Brendan Smyth1,2, Oliver van den Broek-Best3,4, Daqing Hong5,6, Kirsten Howard2, Kris Rogers1,7, Li Zuo8, Nicholas A Gray9,10, Janak R de Zoysa11,12, Christopher T Chan13, Hongli Lin14, Ling Zhang15, Jinsheng Xu16, Alan Cass17, Martin Gallagher1,18, Vlado Perkovic1, Meg Jardine19,18. 1. The George Institute for Global Health, University of New South Wales Sydney, Sydney, Australia. 2. Sydney School of Public Health University of Sydney, Sydney, Australia. 3. Department of Medicine, Westmead Hospital, Sydney, Australia. 4. Sydney Medical School, University of Sydney, Sydney, Australia. 5. Renal Department, Sichuan Provincial People's Hospital, Chengdu, China. 6. University of Electronic Science and Technology of China, Medical School, Chengdu, China. 7. Graduate School of Health, University of Technology Sydney, Ultimo, Australia. 8. Department of Nephrology, Peking University People's Hospital, Beijing, China. 9. Renal Department, Sunshine Coast University Hospital, Birtinya, Australia. 10. Sunshine Coast Clinical School, University of Queensland, Brisbane, Australia. 11. Renal Services, North Shore Hospital, Auckland, New Zealand. 12. Department of Medicine, University of Auckland, Auckland, New Zealand. 13. Department of Medicine, University Health Network, Toronto, Ontario, Canada. 14. Department of Nephrology, First Affiliated Hospital of Dalian Medical University, Dalian, China. 15. Department of Nephrology, China-Japan Friendship Hospital, Beijing, China. 16. Department of Nephrology, Fourth Hospital Affiliated to Hebei Medical University, Shijiazhuang, China. 17. Menzies School of Health Research, Charles Darwin University, Darwin, Australia; and. 18. Renal Unit, Concord Repatriation General Hospital, Sydney, Australia. 19. The George Institute for Global Health, University of New South Wales Sydney, Sydney, Australia; mjardine@georgeinstitute.org.au.
Abstract
BACKGROUND AND OBJECTIVES: Little is known about the effect of changes in dialysis hours on patient-reported outcome measures. We report the effect of doubling dialysis hours on a range of patient-reported outcome measures in a randomized trial, overall and separately for important subgroups. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: The A Clinical Trial of IntensiVE Dialysis trial randomized 200 participants to extended or standard weekly hours hemodialysis for 12 months. Patient-reported outcome measures included two health utility scores (EuroQOL-5 Dimensions-3 Level, Short Form-6 Dimension) and their derived quality-adjusted life year estimates, two generic health scores (Short Form-36 Physical Component Summary, Mental Component Summary), and a disease-specific score (Kidney Disease Component Score). Outcomes were assessed as the mean difference from baseline using linear mixed effects models adjusted for time point and baseline score, with interaction terms added for subgroup analyses. Prespecified subgroups were dialysis location (home- versus institution-based), dialysis vintage (≤6 months versus >6 months), region (China versus Australia, New Zealand, Canada), and baseline score (lowest, middle, highest tertile). Multiplicity-adjusted P values (Holm-Bonferroni) were calculated for the main analyses. RESULTS: Extended dialysis hours was associated with improvement in Short Form-6 Dimension (mean difference, 0.027; 95% confidence interval [95% CI], 0.00 to 0.05; P=0.03) which was not significant after adjustment for multiple comparisons (Padjusted =0.05). There were no significant differences in EuroQOL-5 Dimensions-3 Level health utility (mean difference, 0.036; 95% CI, -0.02 to 0.09; P=0.2; Padjusted =0.2) or in quality-adjusted life years. There were small positive differences in generic and disease-specific quality of life: Physical Component Summary (mean difference, 2.3; 95% CI, 0.6 to 4.1; P=0.01; Padjusted =0.04), Mental Component Summary (mean difference, 2.5; 95% CI, 0.5 to 4.6; P=0.02; Padjusted =0.05) and Kidney Disease Component Score (mean difference, 3.5; 95% CI, 1.5 to 5.5; P=0.001; Padjusted =0.005). The results did not differ among predefined subgroups or by baseline score. CONCLUSIONS: The effect of extended hours hemodialysis on patient-reported outcome measures reached statistical significance in some but not all measures. Within each measure the effect was consistent across predefined subgroups. The clinical importance of these differences is unclear.
RCT Entities:
BACKGROUND AND OBJECTIVES: Little is known about the effect of changes in dialysis hours on patient-reported outcome measures. We report the effect of doubling dialysis hours on a range of patient-reported outcome measures in a randomized trial, overall and separately for important subgroups. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: The A Clinical Trial of IntensiVE Dialysis trial randomized 200 participants to extended or standard weekly hours hemodialysis for 12 months. Patient-reported outcome measures included two health utility scores (EuroQOL-5 Dimensions-3 Level, Short Form-6 Dimension) and their derived quality-adjusted life year estimates, two generic health scores (Short Form-36 Physical Component Summary, Mental Component Summary), and a disease-specific score (Kidney Disease Component Score). Outcomes were assessed as the mean difference from baseline using linear mixed effects models adjusted for time point and baseline score, with interaction terms added for subgroup analyses. Prespecified subgroups were dialysis location (home- versus institution-based), dialysis vintage (≤6 months versus >6 months), region (China versus Australia, New Zealand, Canada), and baseline score (lowest, middle, highest tertile). Multiplicity-adjusted P values (Holm-Bonferroni) were calculated for the main analyses. RESULTS: Extended dialysis hours was associated with improvement in Short Form-6 Dimension (mean difference, 0.027; 95% confidence interval [95% CI], 0.00 to 0.05; P=0.03) which was not significant after adjustment for multiple comparisons (Padjusted =0.05). There were no significant differences in EuroQOL-5 Dimensions-3 Level health utility (mean difference, 0.036; 95% CI, -0.02 to 0.09; P=0.2; Padjusted =0.2) or in quality-adjusted life years. There were small positive differences in generic and disease-specific quality of life: Physical Component Summary (mean difference, 2.3; 95% CI, 0.6 to 4.1; P=0.01; Padjusted =0.04), Mental Component Summary (mean difference, 2.5; 95% CI, 0.5 to 4.6; P=0.02; Padjusted =0.05) and Kidney Disease Component Score (mean difference, 3.5; 95% CI, 1.5 to 5.5; P=0.001; Padjusted =0.005). The results did not differ among predefined subgroups or by baseline score. CONCLUSIONS: The effect of extended hours hemodialysis on patient-reported outcome measures reached statistical significance in some but not all measures. Within each measure the effect was consistent across predefined subgroups. The clinical importance of these differences is unclear.
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