Item response theory may account for unequal item weighting and individual-level measurement error in trials that use PROMs: a psychometric sensitivity analysis of the TOPKAT trial

AbstractObjectivesTo apply item response theory as a framework for studying measurement error in superiority trials which use patient-reported outcome measures (PROMs). Study design and settingWe reanalyzed data from the TOPKAT trial, which compared the Oxford Knee Score (OKS) responses of patients...

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Published in:Journal of clinical epidemiology 2023-06, Vol.158, p.62-69
Main Authors: Harrison, Conrad J, Plessen, Constantin Yves, Liegl, Gregor, Rodrigues, Jeremy N, Sabah, Shiraz A, Cook, Jonathan A, Beard, David J, Fischer, Felix
Format: Article
Language:English
Subjects:
Arthroplasty
Arthroplasty (knee)
Arthroplasty, Replacement, Knee
Clinical trials
EAP
Epidemiology
Error analysis
Humans
Internal Medicine
Item response theory
Joint replacement surgery
Knee
Missing data
Osteoarthritis, Knee
Oxford knee score
Patient Reported Outcome Measures
Patients
Plausible value imputation
Psychometrics
Quantitative psychology
Sensitivity analysis
Statistical analysis
Sums
Treatment Outcome
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Summary:AbstractObjectivesTo apply item response theory as a framework for studying measurement error in superiority trials which use patient-reported outcome measures (PROMs). Study design and settingWe reanalyzed data from the TOPKAT trial, which compared the Oxford Knee Score (OKS) responses of patients undergoing partial or total knee replacement, using traditional sum-scoring, after accounting for OKS item characteristics with expected a posteriori (EAP) scoring, and after accounting for individual-level measurement error with plausible value imputation (PVI). We compared the marginalized mean scores of each group at baseline, 2 months, and yearly for 5 years. We used registry data to estimate the minimal important difference (MID) of OKS scores with sum-scoring and EAP scoring. ResultsWith sum-scoring, we found statistically significant differences in mean OKS score at 2 months (p=0.030) and 1 year (p=0.030). EAP scores produced slightly different results, with statistically significant differences at 1 year (p=0.041) and 3 years (p=0.043). With PVI, there were no statistically significant differences. ConclusionsPsychometric sensitivity analyses can be readily performed for superiority trials using PROMs and may aid the interpretation of results.
ISSN:0895-4356
1878-5921
DOI:10.1016/j.jclinepi.2023.03.013