Abstract
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 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.
Keywords: informed consent, kidney transplant, living donation
Introduction
Due to the shortage of deceased donor kidneys and the increasing use of living donor kidneys from non-related and expanded criteria kidney donors [1–3], almost half of all kidneys donated in the United States come from living donors and the rates of living kidney donation internationally continue to increase [2,4]. The fundamental premise of living kidney transplantation is that the benefits to the recipient and potential psychosocial benefits to the donor significantly outweigh the possible health risks to the donor. However, to date, the lack of a national registry, which would track all kidney donation outcomes, limits comprehensive understanding of the donor's medical, financial and psychosocial risks [5–14].
The ethical practice of medicine requires appropriate informed consent for medical procedures. In the case of living kidney donation, informed consent is particularly important since the donor does not receive any medical benefit from the procedure itself and undertakes the possibility of surgical risks including undergoing anesthesia, wound infection and post-operative bleeding; long-term medical risks such as earlier onset of hypertension or end-stage renal disease (ESRD); and short- and long-term psychological and financial risks. Although some scientists believe there are possible benefits like increased self-esteem for those who donate their kidneys, the data are not definitive, since dissatisfied donors may not participate in follow-up research [3,6,7,15,16].
Major consensus statements have been published to provide recommendations for the care of live kidney donor [17,18]. There is a consensus amongst transplant professionals internationally that informed consent for a living kidney donor should include an accurate conveyance of short- and long-term medical, psychosocial and financial risks and that all steps are taken to minimize such risks [17,18]. However, to date, the informed consent process has not been standardized. Preliminary research has shown that physicians and transplant staff at a subset of transplant centers vary in how risky they perceive living donation to be and how they convey these risks to potential donors [2,19–22]. Since the aforementioned consensus statements were published, no international research across transplant centers has been conducted to assess what is regularly being communicated to potential living donors and the degree to which global practice variations exist regarding the evaluation and informed consent of living kidney donors. Significant variability may indicate a need for further consensus building, practice translation and policy development. Therefore, we surveyed US and non-US transplant professionals attending the World Transplant Congress about their informed consent practices with living donors and compared how risk communication varied between them. We compared US to non-US participants since currently ∼50% of the world's living kidney donations occur in the US and because healthcare policy and medical culture in the US is sufficiently different from most other countries to warrant this comparison.
Methods
Survey content
A 19-question survey addressing both the methods of conveying risk to potential kidney donors and the actual risk parameters conveyed to potential donors was drafted based on a review of the existing literature regarding living kidney donation. The survey was then independently circulated to 10 physicians at various transplant centers for feedback and was modified accordingly.
The survey measured health professional demographics, how the respondent conveyed medical, psychosocial and financial risks to a potential donor and what risks were conveyed during the informed consent process. The survey was divided into three parts, namely (A) Background, (B) Risk Information and (C) Informed Consent Practices. Section B was further subdivided into three areas: (i) Medical Risks, (ii) Financial Risks and (iii) Psychosocial Risks. All questions were close ended with a built-in skip pattern. For example, regarding medical risks, the respondent was asked to check what increase in the relative risk of hypertension was conveyed to the donor. They had a choice of checking various boxes with relative risk increases or checking the ‘not discussed’ box. The only open-ended questions in the survey were the demographic questions: name, contact, center location, and how many donor interactions the respondent had in the past year.
Respondents
Respondents were recruited in a convenience sample of transplant professionals involved with living kidney donation attending the 2006 World Transplant Conference (WTC) in Boston, MA, USA. Conference attendees were invited to take the survey when they received their conference registration materials onsite and before entering any conference lecture dealing with kidney donation. These two recruitment methods were employed to enable a representative sample of conference attendees involved in living kidney donation to be surveyed. The WTC was selected for distribution, because it was the largest gathering of physicians and other healthcare workers involved in transplantation. Respondents were not given any form of compensation.
The survey was approved by the Institutional Review Board at Yale University Medical Center. Consent for study participation was presumed upon returning the survey. An information sheet provided with the survey explained the purpose of the study and indicated that all responses would be confidential. Permission to distribute the survey at the WTC was obtained from the Conference Planning Committee prior to the conference.
Data collection
The surveys were returned in containers located throughout the conference center. The survey also included instructions to mail or fax surveys back to us after the conference. Of the 223 complete surveys we recovered, 220 were returned at the conference, 2 were received by mail and 1 by fax. Two of the surveys returned could not be used in the analysis, because only demographic data were provided. Five surveys did not include country of origin and so could not be used in the comparative analysis; thus the analysis was done using 216 surveys. Each survey was assigned a unique number in order to make the data confidential and the responses were entered into an Excel spreadsheet. The data were checked independently by two people for any typographical or data entry errors.
Statistical analysis
Standard descriptive statistics were computed for all variables. To assess differences between US and non-US respondents, chi-square tests were used for dichotomous variables and the Wilcoxon rank-sum test was used for ordinal variables. In cases where there were a small number of observations for dichotomous outcomes, Fisher's exact test was used. Variables are listed in Tables 3 and 4 along with the results. Respondents from the same transplant center were treated independently such that some centers may be represented greater than others (Table 1). All analyses were based on the respondents, not on the transplant center. All analyses were conducted using SAS 9.1 (SAS Institute Inc., Cary, NC, USA).
Table 3.
Process of donor evaluation and informed consent: US versus non-US
| Overall, N (%) | US, n (%) | Non-US, n (%) | P-value | |
|---|---|---|---|---|
| How medical risks are conveyed | ||||
| Qualitative | 73 (36) | 36 (37) | 37 (35) | 0.35 |
| Relative | 35 (17) | 19 (19) | 16 (15) | |
| Absolute | 69 (34) | 28 (29) | 41 (39) | |
| Varies | 25 (12) | 13 (13) | 12 (11) | |
| What methods are used to convey risks to potential donors | ||||
| In person | 204 (98) | 99 (100) | 105 (95) | 0.03 |
| By telephone | 86 (41) | 57 (58) | 29 (45) | 0.06 |
| Written material | 28 (13) | 23 (23) | 5 (5) | <0.0001 |
| Video/DVD | 42 (20) | 30 (30) | 12 (11) | 0.001 |
| Donor receives written material prior to donation | ||||
| Yes | 184 (88) | 92 (95) | 92 (83) | 0.007 |
| No | 24 (12) | 5 (5) | 19 (17) | |
| Mandatory psychosocial assessment of all potential donors | ||||
| Yes | 167 (80) | 92 (92) | 75 (68) | <0.0001 |
| No | 43 (20) | 8 (8) | 35 (32) | |
| Who is responsible for the psychosocial evaluation | ||||
| Psychiatrist | 76 (44) | 36 (38) | 40 (51) | 0.08 |
| Psychologist | 71 (41) | 34 (36) | 28 (36) | 0.54 |
| Social worker | 117 (68) | 85 (89) | 32 (41) | <0.0001 |
| How long is the evaluation | 0.004 | |||
| <15 min | 5 (8) | 0 (0) | 4 (5) | |
| 15–30 min | 28 (16) | 9 (10) | 19 (25) | |
| 30–60 min | 77 (45) | 50 (54) | 27 (35) | |
| > 60 min | 60 (35) | 34 (37) | 26 (34) | |
| Center provides donors access to a support group | ||||
| Yes | 84 (42) | 50 (54) | 34 (32) | 0.002 |
| No | 115 (58) | 43 (46) | 72 (68) | |
| Center provides a long-term follow-up | ||||
| Yes | 171 (81) | 65 (64) | 106 (96) | <0.0001 |
| No | 41 (19) | 37 (36) | 4 (4) | |
| Center has a specific consent form for live organ donation | ||||
| Yes | 145 (69) | 59 (61) | 86 (77) | 0.012 |
| No | 64 (31) | 38 (39) | 26 (23) | |
| Who is the person responsible for obtaining consent | ||||
| Nephrologist | 48 (24) | 5 (5) | 43 (40) | <0.0001 |
| Surgeon | 124 (62) | 70 (74) | 54 (50) | 0.0007 |
| Nurse/Nurse practitioner | 26 (13) | 18 (19) | 8 (7) | 0.015 |
| Social worker | 8 (4) | 0 (0) | 8 (7) | 0.007 |
| Nephrologist trainee | 5 (3) | 1(1) | 4 (4) | 0.22 |
| Surgical trainee | 7 (4) | 4 (4) | 3 (3) | 0.59 |
| Donor nephrectomy risks are discussed with recipients | ||||
| Yes | 185 (89) | 84 (83) | 101 (93) | 0.085 |
| No | 24 (11) | 17 (17) | 7 (7) | |
| Center would adopt a centralized informed consent template | ||||
| Yes | 159 (81) | 77 (79) | 82 (84) | 0.001 |
| No | 37 (19) | 21 (21) | 16 (16) |
Table 4.
Risks communicated with potential donors: US versus non-US respondents
| Respondents | US, n (%) | Non-US, n (%) | P-value | |||||
|---|---|---|---|---|---|---|---|---|
| (total no. per question) | ||||||||
| Medical risksa | Not increased | Increased | Not discussed | Not increased | Increased | Not discussed | ||
| Hypertension | 198 | 20 (21) | 70 (74) | 4 (4) | 10 (10) | 91 (88) | 3 (3) | 0.057 |
| Proteinuria | 197 | 17 (18) | 69 (74) | 7 (8) | 13 (13) | 85 (82) | 6 (6) | 0.44 |
| Premature death | 199 | 60 (64) | 27(29) | 7 (7) | 72 (69) | 19 (18) | 14 (14) | 0.12 |
| Premature cardiovascular disease | 197 | 60 (64) | 25 (27) | 9 (10) | 61 (59) | 31 (30) | 11 (11) | 0.80 |
| Chronic kidney disease | 196 | 35 (38) | 54 (59) | 3 (3) | 43 (41) | 55 (53) | 6 (6) | 0.58 |
| Requirement of dialysis/kidney transplant | 197 | 37 (40) | 52 (57) | 3 (3) | 58 (55) | 38 (36) | 9 (9) | 0.01 |
| Financial costs | No cost | Cost | Not discussed | No cost | Cost | Not discussed | P-value | |
| Travel expenses | 144 | 5 (8) | 38 (63) | 17 (28) | 21 (25) | 29 (35) | 34 (40) | 0.001 |
| Loss of work days | 147 | 6 (10) | 35 (59) | 18 (31) | 24 (27) | 35 (40) | 29 (33) | 0.019 |
| Family-care needs | 142 | 16 (28) | 18 (32) | 23 (40) | 23 (29) | 29 (29) | 33 (42) | 0.95 |
| Increased cost of insurance | 149 | 29 (43) | 8 (12) | 36 (45) | 33 (43) | 8 (11) | 35 (46) | 0.96 |
| Rehabilitation costs | 136 | 28 (44) | 4 (6) | 31 (49) | 31 (42) | 10 (14) | 32 (44) | 0.37 |
| Total estimated cost | 111 | 6 (13) | 17 (37) | 23 (50) | 11 (17) | 25 (38) | 29 (45) | 0.80 |
| Psychosocial risks | Not likely | Somewhat likely | Not discussed | Not likely | Somewhat likely | Not discussed | P-value | |
| Improved well-being | 171 | 4 (5) | 58 (74) | 16 (21) | 5 (5) | 75 (81) | 13 (14) | 0.53 |
| Recollection of time as traumatic/stressful | 164 | 12 (16) | 38 (51) | 25 (33) | 24 (27) | 45 (51) | 20 (22) | 0.14 |
| Post-operative depression | 162 | 18 (24) | 34 (46) | 22 (30) | 27 (31) | 44 (50) | 17 (19) | 0.28 |
| Suicidal ideation | 158 | 32 (44) | 7 (10) | 33 (46) | 53 (62) | 9 (10) | 24 (28) | 0.06 |
| Marital/familial life adverse effects | 164 | 17 (23) | 35 (47) | 22 (30) | 32 (36) | 43 (48) | 15 (17) | 0.07 |
aMedical risks were not defined in the survey.
Table 1.
Countries represented by survey respondents
| Countries (40) | No. of respondents, n (%) | No. of centers, n (%) |
|---|---|---|
| USA | 104 (47) | 79 (45) |
| Argentina | 3 (1) | 3 (2) |
| Australia | 7 (3) | 4 (2) |
| Belgium | 2 (1) | 2 (1) |
| Brazil | 10 (5) | 9 (5) |
| Canada | 6 (3) | 6 (3) |
| China | 1 (<1) | 1 (1) |
| Columbia | 2 (1) | 2 (1) |
| Denmark | 1 (<1) | 1 (1) |
| Egypt | 3 (1) | 3 (2) |
| France | 1 (<1) | 1 (1) |
| Germany | 10 (5) | 8 (5) |
| Greece | 1 (<1) | 1 (1) |
| Guatemala | 2 (1) | 2 (1) |
| India | 5 (2) | 5 (3) |
| Indonesia | 1 (<1) | 1 (1) |
| Ireland | 1 (<1) | 1 (1) |
| Israel | 1 (<1) | 1 (1) |
| Japan | 2 (1) | 2 (1) |
| Korea | 2 (1) | 2 (1) |
| Kuwait | 2 (1) | 2 (1) |
| Malaysia | 1 (<1) | 1 (1) |
| Mexico | 4 (2) | 3 (2) |
| Netherlands | 2 (1) | 2 (1) |
| Norway | 1 (<1) | 1 (1) |
| New Zealand | 4 (2) | 3 (2) |
| Peru | 1 (<1) | 1 (1) |
| Philippines | 1 (<1) | 1 (1) |
| Poland | 4 (2) | 2 (1) |
| Russia | 1 (<1) | 1 (1) |
| Saudi Arabia | 2 (1) | 2 (1) |
| Singapore | 1 (<1) | 1 (1) |
| Slovakia | 1 (<1) | 1 (1) |
| South Africa | 2 (1) | 2 (1) |
| Spain | 2 (1) | 2 (1) |
| Sweden | 2 (1) | 2 (1) |
| Thailand | 3 (1) | 3 (2) |
| Tunisia | 1 (<1) | 1 (1) |
| Turkey | 1 (<1) | 1 (1) |
| UK | 15 (7) | 11 (6) |
Results
Respondents’ demographics and time spent interacting with donors
The survey respondents (n = 216) represented 40 countries and 177 transplant centers. Of the respondents, 48% were from US centers, representing 77 centers from 29 states (Table 1). The majority of the survey respondents were physicians (78%), and amongst those who described their specialty, the majority were nephrologists. Compared to non-US respondents, more US transplant coordinators (26% versus 6%, P < 0.001) and non-MDs (29% versus 10%, P < 0.001) completed the survey than their counterparts outside of the USA (Table 2).
Table 2.
Demographics of respondents: US versus non-US
| Respondents | US, n (%) | Non-US, n (%) | P-value | |
|---|---|---|---|---|
| (total no. per question) | ||||
| Degree | 208 | |||
| MD (Physician) | 70 (71) | 99 (90) | <0.001 | |
| RN (Nurse) | 21 (21) | 3 (3) | ||
| PA (Physician assistant) | 2 (2) | 0 (0) | ||
| Ph.D. (Doctorate) | 1 (1) | 1 (1) | ||
| Other | 4 (4) | 7 (6) | ||
| Profession | 191 | |||
| Nephrologist | 38 (40) | 46 (48) | 0.001 | |
| Surgeon | 22 (23) | 38 (40) | ||
| Psychiatrist/Psychologist | 2 (2) | 0 (0) | ||
| Transplant coordinator | 25 (26) | 6 (6) | ||
| Nurse | 6 (6) | 2 (2) | ||
| Other | 3 (3) | 3 (3) | ||
| Proportion of professional's time spent with living kidney donors | 208 | |||
| >70% | 42 (41) | 37 (35) | 0.56 | |
| 20–70% | 36 (35) | 38 (36) | ||
| 5–20% | 15 (15) | 23 (22) | ||
| <5% | 9 (9) | 8 (8) | ||
| No. of donor interactions in the previous year, median (range) | 208 | 30 (3–425) | 25 (0–400) | 0.62 |
Most respondents (74%) spent >20% of their time with living kidney donors, with over a third of respondents (38%) spending >70% of their time with living kidney donors. Additionally, about a quarter of respondents (24%) were either the chairpersons or directors of their transplant programs. US versus non-US respondents did not differ in the nature or quantity of interactions with donors in the past year (Table 2).
Process of donor evaluation and conveying risks (Table 3)
According to respondents, across US and non-US transplant centers, potential donors were most likely to receive written material about living donor risk by mail before evaluation (88%), receive risk information in person when undergoing evaluation (98%), have a psychosocial evaluation (80%) that lasted longer than 30 min (80%) and sign an official donation consent form (69%) presented to them by a surgeon or nephrologist (88%). US respondents were more likely to report sending donors written materials prior to donation (95% versus 83%, P = 0.007), require psychosocial evaluations of the potential donors (92% versus 68%, P < 0.0001), have surgeons be responsible for obtaining written consent (74% versus 50%, P < 0.001) and offer donors a support group (54% versus 32%, P< 0.002). In contrast, respondents from non-US centers were more likely to report that donors receive a long-term follow-up (96% versus 64%; P < 0.0001), and were more likely to sign a consent form specifically for organ donation (77% versus 61%, P < 0.01).
Psychosocial evaluations occurring at US and non-US transplant centers varied considerably. In the USA, respondents reported that social workers most commonly conducted the psychosocial evaluation of potential donors, with 91% of these evaluations taking longer than 30 min. In non-US transplant centers, respondents reported that psychiatrists most commonly conducted the evaluations, with 69% taking longer than 30 min.
Content of risk communication (Table 4 unless otherwise noted)
Across all countries, respondents reported that medical risks were generally conveyed qualitatively (e.g. ‘high likelihood, ‘not likely’, etc.) or absolutely (e.g. ‘you will have a 1 in 2000 risk of developing this complication’) (Table 3). More than 90% of respondents discussed multiple possible long-term medical risks with living donors, including hypertension, proteinuria, premature death, premature cardiac disease, chronic kidney disease and the possibility of needing dialysis or a transplant, should their kidney fail in the future. However, respondents varied considerably in whether or not they conveyed an increased risk for the donor as compared to a non-donor. For example, of the respondents who discussed donors’ risk of hypertension in the informed consent process, 84% reported that they told donors that they were at an increased risk for hypertension after donation while 16% reported that they told donors they were not. Similarly, 58% of respondents surveyed who discussed donors’ future risk for chronic kidney disease reported that they did tell donors that they have an increased risk, with 42% reporting that they told donors that they did not have an increased risk post-donation.
The types of financial risks routinely discussed with potential donors included travel costs, the costs associated with inability to work while the donor recovered and costs associated with providing for children and other family-care needs during recovery. Costs associated with increased health insurance and rehabilitation costs were discussed much less often.
Although 76% of transplant centers discussed the potential of future-improved psychosocial well-being for their prospective donors, they were less likely to inform donors about potentially negative psychosocial outcomes. For example, over a quarter of US respondents did not discuss the potentially stressful nature of transplant (33%, not discussed), the possibility of post-operative depression (30%) or suicidal ideation (46%), or the possibility of adverse effects to the donor's marital or family life (30%). If psychosocial risks were discussed, some health professionals told living donors that they were not likely to have these issues arise in their situation while others told donors that these risks were somewhat likely.
Exploring differences in what risks were communicated to potential donors at US and non-US transplant centers, US transplant professionals were more likely to communicate to potential donors that they might have to go on dialysis or receive a transplant if their remaining kidney failed (57% versus 36%; P = 0.01), to discuss with donors that they may have to pay travel costs to the transplant centers (63% versus 35%; P = 0.001) and to discuss possible lost income while they recovered (59% versus 40%; P = 0.01). There were no significant differences in the conveyance of psychosocial risks between US and non-US respondents.
Consensus building, practice translation (Table 3)
Finally, most (82%) respondents reported that they believe their center would be willing to adopt a centralized informed consent template. More non-US transplant professionals said they would be willing to adopt such a template as compared to the US respondents (84% versus 79%; P = 0.001).
Discussion
This study, an international study on informed consent practices during donor evaluation, reveals that the risks communicated to donors and the informed consent process vary considerably across transplant centers and countries. For a potential donor to truly make an informed choice whether to donate their kidney they must understand the medical, financial and psychosocial risks they face. Patients also need sufficient time to have a conversation with a health professional, to have risk percentages explained in a way that makes sense to them, to have education tailored to their level of health literacy and to be provided with additional materials to take home with them to review and discuss with their family members.
Variation in risks conveyed
This study uncovered several important problems that need to be addressed to improve the living donor informed consent process. First, information about the medical risks that a potential donor may face is presented to donors at some transplant centers inaccurately. We found, for example, that while 58% of practitioners told potential donors they had an increased risk of developing ESRD, 42% said that there was no increased risk or did not discuss the risk at all. Most research available to date indicates that while the glomerular filtration rate does decrease following uninephrectomy, the likelihood of ESRD requiring dialysis increases only slightly [2,12,23]. Some research does indicate that the risk of ESRD does not increase after donation [24–26]. Although the variation in what risks are conveyed to the reader is probably due to the debate still occurring about what the actual risks to a living donor are, the result is that potential donors are making donation decisions based on different risk information depending on the center in which they undergo transplant evaluation. Second, discussion of financial and psychosocial outcomes does not always occur and the conclusions drawn by transplant professionals summarizing the current research are inconsistent. In this study, and in others, information about financial and psychosocial risks to the donor was left out about by at least 30% of respondents [21]. Even when discussed, the information communicated to donors varied. For example, although some research indicates that most donors are satisfied with their donation decision, the current research also consistently shows that worsened familial relations are a possible but unlikely risk associated with donating a kidney (2–13%) [7,16,27, 28]. However, we found that while a large percentage of practitioners communicated to donors that donation may negatively affect familial life (48%), many either informed donors that such effects were not likely (30%) or did not discuss this potential risk at all (23%).
Variation in donor evaluation and informed consent processes
Inadequate provision of informed consent for prospective organ donors is not ethically sound clinical practice as it can undermine individuals’ ability to make autonomous medical decisions. Public awareness of unethical practices can threaten public trust in the system of transplantation and donation, which in turn may decrease the percentage of individuals who volunteer to be living donors [29]. In examining differences in the informed consent process across transplant centers, potential donors may or may not receive written material about living donor risk by mail, undergo a psychosocial or medical evaluation of a sufficient duration to get their questions answered, and sign a donor informed consent document. Mandatory psychosocial evaluation varied significantly between US and non-US centers despite an international consensus that psychosocial evaluations are necessary [17,18,20,21,30,31]. Given the recent increase in non-related donations, this step in the evaluation process should become standard in all countries [18,22, 32–34].
Regarding informed consent processes, it is not clear why US centers would be more likely to send donors written information prior to donor evaluation as compared to international transplant centers. However, evidence indicates that having written material available for donor education prior to donation makes donors more comfortable with donation [35]. Thus, consistently providing written materials to potential donors may significantly improve the informed consent process. Additionally, it is not immediately evident why non-US centers would be more likely to use specific organ donation consent forms, whereas US centers use more general surgical consent forms. Perhaps this variation is a result of the USA being a more litigious society and hence less willing to modify basic written forms that have already been deemed appropriate by the legal system.
Finally regarding the donor follow-up, the finding that US centers are less likely to offer a long-term follow-up for donors may be due to different government policies. The availability of National Health Insurance schemes in other countries may facilitate such follow-up for donors. It is not as clear why non-US centers would be less likely to offer support groups; however, cultural differences may explain this variation. For example, in most non-western cultures, patients commonly rely on family members for assistance with self-care management rather than relying primarily on themselves for their care [36,37]. On the other hand, American healthcare expects patients to be self-reliant after medical procedures [38]. Accordingly, patients in the USA may experience additional stress until they are fully recovered and thus, may be more amenable to finding comfort in support groups. While these variations in the follow-up and long-term support exist and may be explained by political and/or cultural differences, there is some evidence that donors, everywhere, would benefit from access to both long-term care and support groups [39].
Furthermore, long-term care and follow-up will lead to an increase in kidney donation in two ways. First, potential donors may be more willing to donate if they are assured that the transplant center will provide them with long-term care. Second, because of the concerns recipients have for donors, potential recipients may become more willing to accept kidneys from living donors if they are assured that transplant centers will treat the health sequelae that result from donating the kidney [4,16,39–41]. For the reasons above, all centers should consider providing both long-term care and support groups available to donors.
In the USA, the Centers of Medicare and Medicaid Services (CMS) have implemented conditions of participation that require a broadening of the follow-up and informed consent practices. As of March 2007, all US transplant centers must follow donors for 2 years after donor nephrectomy. This initial step should provide for a clarification on the immediate outcomes following donor nephrectomy; however, longer term assessment of outcomes following donation can only be obtained through the creation of a mandatory donor registry, which would track all outcomes of living kidney donors over the long term.
The informed consent process mandated by CMS and currently developed by the Organ Procurement and Transplantation Network/United Network for Organ Sharing outlines specific elements that transplant centers must fulfill during the informed consent process. This should limit the variability in informed consent processes that were evident in this survey for US transplant centers.
Study limitations
There were several limitations to our study. First, the survey was only available in English to attendees of the World Transplant Congress; thus non-English-speaking conference attendees could not participate. As a result, it is not evident how generalizable the results of the survey are. However, sampling of professionals at over 177 transplant centers internationally helped to overcome limitations in generalizability raised by this concern. It would have been helpful to compare non-responders to responders using demographic data; however, detailed demographic data of all the conference attendees were not available. Second, it was not possible to determine a true response rate for the survey. Given the broad range of the WTC attendees including professionals working in non-kidney transplantation, non-clinician scientists, individuals working primarily with kidney recipients or with deceased donor kidneys, it was impossible to estimate the number of attendees who worked primarily with living kidney donors. Third, although the survey was pilot tested with experts in transplant and informed consent issues, it had not been previously validated. Fourth, survey responses represent self-reported practices, which may not accurately reflect actual informed consent practices due to social desirability biases and it was not possible to accurately test how knowledgeable each respondent was about the general practices of their center. However, knowing that most of the participants spent a significant amount of their time working with living donors helps in ensuring some substantial working relationship with the overall kidney donation program. Fifth, the closed-ended questions of the survey limit the respondents from providing information about the subtleties of informed consent practices conducted at their respective centers. Additionally, while nephrologists and transplant surgeons were overrepresented in the sample population, transplant coordinators, social workers and psychologists were underrepresented in the sample. This disproportionate representation is a concern because the living kidney donor informed consent process is an iterative team-based process involving all of these disciplines. Sixth, we did not survey about the risk and duration of prolonged post-operative pain and incapacity. Finally, an individual's responses may not represent the true policy of the transplant center.
Recommendations
In summary, the variation in donor informed consent found in this study may be occurring as a function of not having definitive information about what risks donors face or due to the increasing pressures of increasing organ availability conflicting with the ethical obligations of providing complete donor information. Most likely, the variations in practices are a result of a combination of these two. Our study reinforces and further develops previous articles that have also indicated significant geographic variation in informed consent practices [42,43].
We recommend establishing international practice guidelines for informed consent of living kidney donors. According to our survey results, there is a significant interest in a uniform informed consent template, and the next step may be to assess what such a template would actually look like. The benefits of universal guidelines for informed consent for living donors are numerous, such as reducing healthcare costs and improving efficiency of clinical practice by avoiding unnecessarily lengthy informed consent discussions and ensuring that prospective donors are provided with sufficient information necessary for adequate decision making, which would reduce the occurrence of poor decision making and subsequent low patient satisfaction. Some disadvantages of having a uniform consent template may include imposing cultural values and beliefs and foreign concepts onto other cultural groups that do not share such values and beliefs or concepts. Or conversely, a universal template developed in the USA may not address concerns salient in other cultures [44,45]. Moreover, informed consent practices are generally shaped by the local healthcare organizational context in which they occur, which may therefore hinder standardization.
Overall, however, the development of evidence-based guidelines will help to ensure that adequate informed consent for living donation is guaranteed for all potential living donors at transplant centers nationally and internationally. Future research should ascertain how much time is needed for adequate donor decision making, from whom donors are most likely to retain risk information, what methods of risk conveyance are most effective for donor comprehension and whether variations exist along other parameters such as size of program or UNOS region.
Acknowledgments
We thank Heather Thiessen-Philbrook for her statistical assistance in the early stages of the analysis. We also thank the entire World Transplant Congress Coordinating Committee for allowing us to distribute our survey at the meeting. In particular, we would like to thank Pam Ballinger for her support throughout the survey distribution process before, during and after the meeting. C.R.P. was supported by the Career Development Award from the National Institute of Diabetes and Digestive and Kidney Diseases, NIH (K23-064689). E.J.G. was supported by a Career Development Award from the National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (DK063953).
Conflict of interest statement. None declared.
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