PubMed · 9501795
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L Wood. 1998. Inappropriate randomised controlled trials.. https://doi.org/10.1111/j.1471-0528.1998.tb10061.x
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In any clinical trial, the use of imperfect diagnostic procedures or laboratory techniques may lead to misclassification and measurement error in the primary outcome. Although the effects of non-differential outcome misclassification and measurement error on conventional superiority trials have been extensively investigated, less is known about the impact of these errors on the results and interpretation of therapeutic equivalence trials. In this paper we formally investigate the effects of outcome misclassification and measurement error on the estimates of treatment effects, type I error rate, and power of equivalence trials. Our results indicate that, contrary to what one may expect based on the well known attenuating effects of non-differential error in conventional studies, these errors do not always favour the goal of demonstrating equivalence. The magnitude and direction of the influence depend on a number of factors including the nature of the outcome variable, specific formulation of equivalence, size of the error rates, and assumptions regarding the true treatment effect.
BACKGROUND: The effectiveness of a given treatment is only achieved with a due compliance. Our objective was to know the compliance degree of hormone replacement therapy (HRT) in menopausal women. METHOD: A descriptive observational study was carried out in three hospitals in the Valencia Community (Spain). We included menopausal patients who were visited in a menopause unit from 1989 to 1999 and who were administered HRT. We analyzed age, age at menopause, type of menopause, age at starting HRT, education level, prescription reason, treatment duration, information level, side effects, and causes leading to withdrawal. RESULTS: The study was performed in 363 women. There were 75% probabilities that women fulfilled the therapy for 5 years. The median of fulfillment was 11 years. Those women who had side effects were more prone to withdraw the treatment. By contrast, women who experienced benefits were less prone to withdraw it. Risk of withdrawal was also lower in cases of postsurgery menopause and in women who were younger than 55 years when they started HRT. CONCLUSIONS: In our study, the compliance level was high and it was determined either by treatment benefits or side effects, type of menopause and age at starting HRT.