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BackgroundChronic kidney disease (CKD) is a health condition that threatens patient safety; however, few interventions provide patient-centered education about kidney-specific safety hazards. ObjectiveWe sought to develop and test the usability of a mobile tablet–based educational tool designed to promote patient awareness of relevant safety topics in CKD. MethodsWe used plain language principles to develop content for the educational tool, targeting four patient-actionable safety objectives that are relevant for individuals with CKD. These four objectives included avoidance of nonsteroidal anti-inflammatory drugs (NSAIDs); hypoglycemia awareness (among individuals with diabetes); temporary cessation of certain medications during acute volume depletion to prevent acute kidney injury (ie, “sick day protocol”); and contrast dye risk awareness. Our teaching strategies optimized human-computer interaction and content retention using audio, animation, and clinical vignettes to reinforce themes. For example, using a vignette of a patient with CKD with pain and pictures of common NSAIDs, participants were asked “Which of the following pain medicines are safe for Mr. Smith to take for his belly pain?” Assessment methods consisted of preknowledge and postknowledge surveys, with provision of correct responses and explanations. Usability testing of the tablet-based tool was performed among 12 patients with any stage of CKD, and program tasks were rated upon completion as no error, noncritical error (self-corrected), or critical error (needing assistance). ResultsThe 12 participants in this usability study were predominantly 65 years of age or older (n=7, 58%) and female (n=7, 58%); all participants owned a mobile device and used it daily. Among the 725 total tasks that the participants completed, there were 31 noncritical errors (4.3%) and 15 critical errors (2.1%); 1 participant accounted for 30 of the total errors. Of the 12 participants, 10 (83%) easily completed 90% or more of their tasks. Most participants rated the use of the tablet as very easy (n=7, 58%), the activity length as “just right” (rather than too long or too short) (n=10, 83%), and the use of clinical vignettes as helpful (n=10, 83%); all participants stated that they would recommend this activity to others. The median rating of the activity was 8 on a scale of 1 to 10 (where 10 is best). We incorporated all participant recommendations into the final version of the educational tool. ConclusionsA tablet-based patient safety educational tool is acceptable and usable by individuals with CKD. Future studies leveraging iterations of this educational tool will explore its impact on health outcomes in this high-risk population.

Introduction: According to the US Renal Data System (USRDS), patients with end-stage kidney disease (ESKD) on maintenance dialysis had higher mortality during early COVID-19 pandemic. Less is known about the effect of the pandemic on the delivery of outpatient maintenance hemodialysis and its impact on death. We examined the effect of pandemic-related disruption on the delivery of dialysis treatment and mortality in patients with ESKD receiving maintenance hemodialysis in the Veterans Health Administration (VHA) facilities, the largest integrated national healthcare system in the USA. Methods: Using national VHA electronic health records data, we identified 7,302 Veterans with ESKD who received outpatient maintenance hemodialysis in VHA healthcare facilities during the COVID-19 pandemic (February 1, 2020, to December 31, 2021). We estimated the average change in the number of hemodialysis treatments received and deaths per 1,000 patients per month during the pandemic by conducting interrupted time-series analyses. We used seasonal autoregressive moving average (SARMA) models, in which February 2020 was used as the conditional intercept and months thereafter as conditional slope. The models were adjusted for seasonal variations and trends in rates during the pre-pandemic period (January 1, 2007, to January 31, 2020). Results: The number (95% CI) of hemodialysis treatments received per 1,000 patients per month during the pre-pandemic and pandemic periods were 12,670 (12,525–12,796) and 12,865 (12,729–13,002), respectively. Respective all-cause mortality rates (95% CI) were 17.1 (16.7–17.5) and 19.6 (18.5–20.7) per 1,000 patients per month. Findings from SARMA models demonstrate that there was no reduction in the dialysis treatments delivered during the pandemic (rate ratio: 0.999; 95% CI: 0.998–1.001), but there was a 2.3% (95% CI: 1.5–3.1%) increase in mortality. During the pandemic, the non-COVID hospitalization rate was 146 (95% CI: 143–149) per 1,000 patients per month, which was lower than the pre-pandemic rate of 175 (95% CI: 173–176). In contrast, there was evidence of higher use of telephone encounters during the pandemic (3,023; 95% CI: 2,957–3,089), compared with the pre-pandemic rate (1,282; 95% CI: 1,241–1,324). Conclusions: We found no evidence that there was a disruption in the delivery of outpatient maintenance hemodialysis treatment in VHA facilities during the COVID-19 pandemic and that the modest rise in deaths during the pandemic is unlikely to be due to missed dialysis. [ABSTRACT FROM AUTHOR]

Background Adults with chronic kidney disease (CKD) are hospitalized more frequently than those without CKD, but the magnitude of this excess morbidity and the factors associated with hospitalizations are not well known. Methods and findings Data from 3,939 participants enrolled in the Chronic Renal Insufficiency Cohort (CRIC) Study between 2003 and 2008 at 7 clinical centers in the United States were used to estimate primary causes of hospitalizations, hospitalization rates, and baseline participant factors associated with all-cause, cardiovascular, and non-cardiovascular hospitalizations during a median follow up of 9.6 years. Multivariable-adjusted Poisson regression was used to identify factors associated with hospitalization rates, including demographics, blood pressure, estimated glomerular filtration rate (eGFR), and proteinuria. Hospitalization rates in CRIC were compared with rates in the Nationwide Inpatient Sample (NIS) from 2012. Of the 3,939 CRIC participants, 45.1% were female, and 41.9% identified as non-Hispanic black, with a mean age of 57.7 years, and the mean eGFR is 44.9 ml/min/1.73m.sup.2 . CRIC participants had an unadjusted overall hospitalization rate of 35.0 per 100 person-years (PY) [95% CI: 34.3 to 35.6] and 11.1 per 100 PY [95% CI: 10.8 to 11.5] for cardiovascular-related causes. All-cause, non-cardiovascular, and cardiovascular hospitalizations were associated with older age ([greater than or equal to]65 versus 45 to 64 years), more proteinuria ([greater than or equal to]150 to Conclusions In this study, we observed that adults with CKD had a higher hospitalization rate than the general population that is hospitalized, and even moderate reductions in kidney function were associated with elevated rates of hospitalization. Causes of hospitalization were predominantly related to cardiovascular disease, but other causes contributed, particularly, genitourinary, digestive, and endocrine, nutritional, and metabolic illnesses. High levels of proteinuria were observed to have the largest association with hospitalizations across a wide range of kidney function levels., Author(s): Sarah J. Schrauben 1,2,3,*, Hsiang-Yu Chen 3, Eugene Lin 4, Christopher Jepson 5, Wei Yang 3, Julia J. Scialla 6, Michael J. Fischer 7,8, James P. Lash 8, Jeffrey [...]

Background: The serotonin transporter (SERT) mRNA was previously reported to be a quantitative and pathophysiology‐based biomarker of heavy drinking in 5HTTLPR:LL genotype‐carriers treated with ondansetron. Here, we validated the potential use of SERT mRNA for quantitative prediction of recent alcohol consumption (in the absence of treatment) and compared it with the known biomarkers ethyl glucuronide (EtG) and ethyl sulfate (EtS). Methods: Binge drinking men and women of European ancestry aged 21 to 65 years were enrolled in a 12‐day, in‐patient, randomized, double‐blind, crossover study, where they were administered three beverage doses (placebo, 0.5 g/kg [0.4 g/kg] ethanol, and 1 g/kg [0.9 g/kg] ethanol for men [women]) individually in three 4‐day periods (experiments), separated by minimum 7‐day washout period. Diet, sleep, and physical activity were controlled throughout the inpatient experiments. Twenty‐nine participants were randomized to receive beverage doses counterbalancing the sequence of treatment and gender within subgroups stratified by SERT genotypes 5HTTLPR:LL+rs25531:AA (LALA) versus 5HTTLPR:LS/SS. Peripheral venous blood was collected daily for (1) quantification of SERT mRNA (the primary outcome measure) using qRT‐PCR and (2) plasma EtG and EtS levels using tandem mass‐spectrometry. Results: The association between administered beverage dose and SERT mRNA from completers of at least one 4‐day experiment (N = 18) assessed by a linear mixed model was not statistically significant. Significant positive associations were found with beverage dose and plasma EtG, EtS and EtG/EtS ratio (β = 5.8, SE = 1.2, p < 0.0001; β = 1.3, SE = 0.6, p = 0.023; and β = 3.0, SE = 0.7, p < 0.0001, respectively; the C‐statistics for discriminating outcomes were 0.97, 0.8, and 0.92, respectively). Additionally, we observed a sequence effect with a greater placebo effect on SERT mRNA when it was administered during the first experiment (p = 0.0009), but not on EtG/EtS measures. Conclusion: The findings do not validate the use of SERT as a biomarker of heavy drinking. Larger and more innovative studies addressing the effects of placebo, race, gender, and response to treatment with serotonergic agents are needed to fully assess the utility of SERT as a biomarker of heavy and binge drinking. [ABSTRACT FROM AUTHOR]

Metformin has been shown to repress transcription of the bile salt export pump (BSEP) in human primary hepatocytes. The primary objective of this study was to assess the effect of oral metformin on the human pharmacokinetics (PKs) of two BSEP probe substrates: pravastatin and chenodeoxycholic acid (CDCA; also known as chenodiol). Endogenous bile acid levels were assessed as a secondary measure of metformin impact. An open‐label, randomized, single‐dose, placebo‐controlled, fasted, crossover PK study was conducted in 12 healthy adult volunteers. Metformin (500 mg b.i.d.) or placebo (b.i.d.) was administered orally for 6 days. On day 7, a single dose of the BSEP substrates pravastatin (80 mg) and CDCA (250 mg) were administered orally. Plasma samples were quantified for pravastatin, CDCA, and endogenous bile acids. Compared to placebo, metformin increased pravastatin plasma exposure, did not impact CDCA plasma exposure, and reduced conjugated primary bile acid levels in the blood. These results are consistent with metformin repressing BSEP expression. This differential effect reflects the degree of enterohepatic recirculation of victim substrates. [ABSTRACT FROM AUTHOR]

BackgroundHealth information technology has become common in the care of patients with chronic diseases; however, there are few such applications employed in kidney disease. ObjectiveThe aim of the study was to evaluate the use of a website providing disease-specific safety information by patients with predialysis chronic kidney disease. MethodsAs part of the Safe Kidney Care (SKC) study, an educational website was designed to provide information on safety concerns in chronic kidney disease. Phase I study participants were provided a medical alert accessory with a unique ID number, the Safe Kidney Care website, and an in-person tutorial on the use of the Internet and accessing the SKC website at baseline. Participants were asked to visit the website and enter their unique ID as frequently as they desired over the next 365 days or until their annual follow-up visit, whichever occurred first. Participants’ visits and dwell times on specific safety modules were tracked using embedded webpage PHP scripts linked to a MySQL database, enabling the collection of website usage statistics. ResultsOf 108 Phase I participants, 28.7% (31/108) visited the website from 1-6 times during the observation period (median follow-up 365 days). Median access time was 7 minutes per visit (range

Background Patients with chronic kidney disease (CKD) face risks of not only end-stage kidney disease (ESKD), cardiovascular disease (CVD) and death, but also decline in kidney function, quality of life (QOL) and mental and physical well-being. This study describes the multidimensional trajectories of CKD using clinical events, kidney function and patient-reported outcome measures (PROMs). We hypothesized that more advanced CKD stages would associate with more rapid decline in each outcome. Methods Among 3939 participants enrolled in the Chronic Renal Insufficiency Cohort (CRIC) Study, we evaluated multidimensional disease trajectories by G- and A-stages of enrollment estimated glomerular filtration rate (eGFR) and albuminuria, respectively. These trajectories included clinical events (ESKD, CVD, heart failure and death), eGFR decline and PROMs [kidney disease QOL (KDQOL) burden, effects and symptoms questionnaires, as well as the 12-item short form mental and physical component summaries]. We also evaluated a group-based multitrajectory model to group participants on the basis of longitudinal PROMs and compared group assignments by enrollment G- and A-stage. Results The mean participant age was 58 years, 45% were women, mean baseline eGFR was 44 mL/min/1.73 m2 and median urine albumin:creatinine ratio was 52 mg/g. The incidence of all clinical events was greater and eGFR decline was faster with more advanced G- and A-stages. While baseline KDQOL and physical component measures were lower with more advanced G- and A-stage of CKD, changes in PROMs were inconsistently related to the baseline CKD stage. Groups formed on PROM trajectories were fairly distinct from existing CKD staging (observed agreement 60.6%) and were associated with the risk of ESKD, CVD, heart failure and death. Conclusions More advanced baseline CKD stage was associated with a higher risk of clinical events and faster eGFR decline, and was only weakly related to changes in patient-reported metrics over time. [ABSTRACT FROM AUTHOR]