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In magazine advertisements for new drugs, it is common to see summary tables that compare the relative frequency of several side effects for the drug and for a placebo, based on results from placebo-controlled clinical trials. This paper summarizes ways to conduct a global test of equality of the population proportions for the drug and the vector of(More)
SUMMARY Many assessment instruments used in the evaluation of toxicity, safety, pain, or disease progression consider multiple ordinal endpoints to fully capture the presence and severity of treatment effects. Contingency tables underlying these correlated responses are often sparse and imbalanced, rendering asymptotic results unreliable or model fitting(More)
This article suggests a unified framework for testing Proof of Concept (PoC) and estimating a target dose for the benefit of a more comprehensive, robust and powerful analysis in phase II or similar clinical trials. From a pre-specified set of candidate models, we choose the ones that best describe the observed dose-response. To decide which models, if any,(More)
A validated questionnaire to assess the impact of small bowel obstructions (SBO) on patients' quality of life was developed and validated. The questionnaire included measurements for the impact on the patients' quality of life in respect to diet, pain, gastrointestinal symptoms and daily life. The questionnaire was validated using 149 normal subjects.(More)
Time series of discrete random variables present unique statistical challenges due to serial correlation and uneven sampling intervals. While regression models for a series of counts are well developed, only few methods are discussed for the analysis of moderate to long (e.g. from 20 to 152 observations) binary or binomial time series. This article suggests(More)
Small bowel obstructions (SBOs) caused by adhesions are a common, often life-threatening postsurgical complication with few treatment options available for patients. This study examines the efficacy of a manual physical therapy treatment regimen on the pain and quality of life of subjects with a history of bowel obstructions due to adhesions in a(More)