Myeloma Nurse Consultant, Clinical Associate Professor Royal Prince Alfred Hospital, The University of Sydney Sydney, New South Wales, Australia
Introduction: Steroids remain a mainstay in multiple myeloma (MM) treatment, with significant side effects (SE). As no tool existed to monitor steroid SE in this population, we developed the SSQ-MM to inform clinical care. Pilot testing of the SSQ-MM demonstrated high levels of feasibility, acceptability, repeatability, and internal consistency. This paper presents preliminary findings of a multi-site study to test the clinical validity and reliability of the final version SSQ-MM.
Methods: Clinical validity of the SSQ-MM was tested in a prospective, multi-centre, cross sectional study. MM patients attending participating haematology departments and taking steroids as part of MM treatment were invited to participate. The SSQ-MM, EORTC quality of life and MM Patient Reported Outcome Measures (PROM) (QLQ-C30 & MY20) were administered together, with the SSQ-MM repeated 1-week later. Internal consistency reliability was tested with Cronbach’s alpha >0.8 for individual patient decision-making. Test-retest using intraclass correlation coefficient >0.7 to test scale stability reliability. An estimated 200 patients are required to achieve statistical requirements. Clinical and demographic characteristics were collected.
Results: To date, 109/200 patients have been recruited across four hospitals in Sydney, Australia. Participants were 45-86yrs, 57% male, with average 4yrs (range, 1mth to 22yrs) since diagnosis. More than half (65/109; 59.6%) completed the PROMs electronically. Average dexamethasone dose was 28mg weekly (range, 4 to 80), or 124mg per cycle (range, 12 to 180). The most common regimens were Lenalidomide & Bortezomib (29/109, 26.6%), Lenalidomide (24/109, 22%), Daratumumab & Bortezomib (15/109, 13.8%), or Carfilzomib (15/109, 13.8%) based. Cronbach’s alpha at time points 1 (0.83) and 2 (0.84) showed internal consistency, and test-retest indicated the scale was stable (ICC: 0.844, 95%CI: 0.779 to 0.892; p< 0.001). The most frequently reported symptoms were disturbed sleep 100/109 (91.7%), loss of energy/fatigue 88/109 (80.7%), and trouble concentrating 87/109 (79.8%). Patients typically experienced 10 symptoms concurrently (range, 1 to 19), with 4 symptoms rated as severe (range, 0 to 12). Most frequently reported severe symptoms included disturbed sleep 73/109 (67 %), loss of energy/fatigue 55/109 (50.5%), and fragile skin/easy bruising 50/109 (45.9%), with disturbed sleep rated as most bothersome 53/109 (48.6%).
Conclusions: The SSQ-MM currently demonstrates high levels of feasibility, acceptability, and reliability and is suitable for clinical use to manage steroid toxicity and improve treatment outcomes for MM patients. The study continues to evaluate convergent and discriminant validity by exploring relationships between similar and dissimilar constructs within EORTC QLQ-C30 and QLQ-MY20, enabling the SSQ-MM to be used in future clinical trials of steroid treatments for MM. A study characterising sleep disturbance in this patient group is underway.
