We propose a new nonparametric method for
assessing non-inferiority of an experimental therapy compared to a standard of
care. The ratio μE/μR of true median survival times is the parameter of
interest. This is of considerable interest in clinical trials of generic drugs.
We think of the ratio mE/mR of the sample medians as a point estimate of the ratioμE/μR. We use the Fieller-Hinkley distribution of the ratio of two normally
distributed random variables to derive an unbiased level-α test of inferiority null hypothesis, which is stated in terms of
the ratio μE/μR and a pre-specified fixed non-inferiority margin δ. We also explain how to assess equivalence
and non-inferiority using bootstrap equivalent confidence intervals on the
Introduction: Epidemiologic data proposed a
relationship between obesity and depression in older adults. We conducted this
study to evaluate the association between obesity and depressive disorders, as
well as a range of eating disorders in old women. Methods: From a total of 1477
clients referred to an outpatient clinic, 212 obese persons (97 persons 60+ and
115 persons 40 - 59 years of age) were enrolled. Data of demographics,
comorbidities, anthropometrics, physical activity level, and diet, as well as,
depressive and eating disorders were collected. Depressive and eating disorders
were assessed using diagnostic structural interview based on DSM-IV-TR
(Diagnostic Statistical Manual of Mental Disorder—fourth
edition— Text version). BMI more than or equal to 30 was considered as obesity.
Results: The prevalence of dysthymic disorder was significantly lower in older
women compared to younger (p = 0.026).
Comparable but not significant results were observed for major depression
disorder, Bulimia Nervosa, and eating disorders not otherwise specified.
Conclusion: Our findings suggest that obese older women were less likely to suffer
from Comorbid dysthymic disorder/obesity compared to younger.