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

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 d

SUBMITTER: Lee MK 

PROVIDER: S-EPMC11865169 | biostudies-literature | 2025 Feb

REPOSITORIES: biostudies-literature