The New England journal of medicine
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Randomized Controlled Trial Clinical Trial
Treatment of gram-negative bacteremia and shock with human antiserum to a mutant Escherichia coli.
In an effort to decrease deaths from gram-negative bacteremia and endotoxin shock, we treated bacteremic patients with human antiserum to endotoxin (lipopolysaccharide) core. Antiserum was prepared by vaccinating healthy men with heat-killed Escherichia coli J5; this mutant lacks lipopolysaccharide oligosaccharide side chains, so that the core, which is nearly identical to that of most other gram-negative bacteria, is exposed for antibody formation. ⋯ In those with profound shock, mortality was 30 of 39 (77 per cent) in controls and 18 of 41 (44 per cent) in recipients of J5 antiserum (P = 0.003). We conclude that human antiserum to the lipopolysaccharide core can substantially reduce deaths from gram-negative bacteremia.
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Randomized Controlled Trial Clinical Trial
A randomized trial of continuing medical education.
To determine whether continuing medical education affects the quality of clinical care, we randomly allocated 16 Ontario family physicians to receive or not receive continuing-education packages covering clinical problems commonly confronted in general practice. Over 4500 episodes of care, provided before and after study physicians received continuing education, were compared with preset clinical criteria and classified according to quality. Although objective tests confirmed that the study physicians learned from the packages, there was little effect on the overall quality of care. ⋯ When the topics were not preferred, however, the documented quality of care provided by study physicians rose (P less than 0.05) and differed from that provided by control physicians (P = 0.01). Finally, there was no spillover effect on clinical problems not directly covered by the program. In view of the trend toward mandatory continuing education and the resources expended, it is time to reconsider whether it works.
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Randomized Controlled Trial Comparative Study Clinical Trial
A randomized study of the prevention of acute graft-versus-host disease.
Acute graft-versus-host disease is a major problem in allogeneic bone-marrow transplantation. We performed a randomized study to compare the effectiveness of two regimens in the prevention of acute graft-versus-host disease. ⋯ The age of the recipient was a significant factor in the development of acute graft-versus-host disease: Older patients had a higher incidence of the disease (P = 0.001). We conclude that the combination of methotrexate, antithymocyte globulin, and prednisone significantly decreased the incidence of acute graft-versus-host disease and should be used to prevent this disorder in patients receiving allogeneic marrow transplants.
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Randomized Controlled Trial Clinical Trial
Evaluation of neonatal-intensive-care programs.
Within the past 15 years, regional neonatal-intensive-care programs have been introduced and have expanded rapidly. The efficacy of some of the individual interventions that constitute neonatal intensive care has been validated in randomized, controlled clinical trials. It is therefore generally assumed that neonatal-intensive-care programs that incorporate these maneuvers are effective in reducing death and disability. ⋯ Moreover, much of the non-experimental evidence supporting their value is based on the experience of referral units and does not measure the impact on the populations they serve. A definitive economic evaluation of neonatal intensive care has not yet been reported, despite the high cost of such programs. We conclude that neonatal-intensive care programs require further evaluation with rigorous scientific methods.
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Randomized Controlled Trial Comparative Study Clinical Trial
Heparin-associated thrombocytopenia: a comparison of three heparin preparations.
We performed a prospective, double-blind study of the incidence of thrombocytopenia in 149 patients randomly assigned to treatment with one of three heparin preparations--from bovine lung from intestinal-mucosa A, or from intestinal-mucosa O. Thrombocytopenia developed in 21 patients (platelets, < 100 x 10(9) per liter): 13 of the 50 receiving bovine lung heparin, four of 45 receiving intestinal-mucosa-A heparin, and four of 54 receiving intestinal-musoca-O heparin (P < 0.005). ⋯ Thrombocytopenia appeared in the bovine-lung group on days 3 to 16, in the intestinal-mucosa-A groups on Days 4 to 12, and in the intestinal-mucosa-O group on Days 3 to 7; it disappeared in all groups three to eight days after discontinuation of heparin. A total of 121 patients were subsequently given warfarin for four to six months, and thrombocytopenia was not observed.