Intrathecal therapy in tetanus: a meta-analysis

Article Abstract:

Tetanus is an acute, potentially fatal infection of the central nervous system. A total of 800,000 cases of tetanus occur worldwide among newborn infants each year. In the United States the rarity of the disease is in part due to underreporting. Reports of clinical trials using intrathecal (injection into the spinal canal) therapy with either antitetanus equine serum (ATS) or human tetanus immune globulin (TIG) were combined and analyzed. Meta-analysis, a somewhat controversial statistical technique, was used to assess the results. No convincing evidence of the effectiveness of intrathecal therapy with either ATS or TIG was found in the treatment of tetanus in newborn infants. Treatment with TIG was not effective in any of the studies, but ATS may be useful in the treatment of certain subgroups of patients. Extrapolating from the lack of benefit among infants, it is suggested that the beneficial effects in adult ATS studies be viewed with caution. One study was stopped when an interim analysis showed that there was no chance of finding a significant difference, and that there was actually a slight advantage among the control group (the group not receiving therapy). Most of these studies suffer from design inadequacies and the lack of stratification of patients by severity of disease. Many of the studies reported that there were no complications with intrathecal treatment, but deaths were reported during some trials. One study that was excluded from the analysis noted transient blindness and other side effects. TIG is not approved for intrathecal injection; this raises serious safety concerns. (Consumer Summary produced by Reliance Medical Information, Inc.)

Evaluation, Drug therapy, Tetanus, Injections, Spinal, Spinal injections

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The relationship between coronary angioplasty procedure volume and major complications

Article Abstract:

The risk of serious complications following coronary balloon angioplasty appears to decrease among patients who use cardiac catherization laboratories that perform many catheterization procedures. Researchers studied 27,110 balloon angioplasty procedures performed in 48 centers using the 1992 and 1993 registries of the Society for Cardiac Angiography and Interventions. Laboratory volume was divided into four categories: fewer than 200 procedures per year, 200 to 399 procedures per year, 400 to 599 procedures per year, and 600 or more procedures. The risk of complications, such as heart attack, in-hospital death, or emergency bypass surgery, decreased markedly at laboratories that performed 400 to 599 procedures per year compared to laboratories performing 200 to 399 procedures per year and laboratories performing fewer than 200 procedures per year, independent of patient risk factors.

Usage, Complications and side effects, Cardiac catheterization, Heart catheterization, Angioplasty

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Measuring the Quality of Trials: The Quality of Quality Scales

Article Abstract:

A 1999 study illustrates the difficulty in measuring the quality of clinical trials. Meta-analysis is a technique that combines the results of many clinical trials into one result. However, the final result depends on the quality of the individual trials. If a trial is not well-done, the final result may be misleading. Consequently, researchers have devised scales that rate specific parts of a trial and produce a single score to indicate whether a trial is of good quality or poor quality. However, the 1999 study showed that some trials were scored high by some scales but low by others.

Editorial, Clinical trials, Quality management

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