Family refusal of skin donation for transplantation: trends and associated factors

ABSTRACT Objectives: to analyze the trends and factors associated with family refusal of skin donation for transplantation. Methods: this cross-sectional study was conducted in the State of São Paulo, with family authorization terms collected from 2001 to 2020. The variables analyzed included year, age, gender, cause of death, and type of institution. Data were analyzed using linear and multiple logistic regression, with the Odds Ratio estimated at p<0.05 for statistical significance. Results: 1,355 individuals refused skin donation. The trend of refusals decreased between 2001 and 2009 in the age groups of 0-11 years and 12-19 years, but increased in the group aged ≥60 years. This trend continued to decrease in the 0-11 years group from 2010 to 2020, and increased in the 20-40 years group. Males and the age groups of 20-40 years, 41-59 years, and ≥60 years exhibited 27%, 34%, 47%, and 53% lower chances of refusal, respectively. Conclusions: there is an urgent need for measures to mitigate the high number of refusals associated with skin donation.


INTRODUCTION
Worldwide, more than 180,000 individuals die from burns each year, with the majority of these deaths occurring in low-and middle-income countries (1) .In Brazil, burns represent a significant public health issue.Annually, about 1,000,000 such accidents take place in the country, approximately half of which involve children (2) .
In more severe cases, the use of skin grafts for treating burns is essential.Skin grafting is an effective surgical strategy that involves transferring a segment of tissue from one part of the body to another to cover or repair a damaged area (3) .When an autograft is not possible, this treatment can be performed using the skin of a deceased donor (3) .Allografts can be harvested in cases of brain death or cardiopulmonary arrest of the donor (4) .The use of this graft can be life-sustaining for severely burned individuals (3) .Tissue from just a single donor can save up to 100 patients (5) .
In Brazil, allografts are used in burn patients with over 40% of their body surface affected and who lack viable options for temporary coverage of the injured area (4) .However, skin availability in the country is limited and difficult to obtain (3) .Demand still exceeds supply (3) .Only 42.7% of individuals who donated organs also consented to donate their skin (6) .Interestingly, in 2015, Australia had 84% more skin donors than Brazil, despite having a population size that is only 10% of Brazil's (7) .
However, the refusal to donate skin is not a problem exclusive to the Brazilian system.In Iran, the average refusal rate was 51% during the period from 2007 to 2014 (5) .In Mashhad, for example, the annual demand for skin allografts exceeding 3.5 million cm² is not met by the available supply of about 20,000 cm² (5) .In the USA, between 30 and 50 active tissue banks have also reported difficulties (8) .Spain, which has the highest organ donation rates in the world, recorded about a 40% refusal rate for tissue donation (9) .
The reasons behind this phenomenon may be linked to family refusals to donate skin.In Brazil, the organ and tissue donation process is regulated by legislation that requires family authorization (4) .Technical issues with the donation, lack of team training, the manner in which the interview is conducted, the time required to complete the process, and the fear of body mutilation are factors associated with family refusals (10) .
Specific reasons for refusing skin donation are tied to a lack of awareness about the importance and feasibility of donating this tissue.The extraction of skin may evoke the notion of animalization of the donation, potentially leading to feelings of lost dignity for the deceased and negatively influencing family decision-making (11) .In addition to these factors, the low rate of skin donation linked to family refusal might also be related to other reasons, necessitating further investigations to explore various scenarios and the context of the COVID-19 pandemic.
Thus, the following question arises to be addressed by this study: "What are the trends and factors associated with the specific refusal of skin donation?"

OBJECTIVES
To analyze the trends and factors associated with family refusal to donate skin for transplantation.

Ethical Aspects
The study was conducted in accordance with national and international ethical guidelines and was approved by the Research Ethics Committee at the Hospital das Clínicas of the Faculty of Medicine, University of São Paulo.Consent was waived for the patients since the data are derived from individuals who had already passed away.

Study Type
This is a quantitative, cross-sectional, analytical study with an exploratory and retrospective focus on specific refusals of skin donations from donors in brain death situations at an Organ Procurement Organization (OPO) in the State of São Paulo.The research followed the recommendations of the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) checklist.

Data Source
The analytical material consisted of all copies of Organ and Tissue Authorization Terms signed by family members from January 2001 to December 2020.The study variables related to skin donation refusal include: year, donor age, gender, cause of death, type of hospital institution, and instances of skin donation refusals.

Data Analysis
Data were collected and tabulated in Microsoft Excel® and analyzed using Stata 15.0 statistical software, both descriptively and inferentially.Temporal trend analysis was conducted through generalized linear regression using the Prais-Winsten method to calculate trends or percentage changes as indicated by the Annual Percent Change (APC) parameter.For interpreting the results, the following criteria were considered: an increasing trend -APC positive and p<0.05; a decreasing trend -APC negative and p<0.05; stationary, when the null hypothesis that there is no significant difference between the value of the variation and zero is accepted (p>0.05) (12).Multivariable analysis was performed using multiple logistic regression to estimate the crude Odds Ratio (OR) and the respective 95% confidence intervals.
Based on these results, the final reduced model for the association between skin donation refusal and sociodemographic and corporate characteristics was estimated.Variables with a p-value of 0.25 or lower in the crude analyses were adopted.The stepwise method allowed the retention of variables with a p-value of 0.10 or lower in the regression analyses, and the final adjusted model included variables that maintained a p-value of less than 0.05.The fit of the final model was assessed using likelihood ratio statistics, the Wald test, and the coefficient of determination (R²).A significance level of 5% was maintained throughout the analysis.

RESULTS
Among the data analyzed from 2,447 organ or tissue donors, 1,355 (55.37%) refused to donate skin.Gender and age group were associated with the refusal of skin donation (p=0.002 and p<0.001, respectively).The majority of individuals who refused skin extraction were male (55.94%) and belonged to the age group of 41 to 59 years (41.48%)(Table 1).
The year with the highest percentage of refusals was 2008; however, the years 2014 and 2020 saw a significant decrease in refusal rates (Figure 1).
Between 2001 and 2009, it is noticeable that the trend in the percentage of skin donation refusals decreased in the age groups of zero to 11 years (p<0.001) and 12 to 19 years (p=0.001).However, in the age group of 60 years or older, there was an increasing trend (p=0.016)during the same time period.From 2010 to 2020, the trend continued to decrease in the age group of zero to 11 years (p=0.012)and started to increase in the age group of 20 to 40 years (p<0.017)(Table 2).
Considering the gender variable, from 2001 to 2020, male potential donors had a 24% lower likelihood of having their skin donation refused compared to females (p=0.002).Between 2010 and 2020, males had a 31% lower chance of refusal for skin extraction (p<0.001) From 2001 to 2020, the age group of 12 to 19 years experienced a 44% lower chance of skin donation refusal (p=0.045), the 20 to 40 years group had a 56% lower chance (p=0.001),individuals aged 41 to 59 years showed a 63% lower chance (p<0.001), and those aged 60 years or older had a 68% lower chance (p<0.001), when compared to those aged zero to 11 years.
Between 2001 and 2009, individuals aged 12 to 19 years had an 81% lower likelihood of skin donation refusal (p=0.006),those aged 20 to 40 years had 79% lower chances (p=0.004),those aged 41 to 59 years had 83% lower chances (p=0.001), and those aged 60 years or older had 86% lower chances (p=0.001).It is noteworthy that, from 2010 to 2020, individuals aged 60 years or older had a 47% lower chance of having their skin donation refused (p=0.045)(Table 3).In the final reduced model for the period from 2010 to 2020, male individuals had a 34% lower likelihood of having their skin donation refused compared to females (OR = 0.66; CI: 0.54-0.80;p<0.001).Throughout the entire period from 2001 to 2020, this likelihood was 27% lower for males (OR = 0.73; CI: 0.61-0.86;p<0.001).

DISCUSSION
Our results highlight a high rate of specific family refusals to donate skin.This may be related to several factors that contribute to the lower social impact of tissues used for donations compared to other organs (13) .
Generally, the lack of social awareness about skin donation, concerns about body image, misinformation, and in some cases, the inadequate or nonexistent approach by healthcare professionals during family interviews are the main factors influencing and contributing to the high number of refusals observed (11) .A study by Brazilian researchers found that a lack of understanding of brain death, religious beliefs, insufficient time for decision-making, and the lack of technical competence of hospital staff also influence family refusals (14) .Furthermore, research in Spain has shown that despite a strong tradition of organ transplantation in various health institutions, skin donation is largely an unknown process and is only part of routine activities at a few health centers.Both situations corroborate and justify the high rates of tissue refusals (15) .
The findings of this study also revealed that the age and gender of the donor are factors that weaken the skin donation process and contribute to the increase in family refusals.Although descriptive data from the investigation revealed that males have a higher number of refusals, the logistic regression model demonstrated that women are more likely to have their skin extraction refused.
Males, compared to females, also showed lower chances of refusal in a study conducted in Saudi Arabia (16) , indicating that this scenario is not exclusively a national problem.It is assumed that this is linked to the stereotyped image of female skin as a representation of care and delicacy.Therefore, the acceptance for donation from male individuals is higher, considering its social character, which could be an important determinant for family consent (17) .It is worth noting that this phenomenon may be a consequence of historically and socially imposed beauty standards, where female skin is seen as a symbol of perfection, an ideal to be venerated and preserved, something that should not be extracted or supposedly violated in the event of a donation (18) .
The investigation also revealed that the older the donor, the greater the likelihood of family refusal to donate skin.Skin is considered a societal calling card; thus, there is significant concern for its preservation (19) .Consequently, donating skin can symbolically represent an invasion of the donor's privacy and dignity, since touching is viewed as an act of intimacy, a privilege, and a transcendence of social barriers (18) .Prejudice against older skin is also a notable factor in the process (19) .Age can influence family decisions and also affect the offering of tissue by interviewers in cases involving older individuals.Analysis of the profile of skin donors at a Brazilian center shows that the maximum age for skin donation was 60 years, with an average age of 41 years (20) .
It is evident that changes in public policies initiated in 2009 might explain the reduction in refusals from that period.In that year, the Brazilian transplant system underwent restructuring through legislation (4) , which may have optimized skin donation.
It is important to note that the decrease in the refusal rate for skin donation in 2014 might be linked to the fire at the Kiss nightclub in Santa Maria -RS, Brazil, in 2013.This national tragedy may have sensitized the population to skin donation, highlighting a critical deficit of grafts needed for treating the victims in Brazilian skin banks.
It is assumed that the data presented in 2020 also reflect a widespread awareness campaign about organ and tissue donation conducted by the family of a renowned Brazilian artist who died in November 2019.Following the event, data from Google Trends recorded an increase in searches for "Organ and Tissue Donation" and "Brain Death" (21) .
It is concerning to observe that the trend of refusal remained stationary during some periods.This highlights the impact of failing to adopt or adhere to effective measures to alter the situation, emphasizing the need for the development and dissemination of educational initiatives and campaigns focused on skin donation, as well as the training of professionals in the field (6) .

Study limitations
This study has considerable limitations.Although the analytical models were significant, it can be concluded that the variables studied are insufficient to fully explain the outcomes of skin donation refusal.Further scenarios should be considered, such as analyzing data from other regions of Brazil and investigating the characteristics or motivations of the family members of skin donors.

Contributions to the Field of Nursing
Our findings underscore the importance of skin donation and the need for more in-depth discussions on the subject, emphasizing the crucial role played by nursing in this process.In family interviews, these professionals have an advantage in influencing positive outcomes by clarifying doubts and alleviating fears, which facilitates the decision-making process for donations.Additionally, nurses have the capability to propose and support public policies aimed at reducing the high rate of refusals.Our study also identified a significant research gap in the field, highlighting the need for more studies that examine both the obstacles and strategies to improve the donation process.Moreover, we emphasize the importance of developing and implementing evidence-based intervention proposals that can be integrated into training and practice for nurses, strengthening their roles in advocacy and public health education.

CONCLUSIONS
There is a clear need for measures aimed at mitigating the high number of family refusals associated with skin donation.In this context, identifying specific characteristics of refusals may provide a solution to this issue.As the current analysis has shown, it is evident that female donors and those in older age groups tend to have their tissue refused, varying according to the period analyzed.These data suggest that other factors may be associated with family refusal of skin donation, such as lack of awareness, prejudices, and low visibility around the issue, which impact family decision-making.Therefore, it is imperative to deepen research in this area and verify data like those from the current study in order to support actions and strategies to increase the number of skin donations and reduce refusals.Social barriers surrounding the topic can be mitigated with educational measures linked to universities and major media outlets.

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Family refusal of skin donation for transplantation: trends and associated factorsSouto KOL, Pimentel RRS, Brito AN, Moraes EL, Santos MJ.

Family refusal of skin
donation for transplantation: trends and associated factors Souto KOL, Pimentel RRS, Brito AN, Moraes EL, Santos MJ.

Table 2 -
Temporal Trend of the Percentage of Skin Donation Refusals, by Characterization Variables, in Two Periods: 2001 to 2009 and 2010 to 2020, São Paulo, São Paulo, Brazil, 2024

Table 3 -
Association Between Refusal of Skin Donation and Sociodemographic and Clinical Characteristics, Considering Crude Odds Ratios, São Paulo, São Paulo, Brazil, 2024 OR -Odds Ratio.

refusal of skin donation for transplantation: trends and associated factors
Souto KOL, Pimentel RRS, Brito AN, Moraes EL, Santos MJ.