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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

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...

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Autores principales: 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4823441/
https://www.ncbi.nlm.nih.gov/pubmed/27036141
http://dx.doi.org/10.1136/bmjopen-2015-010594
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author 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
author_facet 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
author_sort Kortram, Kirsten
collection PubMed
description 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.
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spelling pubmed-48234412016-04-19 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 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 BMJ Open Surgery 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. BMJ Publishing Group 2016-04-01 /pmc/articles/PMC4823441/ /pubmed/27036141 http://dx.doi.org/10.1136/bmjopen-2015-010594 Text en Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/ This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
spellingShingle Surgery
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
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
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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Surgery
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4823441/
https://www.ncbi.nlm.nih.gov/pubmed/27036141
http://dx.doi.org/10.1136/bmjopen-2015-010594
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