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 ).
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 ). 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
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 ).
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 ). 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 ). 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
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 ). 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 ). 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)