Clinical Validation of an Alternative Specimen Collection Kit for SARS-CoV-2 Testing at Fox Chase Cancer Center.

Background: Supply chain disruptions during the COVID-19 pandemic have affected the availability of components for specimen collection kits to detect SARS-CoV-2. Plastic injection molding offers a rapid and cheap method for mass production of swabs for upper respiratory tract sampling. Local production of virus transport medium increases flexibility to assemble sample collection kits if the medium provides appropriate stability for SARS-CoV-2 detection. Methods: A locally produced virus transport medium and a novel injection molded plastic swab were validated for SARS-CoV-2 detection by reverse-transcription quantitative polymerase chain reaction. Both components were compared to standard counterparts using viral reference material and representative patient samples. Results: Clinical testing showed no significant differences between molded and flocked swabs. Commercial and in-house virus transport media provided stable test results for over 40 days of specimen storage and showed no differences in test results using patient samples. Conclusions: This collection kit provides new supply chain options for SARS-CoV-2 testing.

Prescribing Home Hemodialysis.

Home hemodialysis (HHD), performed more frequently than in-center hemodialysis, is underutilized in the United States but has had a recent resurgence driven predominantly by innovative dialysis equipment that is easy to use, less intrusive to the home, and requires less storage space. There are 3 different hemodialysis machines approved for use in the home but currently NxStage™ accounts for the overwhelming majority of HHD patients. Therefore, it is the focus of this article. To minimize storage space in the home, the NxStage platform minimizes the volume of dialysate that is used per treatment. We refer to this method as the Frequent Low Dialysate Volume Approach (FLDVA). The approach to urea removal with the NxStage platform is much different compared to traditional in-center HD. To minimize the volume of dialysate per treatment, and still achieve target urea removal, the dialysate must be highly saturated. In this article, we explain how to increase the saturation of dialysate fluid. We also draw a parallel between urea removal in peritoneal dialysis and NxStage therapy and use that model to estimate an initial HHD prescription and to alter prescriptions when necessary.

KDOQI US Commentary on the 2020 ISPD Practice Recommendations for Prescribing High-Quality Goal-Directed Peritoneal Dialysis.

The recently published 2020 International Society for Peritoneal Dialysis (ISPD) practice recommendations regarding prescription of high-quality goal-directed peritoneal dialysis differ fundamentally from previous guidelines that focused on "adequacy" of dialysis. The new ISPD publication emphasizes the need for a person-centered approach with shared decision making between the individual performing peritoneal dialysis and the clinical care team while taking a broader view of the various issues faced by that individual. Cognizant of the lack of strong evidence for the recommendations made, they are labeled as "practice points" rather than being graded numerically. This commentary presents the views of a work group convened by the National Kidney Foundation's Kidney Disease Outcomes Quality Initiative (KDOQI) to assess these recommendations and assist clinical providers in the United States in interpreting and implementing them. This will require changes to the current clinical paradigm, including greater resource allocation to allow for enhanced services that provide a more holistic and person-centered assessment of the quality of dialysis delivered.

A Systematic Approach To Promoting Home Hemodialysis during End Stage Kidney Disease.

Home dialysis has garnered much attention since the advent of the Advancing American Kidney Health initiative. For many patients and nephrologists, home dialysis and peritoneal dialysis are synonymous. However, home hemodialysis (HHD) should not be forgotten. Since 2004, HHD has grown more rapidly than other dialytic modalities. The cardinal feature of HHD is customizability of treatment intensity, which can be titrated to address the vexing problems of volume and pressure loading during interdialytic gaps and ultrafiltration intensity during each hemodialysis session. Growing HHD utilization requires commitment to introducing patients to the modality throughout the course of ESKD. In this article, we describe a set of strategies for introducing HHD concepts and equipment. First, patients initiating dialysis may attend a transitional care unit, which offers an educational program about all dialytic modalities during 3-5 weeks of in-facility hemodialysis, possibly using HHD equipment. Second, prevalent patients on hemodialysis may participate in "trial-run" programs, which allow patients to experience increased treatment frequency and HHD equipment for several weeks, but without the overt commitment of initiating HHD training. In both models, perceived barriers to HHD-including fear of equipment, anxiety about self-cannulation, catheter dependence, and the absence of a care partner-can be addressed in a supportive setting. Third, patients on peritoneal dialysis who are nearing a transition to hemodialysis may be encouraged to consider a home-to-home transition (i.e., from peritoneal dialysis to HHD). Taken together, these strategies represent a systematic approach to growing HHD utilization in multiple phenotypes of patients on dialysis. With the feature of facilitating intensive hemodialysis, HHD can be a key not only to satiating demand for home dialysis, but also to improving the health of patients on dialysis.

The home hemodialysis patient experience: A qualitative assessment of modality use and discontinuation.

INTRODUCTION: Home hemodialysis (HHD) is an under-utilized renal replacement modality in the United States in part because of high rates of discontinuation and transfer to in-center hemodialysis. Understanding, from the perspective of patients, facilitators, and barriers to sustained use of HHD is important for increasing successful use of this modality. METHODS: We conducted 25 semistructured interviews with 15 current and 10 former adult patients treated with home hemodialysis (23 short daily HHD and 2 nocturnal HHD). Interview transcripts were audiotaped, transcribed verbatim, and thematically analyzed. FINDINGS: Five themes related to continuation or discontinuation of HHD emerged: (1) degree of independence (increased flexibility, burden of therapy), (2) availability of support (emotional and physical support and caregiver burden), (3) technical aspects (familiarity with machine), (4) home environment (ability to organize supplies, space in home), and (5) attitude and expectations (positive or negative outlook about performing HHD). For each theme, positive aspects facilitated continuation of HHD and negative aspects contributed to discontinuation of HHD. DISCUSSION: HHD can be burdensome to patients and family members, and some discontinuations may be preventable. Helping patients with scheduling and organization, improving communication about expectations and trouble-shooting, supporting patients as well as family members, adapting the dialysis prescription to the patient's lifestyle when possible, and providing respite when needed may make HHD more sustainable for patients.

Exploring Barriers and Potential Solutions in Home Dialysis: An NKF-KDOQI Conference Outcomes Report.

Home dialysis therapy, including home hemodialysis and peritoneal dialysis, is underused as a modality for the treatment of chronic kidney failure. The National Kidney Foundation-Kidney Disease Outcomes Quality Initiative sponsored a home dialysis conference in late 2017 that was designed to identify the barriers to starting and maintaining patients on home dialysis therapy. Clinical, operational, policy, and societal barriers were identified that need to be overcome to ensure that dialysis patients have the freedom to choose their treatment modality. Education of patients and patient partners, as well as health care providers, about home dialysis therapy, if offered at all, is often provided in a cursory manner. Lack of exposure to home dialysis therapies perpetuates a lack of familiarity and thus a hesitancy to refer patients to home dialysis therapies. Patient and care partner support, both psychosocial and financial, is also critical to minimize the risk for burnout leading to dropout from a home dialysis modality. Thus, the facilitation of home dialysis therapy will require a systematic change in chronic kidney disease education and the approach to dialysis therapy initiation, the creation of additional incentives for performing home dialysis, and breakthroughs to simplify the performance of home dialysis modalities. The home dialysis work group plans to develop strategies to overcome these barriers to home dialysis therapy, which will be presented at a follow-up home dialysis conference.

Home hemodialysis education during postdoctoral training: Challenges and innovations.

Inadequate education in home hemodialysis (HHD) fellowship training might contribute to underutilization of this modality in the United States. Most graduates of nephrology fellowships do not grade themselves as competent in HHD suggesting that fellowship training in HHD is inadequate. An essential component for fellow education is at least one faculty member with expertise in HHD who is passionate about promoting the use of this modality. At a minimum, fellow training should utilize a curriculum that includes both lectures about HHD and outpatient clinical exposure to this modality over a period of at least 6-12 months. Fellows benefit from the opportunity to transition at least three patients to a home modality to gain experience with modality education, access placement, initial prescriptions, and home dialysis training. They should spend time with HHD training nurses to learn more about modality education, observe nurse intake interviews with patients in order to learn the criteria for entrance into the home dialysis program as well as recognize how to identify potential barriers to successful home dialysis therapy. To expose fellows to problems that do not occur during clinic visits fellows are encouraged to take first call during the day for HHD patients. There are many opportunities to do research and quality improvement projects which might also propel some fellows into an academic career as a home dialysis nephrologist.

Association of Alternative Approaches to Normalizing Peritoneal Dialysis Clearance with Mortality and Technique Failure: A Retrospective Analysis Using the United States Renal Data System-Dialysis Morbidity and Mortality Study, Wave 2.

♦ BACKGROUND: Total body water (V) is an imprecise metric for normalization of dialytic urea clearance (Kt). This poses a risk of early mortality/technique failure (TF). We examined differences in the distribution of peritoneal Kt/V when V was calculated with actual weight (AW), ideal weight (IW), and adjusted weight (ADW). We also examined the associations of these Kt/V measurements, Kt/body surface area (BSA), and non-normalized Kt with mortality and TF. ♦ METHODS: This is a retrospective cohort study of 534 incident peritoneal dialysis (PD) patients from the Dialysis Morbidity and Mortality Study Wave 2 linked with United States Renal Data System through 2010. Using Cox-proportional hazard models, we examined the relationship of several normalization strategies for peritoneal urea clearance, including Kt/VAW, Kt/VIW, Kt/VADW, Kt/BSA, and non-normalized Kt, with the outcomes of mortality and TF. Harrell's c-statistics were used to assess the relative predictive ability of clearance metrics for mortality and TF. The distributions of Kt/VAW, KT/VIW, and KT/VADW were compared within and between body mass index (BMI) strata. ♦ RESULTS: Median patient age: 59 (54% male; 72% white; 91% continuous ambulatory PD [CAPD]). Median 24-hour urine volume: 700 mL; median estimated glomerular filtration rate (eGFR) at initiation: 7.15 mL/min/1.73 m2. Technique failure and transplant-censored mortality at 5 years: 37%. Death and transplant-censored TF at 5 years: 60%. There were no significant differences in initial eGFR and 24-hour urine volume across BMI strata. There were statistically significant differences in each Kt/V calculation within the underweight, overweight, and obese strata. After adjustment, there were no significant differences in the hazard ratios (HRs) for TF/mortality for each clearance calculation. Harrell's c-statistics for mortality for each clearance calculation were 0.78, and for TF, 0.60 - 0.61. ♦ CONCLUSIONS: Peritoneal urea clearances are sensitive to subtle changes in the estimation of V. However, there were no detectable significant associations of Kt/VAW, Kt/VIW, Kt/VADW, Kt/BSA, or Kt with TF or mortality.

Factors Associated With Discontinuation of Home Hemodialysis.

BACKGROUND: Home hemodialysis (HHD) is associated with improved clinical and quality-of-life outcomes compared to in-center hemodialysis, but remains an underused modality in the United States. Discontinuation from HHD therapy may be an important contributor to the low use of this modality. This study aimed to describe the rate and timing of HHD therapy discontinuation, or technique failure, and identify contributing factors. STUDY DESIGN: Retrospective cohort study. SETTING & PARTICIPANTS: Using data from a large dialysis provider, we identified a nationally representative cohort of patients who initiated HHD therapy from 2007 to 2009 (N=2,840). FACTORS: Demographics, end-stage renal disease duration, kidney transplant listing status, comorbid conditions, level of urbanization or rurality based on residence zip code, socioeconomic status based on residence zip code, and dialysis facility factors. OUTCOMES: Discontinuation from HHD therapy, defined as 60 or more days with no HHD treatments. MEASUREMENTS: Competing-risk models were used to produce cumulative incidence plots and identify sociodemographic and clinical variables associated with HHD therapy discontinuation. Transplantation and death were treated as competing risks for HHD therapy discontinuation. RESULTS: The 1-year incidence of discontinuation was 24.9%, and the 1-year mortality estimate was 7.6%. Median end-stage renal disease duration prior to initiating HHD therapy was 2.1 years. Diabetes and smoking/alcohol/drug use were associated with increased risk for HHD discontinuation (HRs of 1.34 [95% CI, 1.07-1.68] and 1.34 [95% CI, 1.01-1.78], respectively). Listing for kidney transplantation and rural residence (rural-urban commuting area ≥ 7) were associated with decreased risk for HHD therapy discontinuation (HRs of 0.73 [95% CI, 0.61-0.87] and 0.78 [95% CI, 0.59-1.02], respectively). LIMITATIONS: Limited to variables available within the DaVita dialysis and US Renal Data System data sets. CONCLUSIONS: A substantial proportion of patients discontinue HHD therapy within the first 12 months of use of the modality. Patients with diabetes, substance use, nonlisting for kidney transplantation, and urban residence are at greater risk for discontinuation. Targeting high-risk patients for increased support from clinical teams is a potential strategy for reducing HHD therapy discontinuation and increasing technique survival.

Survey of home hemodialysis patients and nursing staff regarding vascular access use and care.

Vascular access infections are of concern to hemodialysis patients and nurses. Best demonstrated practices (BDPs) have not been developed for home hemodialysis (HHD) access use, but there have been generally accepted practices (GAPs) endorsed by dialysis professionals. We developed a survey to gather information about training provided and actual practices of HHD patients using the NxStage System One HHD machine. We used GAP to assess training used by nurses to teach HHD access care and then assess actual practice (adherence) by HHD patients. We also assessed training and adherence where GAPs do not exist. We received a 43% response rate from patients and 76% response from nurses representing 19 randomly selected HHD training centers. We found that nurses were not uniformly instructing HHD patients according to GAP, patients were not performing access cannulation according to GAP, nor were they adherent to their training procedures. Identification of signs and symptoms of infection was commonly trained appropriately, but we observed a reluctance to report some signs and symptoms of infection by patients. Of particular concern, when aggregating all steps surveyed, not a single nurse or patient reported training or performing all steps in accordance with GAP. We also identified practices for which there are no GAPs that require further study and may or may not impact outcomes such as infection. Further research is needed to develop strategies to implement and expand GAP, measure outcomes, and ultimately develop BDP for HHD to improve infectious complications.

Home dialysis in the new USA bundled payment plan: implications and impact.

On 1 January 2011, a new payment system for Medicare patients will be implemented in the United States. This new system bundles services previously charged separately and under a "fee for service" environment. The authors discuss the implications of this approach. Over the next several pages is a response by American physicians and dialysis innovators to a federal initiative to change the way dialysis is paid for in the United States. Peter Blake, the Editor-in-Chief of Peritoneal Dialysis International, invited Thomas Golper to articulate physicians' concerns with this new payment scheme. After the government of the USA closed its comment period over the new payment methodology, called "bundling," Golper sought out colleagues from diverse backgrounds and compiled this collective view of the situation.

Electrolyte management in frequent home hemodialysis.

Short daily hemodialysis (SDHD) and nocturnal home hemodialysis are modalities performed at home at shorter intervals than conventional hemodialysis. Because of their increased frequency, these alternative modalities create the potential for less inter-dialytic fluid gains and therefore fewer episodes of intra-dialytic hypotension. By more closely replicating normal renal physiology, they may also improve electrolyte management. In this article, we review published data on levels of calcium, phosphate, potassium, and bicarbonate levels using these home dialysis modalities. We also present our single-center experience with electrolyte management in patients maintained on SDHD using low dialysate flow rate, a modality of growing prevalence.

Comparison of intradialytic blood pressure variability between conventional thrice-weekly hemodialysis and short daily hemodialysis.

Intradialytic blood pressure (BP) variability may be associated with increased mortality. We examined the effect of short daily hemodialysis (SDHD) on intradialytic BP variability relative to conventional thrice-weekly HD (CHD). This is a retrospective cohort study. Subjects were those converted from CHD to SDHD (n=12). All intradialytic BPs were collected on the last month of CHD, and on month 6 of SDHD. Absolute predialysis BP level and intradialytic BP variability were defined as the intercept and average residual terms, respectively, from a mixed-effects linear regression model of time on BP. Dialysis modality was a predictor variable (CHD vs. SDHD). Outcome variables were intradialytic BP variability and hypotension (BP<90/55 mmHg at any time during HD). In addition to a predictor and outcomes, the demographics, estimated dry weight, and ultrafiltration ratio were examined. The median (range) age of the patients was 48 (34-77); all had hypertension, and 4 (33%) had diabetes. By a mixed effects linear regression model, the intradialytic systolic BP variability was 13.2 (quartile range 9.5-14.0) mmHg and 10.0 (8.3-10.9) mmHg for CHD and SDHD, respectively (P<0.006). Intradialytic diastolic BP variability was also significantly reduced (7.7 [6.4-9.2] vs. 6.1 [5.5-6.6] mmHg, P=0.005). Relative to CHD, less hypotension was observed during treatment on SDHD: the odds ratio (95% confidence interval) was 0.36 (0.16-0.81; P=0.008). In this retrospective study, SDHD was associated with less intradialytic BP variability and with fewer episodes of hypotension during treatments. Further studies are necessary to generalize these findings.

Scope and design of the Following Rehabilitation, Economics and Everyday-Dialysis Outcome Measurements (FREEDOM) Study.

BACKGROUND: Conventional thrice-weekly hemodialysis (HD) has limited the ability to generate further improvements in patient quality of life, morbidity, and mortality. Daily HD (DHD) offers the promise of providing clinical and economic benefits. The objectives of the Following Rehabilitation, Economics and Everyday-Dialysis Outcome Measurements Study are to evaluate outcomes of DHD (6 times/wk) with the NxStage System One (NxStage Medical Inc, Lawrence, MA) device. DESIGN: Cohort study with matched control group. SETTING & PARTICIPANTS: The DHD group will include up to 500 participants at 70 clinical sites, enrolling for 3 years with a minimum of 1-year follow-up. Study candidates include adult patients (age >or= 18 years) with end-stage renal disease who are considered suitable candidates for DHD with the NxStage System One device by the treating physician and who have Medicare as their primary insurance payer. The control group will consist of a matched thrice-weekly in-center HD cohort derived from the US Renal Data System database using a 10:1 ratio, totaling 5,000 patients. PREDICTOR: Treatment with DHD and "standard of care" thrice-weekly HD. OUTCOMES & MEASUREMENTS: The primary intent-to-treat analysis compares hospitalization days/patient-year between the DHD and thrice-weekly HD groups. Other outcomes recorded in both groups include non-treatment-related medical expenditures. In addition, in the DHD cohort, changes in quality-of-life measures (baseline, 4 and 12 months, and every 6 months thereafter); urea kinetics; parameters related to anemia, bone and mineral metabolism, and nutrition; vascular access interventions; and use of medications will be examined. CONCLUSIONS: This study has the potential to elucidate the health and economic benefits of DHD and complement results of current clinical trials.

Chronic tubulointerstitial nephritis presenting as multiple renal nodules and pancreatic insufficiency.

We report a case of chronic tubulointerstitial nephritis associated with multiple nodular lesions of the kidneys in a patient with autoimmune pancreatitis. Serum immunoglobulin G4 (IgG4) level was increased, and immunohistochemical staining for IgG4 on the renal biopsy specimen showed positive staining of plasma cells and tubular basement membrane within areas of chronic tubulointerstitial nephritis. There are a few reports of nodular lesions of kidneys or interstitial nephritis associated with autoimmune pancreatitis. Our case is unique in that all 3 conditions presented together and suggests that interstitial nephritis can present as nodular lesions.

Frequency of elevated serum aluminum levels in adult dialysis patients.

BACKGROUND: Aluminum toxicity, a complication described in dialysis patients exposed to aluminum-containing phosphate binders or water used in dialysate preparations containing elevated levels of aluminum, can cause significant morbidity. Although physicians monitor patient aluminum levels, the frequency of abnormal aluminum levels has not been reported. METHODS: We retrospectively examined 1,410 measurements of serum aluminum in 207 dialysis patients at the Franklin Dialysis Center (FDC; Philadelphia, PA) from January 1, 2000, through April 3, 2003. We also surveyed serum aluminum levels from a nationwide dialysis provider (DaVita) to more than 43,000 patients. Local dialysis facilities were surveyed to determine the annual frequency of aluminum testing in their patients. RESULTS: Of 1,410 serum aluminum measurements performed at FDC, only 30 abnormal levels (2.1%) were found. DaVita measured approximately 117,000 aluminum levels annually during the last 3 years, of which 2.5% were abnormal. Frequencies of abnormal aluminum levels declined significantly each year at FDC and DaVita. CONCLUSION: The current frequency of abnormal aluminum levels in our dialysis facility and a national dialysis provider is extremely low and has significantly declined.