TY - JOUR
T1 - Dutch nOcturnal and hoME dialysis Study To Improve Clinical Outcomes (DOMESTICO)
T2 - rationale and design
AU - van Eck van der Sluijs, A
AU - Bonenkamp, A A
AU - Dekker, F W
AU - Abrahams, A C
AU - van Jaarsveld, B C
AU - de Wit, Ardine (G.A.)
N1 - Funding Information:
This study is supported by grants of ZonMw, Fresenius Medical Care Deutschland GmbH, Baxter Netherlands BV, and Dirinco. The grant of ZonMw is provided from the ‘Health care efficiency research’ programme and focusses on the part of this study concerning health-related quality of life. ZonMw has independently peer reviewed the study protocol. With the Fresenius Medical Care Deutschland GmbH grant, clinical outcomes will be investigated, and the grant of Baxter focusses on costs and cost-effectiveness. The sponsors did not play a role in the study design and the preparation of this article.
Publisher Copyright:
© 2019 The Author(s).
Copyright:
Copyright 2019 Elsevier B.V., All rights reserved.
PY - 2019/9/18
Y1 - 2019/9/18
N2 - BACKGROUND: More than 6200 End Stage Renal Disease patients in the Netherlands are dependent on dialysis, either performed at home or in a dialysis centre. Visiting a dialysis centre three times a week is considered a large burden by many patients. However, recent data regarding the effects of dialysis at home on quality of life, clinical outcomes, and costs compared with in-centre haemodialysis are lacking.METHODS: The Dutch nOcturnal and hoME dialysis Study To Improve Clinical Outcomes (DOMESTICO) is a nationwide, prospective, observational cohort study that will include adult patients starting with a form of dialysis. Health-related quality of life, as the primary outcome, clinical outcomes and costs, as secondary outcomes, will be measured every 3-6 months in patients on home dialysis, and compared with a control group consisting of in-centre haemodialysis patients. During a 3-year period 800 home dialysis patients (600 peritoneal dialysis and 200 home haemodialysis patients) and a comparison group of 800 in-centre haemodialysis patients will be included from 53 Dutch dialysis centres (covering 96% of Dutch centres) and 1 Belgian dialysis centre (covering 4% of Flemish centres).DISCUSSION: DOMESTICO will prospectively investigate the effect of home dialysis therapies on health-related quality of life, clinical outcomes and costs, in comparison with in-centre haemodialysis. The findings of this study are expected to ameliorate the shared decision-making process and give more guidance to healthcare professionals, in particular to assess which type of patients may benefit most from home dialysis.TRIAL REGISTRATION: The DOMESTICO study is registered with the National Trial Register on (number: NL6519 , date of registration: 22 August 2017) and the Central Committee on Research Involving Human Subjects (CCMO) (number: NL63277.029.17).
AB - BACKGROUND: More than 6200 End Stage Renal Disease patients in the Netherlands are dependent on dialysis, either performed at home or in a dialysis centre. Visiting a dialysis centre three times a week is considered a large burden by many patients. However, recent data regarding the effects of dialysis at home on quality of life, clinical outcomes, and costs compared with in-centre haemodialysis are lacking.METHODS: The Dutch nOcturnal and hoME dialysis Study To Improve Clinical Outcomes (DOMESTICO) is a nationwide, prospective, observational cohort study that will include adult patients starting with a form of dialysis. Health-related quality of life, as the primary outcome, clinical outcomes and costs, as secondary outcomes, will be measured every 3-6 months in patients on home dialysis, and compared with a control group consisting of in-centre haemodialysis patients. During a 3-year period 800 home dialysis patients (600 peritoneal dialysis and 200 home haemodialysis patients) and a comparison group of 800 in-centre haemodialysis patients will be included from 53 Dutch dialysis centres (covering 96% of Dutch centres) and 1 Belgian dialysis centre (covering 4% of Flemish centres).DISCUSSION: DOMESTICO will prospectively investigate the effect of home dialysis therapies on health-related quality of life, clinical outcomes and costs, in comparison with in-centre haemodialysis. The findings of this study are expected to ameliorate the shared decision-making process and give more guidance to healthcare professionals, in particular to assess which type of patients may benefit most from home dialysis.TRIAL REGISTRATION: The DOMESTICO study is registered with the National Trial Register on (number: NL6519 , date of registration: 22 August 2017) and the Central Committee on Research Involving Human Subjects (CCMO) (number: NL63277.029.17).
KW - Clinical outcomes
KW - Costs
KW - Health-related quality of life
KW - Home dialysis
KW - Home haemodialysis
KW - In-Centre haemodialysis
KW - Peritoneal dialysis
UR - http://www.scopus.com/inward/record.url?scp=85072379282&partnerID=8YFLogxK
U2 - 10.1186/s12882-019-1526-4
DO - 10.1186/s12882-019-1526-4
M3 - Article
C2 - 31533665
SN - 1471-2369
VL - 20
JO - BMC Nephrology
JF - BMC Nephrology
IS - 1
M1 - 361
ER -