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Logo of nihpaAbout Author manuscriptsSubmit a manuscriptNIH Public Access; Author Manuscript; Accepted for publication in peer reviewed journal;
J Trauma. Author manuscript; available in PMC Dec 27, 2012.
Published in final edited form as:
PMCID: PMC3530615
Determinants of Family Consent to Tissue Donation
Laura A. Siminoff, PhD, Heather M. Traino, PhD, and Nahida Gordon, PhD
Department of Social and Behavioral Health (L.A.S., H.M.T.), Virginia Commonwealth University, Richmond, Virginia; and School of Nursing (N.G.), Case Western University, Cleveland, Ohio
Address for reprints: Laura A. Siminoff, PhD, Department of Social and Behavioral Health, Virginia Commonwealth University, 1112 East Clay Street, PO Box 980149, Richmond, VA 23220; lasiminoff/at/
Family consent to tissue donation currently falls well below that for solid organ donation. Moreover, research suggests that Americans have limited understanding of tissue donation, an activity largely overshadowed by the more publicly visible organ donation. This research sought to identify determinants of families’ consent to tissue donation.
Data collection included a brief, self-administered survey completed by tissue bank staff and telephone interviews with family for a sample of tissue donor-eligible deaths reported to a national sample of 16 United States Tissue banks from 2003 to 2006. Family members (N = 1,418) and tissue bank staff (n = 226) involved in the tissue donation decision participated in the research.
The families of 1,015 (71.6%) tissue donor-eligible patients consented to tissue donation; 403 (26.8%) families refused. Results revealed a multitude of associations between study variables and the donation decision. A subsequent multivariable analysis identified determinants of family consent to tissue donation, including the discussion of key donation-related issues during the request (adjusted odds ratio [AOR], 17.22; 95% confidence interval [CI], 11.61–25.54), the quality of communication during the request (AOR, 12.39; CI, 7.76 –20.02), families’ tissue donation attitudes and knowledge (AOR, 10.01; CI, 6.47–15.50), families’ initial reactions to the request (AOR, 7.86; CI, 5.13–12.05), families’ advance notice of the request (AOR, 3.95; CI, 2.41– 6.46), and patient and family sociodemographic characteristics (AOR, 3.32; CI, 2.01–5.48).
Family consent to tissue donation is affected by many of the same variables influencing consent to solid organ donation. Recommendations for practice are provided.
Keywords: Tissue donation, Family consent, Medical decision-making
Each year, ~1,000,000 American lives are improved through tissue donation.1 Some tissue, such as skin and heart valves, may be used in life-saving capacities.2 Donated skin can be used to prevent fluid loss for burn victims, whereas heart valves may be used to repair deformed or malfunctioning valves.2 A previous study conducted by Siminoff et al.3 found that only 35% of the families of eligible deceased patients consent. This figure is startling because the pool of potential tissue-eligible patients is much greater than that for organ donation. It is estimated that by increasing consent to tissue donation by a mere 10%, the pool of transplantable tissue would increase by 100,000 grafts.4
However, increasing consent is a daunting task. It has taken 20 years of concerted effort to increase family consent to solid organ donation from 40% to 60%.3, 5 The challenge for tissue donation is greater because it is poorly understood by the public. A survey of families who donated tissues indicated only one-half distinguished tissue donation from organ donation.6 Moreover, the public is generally unaware of the details of tissue donation, such as the preparation and distribution process, which can involve for-profit companies.4
Previous studies examining tissue donation have been limited by scope, sample size, and analytic method. Most have small sample sizes (<100) and exclusively focus on families who consented to donation.69 Furthermore, only one study used a multivariate model to identify predictors of family consent.7 This study is the first to examine a large, national sample of potential tissue donors. The goals of this study were to describe the process and content of the requests for tissue donation and to identify the factors associated with family consent.
Tissue Bank Sample
Sixteen tissue banks representing a spectrum of tissue procurement organizations across the United States were sampled. In addition, two organizations procured tissues nationally, whereas the remaining 14 procured tissues from within proscribed geographic areas. Specifically, five organizations were based in the Southwest, four in the Southeast, three in the Midwest, three in the Northeast, and one in the Northwest. Finally, 6 hired and trained their own requesters, whereas 10 contracted at least a percentage of their requests to services that provide full- or part-time telephone coverage for the purpose of contacting and requesting tissue donation from the families of tissue-eligible patients.
Data collection at each tissue bank involved (1) the identification of families from whom tissue donation was requested; (2) self-administered surveys completed by tissue bank requesters immediately after discussing donation with the families; and (3) audiotaped telephone interviews with the family decision makers (FDM) who participated in the donation decisions. Data were collected from February 2003 through 2006.
Tissue Bank Requester Sample
Eligible requesters were defined as those tissue bank staff who discussed donation with family members. Each case was associated with at least one staff requester; 13 cases included more than one requester. Requesters completed a self-administered survey at the completion of each request for tissue donation. A total of 226 tissue requesters participated in the study, and 99.1% of cases had a completed tissue requester survey. Because of the high volume of tissue donation requests made each month, tissue banks were randomized to specific data collection days. During these days, requesters completed a brief, self-administered survey after each request.
Family Decision Maker (FDM) Sample
FDM were identified using the tissue banks’ records. Two months after the death of adult patients and 3 months after the death of pediatric patients, a letter explaining the purpose and methods of the study were sent to a random sample of families from whom requests were made. Past research examining family consent to organ donation has found that this time period allows families to grieve without compromising recall of the events surrounding the patient’s death.10 Ten days after the letters were mailed, families were contacted through telephone and invited to participate in the study. We interviewed 62.5% (n = 1,471) of individuals contacted about tissue donation (4,002), of whom 1,008 (68.5%) donated tissues and 463 (31.5%) did not. Because the interviews relied on FDMs’ memory of the donation request, only those reporting good recollection of the donation conversation were included in these analyses; 53 cases in which respondents reported poor recall were excluded for a final sample of 1,418 cases.
The family interview consisted of two parts. The first contained a series of structured and semistructured questions that systematically collected data on the quality of care the patient received at the hospital, interactions with tissue bank requestors, the donation decision, and the reasons for that decision. The second section measured family members’ attitudes about and knowledge of tissue donation and transplantation. The interview was a modified version of a well-validated interview used extensively with families that were asked to donate solid organs.10 All interviews were audio-taped and transcribed verbatim; interviews lasted 45 minutes to 60 minutes. The study was approved by the appropriate institutional review board, and verbal informed consent was obtained from all participants.
The primary outcome measure was the decision whether to donate tissue (consented/refused). Consent data obtained from FDMs during the interviews were verified through tissue bank reports. Basic demographic information, including sex, ethnicity, and age, were collected for all subjects. In addition data such as income, education, and marital status were obtained for FDMs. Factors thought to influence family consent were assessed during the interviews and are described later. For all scales, higher scores indicate higher levels of the measured variable.
Family members rated the quality of care the patient received while in the hospital, the quality of communications with the health care providers, and health care provider’s care and concern using three 5-point Likert Scales. In addition, FDMs indicated who first approached them about the option of tissue donation and their level of comfort with that person. FDMs also reported their initial response to the donation request and level of surprise at being asked to donate. Both variables were measured on a 7-point Likert Scale. Decision makers provided the rationale behind their donation decision. Similarly, tissue requesters reported their perceptions of families’ initial response to the request. Congruence between requesters’ and family members’ reports of FDMs’ initial response was also ascertained through a paired comparison yielding a variable scored as either concordant or discordant. The relationship between this variable and consent was then assessed to determine whether requesters’ ability to accurately gauge FDMs’ reactions to the donation request influenced the donation decision.
Two measures were used to examine FDMs’ understanding of donation: (1) the sum of correct responses to seven tissue donation knowledge questions; and (2) correctly identifying the tissue requester’s organizational affiliation. A 14-item, 5-point Likert Scale of attitudes toward donation and transplantation used and validated in several studies of organ donation was modified for tissue donation and administered to FDMs.10 Scores are summative and range from 14 to 70. Family respondents also recalled the donation-related topics discussed with the tissue requester, the type(s) of tissue requested, and the total time spent in discussion with the requester.
FDMs’ level of satisfaction with their decision was obtained using the Decisional Regret Scale, a standard 5-item, 5-point Likert Scale.11 To contextualize this measure, an open-ended question allowed respondents to indicate what, if anything, they would have changed about their decision. By using three 7-point Likert questions, requesters rated their comfort speaking with the family and answering the family’s questions as well as their overall satisfaction with the process.
Berlo’s Source Credibility Scale, a 5-item, 7-point Likert Scale, assessed FDMs’ perceptions of requesters’ training, experience, qualifications, skill, and knowledge. Scores on the scale were summed and ranged from 5 to 35.12 Family respondents also indicated whether the tissue requester asked if they had any questions and, if so, how satisfied they were with the requesters’ answers. Satisfaction was rated using a 7-point Likert Scale of agreement. Two 5-point Likert Scales assessed respondents’ perception of requesters’ display of care and concern and the quality of the requester’s communications during the donation conversation. Families also completed a 14-item, 7-point Relational Communication Scale.13 Item responses were based on level of agreement and were summed to range from 14 to 98.
Statistical Analysis
Associations between the independent variables and family consent were performed using the Fisher exact test or the χ2 test, for variables with two categories or three or more categories, respectively. The Mann-Whitney U test was used to examine ordinal-level variables; the Student’s t test was used for interval- or ratio-level variables. Because the sample was skewed toward FDMs who consented to tissue donation, a weighted analysis was conducted. No significant differences were found between the analysis weighted for sampling bias and the unweighted analysis; the results of the unweighted analysis are presented here.
We performed a log-linear regression to describe the relationship between family consent to tissue donation and factors describing the consent process. A theoretical model of donation decision making was used to determine the constituents of each factor.10 First, the study’s independent variables were grouped to create six factors, each representing a different conceptual domain (the Supplementary Table provides a summary of each factor). Second, variables that were significantly associated with donation within each of the domains using bivariate techniques were retained. Third, separate logistic regression analyses were performed on each of the domains using consent as the outcome. This process created six variables representing the estimated probability of consent for each conceptual domain. A cut point of 0.5 was chosen to transform each of these variables into a dichotomous variable. Finally, a log-linear regression was conducted to analyze the interrelationships between the six dichotomous variables and consent. The analyses were performed using SPSS 16.0 for Microsoft Windows and SAS (SPSS Inc., Chicago, IL; SAS Institute Inc., Cary, NC).
Sociodemographics and Consent
Patients’ mean age was 56.1 years (standard deviation [SD], 18.4); 83.3% were white and 68.6% were men. Younger, white patients were more likely to become donors than older, nonwhite patients.
FDMs were predominantly white (85.8%) and women (72.6%) with a mean age of 51.3 years (SD, 13.4). Although most decision makers (44.1%) were the spouse of the deceased, others were adult children (28.1%), parents (13.7%), siblings (9.7%), or other relatives, significant others, or legal guardians (4.4%). Fifty-one percent of family members reported their religious affiliation as Protestant and 22.8% as Catholic. Nearly three quarters of the families (72.4%) had yearly incomes > $30,000 and 14.0 years (SD, 2.4) of education. A minority of family members held health-related occupations (13.0%). Although only 66.5% of families had signed a donor card, nearly all (91.8%) stated a willingness to donate their own tissue.
FDMs who donated were more likely to be white (92.3% vs. 69.2%, p < 0.001) and Catholic (24.5% vs. 18.6%, p < 0.05), to have an annual income > $59,000 (41.1% vs. 25.9%, p < 0.001), and more years of education (14.2% vs. 13.5%, p < 0.001), compared with FDMs who refused donation. Donor families, compared with nondonors, were also more likely to have signed a donor card (66.6% vs. 32.0%, p < 0.001; see Table 1).
Patient and Family Decision Maker Sociodemographics by Donation Decision
Donor families cited implicit or explicit knowledge that the patient wanted to be a donor (66.1%), families’ desire to help others (60.8%), and families’ general inclination toward donation (39.3%) as reasons for their final decision. Of the families who donated, 150 (10.6%) donated with conditions—donating some, but not all tissues requested. Reasons for families’ decision to donate conditionally included concern for potential disfigurement or mutilation of the patient’s body (66.0%), assessment of the patient’s eligibility (15.3%), an emotional attachment to a certain body part (12.0%), family compromise (6.7%), and the implicit or explicit knowledge of the patient’s wishes (6.7%). The most common reason for refusing donation was patient and family fatigue (feeling they or the patient “had been through enough”; 39.5%). Other reasons why nondonors refused included implicit or explicit knowledge that the patient did not want to donate (31.3%), concern over potential disfigurement (22.1%), a belief that the patient was not eligible to donate (19.9%), and feeling uninformed about tissue donation (6.5%). Overall, FDMs were generally satisfied with their donation decisions (mean decisional regret, 6.7; SD, 3.3), although families refusing donation exhibited greater regret than did donating families (9.0 vs. 5.8, p < 0.001).
Tissue requesters (n = 226) were predominately women (n = 155, 68.2%) and white (n = 174, 77.0%). The average age of a requester was 34.2 (SD, 9.5) years and most had at least a college education (n = 138, 61.1%). On average, requesters had 1.5 years of job experience (SD, 2.8); half (50.4%) of the requesters held degrees in a health-related field. Requesters’ sociodemographics were not significantly associated with consent.
Families’ Initial Reactions to the Request and Consent
Thirty-three percent (n = 468) of families were surprised to be asked about tissue donation. Consistent with research examining families asked to donate solid organs,11 family members who refused donation reported higher levels of surprise than consenting family members (4.7 vs. 3.3, p < 0.001; see Table 4). Although many families were surprised at the request, the majority of family members (60.2%) reported being in favor of donation when first asked; 24.3% of families were initially unsure about donation and 15.5% were unfavorable. Tissue requesters correctly judged families’ initial reactions to the donation request 64.4% of the time. Family consent was more likely when the tissue requester correctly assessed the FDM’s reaction to the request than when the assessment was discordant (70.4% vs. 29.6%, p < 0.001).
Univariate Analyses of Study Variables and Consent
Attitudes, Knowledge, and Consent
Donor families reported significantly more favorable attitudes toward donation than did nondonor families (50.5 vs. 44.3 of 70, p < 0.001). Conversely, nondonors were more likely to feel “squeamish” about the idea of tissue donation (35.7% vs. 13.0%, p < 0.001), to agree that donor families should share in any monies made from donated tissue (38.4% vs. 30.6%, p < 0.01), and to agree that families should have some degree of control over how donated tissue is used (57.1% vs. 48.1%, p < 0.01) than donors. Few families (donors or nondonors) were in favor of using donated tissue for cosmetic purposes or involving for-profit companies in the processing and distribution of donated tissue (see Table 2).
Family Respondents Agreeing or Strongly Agreeing to Attitude Statements
On average, respondents’ knowledge about tissue donation was moderately high, with a mean of 5.4 correct answers out of 7 (SD, 1.4). However, donating families displayed more knowledge of tissue donation than families declining donation (5.6 vs. 4.8, p < 0.001). Nondonors commonly and incorrectly thought that tissue donors could not have open casket funerals and that a signed donor card or a license marked “donor” did not apply to tissues or corneas (see Table 3). In addition, although more than half (60.1%) of all FDMs were able to identify the organizational affiliation of the tissue requester by name or type of organization, significantly more donors than nondonors did so correctly (67.6% vs. 40.9%, p < 0.001).
Percent of Correct Responses to Knowledge Questions
Request Process Factors and Consent
Past research in organ donation has indicated that family members’ perceptions of the care and concern exhibited by the patient’s health care team affect the decision to donate.10 The use of the telephone in requests for tissue donation is standard practice. In this sample, 61.0% of the requests for donation were initiated by telephone, and all requests were followed up and completed by telephone. Requests initiated by telephone were significantly more likely to result in refusals than when families were given advance notice in person about the request by hospital personnel (70.0% vs. 30.0%, p < 0.001; see Table 4). Families who consented to donation were most likely to have their first substantive conversation about tissue donation with a tissue requester (36.7%); nondonor families were most likely to have the issue first discussed with clergy, social workers, coroners, funeral directors, or other unspecified hospital personnel (48.9%; p < 0.001). A similar discussion pattern was observed in requests for organ donation.10 Consenting families also reported greater comfort with requesters than did families who refused donation (mean comfort scores 6.2 vs. 4.4, p < 0.001). In addition, families who knew of the patient’s desire to become a donor or who thought the patient would have wanted to donate were more likely to grant consent than FDMs who did not (64.0% vs. 36.0%, p < 0.001).
Quality of Communication and Consent
Discussions with families about donation ranged from 1 minute to 240 minutes, with a median length of 20 minutes (mean, 14.6; SD, 3.1). Consenting families spent considerably more time discussing donation than did families who refused consent (23.0 minutes vs. 4.6 minutes, p < 0.001). Family members consenting to donation discussed significantly more topics with requesters than did family members who refused (9.8 vs. 1.7, p < 0.001). For donors, conversations about donation most often included discussions of the patients’ medical history and the use of donated tissue to save lives and treat disease (see Table 5). The least commonly discussed topics for donors included the involvement of for-profit organizations, families’ religious or spiritual beliefs, and the tissue requesters’ point of view on donation. For nondonors, the most frequently discussed topics were the time to make the decision and the patient’s donation wishes, whereas the processing and storage of donated tissue and the involvement of for-profit companies were discussed least.
Most and Least Commonly Discussed Donation-Related Topics
Almost three quarters (69.4%) of respondents recalled being asked whether they had any questions concerning donation. Families consenting to donation were more likely to be solicited for questions than were families who refused (86.7% vs. 25.8%, p < 0.001). Donor families also rated the communication with the requester of higher quality than nondonors (4.3 vs. 3.4, p < 0.001). Donors thought that the requester was more caring and concerned (4.7 vs. 3.7, p < 0.001), more credible (31.8 vs. 22.8, p < 0.001), and possessed stronger communication skills (79.3 vs. 64.1, p < 0.001) than did nondonors.
Multivariable Analysis of Determinants of Consent
Six key aspects of the tissue request process known to affect consent (see Supplementary Table) were examined to determine how interrelations among the factors affected consent in this population. Results revealed that all six factors were directly related to consent (see Table 6). The strongest association was found between the tissue donation-related topics discussed with FDMs. Families who discussed key issues, such as costs associated with donation, the time available to make the donation decision, the impact of donation on funeral arrangements, and the ability to have an open casket funeral, were 17 times more likely to donate (adjusted odds ratio, 17.22; 95% confidence interval, 11.61–25.54). The quality of communication was also associated with consent, as were donation-related attitudes and knowledge, the role of the individual who raised the issue of donation, and patient and family sociodemographics. Significant associations among the individual factors were also found.
Log-Linear Regression Hierarchical Model of the Relationship Between Family Consent to Tissue Donation and Factors Describing the Consent Process (N = 1,418)
The results of this study reveal that family consent to tissue donation is affected by many of the same factors that influence consent to organ donation. For example, the number of donation-related topics discussed with the FDM and the family member’s degree of surprise at the request predict family consent. In addition, the role of the person who first approached the family about donation (i.e., tissue bank staff or other), the amount of time spent discussing donation, and the FDM’s attitudes toward and knowledge of tissue donation were significantly associated with families’ donation decision. These findings are mirrored in work on organ donation by Siminoff et al. and others.10, 1416
There are several significant differences between organ and tissue donation. First, tissue donation can take place many hours after the patient dies. This has encouraged the use of telephone requesting. Indeed, much attention has been paid to the use of the telephone in requests for tissue donation. 4, 6, 1719 We found that FDMs were more likely to consent when approached first in person rather than by telephone; this is consistent with past research examining the use of the telephone in requests for corneal donation.1719 However, the large number of individuals eligible for tissue donation coupled with the substantial numbers of eligible deaths occurring outside hospitals, make in-person requests often impracticable. Furthermore, Wilson et al.6 found that >90% of families were satisfied with the telephone request process; they and others find that telephone requests can be acceptable for requesting tissue donation.4, 6, 1719
Tissues and organs are also differentiated because tissues are frequently processed and go through several levels of handling before transplantation. As such, some tissue come to resemble a commercial product much more than we might like, given that these are tissue donated freely by deceased individuals. Moreover, for-profit companies may ultimately sell some of the donated tissue, a fact only 12% of families knew. Nearly a quarter of family members interviewed were also unaware that a signed donor card was, in effect, an agreement to donate tissues and corneas as well as organs. Even fewer family members understood that these documents were legally binding and the respondents often confused tissues and organs. Data from this study and others show that families frequently know little about tissue donation, confuse tissue and organ donation, and are surprised to receive these requests. It is notable that the element of surprise significantly decreases consent rates.4, 6, 9 Clearly, the American public still lacks basic knowledge of the differences between organ and tissue donation.
The study also demonstrates that information that might be considered critical to informed consent—the uses, procurement, and distribution of tissue—go largely undisclosed. Indeed, both the Department of Health and Human Services’ Office of the Inspector General20 and the National Kidney Foundations’ National Donor Family Council21 consider these topics critical to families’ decision-making process. The Office of the Inspector General20 also recommends that, at minimum, families should be provided with, among other things, a copy of the consent form. Nonetheless, only 28.8% of consenting families in this study were asked if they would like a copy of the consent form and, of those responding affirmatively, only 32.7% reported they received one.
Given these findings, we propose the following suggestions for improving consent to tissue donation in the United States. First, a general education campaign, targeted primarily to minority communities, is needed to inform the American populace about the nature and benefits of tissue donation. A simple solution would be to distribute pamphlets about tissue donation to all families and patients in hospitals. Our data indicate that preparing families to receive a telephone request can add to the likelihood of a successful request. However, research promoting family consent to organ donation has shown that requesters spending more time with families are more likely to obtain consent.16 Although requesting tissue donation by telephone may be cost effective, consent rates may improve if more requests for tissue were made in person, like those for organs.
Tissue banks should also routinely ensure that all families are provided information on the processing and distribution of donated tissue and of the involvement of for-profit companies. Because families stated these topics would be influential to their choices about donation, they should be included in discussions about donation to provide families with the information needed to make informed donation decisions. Moreover, tissue banks must be vigilant in distributing informed consent documentation to all families who consent to donation. Informed consent is a standard element of medical care and should not be overlooked in this context.
Although this is the largest, most comprehensive examination of the process of requesting tissue donation in the United States, it has limitations. Few minority respondents were of Hispanic (3.8%) or Asian (0.6%) decent; most were African American (11.3%). However, this study’s demographic profile is similar to that of the US population.22 Future research should use stratified sampling techniques to provide a more in-depth analysis of Asian and Hispanic attitudes and behaviors regarding tissue donation. In addition, because the interviews were held 2 months to 4 months after the patient’s death, there is a chance that some FDMs’ failed to accurately recall these events. Recall error is a common threat to validity in retrospective studies but was minimized in this study by careful cognitive interviewing techniques and the vividness of the events. Finally, although the sample was large for a study of this type, there was a significantly higher participation rate for families consenting to donation than for those who refused (71.6% vs. 26.5%, p < 0.001). Nondonors’ participation in similar studies examining organ and tissue donation ranges from a low of 21% to a high of 60%.4, 23, 24
Supplementary Material
Supplementary Table
We thank the 16 tissue banks for their participation and Ms. Aruna Swaminathan, MS, for her skillful data management.
Supported by the Agency for Healthcare Research and Quality (AHRQ) grant #R01 HS-13152. AHRQ played no role in the study’s design, conduct, or reporting.
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