Journal of clinical epidemiology
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Randomized controlled trials (RCTs) with dichotomous outcomes may be analyzed with or without adjustment for baseline characteristics (covariates). We studied type I error, power, and potential reduction in sample size with several covariate adjustment strategies. ⋯ We conclude that adjustment for a predictive baseline characteristic may lead to a potentially important increase in power of analyses of treatment effect. Adjusted analysis should, hence, be considered more often for RCTs with dichotomous outcomes.
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Tumor shrinkage has been adopted as an end point for evaluating the effectiveness of new anticancer agents. The WHO (World Health Organization) criterion suggested measuring the tumor shrinkage by the change in the product of maximal diameter (MD) and the corresponding largest perpendicular diameter (LPD). The RECIST (Response Evaluation Criteria In Solid Tumor) guideline proposed using the change in MD only, based on the observation that this measure is more linearly related to tumor cell kill than the cross product (MD*LPD). Both criteria classify patients into four categories of response: complete response (CR: total disappearance), partial response (PR), stable disease (SD), and progressive disease (PD) but the criteria used in the definition of PD vary. It was anticipated that patients' actual response categorization would not be considerably affected by utilizing the RECIST criteria instead of WHO. Empirical evidence supporting this fact was provided by retrospective analysis of several large datasets. ⋯ Response assessment as measured by RECIST, with both a change in the underlying metric and change in definition of progression, often results in different categorization of response compared to WHO. The difference in response categorization may be problematic when new experimental therapies are compared to conventional agents whose response rates have been established in historical trials. The apparent lower rate of disease progression with RECIST may mean that more patients remain on therapy. Higher percentages of patients with SD need to be interpreted cautiously by distinguishing those due to the change in the response criterion as opposed to those induced by drugs using pathways such as angiogenesis where disease stabilization is expected rather than shrinkage of tumor.
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Despite guidelines recommending the use of formal tests of interaction in subgroup analyses in clinical trials, inappropriate subgroup-specific analyses continue. Moreover, trials designed to detect overall treatment effects have limited power to detect treatment-subgroup interactions. This article quantifies the error rates associated with subgroup analyses. ⋯ Although it is generally recognized that subgroup analyses can produce spurious results, the extent of the problem may be underestimated.
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Comparative Study
24-item Roland-Morris Disability Questionnaire was preferred out of six functional status questionnaires for post-lumbar disc surgery.
Measurement properties of questionnaires should be based on samples of populations on whom these measurements will be used. The purpose of this study is to establish an evidence based recommendation regarding the use of functional status questionnaires in patients following a lumbar disc surgery by a direct comparison of the reproducibility and responsiveness. ⋯ The use of the RDQ-24 for this specific post-surgery population is suggested. The optimal cut-off point of the RDQ-24 that minimizes the overall classification error was found to be 3.5 with a sensitivity of 94.6% and a specificity of 88.2%.
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Sciatica is thought to have a good clinical outcome, but in fact, its natural history is not well known. ⋯ Recovery from sciatica is less frequent than expected. Attention should be given to occupational and personal factors associated with persistence or recurrence of sciatica.