BACKGROUND:

The gap between the supply of organs available for transplantation and demand is growing, especially among ethnic groups.

OBJECTIVE:

To evaluate the effect of a video designed to address concerns of ethnic groups about organ donation.

DESIGN:

Cluster randomized, controlled trial. Randomization was performed by using a random-number table with centralized allocation concealment. Participants and investigators assessing outcomes were not blinded to group assignment. (ClinicalTrials.gov registration number: NCT00870506)

SETTING:

Twelve branches of the Ohio Bureau of Motor Vehicles in northeastern Ohio.

PARTICIPANTS:

952 participants aged 15 to 66 years.

INTERVENTION:

Video (intervention; n = 443) or usual Bureau of Motor Vehicles license practices (control; n = 509).

MEASUREMENTS:

The primary outcome was the proportion of participants who provided consent for organ donation on a newly acquired driver's license, learner's permit, or state identification card. Secondary outcomes included willingness to make a living kidney donation to a family member in need and personal beliefs about donation.

RESULTS:

More participants who viewed the video consented to donate organs than control participants (84% vs. 72%; difference, 12 percentage points [95% CI, 6 to 17 percentage points]). The video was effective among black participants (76% vs. 54%; difference, 22 percentage points [CI, 9 to 35 percentage points]) and white participants (88% vs. 77%; difference, 11 percentage points [CI, 5 to 15 percentage points]). At the end of the trial, fewer intervention than control participants reported having insufficient information about organ donation (34% vs. 44%; difference, -10 percentage points [CI, -16 to -4 percentage points]), wanting to be buried with all of their organs (14% vs. 25%; difference, -11 percentage points [CI, -16 to -6 percentage points]), and having conflicts with organ donation (7% vs. 11%; difference, -4 percentage points [CI, -8 to -2 percentage points]).

LIMITATION:

How the observed increases in consent to donate organs might translate into a greater organ supply in the region is unclear.

CONCLUSION:

Exposure to a brief video addressing concerns that ethnic groups have about organ donation just before obtaining a license, permit, or identification card increased consent to donate organs among white and black participants.

PRIMARY FUNDING SOURCE:

National Institutes of Health and the Robert Wood Johnson Foundation.

To minimize the health risks faced by living kidney donors, multiple clinical practice guidelines have been developed on the assessment and care of potential donors. This study aims to compare the quality, scope, and consistency of these guidelines. We searched for guidelines on living kidney donation in electronic databases, guideline registries, and relevant Web sites to February 21, 2011. Methodological quality was assessed using the Appraisal of Guidelines for Research and Education (AGREE) instrument. Textual synthesis was used to compare guideline recommendations. Ten guidelines, published from 1996 to 2010, were identified. Although generally comprehensive, scope varied considerably and mostly appeared to lack methodological rigor. Many recommendations were consistent, but important differences were evident, particularly for thresholds for comorbidities which precluded donation; obesity/overweight (body mass index, 30-35 kg/m), diabetes/prediabetes (fasting blood glucose level, 6.1-7.0 mmol/L and oral glucose tolerance test, 7.8-11.1 mmol/L), hypertension (130/85 to 140/90 mm Hg), cardiovascular disease, malignancy, and nephrolithiasis. The importance of informed voluntary consent, genuine motivation, support, and psychological health were recognized but difficult to implement as specific tools for conducting psychosocial assessments were not recommended. Multiple major guidelines for living kidney donation have been published recently, resulting in unnecessary duplicative efforts. Most do not meet standard processes for development, and important recommendations about thresholds for exclusion based on comorbidities are contradictory. There is an urgent need for international collaboration and coordination to ensure, where possible, that guidelines for living donation are consistent, evidence based, and comprehensive to promote best outcomes for a precious resource.

BACKGROUND:

Waiting lists for kidney transplantation continue to grow and live organ donation has become more important as the number of brain stem dead cadaveric organ donors continues to fall. The major disincentive to potential kidney donors is the pain and morbidity associated with open surgery.

OBJECTIVES:

To identify the benefits and harms of using laparoscopic compared to open nephrectomy techniques to recover kidneys from live organ donors.

SEARCH METHODS:

We searched the online databases CENTRAL (in The Cochrane Library 2010, Issue 2), MEDLINE (January 1966 to January 2010) and EMBASE (January 1980 to January 2010) and handsearched textbooks and reference lists.

SELECTION CRITERIA:

Randomised controlled trials comparing laparoscopic donor nephrectomy (LDN) with open donor nephrectomy (ODN).

DATA COLLECTION AND ANALYSIS:

Two review authors independently screened titles and abstracts for eligibility, assessed study quality, and extracted data. We contacted study authors for additional information where necessary.

MAIN RESULTS:

Six studies were identified that randomised 596 live kidney donors to either LDN or ODN arms. All studies were assessed as having low or unclear risk of bias for selection bias, allocation bias, incomplete outcome data and selective reporting bias. Four of six studies had high risk of bias for blinding. Various different combinations of techniques were used in each study, resulting in heterogeneity in the results. The conversion rate from LDN to ODN ranged from 1% to 1.8%. LDN was generally found to be associated with reduced analgesia use, shorter hospital stay, and faster return to normal physical functioning. The extracted kidney was exposed to longer warm ischaemia periods (2 to 17 minutes) with no associated short-term consequences. ODN was associated with shorter duration of procedure. For those outcomes that could be meta-analysed there were no significant differences between LDN or ODN for perioperative complications (RR 0.87, 95% CI 0.47 to 4.59), reoperations (RR 0.57, 95% CI 0.09 to 3.64), early graft loss (RR 0.31, 95% CI 0.06 to 1.48), delayed graft function (RR 1.09, 95% CI 0.52 to 2.30), acute rejection (RR 1.41, 95 % CI 0.87 to 2.27), ureteric complications (RR 1.51, 95% CI 0.69 to 3.31), kidney function at one year (SMD 0.15, 95% CI -0.11 to 0.41) or graft loss at one year (RR 0.76, 95% CI 0.15 to 3.85).

AUTHORS' CONCLUSIONS:

LDN is associated with less pain compared with open surgery; however, there are equivalent numbers of complications and occurrences of perioperative events that require further intervention. Kidneys obtained using LDN procedures were exposed to longer warm ischaemia periods than ODN-acquired grafts, although this has not been reported as being associated with short-term consequences.

BACKGROUND:

Live kidney transplantation (LKT) is underutilized, particularly among ethnic/racial minorities. The effectiveness of culturally sensitive educational and behavioral interventions to encourage patients' early, shared (with family and health care providers) and informed consideration of LKT and ameliorate disparities in consideration of LKT is unknown.

METHODS/DESIGN:

We report the protocol of the Talking About Live Kidney Donation (TALK) Study, a two-phase study utilizing qualitative and quantitative research methods to design and test culturally sensitive interventions to improve patients' shared and informed consideration of LKT. Study Phase 1 involved the evidence-based development of culturally sensitive written and audiovisual educational materials as well as a social worker intervention to encourage patients' engagement in shared and informed consideration of LKT. In Study Phase 2, we are currently conducting a randomized controlled trial in which participants with progressing chronic kidney disease receive: 1) usual care by their nephrologists, 2) usual care plus the educational materials, or 3) usual care plus the educational materials and the social worker intervention. The primary outcome of the randomized controlled trial will include patients' self-reported rates of consideration of LKT (including family discussions of LKT, patient-physician discussions of LKT, and identification of an LKT donor). We will also assess differences in rates of consideration of LKT among African Americans and non-African Americans.

DISCUSSION:

The TALK Study rigorously developed and is currently testing the effectiveness of culturally sensitive interventions to improve patients' and families' consideration of LKT. Results from TALK will provide needed evidence on ways to enhance consideration of this optimal treatment for patients with end stage renal disease.

TRIAL REGISTRATION:

ClinicalTrials.gov number, NCT00932334.

CONTEXT:

Many transplant candidates have concerns about living donation.

OBJECTIVE:

To determine whether a structured educational session increased eligible kidney transplant candidates' pursuit of living donation.

DESIGN AND INTERVENTION:

Eligible transplant candidates were randomized to standard of care (n = 50) or to the educational intervention (n = 50), which included both written materials and a 2-hour education session. The primary outcome was having a living donor contact the transplant program to express interest in donation for a patient, and a secondary outcome was the candidates' preference for treatment of end-stage renal disease; both outcomes were determined at 3 months after enrollment.

RESULTS:

Of the 100 patients randomized, 4 in the intervention group and 2 in the standard of care group had a living donor contact the program (P = .45). Within-group changes in treatment preference from baseline were seen in the education intervention group (P = .02), but not in the standard of care group (P = .37).

CONCLUSIONS:

This educational intervention did not increase the likelihood of a potential donor contacting the transplant program, compared with standard care. However, patients who received the educational intervention were more likely to change their treatment preference to living donation at study completion. Research investigating other methods of increasing living transplant rates is urgently required.

Dietary restriction (DR), defined as reduced energy intake without malnutrition, confers protection against renal ischemia and reperfusion injury in animal models. This pilot study investigates for the first time the feasibility of pre-operative DR in the clinical setting. Live-kidney donors were randomized between pre-operative DR or ad libitum intake. Seventeen participants were instructed to follow a 30% calorie-restricted diet, followed by one day of water-only fasting prior to surgery. Thirteen participants were allowed to eat ad libitum pre-operatively. Ninety-four percent of the donors adhered to the diet, 31.4% reduction in caloric intake was achieved. Post-operative well-being, appetite and ability to perform daily tasks were not different between both groups. There was no difference in post-transplant graft function of kidneys obtained from DR donors or control donors as determined by serum creatinine levels during the first post-operative month and renograms at post-operative day one. This study shows that mild dietary restriction is feasible in the setting of live-kidney donation. No effect was observed regarding post-operative graft function. Additional studies are warranted to investigate the appropriate regimen of dietary restriction to protecting against ischemia and reperfusion injury, such as increasing the magnitude and/or duration of the reduction in daily caloric intake.

American Transplant Congress, April 30 - May 4 2011, Philadelphia

Long-term physical and psychosocial effects of laparoscopic and open kidney donation are ill defined. We performed long-term follow-up of 100 live kidney donors, who had been randomly assigned to mini-incision open donor nephrectomy (MIDN) or laparoscopic donor nephrectomy (LDN). Data included blood pressure, glomerular filtration rate, quality of life (SF-36), fatigue (MFI-20) and graft survival. After median follow-up of 6 years clinical and laboratory data were available for 47 donors (94%) in both groups; quality of life data for 35 donors (70%) in the MIDN group, and 37 donors (74%) in the LDN group. After 6 years, mean estimated glomerular filtration rates did not significantly differ between MIDN (75 mL/min) and LDN (76 mL/min, p = 0.39). Most dimensions of the SF-36 and MFI-20 did not significantly differ between groups at long-term follow-up, and most scores had returned to baseline. Twelve percent of the donors reported persistent complaints, but no major complications requiring surgical intervention. Five-year death-censored graft survival was 90% for LDN, and 85% for MIDN (p = 0.50). Long-term outcome of live kidney donation is excellent from the perspective of both the donor and the recipient.