Development of an EORTC questionnaire module to be used in health‐related quality‐of‐life assessment for patients with multiple myeloma

Abstract

Summary.A multiple myeloma-specific quality-of-life questionnaire module has been designed in collaboration with the EORTC Quality-of-Life Study Group to be used in clinical trials with the EORTC QLQ-C30, a general cancer questionnaire. Strict methodology was employed to ensure thorough and appropriate development of the module. An extensive literature review was performed to identify healthrelated quality-of-life issues relevant to patients with multiple myeloma. Semi-structured interviews were then carried out in several European countries with health-care providers experienced in the treatment of patients with multiple myeloma, and with a group of patients with multiple myeloma, to identify the issues which were most important to patients. A questionnaire was devised from the list of issues, using a 1-week time-frame and response categories consistent with the EORTC QLQ-C30. The provisional questionnaire and the EORTC QLQ-C30 were administered to patients with multiple myeloma in each participating country with further semi-structured interviews to refine the content and design of the questionnaire. A review of the results obtained in each stage of development resulted in a 24-item myeloma-specific module, the EORTC QLQ-MY24, which assesses disease-specific symptoms and their impact on everyday life, treatment side-effects, social support, and future perspective. The module is currently undergoing further international field-testing to assess its psychometric properties.Keywords: multiple myeloma, quality of life, questionnaire, EORTC, cross-cultural.The key clinical outcomes of cancer treatment, important for both patients and health-care professionals, are survival and health-related quality of life (HRQoL). It is of paramount importance to choose appropriate and well-developed tools to assess the aspects of HRQoL most likely to be affected by both the disease and the treatment. The development of HRQoL measures is based on principles of test construction and evaluation. A common test construction strategy is to generate a large pool of issues from which to derive the most appropriate and sensitive set. The selection of items is based on patients' opinions as well as on health-professionals' views. The aim of this thorough approach is to ensure that the content and breadth of coverage of the questionnaire under development is appropriate for the population under study, that it asks relevant questions and does not miss out important issues. This task can be achieved only by careful initial construction of the questionnaire, and omissions at this stage cannot be compensated for by statistical analysis at

Pomalidomide and Low-Dose Dexamethasone Improves Health-Related Quality of Life and Prolongs Time to Worsening in Relapsed/Refractory Patients With Multiple Myeloma Enrolled in the MM-003 Randomized Phase III Trial

“…23 for specific use in MM, and the general health-related EQ-5D HRQoL questionnaire that converts five dimensions of patient-reported, current-day health status into a "health utility" score (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). 26 These three questionnaires have been validated and extensively used in MM patients, [27][28][29][30][31][32][33] and can be completed in a few minutes. 34,35 Domains to focus on were chosen following a workshop discussion with specialists, based on perceived clinical relevance and on multivariate regression analysis against the EQ-5D utility index.…”

“…34,35 Domains to focus on were chosen following a workshop discussion with specialists, based on perceived clinical relevance and on multivariate regression analysis against the EQ-5D utility index. 36 Eight clinically relevant domains from the HRQoL questionnaires were selected for detailed analysis: five from the 30-item generic EORT QLQ-C30 (Global Health Status, Physical Functioning, Emotional Functioning, Fatigue, and Pain) [28][29][30][31]37 ; two from EORTC QLQ-MY20 (Disease Symptoms, and Side Effects of Treatment), 32,33 and the EQ-5D health utility index.…”

Health-related quality-of-life in patients with newly diagnosed multiple myeloma in the FIRST trial: lenalidomide plus low-dose dexamethasone versus melphalan, prednisone, thalidomide

“…[26][27][28][29][30][31][32][33][34][35] These questionnaires were administered in paper format at the hospital. Patients completed the questionnaires at several time points: baseline; at the end of Cycle 1 (after 4 weeks of treatment with Rd and after 6 weeks of treatment with MPT); after 3, 6, 12, and 18 months of treatment; and at study discontinuation.…”

“…27,28,32,37,38 Results were transformed into scales ranging from 0 to 100 for QLQ-MY20 and QLQ-C30. For the functional scales (Global Health Status and Physical Functioning), higher scores indicate better HRQoL, whereas for the symptom scales (Fatigue, Pain, Disease Symptoms, and Side Effects of Treatment), lower scores indicate a better health state.…”

An open, randomized, controlled, phase II, single centre, two-period cross-over study to compare the quality of life and toxicity experienced on PEG interferon with interferon-α2b in patients with multiple myeloma maintained on a steady dose of interferon-α2b

“…Patients completed the questionnaires EORTC QLQ-C30 and EORTC QLQ-MY24 at baseline, 3 months (at cross-over to the other arm) and 6 months (end of study) [20,21]. The EORTC QLQ-C30 is a health-related QoL questionnaire with 30 items which assesses QoL mainly during the past week.…”