Aims Survival rates for childhood ALL now exceed 80%. The use of corticosteroids (particularly dexamethasone) has contributed greatly to this success. 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 current UKALL 2011 trial randomises patients to maintenance therapy with or without dexamethasone pulses. Survival and QoL are primary outcome measures. The aim of this study was to develop a sensitive QoL measure that may detect potential differences in QoL in patients receiving dexamethasone.
Methods Children and young adults 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 were conducted with participants being asked to describe their experience of dexamethasone. Version 1 of EQuALL was developed from the themes identified. B) This version was emailed in electronic survey format to healthcare professionals and patients to evaluate the importance and relevance of the questions. Amendments were made to create Version 2. Stage C assessed face validity and interpretation of individual questions using cognitive interviewing. Further modifications were made to define Version 3.
Results Six parents and 8 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 amendments. Face validity was confirmed by cognitive interviewing of 21 patients. EQuALL now 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. Although initial applications are for children with ALL, EQuALL may be a valuable clinical tool for understanding the impact of dexamethasone in other paediatric conditions.