# Assessing the assessment: a scoping review of the mode of patient-reported outcome assessment in solid cancer clinical trials

## TL;DR

This study examines how patient-reported outcomes are collected in cancer trials and finds that reporting is often inadequate despite guidelines.

## Contribution

The study provides the first systematic review of PRO assessment modes in recent solid cancer trials and identifies predictors of reporting practices.

## Key findings

- Only 45.6% of trials reported the mode of PRO assessment, with paper being the most common.
- Industry-sponsored trials and larger trials were more likely to report PRO assessment modes.
- Active in-stream review of PRO data was reported in just 2.0% of trials.

## Abstract

Transparent reporting of how patient-reported outcomes (PROs) are collected is essential to ensure reproducible and interpretable data. Different modes of assessment may affect data quality and feasibility, yet their use in cancer trials is poorly described. Electronic PRO (ePRO) assessment may improve data quality and enable active review, but it is unclear how often different modes of assessment like ePRO assessment are used and in which trials.

We systematically searched PubMed for randomized controlled trials (published 2019–2023) that used cancer-specific PRO measures in patients with the six most common solid cancers. Trial characteristics, PRO reporting practices, and evidence of active review of PRO data were summarized descriptively. Univariate logistic regression was used to examine predictors of (1) reporting the mode of PRO assessment and (2) use of ePROs exclusively.

Of 9331 references screened, 296 trials were included in the analysis. 135 (45.6%) reported the mode of PRO assessment: paper (51.9%), ePRO (20.7%), mixed modes (24.4%). Trials were more likely to report the mode of assessment if they were industry-sponsored (OR = 2.00, 95%, p = .005), or had larger sample sizes (OR = 1.11, 95%, p < .001). ePRO assessment exclusively was used more in recently registered trials (OR = 1.41, p < .001) and in industry-sponsored trials (OR = 8.38, p < .001). Active, in-stream review of PRO results was reported in 2.0% of trials.

Despite clear guidelines, reporting of the mode of PRO assessment remains inadequate, and active review of PRO data is uncommon. Strengthening transparency and using PROs more actively within trials could enhance patient-centered cancer research.

The online version contains supplementary material available at 10.1007/s11136-026-04179-y.

This study looked at how information from patients about their symptoms and quality of life is collected in cancer trials. These patient-reported outcomes are important because they show how treatments affect people’s daily lives, not just medical results. To be useful, this information needs to be collected and reported clearly so that others can trust and learn from it. We reviewed 296 cancer trials published between 2019 and 2023. The aim was to investigate whether the trials explained how they gathered questionnaires, and if the results were checked during the trial to support patient care. We found that less than half of the trials clearly reported how the questionnaires were collected. When it was reported, paper questionnaires were most common, although electronic tools are being used more often in newer and industry-sponsored studies. Only a very small number of trials reported that they actively reviewed questionnaire results from individual patients while the trial was still running. The findings show that in cancer trials, it is often not clearly explained how patient information is collected, even though this is recommended by guidelines. Better reporting of how questionnaires are assessed and used as part of cancer trials is needed to make trial methodology more transparent.

The online version contains supplementary material available at 10.1007/s11136-026-04179-y.