67. U.S. Department of Health and Human Services FDA Center for Drug Evaluation and Research,U.S. Department of Health and Human Services FDA Center for Biologics Evaluation and Research,U.S. Department of Health and Human Services FDA Center for Devices and Radiological Health. Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance. Health Qual Life Outcomes 2006; 4: 79. doi: 10.1186/1477-7525-4-79. 68. Ju A, Tong A. Considerations and challenges in selecting patient-reported outcome measures for clinical trials in nephrology. Clin J Am Soc Nephrol 2017; 12: 1882–1884 69. Manera K, Johnson D, Craig J et al. Establishing a core outcome set for peritoneal dialysis: report of the Standardized Outcomes in Nephrology–Peritoneal Dialysis (SONG-PD) consensus workshop. Am J Kidney Dis 2020; 75: 404–412 70. Derogatis LR. The Psychosocial Adjustment to Illness Scale (PAIS). J Psychosom Res 1986; 30: 77–91 71. Schag CC, Heinrich RL, Ganz PA. Karnofsky performance status revisited: reliability, validity, and guidelines. J Clin Oncol 1984; 2: 187–193 Received: 21 January 2020; Editorial decision: 27 July 2020 Nephrol Dial Transplant (2021) 36: 901–908 doi: 10.1093/ndt/gfaa282 Advance Access publication 12 December 2020 Impact of dialysis modality on major adverse cardiovascular events and all-cause mortality: a national population-based study Ping-Jen Hu 1,2 , Yu-Wei Chen 3,4,5 , Tzu-Ting Chen 6,7 , Li-Chin Sung 8,9,10 , Mei-Yi Wu 3,5,7,10,11 and Mai-Szu Wu 3,5,11 1 Department of Internal Medicine, Division of Gastroenterology and Hepatology, Taitung Mackay Memorial Hospital, Taitung, Taiwan, 2 Department of Internal Medicine, Division of Gastroenterology, Shuang Ho Hospital, Taipei Medical University, New Taipei City, Taiwan, 3 Department of Internal Medicine, Division of Nephrology, Shuang Ho Hospital, Taipei Medical University, New Taipei City, Taiwan, 4 Graduate Institute of Clinical Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan, 5 TMU Research Center of Urology and Kidney, Taipei Medical University, Taipei, Taiwan, 6 Center for Neuropsychiatric Research, National Health Research Institutes, Miaoli County, Taiwan, 7 Institute of Epidemiology and Preventive Medicine, College of Public Health, National Taiwan University, Taipei, Taiwan, 8 Department of Internal Medicine, Division of Cardiology, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan, 9 Department of Internal Medicine, Division of Cardiology, Shuang Ho Hospital, Taipei Medical University, New Taipei City, Taiwan, 10 Department of Primary Care Medicine, Shuang Ho Hospital, Taipei Medical University, New Taipei City, Taiwan and 11 Department of Internal Medicine, Division of Nephrology, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan Correspondence to: Mei-Yi Wu; E-mail: e220121@gmail.com ABSTRACT Background. Only few studies with inconsistent results comparing the relative risk of cardiac mortality between perito- neal dialysis (PD) and hemodialysis (HD). Switches between renal replacement therapy (RRT) modalities render objective assessment of survival beneﬁts a greater challenge. Methods. Data were retrieved from Taiwan’s National Health Insurance Database from 1 January 2006 to 31 December 2015. We included 13662 and 41047 long-term dialysis patients in a propensity score matching study design and a time-varying study design, respectively, to compare major adverse cardiovas- cular events (MACEs) between patients receiving PD and HD. We also included 109 256 dialysis patients to compare the all-cause mortality among different RRT modalities. Results. For MACE, the hazard ratio (HR) for PD patients compared to HD patients was 0.95 [95% conﬁdence interval (CI) 0.89–1.02] in the propensity score study design and 1.06 (95% CI 1.01–1.12) in the time-varying study design. For all- cause mortality, the HR for PD patients compared to HD patients was 1.09 (95% CI 1.05–1.13) in the propensity score study design and 1.13 (95% CI 1.09–1.17) in the time-varying study design. The HR for death was higher at a level of statistical signiﬁcance for females (1.21, 95% CI 1.15–1.28), patients 65 years old (1.30, 95% CI 1.24–1.36) and diabetes mellitus (DM; 1.28, 95% CI 1.22–1.34). Conclusions. The HR for MACE is signiﬁcantly higher among PD patients in time-varying design analysis. In addition, all-cause mortality was higher in PD patients compared to patients with HD, especially in those who were aged 65 years, female or DM. Keywords: dialysis modality, hemodialysis, major adverse car- diovascular events, peritoneal dialysis V C The Author(s) 2020. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved. 901 ORIGINAL ARTICLE Downloaded from https://academic.oup.com/ndt/article/36/5/901/6032194 by guest on 13 October 2022