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A randomized controlled trial is often used to provide high quality evidence regarding treatment interventions. Due to the complex nature of many diseases, trials usually select multiple primary outcomes to capture the efficacy of the interventions. In this thesis, we conducted a literature search to determine the prevalence of the different types of multiple outcomes that have been used in randomized controlled trials. We also reviewed the corresponding statistical methods used to deal with such outcomes. In addition, we described the benefits of using global tests as a statistical method when there are multiple primary outcomes in order to answer the global question of whether the intervention is effective. As an illustration for the global test, we used data from a previously published trial in ulcerative colitis. The global tests included O’Brien’s OLS, Lauter’s test and O’Brien’s rank-sum test, and all of the tests used produced statistically significant results with p-values less than 0.05. Global tests should be considered when using multiple outcomes as well as additional guidelines surrounding how multiple primary outcomes should be managed. |
