Multiple imputation for patient reported outcome measures in randomised controlled trials: advantages and disadvantages of imputing at the item, subscale or composite score level

BMC Medical Research Methodology
Ines RombachOliver Rivero-Arias

Abstract

Missing data can introduce bias in the results of randomised controlled trials (RCTs), but are typically unavoidable in pragmatic clinical research, especially when patient reported outcome measures (PROMs) are used. Traditionally applied to the composite PROMs score of multi-item instruments, some recent research suggests that multiple imputation (MI) at the item level may be preferable under certain scenarios. This paper presents practical guidance on the choice of MI models for handling missing PROMs data based on the characteristics of the trial dataset. The comparative performance of complete cases analysis, which is commonly used in the analysis of RCTs, is also considered. Realistic missing at random data were simulated using follow-up data from an RCT considering three different PROMs (Oxford Knee Score (OKS), EuroQoL 5 Dimensions 3 Levels (EQ-5D-3L), 12-item Short Form Survey (SF-12)). Data were multiply imputed at the item (using ordinal logit and predicted mean matching models), sub-scale and score level; unadjusted mean outcomes, as well as treatment effects from linear regression models were obtained for 1000 simulations. Performance was assessed by root mean square errors (RMSE) and mean absolute errors (MAE). Con...Continue Reading

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Citations

Jan 19, 2019·British Journal of Haematology·Lene Kongsgaard NielsenTobias Wirenfeld Klausen
Jul 20, 2020·Child Psychiatry and Human Development·Panteha Hayati RezvanMary Jane Rotheram-Borus
Aug 2, 2019·BMC Medical Research Methodology·Manuel FeißtGeraldine Rauch
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Nov 3, 2020·Disability and Rehabilitation·Kateri RaymondCynthia Gagnon
Feb 28, 2021·European Child & Adolescent Psychiatry·Katherine Tombeau CostDaphne J Korczak
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Nov 20, 2021·Quality of Life Research : an International Journal of Quality of Life Aspects of Treatment, Care and Rehabilitation·Inka RöselYou-Shan Feng
Sep 25, 2021·Pediatric Critical Care Medicine : a Journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies·Jonathan SteifMatthias Görges

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Software Mentioned

Stata
MNAR
StataSE
OKS
ologit

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