Potential Limitations of Presumed Consent Legislation

Boyarsky, Brian J.1; Hall, Erin C.1,2; Deshpande, Neha A.1; Ros, R. Lorie1; Montgomery, Robert A.1; Steinwachs, Donald M.3; Segev, Dorry L.1,4,5

Transplantation:
doi: 10.1097/TP.0b013e31823173e0
Editorials and Perspectives: Forum
Abstract

A causal link has been proposed between presumed consent (PC) and increased donation; we hypothesized that too much heterogeneity exists in transplantation systems to support this inference. We explored variations in PC implementation and other potential factors affecting donation rates. In-depth interviews were performed with senior transplant physicians from 13 European PC countries. Donation was always discussed with family and would not proceed against objections. Country-specific, nonconsent factors were identified that could explain differences in donation rates. Because the process of donation in PC countries does not differ dramatically from the process in non-PC countries, it seems unlikely that PC alone increases donation rates.

Author Information

1Department of Surgery, Johns Hopkins School of Medicine, Baltimore, MD.

2Department of Surgery, Georgetown University School of Medicine, Washington, DC.

3Department of Health Policy and Management, Johns Hopkins School of Public Health, Baltimore, MD.

4Department of Epidemiology, Johns Hopkins School of Public Health, Baltimore, MD.

The authors declare no funding or conflicts of interest.

Address correspondence to: Dorry L. Segev, M.D., Ph.D., Transplant Surgery, Johns Hopkins Medical Institutions, 720 Rutland Avenue, Ross 771B, Baltimore, MD 21205. E-mail: dorry@jhmi.edu

Received 9 May 2011. Revision requested 4 July 2011.

Accepted 4 August 2011.

Article Outline

Presumed consent (PC) legislation has been advanced as a potential modality to attenuate the organ shortage (1). A PC law in the context of organ donation is one in which a potential organ donor is presumed to have consented to organ donation if he or she had not registered an objection to donation during life. PC systems are referred to as “opt-out” frameworks of organ donation. In comparison with systems that require explicit consent, or “opt-in” systems, PC laws have been motivated by the assumptions that (1) most people support donation, yet never formally record their wishes, and (2) PC might ease the burden of decision making on families at the time of death (2).

Several recent quantitative studies, including a systematic review and a longitudinal study of kidney transplantation in 44 nations, have suggested a causal link between PC and higher national rates of deceased donation and transplantation (3, 4). Rithalia et al. (3) reported a 20% to 30% increase in organ donation and 2.7 to 6.1 more donors per million population (pmp) in countries with PC. However, these studies are limited in that they treat PC as binary, which may oversimplify the complexities of the implementation and enforcement of PC. Furthermore, a number of confounding factors may explain this association, rather than a causal mechanism of PC itself. These factors include the efficiency of a country's transplant coordination; national, regional, and local strategic transplant policies; and population-based and provider attitudes toward organ donation. In addition, quantitative studies of PC lack a true counterfactual model, or a period of time with explicit consent (opt-in) laws in place during the modern era of transplantation, as legislation in most countries with PC originated in the 1970s and 1980s (5).

It is possible that PC itself is not causally responsible for increased rates of organ donation in countries with this legislation. Instead, multiple clinical or cultural confounders, unrelated to the consent system, may lead to increased donation in these countries. As such, we hypothesized that (a) the many nuances of PC implementation and enforcement cannot be fully captured through a quantitative framework, and (b) too much heterogeneity exists in systems of transplantation to support a causal link between PC and increased deceased donation. The goals of this study were to gain a more granular understanding of the possible mechanisms by which PC may or may not functionally increase organ donation rates and to explore potential factors confounding this relationship.

Back to Top | Article Outline

RESULTS

Thematic content analysis of interviews with 15 participants from 13 countries revealed 229 representative quotations, which were coded into nine subthemes and four major themes (Table 1). On comparing responses from participants from countries in which multiple participants were consulted, no differences were found. The following major themes emerged: (1) donation was always discussed with family; (2) content of family discussion varied; (3) donation would not proceed if family objected; and (4) other country-specific, nonconsent practices exist that could explain differences in donation rates.

Back to Top | Article Outline
Major Theme 1: Donation Was Always Discussed With Family

In all 13 participating countries with PC, donation was discussed with the potential donor's family at the time of death (Table 2, theme 1). In 6 of 13 countries, there was even a legal requirement to speak with relatives. In one country, Sweden, donation was discussed with relatives even if the potential donor had previously opted-out. The two major reported reasons to discuss donation with families were (1) to be transparent with the family about the process of donation and (2) to obtain a complete medical and social history of the potential donor.

Back to Top | Article Outline
Major Theme 2: Content of Family Discussion Varied

The content of family discussions about organ donation varied substantially (Table 2, theme 2): participants from 9 of 13 countries mentioned they ask family about the deceased's will regarding organ donation; 1 of 13 countries, Portugal, tells the family donation will proceed in the absence of the potential donor's name on the opt-out registry; and 3 of 13 mentioned that differentiating between the decedent's will and his or her family's is an exercise in futility.

In Portugal, the participant mentioned donation proceeds unless the potential donor had opted-out, yet families are still given the opportunity to object (see theme 3). Other participants described a scenario in which the boundary between the decedent's wishes and the family's wishes is more finely drawn in the clinical context.

Back to Top | Article Outline
Major Theme 3: Donation Would Not Proceed if Family Objected

Participants from all 13 countries described the application of the PC law in a way that respected the wishes of the decedent's family (Table 2, theme 3). Though countries had PC legislation that enabled them to recover organs from patients who had not previously opted-out, each participant stated that if the family objected to donation, the process of donation would not proceed.

As most participants stated they would not proceed with donation if a family was “opposed” to donation, the participant from Austria described the situation saying that donation would not proceed if the family did not “accept” organ donation.

The two reported reasons for not recovering organs from donors when a family objected were (1) fear of negative press and (2) respecting the wishes of the grieving family so as to prevent psychological harm.

Back to Top | Article Outline
Major Theme 4: Other Country-Specific, Nonconsent Practices Exist That Could Explain Differences in Donation Rates

When queried for unique or significant factors that contribute to the donation rate in the participant's country, participants from 3 of 13 countries mentioned programs or initiatives aimed at increasing the deceased donor pool, independent of PC (Table 2, theme 4). The participant from Spain noted that hospitals with donation capacity are staffed by part-time physician-transplant coordinators, generally intensivists or anesthesiologists, who proactively perform brain death audits to detect potential donors, manage their care, and approach their families. Similarly, notes the participant from Portugal, where every main hospital is screened for potential donors daily, “[We have] a system like in Spain.”

Back to Top | Article Outline

DISCUSSION

In this international qualitative study of the mechanisms by which PC may or may not functionally increase organ donation rates, two chief findings emerged: (1) the process of donation in countries with PC does not differ dramatically from the process of donation in countries that require explicit consent and (2) countries with the highest rates of deceased donation have national and local initiatives, independent of PC, designed to attenuate the organ shortage. In all countries participating in this study, despite a PC legal framework, families were always included in the discussion about donation, and the process would not proceed if a family expressed an objection. On the other hand, success of deceased donation was attributed by study participants to other factors independent of PC, such as physician transplant coordinators responsible for daily detection of potential donors in hospitals in Spain and Portugal. These factors may confound the association between PC and higher rates of deceased donation.

Previously suggested causal links between PC and donation rates should be interpreted in the context of our findings. Though PC theoretically obviates the involvement of a potential donor's family in the donation process, our findings suggest that a functional relationship between clinicians and families of potential donors is always necessary to prevent negative press and to protect the well-being of the potential donor's family. There was variation in the manner in which the issue of donation was presented to families. In Austria, families were encouraged to state their preferences; in Portugal, it seems that objections were not actively solicited. These nuances of PC enforcement merit further exploration. PC policies did not seem to encourage a priori family discussion about donation.

Furthermore, our study participants raised a number of key clinical and cultural issues or mechanisms that might confound perceived links between PC and donation rates. Clinical confounders included (1) hospital-level donor detection by physicians in Spain (34.1 donors pmp) and Portugal (26.7 donors pmp), the only two countries with deceased donation rates higher than the United States (26.3 donors pmp) and (2) hospital-level reimbursement for identifying donors in Belgium (25.6 donors pmp). Cultural confounders included (1) public knowledge about organ donation; (2) well-regarded government sponsored health care bound inextricably to the transplant culture; and (3) a positive relationship between the transplant community and the media. Furthermore, other nonconsent factors have been shown to influence donation, including number and availability of transplantation surgeons, number of intensive care unit beds, and government resources devoted to transplantation (68). Having a PC law may have, in fact, encouraged the development of these programs and policies to make organ donation more likely. Furthermore, as Healy notes, regardless of its level of enforcement, PC may act as a “signaling device” by changing the societal default view that donation is in fact the norm. Furthermore, PC may positively impact the decision making of some families because of the manner in which the donation offer is presented to the family (9). However, participants in our study were reluctant to draw causation, and it is difficult to attribute the development of these programs solely to having a PC policy, mainly because these policies and programs were likely developed in favorable medicopolitical environments for organ donation.

Our study is limited in that all data were self-reported; as such, it is possible that physicians' opinions may not have been accurate reflections of national practices. In addition, our study design was not intended to generate quantifiable data; however, a qualitative approach was essential given the heterogeneous nature of PC systems. We hope that our findings will not only inform future quantitative studies but also facilitate the interpretation of current quantitative studies by providing mechanistic insights. Furthermore, opinions of the participants may have been biased by social desirability, thus undermining inferences about the limited impact of PC legislation. However, participants were generally senior-level transplant physicians and experts about their country's transplant system. As this was a study of European countries with PC, our inferences may not be generalizable to countries outside of Europe. Finally, we were unable to contact participants in six European countries with PC: Bulgaria, Croatia, Latvia, Luxemburg, Slovakia, and Turkey. However, these countries have low donation rates, which may represent underdeveloped transplant infrastructure and hence are less relevant for insights of PC increasing donation rates.

In conclusion, we used in-depth interviews and qualitative analysis to help inform the debate about PC and its relationship to rates of deceased organ donation. Because of the inextricable functional relationship between clinicians and families, and country-specific confounding factors influencing deceased donation rates in high-performing countries, it seems unlikely that PC alone increases donation rates.

Back to Top | Article Outline

MATERIALS AND METHODS

Study Population

We conducted in-depth interviews with participants from European countries with PC legislation. Countries with PC were identified based on previous studies of PC legislation (4, 5). Experts in organ transplantation were selected (purposively sampled) with the goal of identifying a chief-of-transplantation at a major university hospital, a physician who represented his or her country in a leadership position in a national or international transplantation organization or a physician who had published at least three peer-reviewed articles about transplantation in the past 5 years. When needed, potential subjects were identified and recruited with the assistance of other participants or international transplant organizations.

The Johns Hopkins School of Medicine Institutional Review Board approved this research study. All participants consented to be interviewed and to be audio-recorded.

Back to Top | Article Outline
In-Depth Interviews

Participants underwent in-depth telephone interviews in a semistructured manner to understand the application of PC legislation within their country and other country-specific practices or factors that might affect donation rates. A semistructured format was selected so as to systematically explore certain elements (application of the law, role of the family, and country-specific factors contributing to donation rate) within each country, whereas allowing aspects not identified a priori to emerge with the assistance of open-ended questions. Interviews were audiotaped and transcribed after participant consent.

Back to Top | Article Outline
Data Analysis

Transcripts of the in-depth interviews were examined using thematic content methods, a type of qualitative analysis which allows for themes to be systematically generated as transcripts of interviews are reviewed and coded (10). A standard process was used to code quotations into relevant subthemes and then into major themes. To enhance the validity of this methodology, two coinvestigators independently coded transcripts and a third arbitrated in cases of incongruity.

Back to Top | Article Outline
ACKNOWLEDGMENTS

The authors thank all participants for their time and shared wisdom. They also thank The Transplantation Society for their assistance in identifying potential participants.

Back to Top | Article Outline

REFERENCES

1. Bird SM, Harris J. Time to move to presumed consent for organ donation. BMJ 2010; 340: c2188.
2. English V. Is presumed consent the answer to organ shortages? Yes. BMJ 2007; 334: 1088.
3. Rithalia A, McDaid C, Suekarran S, et al.. Impact of presumed consent for organ donation on donation rates: A systematic review. BMJ 2009; 338: a3162.
4. Horvat LD, Cuerden MS, Kim SJ, et al.. Informing the debate: Rates of kidney transplantation in nations with presumed consent. Ann Intern Med 2010; 153: 641.
5. Abadie A, Gay S. The impact of presumed consent legislation on cadaveric organ donation: A cross-country study. J Health Econ 2006; 25: 599.
6. Janssen A, Gevers S. Explicit or presumed consent and organ donation post-mortem: Does it matter? Med Law 2005; 24: 575.
7. Bilgel F. The impact of presumed consent laws and institutions on deceased organ donation. Eur J Health Econ [Epub ahead of print, 2010. doi: 10.1007/s10198-010-0277-8].
8. Wright L. Is presumed consent the answer to organ shortages? No. BMJ 2007; 334: 1089.
9. Healy K. Do presumed consent laws raise organ procurement rates? DePaul Law Review 2006; 55: 1017.
10. Burnard P. A method of analysing interview transcripts in qualitative research. Nurse Educ Today 1991; 11: 461.

Presumed consent; Deceased donation; Policy

© 2012 Lippincott Williams & Wilkins, Inc.