Latest Articles
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To determine the prognosis of delirium in elderly patients. ⋯ Delirium in the elderly appears to have a poor prognosis. However, this finding may have been confounded by the presence of concomitant dementia or severe physical illness. Future studies must pay attention to methods and design, particularly the composition of study populations and the control of extraneous prognostic factors.
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Randomized Controlled Trial Meta Analysis Comparative Study Clinical Trial
Another look at the Dalkon Shield: meta-analysis underscores its problems.
Numerous non-comparative clinical trials of the Dalkon Shield appear to provide ample evidence that the Dalkon Shield was an effective IUD; they seem to yield little evidence that it was a dangerous device, nor markedly different from its contemporaries. Equating the performance of the Dalkon Shield IUD to that of the Lippes Loop or of Copper IUDs is erroneous, however, with respect to rates of pregnancy, expulsion, pelvic infection, septic abortion, death with the device in situ, and tubal infertility. Randomized studies show the Dalkon Shield had approximately double the pregnancy rates of the Lippes Loop D or Copper IUDs (P < .05) and a significantly lower expulsion rate. ⋯ A five-fold increased risk of hospitalized pelvic infection among Dalkon Shield users found in the Women's Health Study resulted not from ascertainment bias, but was related to the fact that Dalkon Shield users had more severe hospitalized PID than did other hospitalized women with PID and IUD use. Following cessation of distribution and of use of the Dalkon Shield, and following the FDA's recommendation to remove IUDs in case of pregnancy, there have been no deaths reported among pregnant American women with an IUD in situ in a 15-year period. Neither the IUDs of today nor those in use during 1970-1974 are equitable to the Dalkon Shield [corrected].
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Online J Curr Clin Trials · May 1993
Meta AnalysisMetaanalysis of the effects of intensive glycemic control on late complications of type I diabetes mellitus.
To estimate the effects of intensive glycemic control on the progression of diabetic retinopathy and nephropathy, and to assess the risks of severe hypoglycemia and diabetic ketoacidosis. ⋯ Long-term intensive glycemic control significantly reduced the risks of diabetic retinopathy and nephropathy progression among type I diabetes patients when compared with randomly assigned controls. However, long-term continuous subcutaneous insulin infusion was associated with an increased incidence of diabetic ketoacidosis, and intensive therapy might cause more severe hypoglycemic reactions in some patients.
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Meta Analysis
Postoperative patient-controlled analgesia: meta-analyses of initial randomized control trials.
To compare outcomes during conventional analgesia (as-needed intramuscular dosing) and patient-controlled analgesia (PCA) in postoperative patients by analyzing data from published comparative trials. ⋯ Patient preference strongly favors PCA over conventional analgesia. Patients using PCA also obtain better pain relief than those using conventional analgesia, without an increase in side effects. Favorable effect of PCA upon analgesic usage and length of hospital stay did not in the initial trials attain statistical significance. Nonetheless, the favorable trends in the mean effect sizes for both outcomes argue that further studies of both outcomes should be performed to determine whether the favorable impact of PCA upon either may become statistically significant if larger numbers of patients are enrolled.
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To investigate the association between trial characteristics, findings, and publication. The major factor hypothesized to be associated with publication was "significant" results, which included both statistically significant results and results assessed by the investigators to be qualitatively significant, when statistical testing was not done. Other factors hypothesized to have a possible association with publication were funding institute, funding mechanism (grant versus contract versus intramural), multicenter status, use of comparison groups, large sample size, type of control (parallel versus nonparallel), use of randomization and masking, type of analysis (by treatment received versus by treatment assigned), and investigator sex and rank. ⋯ Even when the overall publication rate is high, such as for trials funded by the NIH, publication bias remains a significant problem. Given the importance of trials and their utility in evaluating medical treatments, especially within the context of metaanalysis, it is clear that we need more reliable systems for maintaining information about initiated studies. Trial registers represent such a system but must receive increased financial support to succeed.