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

• Published in: BMJ open Vol. 6; no. 4; p. e010594
• Main Authors: Kortram, Kirsten, Spoon, Emerentia Q W, Ismail, Sohal Y, d'Ancona, Frank C H, Christiaans, Maarten H L, van Heurn, L W Ernest, Hofker, H Sijbrand, Hoksbergen, Arjan W J, Homan van der Heide, Jaap J, Idu, Mirza M, Looman, Caspar W N, Nurmohamed, S Azam, Ringers, Jan, Toorop, Raechel J, van de Wetering, Jacqueline, Ijzermans, Jan N M, Dor, Frank J M F
• Format: Journal Article
• Language: English
• Published: England British Medical Journal Publishing Group 01.04.2016; BMJ Publishing Group LTD; BMJ Publishing Group
• Subjects: Access to Information; Cohort analysis; Communication; Decision Making; Education; Ethics Committees; Health Services Needs and Demand; Humans; Informed consent; Informed Consent - ethics; Informed Consent - legislation & jurisprudence; Kidney Transplantation - ethics; Kidney Transplantation - legislation & jurisprudence; Kidney transplants; Knowledge; Living Donors - ethics; Living Donors - legislation & jurisprudence; Nephrectomy - ethics; Nephrectomy - legislation & jurisprudence; Netherlands - epidemiology; Patient Education as Topic; Prospective Studies; Questionnaires; Renal Insufficiency - surgery; Surgeons; Surgery; Tissue and Organ Harvesting - ethics; Tissue and Organ Harvesting - legislation & jurisprudence; TRANSPLANT SURGERY; Netherlands; TRANSPLANT SURGERY
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2015-010594

IntroductionInformed 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 analysisThe 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 disseminationApproval 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.ResultsOutcome will be published in a scientific journal.Trial registration numberNTR5374; Pre-results.