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Editorials and Perspectives: Overview

Informed Consent and Decision-Making About Adult-to-Adult Living Donor Liver Transplantation: A Systematic Review of Empirical Research

Gordon, Elisa J.1,2,5; Daud, Amna2; Caicedo, Juan Carlos3; Cameron, Kenzie A.1,4; Jay, Colleen3; Fryer, Jonathan3; Beauvais, Nicole3; Skaro, Anton3; Baker, Talia3

Author Information
doi: 10.1097/TP.0b013e31823817d5

Abstract

Living donor liver transplantation (LDLT) has been increasingly used in response to shortages of liver grafts. LDLT was introduced into pediatric clinical practice in 1989; however, after 1998, the rapid growth in the number of procedures was driven by the expansion of LDLT into adult recipients (1). To date, more than 12,000 LDLTs have been performed worldwide, with more than 4200 in the United States (2, 3). Outcomes of LDLT have been encouraging. One-year adult patient and graft survival after LDLT in US centers has reached 94% and 89%, respectively, compared with 90% and 86% for deceased donor liver transplant (4).

However, well-publicized donor deaths in 2001 and 2010 raised concerns about the safety of the donor procedure (5–7). Significant ethical issues, such as “non-maleficence” (do no harm), utility, and distributive justice (8, 9) arise because donors undergo a technically complex procedure with potentially high risks and no direct health benefits (10). LDLT underscores the importance of ensuring patient autonomy through adequate informed consent. It is critical that potential liver donors obtain the necessary information to fully understand the procedure and its outcomes to effectively decide whether donating coincides with their own values and beliefs.

Opinions vary as to the amount and the specificity of information needed by potential liver donors and recipients (11–17); there is no consensus on what constitutes an acceptable risk of morbidity and mortality for liver donors (18). Furthermore, it is unclear if decision making for living liver donors is truly voluntary. These uncertainties about informed consent call into question the adequacy and comprehensiveness of information provided to living donors, suggesting that ethical guidelines for LDLT are needed.

In this article, we review the empirical literature on living liver donors' processes of informed consent and decision making. This review identifies information needs, gaps in knowledge and understanding, and perceptions about the informed consent process. This systematic review is critical for identifying shortcomings that must be addressed to improve the informed consent process.

RESULTS

Study Quality

Twenty-four studies met the final inclusion criteria, representing a total study population of 2789 respondents. Table 1 reviews the quality of the studies. One study examining both adult and pediatric recipients was included but results pertaining only to adult recipients were included in this review (11). Seven studies were conducted in the United States, whereas 17 were based in other countries. Most studies had clear definitions of the study question (80%) and reported details of population and setting (100%). Most studies were cross-sectional (83%) (11–17, 19–31); only two collected data at two time points (32, 33). One half were quantitative studies using survey questionnaires (50%); others were qualitative, using semistructured interviews or focus groups (38%) (25, 26); the remaining were observational studies using medical chart reviews (12%) (31, 34, 35). Two (8%) used a comparison group (30, 33). None reported use of incentives.

TABLE 1
TABLE 1:
Quality assessment of research studies by number of research studies addressing quality characteristics
TABLE 1
TABLE 1:
Continued

Quality of Quantitative Studies

The 12 survey studies had variable quality of study methodology (11, 13, 16, 17, 19, 21, 22, 28, 30–33). All quantitative studies described the survey tools and scoring approach. Most (83%) described respondent recruitment (11–13, 16, 17, 19, 21, 22, 28, 30), and two addressed mode of delivery (16, 21). Three (25%) described the process of survey development (11, 17, 30), and two (16%) reported pilot-testing survey instruments (11, 17).

Quality of Qualitative Studies

Nine qualitative studies were of variable quality (Table 1) (14, 15, 20, 23–27, 29). Seven studies used semistructured interviews (14, 15, 20, 23, 24, 26, 27), one used unstructured interviews (25), and one conducted a focus group (29). Seven studies adequately described interview methodology, and included an interview guide or presented clear question domains asked (15, 20, 23–27). Two adequately described and applied a theoretical approach (24, 25). Seven provided variable levels of detail about data analysis (15, 23–27, 29); none reported using a qualitative data analysis software program. Three studies reported using strategies to enhance validity (23, 24, 27). Five studies provided illustrative quotations (15, 23–26).

Reasons for Donation

The primary reasons for donating across most studies was to save the life of the recipient (United States [13, 24, 29, 30], Asian [15, 17, 27, 28], Europe [25, 33]), along with love for the recipient and fear of losing the recipient (15–17, 20, 27, 28, 33). Reasons for donating varied by culture, whereas European donors emphasized feeling inescapable necessity, (16, 20, 25) and trust in the medical team (25, 26), Asian donors reported feelings of familial duty, religious beliefs, the desire to comply with doctors' recommendations, relieve a recipient's suffering, and to avoid the guilt and criticism of others (15, 17, 20, 27, 28). Donors were also motivated by the quality of their relationship with the patient and the patient's urgent indication for transplantation (20).

Decision-Making Process

The decision-making process varied cross-culturally. All donors in US studies (24, 29) and most donors (77%–100%) in European studies (16, 20, 25, 26) made up their mind immediately on learning of the severity of the patient's condition, which commonly occurred before receiving information about the risks from the transplant team. By contrast, donors in Asian studies decided to donate after discussing the option with family members, prior donors, and physicians (15–17), when test results demonstrated that they were the most suitable candidate, or when the patient's condition further deteriorated (15, 17). Across countries, some donors downplayed information about risks (24–26, 29), or did not consider information about donation important to their decision making (32%) (26). Most donors (55% [30] to 71% [17]) found it easy to decide to donate, whereas a large minority (14%–23%) reported hesitation or doubt (16, 17, 20, 26).

Comprehension of Information Disclosed About LDLT

Most US and Asian donors (72%–95%) reported receiving all the information they needed to make a decision about donating (13, 28, 30). Twelve studies reported generally high levels of comprehension (up to 94% of donors) of information disclosed about the donation process and risks (11, 13, 15–17, 21, 24, 27–30, 33). European donors also reported good to very good knowledge about risks of donation (14, 21). Although actual donors estimated that their knowledge of donation was better than that of potential donors (21), potential donors perceived the information provided as thorough and excessive (14).

By contrast, 7 (29%) studies reported donors' gaps in knowledge or identification of risks (16, 17, 20, 26, 27, 29, 30). European donors varied in their assessment of risk from hepatectomy as low to moderate (16, 20). When donors in one study were asked to identify risks of surgery from a list of risks discussed during evaluation, most donors identified infection, bleeding, and altered appearance as risks of surgery, whereas only 70% identified death (30). Alternately, donors in other studies reported limited knowledge about the donation process and procedure, and did not know what questions to ask during evaluation (16, 29). Other donors desired more information (26) and perceived the lack of information on certain aspects of the procedure as a major source of concern and anxiety (17, 27).

Voluntariness

Only one half of all studies examined coercion as an aspect of voluntariness. These studies consistently reported that few donors perceived coercion or undue pressure to donate, whether internally or from others, ranging from 0% to 4% in US donors (11, 13, 24, 29, 30), to 14% in European donors (16), and to 5% to 20% in Asian donors (22, 28). Although seven studies used the term “coercion” when interpreting results, no studies or survey questionnaires using this term defined it, which limited the ability to interpret study findings (16, 19, 22, 27–29, 31). Perceived coercion and ambivalence were identified as one of the several criteria used for excluding potential donors from donating (14, 15, 28, 31, 35). Because 39% of potential donors evaluated at one center withdrew suggests that they are capable of expressing a voluntary agreement to donate (34).

Cultural factors seemed to shape donors' perceptions of undue pressure to donate. European donors reported feelings of obligation to donate based on perceptions that no one else wanted to donate, they could not decline, turn back, or disappoint the recipient, and were financially dependent on the recipient (14, 16, 27). By contrast, Asian donors reported feeling “no choice” given cultural values that prioritize the wholeness of the family over the individual family member (15, 27).

Postoperative Complications and Recovery

Donors reported dissonance between what they had expected and what they experienced regarding postoperative complications and recovery. Donors experiencing unanticipated complications after surgery were described in five US, three Asian, and two European studies (11, 13, 16, 17, 21, 24, 28–30, 32). Up to 38% of US and 29% of Asian donors felt that recovery took longer than they had expected (13, 28). In US studies, more than one third of donors felt inadequately prepared to deal with pain (33%–44%) (29) and had a larger surgical scar than expected (28%–37%) (11, 13). Donors in one study reported more complications in self-reported questionnaires than were documented in their medical records (11).

Emotional Experience of Donating

Primarily US and Asian studies documented donors' negative and positive emotional responses to living donation (13–17, 21, 24, 26, 27). Although donors felt low levels of anxiety, they also experienced fear, nervousness, and uncertainty about the risk of death, surgical procedure, recovery, and the effects of donation on donors' future health and quality of life (15–17, 24, 26, 27, 29, 30). Asian donors also mentioned without prompting, having economic anxieties, for example, taking time off work and the cost of donation (15, 27). US and Asian donors also experienced anxiety when spouses and relatives opposed the donation, or when donors did not consult them in decision making (22, 24, 29). US and Asian donors reported that their improved relationships with recipients after donation generated positive feelings in donors about the donation (24, 27). The support of friends, family, and health care providers alleviated donors' preoperative apprehension (15, 24, 26, 35).

Donor Satisfaction With Decision to Donate

Most donors were satisfied with their decision to donate (11, 13, 24, 30). Some donors consistently reported not regretting having donated, even when the recipient had a poor postoperative recovery (11, 24, 30). Most donors across all studies would donate again (74%–100%) (11, 16, 17, 21, 24, 28, 30, 31) and would encourage others to donate (81%–92%) (16, 17, 28, 30).

DISCUSSION

Although LDLT remains ethically charged, relatively few studies have systematically examined the informed consent process from prospective and actual donors' perspectives. Our systematic review suggests that, though potential and actual donors support LDLT, informed consent for LDLT is sub-optimal. Despite the implementation of Centers for Medicare and Medicaid Services' regulations in 2007 requiring formal psychological evaluation of donor candidates (36), and that experienced centers used multiple individuals to provide information about donation at separate times to reinforce essential information, we found that donors still have unmet information needs.

A key finding across studies is that donors perceived shortcomings in the provision of information about postoperative recovery and complications. Donors' experiences of greater complications and longer recovery periods than expected suggest that the disclosure process and their comprehension of disclosed information did not effectively establish donors' realistic expectations. Thus, greater efforts are needed to ensure that donors are optimally informed of and understand the risks of donating.

We also found that information about the risks and benefits to the donor and recipient played little, if any, role in donors' decisions to donate. In fact, some donors seemed to downplay risk information, especially the risk of death, in their decisions, and instead made such decisions based on aiding the recipient (15, 26). The pattern of making decisions to donate before undergoing donor evaluation and education about the donation process suggests that decisions are uninformed. This decision-making approach challenges the ethical and legal requirements of informed consent for donors to be informed of and appreciate the risks before agreeing to undergo them.

Relatively few studies identified donors' accounts of internal or external pressure (or coercion) to donate, suggesting high levels of voluntariness. Low rates of donor-driven withdrawal from evaluation and the infrequent utilization of a medical excuse suggest that transplant centers effectively protect prospective donors from coercion. Conversely, almost a quarter of donors reported hesitancy to donate, casting doubt on donors' voluntary consent to donate. Additionally, donors may not have been conscious of their feelings of undue pressure, or honest with themselves, or may have intentionally concealed such feelings from the transplant center to be cleared to donate, especially in the five studies where the interviewer was associated with the transplant team (14, 20, 26, 27, 33). Thus, rates of reported coercion are likely lower than actuality due to social desirability bias (37).

These conflicting findings, combined with studies' lack of direct assessment of the perception of coercion, indicate that further study must assess whether pressures felt toward donating are undue. Direct inquiry into the perception of coercion is likely not effective in determining the presence of coercion. Therefore, we recommend a more intensive psychological evaluation that assesses factors contributing to feelings of hesitancy or doubts about donating and what level of significance they carry in relationship to voluntary consent, instead of merely the dichotomous presence/absence of coercion.

This empirical review placed informed consent processes within broader social and cultural contexts (38). Most dimensions of informed consent were consistently reported across cultures. However, reasons for donation and for feeling pressured to donate were informed by cultural values and beliefs. Transplant clinicians should therefore be sensitive to cultural beliefs in the psychosocial assessments of potential donors.

The Consensus Statement of the Transplant Society and the American Society of Transplant Surgeons' Position Paper constitute efforts to attain worldwide consensus on ethical guidelines for LDLT (8). Nevertheless, transplant clinicians call for further deliberation to ensure that living donation programs are informed by ethically sound clinical practice (39). Despite documenting inadequacies in the informed consent processes, no center has reported any intervention to improve consent practices. We suggest four potential interventions to improve prospective donor-clinician communication during the LDLT informed consent process.

First, a comprehension assessment tool should be developed to assess live donors' comprehension of the donation process; tool development is currently underway (1R03DK091786-01). This tool will meet CMS requirements and promote standardization in the informed consent process. Relatedly, using the teach-back method can also improve comprehension in surgical patients (40, 41).

Second, a question prompt list should be developed, as used effectively in other clinical contexts to address information needs (42), to help prospective donors identify and address important topics in LDLT to facilitate their efforts to become informed. By obtaining information donors need to know, donors may establish more realistic expectations, which is shown to improve postsurgical health outcomes (43–46).

Third, the development of interactive, health information technology-based (e-health) decision-aids, and educational resources that present current LDLT outcomes data in easily accessible formats is needed to ensure that comprehensive and current information is conveyed clearly to prospective donors. Such interventions are timely given that donor activists are calling for more comprehensive information about donor risks (47), and recent NIH-endorsed technology-enabled behavioral interventions (48). Additionally, e-health interventions effectively increase patients' understanding during informed consent for routine medical care (49–53), which increases satisfaction with the information received (53), decreases clinic consultation time (53, 54), and increases accuracy of risk estimates (53). As videos have been found to improve informed consent process in surgical specialties (55), surgeons are increasingly advocating for the use of health information technology to facilitate patient education and comprehension (46). The American Society for Transplant Surgeons's educational video is one notable example. However, there is room for improvement. Future videos should, for instance, cover information necessary for informed consent per CMS or Organ Procurement and Transplantation Network guidelines; incorporate up-to-date risk information from recent A2ALL analyses (Abecassis et al., unpublished data); be evaluated for effectiveness in viewer comprehension; and use techniques of adult learning to facilitate comprehension.

Furthermore, liver donor consent forms and educational materials should reduce the reading level to a sixth- to eighth-grade reading level, as policy-makers recommend (56, 57). Presenting information using health literacy universal precautions can help ensure comprehension essential for informed consent (58). This step is critically needed considering that a national survey of transplant centers found that consent forms are written on average at the college sophomore reading level (59).

Future research is needed to identify the source of problems within the informed consent process, perhaps due to a failure of current clinical knowledge, clinician disclosure, or donor comprehension. An in-depth description of the content of disclosed information would help to address this issue. To better understand potential donors' concerns and improve the education process, future research must ascertain donors' information needs, investigate why donor candidates withdraw from evaluation, and assess the financial consequences of donating.

Empirical research studies included in this systematic review suffered from limitations in quality and methodology. First, studies were limited in sample size, although the small number of adult-to-adult LDLTs performed at any given transplant center limits the opportunity for large-scale survey studies. Thus, most quantitative findings were limited to descriptive statistics. Second, as many studies were conducted abroad, the generalizability of attitudes and perceptions to the United States is limited as cultural factors seem to influence donation attitudes and decisions. Third, diverse methods of data collection were used across studies. No surveys on informed consent were validated or published for review. Some studies implicitly assessed attitudes about LDLT but did not ask about them directly. Some questionnaires were not anonymous, which may have dissuaded participants from reporting negatively. Some studies included donors whose recipients were still alive, which may have biased reports toward more favorable attitudes. Fourth, most studies conducted retrospective analyses, which are subject to recall bias, poor response rates, and missing data. Only two studies longitudinally assessed informed consent among donors both before and after donating. Further research should assess how the donation experience affects perceptions about information needs. Fifth, studies varied as to when data on donors were collected. Finally, most qualitative research lacked an adequate description of the methodological approach, qualitative data analysis, failed to provide interrater reliability, or insufficiently applied a theoretical approach to the analysis. Most studies (75%) omitted a complete survey or interview guide, limiting a thorough evaluation of study findings.

Broader contextual factors may have contributed to many studies' finding that the informed consent process was suboptimal. Specifically, because many studies were published in the early 2000s, when live donor liver transplant in adults was still in its early stages, there was little knowledge of the actual complications. Donors may have reported a lack of knowledge because many programs had educated prospective donors about this gap in knowledge. Further, as CMS regulations were mandated in 2007, and United Network for Organ Sharing regulations emerged later, it stands to reason that older studies would have less stringent information disclosure procedures, which would translate into less knowledge among prospective donors. Therefore, the 2000s represented an era of great variation in education and consent practices.

In sum, LDLT seems to be perceived by donors as an ethically acceptable procedure. However, this systematic review reveals that concerns remain regarding the adequacy of informed consent for LDLT, particularly in terms of information gaps about the risks of donation. Findings from this review should be used to inform guidelines for psychosocial evaluation to optimize the LDLT informed consent process.

MATERIALS AND METHODS

Review Group

The review group was comprised of a multidisciplinary team, including an epidemiologist/physician, a behavioral social scientist, three transplant surgeons, a postdoctoral surgical fellow, a transplant physician assistant, and a social scientist/clinical ethicist.

Data Source

We performed a systemic review of the MEDLINE database for all publications or references relevant to liver transplantation AND living donors AND decision making, attitudes, OR informed consent.

Inclusion Criteria

Eligibility for inclusion was restricted to studies available in English pertaining to adult (aged older than 18 years) living liver donation, published between 1990 and 2010. Studies included peer-reviewed, empirical studies (entailing primary data collection) relating to potential liver donors' decision-making and informed consent, and studies regarding potential and actual donors. We included international studies because LDLT has been practiced worldwide longer than it has been in the United States.

Exclusion Criteria

We excluded dissertations, case studies, review articles, articles focused on pediatric liver recipients, and abstracts or studies not published as full reports. We also excluded ethical analyses, editorials, opinion pieces about LDLT, and expository analyses. Studies of adult-to-child donation were excluded to avoid confounding our analyses as such donors experience different types of pressures and decision-making processes than adults donating to other adults (60).

Study Selection

We initially identified 1423 articles. All citations were initially screened by two authors (E.J.G. and J.C.C.) to eliminate articles outside the scope of the review (Fig. 1). The remaining abstracts (n=337) were independently reviewed by one transplant surgeon (J.C.C.) and two social scientists and an epidemiologist (E.J.G., K.A.C., and A.D.) to select articles for full-text review based on title, abstract, and keywords. Disagreements were resolved through discussion among reviewers. The bibliographies of selected articles were also searched for relevant references. Of the remaining articles (n=91), 43 were excluded because they focused exclusively on kidney transplantation. On detailed quality assessment, 11 more articles were excluded. Of the remaining 37 articles, 24 articles focusing primarily on liver donors met the final inclusion criteria. Table 2 provides a brief overview of the studies.

FIGURE 1.
FIGURE 1.:
Search strategy and results.
TABLE 2
TABLE 2:
Overview of included studies
TABLE 2
TABLE 2:
Continued
TABLE 2
TABLE 2:
Continued
TABLE 2
TABLE 2:
Continued
TABLE 2
TABLE 2:
Continued

Data Extraction

Articles eligible for full text review were evaluated by a subset of two of the eight total reviewers. Reviews were independently conducted using a data abstraction instrument informed by the Cochrane Collaboration approach to systematic reviews (61–63). The instrument extracted information about article type, research design and methods, population characteristics, sample size, intervention specifics (if relevant), findings, and themes. Reviewers assessed articles for quality criteria including relevance, appropriateness of research questions, theory, and methodology and provided a recommendation for final inclusion; all reviewers agreed on the final set. Heterogeneity among study designs and outcomes precluded quantitative analysis. A checklist was used to appraise qualitative studies, noting study methods, context, analysis, and interpretations (8, 64). Results were organized by geographic area when relevant: Asia, Europe, and United States.

ACKNOWLEDGMENT

The authors thank Jillian Rodde for her helpful edits to the manuscript.

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Keywords:

Adult-to-adult living donor liver transplantation; Systematic review; Informed consent; Ethics; Liver donation; Decision-making; Attitudes; Survey; Outcomes

© 2011 Lippincott Williams & Wilkins, Inc.