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22-09-2022 | Special Section: Methodologies for Meaningful Change

Comparison of raw and regression approaches to capturing change on patient-reported outcome measures

Auteurs: David A. Andrae, Brandon Foster, J. Devin Peipert

Gepubliceerd in: Quality of Life Research

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Abstract

Purpose

Patient-reported outcome (PRO) analyses often involve calculating raw change scores, but limitations of this approach are well documented. Regression estimators can incorporate information about measurement error and potential covariates, potentially improving change estimates. Yet, adoption of these regression-based change estimators is rare in clinical PRO research.

Methods

Both simulated and PROMIS® pain interference items were used to calculate change employing three methods: raw change scores and regression estimators proposed by Lord and Novick (LN) and Cronbach and Furby (CF). In the simulated data, estimators’ ability to recover true change was compared. Standard errors of measurement (SEM) and estimation (SEE) with associated 95% confidence limits were also used to identify criteria for significant improvement. These methods were then applied to real-world data from the PROMIS® study.

Results

In the simulation, both regression estimators reduced variability compared to raw change scores by almost half. Compared to CF, the LN regression better recovered true simulated differences. Analysis of the PROMIS® data showed similar themes, and change score distributions from the regression estimators showed less dispersion. Using distribution-based approaches to calculate thresholds for significant within-patient change, smaller changes could be detected using both regression estimators.

Conclusions

These results suggest that calculating change using regression estimates may result in more increased measurement sensitivity. Using these scores in lieu of raw differences can help better identify individuals who experience real underlying change in PROs in the course of a trial, and enhance the established methods for identifying thresholds for meaningful within-patient change in PROs.
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Metagegevens
Titel
Comparison of raw and regression approaches to capturing change on patient-reported outcome measures
Auteurs
David A. Andrae
Brandon Foster
J. Devin Peipert
Publicatiedatum
22-09-2022
Uitgeverij
Springer International Publishing
Gepubliceerd in
Quality of Life Research
Print ISSN: 0962-9343
Elektronisch ISSN: 1573-2649
DOI
https://doi.org/10.1007/s11136-022-03196-x