Statistics and ethics in surgery and anesthesia.
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Biomedical subjects
Publications and source records attributed to F Mosteller.
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STUDY OBJECTIVE: 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. DESIGN: Meta-analyses of 15 randomized control trials. PATIENTS: Seven hundred eighty-seven adult patients (aged 16 to 65) undergoing various operative procedures. INTERVENTIONS: Either PCA or conventional analgesia for postoperative pain control. MEASUREMENTS AND MAIN RESULTS: Data were extracted on analgesic efficacy, analgesic use, patient satisfaction, length of hospital stay, and side effects. Meta-analyses of the data showed the following: (1) greater analgesic efficacy when PCA was used, with a mean additional benefit of 5.6 on a scale of 0 to 100 (SED, 2.2; p = 0.006); (2) a nonsignificant trend toward reduced analgesic use in PCA patients, based on a count of trials finding in one direction or the other (p = 0.092); (3) a 42% difference in the proportion of patients expressing satisfaction over dissatisfaction (SED, 20%; p = 0.02), with PCA being preferred; (4) a nonsignificant trend toward shortening of length of hospital stay with PCA use (mean, 0.15 days, SED, 0.13; p = 0.24); (5) no significant differences in the occurrence of any side effect. CONCLUSIONS: 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.
The Tennessee class size project is a three-phase study designed to determine the effect of smaller class size in the earliest grades on short-term and long-term pupil performance. The first phase of this project, termed Project STAR (for Student-Teacher Achievement Ratio), was begun in 1985, when Lamar Alexander was governor of Tennessee. Governor Alexander, who later served as secretary of education in the cabinet of President George Bush, had made education a top priority for his second term. The legislature and the educational community of Tennessee were mindful of a promising study of the benefits of small class size carried out in nearby Indiana, but were also aware of the costs associated with additional classrooms and teachers. Wishing to obtain data on the effectiveness of reduced class size before committing additional funds, the Tennessee legislature authorized this four-year study in which results obtained in kindergarten, first, second, and third grade classrooms of 13 to 17 pupils were compared with those obtained in classrooms of 22 to 25 pupils and in classrooms of this larger size where the teacher was assisted by a paid aide. Both standardized and curriculum-based tests were used to assess and compare the performance of some 6,500 pupils in about 330 classrooms at approximately 80 schools in the areas of reading, mathematics, and basic study skills. After four years, it was clear that smaller classes did produce substantial improvement in early learning and cognitive studies and that the effect of small class size on the achievement of minority children was initially about double that observed for majority children, but in later years, it was about the same. The second phase of the project, called the Lasting Benefits Study, was begun in 1989 to determine whether these perceived benefits persisted. Observations made as a part of this phase confirmed that the children who were originally enrolled in smaller classes continued to perform better than their grade-mates (whose school experience had begun in larger classes) when they were returned to regular-sized classes in later grades. Under the third phase, Project Challenge, the 17 economically poorest school districts were given small classes in kindergarten, first, second, and third grades. These districts improved their end-of-year standing in rank among the 139 districts from well below average to above average in reading and mathematics.(ABSTRACT TRUNCATED AT 400 WORDS)
BACKGROUND AND OBJECTIVES: Although rarely used, intracerebroventricular opioid therapy (ICV) is an option for the control of intractable pain due to cancer when systemic treatments have failed. The aim of the present study is to use available data from published trials to compare ICV with the more common epidural (EP) and subarachnoid (SA) opioid treatments in an attempt to establish the utility and safety of ICV. METHODS: Because there are no published controlled trials comparing these routes of administration, the combined data from multiple uncontrolled trials were used, with differences between the treatments analyzed statistically. Trials assessing ICV (13 trials, 268 patients). EPI (29 trials, 909 patients) and SA (21 trials, 410 patients) in cancer patients were identified; data on analgesic efficacy, common pharmacologic side effects, and complications were then extracted and the accumulated incidence data analyzed. RESULTS: The findings (weighted means) indicated ICV to be at least as effective against pain as other neuraxial treatments, with 75% of ICV-treated patients obtaining excellent pain relief as compared with 72% of EPI- and 58% of SA-treated patients (not significant). The failure rate of both spinal treatments tended to be greater than that of ICV and was significantly higher in the case of EPI (P = .045). In general, persistent side effects appeared to be more of a problem with the spinal treatments, while transient symptoms occur more often with ICV. Persistent nausea, urinary retention, and pruritus all were more frequent with the two spinal treatments than with ICV, but transient nausea and respiratory depression occurred more often with ICV. Sedation and confusion appeared to occur more often with ICV than with spinal therapy, while constipation and headache were rarely encountered with ICV. There were no real differences in infectious complication rates among the three treatments (except for a lower rate of infection when an implanted pump was used), but technical problems such as catheter blockage, misplacement, or leakage tended to occur less often with ICV. CONCLUSIONS: Intracerebroventricular therapy appears to be at least as effective against pain as other neuraxial treatments. The ICV technique is the only fixed system that is associated with fewer technical problems than the use of simple percutaneous epidural catheters (difference 9%, standard error of the difference 3.4). The present state of evidence indicates that ICV is a successful treatment for patients with intractable cancer pain and compares well with spinal opioid treatments in terms of efficacy, side effects, and complications.