of 2004. This will involve discussion on the:* National Strategic Framework in Aboriginal and Torres Strait Islander Health* National Strategic Framework for Aboriginal and Torres Strait Islander Peoples Mental Health and Social and Emotional Well Being 2004-2009* National Aboriginal and Torres Strait Islander Health Performance Framework* The roll-out of the Primary Health Care Access Program* The National Aboriginal and Torres Strait Islander Social Survey and the National Indigenous Health SurveyThese developments are consistent with a policy agenda that has evolved, in general terms, since the release of the National Aboriginal Health Strategy in 1989. However, I will also consider significant developments in the broader context for Aboriginal and Torres Strait Islander affairs, particularly the decision made in early 2004 by the Howard government to abolish the Aboriginal and Torres Strait Islander Commission (ATSIC). While the key events and developments that are reported in this paper elaborate on an agenda that has been developing for more than a decade, the decision to abolish ATSIC is likely to have a revolutionary impact on the future development of Aboriginal health strategy.

Editorial↗
PubMed2005

DAS28 best reflects the physician's clinical judgment of response to infliximab therapy in rheumatoid arthritis patients: validation of the DAS28 score in patients under infliximab treatment.

This study is based on an expanded access program in which 511 patients suffering from active refractory rheumatoid arthritis (RA) were treated with intravenous infusions of infliximab (3 mg/kg+methotrexate (MTX)) at weeks 0, 2, 6 and every 8 weeks thereafter. At week 22, 474 patients were still in follow-up, of whom 102 (21.5%), who were not optimally responding to treatment, received a dose increase from week 30 onward. We aimed to build a model to discriminate the decision to give a dose increase. This decision was based on the treating rheumatologist's clinical judgment and therefore can be considered as a clinical measure of insufficient response. Different single and composite measures at weeks 0, 6, 14 and 22, and their differences over time were taken into account for the model building. Ranking of the continuous variables based on areas under the curve of receiver-operating characteristic (ROC) curve analysis, displayed the momentary DAS28 (Disease Activity Score including a 28-joint count) as the most important discriminating variable. Subsequently, we proved that the response scores and the changes over time were less important than the momentary evaluations to discriminate the physician's decision. The final model we thus obtained was a model with only slightly better discriminative characteristics than the DAS28. Finally, we fitted a discriminant function using the single variables of the DAS28. This displayed similar scores and coefficients as the DAS28. In conclusion, we evaluated different variables and models to discriminate the treating rheumatologist's decision to increase the dose of infliximab (+MTX), which indicates an insufficient response to infliximab at 3 mg/kg in patients with RA. We proved that the momentary DAS28 score correlates best with this decision and demonstrated the robustness of the score and the coefficients of the DAS28 in a cohort of RA patients under infliximab therapy.

Antibodies, Monoclonal↗
PubMed2003

Do clinicians use online evidence to support patient care? A study of 55,000 clinicians.

OBJECTIVES: To determine clinicians' (doctors', nurses', and allied health professionals') "actual" and "reported" use of a point-of-care online information retrieval system; and to make an assessment of the extent to which use is related to direct patient care by testing two hypotheses: hypothesis 1: clinicians use online evidence primarily to support clinical decisions relating to direct patient care; and hypothesis 2: clinicians use online evidence predominantly for research and continuing education. DESIGN: Web-log analysis of the Clinical Information Access Program (CIAP), an online, 24-hour, point-of-care information retrieval system available to 55,000 clinicians in public hospitals in New South Wales, Australia. A statewide mail survey of 5,511 clinicians. MEASUREMENTS: Rates of online evidence searching per 100 clinicians for the state and for the 81 individual hospitals studied; reported use of CIAP by clinicians through a self-administered questionnaire; and correlations between evidence searches and patient admissions. RESULTS: Monthly rates of 48.5 "search sessions" per 100 clinicians and 231.6 text hits to single-source databases per 100 clinicians (n = 619,545); 63% of clinicians reported that they were aware of CIAP and 75% of those had used it. Eighty-eight percent of users reported CIAP had the potential to improve patient care and 41% reported direct experience of this. Clinicians' use of CIAP on each day of the week was highly positively correlated with patient admissions (r = 0.99, p < 0.001). This was also true for all ten randomly selected hospitals. CONCLUSION: Clinicians' online evidence use increases with patient admissions, supporting the hypothesis that clinicians' use of evidence is related to direct patient care. Patterns of evidence use and clinicians' self-reports also support this hypothesis.

Attitude to Computers↗
PubMed2006

Phase II study of pemetrexed plus carboplatin in malignant pleural mesothelioma.

PURPOSE: This multicenter, phase II clinical study was conducted to evaluate the activity of the combination of pemetrexed and carboplatin in patients with malignant pleural mesothelioma (MPM). PATIENTS AND METHODS: Chemotherapy-naive patients with measurable disease and adequate organ function, who were not eligible for curative surgery, received pemetrexed 500 mg/m2 and carboplatin area under the plasma concentration-time curve of 5 mg/mL/min, administered intravenously every 21 days. All patients received folic acid and vitamin B12 supplementation. Pemetrexed was provided within the Expanded Access Program. RESULTS: A total of 102 patients were enrolled. An objective response was achieved in 19 patients (two complete and 17 partial responses), for a response rate of 18.6% (95% CI, 11.6% to 27.5%). Forty-eight patients (47.0%; 95% CI, 37.1% to 57.2%) had stable disease after treatment. Overall, 67 patients (65.7%) achieved disease control (95% CI, 55.6% to 74.8%). Median time to progression was 6.5 months; median overall survival time was 12.7 months. Compliance to treatment was excellent, with a relative dose-intensity of 97% for pemetrexed and 98% for carboplatin. Toxicity was mild, with grade 3 or 4 neutropenia occurring in 9.7% of total cycles and grade 3 or 4 anemia occurring in 3.5% of total cycles. Nonhematologic toxicity was negligible. CONCLUSION: Treatment with pemetrexed and carboplatin was active and well tolerated in patients with MPM. Disease control rate, time to disease progression, and overall survival were similar to the results achieved with the standard regimen of pemetrexed and cisplatin, suggesting that the carboplatin combination could be an alternative option for these patients.

Aged↗
PubMed2007

Economics of new oncology drug development.

PURPOSE: Review existing studies and provide new results on the development, regulatory, and market aspects of new oncology drug development. METHODS: We utilized data from the US Food and Drug Administration (FDA), company surveys, and publicly available commercial business intelligence databases on new oncology drugs approved in the United States and on investigational oncology drugs to estimate average development and regulatory approval times, clinical approval success rates, first-in-class status, and global market diffusion. RESULTS: We found that approved new oncology drugs to have a disproportionately high share of FDA priority review ratings, of orphan drug designations at approval, and of drugs that were granted inclusion in at least one of the FDA's expedited access programs. US regulatory approval times were shorter, on average, for oncology drugs (0.5 years), but US clinical development times were longer on average (1.5 years). Clinical approval success rates were similar for oncology and other drugs, but proportionately more of the oncology failures reached expensive late-stage clinical testing before being abandoned. In relation to other drugs, new oncology drug approvals were more often first-in-class and diffused more widely across important international markets. CONCLUSION: The market success of oncology drugs has induced a substantial amount of investment in oncology drug development in the last decade or so. However, given the great need for further progress, the extent to which efforts to develop new oncology drugs will grow depends on future public-sector investment in basic research, developments in translational medicine, and regulatory reforms that advance drug-development science.

Antineoplastic Agents↗
PubMedDate not supplied

Predictors of virological response to atazanavir in protease inhibitor-experienced patients.

BACKGROUND: Atazanavir (ATV) is the latest approved HIV protease inhibitor (PI). Even though it is very convenient (only two capsules once a day), concerns have risen about its potency. METHOD: The clinical performance of ATV 400 mg once a day was examined in all PI-experienced patients who were included in the ATV expanded access program conducted in a single institution. The predictive value of baseline drug resistance HIV genotypes, ATV plasma trough levels, and the genotypic inhibitory quotient (GIQ) on the virological response at week 24 was assessed. RESULTS: Data from 92 patients were analyzed. ATV was prescribed as part of a rescue intervention (45%), a simplification strategy (11%), or an attempt to ameliorate hyperlipidemias (23%) or other toxicities (16%). Tenofovir (TDF) was concomitantly used with ATV in 78% of patients. None received ritonavir boosting. In patients with detectable viremia at baseline (65%), the median HIV RNA drop was 0.7 logs. The median ATV Cmin was 0.12 microg/mL (IQR, 0.05-0.22 microg/mL), which is clearly above the IC90 (90% inhibitory concentration) for ATV in wild-type viruses. The virological response did not correlate significantly with ATV Cmin. The median number of protease resistance mutations was lower in patients showing virological response than in nonresponders (1 vs. 5; p=.07). A higher HIV RNA drop was associated with a higher GIQ (p=.02; beta=-5.4; 95% CI, -10 to -1). Only 4 patients (4%) discontinued treatment due to ATV-related toxicities (hyperbilirubinemia in 1). Bilirubin levels were associated with ATV plasma concentrations (p=.05; beta=3.2; 95% CI, -0.1 to 6.5). The rate of hypertriglyceridemia and hypercholesterolemia declined significantly with respect to baseline. CONCLUSION: ATV is relatively safe and provides significant virological response in PI-experienced patients, mainly among those with a low number of protease resistance mutations. The GIQ predicts accurately the virological response in patients receiving ATV. Hyperbilirubinemia is associated with higher ATV plasma levels.

Adult↗
PubMedDate not supplied

Clinical impact of double protease inhibitor boosting with lopinavir/ritonavir and amprenavir as part of salvage antiretroviral therapy.

PURPOSE: Double protease inhibitor (PI) boosting is being explored as a new strategy in salvage antiretroviral (ARV) therapy. However, if a negative drug interaction leads to decreased drug levels of either or both PIs, double PI boosting could lead to decreased virologic response. A negative drug interaction has been described between amprenavir (APV) and lopinavir/ritonavir (LPV/r). This observational cohort study assessed the virologic impact of the addition of APV to a salvage ARV regimen, which also contains LPV/r, compared to a regimen containing LPV/r alone. METHOD: Patients initiated on a salvage ARV regimen that included LPV/r obtained from the expanded access program in Toronto, Canada, were evaluated. APV (600-1,200 mg bid) was added at the discretion of the treating physician. RESULTS: Using multivariate Cox proportional hazards models, we found that the addition of APV to a LPV/r-containing salvage regimen was not significantly associated with time to virologic suppression (< 50 copies/mL; adjusted hazard ratio [HR] = 0.75, p =.12) or with time to virologic rebound (adjusted HR = 1.46, p =.34). Those patients who received higher doses of APV had an increased chance of virologic suppression (p =.03). In a subset of 27 patients, the median LPV C(trough) was significantly lower in patients receiving APV (p =.04), and the median APV C(trough) was reduced compared to reported controls. CONCLUSION: Our data do not support an additional benefit in virologic reduction of double boosting with APV and LPV/r relative to LPV/r alone in salvage ARV therapy. Our study's limitations include its retrospective nature and the imbalance between the two groups potentially confounding the results. Although these factors were adjusted for in the multivariate analysis, a prospective randomized controlled trial is warranted to confirm our findings.

Adult↗
PubMedDate not supplied

Salvage treatment with lopinavir/ritonavir (Kaletra) in HIV-infected patients failing all current antiretroviral drug families.

BACKGROUND: Lopinavir/ritonavir (Kaletra) is the latest available protease inhibitor (PI). It has shown greater potency than the former PIs in phase II/III trials, either in naive or in PI-experienced patients being naive for nonnucleoside reverse transcriptase inhibitors (NNRTIs). METHOD: We analyzed the first 138 patients recruited during the expanded access program in an HIV/AIDS reference center. Only patients who had significant past exposure to all three different antiretroviral drug families and who were failing their current regimens were chosen. RESULTS: A total of 93 and 76 patients completed, respectively, 3 and 6 months of follow-up. Mean plasma HIV RNA log(10) copies/mL before beginning Kaletra was 4.04 +/- 1.1 and mean CD4 count was 285 +/- 197 cells/mL. Overall, 76.3% and 63.2% of patients showed a significant virologic response (defined as >1 log reduction in plasma HIV RNA and/or a reduction to less than 500 HIV RNA copies/mL) at 3 and 6 months, respectively. The mean CD4 increase was +77.3 cells/mL at 6 months. Thirteen individuals did not complete 6 months on therapy: there were 2 deaths (1 was non-AIDS related), 2 patients were lost to follow-up, 7 patients withdrew due to potential drug adverse events, and 2 patients withdrew due to complications of intercurrent illnesses. Triglyceride levels significantly increased 3 months after initiation of Kaletra (+70 mg/dL; p =.04) while cholesterol levels remained stable (+7.7 mg/dL; p =.7). Sequence analysis at baseline showed a median number of PI mutations of 4 (0 to 12). Overall, 45% of patients harbored >/=5 PI mutations. Attainment of plasma HIV RNA <500 copies/mL occurred in 88% of patients with </=5 PI mutations but only in 48% of those harboring >5 PI mutations (p <.001). Baseline mutations at codons 71 and 82 were associated with a lower response to Kaletra. CONCLUSION: Kaletra is relatively well tolerated and provides potent antiviral activity in heavily pretreated patients. Significant virological responses are seen in more than three quarters of patients at 3 months. Genotyping at the time of initiation of salvage therapy with Kaletra might help to predict which individuals will experience a greater benefit.

Adult↗