A critical review of the use of electronic patient-reported outcomes in cancer clinical trials – developing an EORTC perspective

Patient-reported outcome measures (PROMs) are collected using paper questionnaires or electronic methods, including study-provided devices and patients’ own devices. Each mode has potential advantages and limitations for patients, trial sites, and the quality and management of trial data. However, evidence to guide mode selection in oncology trials has been limited.

This EORTC Quality of Life Group (QLG) project (2023–2026) reviewed current practice in PROM assessment, examined challenges and opportunities across assessment modes, and brought together different stakeholder perspectives to inform evidence-based, practical decisions about PROM data collection in cancer clinical trials.

The project has been completed. Two scoping reviews examined PROM assessment in oncology randomized trials. They found that the mode of assessment was frequently inadequately reported and that, in available aggregated trial-level data, electronic assessment was not significantly associated with higher PRO completion rates than other modes.

An EORTC-wide survey captured members’ experience and preferences regarding PROM assessment. In addition, interviews with stakeholders from academia, industry, clinical trial sites, and patient representation explored the benefits and challenges of different assessment modes.

These findings informed a multi-stakeholder expert panel evaluating paper-based assessment, electronic assessment using study-provided devices, and bring-your-own-device (BYOD) approaches. The resulting EORTC QLG-led review, “Selecting Modes of Patient-Reported Outcome Measure Assessment in Oncology Trials: An EORTC Quality of Life Group-Led Multi-Stakeholder Expert Panel Review,” has been accepted for publication in Value in Health.

The project’s central conclusion is that no single PROM assessment mode is optimal for every trial. Electronic methods can facilitate timely data availability, completion monitoring, and traceability, but require appropriate infrastructure, technical support, and attention to patient accessibility. Paper questionnaires may remain suitable in certain settings, provided that data quality and traceability are safeguarded.

The findings support transparent, context-specific mode selection during trial planning, taking account of patient populations, study procedures, site resources, data requirements, and backup options. Project insights have also informed EORTC discussions on electronic PROM implementation and educational activities.

In cancer clinical trials, patients may be asked to report their symptoms, functioning, and quality of life through questionnaires, either on paper or electronically. Different approaches may work better for different people and study situations.

This project examined the advantages and challenges of these approaches and brought patient perspectives into an expert discussion. Its findings can help trial teams choose methods that make questionnaires accessible and practical while supporting reliable collection of patients’ reports.