ELISA readers and HIV antibody testing in developing countries.
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OBJECTIVE: To evaluate an algorithm using two enzyme immunoassays (EIA) for anti-HIV-1 antibodies in a rural African population and to assess alternative simplified algorithms. METHODS: Sera obtained from 7895 individuals in a rural population survey were tested using an algorithm based on two different EIA systems: Recombigen HIV-1 EIA and Wellcozyme HIV-1 Recombinant. Alternative algorithms were assessed using negative or confirmed positive sera. RESULTS: None of the 227 sera classified as unequivocably negative by the two assays were positive by Western blot. Of 192 sera unequivocably positive by both assays, four were seronegative by Western blot. The possibility of technical error cannot be ruled out in three of these. One of the alternative algorithms assessed classified all borderline or discordant assay results as negative had a specificity of 100% and a sensitivity of 98.4%. The cost of this algorithm is one-third that of the conventional algorithm. CONCLUSIONS: Our evaluation suggests that high specificity and sensitivity can be obtained without using Western blot and at a considerable reduction in cost.
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OBJECTIVES: To assess the effects of folic acid and folinic acid in reducing the mucosal and gastrointestinal (GI) and haematologic side effects of low-dose of Methotrexate (MTX) in patients with Rheumatoid Arthritis (RA) and to determine whether or not folate supplementation alters MTX efficacy. SEARCH STRATEGY: We searched the Cochrane Controlled Clinical Trial's Register (CCTR), the Cochrane Musculoskeletal Group Specialized Register and Medline up to and including June 1999, using the search strategy developed by the Cochrane Collaboration (Dickersin 1994). We also handsearched the following: (i) bibliographic references; (ii) current contents of the last 6 months; (iii) abstracts of the rheumatology meetings; and (iv) all issues of four journals; Journal of Rheumatology, Arthritis & Rheumatism, Clinical and Experimental Rheumatology, and British Journal of Rheumatology. All languages were included. Principal investigators were also contacted in order to look for unpublished literature. SELECTION CRITERIA: We selected all double-blind, randomized, placebo-controlled, clinical trials (RCTs), in which adult RA patients were treated with a low dose of MTX (<20 mg / week) concurrently with folate supplementation. DATA COLLECTION AND ANALYSIS: Two observers extracted the data and assessed the quality of the trials. (BS, Z0) The overall treatment effect across trials was calculated using a fixed effect model. Disease activity was evaluated using standardized mean differences to ensure comparability across outcome measures. Results are presented with 95% Confidence Inervals (95% CI). Subgroup analyses were conducted evaluating different doses and sensitivity analysis looking at the quality of the trials. Publication bias was assessed with an inverted funnel plot technique. Heterogeneity of the trials was measured using a standard chi square test. Costs per month in different countries were compared. MAIN RESULTS: Of the 12 trials retrieved, 7 met the inclusion criteria. The total sample included 307 patients, of which 147 were treated with folate supplementation, 80 patients with folinic acid and 67 patients with folic acid. A 79% reduction in mucosal and GI side effects was observed for folic acid [OR = 0.21 (95% CI 0.10 to 0.44)]. For folinic acid, a clinically but non-statistically significant reduction of 43% was found [OR = 0. 57 (95% CI 0.28 to 1.15)]. No major differences were observed between low and high doses of folic or folinic acid. Haematologic side effects could not be analyzed, since details of each haematologic side effect by patients were not provided. No consistent differences in disease activity parameters were observed when comparing placebo and folic or folinic acid at low or high doses, although patients on high dose folinic acid had an increase in the number of tender joints, but not swollen joints. Large differences in costs across countries were found, but folinic acid was more expensive in all. REVIEWER'S CONCLUSIONS: The results support the protective effect of folate supplementation in reducing MTX side effects related to the oral and GI systems. We could not determine if folic was different from folinic acid. Therefore, for folinic acid to be considered cost-effective it must be found more effective than folic acid at reducing MTX side effects.
Our objective was to determine costs and trends in treating boys with severe haemophilia A before our centre routinely used prophylaxis. One reviewer extracted data from patient charts to determine resource consumption for 17 boys with severe haemophilia A from 1978 to 1998 at Toronto's Hospital for Sick Children. Resources included factor concentrate, doctors and health care professionals (physiotherapists/social workers), tests (laboratory, radiological and diagnostic) and hospitalizations. Subgroup analysis on those patients infected with HIV and/or hepatitis were also performed. Costs in Canadian Dollars were taken from standard lists and discounted at 3%. Total average cost (range) 62 292 dollars (3339-121 738) per year patient(-1); the largest fraction, 59 910 dollars (3103-119 480), 96.2% was accounted for by factor VIII. Hospitalizations accounted for 1832 dollars (0-5217) per patient year(-1) including drugs, nursing care and stay. Doctor and health care professionals visits averaged 252 dollars (36-462) and 72 dollars (0-175) per patient year(-1), laboratory and other tests cost 201 dollars (22-377) and 26 dollars (2-60) per patient year(-1), respectively. The average number of bleeds was 12.9 (2.0-22.0) per patient year(-1), decreasing since 1977 by 0.68 per patient year(-1) (R(2) = 0.56). Hospitalizations averaged 0.22 (0-4) per patient year(-1), lasting 2.3 days. From 1984, hospitalizations decreased by 0.025 patient(-1) year(-1) (R(2) = 0.76). Concurrently, the average treatment costs increased by 5456 dollars patient(-1) year(-1) (R(2) = 0.81). Clotting factor concentrate cost per patient increased by 5521 dollars year(-1) (R(2) = 0.82). Patients with virally transmitted diseases had considerable higher costs. The cost per year was substantial. Costs increased with virally transmitted diseases. Number of bleeds and hospitalizations over the period of study decreased and costs increased because of factor use in secondary prophylaxis.
OBJECTIVE: To assess the clinical and economic impact of surgery based near patient testing in general practice for six commonly used biochemical and bacteriological tests. DESIGN: After four months' monitoring, equipment for two bacteriological and four biochemical tests was introduced without cost into 12 practices using a crossover design. Structured request forms were used to monitor laboratory investigations. SETTING: 12 general practices in west midlands and south west Thames with list sizes above 9000. MAIN OUTCOME MEASURES: Investigation rates per 1000 consultations. Changes from baseline rates. Reasons for requesting investigations and provisional diagnoses. Cost per test and sensitivity of costs to rate of use. RESULTS: Investigation rates for the six tests rose by 16.5% (from 78.6/1000 consultations to 91.6/1000) when equipment was available in the surgery and reverted to baseline rates when it was withdrawn. The average weekly number of tests when equipment was available ranged from 0.5 to 10.5 (mean 9.0). Cholesterol tests were used as an addition to laboratory testing, usually for screening. Midstream urine analysis was often done in the surgery instead of in the laboratory, although 30% of samples were tested by both methods. Doctors' reasons for investigation and conditions tested were largely unaffected by availability of surgery tests. Costs for surgery tests were higher for all tests except midstream urine. CONCLUSIONS: Availability of surgery based testing increased the number of tests performed. It was cost effective only for midstream urine analysis.
BACKGROUND: For individuals with chemotherapy-related anemia, the clinical effectiveness of epoetin alfa (EPO) dosed once weekly ([QW], 40,000 units per dose) has been demonstrated to be indistinguishable from that observed with thrice-weekly dosing ([TIW], 10,000 units per dose). Whether the advantage of less-frequent administration justifies the higher EPO dosage used in the weekly regimen in terms of overall cost of care is unknown. OBJECTIVE: To conduct a cost-minimization analysis comparing QW and TIW EPO dosing from a societal perspective. METHODS: Direct and indirect medical cost data were calculated for a 16-week period for 2 large, prospective, multicenter, community-based studies. Costs measured included EPO, transfusions, laboratory tests, office visits, and opportunity cost of patient time. RESULTS: The average total costs in 2002 (first half) dollars were nearly equivalent across the 2 groups (QW: 9,204 dollars; 95% confidence interval [CI], 9,057 dollars-9,350 dollars. TIW: 9,265 dollars; 95% CI, 9,083 dollars-9,447 dollars. P=0.60). QW incurred mean drug acquisition costs that were 23% higher (QW: 6,725 dollars; 95% CI, 6,611 dollars-6,838 dollars. TIW: 5,474 dollars; 95% CI, 5,350 dollars-5,598 dollars. P<0.001). However, QW patients can avoid the resource use and time cost associated with 2 additional office visits incurred each week (QW: 592 dollars [583 dollars-600 dollars]; TIW: 1,709 dollars [1,678 dollars-1,740 dollars]; P<0.001). Transfusion and laboratory test costs were slightly higher in the TIW group (QW: 1,888 dollars [1,837 dollars-1,940 dollars]; TIW: 2,082 dollars [2,020 dollars-2,144 dollars]; P<0.001). CONCLUSION: Total anemia treatment costs over a 16-week period with EPO QW were similar to those of TIW dosing. In the absence of cost differences between regimens, the noneconomic advantages of less-frequent dosing intervals should make weekly dosing increasingly attractive to patients, clinicians, and payers.
Microbiology is the last of the major labor-intensive sections remaining in the clinical laboratory; other large, previously labor-intensive areas--chemistry and hematology--were automated over the last two decades. Only in recent years has technology been developed to permit automation of microbiology techniques. This assessment describes the historical development and technological aspects of automated microbiology systems. Patient care can be improved by earlier treatment and reduced lengths of stay when clinicians use the rapidly reported information provided by automated microbiology systems. Automated systems may reduce the cost of microbiology testing; whether savings are realized depends both on the manual methods to which the automated technology is compared and also on the particular automated system under consideration. Some studies indicate that the technology is cost saving when used on a large scale; other studies show that, while automated microbiology technology extends laboratories' capabilities, the technology can increase laboratory testing costs. Since automated microbiology systems cannot result in cost savings in every application, it is a technology that should be carefully evaluated in its intended setting, before a decision is made to acquire such a system. Adoption of the technology in hospital laboratories has been relatively limited; problems in perfecting the technology have slowed its acceptance. In states with prospective payment systems in place prior to 1983, hospitals' acquisition of automated microbiology systems has been even more limited.
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