K SHAH1, T YING2, B SHI2, H PILMORE3, A PILMORE4, P KELLY5, A WEBSTER5, S CHADBAN2, R MORTON1
1NHMRC Clinical Trials Centre, Faculty of Medicine and Health, The University of Sydney, Australia, 2Renal Department, Royal Prince Alfred Hospital, Camperdown, Australia, 3Auckland City Hospital, Auckland, New Zealand, 4Auckland District Health Board| ADHB – Department of Renal Medicine, New Zealand, 5School of Public Health, The University of Sydney, Australia
Aim: To identify patient and centre factors associated with non-completion of quality of life (QoL) questionnaires to improve future data completeness.
Background: Incorporating patient experience is important in health research. Missing QoL data in trials can bias the results. QoL is an important secondary endpoint of the Canadian-Australasian Randomised trial of screening kidney transplant candidates for coronary artery disease (CARSK).
Methods: QoL in CARSK was assessed at baseline, 6 and 12 months using the EuroQoL 5 domains 5 levels questionnaire (EQ-5D-5L). QoL non-completion was dichotomized into Yes = all items missing; No = all items complete for eligible patients at each timepoint. Patient age, sex, ethnicity, dialysis modality, diabetes status and centre location associated with EQ-5D-5L non-completion were investigated using multivariable logistic regression models and presented in odds ratio (OR).
Results: Of 508 patients from 14 centres in Australia and New Zealand, at study baseline, mean age 52 years (SD 12), 66% males, 28% Indigenous, 37% diabetics, 189 (37%) were managed with facility-based haemodialysis, 135 (27%) with home haemodialysis, and 184 (36%) with peritoneal dialysis. At 6 and 12-months, 418 (82%) and 332 (65%) patients were eligible for QoL assessment. EQ-5D-5L completion rate was 92%, 70%, and 71% at baseline, 6 and 12-months respectively. In multivariable models at baseline, Asian ethnicity was associated with higher chance of non-completion (3.71, 95%CI 1.52 to 9.07) than other ethnicities. At 6-months, centres in New Zealand had higher chance of non-completion (1.85, 95%CI 1.09 to 3.18) than other centres. At 12 months, diabetics were associated with higher chance of non-completion (3.31, 95%CI 1.74 to 6.46) than non-diabetics.
Conclusions: Patient ethnicity and diabetic status are significantly associated with QoL non-completion.
Professor Rachael Morton (PhD, MSc(Clin Epi)(Hons)) is a senior health economist. She is Director of Health Economics at the NHMRC Clinical Trials Centre and Professor in the Faculty of Medicine and Health, University of Sydney where she leads a specialised team of economists and economic modellers. She has published >150 research articles, and won >$50M in competitive research grants. Professor Morton is Chair of the patient reported outcome measures (PROMs) working group for ANZDATA, and the lead health economist for many kidney research projects including CARSK, MODUS and SWIFT.