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Open Access 06-11-2024 | Constipation

Identification of meaningful individual-level change thresholds for worsening on the patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE®)

Authors: Minji K. Lee, Sandra A. Mitchell, Ethan Basch, Gina L. Mazza, Blake T. Langlais, Gita Thanarajasingam, Brenda F. Ginos, Lauren Rogak, Eric A. Meek, Jennifer Jansen, Allison M. Deal, Philip Carr, Victoria S. Blinder, Mattias Jonsson, Gita N. Mody, Tito R. Mendoza, Antonia V. Bennett, Deborah Schrag, Amylou C. Dueck

Published in: Quality of Life Research

Abstract

Background

We derived meaningful individual-level change thresholds for worsening in selected patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE®) items and their composite scores.

Methods

We used two data sources, the PRO-TECT trial (Alliance AFT-39) that collected PRO-CTCAE data from adults with advanced cancer at 26 United States (U.S.) community oncology practices and the PRO-CTCAE validation study that collected PRO-CTCAE data from adults undergoing chemotherapy or radiation therapy at nine U.S. cancer centers or community oncology practices. Both studies administered selected PRO-CTCAE items and EORTC QLQ-C30 scales. Conceptually, relevant QLQ-C30 domains were used as anchors to estimate meaningful change thresholds for deterioration in corresponding PRO-CTCAE items and their composite scores. Items or composites with ǀρǀ ≥ 0.30 correlation with QLQ-C30 scales were included. Changes in PRO-CTCAE scores and composites were estimated for patients who met or exceeded a 10-point deterioration on the corresponding QLQ-C30 scale. Change scores were computed between baseline and the 3-month timepoint in PRO-TECT, and in the PRO-CTCAE validation study between baseline and a single follow-up visit that occurred between 1 and 7 weeks later. For each PRO-CTCAE item, change scores could range from − 4 to 4; for a composite, change scores could range from − 3 to 3.

Results

Change scores in QLQ-C30 and PRO-CTCAE were available in 406 and 792 patients in PRO-TECT and the validation study, respectively. Across QLQ-C30 scales, the proportion of patients with a 10-point or greater worsening on QLQ-C30 ranged from 15 to 30% in the PRO-TECT data and 13% to 34% in the validation data. Across PRO-CTCAE items, anchor-based meaningful change estimates for deterioration ranged from 0.05 to 0.30 (mean 0.19) in the PRO-TECT data and from 0.19 to 0.53 (mean 0.36) in the validation data. For composites, they ranged from 0.06 to 0.27 (mean 0.17) in the PRO-TECT data and 0.22 to 0.51 (mean 0.37) in the validation data.

Conclusion

In both datasets, the minimal meaningful individual-level change threshold for worsening was one point for all items and composite scores.

ClinicalTrials.gov: NCT03249090 (AFT-39), NCT02158637 (MC1091)

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Title: Identification of meaningful individual-level change thresholds for worsening on the patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE®)
Authors: Minji K. Lee
Sandra A. Mitchell
Ethan Basch
Gina L. Mazza
Blake T. Langlais
Gita Thanarajasingam
Brenda F. Ginos
Lauren Rogak
Eric A. Meek
Jennifer Jansen
Allison M. Deal
Philip Carr
Victoria S. Blinder
Mattias Jonsson
Gita N. Mody
Tito R. Mendoza
Antonia V. Bennett
Deborah Schrag
Amylou C. Dueck
Publication date: 06-11-2024
Publisher: Springer International Publishing
Keywords: Constipation
Constipation
Published in: Quality of Life Research
Print ISSN: 0962-9343
Electronic ISSN: 1573-2649
DOI: https://doi.org/10.1007/s11136-024-03819-5

Keynote series | Spotlight on menopause

Springer Medicine

Identification of meaningful individual-level change thresholds for worsening on the patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE®)

Abstract

Background

Methods

Results

Conclusion

Keynote series | Spotlight on menopause

Springer Medicine

Abstract

Background

Methods

Results

Conclusion

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