P-131: Use of the European Organisation for research and treatment of cancer quality of life Multiple Myeloma questionnaire (EORTC QLQ-MY20): a review of the literature 25 years after development

Background The EORTC QLQ-MY20 is a widely used myeloma-specific patient-reported outcome measure originally developed in 1999. It consists of 20 items covering Disease Symptoms (DS), Side Effects (SE), Future Perspectives (FP) and Body Image (BI). Novel treatments and multiple lines of therapy mean the treatment for myeloma patients and life expectancy has changed dramatically and there is a need to ensure the measurement of health-related quality of life remains current for these patients. The original validation study was almost exclusively in newly diagnosed patients reflecting the nature of clinical trials at the time. This review was conducted as part of an EORTC funded grant to update the QLQ-MY20, with the aim of summarising the published literature from the QLQ-MY20 to date including any further validation results for the QLQ-MY20. Methods Literature search was conducted using the Ovid SP platform (Medline, EMBASE and PsycINFO) from 1996 (first release of the questionnaire). Abstracts were included if they were reporting: a clinical study using the QLQ-MY20 or validation studies. Information about the study design was extracted alongside whether the population were newly diagnosed or relapsed, and the supplementary instruments used alongside the QLQ-MY20. For randomised control trials, information on the type of analysis and results were also extracted. For validation studies data on the instrument structure and data distribution, reliability, validity and ability to detect change/interpretation of change scores was extracted. Results 656 abstracts were screened to 74 included papers (65 clinical studies, of which 21 were interventional clinical trials, and 9 validation studies). Supplementary instruments used alongside QLQ-C30 and MY20 included BPI-SF (Brief pain inventory short form), EQ-5D-5L (generic preference-based measure), FACT-GOG-Ntx (neurotoxicity) and the EORTC QLQ-CIPN20 (chemotherapy induced peripheral neuropathy). In contrast with the original validation study, 34 out of 43 clinical studies included either exclusively relapsed patients (n=24) or a mix of newly diagnosed and relapsed (n=9). DS and SE were the most commonly reported results from the QLQ-MY20. Further validation studies supported the factor structure, reliability and validity, with the only potential issue being observed ceiling effects for the BI subscale. Conclusions The shift in HRQOL measurement to patients experiencing multiple lines of treatment and novel treatments, highlights the need for updating the conceptual model for the QLQ-MY20. Interviews are currently underway internationally with 90 patients and 20 healthcare professionals to identify the issues relevant to myeloma patients today. The current questionnaire has been shown to be psychometrically valid and can be supplemented in the interim using item banks or existing questionnaires to cover new side effects specific to novel treatments.