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PubMed1983

Multicenter beta-blocker trials: certainties.

In general, therapeutic evaluation is based on a comparison between the 'treated' and the 'untreated'. The validity of the inference is based on the methods used in the formation of such groups. Randomized treatment allocation avoids selection bias and leads to interpretable statistical tests of significance. In addition, it defines the point in time at which follow-up starts. The use of placebo in a double-blind manner achieves comparability of information and also makes differences in the use of concomitant medication during follow-up interpretable as effects of the drug under study. Multicenter cooperation may enhance the representativeness of the data for the kind of patient to which the results may apply and makes it possible to check results for consistency between the clinics. These features of the design of recent beta-blocker trials in post-myocardial infarction patients enhance confidence in the results.

Adrenergic beta-Antagonists↗
PubMed1996

Delay in progression of bone metastases in breast cancer patients treated with intravenous pamidronate: results from a multinational randomized controlled trial. The Aredia Multinational Cooperative Group.

PURPOSE: Bone metastases are a major cause of morbidity in breast cancer, resulting in complications that include pain, loss of mobility, pathologic fracture, and tumor-induced hypercalcemia (TIH). Inhibition of osteoclast-mediated bone destruction using bisphosphonates represents a promising new management approach. PATIENTS AND METHODS: Breast cancer patients with bone metastases were randomly allocated to receive chemotherapy alone (152 patients) or chemotherapy plus pamidronate 45 mg in 250 mL of saline as a 1-hour intravenous infusion every 3 weeks (143 patients). Whenever possible, treatment continued until progression of disease (PD) in bone appeared on radiographs or bone scan. Time to PD in bone and pain reduction according to a self-assessment six-point scale were selected as primary end points. PD in bone was verified during extramural review (EMR) of all imaging studies by blinded observers, and these data were used as the main efficacy criterion. Analgesic intake, World Health Organization (WHO) performance status, and complications of bone metastases (radiotherapy, TIH, fractures, orthopedic surgery) were also compared in the two groups. RESULTS AND CONCLUSION: At EMR, median time to PD in bone was increased by 48% in patients who received pamidronate (249 v 168 days; P = .02, Wilcoxon test). Marked pain relief, defined as a two-point decrease lasting for > or = 6 weeks, was reported by 44% of pamidronate patients and by 30% of controls (P = .025, chi 2 test). The infusions (median, nine per patient; range, 0 to 39) were well tolerated, with no major toxicities reported. Pamidronate by repeated infusion can significantly slow the progression of bone metastases and reduce attendant morbidity.

Adult↗
PubMed1987

Human lymphoblastoid interferon for hairy cell leukemia: results from the Italian Cooperative Group.

Since April 1985, 82 patients with HCL entered a multicenter study using lymphoblastoid alpha-interferon; 51 (including 15 who failed splenectomy and 24 with substantial splenomegaly) enrolled before April 1986 are evaluated in this study. The patients were treated with 3 mega units daily subcutaneously until complete or partial response and were thereafter randomly allocated to a maintenance regime of 3 mega units/week or to observation only. Ten cases had a complete response, 18 a partial response, and 15 a minimal response. Two patients had no response, two interrupted therapy due to major toxicity (toxic hepatitis and thrombocytopenia), six died before completing 1 month of therapy of sepsis, and two died of myocardial infarction. In the two groups of splenectomized and nonsplenectomized patients the mean time to hemoglobin recovery was 8.5 and 6.5 weeks, respectively, the neutrophil count recovery was 6.5 and 9.3 weeks, and the time to platelet count recovery was 4.0 and 5.4 weeks, respectively. No significant differences in recovery time and response rate were observed between the two groups. In 31 out of 32 patients with substantial splenomegaly the spleen became either inpalpable (18) or significantly smaller (13). This study confirms the responsiveness of HCL to IFN in nonsplenectomized patients with high tumor burdens and is therefore recommended as a first-line therapy.

Humans↗
PubMed1986

Psychological impact of adjuvant chemotherapy in the first two years after mastectomy.

Psychological symptoms were assessed over two years in a randomised trial of three forms of treatment given to women after mastectomy for stage II breast cancer. The treatments were: three weeks' radiotherapy; one year's adjuvant chemotherapy with cyclophosphamide, methotrexate, and 5-fluorouracil; and radiotherapy followed by chemotherapy. Analysis of the results on an intention to treat basis showed no substantial differences in depression or anxiety among groups at one, three, or six months after the operation. At 13 months, however, patients who had been allocated chemotherapy had significantly more symptoms, especially depression, than control patients treated with radiotherapy alone. Conditioned reflex nausea and vomiting increased considerably during the second six months of chemotherapy and persisted for up to a year afterwards. The psychological morbidity of adjuvant chemotherapy could be substantially reduced if courses of treatment were restricted to about six months.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1979

Metabolic interaction between amitriptyline and perphenazine in psychiatric patients.

1. Steady-state plasma level samples of sixty-five schizophrenic patients from two psychiatric hospitals assigned to three treatment groups (amitriptyline 150 mg/day, perphenazine 20 mg/day and a combination of amitriptyline and perphenazine at 150 mg and 20 mg/day) were assayed for amitriptyline (AT), endogenous nortriptyline (NT) and perphenazine (PPZ) using gas-liquid chromatography. 2. Results reveal that AT and NT levels are independent of sex and hospital environment. 3. PPZ significantly increased the steady-state NT plasma levels, probably through inhibition of the hydroxylation biotransformation pathway, but had no effect on AT levels, thus indicating that PPZ has no influence on the desmethylation pathway, or alternatively, the hydroxylation of AT.

Adult↗
PubMed1984

Disability days associated with detection and treatment in a hypertension control program.

Labeling individuals as hypertensive has been associated with increased absenteeism from work. Distributions of disability days were compared for the years before and after screening for hypertension among 10,049 participants in a clinical trial of intensive antihypertensive therapy. Stepped care participants attended special clinics and referred care participants returned to their usual sources of medical care. For those unaware of their hypertension at screening, disability days increased between baseline and one year among referred care (n = 1805), while there was no change among stepped care (n = 1842) participants. Neither referred care (n = 1868) nor stepped care (n = 1906) participants who were aware but untreated at baseline reported a change in disability days over the following year. For those aware and treated at baseline, there was no change in disability days in referred care (n = 1275), but a decrease was reported in stepped care (n = 1353). Further descriptive analyses suggest that neither labeling alone nor treatment alone was associated with increased absenteeism. However, detection and treatment were associated with increased absenteeism among newly diagnosed referred care hypertensives, while management of previously treated hypertensives in stepped care clinics was associated with reduced absenteeism. Because these latter comparisons are made between groups stratified on a postrandomization variable, selection bias is possible and interpretations must be made with caution.

Absenteeism↗
PubMedDate not supplied

Editor's introduction.

Explore the source record for details and available documents.

AIDS Serodiagnosis↗
PubMed2000

Narrowing the gap.

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AIDS Serodiagnosis↗
PubMed2006

Conflict resolution in insect societies.

Although best known for cooperation, insect societies also manifest many potential conflicts among individuals. These conflicts involve both direct reproduction by individuals and manipulation of the reproduction of colony members. Here we review five major areas of reproductive conflict in insect societies: (a) sex allocation, (b) queen rearing, (c) male rearing, (d) queen-worker caste fate, and (e) breeding conflicts among totipotent adults. For each area we discuss the basis for conflict (potential conflict), whether conflict is expressed (actual conflict), whose interests prevail (conflict outcome), and the factors that reduce colony-level costs of conflict (conflict resolution), such as factors that cause workers to work rather than to lay eggs. Reproductive conflicts are widespread, sometimes having dramatic effects on the colony. However, three key factors (kinship, coercion, and constraint) typically combine to limit the effects of reproductive conflict and often lead to complete resolution.

Animals↗
PubMed2002

Integration of service systems for homeless persons with serious mental illness through the ACCESS program. Access to Community Care and Effective Services and Supports.

OBJECTIVE: The aim of this study was to evaluate the first of the two core questions around which the ACCESS (Access to Community Care and Effective Services and Supports) evaluation was designed: Does implementation of system-change strategies lead to better integration of service systems? METHODS: The study was part of the five-year federal ACCESS service demonstration program, which sought to enhance integration of service delivery systems for homeless persons with serious mental illness. Data were gathered from nine randomly selected experimental sites and nine comparison sites in 15 of the nation's largest cities on the degree to which each site implemented a set of systems integration strategies and the degree of systems integration that ensued among community agencies across five service sectors: mental health, substance abuse, primary care, housing, and social welfare and entitlement services. Integration was measured across all interorganizational relationships in the local service networks (overall systems integration) and across relationships involving only the primary ACCESS grantee organization (project-centered integration). RESULTS: Contrary to expectations, the nine experimental sites did not demonstrate significantly greater overall systems integration than the nine comparison sites. However, the experimental sites demonstrated better project-centered integration than the comparison sites. Moreover, more extensive implementation of strategies for system change was associated with higher levels of overall systems integration as well as project-centered integration at both the experimental sites and the comparison sites. CONCLUSIONS: The ACCESS demonstration was successful in terms of project-centered integration but not overall system integration.

Community Mental Health Services↗
PubMed2002

Impact of drotrecogin alfa (activated) on resource use and implications for reimbursement.

Selecting therapies in health care requires rigorous review of clinical and economic data. The financial implications of new clinical treatment options are an important component. The preferred method for evaluating the costs and effects of therapies is cost-effectiveness analysis along with an estimation of utility associated with the life-years gained. Preliminary reports suggest patients receiving drotrecogin alfa (activated) for severe sepsis have a faster resolution of cardiovascular and pulmonary dysfunction with minimal additional financial burden despite additional survivors. Furthermore, the reported cost/quality-adjusted life-year of $48,800 is consistent with many other common life-saving measures. Recently approved new technology payments for hospitals treating patients with drotrecogin alfa (activated) minimize financial impact. Clinicians and administrators should work collaboratively to optimize the therapy of patients with severe sepsis, minimize the financial impact on the health care system, and maximize the utility of drotrecogin alfa (activated).

APACHE↗