Related Experiment Video
Updated: Jun 15, 2025
06:28
E-Patient Counseling Trial E-PACO: Computer Based Education versus Nurse Counseling for Patients to Prepare for Colonoscopy
Published on: August 1, 2019
8.3K
Measure selection for an electronic patient-reported outcome (ePRO) system for CAR T-cell therapy patients: a
Sarah E Hughes1,2,3,4, Foram Khatsuria1,2,3, Christel McMullan1,2,3
1Centre for Patient Reported Outcome Research, University of Birmingham, Birmingham, UK.
Eclinicalmedicine
|June 13, 2025
Summary
This study established consensus on patient-reported outcome measures for an electronic system to monitor Chimeric Antigen Receptor (CAR) T-cell therapy side effects and quality of life, improving patient care.
Area of Science:
- Oncology
- Clinical Therapeutics
- Health Outcomes Research
Background:
- Chimeric Antigen Receptor (CAR) T-cell therapies offer effective treatment for hematological cancers but are associated with significant toxicity and symptom burden.
- Patient-reported outcomes (PROs) are crucial for managing these adverse events and improving quality of life, yet specific guidance for CAR T-cell therapy is lacking.
- This study addresses the need for standardized PRO measures in electronic PRO (ePRO) systems for CAR T-cell therapy settings.
Purpose of the Study:
- To achieve consensus among patients and healthcare professionals on the selection of PRO measures for an ePRO system.
- To identify and evaluate PRO measures for symptom burden, impacts of cancer and CAR T-cell therapy, treatment tolerability, and health-related quality of life (HRQoL).
Main Methods:
- A modified Delphi study involving a two-round online survey was conducted with patients and healthcare professionals.
- A conceptual framework guided the selection process across four measurement domains.
- Database searches identified 113 PRO measures, with seven shortlisted based on pre-specified criteria.
Main Results:
- Consensus was reached in Round One with 19 participants (5 patients, 14 professionals).
- The Symptom Burden Questionnaire™ (SBQ™) and Quality of Life in Adult Cancer Survivors (QLACS) were selected for symptom burden and impacts.
- EQ5D-5L for HRQoL and FACT-GP5 for treatment tolerability were also chosen for the ePRO system.
Conclusions:
- Consensus-based selection of PRO measures is vital in the absence of specific guidance for CAR T-cell therapies.
- The selected PRO measures will form the basis of an ePRO system to enhance clinical management.
- Limitations include a modest sample size and subgroup representativeness.
