Standardised outcomes in nephrology ᾿Haemodialysis (SONG-HD): study protocol for establishing a core outcome set in haemodialysis

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• 作者：Allison Tong ; Braden Manns ; Brenda Hemmelgarn ; David C. Wheeler ; Peter Tugwell…
• 关键词：Core outcome set ; Outcomes research ; Patient ; centred outcomes clinical trials ; Dialysis ; Haemodialysis ; Chronic kidney disease
• 刊名：Trials
• 出版年：2015
• 出版时间：December 2015
• 年：2015
• 卷：16
• 期：1
• 全文大小：491 KB
• 刊物主题：Medicine/Public Health, general; Biomedicine general; Statistics for Life Sciences, Medicine, Health Sciences;
• 出版者：BioMed Central
• ISSN：1745-6215

文摘

Background Chronic kidney disease is a significant contributor to mortality and morbidity worldwide, and the number of people who require dialysis or transplantation continues to increase. People on dialysis are 15 times more likely to die than the general population. Dialysis is also costly, intrusive, and time-consuming and imposes an enormous burden on patients and their families. This escalating problem has spurred a proliferation of trials in dialysis, yet health and quality of life remain poor. The reasons for this are complex and varied but are attributable in part to problems in the design and reporting of studies, particularly outcome selection. Problems related to outcomes include use of unvalidated surrogates, outcomes of little or no relevance to patients, highly variable outcome selection limiting comparability across studies, and bias in reporting outcomes. The aim of the Standardised Outcomes in Nephrology-Haemodialysis (SONG-HD) study is to establish a core outcome set for haemodialysis trials, to improve the quality of reporting, and the relevance of trials conducted in people on haemodialysis.