Towards a standardised informed consent procedure for live donor nephrectomy: the PRINCE (Process of Informed Consent Evaluation) project—study protocol for a nationwide prospective cohort study
Sohal Y Ismail,
L W Ernest van Heurn,
Jacqueline van de Wetering,
Jan N M IJzermans,
Kirsten Kortram,
Emerentia Q W Spoon,
Frank C H d'Ancona,
Maarten H L Christiaans,
H Sijbrand Hofker,
Arjan W J Hoksbergen,
Jaap J Homan van der Heide,
Mirza M Idu,
Caspar W N Looman,
S Azam Nurmohamed,
Jan Ringers,
Raechel J Toorop,
Frank J M F Dor
Affiliations
Sohal Y Ismail
2Department of Psychiatry, Erasmus MC University Medical Center, Rotterdam, The Netherlands
L W Ernest van Heurn
5 Department of Pediatric Surgery, Academic Medical Center, Amsterdam, The Netherlands
Jacqueline van de Wetering
Department of Internal Medicine, Nephrology, and Transplantation, Erasmus MC, Rotterdam, The Netherlands
Jan N M IJzermans
1 Erasmus MC Transplant Institute, department of Surgery, division of Hepatobiliary and Transplantation Surgery, University Medical Center Rotterdam, Rotterdam, Zuid-Holland, The Netherlands
Kirsten Kortram
1Department of Surgery, Division of HPB & Transplant Surgery, Erasmus MC University Medical Center, Rotterdam, The Netherlands
Emerentia Q W Spoon
1Department of Surgery, Division of HPB & Transplant Surgery, Erasmus MC University Medical Center, Rotterdam, The Netherlands
Frank C H d'Ancona
3Department of Urology, Radboud University Medical Center, Nijmegen, The Netherlands
Maarten H L Christiaans
4Department of Nephrology, University Medical Center Maastricht, The Netherlands
H Sijbrand Hofker
6Department of Surgery, University Medical Center Groningen, The Netherlands
Arjan W J Hoksbergen
7Department of Surgery, VU Medical Center, Amsterdam, The Netherlands
Jaap J Homan van der Heide
8Department of Nephrology, Amsterdam Medical Center, The Netherlands
Mirza M Idu
5Department of Surgery, Amsterdam Medical Center, The Netherlands
Caspar W N Looman
9Department of Public Health, Erasmus MC University Medical Center, Rotterdam, The Netherlands
S Azam Nurmohamed
10Department of Nephrology, VU Medical Center, Amsterdam, The Netherlands
Jan Ringers
11Department of Surgery, Leiden University Medical Center, The Netherlands
Raechel J Toorop
12Department of Surgery, University Medical Center Utrecht, The Netherlands
Frank J M F Dor
1Department of Surgery, Division of HPB & Transplant Surgery, Erasmus MC University Medical Center, Rotterdam, The Netherlands
Introduction Informed consent is mandatory for all (surgical) procedures, but it is even more important when it comes to living kidney donors undergoing surgery for the benefit of others. Donor education, leading to informed consent, needs to be carried out according to certain standards. Informed consent procedures for live donor nephrectomy vary per centre, and even per individual healthcare professional. The basis for a standardised, uniform surgical informed consent procedure for live donor nephrectomy can be created by assessing what information donors need to hear to prepare them for the operation and convalescence.Methods and analysis The PRINCE (Process of Informed Consent Evaluation) project is a prospective, multicentre cohort study, to be carried out in all eight Dutch kidney transplant centres. Donor knowledge of the procedure and postoperative course will be evaluated by means of pop quizzes. A baseline cohort (prior to receiving any information from a member of the transplant team in one of the transplant centres) will be compared with a control group, the members of which receive the pop quiz on the day of admission for donor nephrectomy. Donor satisfaction will be evaluated for all donors who completed the admission pop-quiz. The primary end point is donor knowledge. In addition, those elements that have to be included in the standardised format informed consent procedure will be identified. Secondary end points are donor satisfaction, current informed consent practices in the different centres (eg, how many visits, which personnel, what kind of information is disclosed, in which format, etc) and correlation of donor knowledge with surgeons' estimation thereof.Ethics and dissemination Approval for this study was obtained from the medical ethical committee of the Erasmus MC, University Medical Center, Rotterdam, on 18 February 2015. Secondary approval has been obtained from the local ethics committees in six participating centres. Approval in the last centre has been sought.Results Outcome will be published in a scientific journal.Trial registration number NTR5374; Pre-results.
