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Bias in Area Under the Curve for Longitudinal Clinical Trials With Missing Patient Reported Outcome Data

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  • Melanie L. Bell
  • Madeleine T. King
  • Diane L. Fairclough

Abstract

A common approach to the analysis of longitudinal patient reported outcomes (PROs) is the use of summary measures such as area under the time curve (AUC). However, it is not clear how missing data affects the validity of AUC analysis. This study aimed to compare the use of AUC summary measures (in individuals) with AUC summary statistics (on groups, calculated from the estimated parameters of a mixed model) when data are complete, missing at random, and missing not at random. A simulation experiment based on a two-armed randomized trial was carried out to investigate the precision and bias of AUC in longitudinal analysis where missingness, trajectory, and missingness allocation were varied. Summary measures AUC with ad hoc approaches to missing data were compared with mixed model AUC summary statistics. AUC summary statistics were consistently superior to AUC summary measures in terms of precision and bias. The bias of AUC summary statistic approach was very small, even when data were missing not at random and when differential attrition between groups existed. AUC summary measures on individuals should not be used to analyze longitudinal PRO data in the presence of missing data.

Suggested Citation

  • Melanie L. Bell & Madeleine T. King & Diane L. Fairclough, 2014. "Bias in Area Under the Curve for Longitudinal Clinical Trials With Missing Patient Reported Outcome Data," SAGE Open, , vol. 4(2), pages 21582440145, May.
    • Handle: RePEc:sae:sagope:v:4:y:2014:i:2:p:2158244014534858
    DOI: 10.1177/2158244014534858
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    1. D. R. Cox & R. Fitzpatrick & A. E. Fletcher & S. M. Gore & D. J. Spiegelhalter & D. R. Jones, 1992. "Quality‐Of‐Life Assessment: Can We Keep it Simple?," Journal of the Royal Statistical Society Series A, Royal Statistical Society, vol. 155(3), pages 353-375, May.
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    1. Naitee Ting & Lihong Huang & Qiqi Deng & Joseph C. Cappelleri, 2021. "Average Response over Time as Estimand: An Alternative Implementation of the While on Treatment Strategy," Statistics in Biosciences, Springer;International Chinese Statistical Association, vol. 13(3), pages 479-494, December.

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