Providing Coverage for the Unique Lifelong Health Care Needs of Living Kidney Donors Within the Framework of Financial Neutrality.

Organ donation should neither enrich donors nor impose financial burdens on them. We described the scope of health care required for all living kidney donors, reflecting contemporary understanding of long-term donor health outcomes; proposed an approach to identify donor health conditions that should be covered within the framework of financial neutrality; and proposed strategies to pay for this care. Despite the Affordable Care Act in the United States, donors continue to have inadequate coverage for important health conditions that are donation related or that may compromise postdonation kidney function. Amendment of Medicare regulations is needed to clarify that surveillance and treatment of conditions that may compromise postdonation kidney function following donor nephrectomy will be covered without expense to the donor. In other countries lacking health insurance for all residents, sufficient data exist to allow the creation of a compensation fund or donor insurance policies to ensure appropriate care. Providing coverage for donation-related sequelae as well as care to preserve postdonation kidney function ensures protection against the financial burdens of health care encountered by donors throughout their lives. Providing coverage for this care should thus be cost-effective, even without considering the health care cost savings that occur for living donor transplant recipients.

Economic consequences incurred by living kidney donors: a Canadian multi-center prospective study.

Some living kidney donors incur economic consequences as a result of donation; however, these costs are poorly quantified. We developed a framework to comprehensively assess economic consequences from the donor perspective including out-of-pocket cost, lost wages and home productivity loss. We prospectively enrolled 100 living kidney donors from seven Canadian centers between 2004 and 2008 and collected and valued economic consequences ($CAD 2008) at 3 months and 1 year after donation. Almost all (96%) donors experienced economic consequences, with 94% reporting travel costs and 47% reporting lost pay. The average and median costs of lost pay were $2144 (SD 4167) and $0 (25th-75th percentile 0, 2794), respectively. For other expenses (travel, accommodation, medication and medical), mean and median costs were $1780 (SD 2504) and $821 (25th-75th percentile 242, 2271), respectively. From the donor perspective, mean cost was $3268 (SD 4704); one-third of donors incurred cost >$3000, and 15% >$8000. The majority of donors (83%) reported inability to perform usual household activities for an average duration of 33 days; 8% reported out-of-pocket costs for assistance with these activities. The economic impact of living kidney donation for some individuals is large. We advocate for programs to reimburse living donors for their legitimate costs.

Income of living kidney donors and the income difference between living kidney donors and their recipients in the United States.

Disincentives for living kidney donation are common but are poorly understood. We studied 54 483 living donor kidney transplants in the United States between 2000 and 2009, limiting to those with valid zip code data to allow determination of median household income by linkage to the 2000 U.S. Census. We then determined the income and income difference of donors and recipients. The median household income in donors and recipients was $46 334 ±$17 350 and $46 439 ±$17 743, respectively. Donation-related expenses consume ≥ 1 month's income in 76% of donors. The mean ± standard deviation income difference between recipients and donors in transplants involving a wealthier recipient was $22 760 ± 14 792 and in 90% of transplants the difference was <$40 000 dollars. The findings suggest that the capacity for donors to absorb the financial consequences of donation, or of recipients to reimburse allowable expenses, is limited. There were few transplants with a large difference in recipient and donor income, suggesting that the scope and value of any payment between donors and recipients is likely to be small. We conclude that most donors and recipients have similar modest incomes, suggesting that the costs of donation are a significant burden in the majority of living donor transplants.

Systematic review: kidney transplantation compared with dialysis in clinically relevant outcomes.

Individual studies indicate that kidney transplantation is associated with lower mortality and improved quality of life compared with chronic dialysis treatment. We did a systematic review to summarize the benefits of transplantation, aiming to identify characteristics associated with especially large or small relative benefit. Results were not pooled because of expected diversity inherent to observational studies. Risk of bias was assessed using the Downs and Black checklist and items related to time-to-event analysis techniques. MEDLINE and EMBASE were searched up to February 2010. Cohort studies comparing adult chronic dialysis patients with kidney transplantation recipients for clinical outcomes were selected. We identified 110 eligible studies with a total of 1 922 300 participants. Most studies found significantly lower mortality associated with transplantation, and the relative magnitude of the benefit seemed to increase over time (p < 0.001). Most studies also found that the risk of cardiovascular events was significantly reduced among transplant recipients. Quality of life was significantly and substantially better among transplant recipients. Despite increases in the age and comorbidity of contemporary transplant recipients, the relative benefits of transplantation seem to be increasing over time. These findings validate current attempts to increase the number of people worldwide that benefit from kidney transplantation.

Bariatric surgery: a systematic review and network meta-analysis of randomized trials.

The clinical efficacy and safety of bariatric surgery trials were systematically reviewed. MEDLINE, EMBASE, CENTRAL were searched to February 2009. A basic PubCrawler alert was run until March 2010. Trial registries, HTA websites and systematic reviews were searched. Manufacturers were contacted. Randomized trials comparing bariatric surgeries and/or standard care were selected. Evidence-based items potentially indicating risk of bias were assessed. Network meta-analysis was performed using Bayesian techniques. Of 1838 citations, 31 RCTs involving 2619 patients (mean age 30-48 y; mean BMI levels 42-58 kg/m(2) ) met eligibility criteria. As compared with standard care, differences in BMI levels from baseline at year 1 (15 trials; 1103 participants) were as follows: jejunoileal bypass [MD: -11.4 kg/m(2) ], mini-gastric bypass [-11.3 kg/m(2) ], biliopancreatic diversion [-11.2 kg/m(2) ], sleeve gastrectomy [-10.1 kg/m(2) ], Roux-en-Y gastric bypass [-9.0 kg/m(2) ], horizontal gastroplasty [-5.0 kg/m(2) ], vertical banded gastroplasty [-6.4 kg/m(2) ], and adjustable gastric banding [-2.4 kg/m(2) ]. Bariatric surgery appears efficacious compared to standard care in reducing BMI. Weight losses are greatest with diversionary procedures, intermediate with diversionary/restrictive procedures, and lowest with those that are purely restrictive. Compared with Roux-en-Y gastric bypass, adjustable gastric banding has lower weight loss efficacy, but also leads to fewer serious adverse effects.

A description of the costs of living and standard criteria deceased donor kidney transplantation.

Kidney transplantation improves quality of life and survival and is associated with lower health care costs compared with dialysis. We described and compared the costs of living and standard criteria for deceased donor kidney transplantation. Patients included adult recipients of a first kidney-only transplant between April 1, 1998, and March 31, 2006, as well as their donor information. All costs (outpatient care, diagnostic imaging, inpatient care, physician claims, laboratory tests and transplant medications) for 2 years after transplant for recipients and transplant-related costs prior to transplant (donor workup and management) were included. Complete cost information was available for 357 recipients. The mean total 2-year cost of transplantation, including donor costs, for recipients of living and deceased donors was $118 347 (95% confidence interval [CI], 110 395-126 299) and $121 121 (95% CI 114 287-127 956), respectively (p = 0.7). The mean cost for a living donor was $18 129 (95% CI 16 845-19 414) and for a deceased donor was $36 989 (95% CI 34 421-39 558). Living donor kidney transplantation has similar costs at 2 years compared with deceased donor transplantation. These results can be used by health care decision makers to inform strategies to increase donation.

The long-term quality of life of living kidney donors: a multicenter cohort study.

Previous studies that described the long-term quality of life of living kidney donors were conducted in single centers, and lacked data on a healthy nondonor comparison group. We conducted a retrospective cohort study to compare the quality of life of 203 kidney donors with 104 healthy nondonor controls using validated scales (including the SF36, 15D and feeling thermometer) and author-developed questions. Participants were recruited from nine transplant centers in Canada, Scotland and Australia. Outcomes were assessed a median of 5.5 years after the time of transplantation (lower and upper quartiles of 3.8 and 8.4 years, respectively). 15D scores (scale of 0 to 1) were high and similar between donors and nondonors (mean 0.93 (standard deviation (SD) 0.09) and 0.94 (SD 0.06), p = 0.55), and were not different when results were adjusted for several prognostic characteristics (p = 0.55). On other scales and author-developed questions, groups performed similarly. Donors to recipients who had an adverse outcome (death, graft failure) had similar quality of life scores as those donors where the recipient did well. Our findings are reassuring for the practice of living transplantation. Those who donate a kidney in centers that use routine pretransplant donor evaluation have good long-term quality of life.

Reimbursing live organ donors for incurred non-medical expenses: a global perspective on policies and programs.

Methods to reimburse living organ donors for the non-medical expenses they incur have been implemented in some jurisdictions and are being considered in others. A global understanding of existing legislation and programs would help decision makers implement and optimize policies and programs. We searched for and collected data from countries that practice living organ donation. We examined legislation and programs that facilitate reimbursement, focusing on policy mechanisms, eligibility criteria, program duration and types of expenses reimbursed. Of 40 countries, reimbursement is expressly legal in 16, unclear in 18, unspecified in 6 and expressly prohibited in 1. Donor reimbursement programs exist in 21 countries; 6 have been enacted in the last 5 years. Lost income is reimbursed in 17 countries, while travel, accommodation, meal and childcare costs are reimbursed in 12 to 19 countries. Ten countries have comprehensive programs, where all major cost categories are reimbursed to some extent. Out-of-country donors are reimbursed in 10 jurisdictions. Reimbursement is conditional on donor income in 7 countries, and recipient income in 2 countries. Many nations have programs that help living donors with their financial costs. These programs differ in operation and scope. Donors in other regions of the world are without support.

Life insurance for living kidney donors: a Canadian undercover investigation.

Some living kidney donors encounter difficulties obtaining life insurance, despite previous surveys of insurance companies reporting otherwise. To better understand the effect of donation on insurability, we contacted offices of life insurance companies in five major cities in Canada to obtain $100 000 of life insurance (20-year term) for 40 fictitious living kidney donors and 40 paired controls. These profiles were matched on age, gender, family history of kidney disease and presence of hypertension. The companies were blinded to data collection. The study protocol was reviewed by the Office of Research Ethics. The main study outcomes were the annual premium quoted and total time spent on the phone with the insurance agent. All donor and control profiles received a quote, with no significant difference in the premium quoted (medians $190 vs. $209, p = 0.89). More time was spent on the phone for donor compared to control profiles, but the absolute difference was small (medians 9.5 vs. 7.0 min, p = 0.046). Age, gender, family history of kidney disease and new-onset hypertension had no further effect on donor insurability in regression analysis. We found no evidence that kidney donors were disadvantaged in the first step of applying for life insurance. The effect donation has on subsequent phases of insurance underwriting remains to be studied.

Deceased organ donation in Canada: an opportunity to heal a fractured system.

There has been no significant increase in the number of deceased organ donors in Canada over the past decade. Canada's donation and transplant system will be restructured with the formation of a new national organization to oversee activity in provincially governed donation and transplantation services. We review the current status of deceased organ donation, highlight issues contributing to the current stagnation in donation and identify changes that will enable success in a new Canadian system. Determining Canada's organ donation performance is difficult because the data required to calculate meaningful metrics of donation performance are not available. Canadians wait longer for transplantation than Americans, and Canada is falling further behind the United States primarily because of fewer donations after cardiac death. The ongoing divide between intergovernmental jurisdictional domains limits national initiatives to improve Canada's donation system. The success of a new national system will be enabled by uniform provincial legislation to ensure that all patients are offered the option to donate, commitment of resources to support organ donation by provincial governments, transparent reporting of comparable metrics of donation performance, establishment of processes to introduce and implement new initiatives and alterations to reimbursement models for organ donation and recovery.

Mortality of Canadians treated by peritoneal dialysis in remote locations.

Patients residing in remote locations may be more likely to initiate peritoneal dialysis when starting renal replacement therapy to avoid relocation. These patients may have reduced access to medical care, however. To examine the hypothesis that patients residing some distance from their nephrologists would be more likely to select peritoneal dialysis but have an increased risk of mortality, we used prospectively collected data in a random sample of 26,775 patients initiating dialysis in Canada between 1990 and 2000. The distance between the patient's residence at dialysis inception and the practice location of their nephrologists was calculated. We used Cox proportional hazard models to determine the adjusted relation between this distance and clinical outcomes over a mean follow-up period of 2.5 years up to 14 years. Remote-dwelling patients were more likely than urban dwellers to commence peritoneal dialysis in distances ranging from 50 to greater than 300 km than those residing within 50 km. The adjusted rates of death and the adjusted hazard ratio among patients initiating peritoneal dialysis was significantly higher in those living further from the nephrologists than those living within 50 km. Further study into the quality of care delivered to remote-dwelling patients on peritoneal dialysis is needed.

Patient and allograft survival of Indo Asian and East Asian dialysis patients treated in Canada.

Kidney failure is relatively common among Canadians of Asian origin. However, little is known about the health outcomes after initiation of renal replacement therapy in this population. Our study evaluates differences in the likelihood of renal transplantation and graft loss among Asian and white patients. We studied 21 523 adults of East Asian, Indo Asian or white ethnicity who had initiated dialysis in Canada from 1990-2000. Subjects were followed until death, loss to follow-up or end of study (2004). The proportion of the eligible subjects who were East Asian, Indo Asian, or white was 6, 3, and 91%, respectively. Compared to white patients, East Asian and Indo Asian patients were significantly less likely to receive a renal transplant after adjusting for potential confounding factors. This disparity is greater for transplants from living donors as compared to those from deceased donors. The adjusted death censored graft loss in transplant recipients was not significantly different between ethnic groups. The adjusted risk of death following transplantation, however, was significantly lower in Indo Asian than in white patients. Our findings show that in a Canadian population, patients of East Asian or Indo Asian origin had lower rates of renal transplantation than white patients, especially for living donor transplantation. These findings warrant further study, especially given the good graft outcomes in these individuals.

Systematic review: renal and other clinically relevant outcomes in hepatorenal syndrome trials.

BACKGROUND: Although reversal of pretransplant renal dysfunction in hepatorenal syndrome reduces post-transplant complications, the overall impact on morbidity and mortality requires clarification. AIM: To review trials of pharmacologic interventions in hepatorenal syndrome, with specific assessment of trial quality and study endpoints, including patient survival and renal outcome measures. METHODS: Literature search and selection was carried out by a single reviewer. Data extraction and quality analysis were carried out by two independent reviewers. RESULTS: Of 848 identified articles, 36 were eligible for inclusion. Twenty-one were full-text. Only 19% were randomized-controlled trials. About 50% of studies included only Type 1 hepatorenal syndrome patients. Serum creatinine, urine output and urine sodium were the most common renal outcome measures. Only 42% defined a primary renal endpoint. About 88% of articles reported mortality rates. CONCLUSIONS: Existing literature of pharmacologic agents for use in hepatorenal syndrome is limited by poor study design, including non-randomization, heterogeneous study populations, lack of power, and limited use of clinically relevant outcomes. There is insufficient information in most trials to judge the impact of pharmacologic therapy on mortality or rates of transplantation. The validity of renal outcome measures as surrogate markers of more clinically relevant endpoints has not been established.

Insurability of living organ donors: a systematic review.

Being an organ donor may affect one's ability to obtain life, disability and health insurance. We conducted a systematic review to determine if insurability is affected by living organ donation, and if concern about insurability affects donor decision making. We searched MEDLINE, EMBASE, SCI, EconLit and Cochrane databases for articles in any language, and reviewed reference lists from 1966 until June 2006. All studies discussing the insurability of living organ donors or its impact on donor decision making were included. Data were independently abstracted by two authors, and the methodological quality appraised. Twenty-three studies, from 1972 to 2006, provided data on 2067 living organ donors, 385 potential donors and 239 responses from insurance companies. Almost all companies would provide life and health insurance to living organ donors, usually with no higher premiums. However, concern about insurability was still expressed by 2%-14% of living organ donors in follow-up studies, and 3%-11% of donors actually encountered difficulties with their insurance. In one study, donors whose insurance premiums increased were less likely to reaffirm their decision to donate. Based on available evidence, some living organ donors had difficulties with insurance despite companies reporting otherwise. If better understood, this potential barrier to donation could be corrected through fair health and underwriting policies.

Economic implications of screening strategies in arteriovenous fistulae.

Practice guidelines recommend performing angiography in arteriovenous fistulae (AVF) when access blood flow (Qa) is < 500 ml/min, but a Qa threshold of <750 ml/min is more sensitive for stenosis. No economic evaluation has evaluated the optimal Qa threshold for angiography in AVF, or Determined whether screening AVF is more economically efficient than intervening only when AVF is thrombosed. We compared two screening strategies using Qa thresholds of <750 and <500 ml/min, respectively, with no access screening. Expected per-patient access-related costs (in 2002 Canadian dollars) were $3910, $5130, and $5250 in the no screening, QA500, and QA750 arms, respectively over 5 years. Notably, screening strategies did not reduce expected access-related costs under any clinically plausible scenario. The cost to prevent one episode of AVF failure appeared to be approximately $8000-$10,000 over 5 years for both screening strategies, compared with no screening. Although the incremental cost effectiveness of screening (compared to no screening) was similar in the base case for the QA500 and QA750 strategies, the relative economic attractiveness of the QA750 strategy was adversely affected under several plausible scenarios. Also, the QA750 strategy would require many additional angiograms to prevent an additional episode of AVF failure compared with the QA500 strategy. Screening of AVF resulted in a modest increase in net costs and seems to require a net expenditure of approximately $9000 to prevent one episode of AVF failure. If screening is adopted, our findings suggest that angiography should be performed when Qa is <500 rather than <750 ml/min, especially when access to angiography is limited.

Association between residence location and likelihood of kidney transplantation in Aboriginal patients treated with dialysis in Canada.

For reasons that are not well understood, Aboriginal people with end-stage renal disease (ESRD) have lower rates of kidney transplantation. We hypothesized that distance between residence location and the closest transplant center was greater in Aboriginal dialysis patients and would partially explain the lower rate of transplantation in this population. We studied a random sample of 9905 patients initiating dialysis in Canada between 1990 and 2000. We calculated the distance between residence location at dialysis inception and the closest transplant center. Cox proportional hazards models were used to examine the relation between residence location and the likelihood of transplantation over a median period of 2.3 years. The proportion of Aboriginal participants living 300 km from the closest transplant center was 25, 18, 18, and 39% respectively, compared with 55, 19, 11, and 15% among white subjects. The relative likelihood of transplantation was significantly lower for Aboriginal compared to white participants across all four distance strata, with no apparent effect of residence location. For example, the relative likelihood of transplantation was hazard ratio (HR) 0.47, 95% confidence interval (CI) (0.31-0.72) in Aboriginal participants residing 300 km from the closest transplant center. Results were similar for transplants from deceased donors and living donors, and in all seven regions studied. In conclusion, remote location of residence does not explain the lower rate of kidney transplantation among Aboriginal people treated for ESRD in Canada.