G173 Development of the Evaluating Quality of Life in Acute Lymphoblastic Leukaemia (EQuALL) Questionnaire: A Treatment Specific Measure For the Effects of Corticosteroids on Quality of Life

Abstract

Objectives: The use of corticosteroids (particularly dexamethasone) within acute lymphoblastic leukaemia (ALL) protocols has contributed greatly to the excellent survival rates. However this is not without cost - in addition to physical side effects, corticosteroids influence behaviour, mood and cognitive functioning leading to an impaired quality of life (QoL) for patients. The UKALL 2011 randomisation to maintenance therapy with or without dexamethasone pulses has both survival and QoL as primary outcome measures. The aim of this study was to develop a QoL measure sensitive to the effects of corticosteroids that may detect potential differences in QoL in patients receiving dexamethasone. Methods: Patients aged 8-24 years and parents of children aged 1-15 years receiving maintenance therapy for ALL from 4 UK centres, were invited to participate. The study comprised 3 stages: A) focus groups and interviews asked participants to describe their experience of dexamethasone, and the themes identified formulated Version 1 of EQuALL. B) Version 1 was emailed electronically to healthcare professionals and patients to evaluate the importance and relevance of questions. Amendments were made to create Version 2. C) Cognitive interviewing confirmed face validity and explored question interpretation. Further modifications were made to define Version 3. Results: Six parents and eight patients attended focus groups/interviews. Interpretative phenomenological analysis of transcripts identified that patients feel dexamethasone has adverse effects on behaviour, appetite, body image, mood and family relationships. 121 healthcare professionals and 36 patients/parents completed the electronic survey leading to further amendment of the questions. Face validity was confirmed by cognitive interviewing of 21 patients. EQuALL comprises 35 questions within 4 domains and has age-specific versions. Conclusions: EQuALL is the first treatment-specific QoL measure for corticosteroids. It can be completed in 10-15 minutes by children aged 8 years and above. Further validity and reliability testing will be undertaken within UKALL 2011.