Trial reportJournal of patient-reported outcomes2026
Psychometric analysis of new lymphoma-specific patient-reported symptom measures derived from the EORTC item library.
Trial report in Journal of patient-reported outcomes, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Not yet cited in PubMed.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 3 Open-Label, Randomized Study of LOXO-305 Versus Investigator Choice of BTK Inhibitor in Patients With Previously Treated BTK Inhibitor Naïve Mantle Cell Lymphoma (BRUIN MCL-321)
A Phase 3 Open-Label, Randomized Study of LOXO-305 Versus Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in BTK Inhibitor Pretreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN CLL-321)
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8 authors.
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Abstract
introductionThree patient-reported outcome (PRO) measures specific to lymphoma symptoms were previously defined using mixed-methods research, comprising questions from the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 items (QLQ-C30) and Item Library (IL): measures of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) Symptoms, Mantle Cell Lymphoma (MCL) Symptoms, and an Expanded Fatigue measure. The objective of this study was to assess psychometric properties of the measures and provide guidance for interpretation by identifying thresholds for determining meaningful within-patient change (MWPC).
methodsPsychometric properties of the CLL/SLL-related Symptoms, MCL-related Symptoms, and Expanded Fatigue measures were assessed using classical test theory (CTT) and Rasch measurement theory (RMT) using blinded data collected from two phase 3 trials in participants with CLL/SLL (BRUIN-CLL-321, N = 211) and MCL (BRUIN-MCL-321, N = 523). CTT analyses assessed reliability, construct validity and ability to detect change, while RMT analyses explored adequacy of summing items to generate summary scores. MWPC for each score was estimated using anchor-based and distribution-based methods.
resultsThe three measures demonstrated adequate internal consistency and test-retest reliability, and strong evidence of construct validity. Each showed a good ability to detect worsening and, to a lesser degree, improvement. RMT analyses confirmed adequacy of the response scales but suggested suboptimal targeting for participants with the lowest symptoms severity. For the two symptoms-related measures, items related to fatigue were over-discriminating, suggesting that they are driving the measures. Analyses of MWPC resulted in the following estimates: for the CLL/SLL-related Symptoms score, an improvement of -15.38 points (worsening unable to be estimated); for the MCL-related Symptoms score, an improvement of -10.25 points and a worsening of 5.12 points; and for the Expanded Fatigue score, an improvement -16.66 points in both CLL/SLL and MCL populations and a worsening of 11.11 points in participants with MCL (unable to be estimated in CLL/SLL).
conclusionThe CLL/SLL-related Symptoms, MCL-related Symptoms, and Expanded Fatigue measures showed strong psychometric properties in both CTT and RMT frameworks. Combined with previously published qualitative data, this research showed that the measures are appropriate for use in clinical trials of participants with CLL/SLL and MCL. TRIAL REGISTRATIONS: BRUIN-CLL-321, NCT04666038. Registered 07 December 2020, https://www. CLINICALTRIALS: gov/study/NCT04666038 ; BRUIN-MCL-321, NCT04662255, Registered 04 December 2020, https://clinicaltrials.gov/study/NCT04662255 .
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