Comparison of intent-to-treat analysis strategies for pre-post studies with loss to follow-up.

Paskett ED, Pennell ML, Xi W, Andridge RR
Contemp Clin Trials Commun 11 20-29 09/01/2018

Abstract

In pre-post studies when all outcomes are completely observed, previous studies have shown that analysis of covariance (ANCOVA) is more powerful than a change-score analysis in testing the treatment effect. However, there have been few studies comparing power under missing post-test values. This paper was motivated by the Behavior and Exercise for Physical Health Intervention (BePHIT) Study, a pre-post study designed to compare two interventions on postmenopausal women's walk time. The goal of this study was to compare the power of two methods which adhere to the intent-to-treat (ITT) principle when post-test data are missing: ANCOVA after multiple imputation (MI) and the mixed model applied to all-available data (AA). We also compared the two ITT analysis strategies to two methods which do not adhere to ITT principles: complete-case (CC) ANCOVA and the CC mixed model. Comparisons were made through analyses of the BePHIT data and simulation studies conducted under various sample sizes, missingness rates, and missingness scenarios. In the analysis of the BePHIT data, ANCOVA after MI had the smallest p-value for the test of the treatment effect of the four methods. Simulation results demonstrated that the AA mixed model was usually more powerful than ANCOVA after MI. The power of ANCOVA after MI dropped the fastest as the missingness rate increased; in most simulated scenarios, ANCOVA after MI had the smallest power when 50% of the post-test outcomes were missing.

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