التفاصيل البيبلوغرافية
| العنوان: |
Assessing tolerability with the Functional Assessment of Cancer Therapy item GP5: psychometric evidence from LIBRETTO-531, a phase 3 trial of selpercatinib in medullary thyroid cancer |
| المؤلفون: |
Antoine Regnault, Laurine Bunod, Angely Loubert, Marcia S. Brose, Lisa M. Hess, Patricia Maeda, Yan Lin, Rebecca M. Speck, Adrienne M. Gilligan, Nalin Payakachat |
| المصدر: |
Journal of Patient-Reported Outcomes, Vol 8, Iss 1, Pp 1-10 (2024) |
| بيانات النشر: |
SpringerOpen, 2024. |
| سنة النشر: |
2024 |
| المجموعة: |
LCC:Public aspects of medicine |
| مصطلحات موضوعية: |
Medullary thyroid cancer, Patient-reported tolerability, Psychometric analysis, FACT item GP5, Public aspects of medicine, RA1-1270 |
| الوصف: |
Abstract Background This psychometric analysis generated evidence to support the use of the Functional Assessment of Cancer Therapy item GP5 (GP5) as a measure of tolerability and confirms the appropriateness of categorizing “high side-effect burden” using a rating of 3 or 4 (score ranges 0–4) in patients with advanced/metastatic RET-mutant medullary thyroid cancer (MTC). Methodology Blinded, pooled interim data from the safety population (n=290) enrolled in the phase 3 LIBRETTO-531 trial (NCT04211337) were used. Intraclass correlation coefficients (ICC) were calculated for test-retest reliability using data from cycles 1-2 post-baseline. Construct validity was evaluated by examining the correlations of GP5 ratings with (a) symptomatic adverse events (AEs; measured by the PRO-CTCAE), and (b) functioning scores of EORTC QLQ-C30. The ability to detect change over time was examined by Cochrane-Mantel-Haenszel tests for GP5 ratings and PRO-CTCAE. The relationship of “high side-effect burden” categories with QLQ-C30 functioning scores was examined. Results ICCs for the GP5 ratings after cycle 1 ranged between 0.80 and 0.85, indicating good reliability. Correlations between GP5 and PRO-CTCAE items ranged from 0.18 to 0.62 and ranged from -0.37 to -0.50 for QLQ-C30 functioning scores, consistent with study assumptions. Post-baseline GP5 ratings showed significant associations with PRO-CTCAE scores (p |
| نوع الوثيقة: |
article |
| وصف الملف: |
electronic resource |
| اللغة: |
English |
| تدمد: |
2509-8020 |
| Relation: |
https://doaj.org/toc/2509-8020 |
| DOI: |
10.1186/s41687-024-00823-8 |
| URL الوصول: |
https://doaj.org/article/9e4c0dc027c54c2486527e406556e3cd |
| رقم الانضمام: |
edsdoj.9e4c0dc027c54c2486527e406556e3cd |
| قاعدة البيانات: |
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