Silviya Nikolova1, Claire Hulme2, Robert West3, Neil Pendleton4, Anne Heaven5, Peter Bower6, Sara Humphrey7, Amanda Farrin8, Bonnie Cundill8, Rebecca Hawkins5, Andrew Clegg5. 1. Academic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Leeds, England, UK. Electronic address: s.k.nikolova@leeds.ac.uk. 2. Health Economics Group, Institute of Health Research, University of Exeter, Exeter, England, UK. 3. Division of Health Research, University of Leeds, Leeds, England, UK. 4. Salford Royal NHS Hospital, Division of Neuroscience & Experimental Psychology, School of Biological Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre, University of Manchester, Manchester, England, UK. 5. Academic Unit of Elderly Care and Rehabilitation, Bradford Institute for Health Research, Bradford Teaching Hospital NHS Foundation Trust, Bradford, Leeds Institute of Health Sciences, Leeds, England, UK. 6. NIHR School for Primary Care Research, Centre for Primary Care and Health Services Research, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre, University of Manchester, Manchester, England, UK. 7. North Street Surgery, Partner Affinity Care, Westcliffe Health Innovations, Yorkshire & Humber Dementia CN, Bradford University School of Dementia Studies, England, UK. 8. Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, England, UK.
Abstract
BACKGROUND: Previous studies have summarized evidence on health-related quality of life for older people, identifying a range of measures that have been validated, but have not sought to present results by degree of frailty. Furthermore, previous studies did not typically use quality-of-life measures that generate an overall health utility score. Health utility scores are a necessary component of quality-adjusted life-year calculations used to estimate the cost-effectiveness of interventions. METHODS: We calculated normative estimates in mean and standard deviation for EQ-5D-5L, short-form 36-item health questionnaire in frailty (SF-36), and short-form 6-dimension (SF-6D) for a range of established frailty models. We compared response distributions across dimensions of the measures and investigated agreement using Bland-Altman and interclass correlation techniques. RESULTS: The EQ-5D-5L, SF-36, and SF-6D scores decrease and their variability increases with advancing frailty. There is strong agreement between the EQ-5D-5L and SF-6D across the spectrum of frailty. Agreement is lower for people who are most frail, indicating that different components of the 2 instruments may have greater relevance for people with advancing frailty in later life. There is a greater risk of ceiling effects using the EQ-5D-5L rather than the SF-6D. CONCLUSIONS: We recommend the SF-36/SF-6D as an appropriate measure of health-related quality of life for clinical trials if fit older people are the planned target. In trials of interventions involving older people with increasing frailty, we recommend that both the EQ-5D-5L and SF36/SF6D are included, and are used in sensitivity analyses as part of cost-effectiveness evaluation.
BACKGROUND: Previous studies have summarized evidence on health-related quality of life for older people, identifying a range of measures that have been validated, but have not sought to present results by degree of frailty. Furthermore, previous studies did not typically use quality-of-life measures that generate an overall health utility score. Health utility scores are a necessary component of quality-adjusted life-year calculations used to estimate the cost-effectiveness of interventions. METHODS: We calculated normative estimates in mean and standard deviation for EQ-5D-5L, short-form 36-item health questionnaire in frailty (SF-36), and short-form 6-dimension (SF-6D) for a range of established frailty models. We compared response distributions across dimensions of the measures and investigated agreement using Bland-Altman and interclass correlation techniques. RESULTS: The EQ-5D-5L, SF-36, and SF-6D scores decrease and their variability increases with advancing frailty. There is strong agreement between the EQ-5D-5L and SF-6D across the spectrum of frailty. Agreement is lower for people who are most frail, indicating that different components of the 2 instruments may have greater relevance for people with advancing frailty in later life. There is a greater risk of ceiling effects using the EQ-5D-5L rather than the SF-6D. CONCLUSIONS: We recommend the SF-36/SF-6D as an appropriate measure of health-related quality of life for clinical trials if fit older people are the planned target. In trials of interventions involving older people with increasing frailty, we recommend that both the EQ-5D-5L and SF36/SF6D are included, and are used in sensitivity analyses as part of cost-effectiveness evaluation.
Authors: Lesley Brown; Anne Heaven; Catherine Quinn; Victoria Goodwin; Carolyn Chew-Graham; Farhat Mahmood; Sarah Hallas; Ikhlaq Jacob; Caroline Brundle; Kate Best; Amrit Daffu-O'Reilly; Karen Spilsbury; Tracey Anne Young; Rebecca Hawkins; Barbara Hanratty; Elizabeth Teale; Andrew Clegg Journal: BMJ Open Date: 2021-11-22 Impact factor: 2.692