Evaluating multiple living kidney donor candidates simultaneously is more cost-effective than sequentially.

When multiple living donor candidates come forward to donate a kidney to the same recipient, some living donor programs evaluate one candidate at a time to avoid unnecessary evaluations. Evaluating multiple candidates concurrently rather than sequentially may be cost-effective from a societal perspective if it reduces the time recipients spend on dialysis. We used a simple decision tree to estimate the cost-effectiveness of evaluating two to four candidates simultaneously rather than sequentially as potential kidney donors for the same intended recipient. Evaluating two donor candidates simultaneously cost $1,266 (CAD) more than if they were evaluated sequentially, but living donation occurred one month earlier. This translated into $6,931 in averted dialysis costs and a total cost-savings of $5,665 per intended recipient. Simultaneous evaluations also resulted in one percent more living donor transplants and overall gains in quality-of-life as recipients spent less time on dialysis. If recipients were free from dialysis at the start of donor candidate evaluations, simultaneous evaluations also reduced the rate of dialysis initiation by two percent. Benefits were also observed in the three- and four-candidate scenarios. Thus, living donor programs should consider evaluating up to four living donor candidates simultaneously when they come forward for the same recipient as health care system costs incurred are more than offset by avoided dialysis costs.

Financial Costs Incurred by Living Kidney Donors: A Prospective Cohort Study.

BACKGROUND: Approximately 40% of the kidneys for transplant worldwide come from living donors. Despite advantages of living donor transplants, rates have stagnated in recent years. One possible barrier may be costs related to the transplant process that potential willing donors may incur for travel, parking, accommodation, and lost productivity. METHODS: To better understand and quantify the financial costs incurred by living kidney donors, we conducted a prospective cohort study, recruiting 912 living kidney donors from 12 transplant centers across Canada between 2009 and 2014; 821 of them completed all or a portion of the costing survey. We report microcosted total, out-of-pocket, and lost productivity costs (in 2016 Canadian dollars) for living kidney donors from donor evaluation start to 3 months after donation. We examined costs according to (1) the donor's relationship with their recipient, including spousal (donation to a partner), emotionally related nonspousal (friend, step-parent, in law), or genetically related; and (2) donation type (directed, paired kidney, or nondirected). RESULTS: Living kidney donors incurred a median (75th percentile) of $1254 ($2589) in out-of-pocket costs and $0 ($1908) in lost productivity costs. On average, total costs were $2226 higher in spousal compared with emotionally related nonspousal donors (P=0.02) and $1664 higher in directed donors compared with nondirected donors (P<0.001). Total costs (out-of-pocket and lost productivity) exceeded $5500 for 205 (25%) donors. CONCLUSIONS: Our results can be used to inform strategies to minimize the financial burden of living donation, which may help improve the donation experience and increase the number of living donor kidney transplants.

Direct and indirect costs incurred by Australian living kidney donors.

AIM: To describe the direct and indirect costs incurred by Australian living kidney donors. METHODS: A total of 55 living kidney donors from three centres in Perth, Australia and one centre in Melbourne, Australia (2010-2014) was studied. Forty-nine donors provided information on expenses incurred during the donor evaluation period and up to 3 months after donation. A micro-costing approach was used to measure and value the units of resources consumed. Expenses were grouped as direct costs (ground and air travel, accommodation, and prescription medications) and indirect costs (lost wages and lost productivity). Costs were standardized to the year 2016 in Australian dollars. RESULTS: The most common direct costs were for ground travel (100%), parking (76%), and post-donation pain medications or antibiotics (73%). The highest direct costs were for air travel (median $1986 [three donors]) and ground travel (median $459 [49 donors]). Donors also reported lost wages (median $9891 [37 donors]). The inability to perform household activities or care for dependants were reported by 32 (65%) and 23 (47%) donors. Total direct costs averaged $1682 per donor (median $806 among 49 donors). Total indirect costs averaged $7249 per donor (median $7273 among 49 donors). Total direct and indirect costs averaged $8932 per donor (median $7963 among 49 donors). CONCLUSION: Many Australian living kidney donors incur substantial costs during the donation process. Our findings inform the continued development of policies and programmes designed to minimize costs incurred by living kidney donors.

Determining the research priorities for patients with chronic kidney disease not on dialysis.

BACKGROUND: The importance of engaging key stakeholders, and patients in particular, in determining research priorities has been recognized. We sought to identify the top 10 research priorities for patients with non-dialysis chronic kidney disease (CKD), their caregivers, and the clinicians and policy-makers involved in their care. METHODS: We used the four-step James Lind Alliance process to establish the top 10 research priorities. A national survey of patients with non-dialysis CKD (estimated glomerular filtration rate <45 mL/min/1.73 m 2 ), their caregivers, and the clinicians and policy-makers involved in their care was conducted to identify research uncertainties. A Steering Group of patients, caregivers, clinicians and researchers combined and reduced these uncertainties to 30 through a series of iterations. Finally, a workshop with participants from across Canada (12 patients, 6 caregivers, 3 physicians, 2 nurses, 1 pharmacist and 1 policy-maker) was held to determine the top 10 research priorities, using a nominal group technique. RESULTS: Overall, 439 individuals responded to the survey and identified 1811 uncertainties, from which the steering group determined the top 30 uncertainties to be considered at the workshop. The top 10 research uncertainties prioritized at the workshop included questions about treatments to prevent progression of kidney disease (including diet) and to treat symptoms of CKD, provider- and patient-targeted strategies for managing CKD, the impact of lifestyle on disease progression, harmful effects of medications on disease progression, optimal strategies for treatment of cardiovascular disease in CKD and for early identification of kidney disease, and strategies for equitable access to care for patients with CKD. CONCLUSIONS: We identified the top 10 research priorities for patients with CKD that can be used to guide researchers, as well as inform funders of health-care research.

Patient Education and Peritoneal Dialysis Modality Selection: A Systematic Review and Meta-analysis.

BACKGROUND: Educational interventions are increasingly used to promote peritoneal dialysis (PD), the most common form of home therapy for end-stage renal disease. A systematic review of the evidence in support of dialysis modality education is needed to inform the design of patient-targeted interventions to increase selection of PD. We performed a systematic review and meta-analysis to characterize the relationship between patient-targeted educational interventions and choosing and receiving PD. STUDY DESIGN: Systematic review and meta-analysis. SETTING & POPULATION: Published original studies and abstracts. SELECTION CRITERIA FOR STUDIES: We searched MEDLINE, EMBASE, CINAHL and EBMR. We included controlled observational studies and randomized trials of educational interventions designed to increase PD selection. INTERVENTION: Predialysis educational interventions. OUTCOMES: The primary outcome was choosing PD, defined as intention to use PD regardless of whether PD was ever used. The secondary outcome, receiving PD, was defined as an individual receiving PD as his or her treatment. RESULTS: Of 3,540 citations, 15 studies met our inclusion criteria, including 1 randomized trial. In the single randomized trial (N=70), receipt of an educational intervention was associated with a more than 4-fold increase in the odds of choosing PD (OR, 4.60; 95% CI, 1.19-17.74). Based on results from 4 observational studies (N=7,653), patient-targeted educational interventions were associated with a 2-fold increase in the odds of choosing PD (pooled OR, 2.15; 95% CI, 1.07-4.32; I(2)=76.7%). Based on results from 9 observational studies (N=8,229), patient-targeted educational intervention was associated with a 3-fold increase in the odds of receiving PD as the initial treatment modality (OR, 3.50; 95% CI, 2.82-4.35; I(2)=24.9%). LIMITATIONS: Most studies were observational studies, which can establish an association between education and choosing PD or receiving PD, but does not establish causality. CONCLUSIONS: This systematic review demonstrates a strong association between patient-targeted education interventions and the subsequent choice and receipt of PD.

Determining research priorities through partnership with patients: an overview.

There is an increasing level of emphasis being placed on health care providers and funders to incorporate patient-centered care into research. Involving patients and caregivers in establishing research priorities ensures the relevance of the research produced. Priority setting is a process that can be used to produce a robust set of research questions that researchers can address over the coming years. One of the methods for determining research priorities that involves patients, caregivers and clinicians is the James Lind Alliance priority setting partnership model. This method is focused on being exclusive, transparent, and evidence-based. Using a recent example of patients on or nearing dialysis, we highlight the key steps to assess research priorities in patients, caregivers and clinicians: (i) formation of a steering committee to guide the overall process; (ii) form priority setting partnerships; (iii) identify and gather research uncertainties; (iv) process and collate submitted research uncertainties; and (v) final priority setting workshop to determine the top 10 research priorities.

Financial incentives to increase Canadian organ donation: quick fix or fallacy?

Unlike the United States, the potential to increase organ donation in Canada may be sufficient to meet the need for transplantation. However, there has been no national coordinated effort to increase organ donation. Strategies that do not involve payment for organs, such as investment in health care resources to support deceased donor organ donation and introduction of a remuneration framework for the work of deceased organ donation, should be prioritized for implementation. Financial incentives that may be permitted under existing legislation and that pose little risk to existing donation sources should be advanced, including the following: payment of funeral expenses for potential donors who register their decision on organ donation during life (irrespective of the decision to donate or actual organ donation) and removal of disincentives for directed and paired exchange living donation, such as payment of wages, payment for pain and suffering related to the donor surgery, and payment of directed living kidney donors for participation in Canada's paired exchange program. In contrast, it would be premature to contemplate a regulated system of organ sales that would require a paradigm shift in the current approach to organ donation and legislative change to implement.

A synthesis of drug reimbursement decision-making processes in organisation for economic co-operation and development countries.

BACKGROUND: The use of a restrictive formulary, with placement determined through a drug-reimbursement decision-making process, is one approach to managing drug expenditures. OBJECTIVE: To describe the processes in drug reimbursement decision-making systems currently used in national publicly funded outpatient prescription drug insurance plans. METHODS: By using the Organisation for Economic Co-operation and Development (OECD) nations as the sampling frame, a search was done in the published literature, followed by the gray literature. Collected data were verified by a system expert within the prescription drug insurance plan in each country to ensure the accuracy of key data elements across countries. RESULTS: All but one country provided at least one publicly funded prescription drug formulary. Many systems have adopted similar processes of drug reimbursement decision making. All but three systems required additional consideration of clinical evidence within the decision-making process. Transparency of recommendations varied between systems, from having no information publicly available (three systems) to all information available and accessible to the public (16 systems). Only four countries did not consider cost within the drug reimbursement decision-making process. CONCLUSIONS: There were similarities in the decision-making process for drug reimbursement across the systems; however, only five countries met the highest standard of transparency, requirement of evidence, and ability to appeal. Future work should focus on examining how these processes may affect formulary listing decisions for drugs between countries.

The cost of kidney transplant over time.

BACKGROUND: Kidney transplant improves quality of life and survival compared with dialysis. Despite advances in immunosuppressant regimens and the prevention and treatment of acute rejection, graft survival rates have not improved significantly in the past decade. Although the clinical effectiveness of these regimens has been studied, the impact of changes over time on cost has not. METHODS: Costs of kidney transplant were compared between 2 periods demarcated by a programmatic change from cyclosporine (early) to tacrolimus (late) and from nonroutine induction (early) to routine induction (late) therapy in adult patients receiving a first kidney-only transplant in Calgary, Alberta, Canada, in an 8-year period. RESULTS: Complete costs for 3 years after transplant was available for 344 patients, including 161 adult recipients in the early period (April 1, 1998-December 31, 2001) and 183 adult recipients in the late period (January 1, 2002-March 31, 2006). The mean total 3-year cost of transplant for recipients was Can$100 034 in the early period and Can$144 712 in the late period largely attributed to increases in the cost of immunosuppressants (P< .001). CONCLUSIONS: Given that the cost of transplant has increased significantly over time, the cost-effectiveness of these and other immunosuppressive regimens should be evaluated carefully.

Remdesivir for Hospitalized COVID-19 Patients in the United States: Optimization of Health Care Resources.

INTRODUCTION: In addition to significant morbidity and mortality, the coronavirus disease (COVID-19) has strained health care systems globally. This study investigated the cost-effectiveness of remdesivir + standard of care (SOC) for hospitalized COVID-19 patients in the USA. METHODS: This cost-effectiveness analysis considered direct and indirect costs of remdesivir + SOC versus SOC alone among hospitalized COVID-19 patients in the US. Patients entered the model stratified according to their baseline ordinal score. At day 15, patients could transition to another health state, and on day 29, they were assumed to have either died or been discharged. Patients were then followed over a 1-year time horizon, where they could transition to death or be rehospitalized. RESULTS: Treatment with remdesivir + SOC avoided, per patient, a total of 4 hospitalization days: two general ward days and a day for both the intensive care unit and the intensive care unit plus invasive mechanical ventilation compared to SOC alone. Treatment with remdesivir + SOC presented net cost savings due to lower hospitalization and lost productivity costs compared to SOC alone. In increased and decreased hospital capacity scenarios, remdesivir + SOC resulted in more beds and ventilators being available versus SOC alone. CONCLUSIONS: Remdesivir + SOC alone represents a cost-effective treatment for hospitalized patients with COVID-19. This analysis can aid in future decisions on the allocation of healthcare resources.

A Critical Appraisal of Matching-Adjusted Indirect Comparisons in Spinal Muscular Atrophy.

In the absence of head-to-head trials, indirect treatment comparisons (ITCs) are often used to compare the efficacy of different therapies to support decision-making. Matching-adjusted indirect comparison (MAIC), a type of ITC, is increasingly used to compare treatment efficacy when individual patient data are available from one trial and only aggregate data are available from the other trial. This paper examines the conduct and reporting of MAICs to compare treatments for spinal muscular atrophy (SMA), a rare neuromuscular disease. A literature search identified three studies comparing approved treatments for SMA including nusinersen, risdiplam, and onasemnogene abeparvovec. The quality of the MAICs was assessed on the basis of the following principles consolidated from published MAIC best practices: (1) justification for the use of MAIC is clearly stated, (2) the included trials with respect to study population and design are comparable, (3) all known confounders and effect modifiers are identified a priori and accounted for in the analysis, (4) outcomes should be similar in definition and assessment, (5) baseline characteristics are reported before and after adjustment, along with weights, and (6) key details of a MAIC are reported. In the three MAIC publications in SMA to date, the quality of analysis and reporting varied greatly. Various sources of bias in the MAICs were identified, including lack of control for key confounders and effect modifiers, inconsistency in outcome definitions across trials, imbalances in important baseline characteristics after weighting, and lack of reporting key elements. These findings highlight the importance of evaluating MAICs according to best practices when assessing the conduct and reporting of MAICs.

Cost-effectiveness analysis of HIV pre-exposure prophylaxis in Japan.

BACKGROUND: While global efforts have been made to prevent transmission of HIV, the epidemic persists. Men who have sex with men (MSM) are at high risk of infection. Despite evidence of its cost-effectiveness in other jurisdictions, pre-exposure prophylaxis (PrEP) for MSM is neither approved nor reimbursed in Japan. METHOD: The cost-effectiveness analysis compared the use of once daily PrEP versus no PrEP among MSM over a 30-year time horizon from a national healthcare perspective. Epidemiological estimates for each of the 47 prefectures informed the model. Costs included HIV/AIDS treatment, HIV and testing for sexually transmitted infections, monitoring tests and consults, and hospitalization costs. Analyses included health and cost outcomes, as well as the incremental cost-effectiveness ratio (ICER) reported as the cost per quality-adjusted life year (QALY) for all of Japan and each prefecture. Sensitivity analyses were performed. FINDINGS: The estimated proportion of HIV infections prevented with the use of PrEP ranged from 48% to 69% across Japan, over the time horizon. Cost savings due to lower monitoring costs and general medical costs were observed. Assuming 100% coverage, for Japan overall, daily use of PrEP costs less and was more effective; daily use of PrEP was cost-effective at a willingness to pay threshold of ¥5,000,000 per QALY in 32 of the 47 prefectures. Sensitivity analyses found that the ICER was most sensitive to the cost of PrEP. INTERPRETATION: Compared to no PrEP use, once daily PrEP is a cost-effective strategy in Japanese MSM, reducing the clinical and economic burden associated with HIV.

HIV remains an epidemic, and men who have sex with men (MSM) are at higher risk of infection. Pre-exposure prophylaxis (PrEP) is a preventive treatment that can reduce someone's risk of getting infected with HIV and has been shown to provide good value for money. PrEP, however, is neither approved nor reimbursed in Japan. In order to determine the value for money in Japan, an economic model was developed to estimate the number of HIV infections and AIDS cases that could be avoided, along with whether daily use of PrEP among MSM in Japan is cost effective. Findings showed that with use of daily PrEP, the proportion of HIV infections and AIDS cases prevented was 63% and 59%, respectively, across Japan. Over a 30-year time horizon, daily use of PrEP would cost the health system less and be more effective than no use of PrEP. Daily PrEP should therefore be considered for reimbursement in MSM in Japan, given its value for money.

The cost-effectiveness of non-invasive stool-based colorectal cancer screening offerings from age 45 for a commercial and medicare population.

AIM: The United States Preventive Services Taskforce (USPSTF) recently recommended lowering the age for average-risk colorectal cancer (CRC) screening from 50 to 45 years. While initiating screening at age 45 versus 50 provides a greater opportunity for CRC early detection and prevention, the full profile of benefits, risks, and cost-effectiveness of expanding the screen-eligible population requires further evaluation. MATERIALS AND METHODS: The costs and clinical outcomes for screening at age 45 for triennial multi-target stool DNA [mt-sDNA], and other non-invasive stool-based modalities (annual fecal immunochemical test [FIT] and annual fecal-occult blood test [FOBT]), were estimated using the validated CRC-AIM microsimulation model over a lifetime horizon. Test sensitivity and specificity inputs were based on 2021 USPSTF modeling analyses; adherence rates were based on published real-world data and the costs of the screening test, follow-up colonoscopies, complications, and CRC care were included. Outcomes are reported from the perspective of a United States payer as clinical, life-years gained (LYG), and incremental cost-effectiveness ratio (ICER); stool-based and follow-up colonoscopy adherence ranges were explored in one-way, probabilistic and threshold analyses. RESULTS: When compared to initiation of CRC screening at age 45 versus 50, all modalities reduced both the incidence of and mortality from CRC and increased LYG. Initiating CRC screening at age 45 was cost-effective with an ICER of $59,816 and $35,857 per quality-adjusted life year (QALY) for mt-sDNA versus FIT and FOBT, respectively. In the threshold analyses, at equivalent rates to stool-based screening, mt-sDNA was always cost-effective at a willingness-to-pay threshold of $100,000 per QALY versus FIT and FOBT. CONCLUSIONS: Initiating average-risk CRC screening at age 45 instead of age 50 increases the estimated clinical benefit by reducing disease burden while remaining cost-effective. Among stool-based screening modalities, mt-sDNA provides the most clinical benefit in a Commercial and Medicare population.

Screening for colorectal cancer at an earlier age can provide additional benefits in terms of reducing disease complications and death. This study looked at the occurrence of disease complications and costs related to different types of colorectal cancer screening in 45 vs. 50 year old people. A model that has previously been used to project lifetime costs and disease complications in people receiving colorectal cancer screening was used in this study. We found that beginning screening at age 45 as compared to at age 50 reduced disease complications and death. In people who started screening at age 45, one particular screening type (multitarget stool DNA) was found to provide better economic value to a greater degree relative to other strategies. These findings were consistent even when many inputs into the model were changed over reasonable ranges. Therefore, our study helps show that starting screening in people at age 45 with average risk for developing colorectal cancer is beneficial by reducing disease complications and deaths, and that multitarget stool DNA is the strategy that provides the most benefits while being economically justifiable.

Lessons learned from the Alberta Border Testing Pilot Program.

Background: During the Coronavirus disease (COVID-19) pandemic, countries implemented border control and quarantine measures to reduce transmission. The Alberta Border Testing Pilot Program (ABTPP) allowed international travellers entering Alberta to reduce their quarantine period following two negative COVID-19 tests. We evaluated participant experiences with the ABTPP and implementation. Method: We used a parallel convergent mixed-methods design to explore participant experiences through electronic web-based questionnaires (n = 21,089; n = 13,839) and semi-structured telephone interviews (n = 30). We evaluated implementation through three staff focus groups (n = 11). We analysed questionnaires using descriptive statistics and analysed interviews using inductive and deductive thematic analysis. We deductively coded focus group data using the 2009 Consolidated Framework for Implementation Research (CFIR). Results: Questionnaires indicated minimal issues with registration forms (91.7%), symptom reports (95.5%), and COVID-19 testing (95.7%). Most respondents (95.1%) expressed willingness to participate in the ABTPP again. Interviews revealed three themes related to participant experience: program efficiency, clarity of information, and requisite effort. Focus groups identified key implementation facilitators including the single health information system, strong stakeholder partnerships, and good communication across partnerships. Barriers included program complexity, implementation timeline, and evolving external context. Discussion: Participants reported high satisfaction with the ABTPP. Border testing programs should have high efficiency, require low effort, and use messaging that is clear and consistent. The effective implementation of border testing programs may be facilitated by strong leadership, adaptability, automated components, good communication, and simple technology. Learnings from participants and staff may help improve the implementation of border control programs for future pandemics or other emergencies. Conclusions: The ABTTP was a novel border control measure during the COVID-19 pandemic. Our evaluation of both participant and staff experiences demonstrated high levels of traveller satisfaction and identified areas for improvement that can inform the development of future border control measures.

Exploring the treatment gap among patients with osteoporosis-related fractures in France.

The use of anti-osteoporosis treatment following a diagnosis of osteoporosis with fracture or a relevant fragility fracture remains low in France. Initiating an anti-resorptive may reduce the incidence of a subsequent fracture by 60%. PURPOSE: To describe real-world osteoporosis treatment patterns in individuals with a fragility fracture in France and to explore the impact of initiating treatment on the risk of subsequent fracture. METHODS: A retrospective cohort study, using the national French Health Insurance claims database. Males and females 50 years and over, with a hospital discharge diagnosis of osteoporosis with fracture or a relevant fragility fracture between 2011 and 2014, were included and followed until death or the end of 2016, whichever came first. The primary outcome was the proportion of patients receiving anti-osteoporosis treatments prior to and post-index fracture. Change in fracture rates before and after treatment initiation was assessed in an exploratory analysis. RESULTS: A total of 574,133 patients (138,567 males, 435,566 females) had a qualifying index fracture. The proportion of patients receiving any anti-osteoporosis treatment increased pre-index fracture to post-index fracture from 2.2 to 5.6% among males, and from 11.8 to 18.2% among females. Oral bisphosphonates were the most prescribed anti-osteoporosis treatment for both males and females among post-index fractures (60.6% and 68.8% of patients initiating treatment). Following initiation of anti-resorptives, the incidence of subsequent fracture was reduced by 60% (rate ratio (RR): 0.40, 95% confidence interval [CI]: 0.34-0.45). CONCLUSION: Anti-osteoporosis treatment following an index fracture in France remains low. Improved identification and pharmacologic management of patients at risk of fragility fractures are necessary to reduce the risk of subsequent fractures.

Barriers to living kidney donation identified by eligible candidates with end-stage renal disease.

BACKGROUND: Among eligible transplant candidates with end-stage renal disease, only a minority receive a living donor kidney transplant (LDKT), suggesting that there are barriers to receipt of this optimal therapy. METHODS: A validated questionnaire was administered to adults active on the deceased donor transplant waiting list, identified from the Southern Alberta Renal Program database. The questionnaire included both quantitative and qualitative items addressing issues related to LDKT in the categories of knowledge, opportunity, fear and guilt. RESULTS: Of the 196 subjects invited to complete the questionnaire, 145 (74%) responded. Not knowing how to ask someone for their kidney was the most frequently reported barrier, identified by 71% of respondents. Those that stated that living donation did not pose significant long-term health risks to the donor [odds ratio (OR)=3.40, 95% CI 1.17-9.46, P=0.01] and those who understood how and why to begin the living donation process (OR=4.21, 95% CI 1.41-12.04, P=0.002) were more likely to have discussed living donation with potential donors. CONCLUSIONS: Knowledge about living donation was associated with having discussed living donation with a family member or friend. Studies examining the impact of educational programmes which address these barriers to living donor kidney transplantation are required.

Evaluation of an electronic warfarin nomogram for anticoagulation of hemodialysis patients.

BACKGROUND: Warfarin nomograms to guide dosing have been shown to improve control of the international normalized ratio (INR) in the general outpatient setting. However, the effectiveness of these nomograms in hemodialysis patients is unknown. We evaluated the effectiveness of anticoagulation using an electronic warfarin nomogram administered by nurses in outpatient hemodialysis patients, compared to physician directed therapy. METHODS: Hemodialysis patients at any of the six outpatient clinics in Calgary, Alberta, treated with warfarin anticoagulation were included. Two five-month time periods were compared: prior to and post implementation of the nomogram. The primary endpoint was adequacy of anticoagulation (proportion of INR measurements within range ± 0.5 units). RESULTS: Overall, 67 patients were included in the pre- and 55 in the post-period (with 40 patients in both periods). Using generalized linear mixed models, the adequacy of INR control was similar in both periods for all range INR levels: in detail, range INR 1.5 to 2.5 (pre 93.6% (95% CI: 88.6% - 96.5%); post 95.6% (95% CI: 89.4% - 98.3%); p = 0.95); INR 2.0 to 3.0 (pre 82.2% (95% CI: 77.9% - 85.8%); post 77.4% (95% CI: 72.0% - 82.0%); p = 0.20); and, INR 2.5 to 3.5 (pre 84.3% (95% CI: 59.4% - 95.1%); post 66.8% (95% CI: 39.9% - 86.0%); p = 0.29). The mean number of INR measurements per patient decreased significantly between the pre- (30.5, 95% CI: 27.0 - 34.0) and post- (22.3, 95% CI: 18.4 - 26.1) (p = 0.003) period. There were 3 bleeding events in each of the periods. CONCLUSIONS: An electronic warfarin anticoagulation nomogram administered by nurses achieved INR control similar to that of physician directed therapy among hemodialysis patients in an outpatient setting, with a significant reduction in frequency of testing. Future controlled trials are required to confirm the efficacy of this nomogram.

The effect of nocturnal and conventional hemodialysis on markers of nutritional status: results from a randomized trial.

OBJECTIVE: More frequent dialysis may improve nutrition and remove dietary restrictions in hemodialysis (HD) patients. We present results from a trial comparing nutritional parameters between nocturnal hemodialysis (NHD) and conventional HD patients. METHODS: Patients were randomized to conventional thrice weekly HD or NHD for a 6-month study period. Dietary intake was recorded by patients using a 3-day food record at baseline and study exit. RESULTS: Of 51 patients, 23 completed baseline and exit food records and were included in the analysis. Although dietary intake of calcium, potassium, and lipids increased in the NHD group, serum levels of calcium and potassium remained within target limits. The majority of NHD subjects were able to reduce or discontinue their phosphate binders and maintain serum phosphate levels within target limits. Serum albumin improved among the NHD group (0.7 g/L) and declined for the conventional group (-1.6 g/L). None of the between group differences achieved statistical significance. CONCLUSIONS: As compared with conventional dialysis, NHD was associated with a nonstatistically significant increase in dietary intake for some nutrients, with maintenance of serum levels for potassium, calcium, and phosphorus. Whether increased dietary intake translates into improvement in morbidity and mortality remains to be determined.