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NDT Advance Access originally published online on March 22, 2006
Nephrology Dialysis Transplantation 2006 21(7):1952-1960; doi:10.1093/ndt/gfl069
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© The Author [2006]. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved. For Permissions, please email: journals.permissions@oxfordjournals.org

Original Articles: Dialysis and Transplantation

The direct and indirect economic costs incurred by living kidney donors—a systematic review

Katherine S. Clarke1, Scott Klarenbach2,3, Sorina Vlaicu4,5, Robert C. Yang1, Amit X. Garg1,5,6 for the Donor Nephrectomy Outcomes Research (DONOR) Network

1 Division of Nephrology, University of Western Ontario, London, 2 Division of Nephrology, University of Alberta, Edmonton, Canada, 3 Institute of Health Economics, Edmonton, 4 Department of Political Science, University of Western Ontario, Ontario, 5 Department of Epidemiology and Biostatistics, University of Western Ontario, London and 6 Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Canada

Correspondence and offprint requests to: Dr Amit Garg, Kidney Clinical Research Unit, Room ELL-101, London Health Sciences Centre, 800 Commissioners Road East, London, Ontario N6A 4G5, Canada. Email: amit.garg{at}lhsc.on.ca



   Abstract
Top
 Abstract
Introduction
 Methods
 Results
 Direct costs
 Indirect costs
 Discussion
 References
 
Background. Despite the many benefits of living donor kidney transplantation, economic consequences can result for donors. We reviewed studies which quantified the direct and indirect costs incurred by living kidney donors, in order to understand the strengths and limitations of existing literature.

Methods. We identified relevant studies in MEDLINE, EMBASE and ECONOLIT bibliographic databases, in the Science Citation Index and study reference lists. Any study which reported at least one cost relevant to donors was included. The accuracy of abstracted data was verified by two reviewers and reported in year 2004 US dollars.

Results. Thirty-five studies from 12 countries described costs incurred by individuals who donated between the years 1964 and 2003. No study comprehensively quantified all relevant expenses—the sum of select costs considered in one US study averaged $837 per donor and ranged from $0 to 28 906. Travel and/or accommodation costs were incurred by 9–99% of donors, and were higher in countries with a larger land mass. Post-discharge analgesics were required by 4–24% of donors, but prescription costs were not reported. Between 14 and 30% of donors incurred costs for lost income, with an average loss of $3386 in one study from the UK and $682 in another study from the Netherlands. Costs for dependent care were incurred by 9–44% of donors, while costs for domestic help were incurred by 8% of donors.

Conclusions. Donors incur many types of costs attributable to kidney donation and the total costs are certainly higher than previously reported. To guide informed consent and fair reimbursement policies, further data on all relevant costs, preferably from a detailed prospective multi-centre cohort study, are required.

Keywords: health economics; living kidney donors; reimbursement; systematic review



   Introduction
Top
 Abstract
 Introduction
Methods
 Results
 Direct costs
 Indirect costs
 Discussion
 References
 
Despite the many benefits of living donor kidney transplantation, economic consequences can result for donors. While expenditures for medical evaluation, surgery and hospital care are generally covered through public or private insurance, donors are often responsible for other costs associated with the donation process [1,2]. The prevalence of economic hardship amongst some living kidney donors is well recognized by members of the transplantation field. Major international organizations have moved towards acceptance of reimbursement and now distinguish commercial trade in organs from the reimbursement of ‘out of pocket’ expenses. In a policy developed in 2002, the Council of Europe defined both concepts. While it is unethical for any party participating in the procedure to financially benefit from the process, the additional protocol identified forms of payment not considered financial gain, such as compensation for loss of earnings and other fees [3]. The World Medical Association, at the 52nd General Assembly in Edinburgh in October 2000, also made similar statements: ‘payment for organs and tissues for donation and transplantation should be prohibited’, but ‘... reasonable reimbursement of expenses such as those incurred in procurement, transport, processing, preservation, and implantation’ should be allowed [4]. The American Medical Association's Council on Ethics and Judicial Affairs followed suit by amending Opinion E-2.15, in June 2004, to specifically address living donors: ‘It is not ethical to participate in a procedure to enable a living donor to receive payment, other than for the reimbursement of expenses necessarily incurred in connection with removal, for any of the donor's solid organs’. Thus, as nations now consider new approaches to increase organ donation and transplantation, many have relaxed regulations to allow living donors to be reimbursed for incurred expenses [5]. Comprehensively understanding the economic consequences faced by donors, including the economic impact, monetary value and timing of incurred expenses is essential to the process of informed consent and to the creation of fair and sustainable programmes for reimbursement. Here, we reviewed existing quantitative data on the direct and indirect costs incurred by living kidney donors, in order to understand the strengths and limitations of existing literature and to guide future research.



   Methods
Top
 Abstract
 Introduction
 Methods
Results
 Direct costs
 Indirect costs
 Discussion
 References
 
Definitions
We identified all categories of costs relevant to donors using our collective clinical experience, extensive cost lists [6–8], and previous literature [1,2]. Identified costs were then refined and expanded using detailed information provided through correspondence with 16 transplantation experts from 10 countries. The resulting cost framework is presented in Table 1. Direct costs were defined as those incurred because of resources consumed. Categories of direct costs included out-of-pocket expenses for travel, accommodation, long-distance phone calls, and incidental medical fees, such as post-discharge medication. Indirect costs were defined as those incurred due to lost productivity either at work, or in and around the home. Categories of indirect costs included lost income and additional out-of-pocket expenses for help with dependent care, housework, and other domestic activities.


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  		Table 1. The direct and indirect costs incurred by living kidney donorsa

 
Research questions
The primary questions of this review were directed at quantifying the economic impact, monetary value and timing of donors’ direct and indirect costs: economic impact: (1a) What percentage of donors incur overall costs as a result of donation?; (1b) What percentage of donors incur each direct and indirect cost as a result of donation?; monetary value: (2a) What is the monetary value of the total costs incurred by donors?; (2b) What is the monetary value of each direct and indirect cost incurred by donors?; timing: (3a) How many times do donors incur each direct and indirect cost?; (3b) Over what duration of time do donors incur each direct and indirect cost?

Studies eligible for review
We included studies written in English, which assessed five or more living kidney donors and reported impact, monetary or time data related to our research questions. Hospitalization alone was measured in numerous studies, but duration of hospital stay alone has little impact on the economic consequences to the donor. As reviewing all of these studies would not have influenced the results, we excluded studies that reported length of hospital stay and no other data of interest.

Selection of studies
We searched MEDLINE, EMBASE and ECONOLIT bibliographic databases until May 2005. The search strategy was comprised of the terms live or living kidney donor or donation, and out-of-pocket costs or expenses (full strategy available from authors upon request). Full-text articles were retrieved for all citations eligible for review and considered potentially relevant. When data from the same group of donors were presented in multiple publications, the most comprehensive was cited, and all others were reviewed [9–16]. As a final step in the selection process, the Science Citation Index, the PubMed ‘see related articles’ feature, and the reference lists from all included studies were used to locate additional citations.

Data extraction and analysis
Impact, monetary and time data from each included study were extracted and analysed by one reviewer (KC) and independently confirmed by a second reviewer (RY). Other data extracted and analysed were: primary location, aim, methods, surgical approach, donor response rate and donor recall time (i.e. the period of time over which donors were asked to remember costs incurred as a result of donation). Monetary data were assigned a currency year, which corresponded to the average year of donation in each study. Historical currency conversions to US dollars were then performed, followed by consumer price index conversions to change all monetary data to 2004 US dollars. For all data types, average values generally refer to mean values. Where mean values were not presented in studies, median values were substituted.



   Results
Top
 Abstract
 Introduction
 Methods
 Results
Direct costs
 Indirect costs
 Discussion
 References
 
Selected studies
After screening over 3000 citations, 84 full-text articles were retrieved. Inclusion and exclusion criteria were then applied, resulting in 35 studies being summarized in the review.

Description of studies
Table 2 summarizes the key characteristics of the 35 studies while Table 3 depicts the data types reported in each study. Overall, 35 studies from 12 countries described cost data for individuals who donated between the years 1964 and 2003, and were published between the years 1986 and 2005. Most studies were conducted in the USA (n = 17) [17–33], followed by Germany (n = 3) [34–36], Britain (n = 3) [37–39], Australia (n = 2) [40,41], Canada (n = 2) [42,43], the Netherlands (n = 2) [44,45], Iran (n = 1) [46], Japan (n = 1) [47], Norway (n = 1) [48], Spain (n = 1) [49], Sweden (n = 1) [50], and Switzerland (n = 1) [51]. Relative economic impact data were reported in 14 studies [20,22,25,31,32,34,36,38,40,42,43,47–49], monetary value data in 5 [23,26,32,38,45], and data on the timing of donor costs in 25 [17–19,21–30,33,35,37,39–41,44,46,48–51]. In only four of the 35 studies was the analysis of costs incurred by donors a primary aim [32,36,38,45]. Donor costs were considered in an additional 16 studies, secondary to the assessment of other medical and psychosocial outcomes [20,22,23,25,27,31,34,35,40–43,47–49,51]. Nearly all economic impact and monetary value data were obtained from the aforementioned 20 studies. The remaining 15 studies were comparative evaluations of open vs laparoscopic surgical approaches, in which donor costs were also a secondary aim of each study. These 15 studies provided the majority of data regarding the timing of donor costs [17–19,21,24,26,28–30,33,37,39,44,46,50].


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  		Table 2. Characteristics of studies quantifying the direct and indirect costs incurred by living kidney donors

 

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  		Table 3. Impact, monetary and time data considered in studies quantifying the costs incurred by living kidney donors [1,2]

 
Quality of studies
Of the 35 studies, 30 were conducted retrospectively and assessed historical donors [17–24,26,27,29,31–45,47–49,51]. Studies employed a variety of data collection methods. In some cases, several methods were combined to increase donor-response rates or data accuracy. Donor surveys developed by the primary authors and administered through the mail were most common. Other strategies included the review of hospital records, and informal telephone, personal and group interviews. When reported, response rates for donors considered eligible for study ranged from 45 to 100% [17,20–23,25–27,31–36,39,40,42–44,47–51], while donor recall times ranged from 8 weeks to 9 years [21,24,36,49,51]. No prospective study had donors document their incurred costs by saving and submitting receipts, or by recording their experiences in a diary. None of the studies that analysed total costs explicitly stated which individual cost categories were accounted for. Furthermore, none of the studies that specifically analysed individual categories of direct and indirect costs provided a complete definition of the cost category to describe where, when and why donors incurred it. In 5 of the 35 studies, donors were reimbursed for reported costs either in full, or in part, through existing reimbursement programmes. In two such studies, the analysis of donors’ out-of-pocket costs was conducted to evaluate the coverage of existing reimbursement programmes, although in both, it was unclear whether all donors were 100% reimbursed [38,45]. Another two studies reported the percentage of donors who relied on various means of support to defray costs associated with donation, some of which were forms of reimbursement (through sick leave, vacation time, insurance and community organizations) [25,32]. However, it was not specified whether cost data reported in these two studies included or excluded reimbursed out-of-pocket expenses. Only a single study indicated that none of the donors who reported incurred costs received any reimbursement [49].

Overall costs
A total of 11 studies collected data on the overall costs donors incurred. These studies did not report data for individual cost categories, and no study comprehensively quantified all relevant expenses. Ten studies from seven countries found that an average 9 to 45% of living kidney donors incurred at least some costs as a result of donation [22,31,32,34,36,40,42,47–49]. Three studies, all from the USA, measured their summed value. In the first, overall costs ranged from $0 to 28 906, with an average of $837 per donor [22]. Average overall costs in the second was $107, however values ranged from $0 to 13 788 and 8% of donors assumed overall costs greater than $1724 [32]. The third study compared laparoscopic surgery with open nephrectomy costs. Donors’ personal costs with the open approach were an average of $3089±2354 overall, and $907±579 with the laparoscopic approach [26].



   Direct costs
Top
 Abstract
 Introduction
 Methods
 Results
 Direct costs
Indirect costs
 Discussion
 References
 
Travel and accommodation
Four studies considered donors’ travel and accommodation costs. In one, 9% of living kidney donors at a UK transplant centre incurred an average of $1720 for travel and accommodation combined, while costs incurred by individual donors ranged from $76 to 12 579 [38]. In contrast, a study from Canada, a country with a large land mass, reported that 53% of donors were affected by transportation and parking costs [43]. A third study from multiple centres in USA found that almost all donors experienced travel and accommodation costs. Transportation costs were claimed by 99% of donors in this study, while 88% declared costs for lodging. Demographic data revealed that 32% of donors in this US study had travelled from outside the state [25]. A fourth study only assessed foreign donors, who accounted for 8% of those to visit a transplant centre in the Netherlands. Non-resident donors incurred an average cost of $946 for travel and accommodation, which was comprised of: $22 for visa, $544 for travel, $55 for insurance and $325 for living expenses [45]. Limited information on the number of times donors were required to travel was available in an additional study [17]. Specifically, US donors required an average 3–4 physician office visits following discharge [17].

Medical
No study clearly documented the percentage of donors who incurred incidental medical costs, or the monetary value of such costs. A study from Canada, where provincial health plans cover evaluation, surgery and hospitalization fees, identified that 8% of donors encountered additional personal medical costs, however, the contributing charges were not clarified [43]. Some data on the extent and duration of post-discharge medication use were available. A study from Australia reported that 20% of donors endured operative site pain for several months and relied on mild analgesics as a result [40]. In a comparative study from USA, and one from Sweden, 4–24% of donors still required pain medication after an elapsed recovery period of 1 month [28,50]. Total durations of outpatient analgesic use were reported in three studies from USA and one from Iran. In total, prescription and/or over-the-counter pain medications were used for an average of 1–20 days outside of hospital [17,21,29,46].



   Indirect costs
Top
 Abstract
 Introduction
 Methods
 Results
 Direct costs
 Indirect costs
Discussion
 References
 
Lost income
Three studies, one each from Canada, UK and USA, reported that 14–30% of living kidney donors incurred costs for lost income [22,38,43]. In addition, one study from Australia and another from Germany, reported that physical limitations following surgery caused 3% of donors to either be fired or resign from previously held employment [34,40]. A US study found that over the long term, donors were 37% less likely than non-donors to have growth in household income [20]. The monetary value of donors’ lost earnings was determined in only two studies. Average losses were $3386 in a UK study [38] and $682 in a study from the Netherlands [45]. Length of hospital stay and/or leave from employment was documented in 27 studies, most of which were from the USA. Overall, average hospitalization lasted 2–13 days [18,19,21,23,24,26–30,33,35,37,39,40,46,48,49,51], while return to work occurred after an average leave of 16–105 days [17–19,21,24–30,33,37–39,41,44,49–51]. Two studies surveyed donors’ return to work in greater detail. In one, return to part-time work occurred after an average of 22 days [17], while in the second, return to physically demanding work occurred after an average of 41–57 days [29].

Lost home productivity
Two studies, one from Canada and the second from USA, found that 9–44% of donors incurred dependent-care costs [43,25]. The former also documented that 8% of living kidney donors incurred costs for domestic help [43]. A third study reported that help with personal care was needed by 30–55% of donors for an average of 2–12 days post-discharge [21]. No study measured the monetary value of fees paid for any form of hired assistance. Average times to resume various productive activities in and around the home were reported in eight studies. Care for others was recommenced after an average of 13–22 days [21,29]. Donors began to perform housework after an average of 7–34 days [18,19,21,29]. Shopping was continued after an average of 7–35 days [18,21,29,39], and driving after an average of 11–42 days [18,19,21,29,33,46,39].



   Discussion
Top
 Abstract
 Introduction
 Methods
 Results
 Direct costs
 Indirect costs
 Discussion
References
 
Donors incur many types of costs attributable to kidney donation, however no study to date has quantified all relevant expenses. In some studies, single cost categories were found to cause economic impact for nearly all donors surveyed [25], costs were found to be of significant value [22], and donors reported being out of work, or unable to perform productive daily activities for lengthy periods of time [39,44]. Given that true costs are certainly higher than reported, further data on all relevant expenses, preferably from a detailed prospective cohort study of a representative number of countries, are now required. Such data would be used to improve informed consent prior to donation, and guide the development of sustainable programmes which fairly reimburse donors for their out of pocket expenses.

Limitations of existing literature
This review was the first to assemble and analyse quantitative data on the direct and indirect costs incurred by living kidney donors because of donation. We highlight limitations in the quantity and quality of data reported in the primary studies.

First, cost data were incomplete. No economic impact or monetary value data were available for incidental medical expenses, and no monetary value data were available for lost productivity in and around the home. Long-distance telephone charges were a cost category identified in our framework as relevant to donors, but were not quantified in any study. Other costs largely not quantified were those that were incurred over the long term. With a single exception [20], all costs described accumulated within the year in which the donation occurred. However, long-term costs may incur many years after donation, including incremental increases in insurance premiums and expenses related to medical conditions suffered over time as a consequence of donation (e.g. anti-depressant medication costs for donors who develop depression after graft or recipient loss). Moreover, information necessary to precisely convert reported monetary data to current US dollars was missing in all cases. Conservative estimates of currency year were used, which likely led to lower values being reported. Finally, it is probable that an overall lack of methodological precision in the studies corresponded to an incomplete capture of data for the costs reported. It was unclear how overall costs were summated. Studies did not identify which cost categories were accounted for, nor did they define whether their calculations included or excluded reimbursed expenses. Similar problems were encountered for studies that reported on specific categories of costs. In most studies, the related expenses comprising each cost category were not identified, and again, studies did not define whether their calculations included or excluded reimbursed expenses.

Second, the majority of studies were conducted retrospectively, and data were collected by having donors recall historically incurred costs. The years of donation spanned 1964–2003, yet no study was published before 1986. Of the five studies that reported donor recall time, four asked at least some donors to remember costs incurred 12 months prior or longer. The longest reported recall time was 9 years [34]. Research suggests that after 12 months, recalled personal costs are likely to be underestimated [52] and a 90 day timeframe may be more ideal to capture self-reported information on costs incurred [53]. Retrospective approaches to data collection may also lead to erroneous results, as they cannot accommodate for secular changes, including those within the economy, or the field of kidney transplantation. Factors such as inflation and the development of new donation protocols, use of laparoscopy, and policies for partial reimbursement make historical cost data less applicable and possibly inconclusive for modern day donors.

Lastly, most studies were only concerned with the costs incurred specifically by donors themselves, however other individuals involved with the process of living kidney donation often experience costs as well. Persons who volunteer to donate, but do not proceed with donation, experience out-of-pocket expenses during the evaluation phase. Also, family members, spouses or friends who support donors by providing accompaniment to the transplant centre and care during convalescence may incur many of the costs that are relevant to donors. Only one study captured the costs of potential donors who did not donate [45]. Mean expenses in this group were $24 for visa, $400 for travel and $12 for insurance. Similarly, only one study measured the out-of-pocket expenses of persons who provided support to donors, with 9.7% of donors’ family members reporting lost wages [43]. Otherwise, the incurred costs of both potential donors and donors’ primary support persons were not reported or discussed. Not considering these additional expenses underestimates the overall economic impact of living kidney donation on donor families.

Informed consent and the development of reimbursement policies
Prospective donors must be fully aware of the economic consequences of donation, alongside all risks, in order to prepare and plan for the personal costs they may encounter. Furthermore, comprehension of the percentage of donors impacted by costs, the monetary value of these costs, and their expected timing is essential for choosing and implementing the most appropriate strategy to develop and allocate programme funds for reimbursement. Reimbursement options currently being considered by various countries include government grants, tax incentives, paid leave programmes, social assistance, and unemployment insurance. The current movement towards donor reimbursement is motivated by two main factors. The first is the belief that reimbursing donors for their out-of-pocket costs, a concept different from payment for financial gain, is just. The second is the scarce availability of kidneys combined with the growing need for transplantation. As a result, numerous efforts are underway to identify and remove potential barriers to living kidney donation. Surveys of the general public [54,55], potential donors [56], and actual donors [57] have identified economic disincentives as a potential worry when deciding whether to donate. Fair donor reimbursement policies may help remove this perceives barrier to living kidney donation, although whether this will truly increase rates of transplantation remains to be seen.

Donor Nephrectomy Outcome Research (DONOR) Network Investigators: Neil Boudville, Larry Chan, Amit Garg, Colin Geddes, Eric Gibney, John Gill, Martin Karpinski, Scott Klarenbach, Greg Knoll, Norman Muirhead, Chirag Parikh, Ramesh Prasad, Leroy Storlsey, Sudha Tata, Darin Treleaven, Robert Yang.



   Acknowledgments
 
We acknowledge the work of Jan Challis, MLIS who provided administrative help. We thank the experts from the transplantation field who generously shared their knowledge about the direct and indirect costs incurred by living kidney donors, especially Jennifer Cross our living donor nurse co-ordinator. This review was supported by the Canadian Institutes of Health Research (CIHR) and the Canadian Council for Donation and Transplantation. Dr Garg was supported by a CIHR Clinician Scientist Award.

Conflict of interest statement. None declared.

(See related article by Jacobs. Nephrol Dial Transplant 2006; 21:1764–1765.)



   References
Top
 Abstract
 Introduction
 Methods
 Results
 Direct costs
 Indirect costs
 Discussion
 References
 

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Received for publication: 4.11.05
Accepted in revised form: 6. 2.06


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