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PubMed2005

Open-label study of pemetrexed alone or in combination with cisplatin for the treatment of patients with peritoneal mesothelioma: outcomes of an expanded access program.

BACKGROUND: To date, few large studies have been reported of patients with peritoneal mesothelioma, and treatment of this disease has been largely extrapolated from the treatment of pleural disease. Hence, it was considered important to study and report on this specific patient population. Before the regulatory approval of pemetrexed, an expanded access program (EAP) provided access to eligible patients with malignant pleural or peritoneal mesothelioma. PATIENTS AND METHODS: Patients received pemetrexed 500 mg/m2 alone or in combination with cisplatin 75 mg/m2 once every 21 days for > or = 6 cycles. All patients received folic acid, vitamin B12, and steroid prophylaxis. Serious adverse events (SAEs) were compiled in a pharmacovigilance database, which included all patients in the EAP with pleural or peritoneal mesothelioma. From June 12, 2002 to February 18, 2004, 1056 patients with malignant mesothelioma were enrolled and received > or = 1 dose of treatment at 462 sites in the United States. Of these patients, 98 (9.3%) had peritoneal mesothelioma (57 previously treated, 38 chemotherapy-naive, and 3 with missing data). RESULTS: Response data were available for 73 patients (43 previously treated, 28 chemotherapy-naive, and 2 not classified), indicating response rates of 23.3% for previously treated patients (0 complete responses [CRs], 10 partial responses [PRs], 21 cases of stable disease [SDs], 12 cases of progressive disease [PDs]) and 25% for chemotherapy-naive patients (3 CRs, 4 PRs, 12 SDs, and 9 PDs). Median survival was 13.1 months for previously treated patients and has not been reached for chemotherapy-naive patients. The most commonly reported SAEs for the total EAP were dehydration (7.2%), nausea (5.2%), and vomiting (4.9%). CONCLUSION: Pemetrexed with or without cisplatin had a favorable safety profile, and the disease control rate (CR + PR + SD) of 71.2% in the subset of patients with peritoneal mesothelioma indicated activity in this patient population.

Adult↗

PubMed1999

The impact of a community-wide vascular access program on the management of graft thromboses in a dialysis population of 495 patients.

BACKGROUND: The unpredictability of prosthetic vascular access thrombosis precludes the scheduling of elective graft thrombectomy. This results in inconsistent dialysis for patients, as well as logistical challenges for dialysis clinics and surgeons, and increased cost. In an effort to solve this problem a community-wide, prospective vascular access program (VAP) was established. This study evaluates the impact of the VAP by comparing the operative procedures and outcomes of vascular access surgery performed in the community before and after establishment of the program. METHODS: All 17 surgeons who perform vascular access, representing five independent practice groups in Greenville, South Carolina, formed a VAP in November 1996. Dialysis patients were pooled, and all graft thrombectomies were managed on a rotational basis by a surgeon assigned daily to a specifically designated access thrombectomy operating room. The hospital records of all patients undergoing vascular access procedures from November 1, 1995, through October 31, 1996 (pre-VAP), and November 1, 1996, through October 31, 1997 (post-VAP), were reviewed. RESULTS: Comparison of the pre-VAP and post-VAP groups showed no significant difference in the number of patients undergoing vascular access procedures (391 versus 378), number of vascular access procedures performed (1034 versus 1,048), or average number of vascular access procedures performed per patient (2.64 versus 2.79). There was no statistical difference in the number of thrombectomies and revisions (786 versus 765; P = 0.114) or thrombectomies alone (248 versus 283; P = 0.114) in the pre-VAP and post-VAP groups. There was a significant increase in the number of procedures performed on an outpatient basis in the post-VAP group (757; 73%) compared with the pre-VAP group (575; 56%); P <0.001. There was also a significant difference in the percentage of cases performed after 6:00 PM in the pre-VAP group (262; 25%) compared with the post-VAP group (48; 4.5%; P = 0.001). CONCLUSIONS: Dialysis graft thrombosis, occurring in 75% of our patients annually, represents a substantial logistical dilemma necessitating the incorporation of 1,000 additional operations into a busy elective surgery schedule. An organized VAP reduces inpatient hospitalization, minimizes expensive after hours surgery, and enhances patient and physician convenience while providing a mechanism to monitor clinical outcomes and assure timely dialysis.

Ambulatory Surgical Procedures↗

PubMed2002

Successful program maintenance when federal demonstration dollars stop: the ACCESS program for homeless mentally ill persons.

A major issue that has long dogged federal human services demonstration programs is the perception that when federal dollars end, the programs end-regardless of any proven successes. Access to Community Care and Effective Services and Supports (ACCESS) was a 5-year federal demonstration project to foster partnerships between service providers for homeless people with serious mental illness and co-occurring substance abuse disorders; and to identify effective, replicable systems integration strategies. After federal funding ended, research teams visited the ACCESS sites to determine which project elements remained and which strategies were used by the sites to continue ACCESS. This article describes ACCESS services and systems integration activities retained by the sites, new funding streams, and strategies used to obtain continued funding.

Community Mental Health Services↗

PubMedDate not supplied

Long-term effectiveness of the ACCESS program in linking community mental health services to homeless persons with serious mental illness.

This study examined the long-term effectiveness of the ACCESS (Access to Community Care and Effective Services and Supports) project on service utilization and continuity of care among homeless persons with serious mental illness. A 3-year longitudinal analysis, using Medicaid claims data, tracked behavioral health service utilization among 146 Medicaid-eligible participants in the Pennsylvania ACCESS program. Utilization patterns of inpatient, outpatient, and emergency department services for psychiatric and substance abuse treatment were examined during the year prior to, during, and one year after the implementation of the ACCESS project. Use of psychiatric ambulatory care significantly increased among intervention participants and remained greater following ACCESS intervention. Better continuity of care following hospitalization was achieved during and after the intervention. The number of days spent hospitalized significantly decreased during the intervention. These results suggest that the ACCESS intervention was effective in linking hard-to-reach homeless persons with serious mental illness to the community mental health service system, and that this effect was maintained after termination of the intervention.

Adult↗

PubMed2001

Vocational outcomes among formerly homeless persons with severe mental illness in the access program.

OBJECTIVE: This study examined the vocational outcomes of 4,778 formerly homeless individuals with severe mental illness who were enrolled in the Access to Community Care and Effective Services and Support (ACCESS) program, a multisite demonstration project designed to provide services to this population. METHODS: Participants were interviewed at the time of enrollment and again three months and 12 months later by trained researchers who were not part of the treatment team to determine their employment status. At 12 months, participants were also asked about the types of services they had received during the past 60 days. Multiple logistic regression analysis was used to predict employment at 12 months. RESULTS: ACCESS participants reported receiving relatively few job-related services. Nonetheless, modest but significant increases occurred between baseline and three months and between three months and 12 months in the total proportion of participants who were employed and who were employed full-time and in hourly earnings and estimated monthly earnings. The number of hours worked per week increased significantly between three months and 12 months. When the analysis controlled for site, study condition (whether the ACCESS site received or did not receive extra funds to improve service integration), minority status, addiction treatment, and mental health treatment, participants who were employed at 12 months were more likely to have received job training and job placement services. CONCLUSIONS: Programs that work with homeless mentally ill persons may better serve their clients by placing as great an emphasis on providing employment services as on providing housing and clinical treatment.

Adolescent↗

PubMed2005

The Chilean AIDS cohort: a model for evaluating the impact of an expanded access program to antiretroviral therapy in a middle-income country--organization and preliminary results.

Chile, middle-income country with 15 million people, began an expanded access program (EAP) to antiretroviral therapy (ART) in 2001. EAP provides ART, monitoring, and funding for management of associated complications in 32 points of care. A national cohort (Chilean AIDS Cohort [ChiAC]), enrolling 98% of these patients, was created for standardized treatment and impact evaluation. Information exchange is mainly through the Internet. By December 2004, the ChiAC had 4365 participants (83.3% male). At baseline, 47.5% had clinical AIDS, 26.2% were asymptomatic, 80.2% had a CD4 count <200 cells/mm and 58.2% were ART naive; in these patients, the most frequent regimen is zidovudine, lamivudine, and efavirenz. A 6-month follow-up in 1057 patients showed a global mortality of 5% (0.5% if patients were asymptomatic at baseline and 8.3% if patients had baseline AIDS). There was a similar risk of death if the baseline CD4 count was 100 to 200 cells/mm or >200 cells/mm ( approximately 1%), but this increased to 4.8% (relative risk [RR] = 5.2) and 10.7% (RR = 11.5) if the CD4 count was 51 to 100 cells/mm or <or=50 cells/mm, respectively. Discontinuation occurred in 7.7% of patients because of drug toxicity, and progression occurred in 2.9%. A successful EAP to ART with the resources of a middle-income country is possible. Early results are similar to those of industrialized countries. A national cohort allows better implementation and evaluation of the program and may be a useful model for other countries.

AIDS-Related Opportunistic Infections↗

PubMed2005

The Arkansas Southern Rural Access Program: strategies for improving health care in rural areas of the state.

Rural residents often have poorer health than their urban counterparts. Many factors, including the availability of rural health care providers, contribute to their poorer health status. The Arkansas Southern Rural Access Program offers innovative strategies for improving health care in rural areas of the state including assisting with recruitment and retention, developing rural health networks, nurturing rural health leaders, and facilitating the availability of development capital to enhance the rural health care infrastructure. This paper describes the program, its components and successes, as well as how these resources can be accessed by health care providers around the state.

Arkansas↗

PubMed2003

A description of the Southern Rural Access Program's practice management strategies.

CONTEXT: Many state, federal, and foundation resources have been invested in improving the recruitment of primary care providers to rural communities. The Southern Rural Access Program of the Robert Wood Johnson Foundation (RWJF) has provided varying levels of support to several southern states to assist with retention of those providers. PURPOSE: This study describes the strategies that 6 states used to develop and implement practice management technical assistance services for rural health care providers. METHODS: Practice managers in each of the 6 states were surveyed regarding how their service was structured, what types of entities were eligible, and the nature of the technical assistance offered. Information regarding what types of entities used the service, characteristics of the practices, and the number of practices served was also collected. FINDINGS: The survey results showed that almost half (46%) of all practices assisted were private stand-alone physician practices, with overall practice assessments being the practice management service rendered most often. Although the type of organisational home for the technical assistance services varied by state, overall states employed an average of 1.67 full-time equivalent practice managers (0.81 full-time equivalent supported by RWJF) and received an average of $136,055 per state from the RWJF for the 2-year period beginning April 2002 for practice management support. CONCLUSIONS: Overall, the study found that the type of organizational home did not appear to affect the type of technical assistance services offered. However, the type of orgnizational home did appear to affect what types of providers used the service, with trade associations assisting their members or constituents at least half the time.

Community Health Planning↗

PubMed2004

One-year housing arrangements among homeless adults with serious mental illness in the ACCESS program.

OBJECTIVE: This study examined the various living arrangements among formerly homeless adults with mental illness 12 months after they entered case management. METHODS: The study surveyed 5,325 clients who received intensive case management services in the Access to Community Care and Effective Services and Supports (ACCESS) program. Living arrangements 12 months after program entry were classified into six types on the basis of residential setting, the presence of others in the home, and stability (living in the same place for 60 days). Differences in perceived housing quality, unmet housing needs, and overall satisfaction were compared across living arrangements by using analysis of covariance. RESULTS: One year after entering case management, 37 percent of clients had been independently housed during the previous 60 days (29 percent lived alone in their own place and 8 percent lived with others in their own place), 52 percent had been dependently housed during the previous 60 days (11 percent lived in someone else's place, 10 percent lived in an institution, and 31 percent lived in multiple places), and 11 percent had literally been homeless during the previous 60 days. Clients with less severe mental health and addiction problems at baseline and those in communities that had higher social capital and more affordable housing were more likely to become independently housed, to show greater clinical improvement, and to have greater access to housing services. After the analysis adjusted for potentially confounding factors, independently housed clients were more satisfied with life overall. However, no significant association was found between specific living arrangements and either perceived housing quality or perceived unmet needs for housing. CONCLUSIONS: Living independently was positively associated with satisfaction of life overall, but it was not associated with the perception that the quality of housing was better or that there was less of a need for permanent housing.

Adult↗

PubMed2000

[Toxicity associated to efavirenz in HIV-infected persons enrolled in an expanded access program].

BACKGROUND: Efavirenz (EFV) is one of the latest antiretroviral compounds appeared in the market. Its toxicity profile is not well known. PATIENTS AND METHODS: The rate of adverse events was examined in 250 subjects enrolled in the expanded access program in a single institution located in Madrid, Spain. RESULTS: Adverse events grade >= 2 (WHO) were recorded in 33 (13.2%) persons. The most common were neuropsychiatric disorders (8.4%), cutaneous lesions (3.2%), and gastrointestinal problems (0.8%). The drug needed to be discontinued in 17 (6.8%) patients. CONCLUSION: The rate of adverse events grade moderate-to-severe in patients receiving EFV is relatively low (13. 4%), without evidence of cross-toxicity (i.e., rash by nevirapine). Neuropsychiatric and dermatological conditions are the most common, and ten to resolve spontaneously in two

Alkynes↗

PubMed2005

Use of the SF-8 to assess health-related quality of life for a chronically ill, low-income population participating in the Central Louisiana Medication Access Program (CMAP).

OBJECTIVES: The utility of the SF-8 for assessing health-related quality of life (HRQL) is demonstrated. Race and gender differences in physical component (PCS) and mental component (MCS) summary scores among participants in the CENLA Medication Access Program (CMAP), along with comparisons to the United States population are made. METHODS: Age-adjusted multiple linear regression analyses were used to compare 1687 CMAP participants to the US population. Internal race and gender comparisons, adjusting for age and the number of self reported diagnoses, were also obtained. The paired t-test was used to assess 6-month change in PCS and MCS scores for a subset of 342 participants. RESULTS: CMAP participants have PCS and MCS scores that are significantly 10-12 points lower than the US population, indicating lower self-reported HRQL. Females have significantly higher PCS and significantly lower MCS than males. African-Americans have significantly higher MCS than Caucasians. Significant increases in both PCS and MCS were observed for the subset of participants after 6 months of intervention. CONCLUSIONS: The expected lower baseline PCS and MCS measures and the expected associations with age and number of diagnoses indicate that the SF-8 survey is an effective tool for measuring the HRQL of participants in this program. Preliminary results indicate significant increases in both PCS and MCS 6 months after intervention.

Adult↗

PubMed2006

[Efficacy of gefitinib on advanced non-small cell lung cancer in expanded access program (EAP)].

BACKGROUND & OBJECTIVE: Gefitinib is a selective inhibitor of epidermal growth factor receptor (EGFR) tyrosine kinase, and has been used in treating advanced non-small cell lung cancer (NSCLC). This study was to evaluate the efficacy of Gefitinib on advanced NSCLC, and observe adverse events. METHODS: An open labeled, expanded access program (EAP) was conducted. Pathologically confirmed advanced NSCLC patients who had progressed after systemic chemotherapy or was not suitable for systemic chemotherapy were eligible for this program. Gefitinib (250 mg) was orally administered daily till disease progression or intolerable adverse events developed. RESULTS: From Sep. 2002 to Mar. 2005, 120 patients were enrolled, and 103 of them were assessable for response. The objective response rate was 18.4% (19/103). The disease control rate was 51.5% (53/103). The median survival time was 6 months (0.5-33 months). Adverse events were generally mild (grade I or II), including skin rash (30.1%), dry skin (12.6%), and diarrhea (25.2%). Two (1.9%) patients developed grade III elevation of serum glutamate pyruvate transaminase (SGPT). No grade IV adverse event occurred. CONCLUSION: Gefitinib is effective in treating advanced NSCLC, and the adverse events are mild.

Adenocarcinoma↗

PubMed2006

Asian ethnicity as a predictor of response in patients with non-small-cell lung cancer treated with gefitinib on an expanded access program.

BACKGROUND: The primary objective of this retrospective study was to investigate the potential role of East Asian ethnicity or origin in predicting response to gefitinib in advanced-stage non-small-cell lung cancer (NSCLC). PATIENTS AND METHODS: A chart review was done of all patients treated with gefitinib at M. D. Anderson Cancer Center on the Expanded Access Program. RESULTS: There were 223 patients with advanced-stage NSCLC who were enrolled. Of these, 182 received >or= 1 dose, and 160 were evaluable for response. The partial response rate was 8.8%, and the stable disease rate was 26.3%. Median time to progression was 2.5 months, and median survival was 6.8 months. The 1- and 2-year survival rates were 35.3% and 12.4%, respectively. Partial responses were seen in 7 of 12 patients (58.3%) of East Asian origin compared with 7 of 131 patients who were white (5.3%). This difference was statistically significant when controlling for histology, smoking status, hemoglobin, and diarrhea. Never smoking and diarrhea were also independent predictors of response. CONCLUSION: For the first time, in a multivariate analysis, we observed a positive relationship between East Asian origin and response to gefitinib. These findings might help determine which patients will likely benefit from gefitinib.

Adult↗

PubMed2006

Efficacy and safety of gefitinib in chemonaive patients with advanced non-small cell lung cancer treated in an Expanded Access Program.

Chemotherapy (CT) is recommended in numerous clinical guidelines for advanced non-small cell lung cancer (NSCLC) and offers improved survival over best supportive care. However, many patients with advanced NSCLC never receive CT because of advanced age, poor performance status, comorbidities, or patient refusal. The epidermal growth factor receptor tyrosine kinase inhibitor gefitinib has shown antitumor activity and a favorable toxicity profile in pretreated patients with recurrent advanced NSCLC and was made available in a worldwide Expanded Access Program (EAP) to >37,000 patients who did not respond to standard treatment or were ineligible for or refused CT. A retrospective chart review of 1671 consecutive patients enrolled at 11 sites in the US arm of the EAP identified 198 patients with advanced NSCLC who had not received previous CT. All patients were treated with gefitinib 250 mg/d until treatment failure or toxicity occurred. Patients were treated for a mean of 4.7 months. The most common adverse events were diarrhea (31.3%) and rash (31.3%). Complete and partial response rates were 0.7 and 5.6%, respectively, and 40.6% had stable disease. Median survival was 6 months, and estimated 1-year survival was 29.7%. The majority of patients did not receive subsequent CT.

Adult↗

PubMed2003

Antitumor activity and tolerability of gefitinib in patients with non-small-cell lung cancer treated in an expanded access program.

We present a series of cases that illustrate potential benefits of the targeted agent gefitinib for patients with advanced and heavily pretreated non-small-cell lung cancer (NSCLC). In 2 phase II clinical trials, 250 mg/day of gefitinib produced objective tumor response rates of 18% and 11%, with excellent tolerance in patients with advanced NSCLC who had previously received standard chemotherapy. Treatment with gefitinib also led to improvements in disease-related symptoms in approximately 40% of cases. Gefitinib is one of a class of agents that selectively inhibit the epidermal growth factor receptor-tyrosine kinase, which is aberrantly activated in many human solid tumors. Gefitinib treatment resulted in objective radiographic regressions of tumor and symptom improvement in patients with advanced, heavily pretreated NSCLC in clinical trials and in the Expanded Access Program. This series illustrates that the benefits of gefitinib are not limited to patients selected for clinical trial participation but can be generalized to the broader population of patients with NSCLC.

Aged↗

PubMed2000

Successful systems integration strategies: the access program for persons who are homeless and mentally ill.

In 1993, the Access to Community Care and Effective Services and Supports (ACCESS) federal demonstration program was initiated. Using a quasi-experimental design, the 5-year demonstration program sought to assess the impact of integrated systems of care on outcomes for homeless persons with mental illness. The authors report on which integration strategies were chosen and how their implementation is quantified. Data collected primarily through annual site visits revealed that only two strategies were used by all nine systems. The systems integration strategies employed remained relatively stable over the 5 years. Successful implementation appears to be related to the strategies selected.

Delivery of Health Care, Integrated↗

PubMedDate not supplied

Peritoneal dialysis underutilization: the impact of an interventional nephrology peritoneal dialysis access program.

Peritoneal dialysis (PD) is an underutilized form of renal replacement therapy. Recent data have emphasized that only 12% of end-stage renal disease (ESRD) patients are initiated on this form of therapy in the United States. Patients requiring PD have most often been referred to general surgeons for catheter placement. This has incurred additional delays in starting treatment and loss of decision-making control by the referring nephrologist. To address this issue, we developed and incorporated our own PD access placement program into the preexisting chronic kidney disease (CKD) education program. To date, 46 patients have undergone 71 procedures. These included 51 (72%) PD catheter insertions, 14 (20%) removals, and 6 (8%) repositioning procedures for poor drainage. PD catheter insertion was performed peritoneoscopically under local anesthesia and a Fogarty catheter was used to reposition a migrated catheter. All of the procedures were performed by nephrologists in a dedicated interventional nephrology (IN) laboratory. All six repositioning procedures failed to restore optimal drainage. Five of these patients had the catheter removed and a new catheter placed during the same procedure. Of these five patients, one had recurrence of poor drainage and opted for hemodialysis (HD). The sixth patient declined reinsertion and chose HD. Of the remaining seven removal procedures, three were due to fungal peritonitis, one due to bowel perforation, one due to severe depression, one due to transplant, and one catheter was removed at the request of the primary physician in a terminally ill patient. Eight of the 51 catheter insertions were during the initial admission of a catastrophic dialysis start. Two of these patients started acute PD and avoided catheter placement for HD. Thirty-seven of 46 patients have a functional PD catheter with a follow-up of 8.6 +/- 0.8 (mean +/- SE) months. During an 18-month period our PD population has increased from 43 to 80 patients. We conclude that a dedicated PD access placement program coupled with a CKD education program can have a dramatic impact on patient choice and PD growth.

Adult↗

PubMed2007

Implementation of an antiretroviral access program for HIV-1-infected individuals in resource-limited settings: clinical results from 4 African countries.

BACKGROUND: We assessed the effectiveness and safety of highly active antiretroviral therapy (HAART) in HIV-1-infected patients in resource-limited African countries. HIV-1 screening, therapy, counseling, monitoring, training, and education were provided free of charge. METHODS: In an open-label cohort program, 206 antiretroviral-naive HIV-1-infected patients who could not afford HAART were recruited in 4 urban clinics in Senegal, Côte d'Ivoire, Uganda, and Kenya and were treated with saquinavir boosted with ritonavir (1600/100 mg once daily), lamivudine (150 mg twice daily), and zidovudine (300 mg twice daily). The primary outcome was a plasma viral load (pVL) of <400 copies/mL after 96 weeks of treatment. Secondary analyses included CD4 cell count changes and the occurrence of treatment-emergent adverse events. RESULTS: The median age of the patient group was 36 years, 38% were male, 35% of the patients had AIDS, the median CD4 count was 119 cells/microL, and the median pVL was 304,210 copies/mL. Overall, 65%/52% (on treatment [OT]/intent to treat [ITT]) of the patients had a pVL <400 copies/mL after 96 weeks of follow-up. This proportion varied significantly between sites, however; although in Nairobi and Dakar, 51%/40% and 56%/46% (OT/ITT) were found, respectively, Abidjan and Kampala showed proportions of 69%/54% and 83%/69% (OT/ITT), respectively. The median increase in the CD4 count was 198 cells/microL (interquartile range: 86-319 cells/microL), ranging from 191 to 292 cells/microL between the sites. Fourteen patients (6.8%) died between 8 and 96 weeks of follow-up, whereas 18 (9%) developed an AIDS-defining event between 8 and 96 weeks of follow-up. Non-HIV-related serious adverse events occurred in 55 patients (26.7%), of whom 13 were diagnosed with severe anemia. Thirty-five patients (17%) changed treatment for toxicity reasons. CONCLUSIONS: Although a statistically significant difference was observed between sites with respect to virologic success, overall virologic and immunologic responses to HAART in resource-limited African settings can be as good as in Western settings. There were some difficulties (eg, laboratory, logistics, proper training) during the early phase of the program. Therefore, provision of adequate medical care, counseling, proper instruction, and education of patients and medical staff during the entire study is warranted in such programs, with special care in the early phase.

Adult↗