Lucy D. Horvat, MSc; Meaghan S. Cuerden, MSc; S. Joseph Kim, MD, PhD; John J. Koval, PhD; Ann Young, PhD; Amit X. Garg, MD, PhD
Disclaimer: The opinions, results, and conclusions reported in this article are those of the authors and are independent of the funding sources, organizations, or nations cited in this report.
Acknowledgment: The authors thank Salimah Shariff, BMath; Amanda Rosenblum, BHSc; Arsh Jain, MD; Kathy Speechley, PhD; William Wall, MD; and Dan Hackam, MD, PhD, at the University of Western Ontario for their help.
Grant Support: By research funds from the Canadian Institutes of Health Research. Ms. Horvat was supported by a Schulich Graduate Scholarship from the University of Western Ontario and a research award from the Lawson Health Research Institute. Ms. Cuerden was supported by a National Sciences and Engineering Research Council of Canada Doctoral Scholarship. Drs. Kim and Garg were supported by Clinician Scientist Awards from the Canadian Institutes of Health Research. Dr. Young was supported by a Canadian Institutes of Health Research Doctoral Award.
Potential Conflicts of Interest: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M10-1562.
Reproducible Research Statement:Study protocol, statistical code, and data set: Available from Dr. Garg (e-mail, email@example.com) until 31 December 2015.
Requests for Single Reprints: Amit X. Garg, MD, PhD, London Kidney Clinical Research Unit, Room ELL-101, Westminster, London Health Sciences Centre, 800 Commissioners Road East, London, Ontario N6A 4G5, Canada; e-mail, firstname.lastname@example.org.
Current Author Addresses: Ms. Horvat, Ms. Cuerden, and Drs. Young and Garg: Room ELL-101, Kidney Clinical Research Unit, London Health Sciences Centre, 800 Commissioners Road East, London, Ontario N6A 4G5, Canada.
Dr. Kim: Division of Nephrology and the Kidney Transplant Program, Toronto General Hospital, University Health Network, Faculty of Medicine, University of Toronto, 585 University Avenue, CSB 11C-1183 Toronto, Ontario M5G 2N2, Canada.
Dr. Koval: Department of Epidemiology and Biostatistics, University of Western Ontario, London, Ontario N6A 5C1, Canada.
Author Contributions: Conception and design: L.D. Horvat, A.X. Garg.
Analysis and interpretation of the data: L.D. Horvat, M.S. Cuerden, S.J. Kim, J.J. Koval, A. Young, A.X. Garg.
Drafting of the article: L.D. Horvat, A.X. Garg.
Critical revision of the article for important intellectual content: L.D. Horvat, S.J. Kim, J.J. Koval, A. Young, A.X. Garg.
Final approval of the article: L.D. Horvat, S.J. Kim, J.J. Koval, A. Young, A.X. Garg.
Statistical expertise: M.S. Cuerden, S.J. Kim, J.J. Koval, A. Young.
Obtaining of funding: L.D. Horvat, J.J. Koval, A.X. Garg.
Administrative, technical, or logistic support: L.D. Horvat, A. Young, A.X. Garg.
Collection and assembly of data: L.D. Horvat.
Horvat L., Cuerden M., Kim S., Koval J., Young A., Garg A.; Informing the Debate: Rates of Kidney Transplantation in Nations With Presumed Consent. Ann Intern Med. 2010;153:641-649. doi: 10.7326/0003-4819-153-10-201011160-00006
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Published: Ann Intern Med. 2010;153(10):641-649.
The kidney is the most common transplanted organ, accounting for almost all living donor transplantations and most deceased donor organ transplantations. The organ shortage has caused policymakers in many nations to debate the merits of adopting presumed consent legislation as a way to increase donor organ donation from deceased donors.
To compare characteristics and kidney transplantation rates for countries with presumed consent for deceased organ donation with countries with explicit consent.
A longitudinal study of international kidney transplantation from 1997 to 2007.
44 nations performing kidney transplantation.
Recipients of deceased and living kidney donor transplants.
Rates of transplantation of kidneys from deceased and living donors.
National characteristics, such as population size, proportion of the population self-identified as Catholic, per capita gross domestic product, health expenditures, and physician density, varied widely for the 22 nations with presumed consent and the 22 nations with explicit consent. Deceased donor kidney transplantation rates were higher in nations with presumed consent (median, 22.6 transplantations per million population [pmp]; interquartile range [IQR], 9.3 to 33.8) versus nations with explicit consent (median, 13.9 transplantations pmp; IQR, 3.6 to 23.1). Living donor kidney transplantation rates were lower in nations with presumed consent (median, 2.4 transplantations pmp; IQR, 1.7 to 4.3) versus nations with explicit consent (median, 5.9 transplantations pmp; IQR, 2.3 to 12.2). The findings were consistent when nations were classified according to per capita gross domestic product, health expenditures, and physician density.
As with any observational study, associations may not be causal.
Nations with presumed consent have higher rates of deceased donor kidney transplantation than nations with explicit consent. Any nation deciding to adopt presumed consent should carefully consider and reduce any negative effect on rates of living donation.
Canadian Institutes of Health Research and Lawson Health Research Institute.
Amer A. Alkhatib
Department of Medicine, University of Utah
November 30, 2010
Presumed Consent versus Explicit Consent for Organ Donation in USA
TO THE EDITOR:
I read with interest the study done by Dr Horvat et al regarding the presumed vs. the explicit consent for organ donation(1). The presumed consent is a very controversial issue. Organ donation has shown an increase over the last 10 years but the equation between donors and recipients still remains unbalanced. The shortage in organ donation caught the attention of media. Recently Apple CEO Steve Jobs joined Governor Aronld Schwarzenegger to push organ donor registry(2). New York Assemblyman Richard Brodsky's controversial presumed consent legislation was discussed in media extensively. Nevertheless, the legislation was attacked by many groups and was considered inappropriate(3).
As a physician treatung patients with chronic liver disease and liver transplantation, I appreciate any novel idea that would potentially decrease the annual loss of 1500-2000 souls on the liver transplant list due to organ shortage(4). In the USA, donated livers are allocated based on MELD score which is dependent on the results of INR, serum creatinine and total bilirubin. One suggestion is to assign some priority by giving few extra MELD points for organ donors or their first degree relatives should organ donors need liver transplant in the future. Currently only 40% of general population of USA are donors(4). This translates to around 6000 deceased donors yearly (4). Thus if donation rate increased significantly, the mortality on the waiting list would almost be eliminated.
The simplest equation that explain human behavior is Performance = Ability X Motivation(5) The motivation can be altruism, financial which is very controversial ethical issue in transplant or assigning a higher priority on the transplant list for the donors or their families. Since Ability is a constant in the equation above, we should focus more on improving the public motivation for organ donation. When altruism is not enough to drive people to donate their organs, we should start to explore other methods to motivate the 60% of USA population to move to the donors side. Recently, when the government obligated people to have a health insurance, it mounted a huge public and political resistance. With the multicultural society we live in and the different interests groups that exist, imposing explicit consent would be very challenging in the USA.
1. Horvat LD, Cuerden MS, Kim SJ, Koval JJ, Young A, Garg AX. Informing the debate: rates of kidney transplantation in nations with presumed consent. Ann Intern Med;153(10):641-9.
2. Krieger LM. Apple CEO Steve Jobs joins Schwarzenegger to push organ donor registry. The Mercury News. Vol. 2010; 2010.
3. New York - NY Assemblyman Launches Campaign To Halt 'presumed consent legislation' (Accessed 05-04-2010, at http://www.vosizneias.com/54628/2010/05/03/new-york-ny-assemblyman- launches-campaign-to-halt-presumed-consent-legislation/.)
4. Lai M. Do we need to change our national organ donation policy? Hepatology;51(5):1479-82.
5. Kerr S. Ultimate rewards : what really motivates people to achieve [Boston, MA: Harvard Business School Press]; 1997 A Harvard business review book).
Yorick J. de Groot
Erasmus MC University Medical Center, Rotterdam
December 13, 2010
Is the succes of presumed consent for organ donation generalizable?
TO THE EDITOR: We read with great interest the article of Horvat and colleagues (1) concerning the rates of kidney transplantation in nations with presumed consent. Although we applaud the initiative to investigate this much debated and delicate topic we have some concerns about the methodology, the practical implementation of the consent legislation, and the conclusions.
The authors report that crude rates of deceased donor kidney transplantation were higher in countries with presumed consent; rates of living donor donations were higher in nations with explicit consent. There are however several differences between the compared groups, such as the mean population and the gross domestic product. The authors make an attempt to account for these differences by making comparisons stratified for each of these characteristics. This is insufficient for several reasons. First, each stratification accounts for just one characteristic, e.g. only gross domestic product. If each characteristic account for part of the differences in donation rates between explicit and presumed consent, comparisons stratified for only one characteristic will still be confounded by other characteristics. A second methodological concern is that some of the strata are very small, containing only 1 or 2 countries. Since there is also an enormous difference in the donation rates (less then 1 million inhabitants - to almost 50) the estimated rates within the strata are very unstable. For these reasons we believe that regression analysis would have been preferable. Although we agree with the authors that 44 countries is a too low number to do extensive multivariable analysis, we feel that some attempt to a multivariable model should have been made. This model could include only characteristics found to be related to donation rates (health care expenditures, gross domestic product and physicians numbers) and still would account more comprehensive for the differences between countries than stratification by a single characteristic does.
With regard to the practical implications of the consent legislation, presumed consent and actual consent are two completely different entities. For instance Spain, with the highest donating rate of deceased organ donors of the world, adopted the concept of presumed consent in 1979. In practice however the actual decision about organ donation rests with the potential donor's family, which makes the actual difference with explicit consent small. (2)
With these considerations in mind we feel that the conclusions of this paper should have been less firm.
1. Horvat LD, Cuerden MS, Kim SJ, Koval JJ, Young A, Garg AX. Informing the debate: rates of kidney transplantation in nations with presumed consent. Ann Intern Med. 2010;153(10):641-9.
2. Fabre J, Murphy P, Matesanz R. Presumed consent: a distraction in the quest for increasing rates of organ donation. BMJ. 2010;341:c4973.
Lucy D. Horvat
From University of Western Ontario, London
February 9, 2011
Response to Letter to the Editor: De Groot
The outcomes of deceased and living transplants were adjusted for gross domestic product, healthcare expenditures, and mean physician density.
1. Rithalia A, McDaid C, Suekarran S, Myers L, Sowden A. Impact of presumed consent for organ donation on donation rates: a systematic review. BMJ 2009;338:a3162.
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