Contributions
Abstract: PB1747
Type: Publication Only
Session title: Quality of life, palliative care, ethics and health economics
Background
The EORTC QLQ-MY20 was originally developed in 1996 to assess health-related QoL (HRQoL) in multiple myeloma (MM) patients. Since its development, the use of multiple new myeloma treatment options has had a major impact on prolong survival in MM patients. The continuous introduction of new Myeloma combination agents is likely to have further implications on HRQoL outcomes and its measurement.
Aims
In the era of new therapies the aim of this review was to explore the use and performance of the QLQ-MY20 in clinical studies, the population characteristics (i.e the number of treatment lines patients had received), therapy types, positioning to support randomised controlled trial (RCT) endpoints and psychometric performance.
Methods
Original research (1996-June 2020) that used the QLQ-MY20 in a clinical study or that assessed the psychometric properties of the questionnaire was identified through an electronic database search. Abstracts were screened to remove irrelevant results and duplicates. Data were extracted from full text publications/conference abstracts and checked by a second rater.
Results
66 clinical studies and 9 validation studies were identified. The QLQ-MY20 had been used in RCTs (n=19, 29%), clinical trial-single arm (n=3, 5%), cross-sectional observational (n=26, 39%), and longitudinal/cohort observational (n=18, 27%) studies. The publication of QLQ-MY20 data in clinical trials increased over time from 2006-2010 (n=1), 2011-2015 (n=8) and 2016-2020 (n=13). Clinical trials most frequently included relapsed MM patients (n=15, 68%), and assessed a range of combinations therapies with Steroids (n=18, 82%), Proteasome inhibitors (n=13, 59%), immunomodulatory IMiDS (n=12, 55%) and Chemotherapeutic drugs (n=10, 46%). QLQ-MY20 subscales were most frequently defined as secondary (n=12, 55%) or exploratory (n=7, 32%) trial endpoints. The subscales most frequently used to support trial endpoints were Disease Symptoms (DS; n=16, 72%) and Side Effects (SE; n=16, 72%). Validation articles demonstrated that all domains were performing well in terms of internal consistency reliability (>0.7), test-reset reliability (intraclass correlation coefficient >=0.85) and internal and external convergent and discriminant validity. The DS, SE and Future Perspectives (FP) domains were performing well with respect to floor and ceiling effects however four articles reported a high percentage of ceiling effects in the Body Image (BI) domain.
Conclusion
Overall the results showed that the EORTC QLQ-MY20 remains a widely used and psychometrically robust instrument. An update to prospectively optimize this EORTC QLQ MY20 is currently underway in a European trial, to keep up the conceptual relevance in reporting QOL with survival outcomes using new therapies.
Keyword(s): Multiple myeloma, Quality of life
Abstract: PB1747
Type: Publication Only
Session title: Quality of life, palliative care, ethics and health economics
Background
The EORTC QLQ-MY20 was originally developed in 1996 to assess health-related QoL (HRQoL) in multiple myeloma (MM) patients. Since its development, the use of multiple new myeloma treatment options has had a major impact on prolong survival in MM patients. The continuous introduction of new Myeloma combination agents is likely to have further implications on HRQoL outcomes and its measurement.
Aims
In the era of new therapies the aim of this review was to explore the use and performance of the QLQ-MY20 in clinical studies, the population characteristics (i.e the number of treatment lines patients had received), therapy types, positioning to support randomised controlled trial (RCT) endpoints and psychometric performance.
Methods
Original research (1996-June 2020) that used the QLQ-MY20 in a clinical study or that assessed the psychometric properties of the questionnaire was identified through an electronic database search. Abstracts were screened to remove irrelevant results and duplicates. Data were extracted from full text publications/conference abstracts and checked by a second rater.
Results
66 clinical studies and 9 validation studies were identified. The QLQ-MY20 had been used in RCTs (n=19, 29%), clinical trial-single arm (n=3, 5%), cross-sectional observational (n=26, 39%), and longitudinal/cohort observational (n=18, 27%) studies. The publication of QLQ-MY20 data in clinical trials increased over time from 2006-2010 (n=1), 2011-2015 (n=8) and 2016-2020 (n=13). Clinical trials most frequently included relapsed MM patients (n=15, 68%), and assessed a range of combinations therapies with Steroids (n=18, 82%), Proteasome inhibitors (n=13, 59%), immunomodulatory IMiDS (n=12, 55%) and Chemotherapeutic drugs (n=10, 46%). QLQ-MY20 subscales were most frequently defined as secondary (n=12, 55%) or exploratory (n=7, 32%) trial endpoints. The subscales most frequently used to support trial endpoints were Disease Symptoms (DS; n=16, 72%) and Side Effects (SE; n=16, 72%). Validation articles demonstrated that all domains were performing well in terms of internal consistency reliability (>0.7), test-reset reliability (intraclass correlation coefficient >=0.85) and internal and external convergent and discriminant validity. The DS, SE and Future Perspectives (FP) domains were performing well with respect to floor and ceiling effects however four articles reported a high percentage of ceiling effects in the Body Image (BI) domain.
Conclusion
Overall the results showed that the EORTC QLQ-MY20 remains a widely used and psychometrically robust instrument. An update to prospectively optimize this EORTC QLQ MY20 is currently underway in a European trial, to keep up the conceptual relevance in reporting QOL with survival outcomes using new therapies.
Keyword(s): Multiple myeloma, Quality of life