Publications by authors named "Jesse Hsu"

51 Publications

Identification of distinct clinical subphenotypes in critically ill patients with COVID-19.

Chest 2021 May 5. Epub 2021 May 5.

Center for Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA; Pulmonary, Allergy and Critical Care Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.

Background: Subphenotypes have been identified in patients with sepsis and acute respiratory distress syndrome (ARDS), and are associated with different outcomes and response to therapies.

Research Question: Can unique subphenotypes be identified among critically ill patients with coronavirus disease 2019 (COVID-19)?

Study Design: & Methods: Using data from a multicenter cohort study that enrolled critically ill patients with COVID-19 from 67 hospitals across the United States, we randomly divided centers into Discovery and Replication cohorts. We utilized latent class analysis independently in each cohort to identify subphenotypes based on clinical and laboratory variables. We then analyzed the associations of subphenotypes with 28-day mortality.

Results: Latent class analysis identified four subphenotypes (SP) with consistent characteristics across Discovery (45 centers, n=2,188) and Replication (22 centers, n=1,112) cohorts. SP1 was characterized by shock, acidemia, and multi-organ dysfunction, including acute kidney injury treated with renal replacement therapy. SP2 was characterized by high C-reactive protein, early need for mechanical ventilation, and the highest rate of ARDS. SP3 had the highest burden of chronic diseases, while SP4 had limited chronic disease burden and mild physiologic abnormalities. 28-day mortality in the Discovery cohort ranged from 20.6% (SP4) to 52.9% (SP1). Mortality across subphenotypes remained different after adjustment for demographics, comorbidities, organ dysfunction and illness severity, regional and hospital factors: compared with SP4, SP1 relative risk (RR) 1.67 (95% CI 1.36-2.03); SP2 RR 1.39 (1.17-1.65); SP3 RR 1.39 (1.15-1.67). Findings were similar in the Replication cohort.

Interpretation: We identified four subphenotypes of COVID-19 critical illness with distinct patterns of clinical and laboratory characteristics, comorbidity burden, and mortality.
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http://dx.doi.org/10.1016/j.chest.2021.04.062DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8099539PMC
May 2021

Identification of Patient-Reported Outcome Phenotypes Among Oncology Patients With Palliative Care Needs.

JCO Oncol Pract 2021 Mar 24:OP2000849. Epub 2021 Mar 24.

Division of Hematology and Oncology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.

Purpose: Despite evidence-based guidelines recommending early palliative care, it remains unclear how to identify and refer oncology patients, particularly in settings with constrained access to palliative care. We hypothesize that patient-reported outcome (PRO) data can be used to characterize patients with palliative care needs. To determine if PRO data can identify latent phenotypes that characterize indications for specialty palliative care referral.

Methods: We conducted a retrospective study of self-reported symptoms on the Edmonton Symptom Assessment System collected from solid tumor oncology patients (n = 745) referred to outpatient palliative care. Data were collected as part of routine clinical care from October 2012 to March 2018 at eight community and academic sites. We applied latent profile analysis to identify PRO phenotypes and examined the association of phenotypes with clinical and demographic characteristics using multinomial logistic regression.

Results: We identified four PRO phenotypes: (1) Low Symptoms (n = 295, 39.6%), (2) Moderate Pain/Fatigue + Mood (n = 180, 24.2%), (3) Moderate Pain/Fatigue + Appetite + Dyspnea (n = 201, 27.0%), and (4) High Symptoms (n = 69, 9.3%). In a secondary analysis of 421 patients, we found that two brief items assessing social and existential needs aligned with higher severity symptom and psychological distress phenotypes.

Conclusion: Oncology patients referred to outpatient palliative care in a real-world setting can be differentiated into clinically meaningful phenotypes using brief, routinely collected PRO measures. Latent modeling provides a mechanism to use patient-reported data on a population level to identify distinct subgroups of patients with unmet palliative needs.
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http://dx.doi.org/10.1200/OP.20.00849DOI Listing
March 2021

Atrial Fibrillation and Longitudinal Change in Cognitive Function in CKD.

Kidney Int Rep 2021 Mar 5;6(3):669-674. Epub 2021 Jan 5.

Department of Medicine, University of Illinois at Chicago, Chicago, Illinois, USA.

Background: Studies in the general population suggest that atrial fibrillation (AF) is an independent risk factor for decline in cognitive function, but this relationship has not been examined in adults with chronic kidney disease (CKD). We investigated the association between incident AF and changes in cognitive function over time in this population.

Methods And Results: We studied a subgroup of 3254 adults participating in the Chronic Renal Insufficiency Cohort Study. Incident AF was ascertained by 12-lead electrocardiogram (ECG) obtained at a study visit and/or identification of a hospitalization with AF during follow-up. Cognitive function was assessed biennially using the Modified Mini-Mental State Exam. Linear mixed effects regression was used to evaluate the association between incident AF and longitudinal change in cognitive function. Compared with individuals without incident AF ( = 3158), those with incident AF ( = 96) were older, had a higher prevalence of cardiovascular disease and hypertension, and lower estimated glomerular filtration rate. After median follow-up of 6.8 years, we observed no significant multivariable association between incident AF and change in cognitive function test score.

Conclusion: In this cohort of adults with CKD, incident AF was not associated with a decline in cognitive function.
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http://dx.doi.org/10.1016/j.ekir.2020.12.023DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7938064PMC
March 2021

Effect of Kidney Function on Relationships between Lifestyle Behaviors and Mortality or Cardiovascular Outcomes: A Pooled Cohort Analysis.

J Am Soc Nephrol 2021 Mar 5;32(3):663-675. Epub 2021 Feb 5.

Renal, Electrolyte-Hypertension Division, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.

Background: Adherence to healthy behaviors reduces risks of cardiovascular disease and death in the general population. However, among people with kidney disease, a group at higher risk for cardiovascular disease, such benefits have not been established.

Methods: We pooled data from three cohort studies with a total of 27,271 participants. Kidney function was categorized on the basis of eGFR (≥60, 45 to <60, and <45 ml/min per 1.73 m). We used proportional hazard frailty models to estimate associations between healthy behaviors (not smoking, at recommended body mass index [BMI], physical activity, healthy diet, and moderate to no alcohol intake) and outcomes (all-cause death, major coronary events, ischemic stroke, and heart failure events).

Results: All recommended lifestyle behaviors were significantly associated with lower risks of death, regardless of eGFR. Not smoking (versus current) and any moderate to vigorous physical activity (versus none) was significantly associated with reduced risks of major coronary and heart failure events, regardless of eGFR. Any (versus no) moderate or vigorous physical activity significantly associated with decreased risk of ischemic stroke events only among those with eGFR ≥60. Moderate to no daily alcohol intake (versus excessive) was significantly associated with an increased risk of major coronary events, regardless of eGFR. For heart failure events, a BMI of 18.5 to 30 associated with decreased risk, regardless of eGFR. Across all eGFR categories, the magnitude of risk reduction for death and all cardiovascular outcomes increased with greater numbers of recommended lifestyle behaviors.

Conclusions: Recommended lifestyle behaviors are associated with lower risk of death and cardiovascular disease events among individuals with or without reduced kidney function, supporting lifestyle behaviors as potentially modifiable risk factors for people with kidney disease.
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http://dx.doi.org/10.1681/ASN.2020040394DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7920187PMC
March 2021

Clinical events and patient-reported outcome measures during CKD progression: findings from the CRIC study.

Nephrol Dial Transplant 2020 Dec 16. Epub 2020 Dec 16.

University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.

Background: Patients with chronic kidney disease (CKD) face risk of 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. We hypothesized that more advanced CKD stages would associate with more rapid decline in each outcome.

Methods: Among 3,939 participants enrolled in the Chronic Renal Insufficiency Cohort (CRIC) Study, we evaluated multidimensional disease trajectories by G- and A-stages of enrollment eGFR and albuminuria, respectively. These trajectories included clinical events (ESKD, CVD, heart failure, death), eGFR decline, and patient-reported outcome measures (kidney disease QOL [KDQOL] burden, effects, and symptoms questionnaires, as well as the short-form-12 mental and physical composite).We also evaluated a group-based multi-trajectory model to group participants on the basis of longitudinal patient-reported outcome measures and compared group assignments by enrollment G- and A-stage.

Results: Mean participant age was 58 years, 45% were women, mean baseline eGFR was 44 mL/min/1.73 m2, and median urine albumin-to-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 patient-reported outcome measures were inconsistently related to the baseline CKD stage. Groups formed on patient-reported outcome measure trajectories were fairly distinct from existing CKD staging (observed agreement, 60.6%) but also were associated with risk of ESKD, CVD, heart failure, and death.

Conclusions: More advanced baseline CKD stage was associated with higher risk of clinical events and faster eGFR decline, but was only weakly related to changes in patient-reported metrics over time.
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http://dx.doi.org/10.1093/ndt/gfaa364DOI Listing
December 2020

Acute Kidney Injury in Deceased Organ Donors and Kidney Transplant Outcomes: A National Cohort Study using a Novel Data Source.

Ann Surg 2020 Nov 13. Epub 2020 Nov 13.

Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA, USA.

Objective: To determine graft function and survival for kidney transplants from deceased donors with acute kidney injury (AKI) that persists at the time of organ procurement.

Background: Kidneys from donors with AKI are often discarded and may provide an opportunity to selectively expand the donor pool.

Methods: Using OPTN and DonorNet data, we studied adult kidney-only recipients between 5/1/2007-12/31/2016. DonorNet was used to characterize longitudinal creatinine trends and urine output. Donor AKI was defined using KDIGO guidelines and terminal creatinine ≥ 1.5 mg/dL. We compared outcomes between AKI kidneys versus "ideal comparator" kidneys from donors with no or resolved AKI stage 1 plus terminal creatinine < 1.5 mg/dL. We fit proportional hazards models and hierarchical linear regression models for the primary outcomes of all-cause graft failure (ACGF) and 12-month estimated glomerular filtration rate (eGFR), respectively.

Results: We identified 7,660 donors with persistent AKI (33.2% with AKI stage 3) from whom ≥1 kidney was transplanted. Observed rates of ACGF within 3 years were similar between recipient groups (15.5% in AKI vs 15.1% ideal comparator allografts, p = 0.2). After risk adjustment, ACGF was slightly higher among recipients of AKI kidneys (aHR 1.05, 95%CI:1.01-1.09). The mean 12-month eGFR for AKI kidney recipients was lower, but differences were not clinically important (56.6 vs. 57.5 mL/min/1.73m for ideal comparator kidneys; p < 0.001). There were 2,888 kidneys discarded from donors with AKI, age ≤ 65, without hypertension or diabetes, and terminal creatinine ≤ 4 mg/dL.

Conclusions: Kidney allografts from donors with persistent AKI are often discarded, yet those that were transplanted did not have clinically meaningful differences in graft survival and function.
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http://dx.doi.org/10.1097/SLA.0000000000004597DOI Listing
November 2020

Cardiac Biomarkers and Risk of Mortality in CKD (the CRIC Study).

Kidney Int Rep 2020 Nov 10;5(11):2002-2012. Epub 2020 Sep 10.

Kidney Research Institute, Seattle, Washington, USA.

Introduction: Cardiovascular disease (CVD) is the leading cause of mortality among individuals with chronic kidney disease (CKD). Cardiac biomarkers of myocardial distention, injury, and inflammation may signal unique pathways underlying CVD in CKD. In this analysis, we studied the association of baseline levels and changes in 4 traditional and novel cardiac biomarkers with risk of all-cause, CV, and non-CV mortality in a large cohort of patients with CKD.

Methods: Among 3664 adults with CKD enrolled in the Chronic Renal Insufficiency Cohort Study, we conducted a cohort study to examine the associations of baseline levels of N-terminal pro-B-type natriuretic peptide (NT-proBNP), cardiac high-sensitivity troponin T (hsTnT), growth differentiation factor-15 (GDF-15), and soluble ST-2 (sST-2) with risks of all-cause and cardiovascular (CV) mortality. Among a subcohort of 842 participants, we further examined the associations between change in biomarker levels over 2 years with risk of all-cause mortality. We used Cox proportional hazards regression models and adjusted for demographics, kidney function measures, cardiovascular risk factors, and medication use.

Results: After adjustment, elevated baseline levels of each cardiac biomarker were associated with increased risk of all-cause mortality: NT-proBNP (hazard ratio [HR] = 1.92, 95% confidence interval [CI] = 1.73-2.12); hsTnT (HR = 1.62, 95% CI = 1.48, 1.78]); GDF-15 (HR = 1.61, 95% CI = 1.46-1.78]); and sST-2 (HR = 1.26, CI = 1.16-1.37). Higher baseline levels of all 4 cardiac biomarkers were also associated with increased risk of CV. Declines in NT-proBNP (adjusted HR = 0.55, 95% CI = 0.36-0.86) and sST2 (HR = 0.55, 95% CI = 0.36-0.86]) over 2 years were associated with lower risk of all-cause mortality.

Conclusion: In a large cohort of CKD participants, elevations of NT-proBNP, hsTnT, GDF-15, and sST-2 were independently associated with greater risks of all-cause and CV mortality.
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http://dx.doi.org/10.1016/j.ekir.2020.08.028DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7609912PMC
November 2020

Systematic integrated analysis of genetic and epigenetic variation in diabetic kidney disease.

Proc Natl Acad Sci U S A 2020 11 3;117(46):29013-29024. Epub 2020 Nov 3.

Department of Medicine, Renal Electrolyte and Hypertension Division, University of Pennsylvania, Philadelphia, PA 19104;

Poor metabolic control and host genetic predisposition are critical for diabetic kidney disease (DKD) development. The epigenome integrates information from sequence variations and metabolic alterations. Here, we performed a genome-wide methylome association analysis in 500 subjects with DKD from the Chronic Renal Insufficiency Cohort for DKD phenotypes, including glycemic control, albuminuria, kidney function, and kidney function decline. We show distinct methylation patterns associated with each phenotype. We define methylation variations that are associated with underlying nucleotide variations (methylation quantitative trait loci) and show that underlying genetic variations are important drivers of methylation changes. We implemented Bayesian multitrait colocalization analysis (moloc) and summary data-based Mendelian randomization to systematically annotate genomic regions that show association with kidney function, methylation, and gene expression. We prioritized 40 loci, where methylation and gene-expression changes likely mediate the genotype effect on kidney disease development. Functional annotation suggested the role of inflammation, specifically, apoptotic cell clearance and complement activation in kidney disease development. Our study defines methylation changes associated with DKD phenotypes, the key role of underlying genetic variations driving methylation variations, and prioritizes methylome and gene-expression changes that likely mediate the genotype effect on kidney disease pathogenesis.
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http://dx.doi.org/10.1073/pnas.2005905117DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7682409PMC
November 2020

Anemia and Incident End-Stage Kidney Disease.

Kidney360 2020 Jul;1(7):623-630

Department of Medicine, University of Illinois at Chicago, Chicago, IL.

Background: Chronic kidney disease (CKD) progression can be a cause and potentially a consequence of anemia. Previous studies suggesting that anemia is associated with CKD progression have not utilized methodologic approaches to address time-dependent confounding.

Methods: We evaluated the association of anemia (defined using World Health Organization criteria of hemoglobin <12 g/dL in women and <13 g/dL in men) with incident ESRD and all-cause death in individuals with CKD using data from the Chronic Renal Insufficiency Cohort Study. Marginal structural models were used to account for time-dependent confounding.

Results: Among 3919 participants, 1859 (47.4%) had anemia at baseline. Over median follow up of 7.8 years, we observed 1,010 ESRD events and 994 deaths. In multivariable analyses, individuals with anemia had higher risk for ESRD compared to those without (HR 1.62, 95% CI 1.24-2.11). In stratified analyses, the increased risk for incident ESRD with anemia was observed in males (HR 2.15, 95% CI: 1.53-3.02) but not females (HR 1.20, 95% CI 0.82-1.78. The association between anemia and ESRD was significant among all racial/ethnic groups except non-Hispanic blacks (non-Hispanic white, HR 2.16, 95% CI 1.53-3.06; Hispanic, HR 1.92, 1.04-3.51; others, HR 2.94; 95% CI 1.16-7.44; non-Hispanic black, HR 1.39; 95% CI 0.95-2.02). There was no association between anemia and all-cause death.

Conclusions: In this cohort, anemia was independently associated with increased risk for incident ESRD. Future work is needed to evaluate the mechanisms by which anemia leads to CKD progression as well as the impact of novel therapeutic agents to treat anemia.
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http://dx.doi.org/10.34067/kid.0000852020DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7591144PMC
July 2020

Risk for Serious Infection With Low-Dose Glucocorticoids in Patients With Rheumatoid Arthritis : A Cohort Study.

Ann Intern Med 2020 12 22;173(11):870-878. Epub 2020 Sep 22.

University of Alabama at Birmingham, Birmingham, Alabama (L.C., F.X., H.Y., J.R.C.).

Background: Low-dose glucocorticoids are frequently used for the management of rheumatoid arthritis (RA) and other chronic conditions, but the safety of long-term use remains uncertain.

Objective: To quantify the risk for hospitalized infection with long-term use of low-dose glucocorticoids in patients with RA receiving stable disease-modifying antirheumatic drug (DMARD) therapy.

Design: Retrospective cohort study.

Setting: Medicare claims data and Optum's deidentified Clinformatics Data Mart database from 2006 to 2015.

Patients: Adults with RA receiving a stable DMARD regimen for more than 6 months.

Measurements: Associations between glucocorticoid dose (none, ≤5 mg/d, >5 to 10 mg/d, and >10 mg/d) and hospitalized infection were evaluated using inverse probability-weighted analyses, with 1-year cumulative incidence predicted from weighted models.

Results: 247 297 observations were identified among 172 041 patients in Medicare and 58 279 observations among 44 118 patients in Optum. After 6 months of stable DMARD use, 47.1% of Medicare patients and 39.5% of Optum patients were receiving glucocorticoids. The 1-year cumulative incidence of hospitalized infection in Medicare patients not receiving glucocorticoids was 8.6% versus 11.0% (95% CI, 10.6% to 11.5%) for glucocorticoid dose of 5 mg or less per day, 14.4% (CI, 13.8% to 15.1%) for greater than 5 to 10 mg/d, and 17.7% (CI, 16.5% to 19.1%) for greater than 10 mg/d (all < 0.001 vs. no glucocorticoids). The 1-year cumulative incidence of hospitalized infection in Optum patients not receiving glucocorticoids was 4.0% versus 5.2% (CI, 4.7% to 5.8%) for glucocorticoid dose of 5 mg or less per day, 8.1% (CI, 7.0% to 9.3%) for greater than 5 to 10 mg/d, and 10.6% (CI, 8.5% to 13.2%) for greater than 10 mg/d (all < 0.001 vs. no glucocorticoids).

Limitation: Potential for residual confounding and misclassification of glucocorticoid dose.

Conclusion: In patients with RA receiving stable DMARD therapy, glucocorticoids were associated with a dose-dependent increase in the risk for serious infection, with small but significant risks even at doses of 5 mg or less per day. Clinicians should balance the benefits of low-dose glucocorticoids with this potential risk.

Primary Funding Source: National Institute of Arthritis and Musculoskeletal and Skin Diseases.
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http://dx.doi.org/10.7326/M20-1594DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8073808PMC
December 2020

Noninvasive Ventilation Use Is Associated with Better Survival in Amyotrophic Lateral Sclerosis.

Ann Am Thorac Soc 2021 03;18(3):486-494

Department of Medicine.

Noninvasive ventilation (NIV) is standard of care in amyotrophic lateral sclerosis (ALS), yet few data exist regarding its benefits. We sought to identify whether the use of NIV was associated with survival in ALS. This was a single-center retrospective cohort study of 452 patients with ALS seen between 2006 and 2015. We matched one or more NIV subjects (prescribed NIV) to non-NIV subjects (never prescribed NIV) without replacement. The outcome was time from NIV prescription date (NIV subjects) or matched date (non-NIV subjects) until death. We performed a multivariable Cox proportional hazards model with NIV hourly usage as a time-varying covariate and stratified by matched groups. After creating 180 matched groups and adjusting for age, body mass index, ALS Functional Rating Scale Revised dyspnea score, and hourly NIV use, NIV was associated with a 26% reduction in the rate of death compared with non-NIV subjects (hazard ratio [HR], 0.74; 95% confidence interval [CI], 0.57-0.98;  = 0.04). Among those with limb-onset ALS, NIV subjects had a 37% lower rate of death compared with non-NIV subjects (HR, 0.63; 95% CI, 0.45-0.87;  = 0.006). Among NIV subjects, we found that NIV use for an average of ≥4 h/d was associated with improved survival. NIV use was associated with significantly better survival in ALS after matching and adjusting for confounders. Increasing duration of daily NIV use was associated with longer survival. Randomized clinical trials should be performed to identify ideal thresholds for improving survival and optimizing adherence in ALS.
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http://dx.doi.org/10.1513/AnnalsATS.202002-169OCDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7919153PMC
March 2021

Wide Variation in the Percentage of Donation After Circulatory Death Donors Across Donor Service Areas: A Potential Target for Improvement.

Transplantation 2020 08;104(8):1668-1674

Department of Surgery, University of Pennsylvania, Philadelphia, PA.

Background: Substantial differences exist in the clinical characteristics of donors across the 58 donor service areas (DSAs). Organ procurement organization (OPO) performance metrics incorporate organs donated after circulatory determination of death (DCDD) donors but do not measure potential DCDD donors.

Methods: Using 2011-2016 United Network for Organ Sharing data, we examined the variability in DCDD donors/all deceased donors (%DCDD) across DSAs. We supplemented United Network for Organ Sharing data with CDC death records and OPO statistics to characterize underlying process and system factors that may correlate with donors and utilization.

Results: Among 52 184 deceased donors, the %DCDD varied widely across DSAs, with a median of 15.1% (interquartile range [9.3%, 20.9%]; range 0.0%-32.0%). The %DCDD had a modest positive correlation with 4 DSA factors: median match model for end-stage liver disease, proportion of white deaths out of total deaths, kidney center competition, and %DCDD livers by a local transplant center (all Spearman coefficients 0.289-0.464), and negative correlation with 1 factor: mean kidney waiting time (Spearman coefficient -0.388). Adjusting for correlated variables in linear regression explained 46.3% of the variability in %DCDD.

Conclusions: Donor pool demographics, waitlist metrics, center competition, and DCDD utilization explain only a portion of the variability of DCDD donors. This requires further studies and policy changes to encourage consideration of all possible organ donors.
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http://dx.doi.org/10.1097/TP.0000000000003019DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7170761PMC
August 2020

Neighborhood socioeconomic status and risk of hospitalization in patients with chronic kidney disease: A chronic renal insufficiency cohort study.

Medicine (Baltimore) 2020 Jul;99(28):e21028

Department of Medicine, University of Illinois at Chicago, Chicago, IL.

Patients with chronic kidney disease (CKD) experience significantly greater morbidity than the general population. The hospitalization rate for patients with CKD is significantly higher than the general population. The extent to which neighborhood-level socioeconomic status (SES) is associated with hospitalization has been less explored, both in the general population and among those with CKD.We evaluated the relationship between neighborhood SES and hospitalizations for adults with CKD participating in the Chronic Renal Insufficiency Cohort Study. Neighborhood SES quartiles were created utilizing a validated neighborhood-level SES summary measure expressed as z-scores for 6 census-derived variables. The relationship between neighborhood SES and hospitalizations was examined using Poisson regression models after adjusting for demographic characteristics, individual SES, lifestyle, and clinical factors while taking into account clustering within clinical centers and census block groups.Among 3291 participants with neighborhood SES data, mean age was 58 years, 55% were male, 41% non-Hispanic white, 49% had diabetes, and mean estimated glomerular filtration rate (eGFR) was 44 ml/min/1.73 m. In the fully adjusted model, compared to individuals in the highest SES neighborhood quartile, individuals in the lowest SES neighborhood quartile had higher risk for all-cause hospitalization (rate ratio [RR], 1.28, 95% CI, 1.09-1.51) and non-cardiovascular hospitalization (RR 1.30, 95% CI, 1.10-1.55). The association with cardiovascular hospitalization was in the same direction but not statistically significant (RR 1.21, 95% CI, 0.97-1.52).Neighborhood SES is associated with risk for hospitalization in individuals with CKD even after adjusting for individual SES, lifestyle, and clinical factors.
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http://dx.doi.org/10.1097/MD.0000000000021028DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7360239PMC
July 2020

Impact of flow disruptions in the delivery room.

Resuscitation 2020 05 16;150:29-35. Epub 2020 Mar 16.

Department of Pediatrics, Division of Neonatology, The Children's Hospital of Philadelphia and The University of Pennsylvania Perelman School of Medicine, Division of Neonatology, 2(nd) Floor, Main Building, 3401 Civic Center Boulevard, Philadelphia, PA 19104, USA. Electronic address:

Aim: Flow disruptions (FDs) are deviations from the progression of care that compromise safety and efficiency of a specific process. The study aim was to identify the impact of FDs during neonatal resuscitation and determine their association with key process and outcome measures.

Methods: Prospective observational study of video recorded delivery room resuscitations of neonates <32 weeks gestational age. FDs were classified using an adaptation of Wiegmann's FD tool. The primary outcome was target oxygenation saturation achievement at 5 min. Secondary outcomes included achieving target saturation at 10 min, time to positive pressure ventilation for initially apnoeic/bradycardic neonates, time to electrocardiogram signal, time to pulse oximetry signal, and time to stable airway. Multivariable logistic regression assessed association between FDs and achieving target saturations adjusting for gestational age and leader. Associations between FDs and time to event outcomes were assessed using Cox proportional hazards models.

Results: Between 10/2017-7/2018, 32 videos were included. A mean of 52.6 FDs (standard deviation 17.9) occurred per resuscitation. Extraneous FDs were the most common FDs. FDs were associated with an adjusted odds ratio of 0.92 (95% confidence interval [CI] 0.80-1.05) of achieving target saturation at 5 min and 0.94 (95% CI 0.84-1.05) at 10 min. There was no significant evidence to show FDs were associated with time to event outcomes.

Conclusions: FDs occurred frequently during neonatal resuscitation. Measuring FDs is a feasible method to assess the impact of human factors in the delivery room and identify modifiable factors and practices to improve patient care.
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http://dx.doi.org/10.1016/j.resuscitation.2020.02.037DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7205586PMC
May 2020

Neighborhood Food Outlet Access and Dietary Intake among Adults with Chronic Kidney Disease: Results from the Chronic Renal Insufficiency Cohort Study.

J Acad Nutr Diet 2020 07 4;120(7):1151-1162.e3. Epub 2020 Mar 4.

Background: Healthy diet is essential in the management of chronic kidney disease (CKD) and preventing related comorbidities. Food outlet access has been studied in the general population; however, the influence of the local food environment on dietary intake among people with CKD has not been evaluated.

Objectives: This study examined the associations of food outlet density and type of outlets with dietary intake in a multicenter cohort of racially and ethnically diverse patients with CKD.

Methods: The Chronic Renal Insufficiency Cohort Study is a multicenter prospective study of patients with CKD that used a validated food frequency questionnaire to capture dietary intake at the baseline visit. This is a cross-sectional analysis of 2,484 participants recruited in 2003-2006 from seven Chronic Renal Insufficiency Cohort Study centers. Food outlet data were used to construct a count of the number of fast-food restaurants, convenience stores, and grocery stores per 10,000 population for each geocoded census block group. Multivariable linear and logistic regression models were used to evaluate the associations between measures of food outlet availability and dietary factors.

Results: The proportion of participants living in zero-, low-, and high-food outlet density areas differed by gender, race or ethnicity, and income level. Among male subjects, living in areas with zero or the highest number of outlets was associated with having the highest caloric intakes in multivariable models. Male subjects living in areas with zero outlets consumed the highest levels of sodium and phosphorous. Female subjects living in areas with zero outlets had the lowest average intake of calories, sodium, and phosphorous. Among low-income female subjects, close proximity to more outlets was associated with higher calorie consumption. Among all participants, access to fast-food restaurants was not associated with an unhealthy diet score, and access to grocery stores was not associated with a healthy diet score.

Conclusions: Average caloric and nutrient intakes differed by outlet availability; however, there were no strong associations with type of food outlet. This should be considered when developing food-focused public health policies.
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http://dx.doi.org/10.1016/j.jand.2019.12.013DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7321867PMC
July 2020

Comparative Effectiveness Analysis of Complex Lower Extremity Reconstruction: Outcomes and Costs for Biologically Based, Local Tissue Rearrangement, and Free Flap Reconstruction.

Plast Reconstr Surg 2020 03;145(3):608e-616e

From the Division of Plastic Surgery, Department of Surgery, University of Pennsylvania.

Background: Various surgical techniques exist for lower extremity reconstruction, but limited high-quality data exist to inform treatment strategies. Using multi-institutional data and rigorous matching, the authors evaluated the effectiveness and cost of three common surgical reconstructive modalities.

Methods: All adult subjects with lower extremity wounds who received bilayer wound matrix, local tissue rearrangement, or free flap reconstruction were retrospectively reviewed (from 2010 to 2017). Cohorts' comorbidities and wound characteristics were balanced. Graft success at 180 days was the primary outcome; readmissions, reoperations, and costs were secondary outcomes.

Results: Five hundred one subjects (166 matrix, 190 rearrangement, and 145 free flap patients) were evaluated. Matched subjects (n = 312; 104/group) were analyzed. Reconstruction success at 180 days for matrix, local tissue rearrangement, and free flaps was 69.2 percent, 91.3 percent, and 93.3 percent (p < 0.001), and total costs per subject were $34,877, $35,220, and $53,492 (p < 0.001), respectively. Median length of stay was at least 2 days longer for free flaps (p < 0.0001). Readmissions and reoperations were greater for free flaps. Local tissue rearrangement, if achievable, provided success at low cost. Free flaps were effective with large, traumatic wounds but at higher costs and longer length of stay. Matrices successfully treated older, obese patients without exposed bone.

Conclusions: Lower extremity reconstruction can be performed effectively using multiple modalities with varying degrees of success and costs. Local tissue rearrangement and free flaps demonstrate success rates greater than 90 percent. Bilayer wound matrix-based reconstruction effectively treats a distinct patient population.

Clinical Question/level Of Evidence: Therapeutic, III.
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http://dx.doi.org/10.1097/PRS.0000000000006589DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7043725PMC
March 2020

Prognostic values of left ventricular mass index in chronic kidney disease patients.

Nephrol Dial Transplant 2021 03;36(4):665-672

CNR-IFC, Clinical Epidemiology of Renal Diseases and Hypertension, Ospedali Riuniti, Reggio Calabria, Italy.

Background: Left ventricular hypertrophy is causally implicated in the high risk of death and heart failure (HF) in chronic kidney disease (CKD) patients. Whether the left ventricular mass index (LVMI) adds meaningful predictive power for mortality and de novo HF to simple risk models has not been tested in the CKD population.

Methods: We investigated this problem in 1352 CKD patients enrolled in the Chronic Renal Insufficiency Cohort (CRIC). LVMI was measured by echocardiography and the risks for death and HF were estimated by the Study of Heart and Renal Protection (SHARP) score, a well-validated risk score in CKD patients.

Results: During a median follow-up of 7.7 years, 326 patients died and 208 had de novo HF. The LVMI and the SHARP score and a cross-validated model for HF (CRIC model) were all significantly (P < 0.001) related to the risk of death and HF. LVMI showed a discriminatory power for death (Harrell's C index 66%) inferior to that of the SHARP score (71%) and the same was true for the risk of HF both in the test (LVMI 72%, CRIC model 79%) and in the validation cohort (LVMI 71%, CRIC model 74%). LVMI increased very little the discriminatory (2-3%) and the risk reclassification power (3.0-4.8%) by the SHARP score and the CRIC model for HF for the same outcomes.

Conclusions: In CKD, measurement of LVMI solely for the stratification of risk of death and perhaps for the risk of HF does not provide evident prognostic values in this condition.
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http://dx.doi.org/10.1093/ndt/gfz254DOI Listing
March 2021

Risk of Biologics and Glucocorticoids in Patients With Rheumatoid Arthritis Undergoing Arthroplasty: A Cohort Study.

Ann Intern Med 2019 06 21;170(12):825-836. Epub 2019 May 21.

University of Alabama at Birmingham, Birmingham, Alabama (L.C., F.X., S.Y., J.R.C.).

Background: Patients with rheumatoid arthritis (RA) are at increased risk for infection after arthroplasty, yet risks of specific biologic medications are unknown.

Objective: To compare risk for postoperative infection among biologics and to evaluate the risk associated with glucocorticoids.

Design: Retrospective cohort study.

Setting: Medicare and Truven MarketScan administrative data from January 2006 through September 2015.

Patients: Adults with RA who were having elective inpatient total knee or hip arthroplasty, either primary or revision, and had a recent infusion of or prescription for abatacept, adalimumab, etanercept, infliximab, rituximab, or tocilizumab before surgery.

Measurements: Propensity-adjusted analyses using inverse probability weights evaluated comparative risks for hospitalized infection within 30 days and prosthetic joint infection (PJI) within 1 year after surgery between biologics or with different dosages of glucocorticoids. Secondary analyses evaluated non-urinary tract hospitalized infections and 30-day readmissions.

Results: Among 9911 patients treated with biologics, 10 923 surgical procedures were identified. Outcomes were similar in patients who received different biologics. Compared with an 8.16% risk for hospitalized infection with abatacept, predicted risk from propensity-weighted models ranged from 6.87% (95% CI, 5.30% to 8.90%) with adalimumab to 8.90% (CI, 5.70% to 13.52%) with rituximab. Compared with a 2.14% 1-year cumulative incidence of PJI with abatacept, predicted incidence ranged from 0.35% (CI, 0.11% to 1.12%) with rituximab to 3.67% (CI, 1.69% to 7.88%) with tocilizumab. Glucocorticoids were associated with a dose-dependent increase in postoperative risk for all outcomes. Propensity-weighted models showed that use of more than 10 mg of glucocorticoids per day (vs. no glucocorticoid use) resulted in a predicted risk for hospitalized infection of 13.25% (CI, 9.72% to 17.81%) (vs. 6.78%) and a predicted 1-year cumulative incidence of PJI of 3.83% (CI, 2.13% to 6.87%) (vs. 2.09%).

Limitation: Residual confounding is possible, and sample sizes for rituximab and tocilizumab were small.

Conclusion: Risks for hospitalized infection, PJI, and readmission after arthroplasty were similar across biologics. In contrast, glucocorticoid use, especially with dosages above 10 mg/d, was associated with greater risk for adverse outcomes.

Primary Funding Source: Rheumatology Research Foundation, National Institutes of Health, and Bristol-Myers Squibb.
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http://dx.doi.org/10.7326/M18-2217DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7197029PMC
June 2019

Association of Kidney Transplant Center Volume With 3-Year Clinical Outcomes.

Am J Kidney Dis 2019 10 7;74(4):441-451. Epub 2019 May 7.

Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA; Renal-Electrolyte and Hypertension Division, University of Pennsylvania, Philadelphia, PA; Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, PA. Electronic address:

Rationale & Objective: A robust relationship between procedure volume and clinical outcomes has been demonstrated across many surgical fields. This study assessed whether a center volume-outcome relationship exists for contemporary kidney transplantation, specifically for diabetic recipients, older recipients (aged ≥65 years), and recipients of high kidney donor profile index (KDPI ≥ 85) kidneys.

Study Design: Retrospective cohort study.

Setting & Participants: Adult kidney-only transplant recipients who underwent transplantation between 2009 and 2013 (N = 79,581).

Exposures: The primary exposure variable was center volume, categorized into quartiles based on the total kidney transplantation volume. Quartile 1 (Q1) centers performed a mean of fewer than 66 kidney transplantations per year, whereas Q4 centers performed a mean of more than 196 kidney transplantations per year.

Outcomes: All-cause graft failure and mortality within 3 years of transplantation.

Analytical Approach: Multivariable Cox frailty models were used to adjust for donor characteristics, recipient characteristics, and cold ischemia time.

Results: Minor differences in rates of 3-year deceased donor all-cause graft failure across quartiles of center volume were observed (14.9% for Q1 vs 16.7% for Q4), including in subgroups (diabetic recipients, 18.4% for Q1 vs 19.7% for Q4; older recipients, 19.4% for Q1 vs 22.5% for Q4; recipients of high KDPI kidneys, 26.5% for Q1 vs 26.5% for Q4). Results were similar for 3-year mortality. After adjustment for donor, recipient, and graft characteristics using Cox regression, center volume was not significantly associated with all-cause graft failure or mortality within 3 years, except that diabetic recipients at Q3 centers had slightly lower mortality (compared with Q1 centers, adjusted HR of 0.85 [95% CI, 0.73-0.99]).

Limitations: Potential unmeasured confounding from patient comorbid conditions and organ selection.

Conclusions: These findings provide little evidence that care in higher volume centers is associated with better adjusted outcomes for kidney transplant recipients, even in populations anticipated to be at increased risk for graft failure or death.
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http://dx.doi.org/10.1053/j.ajkd.2019.02.019DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6756929PMC
October 2019

The TiME Trial: A Fully Embedded, Cluster-Randomized, Pragmatic Trial of Hemodialysis Session Duration.

J Am Soc Nephrol 2019 05 18;30(5):890-903. Epub 2019 Apr 18.

Department of Biostatistics, Epidemiology, and Informatics, and.

Background: Data from clinical trials to inform practice in maintenance hemodialysis are limited. Incorporating randomized trials into dialysis clinical care delivery should help generate practice-guiding evidence, but the feasibility of this approach has not been established.

Methods: To develop approaches for embedding trials into routine delivery of maintenance hemodialysis, we performed a cluster-randomized, pragmatic trial demonstration project, the Time to Reduce Mortality in ESRD (TiME) trial, evaluating effects of session duration on mortality (primary outcome) and hospitalization rate. Dialysis facilities randomized to the intervention adopted a default session duration ≥4.25 hours (255 minutes) for incident patients; those randomized to usual care had no trial-driven approach to session duration. Implementation was highly centralized, with no on-site research personnel and complete reliance on clinically acquired data. We used multiple strategies to engage facility personnel and participating patients.

Results: The trial enrolled 7035 incident patients from 266 dialysis units. We discontinued the trial at a median follow-up of 1.1 years because of an inadequate between-group difference in session duration. For the primary analysis population (participants with estimated body water ≤42.5 L), mean session duration was 216 minutes for the intervention group and 207 minutes for the usual care group. We found no reduction in mortality or hospitalization rate for the intervention versus usual care.

Conclusions: Although a highly pragmatic design allowed efficient enrollment, data acquisition, and monitoring, intervention uptake was insufficient to determine whether longer hemodialysis sessions improve outcomes. More effective strategies for engaging clinical personnel and patients are likely required to evaluate clinical trial interventions that are fully embedded in care delivery.
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http://dx.doi.org/10.1681/ASN.2018090945DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6493975PMC
May 2019

Changes in Alcohol Use and Associations With Disease Activity, Health Status, and Mortality in Rheumatoid Arthritis.

Arthritis Care Res (Hoboken) 2020 03 12;72(3):301-308. Epub 2020 Feb 12.

University of Nebraska Medical Center, Omaha, and Forward, The National Databank for Rheumatic Diseases, Wichita, Kansas.

Objective: Better disease activity and quality of life have been observed among patients with rheumatoid arthritis (RA) who drink alcohol. This association might be explained by reverse causality. We undertook this study to identify predictors of change in alcohol use and to evaluate independent associations between alcohol use and RA activity and mortality.

Methods: Participants in Forward, The National Databank for Rheumatic Diseases, were asked about alcohol use (any versus none), and disease activity was collected through the Patient Activity Scale-II (PAS-II) on semiannual surveys. We identified factors associated with changes in alcohol use and determined associations between alcohol use and disease activity and mortality using linear and logistic regression models, Cox proportional hazards models, and marginal structural models.

Results: A total of 121,280 observations were studied among 16,762 unique participants. Discontinuation and initiation of alcohol were common among drinkers and abstainers (8.2% and 9.2% of observations, respectively). Greater discontinuation and less initiation were observed with greater disease activity, older age, female sex, nonwhite race, obesity, greater comorbidity, low quality of life, low educational level, low income, and work disability. While alcohol users had lower PAS-II (β = -0.15 [95% confidence interval (95% CI) -0.18, -0.11], P < 0.001) and a lower mortality (odds ratio 0.87 [95% CI 0.76, 0.98], P = 0.03) in traditional models, associations were not seen in marginal structural models.

Conclusion: Higher disease activity, disability, comorbidity, and poor quality of life contribute to reductions in alcohol use. Active use and changes in use were not associated with disease activity or mortality when adjusting for confounding, suggesting no clear benefit of alcohol consumption in RA.
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http://dx.doi.org/10.1002/acr.23847DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6754326PMC
March 2020

Insulin resistance and chronic kidney disease progression, cardiovascular events, and death: findings from the chronic renal insufficiency cohort study.

BMC Nephrol 2019 02 20;20(1):60. Epub 2019 Feb 20.

Division of Renal-Electrolyte and Hypertension, Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, 19103, PA, USA.

Background: Insulin resistance contributes to the metabolic syndrome, which is associated with the development of kidney disease. However, it is unclear if insulin resistance independently contributes to an increased risk of chronic kidney disease (CKD) progression or CKD complications. Additionally, predisposing factors responsible for insulin resistance in the absence of diabetes in CKD are not well described. This study aimed to describe factors associated with insulin resistance and characterize the relationship of insulin resistance to CKD progression, cardiovascular events and death among a cohort of non-diabetics with CKD.

Methods: Data was utilized from Chronic Renal Insufficiency Cohort Study participants without diabetes (N = 1883). Linear regression was used to assess associations with insulin resistance, defined using the Homeostasis Model Assessment of Insulin Resistance (HOMA-IR). The relationship of HOMA-IR, fasting glucose, hemoglobin A1c (HbA1c), and C-peptide with CKD progression, cardiovascular events, and all-cause mortality was examined with Cox proportional hazards models.

Results: Novel positive associations with HOMA-IR included serum albumin, uric acid, and hemoglobin A1c. After adjustment, HOMA-IR was not associated with CKD progression, cardiovascular events, or all-cause mortality. There was a notable positive association of one standard deviation increase in HbA1c with the cardiovascular endpoint (HR 1.16, 95% CI: 1.00-1.34).

Conclusion: We describe potential determinants of HOMA-IR among a cohort of non-diabetics with mild-moderate CKD. HOMA-IR was not associated with renal or cardiovascular events, or all-cause mortality, which adds to the growing literature describing an inconsistent relationship of insulin resistance with CKD-related outcomes.
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http://dx.doi.org/10.1186/s12882-019-1220-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6383235PMC
February 2019

Timing of Abatacept Before Elective Arthroplasty and Risk of Postoperative Outcomes.

Arthritis Care Res (Hoboken) 2019 09 11;71(9):1224-1233. Epub 2019 Jul 11.

University of Alabama at Birmingham.

Objective: Guidelines recommend withholding biologic therapies before hip and knee arthroplasty, yet evidence to inform optimal timing is limited. The aim of this study was to determine whether withholding abatacept infusions is associated with lower risk of adverse postoperative outcomes.

Methods: This retrospective cohort study, which used US Medicare and Truven MarketScan administrative data from January 2006 to September 2015, evaluated adults with rheumatoid arthritis who received intravenous abatacept (precisely dated in claims data) within 6 months of elective primary or revision hip or knee arthroplasty. Propensity weighted analyses using inverse probability weights compared the risk of 30-day hospitalized infection and 1-year prosthetic joint infection (PJI) between patients with different abatacept stop timing (time between last infusion and surgery). Secondary analyses evaluated nonurinary hospitalized infections and 30-day readmissions.

Results: After 1,939 surgeries among 1,780 patients, there were 175 hospitalized infections (9.0%), 115 nonurinary hospitalized infections (5.9%), 39 PJIs (2.4/100 person-years), and 114/1,815 30-day readmissions (6.3%). There were no significant differences in outcomes with abatacept stop timing <4 weeks (1 dosing interval) versus 4-8 weeks (hospitalized infection odds ratio [OR] 0.93 [95% confidence interval (95% CI) 0.65-1.34]; nonurinary hospitalized infection OR 0.93 [95% CI 0.60-1.44]; PJI hazard ratio 1.29 [95% CI 0.62-2.69]; 30-day readmission OR 1.00 [95% CI 0.65-1.54]). Similarly, there were no significant differences in outcomes with abatacept stop timing <4 weeks versus ≥8 weeks. Glucocorticoid use >7.5 mg/day was associated with greater risk of hospitalized infection (OR 2.19 [95% CI 1.28-3.77]) and nonurinary hospitalized infection (OR 2.38 [95% CI 1.22-4.64]).

Conclusion: Compared to continuing intravenous abatacept, withholding abatacept for ≥4 weeks (one dosing interval) before surgery was not associated with a lower risk of hospitalized infection, nonurinary hospitalized infection, PJI, or 30-day readmission.
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http://dx.doi.org/10.1002/acr.23843DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6689456PMC
September 2019

Health Behaviors in Younger and Older Adults With CKD: Results From the CRIC Study.

Kidney Int Rep 2019 Jan 17;4(1):80-93. Epub 2018 Sep 17.

Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, USA.

Introduction: A cornerstone of kidney disease management is participation in guideline-recommended health behaviors. However, the relationship of these health behaviors with outcomes, and the identification of barriers to health behavior engagement, have not been described among younger and older adults with chronic kidney disease.

Methods: Data from a cohort study of 5499 individuals with chronic kidney disease was used to identify health behavior patterns with latent class analysis stratified by age <65 and ≥65 years. Cox models, stratified by diabetes, assessed the association of health behavior patterns with chronic kidney disease (CKD) progression, atherosclerotic events, and death. Logistic regression was used to assess for barriers to health behavior engagement.

Results: Three health behavior patterns were identified: 1 "healthy" pattern, and 2 "less healthy" patterns comprising 1 pattern with more obesity and sedentary activity and 1 with more smoking and less obesity. Less healthy patterns were associated with an increased hazard of poor outcomes. Among participants <65 years of age, the less healthy patterns (vs. healthy pattern) was associated with an increased hazard of death in diabetic individuals (hazard ratio [HR] = 2.17, 95% confidence interval [CI] = 1.09-4.29; and HR = 2.50, 95% CI = 1.39-4.50) and cardiovascular events among nondiabetic individuals (HR = 1.49, 95% CI = 1.04-2.43; and HR = 2.97, 95% CI = 1.49-5.90). Individuals with the more obese/sedentary pattern had an increased risk of CKD progression in those who were diabetic (HR = 1.34, 95% CI = 1.13-1.59). Among older adults, the less healthy patterns were associated with increased risk of death (HR = 2.97, 95% CI = 1.43-6.19; and HR = 3.47, 95% CI = 1.48-8.11) in those who were nondiabetic. Potential barriers to recommended health behaviors include lower health literacy and self-efficacy.

Conclusion: Identifying health behavior patterns and barriers may help target high-risk groups for strategies to increase participation in health behaviors.
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http://dx.doi.org/10.1016/j.ekir.2018.09.003DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6308910PMC
January 2019

Safety and cardiovascular efficacy of spironolactone in dialysis-dependent ESRD (SPin-D): a randomized, placebo-controlled, multiple dosage trial.

Kidney Int 2019 04 23;95(4):973-982. Epub 2018 Nov 23.

Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA; Renal, Electrolyte and Hypertension Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.

The safety and efficacy of spironolactone is uncertain in end-stage renal disease. We randomized 129 maintenance hemodialysis patients to placebo (n=51) or spironolactone 12.5 mg (n=27), 25 mg (n=26), or 50 mg (n=25) daily for 36 weeks in a double-blind, placebo-controlled, multiple dosage trial to assess safety, tolerability and feasibility and to explore cardiovascular efficacy. The primary safety endpoints were hyperkalemia (potassium > 6.5 mEq/L) and hypotension requiring emergency department visit or hospitalization. Diastolic function was assessed by Doppler echocardiography. 125 participants (97%) completed dose escalation, with no significant difference in permanent study drug discontinuation between the groups (27.5% in placebo versus 16.7% in the combined spironolactone groups and 28% in the 50 mg group). Hyperkalemia frequency was similar between spironolactone and placebo (0.49 versus 0.50 events per patient-year) but demonstrated a significant linear trend due primarily to an increased event rate at the 50 mg dose (0.89 events per patient-year). The primary hypotension outcome was infrequent and similar with spironolactone and placebo (0.11 versus 0 events per patient-year). Gynecomastia was rare and did not differ significantly between groups. Change in diastolic function was similar with spironolactone and placebo. Spironolactone appears safe in carefully monitored maintenance hemodialysis patients, but did not affect cardiovascular parameters in this small study. Hyperkalemia occurs more frequently as dosage increases to 50 mg daily.
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http://dx.doi.org/10.1016/j.kint.2018.08.034DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6431563PMC
April 2019

Patient Experience with Primary Care Physician and Risk for Hospitalization in Hispanics with CKD.

Clin J Am Soc Nephrol 2018 11 18;13(11):1659-1667. Epub 2018 Oct 18.

Department of Medicine, University of Illinois at Chicago, Chicago, Illinois;

Background And Objectives: In the general population, the quality of the patient experience with their primary care physician may influence health outcomes but this has not been evaluated in CKD. This is relevant for the growing Hispanic CKD population, which potentially faces challenges to the quality of the patient experience related to language or cultural factors. We evaluated the association between the patient experience with their primary care physician and outcomes in Hispanics with CKD.

Design, Setting, Participants, & Measurements: This prospective observational study included 252 English- and Spanish-speaking Hispanics with entry eGFR of 20-70 ml/min per 1.73 m, enrolled in the Hispanic Chronic Renal Insufficiency Cohort study between 2005 and 2008. Patient experience with their primary care physician was assessed by the Ambulatory Care Experiences Survey subscales: communication quality, whole-person orientation, health promotion, interpersonal treatment, and trust. Poisson and proportional hazards models were used to assess the association between the patient experience and outcomes, which included hospitalization, ESKD, and all-cause death.

Results: Participants had a mean age of 56 years, 38% were women, 80% were primary Spanish speakers, and had a mean eGFR of 38 ml/min per 1.73 m. Over 4.8 years (median) follow-up, there were 619 hospitalizations, 103 ESKD events, and 56 deaths. As compared with higher subscale scores, lower scores on four of the five subscales were associated with a higher adjusted rate ratio (RR) for all-cause hospitalization (communication quality: RR, 1.54; 95% confidence interval [95% CI], 1.25 to 1.90; health promotion: RR, 1.31; 95% CI, 1.05 to 1.62; interpersonal treatment: RR, 1.50; 95% CI, 1.22 to 1.85; and trust: RR, 1.57; 95% CI, 1.27 to 1.93). There was no significant association of subscales with incident ESKD or all-cause death.

Conclusions: Lower perceived quality of the patient experience with their primary care physician was associated with a higher risk of hospitalization.
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http://dx.doi.org/10.2215/CJN.03170318DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6237062PMC
November 2018

Incident Type 2 Diabetes Among Individuals With CKD: Findings From the Chronic Renal Insufficiency Cohort (CRIC) Study.

Am J Kidney Dis 2019 01 1;73(1):72-81. Epub 2018 Sep 1.

Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA; Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, PA.

Rationale & Objective: Few studies have examined incident type 2 diabetes mellitus (T2DM) in chronic kidney disease (CKD). Our objective was to examine rates of and risk factors for T2DM in CKD, using several alternative measures of glycemic control.

Study Design: Prospective cohort study.

Setting & Participants: 1,713 participants with reduced glomerular filtration rates and without diabetes at baseline, enrolled in the Chronic Renal Insufficiency Cohort (CRIC) Study.

Predictors: Measures of kidney function and damage, fasting blood glucose, hemoglobin A (HbA), HOMA-IR (homeostatic model assessment of insulin resistance), demographics, family history of diabetes mellitus (DM), smoking status, medication use, systolic blood pressure, triglyceride level, high-density lipoprotein cholesterol level, body mass index, and physical activity.

Outcome: Incident T2DM (defined as fasting blood glucose ≥ 126mg/dL or prescription of insulin or oral hypoglycemic agents).

Analytical Approach: Concordance between fasting blood glucose and HbA levels was assessed using κ. Cause-specific hazards modeling, treating death and end-stage kidney disease as competing events, was used to predict incident T2DM.

Results: Overall T2DM incidence rate was 17.81 cases/1,000 person-years. Concordance between fasting blood glucose and HbA levels was low (κ for categorical versions of fasting blood glucose and HbA = 13%). Unadjusted associations of measures of kidney function and damage with incident T2DM were nonsignificant (P ≥ 0.4). In multivariable models, T2DM was significantly associated with fasting blood glucose level (P = 0.002) and family history of DM (P = 0.03). The adjusted association of HOMA-IR with T2DM was comparable to that of fasting blood glucose level; the association of HbA level was nonsignificant (P ≥ 0.1). Harrell's C for the models ranged from 0.62 to 0.68.

Limitations: Limited number of outcome events; predictors limited to measures taken at baseline.

Conclusions: The T2DM incidence rate among individuals with CKD is markedly higher than in the general population, supporting the need for greater vigilance in this population. Measures of glycemic control and family history of DM were independently associated with incident T2DM.
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http://dx.doi.org/10.1053/j.ajkd.2018.06.017DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6309655PMC
January 2019

Comparative Effectiveness of Retromuscular and Intraperitoneal Repair: What Is the Value of Posterior Sheath Reconstruction?

Plast Reconstr Surg 2018 05;141(5):733e-741e

Philadelphia, Pa.; and Lexington, Ky.

Background: The authors hypothesize that posterior sheath reconstruction to achieve retromuscular mesh placement provides outcomes comparable to traditional retromuscular mesh placement and superior to intraperitoneal repair.

Methods: Patients were divided into three groups: (1) retromuscular mesh placement with repaired posterior sheath defects, (2) retromuscular repair with an intact posterior sheath, and (3) intraperitoneal repair. Primary outcomes included recurrence, surgical-site occurrences, and cost.

Results: Overall, 179 patients were included. Posterior sheath defects were repaired primarily with absorbable suture or biological mesh. Recurrence rates differed significantly between standard retromuscular repair and intraperitoneal repair groups (p < 0.009), trended toward significance between repaired posterior sheath and intraperitoneal repair groups (p < 0.058), and showed no difference between repaired posterior sheath and standard retromuscular repair (p < 0.608). Retromuscular repair was clinically protective and cost-effective.

Conclusions: This analysis of posterior sheath reconstruction suggests outcomes comparable to traditional retromuscular repair and a trend toward superiority compared with intraperitoneal repair. Achieving retromuscular closure appears to demonstrate clinical and cost efficacy.

Clinical Question/level Of Evidence: Therapeutic, III.
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http://dx.doi.org/10.1097/PRS.0000000000004298DOI Listing
May 2018

CKD Self-management: Phenotypes and Associations With Clinical Outcomes.

Am J Kidney Dis 2018 09 24;72(3):360-370. Epub 2018 Mar 24.

Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, PA.

Background: To slow chronic kidney disease (CKD) progression and its complications, patients need to engage in self-management behaviors. The objective of this study was to classify CKD self-management behaviors into phenotypes and assess the association of these phenotypes with clinical outcomes.

Study Design: Prospective cohort study.

Setting & Participants: Adults with mild to moderate CKD enrolled in the Chronic Renal Insufficiency Cohort (CRIC) Study. 3,939 participants in the CRIC Study recruited between 2003 and 2008 served as the derivation cohort and 1,560 participants recruited between 2013 and 2015 served as the validation cohort.

Predictors: CKD self-management behavior phenotypes.

Outcomes: CKD progression, atherosclerotic events, heart failure events, death from any cause.

Measurements: Latent class analysis stratified by diabetes was used to identify CKD self-management phenotypes based on measures of body mass index, diet, physical activity, blood pressure, smoking status, and hemoglobin A concentration (if diabetic); Cox proportional hazards models.

Results: 3 identified phenotypes varied according to the extent of implementation of recommended CKD self-management behaviors: phenotype I characterized study participants with the most recommended behaviors; phenotype II, participants with a mixture of recommended and not recommended behaviors; and phenotype III, participants with minimal recommended behaviors. In multivariable-adjusted models for those with and without diabetes, phenotype III was strongly associated with CKD progression (HRs of 1.82 and 1.49), death (HRs of 1.95 and 4.14), and atherosclerotic events (HRs of 2.54 and 1.90; each P < 0.05). Phenotype II was associated with atherosclerotic events and death among those with and without diabetes.

Limitations: No consensus definition of CKD self-management; limited to baseline behavior data.

Conclusions: There are potentially 3 CKD self-management behavior phenotypes that distinguish risk for clinical outcomes. These phenotypes may inform the development of studies and guidelines regarding optimal self-management.
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http://dx.doi.org/10.1053/j.ajkd.2018.01.047DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6109611PMC
September 2018