The need for a standardized informed consent procedure in live donor nephrectomy: a systematic review (original) (raw)
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Living kidney donor informed consent practices vary between US and non-US centers
Nephrology Dialysis Transplantation, 2008
Background. Living kidney donation rates are increasing in the United States and internationally. Major consensus statements on the care of living kidney donors recommend communicating all potential health and psychosocial risks to donors. We evaluated the degree of international variation in the process of informed consent of potential donors during their evaluation. Methods. Transplant professionals attending the 2006 World Transplant Congress responded to a survey assessing their process of informed consent, evaluation and communication of living donor risk. US-based respondents were compared to non-US respondents. Results. There were 221 respondents from 177 transplant centers and 40 countries (48% US respondents). Across US and non-US transplant centers, potential donors were most likely to receive written material about living donor risk by mail prior to evaluation, receive risk information in person during evaluation, have a psychosocial evaluation, which usually lasted longer than 30 min and sign an official donation consent form presented to them by a surgeon or nephrologist. Although over 75% of respondents stated that donors received information about medical risks such as hypertension, chronic kidney disease and potential need for dialysis, there was less consistency regarding whether or not respondents conveyed an increased risk of these medical complications to donors. Additionally, the financial and psychosocial costs associated with being a living donor were inconsistently communicated to donors during the informed consent process. Compared to non-US respondents, US respondents were more likely to use written material and visual aids to convey risks to donors, have mandatory psychosocial evaluations and provide access to donor support groups. US transplant centers were also more Correspondence and offprint requests to: Chirag Parikh, Section of Nephrology, Yale University and VAMC, likely to discuss the possibility of the donors needing dialysis or a transplant if their remaining kidney fails in the future, possible travel expenses and loss of work income due to donation recovery. Conversely, the US respondents were less likely to offer long-term follow-up and to utilize nephrologists to obtain written donor consent for donation. Conclusions. As dependence on living organ donation increases best practices for informed consent, donor evaluation and uniform risk conveyance need to be established. This may be accomplished by using a model informed consent template to ensure that informed consent from donors is consistently obtained.
Living Kidney Donor Knowledge of Provided Information and Informed Consent: The PRINCE Study
Journal of Clinical Medicine, 2022
Background: Informed consent for living kidney donation is paramount, as donors are healthy individuals undergoing surgery for the benefit of others. The informed consent process for living kidney donors is heterogenous, and the question concerns how well they are actually informed. Knowledge assessments, before and after donor education, can form the basis for a standardized informed consent procedure for live kidney donation. Methods: In this prospective, a multicenter national cohort study conducted in all eight kidney transplant centers in The Netherlands, we assessed the current status of the informed consent practice for live donor nephrectomy. All of the potential living kidney donors in the participating centers were invited to participate. They completed a pop quiz during their first outpatient appointment (Cohort A). Living kidney donors completed the same pop quiz upon admission for donor nephrectomy (Cohort B). Results: In total, 656 pop quizzes were completed (417 in Co...
Informed consent in renal transplantation
Postgraduate Medical Journal, 2005
Purpose: This study was performed to assess how well completed the new consent forms are for patients undergoing renal transplantation. Methodology: 100 patients were randomly selected from the 160 who had a renal transplantation, at a single centre in the UK, over an 18 month period. The notes were located and the consent forms scrutinised. Findings: Seven sets of notes could not be traced and 10 did not contain a relevant consent form. Forty eight per cent of completed forms mentioned the source of organ while 8% mentioned on which side the operation was to be performed. Twelve risks and complications were identified as being relevant to this procedure but no single form mentioned all 12. In most cases a senior member of the surgical team obtained consent. Implications: The demonstrated variability in the amount of detail on consent forms lends weight to the call for the use of procedure specific forms. While such variability does not necessarily equate with not gaining valid, informed consent, this form, at present, serves as the only record of what has been discussed with the patient. These findings should encourage all surgeons to complete the forms themselves, be as detailed as possible, and ensure that the form is filed in the patients' notes.
Informed Consent in High-Risk Renal Transplant Recipients
Transplantation Proceedings, 2009
Before performing a clinical, diagnostic, and/or therapeutic action, the doctor is required to provide the patient with a bulk of information defined as informed consent. This expression was used for the first time in 1957 during a court case in California and the two words-informed and consent-are used together to underline the fact that the patient cannot give his or her true consent without first receiving correct information concerning the medical act in question. With regard to the medicolegal aspects governing organ transplants, despite the bulk of detailed work performed by health service workers involved in this surgical field with the aim of preparing adequate informed consent models, this has not yet been accompanied by the necessary legislative development. The informed consent model to be presented to the kidney transplant candidate should include a detailed description of the recipient's comorbidity and should aim at reducing the number of medicolegal actions, which have become more and more frequent in the last few years due to the ever increasing number of patients considered as suitable for transplantation. Informed consent, therefore, should not be a mere bureaucratic formality to be obtained casually, but should be carefully stipulated together with the patient by the transplant surgeon. It is, in fact, an indispensable condition for transforming a potentially illegal action, that is, the violation of an individual's psychophysical integrity, into a legal one.
Issues of consent in renal transplantation
Annals of The Royal College of Surgeons of England, 2003
Background: Renal transplantation is a semi-elective procedure. The specific risks of surgery are well-known. Obtaining informed consent is a complex process made more complicated in transplantation by the long-term nature of some of the risks involved. Methods: A questionnaire survey was conducted of consultant transplant surgeons to establish current practice regarding the levels of information and risks discussed as part of the consent process. Results: Responses were received from 47 (76%) of consultants. Risks were discussed by a range of individuals. Pre-assessment clinics were used by 70% of units to start the process. Only 74% routinely discussed malignancy and only 75% the risks of cytomegalovirus infection. Risks with individual organs were discussed by 32 (68%) -particularly HLA match, cold ischaemia, sensitisation, donor age and caused of donor death. Conclusions: The current practice identified by this study falls broadly within General Medical Council guidelines on informed consent. There is wide variation in current practice which is highlighted and discussed in relation to case law and the levels of risk that a patient should expect to be informed of.
American Journal of Transplantation, 2003
There have been two recent trends in living kidney donation: increased acceptance of living donors and increased acceptance of laparoscopic nephrectomy (LN). We surveyed 234 UNOS-listed kidney transplant programs to determine current living donor morbidity and mortality for open nephrectomy, hand-assisted LN, and non-hand-assisted LN. Of the 234 centers, 171 (73%) responded. Between 1/1/1999 and 7/1/2001, these centers carried out 10 828 living donor nephrectomies: 52.3% open, 20.7% hand-assisted LN, and 27% non-hand-assisted LN. Two donors (0.02%) died from surgical complications and one is in a persistent vegetative state (all after LN). Reoperation was necessary in 22 (0.4%) open, 23 (1.0%) hand-assisted LN, and 21 (0.9%) nonhand-assisted LN cases (p = 0.001). Complications not requiring reoperation were reported for 19 (0.3%) open, 22 (1.0%) hand-assisted LN, and 24 (0.8%) nonhand-assisted LN cases (p = 0.02). Readmission rate was higher for LN (1.6%) vs. open (0.6%) donors (p < 0.001), almost entirely as a result of an increase in gastrointestinal complications in LN donors. Morbidity and mortality for living donor nephrectomy at transplant centers in the United States remain low. We provide current data from which comprehensive informed consent can be obtained from donors.
International Urology and Nephrology, 2012
Objectives We surveyed the following groups of individuals concerning their attitudes towards the pathway leading up to live donor kidney transplantation (LDKT) and post-operative follow-up: kidney transplant (deceased and live donor) recipients, live kidney donors and medical and nursing staff caring for end-stage renal disease and dialysis patients. Materials and methods Participants were recruited within a tertiary renal and transplant centre and invited to complete anonymized questionnaires, be involved in focus groups and undertake structured interviews. Results A total of 464 participants completed the questionnaire (36% health care professionals and 64% patients). Most perceived donor risk as small or very small (62%), and 49% stated that a potential donor should be given up to 3 months to reconsider the decision to donate. Participants were almost equally divided as to whether consensus of the donor's family is necessary (46%) or not (44%) in LDKT. Seventyone percentage of the participants suggested that patients have a greater appreciation of a LDKT if they have been on dialysis; 58% of participants thought that donor and recipient should recuperate beside each other after surgery; 45% thought that the post-operative follow-up for the donor should last up to a year; and 83% thought that donor follow-up should include medical status and quality of life. In the interviews, participants expressed several interesting views. Conclusions Participants believed that LDKT is safe for the donor, and the pathway to surgery and post-operative follow-up should be performed in a way that ensures lack of coercion and includes family support and an extensive post-operative follow-up.
The General Public's Concerns about Clinical Risk in Live Kidney Donation
American Journal of Transplantation, 2002
Difficulty in attracting live kidney donors may be related to fears regarding both the surgical procedure for kidney harvesting and future failure of the remaining kidney. We conducted a cross-sectional study of households in Maryland to identify public disincentives to living related kidney donation. In multivariate analyses, we assessed the independent effects of several factors on willingness to donate a kidney to a sibling. We also assessed thresholds for factors above which persons would not donate a kidney. Of 385 participants, 66% were extremely willing to donate to a sibling. After adjustment, those who considered the length of a hospital stay, out-of-pocket expenses, size and appearance of a scar, the time it takes to get to the transplant center, and the donor risk of developing kidney failure very important had 50-60% less odds of being extremely willing to donate. Median acceptable levels for risk of complications, hospital stay, compensated and uncompensated time from work, time requiring pain medications, and out-of-pocket expenses were greater than levels from clinical evidence regarding both laparoscopic and open nephrectomy. Unrealistic concerns among the general public regarding live donation may serve as potential disincentives to donation. Efforts to educate the public regarding live donation might help assuage fears and attract those who may not otherwise donate.