Buttonhole versus Stepladder Cannulation for Home Hemodialysis: A Multicenter, Randomized, Pilot Trial.

BACKGROUND AND OBJECTIVES: Canadian home hemodialysis guidelines highlight the potential differences in complications associated with arteriovenous fistula (AVF) cannulation technique as a research priority. Our primary objective was to determine the feasibility of randomizing patients with ESKD training for home hemodialysis to buttonhole versus stepladder cannulation of the AVF. Secondary objectives included training time, pain with needling, complications, and cost by cannulation technique. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: All patients training for home hemodialysis at seven Canadian hospitals were assessed for eligibility, and demographic information and access type was collected on everyone. Patients who consented to participate were randomized to buttonhole or stepladder cannulation technique. Time to train for home hemodialysis, pain scores on cannulation, and complications over 12 months was recorded. For eligible but not randomized patients, reasons for not participating in the trial were documented. RESULTS: Patient recruitment was November 2013 to November 2015. During this time, 158 patients began training for home hemodialysis, and 108 were ineligible for the trial. Diabetes mellitus as a cause of ESKD (31% versus 12%) and central venous catheter use (74% versus 6%) were more common in ineligible patients. Of the 50 eligible patients, 14 patients from four out of seven sites consented to participate in the study (28%). The most common reason for declining to participate was a strong preference for a particular cannulation technique (33%). Patients randomized to buttonhole versus stepladder cannulation required a shorter time to complete home hemodialysis training. We did not observe a reduction in cannulation pain or complications with the buttonhole method. Data linkages for a formal cost analysis were not conducted. CONCLUSIONS: We were unable to demonstrate the feasibility of conducting a randomized, controlled trial of buttonhole versus stepladder cannulation in Canada with a sufficient number of patients on home hemodialysis to be able to draw meaningful conclusions.

Hypertension Canada's 2017 Guidelines for Diagnosis, Risk Assessment, Prevention, and Treatment of Hypertension in Adults.

Hypertension Canada provides annually updated, evidence-based guidelines for the diagnosis, assessment, prevention, and treatment of hypertension. This year, we introduce 10 new guidelines. Three previous guidelines have been revised and 5 have been removed. Previous age and frailty distinctions have been removed as considerations for when to initiate antihypertensive therapy. In the presence of macrovascular target organ damage, or in those with independent cardiovascular risk factors, antihypertensive therapy should be considered for all individuals with elevated average systolic nonautomated office blood pressure (non-AOBP) readings ≥ 140 mm Hg. For individuals with diastolic hypertension (with or without systolic hypertension), fixed-dose single-pill combinations are now recommended as an initial treatment option. Preference is given to pills containing an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker in combination with either a calcium channel blocker or diuretic. Whenever a diuretic is selected as monotherapy, longer-acting agents are preferred. In patients with established ischemic heart disease, caution should be exercised in lowering diastolic non-AOBP to ≤ 60 mm Hg, especially in the presence of left ventricular hypertrophy. After a hemorrhagic stroke, in the first 24 hours, systolic non-AOBP lowering to < 140 mm Hg is not recommended. Finally, guidance is now provided for screening, initial diagnosis, assessment, and treatment of renovascular hypertension arising from fibromuscular dysplasia. The specific evidence and rationale underlying each of these guidelines are discussed.

Hypertension Canada's 2016 Canadian Hypertension Education Program Guidelines for Blood Pressure Measurement, Diagnosis, Assessment of Risk, Prevention, and Treatment of Hypertension.

Hypertension Canada's Canadian Hypertension Education Program Guidelines Task Force provides annually updated, evidence-based recommendations to guide the diagnosis, assessment, prevention, and treatment of hypertension. This year, we present 4 new recommendations, as well as revisions to 2 previous recommendations. In the diagnosis and assessment of hypertension, automated office blood pressure, taken without patient-health provider interaction, is now recommended as the preferred method of measuring in-office blood pressure. Also, although a serum lipid panel remains part of the routine laboratory testing for patients with hypertension, fasting and nonfasting collections are now considered acceptable. For individuals with secondary hypertension arising from primary hyperaldosteronism, adrenal vein sampling is recommended for those who are candidates for potential adrenalectomy. With respect to the treatment of hypertension, a new recommendation that has been added is for increasing dietary potassium to reduce blood pressure in those who are not at high risk for hyperkalemia. Furthermore, in selected high-risk patients, intensive blood pressure reduction to a target systolic blood pressure ≤ 120 mm Hg should be considered to decrease the risk of cardiovascular events. Finally, in hypertensive individuals with uncomplicated, stable angina pectoris, either a ß-blocker or calcium channel blocker may be considered for initial therapy. The specific evidence and rationale underlying each of these recommendations are discussed. Hypertension Canada's Canadian Hypertension Education Program Guidelines Task Force will continue to provide annual updates.

The 2015 Canadian Hypertension Education Program recommendations for blood pressure measurement, diagnosis, assessment of risk, prevention, and treatment of hypertension.

The Canadian Hypertension Education Program reviews the hypertension literature annually and provides detailed recommendations regarding hypertension diagnosis, assessment, prevention, and treatment. This report provides the updated evidence-based recommendations for 2015. This year, 4 new recommendations were added and 2 existing recommendations were modified. A revised algorithm for the diagnosis of hypertension is presented. Two major changes are proposed: (1) measurement using validated electronic (oscillometric) upper arm devices is preferred over auscultation for accurate office blood pressure measurement; (2) if the visit 1 mean blood pressure is increased but < 180/110 mm Hg, out-of-office blood pressure measurements using ambulatory blood pressure monitoring (preferably) or home blood pressure monitoring should be performed before visit 2 to rule out white coat hypertension, for which pharmacologic treatment is not recommended. A standardized ambulatory blood pressure monitoring protocol and an update on automated office blood pressure are also presented. Several other recommendations on accurate measurement of blood pressure and criteria for diagnosis of hypertension have been reorganized. Two other new recommendations refer to smoking cessation: (1) tobacco use status should be updated regularly and advice to quit smoking should be provided; and (2) advice in combination with pharmacotherapy for smoking cessation should be offered to all smokers. The following recommendations were modified: (1) renal artery stenosis should be primarily managed medically; and (2) renal artery angioplasty and stenting could be considered for patients with renal artery stenosis and complicated, uncontrolled hypertension. The rationale for these recommendation changes is discussed.

Cost-effectiveness analysis of therapies for chronic kidney disease patients on dialysis: a case for excluding dialysis costs.

In many jurisdictions, cost-effectiveness analysis (CEA) plays an important role in determining drug coverage and reimbursement and, therefore, has the potential to impact patient access. Health economic guidelines recommend the inclusion of future costs related to the intervention of interest within CEAs but provide little guidance regarding the definition of 'related'. In the case of CEAs of therapies that extend the lives of patients with chronic kidney disease (CKD) on dialysis but do not impact the need for or the intensity of dialysis, the determination of the relatedness of future dialysis costs to the therapy of interest is particularly ambiguous. The uncertainty as to whether dialysis costs are related or unrelated in these circumstances has led to inconsistencies in the conduct of CEAs for such products, with dialysis costs included in some analyses while excluded in others. Due to the magnitude of the cost of dialysis, whether or not dialysis costs are included in CEAs of such therapies has substantial implications for the results of such analyses, often meaning the difference between a therapy being deemed cost effective (in instances where dialysis costs are excluded) or not cost effective (in instances where dialysis costs are included). This paper explores the issues and implications surrounding the inclusion of dialysis costs in CEAs of therapies that extend the lives of dialysis patients but do not impact the need for dialysis. Relevant case studies clearly demonstrate that, regardless of the clinical benefits of a life-extending intervention for dialysis patients, and due to the high cost of dialysis, the inclusion of dialysis costs in the analysis essentially eliminates the possibility of obtaining a favourable cost-effectiveness ratio. This raises the significant risk that dialysis patients may be denied access to interventions that are cost effective in other populations due solely to the high background cost of dialysis itself. Finally, the paper presents a case for excluding dialysis costs in CEAs of therapies that extend the lives of patients receiving dialysis but do not impact the need for dialysis. The argument is founded on the following: (i) health economic guidelines imply that dialysis costs are unrelated to such therapies and therefore should not be included in CEAs of such therapies; (ii) the high cost and cost-effectiveness ratio associated with dialysis place an unreasonable and insurmountable barrier to demonstrating the cost effectiveness of such therapies, particularly since the decision to fund dialysis has already been made; and (iii) current clinical and reimbursement practices include the use of such therapies for patients with CKD receiving dialysis. We conclude that the exclusion of dialysis costs in such cases is methodologically correct given current health economic guidelines and is consistent with current practices regarding the treatment of dialysis patients.

Nocturnal hemodialysis: effects on solute clearance, quality of life, and patient survival.

PURPOSE OF REVIEW: Conventional hemodialysis is often an incomplete treatment for uremia. People receiving hemodialysis often report a poor quality of life and suffer from an accelerated mortality rate. Nocturnal hemodialysis provides long treatments at night in the home or dialysis center. This review will examine how long nocturnal treatments have impact on the clearance of small and larger retention products, and how these treatments influence quality of life and survival. RECENT FINDINGS: Nocturnal hemodialysis is more effective at clearing most small and middle molecule retention products, and has been associated with improvements in quality of life, especially in those domains related to the effects of kidney disease. Survival on nocturnal hemodialysis is higher than expected, and studies suggest that patients receiving nocturnal hemodialysis have a mortality rate that is about one third of what is seen in similar patients receiving conventional hemodialysis. SUMMARY: Although impressive, it is difficult to be sure how much of the results of these studies is due to the duration and timing of dialysis and how much relates to patient level factors and residual confounding, and further research in this area is required.

Should patients remain on intensive hemodialysis rather than choosing to receive a kidney transplant?

Most dialysis patients would choose to receive a kidney transplant if possible. However, some patients who are receiving intensive hemodialysis (HD) have opted against transplantation and have chosen to remain on dialysis. In this paper, we examine studies that help to inform the decision between receiving a kidney transplant and remaining on intensive HD. There are no randomized trials directly comparing transplant to intensive HD. Database and prospective nonrandomized studies support a number of conclusions. First, compared to conventional HD, survival appears to be better with either transplantation or intensive HD. Survival appears to be similar between intensive HD and deceased donor kidney transplantation, but the best survival is reported with live donor transplantation. Secondly, people with a kidney transplant or receiving intensive HD report a higher quality of life than people on conventional HD. There is insufficient evidence to determine whether there are significant quality of life differences between these treatments. Finally, the costs of intensive HD compare favorably to those of conventional HD. Renal transplantation is more costly in the first year, but after about 2 years should be less costly than any form of HD. Based on these studies eligible intensive HD patients should be encouraged to pursue transplantation, especially live kidney donor transplantation. Individual concerns about the relative risks and benefits of renal transplantation may drive some patients to choose to stay on dialysis. Clinicians should explore the reasons behind such a decision to ensure that the patient is properly informed; however, appropriately reasoned decisions should be respected.

International trends in erythropoietin use and hemoglobin levels in hemodialysis patients.

Hemoglobin levels and the dose of erythropoiesis-stimulating agents (ESAs) have risen over time in hemodialysis patients within the United States. There are concerns that these trends may be driven by reimbursement policies that provide potential incentives to increase this use. To determine this we studied trends in the use of ESA and hemoglobin levels in hemodialysis patients and the relationship of these trends to the mode of reimbursement. Using the Dialysis Outcomes and Practice Patterns Study (DOPPS) database of hemodialysis we analyzed facility practices in over 300 randomly selected dialysis units in 12 countries. At each of three phases (years 1996-2001, 2002-2004, and 2005-present), we randomly selected over 7500 prevalent hemodialysis, hemofiltration, or hemodiafiltration patients. ESA usage rose significantly in every country studied except Belgium. All but Sweden demonstrated a substantial increase in hemoglobin levels. In 2005 more than 40% of patients had hemoglobin levels above the KDOQI upper target limit of 120 g/l in all but Japan. These trends appeared to be independent of the manner of reimbursement even though the United States is the only country with significant financial incentives promoting increased use of these agents. Thus, our study found that prescribing higher doses of ESAs and achieving higher hemoglobin levels by physicians reflects a broad trend across DOPPS countries regardless of the reimbursement policies.

More of the same: improving outcomes through intensive hemodialysis.

The typical dialysis patient faces both a poor quality of life and a significantly shortened survival. This is often blamed on "uremia." However, defining the clinical entity of uremia is surprisingly difficult. It represents the clinical sequelae of the effects of retention products, other effects of renal disease, and the effects of other comorbid conditions. The list of retention products that could act as uremic toxins is lengthy, but it would appear that urea itself does not contribute significantly to the uremic state. Larger molecular weight substances are likely the major contributors to the uremic milieu. Regardless of the causes, the uremic state persists in many patients who are reaching their dialysis adequacy targets as defined by urea clearance. This raises the possibility that more intensive hemodialysis could improve patient outcomes. Hemodialysis can be intensified by increasing dialysis efficiency without changing duration or frequency. Alternatively, hemodialysis duration, frequency, or both can be increased. All intensification methods increase small solute removal, but the removal of larger molecular weight retention products depends more upon treatment time. Modalities such as short daily hemodialysis, long intermittent hemodialysis, and quotidian nocturnal hemodialysis have been associated with a variety of clinical improvements, as well as improvements in quality of life and a lower standardized mortality ratio. However, the HEMO study approach of intensifying small solute clearance without significant modifications of the dialysis schedule does not appear to be effective. Future research will help to define the optimal treatment duration and frequency in hemodialysis patients.

A change from subcutaneous to intravenous erythropoietin increases the cost of anemia therapy.

BACKGROUND: It seems that more erythropoietin (EPO) is required when given intravenously (IV) than when given subcutaneously (SC). Estimates of the magnitude of this difference vary widely, impeding development of economic models in this area. Concerns about pure red cell aplasia led our program to switch from SC to IV EPO, so we studied the impact of this change on the cost of anemia therapy. METHODS: All in-center hemodialysis patients who had received EPO for at least 3 months prior to and following conversion to IV EPO were studied. Data was obtained retrospectively for 1 year prior to and prospectively for 1 year following conversion. The costs of anemia therapy (EPO, transfusions and iron) were calculated from the hospital's perspective. RESULTS: 158 patients were studied. One month after switching, the hemoglobin fell significantly, reaching a nadir at 3 months. This triggered more use of EPO, iron and transfusions. By month 7 hemoglobin levels had returned to initial levels, with a median rise in EPO dose of 1,250 units/week (p < 0.001). After the switch, the median rise in total anemia therapy costs was 13.1% (CAD 665/patient-year, p < 0.01). CONCLUSIONS: Conversion of EPO from SC to IV dosing increased the costs of anemia therapy at our center.

Acceptance and rejection: cost-effectiveness and the working nephrologist.

While many nephrologists have developed a sophisticated approach to appraising clinical trials, an equal comfort in critiquing cost-effectiveness literature is often lagging. Readers can wonder how new results compare to those from other cost-effectiveness trials, and whether they should accept a new intervention as cost-effective or reject it as too costly for the benefit it produces. Critical readers should first judge whether the authors have made the correct trade-off between complexity and generalizability when selecting a study perspective, and should examine the method of linkage between costs and effectiveness. The most popular method is the incremental cost-effectiveness ratio (ICER), which has limitations that have led some authors to prefer the net monetary benefit (NMB), where confidence intervals are more easily determined and which can more readily be used in regression analyses. Interpretation of the ICER and NMB require the choice of a cost-effectiveness ceiling, representing the maximum that society would be willing to pay for an incremental health benefit, and the development of a decision rule based on this maximum. Comparing cost-effectiveness studies from different disciplines requires the use of "universal" effectiveness measures, such as the quality-adjusted life-year (QALY). An understanding of study perspective, the relative strengths of different cost-effectiveness measures, the methods for measuring uncertainty in these estimates, and how to select and use cost-effectiveness ceiling ratios will help the critical reader to determine if a new intervention should be accepted or rejected.

Reducing hemodialysis costs: conventional and quotidian home hemodialysis in Canada.

The cost of hemodialysis is a concern as the prevalence of end-stage renal disease (ESRD) increases. While home hemodialysis has been described as less expensive than in-center hemodialysis, the proportion of patients performing home hemodialysis has been declining. In Canada, there is increasing interest in daily (or quotidian) forms of home hemodialysis, such as nocturnal hemodialysis and short daily hemodialysis. We reviewed the recent Canadian experience with the costs of these modalities and identified four descriptive costing studies: two whole-program comparisons of home conventional hemodialysis and unmatched in-center hemodialysis patients, and two comparing quotidian home hemodialysis and matched in-center hemodialysis patients. All costs are listed as per patient-year in 2003 U.S. dollars. In the two whole-program analyses, conventional home hemodialysis was less expensive than in-center hemodialysis (36,840 USD versus 100,198 USD[p < 0.001] and 34,466 USD versus 58,959 USD[p < 0.001]). Reductions in categories such as staffing and overhead are likely due to the modality, while reductions in medications and hospital admissions may be due to differences in the patient mix. The savings for quotidian home hemodialysis are significant, but less striking. In the two matched analyses, nocturnal hemodialysis cost less than in-center hemodialysis (48,656 USD versus 59,476 USD [p = 0.006]), and costs decreased by 8,046 USD in those converted to short daily hemodialysis and by 14,341 USD in those converted to nocturnal hemodialysis, while increasing by 2,521 USD in those who remained on in-center hemodialysis. Home conventional hemodialysis is less expensive than in-center hemodialysis. Much of these savings are lost when dialysis frequency increases; however, quotidian home hemodialysis remains less expensive than in-center hemodialysis.

The quality of life and cost utility of home nocturnal and conventional in-center hemodialysis.

BACKGROUND: Home nocturnal hemodialysis is an intensive form of hemodialysis, where patients perform their treatments at home for about 7 hours approximately 6 nights a week. Compared with in-center conventional hemodialysis, home nocturnal hemodialysis has been shown to improve physiologic parameters and reduce health care costs; however, the effects on quality of life and cost utility are less clear. We hypothesized that individuals performing home nocturnal hemodialysis would have a higher quality of life and superior cost utility than in-center hemodialysis patients. METHODS: Home nocturnal hemodialysis patients and a demographically similar group of in-center hemodialysis patients from a hospital without a home hemodialysis program underwent computer-assisted interviews to assess their utility score for current health by the standard gamble method. RESULTS: Nineteen in-center hemodialysis and 24 home nocturnal hemodialysis patients were interviewed. Mean annual costs for home nocturnal hemodialysis were about 10,000 dollars lower for home nocturnal hemodialysis (55,139 dollars +/- 7651 dollars for home nocturnal hemodialysis vs. 66,367 dollars +/- 17,502 dollars for in-center hemodialysis, P = 0.03). Home nocturnal hemodialysis was associated with a higher utility score than in-center hemodialysis (0.77 +/- 0.23 vs. 0.53 +/- 0.35, P = 0.03). The cost utility for home nocturnal hemodialysis was 71,443 dollars/quality-adjusted life-year (QALY), while for in-center hemodialysis it was 125,845 dollars/QALY. Home nocturnal hemodialysis was the dominant strategy, with an incremental cost-effectiveness ratio (ICER) of -45,932 dollars. The 95% CI for the ICER, and 2500 bootstrap iterations of the ICER all fell below the cost-effectiveness ceiling of 50,000 dollars. The net monetary benefit of home nocturnal hemodialysis ranged from 11,227 dollars to 35,669 dollars. CONCLUSION: Home nocturnal hemodialysis is associated with a higher quality of life and a superior cost utility when compared to in-center hemodialysis.

Renal transplant recipient attitudes toward steroid use and steroid withdrawal.

Although steroid avoidance and withdrawal in renal transplant recipients (RTR) are actively being evaluated by physicians, the attitudes of recipients toward steroid use have not been systematically studied in the modern era. We conducted a confidential written survey of single-organ adult RTR pertaining to prednisone-related side-effects. Recipients were asked which drug they felt maximized graft life, which drug they wished to avoid if graft life was unaffected, and which drug they had most compliant with. They also rated 16 common immunosuppressive-related side-effects on a Likert scale with 1 meaning complete disagreement and 10 complete agreement with their own prednisone-attributed experience. A comparison of responses based on RTR demographic characteristics was made by ANOVA or chi-square analysis with Bonferroni correction. The questionnaire was completed by 223 recipients, of whom 93% were primary recipients, 57% were cadaveric organ recipients, and 69% were white people, 7% black people, and 23% Asian people. Age at transplant, age at survey and time since transplant were 41.5 +/- 11, 47.5 +/- 11 and 6.0 +/- 5 yr, respectively. For the entire group, overall side-effect profile for prednisone was rated as 6.1 +/- 3 on the Likert scale, while efficacy was rated as 7.3 +/- 3. If offered monotherapy, 67% preferred a calcineurin-inhibitor (CI), 23% mycophenolate mofetil (MMF)/azathioprine (AZA), and 10% prednisone. When asked which drug they would like to discontinue, 19% chose CI, 16% MMF/AZA, and 65% prednisone. Most recipients felt that CI was the most efficacious drug (80%), followed by MMF/AZA (12%), and prednisone (8%). The side-effects reported as most common were unacceptable weight gain (5.8 +/- 3) and bone/joint disease (5.3 +/- 3). The least common side-effects were blood disorders (2.2 +/- 2) and cancer (2.3 +/- 2). Black people were more likely than non-black people to report developing diabetes (p = 0.02), blood disorders (p = 0.003) and headaches (p = 0.003) as a result of prednisone use. Males reported more liver damage (p = 0.01) while females reported more body fat (p = 0.01) and fluid retention (p = 0.006). RTR >5 yr post-transplant reported more infections (p = 0.008), skin/hair problems (p = 0.02), gastrointestinal irritation (p = 0.02), and bone disease (p = 0.02) compared with RTR <1 yr. Donor source and recipient age did not determine any responses. If given a 'risk-free' choice, the majority of recipients prefer withdrawal of steroids over other agents. Demographic data may be used to predict prednisone-related side-effects and guide steroid use in this population. Study designs related to steroid withdrawal should account for patient preferences in this context.

Cost savings of home nocturnal versus conventional in-center hemodialysis.

BACKGROUND: Home nocturnal hemodialysis (HNHD) can improve clinical and biochemical factors in people with renal failure, but its cost-effectiveness relative to conventional in-center hemodialysis (IHD) is uncertain. We hypothesized that HNHD would provide more dialysis treatments at a lower total cost than IHD. METHODS: A prospective one-year descriptive costing study was performed at two centers in Toronto, Canada, involving patients enrolled from a HNHD program (N = 33), and a matched cohort from an IHD program (N = 23). All costs are expressed as mean weekly amount in Canadian year 2000 dollars. A projected mean annual cost (PMA) was calculated also. RESULTS: The mean number of treatments per week was much higher with HNHD (5.7 vs. 3.0, P = 0.004). Cost categories found to be less expensive for HNHD were staffing (weekly $210 vs. $423, P < 0.001, PMA $10,932 vs. $22,056) and overhead and support (weekly $80 vs. $238, P < 0.001, PMA $4179 vs. $12,393). There was a trend toward lower costs for hospital admissions and procedures (weekly $23 vs. $134, P = 0.355, PMA $1173 vs. $6997) and for medications ($172 vs. $231, P = 0.082, PMA $8989 vs. $12,029). Costs found to be more expensive for HNHD were the cost of direct hemodialysis materials (weekly $318 vs. $126, P < 0.001, PMA $16,587 vs. $6575) and capital costs (weekly $118 vs. $17, P < 0.001, PMA $6139 vs. $871), with a trend toward higher cost for laboratory tests (weekly $33 vs. $26, P = 0.094, PMA $1744 vs. $1364). Physician costs were the same at $128 per week (PMA $6650). The weekly mean total cost for health care delivery was 20% less for HNHD ($1082 vs. $1322, P = 0.006), with projected mean annual costs more than $10,000 lower ($56,394 vs. $68,935). CONCLUSIONS: HNHD provides about three times as many treatment hours at nearly a one-fifth lower cost, with savings evident even when only program and funding-specific costs are considered.