NCT04066868

Evaluating the Use of Patient-Reported Outcome Measures for Improving the Inter-Rater Reliability of Common Terminology Criteria for Adverse Event Ratings

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,013 (actual)
• Sponsor: Medical University Innsbruck · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This open randomized trial investigates, if clinicians complete CTCAE ratings differently when receiving patients' patient-reported outcome (PRO) data prior to their CTCAE completion. The primary objective is to demonstrate superior inter-rater reliability of CTCAE ratings from physicians relying on EORTC PRO data as additional data source over traditional CTCAE ratings not including PRO information.

Detailed description

In oncology, detection and tracking of adverse events (AEs) are a top priority in both clinical trials and routine care. The classification of AEs mostly relies on the Common Toxicity Terminology for Adverse Events (CTCAE) developed by the US-American National Institutes of Health and the National Cancer Institute. It is known, however, that the assessment of AEs can greatly vary depending on whether they are assessed by patients or by clinicians. Procedure: The patients (any oncological diagnosis, day clinic or inpatient for treatment with chemotherapy or immunotherapy; open 1:1 randomized) fill out an EORTC quality of life questionnaire electronically (C30 + further questions). These PRO data are immediately available for the clinicians. Independently of each other, two different clinicians conduct a medical consultation with the patient and electronically a CTCAE rating. For the intervention Group, clinicians see the PRO values directly next to the input options for the CTCAE rating. For the control Group, clinicians see the input options for the CTCAE rating. The similarity of the assessments is checked using intra-class correlation. The combined use of PROs and CTCAE data makes particular sense for AEs/aspects that are directly experienced by the patient (fatigue, pain, cognitive problems, emotional functioning, ...) and can only be adequately recorded by the clinician through communication with the patient.

Conditions

• Cancer

Interventions

Type	Name	Description
OTHER	Patient-reported outcomes assessment	Patient-reported outcomes are electronically assessed using EORTC QOL measures
OTHER	CTCAE rating	CTCAE Ratings are conducted by clinicians
OTHER	PRO data is displayed	PRO data is displayed right next to the CTCAE rating

Timeline

• Start date: 2020-02-10
• Primary completion: 2024-12-06
• Completion: 2024-12-06
• First posted: 2019-08-26
• Last updated: 2025-04-20

Locations

1 site across 1 country: Austria