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

被引:3
|
作者
Harrison, Conrad J. [1 ,6 ]
Plessen, Constantin Yves [2 ,3 ,4 ]
Liegl, Gregor [2 ,3 ,4 ]
Rodrigues, Jeremy N. [5 ]
Sabah, Shiraz A. [1 ]
Cook, Jonathan A. [1 ]
Beard, David J. [1 ]
Fischer, Felix [2 ,3 ,4 ]
机构
[1] Univ Oxford, Nuffield Dept Orthopaed Rheumatol & Musculoskeleta, Surg Intervent Trials Unit, Oxford, England
[2] Humboldt Univ, Dept Psychosomat Med, Berlin, Germany
[3] Charite Univ Med Berlin, Berlin Inst Hlth, Ctr Internal Med & Dermatol, Berlin, Germany
[4] Free Univ Berlin, Berlin, Germany
[5] Univ Warwick, Clin Trials Unit, Coventry, England
[6] Univ Oxford, Botnar Res Ctr, Old Rd, Oxford OX3 7LD, England
关键词
Oxford knee score; Item response theory; Psychometrics; EAP; Plausible value imputation; Arthroplasty; HEALTH;
D O I
10.1016/j.jclinepi.2023.03.013
中图分类号
R19 [保健组织与事业(卫生事业管理)];
学科分类号
摘要
Objectives: To apply item response theory as a framework for studying measurement error in superiority trials which use patient -reported outcome measures (PROMs).Methods: We reanalyzed data from the The Total or Partial Knee Arthroplasty 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 charac-teristics with expected a posteriori (EAP) scoring, and after accounting for individual-level measurement error with plausible value impu-tation (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.Results: With 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. Conclusion: Psychometric sensitivity analyses can be readily performed for superiority trials using PROMs and may aid the interpre-tation of results.(c) 2023 The Author(s). Published by Elsevier Inc. This is an open access article under the CC BY license (http://creative commons.org/licenses/by/4.0/).
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页码:62 / 69
页数:8
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