The Live Donor Assessment Tool: A Psychosocial Assessment Tool for Live Organ Donors

Psychosomatics 2015:56:254–261

& 2015 The Academy of Psychosomatic Medicine. Published by Elsevier Inc. All rights reserved.

Original Research Reports The Live Donor Assessment Tool: A Psychosocial Assessment Tool for Live Organ Donors Brian M. Iacoviello, Ph.D., Akhil Shenoy, M.D., M.P.H., Jenna Braoude, C.S.W., Tiane Jennings, C.S.W., Swapna Vaidya, M.D., Julianna Brouwer, M.P.H., Brandy Haydel, C.C.R.C., Hansel Arroyo, M.D., Devendra Thakur, M.D., Joseph Leinwand, M.A., Dianne LaPointe Rudow, D.N.P.

Background: Psychosocial evaluation is an important part of the live organ donor evaluation process, yet it is not standardized across institutions, and although tools exist for the psychosocial evaluation of organ recipients, none exist to assess donors. Objective: We set out to develop a semistructured psychosocial evaluation tool (the Live Donor Assessment Tool, LDAT) to assess potential live organ donors and to conduct preliminary analyses of the tool’s reliability and validity. Methods: Review of the literature on the psychosocial variables associated with treatment adherence, quality of life, live organ donation outcome, and resilience, as well as review of the procedures for psychosocial evaluation at our center and other centers around the country, identified 9 domains to address; these domains were distilled into several items each, in collaboration with colleagues at transplant centers

across the country, for a total of 29 items. Four raters were trained to use the LDAT, and they retrospectively scored 99 psychosocial evaluations conducted on live organ donor candidates. Reliability of the LDAT was assessed by calculating the internal consistency of the items in the scale and interrater reliability between raters; validity was estimated by comparing LDAT scores between those with a “positive” evaluation outcome and “negative” outcome. Results: The LDAT was found to have good internal consistency, interrater reliability, and showed signs of validity: LDAT scores differentiated the positive vs. negative outcome groups. Conclusions: The LDAT demonstrated good reliability and validity, but future research on the LDAT and the ability to implement the LDAT prospectively is warranted. (Psychosomatics 2015; 56:254–261)

INTRODUCTION

and although liver donation portends a higher risk than kidney donation, it is still believed to be safe enough to perform at experienced centers.4,5

Live organ donors have long been a valued source of donor organs for transplantation. Live kidney donation is considered the best option for most patients with chronic kidney failure and has been performed for more than 5 decades. Studies have revealed that kidney donation is safe and kidney donors have minimal risk of end-stage renal disease provided they lead a healthy lifestyle.1–3 Live liver donation has been performed for children routinely and in adults since 1998, particularly at large centers in geographic areas with deceased donor shortages. Medical outcomes have been studied, 254

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Received October 27, 2014; revised February 4, 2015; accepted February 5, 2015. From Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY (BMI, AS, HA, DT, JL); Recanati-Miller Transplantation Institute at Mount Sinai and the Zweig Family Center for Living Donation, New York, NY (AS, JB, TJ, SV, JB, BH, DLR); Send correspondence and reprint requests to Brian M. Iacoviello, Ph.D., Department of Psychiatry, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Pl., Box 1230, New York, NY 10029; e-mail: [email protected] & 2015 The Academy of Psychosomatic Medicine. Published by Elsevier Inc. All rights reserved.

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Iacoviello et al. Psychologic outcomes for both liver and kidney donors have been investigated, but most studies are single-center, cross-sectional, and retrospective. These studies have shown that donors often exhibit higher quality of life scores than age-matched healthy adults and almost all donors report that they would donate again.6–8 Research has also indicated that the live donor population exhibit more adaptive personality traits (agreeableness, conscientiousness, and lower neuroticism) compared with age-matched healthy adults, are equally resilient when compared to the general population and significantly more resilient than the population of primary care patients, and they score in the very high range on measures of Purpose in Life and Growth.9 However, there have been reports of negative outcomes associated with liver and kidney donation, including suicides and severe psychiatric complications,10 often associated with predonation psychiatric histories. Many donors require counseling in the year after donation, with a smaller number requiring pharmacotherapy for depression or anxiety.11 Donation can be a very stressful situation for the donor and their families, and intact family and social supports after donation are important for resilient outcomes.12 Psychosocial risk factors, in addition to medical factors, are therefore very important considerations when assessing potential donors. Review of the literature on live organ donation, organ recipients and studies of resilience, as well as clinical experience with the live organ donor population, all inform which psychosocial factors to consider in a live donor evaluation. The Organ Procurement and Transplant Network/United Network for Organ Sharing have policies13 and the Centers for Medicare & Medicaid Services Conditions of Participations also have requirements for key components to include in the psychosocial evaluation.14 Motivations for donation, feelings about donation, and comfort level with the decision to donate have been shown to delay the evaluation process and likely influence the postdonation experience.15,16 Other domains to assess in the psychosocial evaluation associated with resilience include adequacy and stability of support available after donation (financial, family, and social), behavioral and psychological health, appropriateness of expectations about donation, and the donor-recipient relationship.9,12 Obstacles to the evaluation process should also be addressed in the psychosocial evaluation and include impression management, personal biases and subjectivity, overt deception, behavioral risk Psychosomatics 56:3, May/June 2015

factors, and cultural/language differences. Knowledge and understanding about donation, donor autonomy, and freedom from coercion are important aspects of informed consent and affect the ethical and psychosocial appropriateness of the potential donor as well.17 Comprehensive live donor evaluations are essential to predict patients that will have positive vs negative donation experiences and outcomes. Traditionally, the psychosocial evaluation for live donors has relied on a clinical interview to explore predonation psychosocial stressors and underlying psychologic disorders that might make donation high risk. However, there is no standardized approach to the psychosocial evaluation across providers and institutions even with the same patient, and there are no validated psychometric instruments available to determine psychosocial risks for donation. Accordingly, the process of screening and approving/declining potential donors can vary widely across institutions.18 For the assessment of recipients, there are several such tools used in practice: the Stanford Integrated Psychosocial Assessment for Transplantation,19 the Psychosocial Assessment of Candidates for Transplantation,20 and the Transplant Evaluation Rating Scale.21 The Stanford Integrated Psychosocial Assessment for Transplantation is the newest of these tools; its strengths include its comprehensive nature and standardization of the information collected during the psychosocial evaluation process. One empirical study of the Stanford Integrated Psychosocial Assessment for Transplantation has been published; in it, the Stanford Integrated Psychosocial Assessment for Transplantation was found to have excellent inter-rater reliability and to be predictive of the transplant psychosocial outcome.19 This type of assessment tool is needed for the assessment of live organ donors. Further research aimed at developing a standardized, validated screening process across institutions, which can predict positive vs negative postdonation outcomes, is clearly warranted. The purpose of the project reported in this article was to develop a tool for the psychosocial assessment of live organ donors and to pilot test the potential reliability and validity of the tool in a retrospective medical record review. METHODS Development of the Live Donor Assessment Tool Our group sought to develop a standardized, semistructured psychosocial evaluation tool for www.psychosomaticsjournal.org

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The LDAT psychiatrists, psychologists, social workers, and other clinicians involved in the evaluation process to quantify the degree of psychosocial appropriateness versus riskiness of potential donors. We began by scrutinizing the current psychosocial evaluation process at our center, the Organ Procurement and Transplant Network/United Network for Organ Sharing/Centers for Medicare & Medicaid Services guidelines and requirements, and reviewing the literature on the psychosocial variables that have demonstrated associations with treatment adherence, quality of life and live organ donation outcome,6–11,15–17 and resilience.12 We identified the following psychosocial domains to assess: motivations for donation,6,9,15,16 knowledge about donation,6,9,15–17 relationship with the recipient,7,15,17 support available to the donor,7,12,15 donor’s feelings about donation,6,9,12,16,17 postdonation expectations,6,9,12,16,17 stability in life,6,7,12,15 psychiatric issues,8,10,11 and alcohol and substance use.8,10,11 These domains were distilled into several items each. The items were then circulated among a group of colleagues involved in the live organ donation programs at other transplant centers and revised based on consensus feedback. Item scoring was also determined by consensus among the group and the consultants. A 0–3 or 0–2 point score range was applied for each item based on the availability of discernable anchors for each score point. In providing anchors for each score, we realized that for some items the score ranges will necessarily be different. In general, we tried to apply a 0–3-point scale for all items, but some items did not lend themselves to that scale; in those cases, (e.g., dichotomous choices) the scale ranges from 0–2. It is important to note that this was the first step in developing the Live Donor Assessment Tool (LDAT) items and scoring rubric; this could be revised with further, prospective research into the individual items and their scores. The resulting tool, the LDAT, comprises 29 items across 9 domains (Table 1) and is scored such that higher scores indicate greater psychosocial appropriateness for donation. Medical Record Review Methods, Raters and Rater Training As a preliminary investigation of the reliability and validity of the LDAT, we trained 4 raters (2 social workers and 2 psychiatry residents) to administer the LDAT in a retrospective medical record review of 256

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psychosocial evaluations for donation. Donor charts with 2 psychosocial evaluations, conducted by both a psychiatrist and social worker, were included for analysis. The medical record review included the 2 psychosocial narrative evaluations, with any final determinations or recommendations removed. The raters were also blinded to any outcome of the evaluations. Charts from all potential donors presenting to our center for evaluation between 2010 and 2012 were searched for the following: medical records that included notes from both psychosocial evaluations

TABLE 1.

Psychosocial Domains and Items Measured by the LDAT

(A) Motivation for Donation (3 items) Item 1: Internal motivations Item 2: External motivations Item 3: Appropriateness of motives (B) Knowledge about donation (2 items) Item 4: Knowledge of donation process Item 5: Knowledge of recipient’s diagnosis and prognosis (C) Relationship with the recipient (1 item) Item 6: Closeness to recipient (D) Support available to the donor (2 items) Item 7: Others' agreeableness to donor's decision Item 8: Available support from a caregiver (E) Feelings About Donation (5 items) Item 9: Coercion Item 10: Anxiety/fear Item 11: Indecision behavior Item 12: Impulsivity Item 13: Ambivalence (F) Postdonation Expectations (3 items) Item 14: Physical expectations Item 15: Psychosocial expectations Item 16: Posttransplant expectations for the recipient (G) Stability in Life (6 items) Item 17: Early life stability Item 18: Current relationship stability Item 19: Current employment stability Item 20: Current external life stressors Item 21: Pain tolerance Item 22: Sleep (H) Psychiatric Issues (3 items) Item 23: History of psychopathology Item 24: Personality disorder traits Item 25: Truthfulness versus deceptive behavior in presentation (I) Alcohol and Substance Use (4 items) Item 26: Alcohol use/abuse/dependence Item 27: Substance use/abuse/dependence (excluding marijuana and alcohol) Item 28: Marijuana use/abuse/dependence Item 29: Nicotine use/abuse/dependence

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Iacoviello et al. and for which evaluation outcome data (cleared to donate vs rejected) were available. As both live kidney and liver donations are performed at our center, we also sought to balance the number of evaluations coming from potential liver compared with kidney donors in our sample. The final sample included 99 medical records for review. Table 2 provides descriptive characteristics of these donor candidates. The psychosocial assessments contained information for most but sometimes not all of the items included in the LDAT (information regarding the handling of missing data is provided in the Data Analytic Strategy section below). For this reason, the LDAT items for rating sleep and pain tolerance included an “N/A” option for this study. These items are not routinely specified in the psychosocial evaluations and this information was expected to be missing from the charts. Raters were instructed to rate these items as “N/A” if there was no information in the medical record on which to base the rating, and these items were excluded a priori from any analyses but are retained in the LDAT for future, prospective study in which they can be assessed. The trainee raters had experience observing the psychosocial evaluations of transplant patients and donors, but none participated in the development of the LDAT. The team that developed the tool conducted 3 1-hour training sessions with the raters to acquaint them with the tool and the goals of the assessment. Training sessions involved discussion of each item and the anchors for scoring, with examples provided. The raters and members of the study team TABLE 2.

Characteristics of the Sample of Donor Candidates Kidney donor Liver donor candidates (n ¼ 40) candidates (n ¼ 59)

Age (y) Sex (% female) Ethnicity Caucasian/white African American/black Hispanic/Latino Asian Positive evaluation outcome Negative evaluation outcome

35.0 (8.69) 57.5

37.0 (9.72) 45.8

20 (50.0) 4 (10.0)

31 (52.5) 7 (11.9)

12 (30.0) 4 (10.0) 72.5

17 (28.8) 4 (6.8) 79.7

27.5

20.3

Note: Values shown indicate mean (and standard deviation) or percentage.

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then used the LDAT to rate 2 practice cases together based on review of the psychosocial evaluation notes; scores for each item were reviewed and discussed as a group with consensus scores agreed upon for each item. Four practice cases were then rated independently by the trainees using the LDAT. Raters’ scores were reviewed as a group and discrepancies discussed to arrive at consensus agreement for each item. At this point, raters demonstrated greater than 85% agreement in scores on the practice cases and were deemed suitable to conduct retrospective ratings using the LDAT. Raters then completed an LDAT to retrospectively rate the 99 case reports based on the psychosocial evaluation notes from donor candidate charts. Data Analytic Strategy The total score on the LDAT, which could range from 0–82, is calculated as the sum of the individual item scores. Higher scores indicate more desirable predonation psychosocial characteristics, and lower scores indicate less desirable characteristics or increased risk for donation. Four raters utilized the LDAT to score 99 charts, for a total of 396 ratings. The reliability of the LDAT was assessed in 2 ways. Internal consistency of the LDAT, or the degree to which the various items tap into the same or related constructs, was measured by calculating Cronbach alpha across all 396 ratings, with the value interpreted according to established ranges (e.g., 0.6 r α o 0.7 ¼ “acceptable”, 0.7 r α o 0.9 ¼ “good”, α Z 0.9 ¼ “excellent”; 23).22 Inter-rater reliability was measured by computing correlation coefficients for the scores assigned by each permutation of rater pairs. To assess the potential validity of the LDAT in standardizing and predicting evaluation outcome, LDAT scores were compared between the “positive evaluation outcome” and “negative evaluation outcome” groups, and univariate logistic regression analysis was conducted using raters’ LDAT scores to predict the positive or negative evaluation outcome. To classify donor candidates, their full medical records, including psychosocial evaluations, were reviewed by the study team from 2 sources: documentation in electronic records and corroboration with the transplant nurse coordinator and evaluation team familiar with the candidate’s psychosocial evaluation. www.psychosomaticsjournal.org

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The LDAT Consensus ratings of the psychosocial evaluation outcome were determined independently from and without the raters present. “Negative outcome” included candidates ruled out as potential donors for psychosocial reasons during the evaluation process; “positive outcome” included patients being psychosocially cleared to donate regardless of whether they ended up donating (0 ¼ positive outcome; 1 ¼ negative outcome in our analyses). Besides the sleep and pain tolerance items, on which almost all cases were rated as “N/A”, few data were missing from the ratings. The impulsivity item had 5 of 396 cases missing, ambivalence had 7 missing, and current employment stability had 18 missing. In these cases, a median imputation technique was used to infer scores for the missing values, in which the median score for the item across all completed ratings was imputed for each of the missing values. RESULTS LDAT scores assigned by raters ranged from 40.0 – 73.0. Each case was rated by 4 raters using the LDAT. Each case was then assigned an overall LDAT score, for subsequent analyses, which was calculated as the median of the 4 raters’ scores. These scores were FIGURE 1.

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skewed in the positive direction and were not normally distributed (Shapiro-Wilk test of departure from normality ¼ 0.935, p o0.001; Figure 1). The median is the most appropriate, robust measure of the central tendency of the data in this case; median LDAT score in the whole sample was 64.5. Although the LDAT scores for the kidney group were normally distributed, the LDAT scores for liver donors were not (Shapiro-Wilk ¼ 0.919, p ¼0.001), so a Wilcoxon-Mann-Whitney U test was indicated to explore kidney vs liver group differences. Median LDAT scores for the kidney and liver groups were 61.25 (range: 40.0–70.5) and 65.0 (range: 43.5–73), respectively; the distributions of the groups differed significantly (Mann-Whitney U ¼ 847.0, n1 ¼ 40, n2 ¼ 59, p ¼0.016). As a measure of reliability, the internal consistency (Cronbach alpha) of LDAT items across all 396 LDAT ratings was calculated at α ¼ 0.795. This value is in the “good” range and indicates that the items are generally tapping into the same construct without being overly redundant.23 As LDAT scores were not normally distributed, inter-rater reliability was assessed by computing the nonparametric correlation Spearman rho for the scores assigned by each pair of raters (Table 3). The median agreement between all

Distribution of LDAT Scores in the Sample. Individual LDAT Scores (Median of 4 Raters’ Scores) Were Skewed in the Positive Direction, With a Median Score of 64.5

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Iacoviello et al. TABLE 3.

SW1 SW2 PSY1 PSY2

Inter-rater Reliability of LDAT Scores SW1

SW2

PSY1

PSY2

–

0.807 –

0.615 0.739 –

0.796 0.850 0.751 –

Note: Values presented are Spearman’ rho; SW ¼ social worker rater; PSY ¼ psychiatry resident rater.

pairs of raters was 0.774. This value indicates “strong” to “very strong” inter-rater reliability of LDAT scores in these retrospective ratings. Overall, 76 patients were categorized under “positive outcome” and 23 under “negative outcome” of the psychosocial evaluation. Figure 2 depicts the spread of LDAT scores by outcome group. Median LDAT score for the positive outcome group was 65.5, significantly greater than the median LDAT score for the negative outcome group, which was 56.0 (MannWhitney U ¼ 134.5, n1 ¼ 76, n2 ¼ 23, p o0.001). Univariate logistic regression models were also fit to predict the actual psychosocial evaluation outcome (positive or negative) using the LDAT score FIGURE 2.

determined by each rater. Coefficients for the LDAT score in the regression model for each rater were 0.245, p o 0.001; 0.234, p o 0.001; 0.340, p o 0.001; 0.315, p o 0.001. Note that LDAT coefficients are negative because a higher LDAT score is associated with positive outcome (0 ¼ positive evaluation outcome; 1 ¼ negative outcome). These results show that LDAT scores are highly predictive of the psychosocial evaluation outcome. DISCUSSION We set out to develop and study a psychosocial evaluation tool for the assessment of live organ donors. The need for such a tool is twofold: to provide a quantitative indicator of the psychosocial risk level of potential live organ donors and to standardize the process by which donor candidates are evaluated within and across institutions. Toward that end, the LDAT was developed to address the psychosocial factors that are associated, in the literature and through clinical experience of experts in the live donor field, with the live organ donation process, donation and transplant recipient outcomes, and resilience. The

Distribution of LDAT in the Positive vs Negative Outcome Groups. Median LDAT Score for the Positive Outcome Group (n ¼ 76) Was 65.5, Significantly Greater Than the Median LDAT Score for the Negative Outcome Group (n ¼ 23) of 56.0 (Mann-Whitney U ¼ 134.5, n1 ¼ 76, n2 ¼ 23, p o 0.001)

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The LDAT scale provides a score that can be used to quantify the level of psychosocial risk vs appropriateness of a live organ donor candidate. This study found that LDAT items demonstrate good internal consistency. The items appear to measure related facets of a construct (in this case the psychosocial appropriateness of a donor candidate) but are not overly redundant as an “excellent” degree of internal consistency (α Z 0.9) might indicate. In addition, the LDAT can be reliably scored across trained raters; this study found the LDAT demonstrated good inter-rater reliability across 99 cases rated by 4 raters in a retrospective medical record review. The LDAT also exhibited signs of validity in this preliminary study; LDAT scores differentiated the “positive outcome” and “negative outcome” groups, as related to the result of the psychosocial evaluation process, and there were significantly strong associations between the LDAT scores assigned each case and the case’s evaluation outcome. Moreover, post hoc analysis shows that LDAT scores show indications of specificity and sensitivity in determining positive vs negative evaluation outcomes: a cutoff score of 60, for example, would correctly categorize 67 of 76 (88%) in the positive group and 19 of 23 (83%) of the negative group in this sample. However, the study design, small sample, and the post hoc analyses prevent drawing any firm conclusions regarding sensitivity, specificity, or appropriate LDAT cutoff scores. Nonetheless, taken together, the results of this preliminary study suggest that the LDAT could be a reliable and valid tool for assessing the psychosocial risk level of a live organ donor candidate. However, prospective studies are clearly needed to continue to investigate these properties of the LDAT and to further develop the tool. The results of the analyses suggested that, in this sample, the liver donor group demonstrated greater LDAT scores than the kidney donor group did. Equivalent groups, or greater LDAT scores for the kidney donors, may have been predicted a priori, as kidney donation is generally seen as less risky. However, this may mean that the bar to donation is higher for liver donors, who must demonstrate more adaptive characteristics to be deemed a “good candidate”, which would be reflected with higher LDAT scores. Additionally, the liver donors may have been self-selecting before presenting for evaluation. Liver donation is riskier and potential donors who are ambivalent or not highly motivated may not pursue the donation evaluation. In addition, New York State (where this team is located) law requires 260

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a close emotional bond to be a liver donor; this means that they would likely receive a significant benefit from the recipient getting well, may sense urgency to donate, or may have a greater understanding of liver disease and the patient’s condition. Kidney donation is often considered a simpler procedure, so many come forward to be evaluated without having done a lot of research ahead of time. Kidney donors can be strangers or distant friends so they may not sense as much urgency to donate. All of these factors could result in higher LDAT scores for the liver group than the kidney group. Further research in a larger, prospective sample that takes these factors into account is warranted to investigate whether this group difference is genuine or if it is an artifact of this study design. This study has some notable strengths. The LDAT was developed by a team with vast experience in the live organ donation process and psychosocial research, and in consultation with outside experts around the country. Consequently, the LDAT covers a range of psychosocial factors related to resilience in general and the process of live organ donation specifically. The preliminary investigation of the LDAT’s reliability and validity included a diverse sample in age, gender, ethnicity, and both liver and kidney donor candidates, so the generalizability of the results to the larger live organ donor population appears encouraging. However, there are also limitations of the study. Although the sample was diverse in many ways, this retrospective study relied on a convenience sample that included only potential donors who completed 2 psychosocial evaluations. This could skew the sample in the “positive” direction, as potential donors that drop out earlier in the process, who may be expected to exhibit increased risk or poorer psychosocial characteristics, might not be adequately represented in this sample. Indeed, there were more “positive outcome” donors in this sample, which we would expect to score higher on the LDAT; this could also contribute to the skewed LDAT scores in the sample. Therefore, the sample might not be representative of the entire population of donor candidates who present for screening. This also highlights the need for prospective study of the LDAT across the entire range of live organ donor candidates. One other confounding factor that may limit interpretation of the findings is that the tool was developed and tested in the same center. It is conceivable that the items were conceived of and developed in a way biased Psychosomatics 56:3, May/June 2015

Iacoviello et al. toward how the evaluations are conducted at this center; this could artificially inflate measures of inter-rater reliability and the congruence between LDAT scores and the outcomes of the psychosocial evaluations conducted. This suggests that further research on the LDAT should include other centers. In summary, the LDAT was developed to address the need for a psychosocial evaluation tool for live organ donors. In a preliminary retrospective study, the tool demonstrated good psychometric properties

(reliability and validity). Future research on the properties of the LDAT and the ability to implement and utilize the LDAT prospectively are warranted. Disclosure: The authors acknowledge partial financial support for this project in the form of a NATCO 2011 Research Grant to D.L.R. The funding agency did not play a role in the study design, data collection, analysis or interpretation, writing of the report, or decision to submit for publication.

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