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Living donation is a mainstay of transplantation due to both the continued organ shortage and the medical benefits for transplant recipients [1, 2]. However, the need for living donors must be balanced against the risks to these individuals, who undergo surgery for no personal medical benefit [2-4]. Indeed, among the highest priorities in transplantation are the protection of donors' well-being and the prevention of adverse consequences of donation; these priorities drive the continued refinement of practice guidelines and requirements designed to promote donor safety [5-9].
The mandate to protect donors compels attention to not only medical but psychosocial outcomes. Recent reviews of the donor psychosocial outcomes literature suggest that, although many individuals experience no adverse psychosocial consequences of donation, others develop enduring somatic complaints (e.g. fatigue, pain), psychological distress (e.g. depressive or anxiety symptoms) and/or strained relationships with family members [10-16]. Over half of all donors may experience such difficulties .
These findings are striking given rigorous evaluation protocols designed to screen out potential donors with significant medical or psychosocial contraindications to donation [7, 8, 17-20]. These protocols' success is evidenced by descriptive studies' findings that individuals approved as donors show high levels of physical, psychological and social well-being relative to normative or comparison groups [21-28]. However, to the extent that even carefully selected donors are at risk for adverse psychosocial outcomes postdonation, additional strategies are required to ensure that donors' well-being is preserved.
There are no evidence-based interventions available to prevent poor postdonation psychosocial outcomes. We sought to address this gap by developing a “selective” preventive intervention, that is, one focused on a key risk factor for postdonation psychosocial difficulties [29, 30]. Namely, residual ambivalence about donating—i.e. lingering feelings of hesitation and uncertainty that remain after the prospective donor's (PD's) predonation evaluation and that coexist with his/her intention to donate—is not only prevalent but one of the few factors consistently found to predict poor postdonation psychosocial outcomes [10, 11, 31-37]. Residual ambivalence is distinct from acute ambivalence, or feelings of indecision so marked that the PD is deemed unable to donate [6, 38, 39]. Although acute ambivalence, resulting in the individual being ruled out as a donor, is rare (≤3% of rule-outs) [17, 40, 41], some degree of residual ambivalence shortly before donation has been noted in up to 75% of donors [11, 27, 31, 33, 34].
We reasoned that if an intervention targeted predonation residual ambivalence, poor postdonation psychosocial outcomes—the primary outcomes in the current study—might be prevented. To this end, our intervention utilizes a novel application of motivational interviewing (MI) [42, 43]. The intervention puts MI to a use for which it is well-suited but has been overlooked. In all past MI clinical and research applications, the aim has been to enhance motivation for behavior change [44-46]. However, equally important is MI's focus on exploring and resolving ambivalence, no matter what the individual's ultimate choice regarding any behavior they might undertake, or decision they might make . The goal of our MI intervention is neither to encourage nor to discourage donation, but to enable PDs to resolve residual ambivalence associated with their own decisions about donation, and hence to prevent psychosocial difficulties in these individuals after donation.
Building on developmental work showing that the MI intervention was acceptable and relevant to PDs' concerns , we now present results from a Phase II  randomized controlled trial (RCT) designed to examine intervention feasibility and efficacy. We hypothesized that the MI intervention would not only reduce predonation residual ambivalence, relative to that in individuals not receiving the intervention, but lead to lower rates of postdonation difficulties in our primary trial outcomes: psychosocial variables in somatic, psychological and family relationship domains.
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The mandate to promote living donors' safety has led not only to careful evaluation protocols to select them, but to guidelines and policies for monitoring postdonation health status [6, 8, 9]. Postdonation monitoring may allow for timely intervention should medical or psychosocial problems be revealed. However, efforts to avert problems may be more efficient than deploying postdonation interventions, especially if prevention efforts are targeted to PDs at heightened risk. This “selective” prevention approach [29, 30, 74] is also likely to be more practical and cost-effective than “universal” prevention, in which even individuals with no risk factors receive preventive interventions . Although one might argue that PDs at risk for poor psychosocial outcomes should not donate, use of effective preventive interventions could allow them to donate more safely and thus help to ensure that living donation remains an option for transplant candidates who might otherwise be unable to receive transplants.
Our results suggest that a brief intervention offered to an at-risk population—PDs with residual ambivalence about donation—may be useful for prevention purposes. Such feelings of lingering hesitation and uncertainty are common in PDs and, similar to rates in other studies , we observed that 71% of the PDs we screened evidenced some degree of residual ambivalence.
Because the timeline between donor approval and surgery may be brief, feasibility concerns arise in mounting a preventive intervention in this population. MI-based interventions are usually brief and can be conducted effectively by telephone [44, 45]; both factors are likely to have contributed to our success in completing the intervention and study assessments before donation surgery. Equally striking, we had no attrition across postdonation assessments. However, some PDs did not donate due to factors beyond their control (e.g. transplant candidate health changes). We had not expected this to happen as often as it did; a full-scale RCT would need to consider this in estimating sample size needs.
Concerning intervention effects, subjects receiving the MI intervention showed reduced ambivalence relative to the comparison groups. We believed that, if ambivalence was resolved, PDs would be better able to reach their own final choice regarding whether to proceed with donation. The fact that three PDs receiving the MI intervention ultimately decided against donation, while no PDs in other study groups changed their minds, suggests that the MI intervention was, as designed, helping PDs to reach decisions that they personally judged to be best. This effect demands more thorough evaluation in a larger trial. Nevertheless, we view the result as a positive: there is strong sentiment in the transplant community that no one should donate if they are unsure it is the right choice.
An intervention that helps PDs to feel they have made the right choice, and to feel at peace with that choice, seems to have potential: it may explain why subjects in the MI group who did donate (the vast majority) appeared to have more favorable postdonation outcomes than other subjects. It is well-known that individuals with concerns and negative expectations about undergoing surgical procedures often report negative psychological reactions and somatic problems after surgery . In the context of living donation, where donors experience no direct medical benefit from surgery, the importance of resolving any lingering concerns, doubts and worries may be even further heightened. These components of residual ambivalence may color donors' experiences of the donation and recovery even in the first several days after surgery ; this very early response may ultimately contribute to poorer outcomes . It has been recommended that PDs with such concerns before donation receive additional attention and support from the donor team in order to promote optimal postdonation outcomes [31, 76]. Our intervention provided uniquely tailored support in this regard.
In terms of outcomes, the MI intervention appeared most potent for reducing risk for somatic complaints by 3 months postdonation. Donors in the MI group reported fewer symptoms, lower rates of fatigue and pain, a quicker recovery and fewer unexpected medical problems. They were less likely to have anxiety symptoms and reported fewer unexpected donation-related family problems at 3 months postdonation. The sizes of these effects were generally moderate. Of importance, for dichotomous variables, for example, these effects translate into numbers needed to treat (NNT, the number of persons needing to receive a preventive intervention in order to avoid one new case of the adverse outcome)  of between three and five. NNTs of 3–5 indicate clinical effectiveness and hence clinically important impact [78, 79]. While our results cannot be used to estimate effect sizes likely in a full-scale RCT [68, 69], they suggest we observed a sufficient “signal” regarding intervention efficacy to warrant additional evaluation .
Key study limitations are, first, its small size and single-center focus. While these limitations are acceptable for Phase II work, a full-scale trial would require a larger sample, from multiple sites, in order to determine generalizability and to be powered to examine mechanisms accounting for intervention effects. Second, we found relatively little impact of the MI intervention on the family relationship domain, due either to our choice of measures or to a true absence of effects. However, it seems premature to exclude this domain from even exploratory consideration in a future trial, since family relationship difficulties have been reported in donors . Third, we did not assess psychosocial outcomes at baseline in order to determine that the groups were equivalent on these variables before the intervention or donation. The fact that subjects were randomized reduces the likelihood of such imbalances. Moreover, many of our outcomes were donation-specific (e.g. somatic complaints related to the surgery; unexpected donation-related problems) and logically could not be assessed predonation. Nevertheless, for other factors such as psychological symptoms, future work should examine change from baseline rather than postdonation levels alone. A fourth limitation is that our postdonation follow-up was brief. Whether effects would be maintained beyond 3 months is unknown. Fifth, the study groups may have differed on unassessed background characteristics (e.g. recipient outcomes other than survival status) that could have served as confounding factors.
Despite these limitations, the study provides the first empirical evaluation of a preventive intervention designed to avert poor psychosocial outcomes in living donors. Feasibility and efficacy results suggest that the intervention merits testing in a larger, multisite trial. The trial's design should take into account uncontrollable factors that affect subjects' progress toward donation (e.g. changes in transplant candidates' status), and it should include a sufficiently long follow-up period to determine whether any intervention effects are maintained. We are currently designing such a trial, with follow-up through 1 year postdonation. If a full-scale trial demonstrates reliable effects, issues of dissemination into routine clinical care would become prominent. These issues would pertain, for example, to resources needed and associated costs. Given its focus on ambivalence and on giving PDs an opportunity to reflect on their reasons for donating, the intervention may logically fit within activities performed by the independent donor advocate (IDA). IDAs come from a wide variety of disciplines; it is thus an asset that MI-based interventions' effects are not influenced by interventionist discipline (e.g. nursing, medicine, psychology, social work) . Finally, the brevity of our intervention serves to increase its potential for cost-effectiveness and potential uptake by living donor programs.