Use and reporting of patient-reported outcomes in randomized controlled trials in non-Hodgkin lymphoma: a scoping review

TL;DR

This study reviews how patient-reported outcomes are used in clinical trials for non-Hodgkin lymphoma, finding they are underused and often poorly reported.

Contribution

The study provides a comprehensive analysis of PRO usage and reporting gaps in NHL RCTs, highlighting the need for standardized practices.

Findings

Only 32.1% of NHL RCTs included patient-reported outcomes.

25% of trials omitted PRO findings from their main publications.

EORTC QLQ-C30, FACT-Lymphoma, and EQ-5D were the most commonly used PRO measures.

Abstract

Non-Hodgkin lymphoma (NHL) constitutes a biologically and clinically heterogeneous group of lymphoid malignancies, with varying prognoses and treatment aims between indolent and aggressive subtypes. While survival outcomes remain key efficacy measures, they insufficiently capture the impact of disease and treatment on daily physical and psychosocial functioning, as well as quality of life (QoL).

To characterize the use and reporting of patient-reported outcomes (PROs) in adult NHL randomized controlled trials (RCTs), including the trajectory of PRO dissemination throughout the trial reporting process.

MEDLINE, CENTRAL, ClinicalTrials.gov, and WHO ICTRP were systematically searched from 1 January 2017 to 19 January 2023 for NHL RCTs irrespective of subtype, with databases being re-searched until 4 February 2025. Cross-sectional and longitudinal descriptive analyses were conducted to investigate PRO use and reporting practices.

549 completed and ongoing RCTs met the eligibility criteria, of which 176 trials (32.1%) included a reference to PROs, and 27 (4.9%) used a PRO as a primary outcome. Overall, 95 PRO measures were identified across trials, with EORTC QLQ-C30, FACT-Lymphoma, and EQ-5D being referenced most frequently. Among trials with published results that pre-specified PROs, 25.0% entirely and 10.5% partly omitted PRO findings from their main full-texts, without addressing this shortcoming in subsequent publications.

PROs are underused and underreported in RCTs in NHL. Standardized PRO evaluation methodology and guidance for the selection of fit-for-purpose PRO measures are needed, along with clear positioning of PROs alongside survival outcomes in clinical trial design and interpretation.

The online version contains supplementary material available at 10.1186/s41687-026-00999-1.

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