title: 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.
abstract: BACKGROUND
  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
  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.
  
  
  BACKGROUND
  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.
  
  
  BACKGROUND
  NTR5374; Pre-results.
authors.affiliation: Department of Surgery, Division of HPB & Transplant Surgery, Erasmus MC University Medical Center, Rotterdam, The Netherlands.
authors.forename: Kirsten
authors.initials: K
authors.lastname: Kortram
authors.affiliation: Department of Surgery, Division of HPB & Transplant Surgery, Erasmus MC University Medical Center, Rotterdam, The Netherlands.
authors.forename: Emerentia Q W
authors.initials: EQ
authors.lastname: Spoon
authors.affiliation: Department of Psychiatry, Erasmus MC University Medical Center, Rotterdam, The Netherlands.
authors.forename: Sohal Y
authors.initials: SY
authors.lastname: Ismail
authors.affiliation: Department of Urology, Radboud University Medical Center, Nijmegen, The Netherlands.
authors.forename: Frank C H
authors.initials: FC
authors.lastname: d'Ancona
authors.affiliation: Department of Nephrology, University Medical Center Maastricht, The Netherlands.
authors.forename: Maarten H L
authors.initials: MH
authors.lastname: Christiaans
authors.affiliation: Department of Surgery, Amsterdam Medical Center, The Netherlands.
authors.forename: L W Ernest
authors.initials: LW
authors.lastname: van Heurn
authors.affiliation: Department of Surgery, University Medical Center Groningen, The Netherlands.
authors.forename: H Sijbrand
authors.initials: HS
authors.lastname: Hofker
authors.affiliation: Department of Surgery, VU Medical Center, Amsterdam, The Netherlands.
authors.forename: Arjan W J
authors.initials: AW
authors.lastname: Hoksbergen
authors.affiliation: Department of Nephrology, Amsterdam Medical Center, The Netherlands.
authors.forename: Jaap J
authors.initials: JJ
authors.lastname: Homan van der Heide
authors.affiliation: Department of Surgery, Amsterdam Medical Center, The Netherlands.
authors.forename: Mirza M
authors.initials: MM
authors.lastname: Idu
authors.affiliation: Department of Public Health, Erasmus MC University Medical Center, Rotterdam, The Netherlands.
authors.forename: Caspar W N
authors.initials: CW
authors.lastname: Looman
authors.affiliation: Department of Nephrology, VU Medical Center, Amsterdam, The Netherlands.
authors.forename: S Azam
authors.initials: SA
authors.lastname: Nurmohamed
authors.affiliation: Department of Surgery, Leiden University Medical Center, The Netherlands.
authors.forename: Jan
authors.initials: J
authors.lastname: Ringers
authors.affiliation: Department of Surgery, University Medical Center Utrecht, The Netherlands.
authors.forename: Raechel J
authors.initials: RJ
authors.lastname: Toorop
authors.affiliation: Department of Nephrology, Erasmus MC University Medical Center, Rotterdam, The Netherlands.
authors.forename: Jacqueline
authors.initials: J
authors.lastname: van de Wetering
authors.affiliation: Department of Surgery, Division of HPB & Transplant Surgery, Erasmus MC University Medical Center, Rotterdam, The Netherlands.
authors.forename: Jan N M
authors.initials: JN
authors.lastname: Ijzermans
authors.affiliation: Department of Surgery, Division of HPB & Transplant Surgery, Erasmus MC University Medical Center, Rotterdam, The Netherlands.
authors.forename: Frank J M F
authors.initials: FJ
authors.lastname: Dor
mesh_terms: D022126:Access to Information; D003142:Communication; D003657:Decision Making; D017041:Ethics Committees; D006301:Health Services Needs and Demand; D006801:Humans; D007258:Informed Consent / Q000941:ethics / Q000331:legislation & jurisprudence; D016030:Kidney Transplantation / Q000941:ethics / Q000331:legislation & jurisprudence; D019520:Living Donors / Q000941:ethics / Q000331:legislation & jurisprudence; D009392:Nephrectomy / Q000941:ethics / Q000331:legislation & jurisprudence; D009426:Netherlands / Q000453:epidemiology; D010353:Patient Education as Topic; D011446:Prospective Studies; D051437:Renal Insufficiency / Q000601:surgery*; D020858:Tissue and Organ Harvesting / Q000941:ethics / Q000331:legislation & jurisprudence*
keywords: TRANSPLANT SURGERY