Publications by authors named "A Regnault"
Background: This psychometric analysis generated evidence to support the use of the Functional Assessment of Cancer Therapy item GP5 (GP5) as a measure of tolerability and confirms the appropriateness of categorizing "high side-effect burden" using a rating of 3 or 4 (score ranges 0-4) in patients with advanced/metastatic RET-mutant medullary thyroid cancer (MTC).
Methodology: Blinded, pooled interim data from the safety population (n=290) enrolled in the phase 3 LIBRETTO-531 trial (NCT04211337) were used. Intraclass correlation coefficients (ICC) were calculated for test-retest reliability using data from cycles 1-2 post-baseline.
Article Synopsis
- The research aimed to provide psychometric evidence that supports the use of patient-reported outcome (PRO) scales for measuring the severity of myasthenia gravis (MG) symptoms, utilizing data from a phase 3 study.
- Data from the MycarinG study analyzed with classical test theory and Rasch measurement theory revealed that the MG Symptoms PRO scales have good reliability and validity, confirming their effectiveness in measuring core symptoms.
- The findings also established clinically meaningful benchmarks for patient improvement in key symptoms, offering insights for their interpretation in clinical trials and enhancing the assessment of treatment effects.
Patient-reported outcomes (PROs) are increasingly used in healthcare research to provide evidence of the benefits and risks of interventions from the patient perspective and to inform regulatory decisions and health policy. The use of PROs in clinical practice can facilitate symptom monitoring, tailor care to individual needs, aid clinical decision-making and inform value-based healthcare initiatives. Despite their benefits, there are concerns that the potential burden on respondents may reduce their willingness to complete PROs, with potential impact on the completeness and quality of the data for decision-making.
View Article and Find Full Text PDFBackground: No specific measures exist to assess patient-reported symptoms experienced by individuals with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) or mantle cell lymphoma (MCL). This study was conducted to elicit patient-reported CLL/SLL- and MCL-related symptoms and their impact on patients' lives. The study qualitatively and quantitatively evaluated sets of conceptually-selected EORTC Item Library items for assessing CLL/SLL- and MCL-related symptoms.
View Article and Find Full Text PDF