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

PURPOSE: 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.

METHODS

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.

RESULTS

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.

CONCLUSION

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.