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Background: Pre-marketing clinical studies of tegaserod suggested an increased risk of abdominal surgery, particularly cholecystectomy. We sought to quantify the association between tegaserod use and the occurrence of abdominal or pelvic surgery, including cholecystectomy. Methods: This cohort study was conducted within an insured population. Tegaserod initiators and similar persons who did not initiate tegaserod were followed for up to six months for the occurrence of abdominal or pelvic surgery. Surgical procedures were identified from health insurance claims validated by review of medical records. The incidence of confirmed outcomes was compared using both as-matched and as-treated analyses. Results: Among 2,762 tegaserod initiators, there were 94 abdominal or pelvic surgeries (36 gallbladder): among 2,762 comparators there were 134 abdominal or pelvic surgeries (37 gallbladder) (hazard ratio HR] = 0.70, 95% confidence interval [C.I.] = 0.54-0.91 overall, HR = 0.98, 95% C.I. = 0.62-1.55 for gallbladder). Current tegaserod exposure compared to nonexposure was associated with a rate ratio [RR] of 0.68 (95% C.I. = 0.48-0.95) overall, while the RR was 0.99 (95% C.I. = 0.56-1.77) for gallbladder surgery. Conclusions: In this study, tegaserod use was not found to increase the risk of abdominal or pelvic surgery nor the specific subset of gallbladder surgery. [ABSTRACT FROM AUTHOR]

Purpose: To estimate the rate of new-onset afebrile provoked and unprovoked seizure in a general pediatric population and subgroups of patients with and without psychiatric diagnoses other than attention deficit hyperactivity disorder (ADHD). Methods: A retrospective cohort study of 133,440 pediatric patients, between the ages of 6 and 17 years, and without history of seizure or prior use of anticonvulsant medications, with follow-up during 2003. The data source for this study was Ingenix's research database containing pharmacy and medical claims for members of a large US-based managed care organization. The main outcome measure was new-onset nonfebrile seizure. Incidence rates of seizure and 95% confidence intervals (CI) were calculated and expressed as rates per 100,000 person-years. Results: There were 132 new-onset provoked and unprovoked seizures in 78,423 person-years of follow-up among the general pediatric population sample. The incidence rate of seizure among the general pediatric population was 168 per 100,000 p-y (95% CI 141–200). The incidence rate of seizure among patients without psychiatric diagnoses was 149 per 100,000 p-y (95% CI 122–180). The incidence rate of seizure among patients with psychiatric diagnoses other than ADHD was 513 per 100,000 p-y (95% CI 273–878). There were increases in the incidence rates of seizure in all of the seizure risk factor groups, but this was more pronounced among males ages 6–12 with psychiatric diagnoses. Conclusions: The results of this study are consistent with previous reports showing that pediatric patients with psychiatric disorders have a higher incidence rate of seizure than the general pediatric population. [ABSTRACT FROM AUTHOR]

Abstract: The areas of overlap of confidence intervals from several studies can be used to create summary confidence regions. These summary regions lend themselves to graphical display, have readily derivable statistical properties, and can carry information about the influence both of available studies and of hypothetical future investigations. The case of a region covered by at least N-1 out of N confidence intervals is presented in some detail. (Am J Public Health 1988; 78:961-966.) [ABSTRACT FROM AUTHOR]

We have explored the use of data from the Commission on Professional and Hospital Activities-Professional Activity Study (CPHA-PAS) for ascertaining information on cancer incidence, with regional breakdowns. Extirpative surgical procedures were linked with discharge diagnoses to provide estimates of numbers of incident cases. We calculated incidence rates for four cancers: breast, colon, ovary, and testis. CPHA-PAS inferred rates corresponded closely to those of other reporting systems for breast cancer in most age groups, and for colonic and testicular cancer in some age groups. Ovarian cancer rates were consistently underestimated. We conclude that a cancer incidence reporting scheme based on hospital discharge data can work for certain cancers, and be very inexpensive and efficient. It must, however, be used with care. [ABSTRACT FROM AUTHOR]

The authors developed and cross-validated prediction models for newty diagnosed cases of liver disorders by using logistic regression and neural networks. Computerized files of health care encounters from the Fallon Community Health Plan were used to identify 1,674 subjects who had had liver-related health services between July 1,1992, and June 30, 1993. A total of 219 subjects were confirmed by review of medical records as incident cases. The 1, 674 subjects were randomly and evenly divided into training and test sets. The training set was used to derive prediction algorithms based solely on the automated data; the test set was used for cross-validation. The area under the Receiver Operating Characteristic curve for a neural network model was significantly larger than that for logistic regression in the training set (p = 0.04). However, the performance was statistically equivalent in the test set (p = 0.45). Despite its superior performance in the training set, the generalizability of the neural network model is limited. Logistic regression may therefore be preferred over neural network on the basis of its established advantages. More generalizable modeling techniques for neural networks may be necessary before they are practical for medical research. Am J Epidemiol 1998; 147: 407–13. [ABSTRACT FROM AUTHOR]

The article points out ways in which clarity in reporting the results of epidemiological studies may be achieved. Clarity may be attained through attention to the methods of research and to the underlying substantive issues in the execution and reporting of a study. Ideas presented in the article are a collation of what the author believes to be successes in presentation that he has observed in other people's work and occasionally in his own. Important considerations are the context of the study, study subjects and the source of population, data collection and implications.