Patient information 

 

Renal Insufficiency Therapy in Children; Quality Assessment and Improvement.

Introduction 
In the Netherlands and in Belgium, chronic renal replacement therapy in children is provided by 4, respectively 5 rather small medical centres. Until now, no structural corporation exists between these centres and there is no consensus on general guidelines with respect to dialysis treatment or treatment after transplantation. From oral communication, the impression is that the centres have a quite different therapeutic approach of children with end-stage renal disease (ESRD).

Cardiovascular co morbidity is common in patients with paediatric ESRD. In adults with ESRD, several non-invasive diagnostic tools have been developed to detect cardiovascular disease. Reliable data in children with respect to these methods are scarce. Early detection and therapeutic intervention of cardiovascular disease appears to be essential in children with ESRD. 

It is known that ESRD has a great impact on the psychosocial development of a growing child, in this study there will be attention for this subject as well. Central quality assessment by registration of certain treatment characteristics that predict outcome in combination with a quality research project has proven to be an important tool to improve the quality of treatment.  

 

Aim of the study
The main aim of the study is to improve the quality of care for children with renal replacement therapy in the Netherlands and Belgium. To reach this, the following questions will be answered:

1. What is  the current quality of care of children with ESRD in the Netherlands and in Belgium?
2. Does central registration and frequent peer review ('intervision') lead to an improvement of  quality of care in chronic RRT in children? 3. What is the psychosocial welfare of these children?

What does participation in this study mean to you and your child?
For this research we ask your permission to use the data gathered during the regular checkups of your son / daughter. The local nurse or doctor of your own hospital will fill in the research files and send these data to the research group.  Once a year we want to take two extra samples of blood for some additional research and storage for future research. These samples will be stored anonymous.

During one of the regular check-ups at your paediatric nephrologist an investigator will do a non-invasive vascular research. This is an ultra-sound examination which will take about 45 minutes and is important to assess the stiffness of the vessels. This examination will be repeated after 6, 12, 24, 36 and 48 months. Last we'll ask you and / or your son / daughter to fill in a questionnaire on the psychosocial welfare of you child. These questionnaires will be repeated twice a year.

Insurance
According to the Dutch law (WMO) all participants in this study will be included in the insurance designated by the AMC Medical Research BV. More information can be found in the appendix of the patient information folder handed to you by your own paediatric nephrologist.

Voluntary participation  
Participation in RICH-Q is voluntary. Therefore we ask for your permission and assignment. If you want, withdrawal from the study is possible any moment. There will be no consequences for your regular treatment when participation has ended. Of course we hope you'll participate during the whole study phase.

Privacy 
Data gathered in this study will be treated with care. All data will be saved and processed anonymously, so they can never be related to an individual patient.

Do you want to know more? 
If you want to know more, please feel free to contact us. Questions can be asked by email to Mrs. Drs. W.F. Tromp, physician and RICH-Q investigator AMC Amsterdam. Email: info@rich-q.nl.