ABSTRACT
The issue of multiple comparisons in clinical trials assessing HRQoL arises from three sources: (1) multiple HRQoL measures (scales or subscales), (2) repeated postrandomization assessments, and (3) multiple (three or more) treatment arms. As a result, the problem of multiple comparisons is one of the major analytic challenges in these trials [79]. For example, in the NSCLC study, there are five major subscales in the FACT-Lung instrument (physical, functional, emotional, and social/family well-being, plus the disease-specific concerns). There are three follow-up assessments, at 6, 12, and 26 weeks, and three treatment arms. If we consider the three possible pairwise comparisons of the treatment arms at each of the three follow-ups for the five primary subscales, we have 45 tests. Not only does this create concerns about Type I error, but reports containing large numbers of statistical tests generally result in a confusing picture of HRQoL.
