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PubMed1998

Classification of the Substances on the Basis of the Acute-Toxic-Class Method (ATC).

The acute-toxic-class method (ATC) is an alternative to the classical LD&inf50; test. Four substances were tested with an ATC testing procedure. The results were compared with LD&inf50; data obtained from the literature. Great importance was attached to the observations of toxic signs following administration. The results of this study have shown that the ATC method allows allocation to toxicity classes in the same manner as on the basis of the classical LD&inf50; tests. The ATC method uses fewer animals and yields the same information on toxic signs. Introducing the ATC method into the quality system allows estimating the acute oral toxicity of chemicals according to the Organisation for Economic Cooperation and Development (OECD; OECD, 1992, 1996).

Journal Article↗
PubMedDate not supplied

Breaking the turnover cycle.

The Paraprofessional Healthcare Institute, Bronx, NY, identifies seven elements which are essential for employers in their creation of a stable, well-qualified direct-care workforce. These "common sense" elements--ranging from paying family-sustaining wages to strengthening the caregiving relationship between the workers and those whom they serve--can make the difference between chronic turnover, on one hand, and employing a dedicated staff large enough to keep pace with the growing need for long-term care and services, on the other. However, implementing the seven elements requires the commitment, coordination, and the cooperation of the entire long-term care system, especially the state and federal reimbursement systems that pay for most care and services. By joining forces with other long-term care stakeholders, through organizations such as the Direct Care Alliance, providers can help stabilize the workforce and, ultimately, help to increase the allocation of public resources.

Humans↗
PubMed2006

The effectiveness of Teratology Information Services (TIS).

BACKGROUND: Women and their health care providers have few reliable sources of information regarding the safety of exposures in pregnancy and lactation. Evidence-based information on these topics is provided by Teratology Information Services (TIS). Access to TIS, however, is limited in many regions, and many services have difficulty maintaining ongoing funding. The objective of this review is to highlight published reports of the effectiveness of TIS in improving maternal and neonatal health. METHODS: A search of the Pub Med and Econ Lit databases was performed with no date restriction, using the search terms teratology, information, counseling, pregnancy, effectiveness, birth defects. RESULTS: Information disseminated from TIS has been shown to prevent congenital malformations, unnecessary pregnancy terminations, and occupational risks. TIS support optimal nutritional supplementation in pregnancy and optimal drug therapy in pregnancy and breast-feeding. In addition, they correct misperceptions of risk and facilitate knowledge transfer and translation. TIS have the potential to provide health care cost savings. CONCLUSIONS: TIS are vital services in supporting optimal maternal and neonatal health. A formal economic evaluation of TIS is required in order to inform resource allocation decision-making and continued funding of these services.

Abnormalities, Drug-Induced↗
PubMed2003

Stroke: awareness of the signs, symptoms and risk factors--a population-based survey.

BACKGROUND: This article reports the findings from a population-based survey conducted to determine baseline knowledge regarding the signs, symptoms and risk factors of stroke. METHODS: Data were collected in Northern Ireland from 892 adults using a self-completed questionnaire. RESULTS: In general, the results indicate that respondents appeared knowledgeable about the risk factors of stroke but their recognition of the warning signs was poor. In addition, approximately half of those surveyed would not contact the ambulance service in the case of a suspected stroke but instead would make initial contact with their general practitioner (41.5%) or family/relatives (2.3%). CONCLUSIONS: Given the importance of early hospital presentation for effective stroke rehabilitation, these findings are of particular concern in a community where the death rate from stroke is one of the highest in Europe. Future health education campaigns should provide accurate and appropriate information regarding the warning signs of stroke and highlight the importance of early hospital presentation.

Adolescent↗
PubMed2004

Organ allocation for transplantation in the USA and Korea: the changing roles of equity and utility.

Realizing the promise and managing the success of organ transplantation requires the creation of unique institutions. An Organ Procurement and Transplant Network (OPTN) must be capable of increasing the supply of cadaver donor organs, of allocating those organs properly to recipients with due consideration for equity and utility, and of using scientific data to improve the system for the good of society. The OPTN should answer to the public and should expect public support. Both in the United States and in Korea major changes in deceased donor organ procurement and allocation are in progress. In the United States change takes the form of a renewed emphasis on achieving equity in kidney allocation without significantly sacrificing transplant graft or patient survival and the first ever use of purely objective, statistically evaluated criteria for liver allocation. In Korea where the OPTN is only four years old, change takes the form of a new brain death law and the creation of that country's first organ procurement organizations. In both countries, success in meeting the transplant needs of their populations will ultimately depend on the support of society and the cooperation of the entire medical community.

Health Care Rationing↗
PubMed1986

Cyclosporine improves psoriasis in a double-blind study.

In a double-blind trial, 21 patients with severe plaque psoriasis were randomly assigned to receive oral cyclosporine, 14 mg/kg/d, or its vehicle. After four weeks of therapy the 11 cyclosporine recipients had the following response to treatment: two had total clearing and six improved markedly, two moderately, and one minimally; whereas ten vehicle-treated patients showed no change or minimal improvement. Vehicle-treated patients, after a switch to cyclosporine for four weeks, demonstrated impressive improvement similar to that seen in patients who initially received only cyclosporine. Moderate or marked improvement or total clearing was noted in 17 (81%) of 21 and 20 (95%) of 21 after one and four weeks of therapy, respectively. Mitotic figures and leukotriene B4 levels in lesions decreased 86% and 64%, respectively, after seven days of cyclosporine therapy. Mononuclear (including activated T cells) and polymorphonuclear leukocyte infiltrates were markedly reduced in lesions of all patients after seven days of cyclosporine therapy. These results suggest that psoriasis may have an immunologic basis mediated by activated T cells and/or other immune cells; if a long-term regimen with a favorable efficacy-side effect ratio can be determined, cyclosporine would be a significant advance in the treatment of psoriasis.

Adult↗
PubMed1996

Five-year followup of a prospective trial of radical cystectomy and neoadjuvant chemotherapy: Nordic Cystectomy Trial I. The Nordic Cooperative Bladder Cancer Study Group.

PURPOSE: Chemotherapy is widely used in patients with locally advanced bladder cancer but until now there has been no conclusive evidence that this therapy improves survival. The Nordic Cooperative Bladder Cancer Study Group conducted a randomized phase III study to assess the possible benefit of neoadjuvant chemotherapy in patients with bladder cancer undergoing radical cystectomy after short-term radiotherapy. MATERIALS AND METHODS: Our trial included 325 patients with locally advanced stage T1 grade 3 or stages T2 to T4aNXM0 bladder cancer allocated randomly into a chemotherapy or no chemotherapy group (control). The chemotherapy schedule consisted of 2 cycles of 70 mg./m.2 cisplatin and 30 mg./m.2 doxorubicin with a 3-week interval between the cycles. RESULTS: After 5 years the overall survival rate was 59% in the chemotherapy group and 51% in the control group (p = 0.1). The corresponding cancer specific survival rate was 64 and 54%, respectively. In regard to treatment, no difference was observed for stages T1 and T2 disease, while there was a 15% difference in overall survival for patients with stages T3 to T4a disease (p = 0.03). In a multivariate analysis only chemotherapy and T category emerged as independent prognostic factors. The relative death risk for patients who received chemotherapy was 0.69 (95% confidence interval 0.49 to 0.98) compared to the control group after adjustment for the other tested factors. CONCLUSIONS: Neoadjuvant chemotherapy seems to improve long-term survival after cystectomy in patients with stages T3 to T4a bladder carcinoma, while no survival benefit was found for stages T1 to T2 disease.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1983

Intraocular lenses versus extended-wear contact lenses in aphakic rehabilitation. A controlled clinical study.

A controlled clinical study with random allocation of method of rehabilitation (lens implant or contact lenses) was designed for comparative outcome assessments. Sixty-one patients were included in the study: 31 patients randomized to lens implantation and 30 patients to extended-wear contact lens rehabilitation with early post-operative fitting. Complication rates were low in both groups with slight accumulation of intraocular complications in the implant group and of external complications in the contact lens group. We found no significant differences between the groups in final visual acuity, in vision dependent practical functioning, or in patients' contentment. Two main points summarize our results and impressions from this study: At the expense of a slightly higher risk the lens implant patients get the most convenient and comfortable rehabilitation and at the expense of frequent visits for follow-up and lens cleaning the contact lens patients get the safest rehabilitation. The patient offered contact lens rehabilitation should be capable of alert cooperation, fairly mobile and living within easy access to ophthalmic service, while the patient offered lens implant does not need to fulfill these criteria.

Aged↗
PubMed1993

Plasma exchange morbidity in Guillain-Barré syndrome: results from the French prospective, randomized, multicenter study. The French Cooperative Group.

OBJECTIVES: To describe all adverse events occurring during plasma exchange sessions in adult patients with the Guillain-Barré syndrome. To analyze these events with regard to the technical modalities and biological changes induced by sessions, and to try to identify a population at high risk for adverse events. DESIGN: Double-blind, randomized, prospective, multicenter trial. SETTING: A total of 28 French and Swiss intensive care units. PATIENTS: The study is based on 220 patients allocated either to plasma exchange (n = 109) or not (n = 111). This study focused on 105 patients who received at least one plasma exchange, with replacement fluid secondly allocated by randomization to albumin, or fresh frozen plasma. A total of 105 patients underwent 390 plasma exchanges. Fifty-five patients received albumin (208 sessions) as replacement fluid, and 50 patients received fresh frozen plasma (182 sessions). INTERVENTIONS: Prospective monitoring of patients for each session including technical modalities, adverse effects, and biological parameters. MEASUREMENTS AND MAIN RESULTS: A total of 253 adverse incidents were recorded. At least one adverse incident occurred in 39% of plasma exchange sessions among 80 (76%) patients. In 15 patients, plasma exchange treatment had to be discontinued because of severe intolerance (six patients, including three patients with severe bradycardias), intercurrent complications, mainly infections (four patients), and technical difficulties. One patient with pneumococcal septicemia and pneumonia died during the second plasma exchange session. Fresh frozen plasma was associated with more adverse incidents than albumin (135 vs. 118, p = .008). The occurrence of adverse events was also related to the preplasma exchange hemoglobin level assessed before the session (p = .04). Otherwise, the frequency of adverse effects did not depend on technical modalities (type of equipment, anticoagulation). Age, sex, previous history, neurologic severity, and the need for mechanical ventilation, as assessed on inclusion in the study, did not modify the risk of adverse effects. Finally, occurrence of bradycardia did not rely on initial neurologic severity. CONCLUSIONS: These results confirm that fresh frozen plasma should be abandoned as replacement fluid in plasma exchanges of Guillain-Barré syndrome patients. They also underline the need for close monitoring of patients during sessions and, especially, the respect of treatment contraindications. Some adverse incidents could be attributed to the underlying disease rather than to the plasma exchange session.

Albumins↗
PubMedDate not supplied

Controlled clinical evaluation of enalapril in dogs with heart failure: results of the Cooperative Veterinary Enalapril Study Group. The COVE Study Group.

The clinical efficacy and safety of enalapril were evaluated in dogs with moderate or severe heart failure. This study was conducted at 19 centers and included 211 client-owned dogs with heart failure caused by mitral regurgitation (MR) due to acquired valvular disease or dilated cardiomyopathy (DCM). Dogs of various breeds, ages, and weights were included in the study. Replicates of 2 dogs each were formed, using separate allocation schedules for dogs with MR or DCM. One dog within each replicate received placebo tablets (vehicle tablets without enalapril) PO sid or bid, and the other dog received enalapril tablets at approximately 0.5 mg/kg sid or bid, based on individual need. In addition to the experimental drug, all dogs, except 1 in the placebo group, received furosemide; 73.3% of the dogs in the placebo group and 78.3% of those in the enalapril group received digoxin. Doses of enalapril or placebo were administered for approximately 28 days. In the placebo group, 68.6% of the dogs completed the study compared with 84.9% in the enalapril group; the difference between groups was significant (P < .01). Significantly (P < .01) more dogs in the placebo group compared with the enalapril group died or were removed from the study because of progression of heart failure. On day 28, all 14 clinical variables measured improved significantly (P < .01) in the enalapril group compared with the placebo group. Five dogs (3 from the placebo group and 2 from the enalapril group) had to be removed from the study as a result of azotemia.

Angiotensin-Converting Enzyme Inhibitors↗
PubMed1989

[An effect of adjuvant immunochemotherapy using krestin and 5-FU on gastric cancer patients with radical surgery (first report)--a randomized controlled trial by the cooperative study group. Study Group of Immuno-chemotherapy with PSK for Gastric Cancer].

To evaluate the efficacy of PSK for adjuvant immuno-chemotherapy in patients who had undergone radical gastrectomy, a randomized controlled trial has been in progress in collaboration with 46 institutions in the Chubu district of Japan. A total of 262 patients were registered for this trial during the two years from July 1985 to June 1987 with a centralized registration system, and were allocated into the 5-FU+PSK group (Group P) and 5-FU alone group (Group C) by the minimization method following the random permuted blocks method. Between the two groups, the parameters of sex, age, serosal invasion (S), lymph-node metastasis (N), and the combination of S . N factor levels were distributed without significant differences. An induction treatment with MMC 6 mg/m2 was given to all patients following curative gastrectomy and on the 7th post-operative day. Two weeks after surgery, Group P received alternately PSK 3 g/day for 4 week and 5-FU 150 mg/day for 4 weeks as one course, and 10 courses were given. Group C received 5-FU alone for 4 weeks using alternate rest interval for 4 weeks. Since both experimental and clinical studies suggested that alternate treatments using PSK and anticancer agents were effective, treatment in this trial alternated PSK and 5-FU. A final follow-up study will be completed in June 1992, when all patients shall have survived more than 5 years after surgery. The administration of 5-FU was completed by January. 1989, but PSK has been administered to group P. The period from 18 to 42 months after surgery was reached in all eligible patients (253) at the end of December 1988. The disease-free survival curves and overall survival curves of group P were significantly (p = 0.018 and p = 0.045,) better than those of group C.

Adjuvants, Immunologic↗
PubMed1989

Fixed combinations of low-molecular weight or unfractionated heparin plus dihydroergotamine in the prevention of postoperative deep vein thrombosis.

A prospective, double-blind, randomized, controlled clinical trial compared the efficacy and safety of fixed combinations of low-molecular weight heparin or standard unfractionated heparin plus dihydroergotamine mesylate in the prevention of deep vein thrombosis in high-risk patients undergoing elective major abdominal surgery. Two hundred patients, with a mean age of 66.6 years and almost half with malignancy, were allocated to receive either 5,000 IU unfractionated heparin plus 0.5 mg dihydroergotamine mesylate twice daily or 1,500 IU low-molecular weight heparin plus 0.5 mg dihydroergotamine mesylate once daily together with one placebo injection per day. Treatment was commenced 2 hours preoperatively and continued for at least 7 days. The incidence of deep vein thrombosis, determined by radiolabelled fibrinogen uptake and phlebography, was 11 percent in the unfractionated heparin plus dihydroergotamine mesylate group and 11.4 percent in the low-molecular weight heparin and dihydroergotamine mesylate group. Neither these figures nor those for major proximal thrombi proved significantly different. Of the four parameters used to assess hemorrhagic complications, only the decrease in postoperative hemoglobin levels in the low-molecular weight and dihydroergotamine mesylate group reached statistical significance. These results indicate that once-daily prophylaxis with a combination of low-molecular weight heparin and dihydroergotamine is safe, effective, and convenient in high-risk patients undergoing major abdominal surgery.

Adult↗
PubMedDate not supplied

Extracranial non-testicular teratoma in childhood and adolescence: introduction of a risk score for stratification of therapy.

PATIENTS AND METHODS: According to previous literature incomplete tumor resection, coccygeal or ovarian primary site and immaturity are known risk factors for relapse in teratoma. To establish a risk score points are allocated for resection, primary site and histology in the following manner and added: incomplete resection 4 points, primary site coccyx 3 points, ovary 2 points, other site 1 point, histological grading 0-3 points. This score system is evaluated on 270 extracranial non-testicular teratoma cases collected between 1982 and 1995 in the MAKEI cooperative treatment protocols of the German Society of Pediatric Oncology and Hematology. Treatment was resection alone (230 patients) or resection followed by postoperative adjuvant chemotherapy (40 patients). RESULTS: Patients treated with surgery alone: 28/230 (12%) patients relapsed, 14/230 (6%) patients showed highly malignant histology (mostly yolk sac tumor) in relapse. Mortality in case of relapse was 6/28 (21%). Patients scoring > or = 6 points (n = 45) had a relapse rate of 21/45 (47%) resulting in a 23%-mortality (5/21). Patients scoring < 6 points (n = 185) had a 4%-relapse risk (8/185) resulting in 13%-mortality (1/8) (p < 0.01). Patients treated with surgery and adjuvant chemotherapy: 7/40 patients (18%) suffered a relapse, none of them showing malignant histology. Mortality rate in case of relapse was 3/7 (43%). Patients scoring > or = 6 points initially treated with adjuvant chemotherapy (n = 18) had a relapse rate of 7/18 (39%), compared to patients scoring < 6 points (n = 22), in whom no relapses occurred (p < 0.01). There were no highly malignant relapses in the group treated with adjuvant chemotherapy. Regardless of the scored points the difference in highly malignant relapse histology comparing the group treated with surgery and adjuvant chemotherapy to the group treated with surgery was statistically significant (p = 0.02). CONCLUSION: The risk score system marks a high risk group including 63/270 (23%) of all evaluated extracranial non-testicular teratoma cases (scoring > or = 6 points). In this group 28/35 (80%) of relapses and 8/9 (89%) of tumor deaths occurred. For this high risk group a randomized trial will be suggested to evaluate the effect of adjuvant chemotherapy on the rate of malignant relapses. It should also be investigated, if adjuvant chemotherapy will influence relapse rate and mortality.

Child↗