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Improved Small Sample Inference Methods for a Mixed-Effects Model for Repeated Measures Approach in Incomplete Longitudinal Data Analysis

Author

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  • Yoshifumi Ukyo

    (Department of Biostatistics, Janssen Pharmaceutical K. K., 5-2 Nishi-kanda 3-chome, Chiyoda-ku, Tokyo 101-0065, Japan
    Department of Statistical Science, School of Multidisciplinary Sciences, The Graduate University for Advanced Studies, 10-3 Midori-cho, Tachikawa, Tokyo 190-8562, Japan)

  • Hisashi Noma

    (Department of Data Science, The Institute of Statistical Mathematics, 10-3 Midori-cho, Tachikawa, Tokyo 190-8562, Japan)

  • Kazushi Maruo

    (Department of Biostatistics, Faculty of Medicine, University of Tsukuba, 1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575, Japan)

  • Masahiko Gosho

    (Department of Biostatistics, Faculty of Medicine, University of Tsukuba, 1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575, Japan)

Abstract

The mixed-effects model for repeated measures (MMRM) approach has been widely applied for longitudinal clinical trials. Many of the standard inference methods of MMRM could possibly lead to the inflation of type I error rates for the tests of treatment effect, when the longitudinal dataset is small and involves missing measurements. We propose two improved inference methods for the MMRM analyses, (1) the Bartlett correction with the adjustment term approximated by bootstrap, and (2) the Monte Carlo test using an estimated null distribution by bootstrap. These methods can be implemented regardless of model complexity and missing patterns via a unified computational framework. Through simulation studies, the proposed methods maintain the type I error rate properly, even for small and incomplete longitudinal clinical trial settings. Applications to a postnatal depression clinical trial are also presented.

Suggested Citation

  • Yoshifumi Ukyo & Hisashi Noma & Kazushi Maruo & Masahiko Gosho, 2019. "Improved Small Sample Inference Methods for a Mixed-Effects Model for Repeated Measures Approach in Incomplete Longitudinal Data Analysis," Stats, MDPI, vol. 2(2), pages 1-15, March.
    • Handle: RePEc:gam:jstats:v:2:y:2019:i:2:p:13-188:d:218006
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    References listed on IDEAS

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    1. Stein, Markus Chagas & da Silva, Michel Ferreira & Duczmal, Luiz Henrique, 2014. "Alternatives to the usual likelihood ratio test in mixed linear models," Computational Statistics & Data Analysis, Elsevier, vol. 69(C), pages 184-197.
    2. Guolo, Annamaria & Brazzale, Alessandra R. & Salvan, Alessandra, 2006. "Improved inference on a scalar fixed effect of interest in nonlinear mixed-effects models," Computational Statistics & Data Analysis, Elsevier, vol. 51(3), pages 1602-1613, December.
    3. David M. Zucker & Offer Lieberman & Orly Manor, 2000. "Improved small sample inference in the mixed linear model: Bartlett correction and adjusted likelihood," Journal of the Royal Statistical Society Series B, Royal Statistical Society, vol. 62(4), pages 827-838.
    4. Melo, Tatiane F.N. & Ferrari, Silvia L.P. & Cribari-Neto, Francisco, 2009. "Improved testing inference in mixed linear models," Computational Statistics & Data Analysis, Elsevier, vol. 53(7), pages 2573-2582, May.
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