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1.  Race modifies the association between adiposity and inflammation in patients with chronic kidney disease: findings from the CRIC study 
Obesity (Silver Spring, Md.)  2014;22(5):1359-1366.
To examine the race-specific association of inflammation with adiposity and muscle mass in subjects with chronic kidney disease (CKD).
Design and Methods
Plasma concentration of IL-1β, IL-Receptor antagonist (IL-1RA), IL-6, IL-10, TNF-α, TGF-β, hs-CRP, fibrinogen, and serum albumin were measured in 3,939 Chronic Renal Insufficiency Cohort study participants. Bioelectric impedance analysis was used to determine body fat mass (BFM) and fat free mass (FFM).
Plasma levels of hs-CRP, fibrinogen, IL-1RA, IL-6, and TNF-α increased and serum albumin decreased across the quartiles of body mass index. In multivariable analysis, BFM and FFM were positively associated with hs-CRP, fibrinogen, IL-1β, IL-1RA and IL-6. One standard deviation (SD) increase in BFM and FFM was associated with 0.36 (95% CI 0.33, 0.39) and 0.26 (95% CI 0.22, 0.30) SD increase in log transformed hs-CRP, respectively (p<0.001). Race stratified analysis showed that the association between biomarkers and BFM and FFM differed by race, with Caucasians demonstrating a stronger association with markers of inflammation than African Americans.
BFA and FFM are positively associated with markers of inflammation in patients with CKD. Race stratified analysis showed that Caucasians have a stronger association with markers of inflammation compared to African Americans.
PMCID: PMC4327849  PMID: 24415732
Bioelectric impedance analysis; cytokines; acute phase proteins; muscle mass; Body mass index; African Americans
2.  Association of Serum Bicarbonate With Risk of Renal and Cardiovascular Outcomes in CKD: A Report From the Chronic Renal Insufficiency Cohort (CRIC) Study 
The purpose of this study is to evaluate serum bicarbonate as a risk factor for renal outcomes, cardiovascular events and mortality in patients with chronic kidney disease (CKD).
Study Design
Observational cohort study.
Setting & Participants
3939 participants with CKD stages 2-4 who enrolled in the Chronic Renal Insufficiency Cohort (CRIC) between June 2003 - December 2008.
Serum bicarbonate.
Renal outcomes, defined as end-stage renal disease (either initiation of dialysis or kidney transplantation) or 50% reduction in eGFR; atherosclerotic events (myocardial infarction, stroke, peripheral arterial disease); congestive heart failure events; and death.
Time to event.
The mean eGFR was 44.8 ± 16.8 (SD) mL/min/1.73 m2, and the median serum bicarbonate was 24 (IQR, 22-26) mEq/L. During a median follow-up of 3.9 years, 374 participants died, 767 had a renal outcome, and 332 experienced an atherosclerotic event and 391 had a congestive heart failure event. In adjusted analyses, the risk of developing a renal endpoint was 3% lower per mEq/L increase in serum bicarbonate (HR, 0.97; 95% CI, 0.94-0.99; p=0.01). The association was stronger for participants with eGFR> 45ml/min/1.73m2 (HR, 0.91; 95%CI, 0.85-0.97; p=0.004). The risk of heart failure increased by 14% (HR, 1.14; 95%CI, 1.03-1.26; p=0.02) per mEq/L increase in serum bicarbonate over 24 mEq/L. Serum bicarbonate was not independently associated with atherosclerotic events (HR, 0.99; 95%CI, 0.95-1.03; p=0.6) and all-cause mortality (HR, 0.98; 95%CI, 0.95-1.02; p=0.3).
Single measurement of sodium bicarbonate.
In a cohort of participants with CKD, low serum bicarbonate was an independent risk factor for kidney disease progression, particularly for participants with preserved kidney function. The risk of heart failure was higher at the upper extreme of serum bicarbonate. There was no association between serum bicarbonate and all-cause mortality or atherosclerotic events.
PMCID: PMC3701754  PMID: 23489677
metabolic acidosis; serum bicarbonate; chronic kidney disease; cardiovascular morbidity
3.  Effectiveness of Interventions in Reducing Antibiotic Use for Upper Respiratory Infections in Ambulatory Care Practices 
Population Health Management  2013;16(1):22-27.
The objective was to evaluate the effect of separate interventions on antimicrobial prescribing for uncomplicated upper respiratory tract infections. The authors conducted a quasi-experimental pre-post study with concurrent control groups for each intervention. Academic detailing led to a significant reduction in unnecessary antibiotic prescribing. However, there was no significant change in antibiotic prescribing in response to educational mailings to providers or to provider involvement in patient mailings. Organizations that seek to reduce inappropriate use of antibiotics should use proven approaches, even when they are more expensive. (Population Health Management 2013;16:22–27)
PMCID: PMC3595097  PMID: 23113630
4.  Adherence to Hepatitis C Virus Therapy in HIV/Hepatitis C-Coinfected Patients 
AIDS and behavior  2013;17(1):94-103.
Adherence to hepatitis C virus (HCV) therapy has been incompletely examined among HIV-infected patients. We assessed changes in interferon and ribavirin adherence and evaluated the relationship between adherence and early (EVR) and sustained virologic response (SVR). We performed a cohort study among 333 HIV/HCV-coinfected patients who received pegylated interferon and ribavirin between 2001 and 2006 and had HCV RNA before and after treatment. Adherence was calculated over 12-week intervals using pharmacy refills. Mean interferon and ribavirin adherence declined 2.5 and 4.1 percentage points per 12-week interval, respectively. Among genotype 1/4 patients, EVR increased with higher ribavirin adherence, but this association was less strong for interferon. SVR among these patients was higher with increasing interferon and ribavirin adherence over the first, second, and third, but not fourth, 12-week intervals. Among HIV/HCV patients, EVR and SVR increased with higher interferon and ribavirin adherence. Adherence to both antivirals declined over time, but more so for ribavirin.
PMCID: PMC3514597  PMID: 22907288
Adherence; hepatitis C virus; HIV; antiviral therapy; pegylated interferon; ribavirin
5.  Factors Associated With Depressive Symptoms and Use of Antidepressant Medications Among Participants in the Chronic Renal Insufficiency Cohort (CRIC) and Hispanic-CRIC Studies 
Depressive symptoms are correlated with poor health outcomes in adults with chronic kidney disease (CKD). The prevalence, severity, and treatment of depressive symptoms and potential risk factors, including level of kidney function, in diverse populations with CKD have not been well studied.
Study Design
Cross-sectional analysis
Settings and Participants
Participants at enrollment into the Chronic Renal Insufficiency Cohort (CRIC) and Hispanic-CRIC (H-CRIC) Studies. CRIC enrolled Hispanics and non-Hispanics at seven centers from 2003-2007, and H-CRIC enrolled Hispanics at the University of Illinois from 2005-2008.
Depressive symptoms measured by Beck Depression Inventory (BDI)
Demographic and clinical factors
Elevated depressive symptoms (BDI >= 11) and antidepressant medication use
Among 3853 participants, 28.5% had evidence of elevated depressive symptoms and 18.2% were using antidepressant medications; 30.8% of persons with elevated depressive symptoms were using antidepressants. The prevalence of elevated depressive symptoms varied by level of kidney function: 25.2% among participants with eGFR ≥ 60 ml/min/1.73m2, and 35.1% of those with eGFR < 30 ml/min/1.73m2. Lower eGFR (OR per 10 ml/min/1.73m2 decrease, 1.09; 95% CI, 1.03-1.16), Hispanic ethnicity (OR, 1.65; 95% CI, 1.12-2.45), and non-Hispanic black race (OR, 1.43; 95% CI, 1.17-1.74) were each associated with increased odds of elevated depressive symptoms after controlling for other factors. In regression analyses incorporating BDI score, while female sex was associated with a greater odds of antidepressant use, Hispanic ethnicity, non-Hispanic black race, and higher levels of urine albumin were associated with decreased odds of antidepressant use (p<0.05 for each).
Absence of clinical diagnosis of depression and use of non-pharmacologic treatments
Although elevated depressive symptoms were common in individuals with CKD, use of antidepressant medications is low. African Americans, Hispanics, and individuals with more advanced CKD had higher odds of elevated depressive symptoms and lower odds of antidepressant medication use.
PMCID: PMC3378778  PMID: 22497791
6.  Relationship of Estimated GFR and Coronary Artery Calcification in the (CRIC) Chronic Renal Insufficiency Cohort Study 
Coronary artery calcification (CAC) is associated with increased mortality risk in the general population. Although individuals with chronic kidney disease (CKD) are at markedly increased mortality risk, the incidence, prevalence, and prognosis of CAC in CKD is not well-understood.
Study Design
Cross-sectional observational study.
Setting and Participants
Analysis of 1,908 participants who underwent coronary calcium scanning as part of the multi-ethnic CRIC (Chronic Renal Insufficiency Cohort) Study.
Estimated glomerular filtration rate (eGFR) computed using the Modification of Diet in Renal Disease (MDRD) Study equation, stratified by race, sex and diabetic status. eGFR was treated as a continous variable and a categorical variable compared to the reference range of >60 ml/min/1.73 m2
CAC detected using CT scans using either an Imatron C-300 electron beam computed tomography scanner or multi-detector CT scanner. CAC was computed using the Agatston score, as a categorical variable. Analyses were performed using ordinal logistic regression.
We found a strong and graded relationship between lower eGFR and increasing CAC. In unadjusted models, ORs increased from 1.68 (95% CI, 1.23–2.31) for eGFR from 50–59 to 2.82 (95% CI, 2.06–3.85) for eGFR of <30. Multivariable adjustment only partially attenuated the results (OR, 1.53; 95% CI, 1.07–2.20) for eGFR<30.
Use of eGFR rather than measured GFR.
We demonstrated a graded relationship between severity of CKD and CAC, independent of traditional risk factors. These findings supports recent guidelines that state that if vascular calcification is present, it should be considered as a complementary component to be included in the decision making required for individualizing treatment of CKD.
PMCID: PMC3183168  PMID: 21783289
7.  Relationship between adherence to hepatitis C virus therapy and virologic outcomes: a cohort study 
Annals of Internal Medicine  2011;155(6):353-360.
Adherence to hepatitis C virus (HCV) therapy with pegylated interferon and ribavirin has been incompletely examined.
To evaluate the relationship between adherence to HCV therapy and early and sustained virologic response, assess changes in adherence over time, and examine risk factors for non-adherence.
Retrospective cohort study.
National Veterans Affairs Hepatitis C Clinical Case Registry
5,706 HCV-infected patients (genotypes 1, 2, 3, or 4) with at least one prescription for pegylated interferon and ribavirin between 2003 and 2006 and HCV RNA results prior to and after treatment initiation.
Adherence was calculated over 12-week intervals using pharmacy refill data. Endpoints included early virologic response (decrease of ≥2 log10 HCV RNA at 12 weeks) and sustained virologic response (undetectable HCV RNA 24 weeks after end of treatment).
Early virologic response increased with higher levels of ribavirin adherence over the initial 12 weeks of therapy (genotype 1, 4: 25/68 [37%] with the lowest category [≤40% adherence] versus 1,367/2,187 [63%] with the highest category [91–100% adherence], p<0.001; genotype 2, 3: 12/18 [67%] with ≤40% adherence versus 651/713 [91%] with 91–100% adherence, p<0.001). Among genotype 1 and 4 patients, sustained response increased with higher ribavirin adherence over the second, third, and fourth 12-week intervals. Results were similar for interferon adherence. Mean adherence to interferon and ribavirin decreased 3.4% and 6.6% per 12-week interval, respectively (test for trend, p<0.001 for each drug). Patients prescribed growth factors or thyroid medications during treatment had higher mean antiviral adherence.
Observational study without standardized timing for outcomes measurements.
Early and sustained virologic responses increased with higher levels of adherence to interferon and ribavirin. Adherence to both antivirals declined over time, but more so for ribavirin.
PMCID: PMC3366635  PMID: 21930852
Adherence; hepatitis C virus; HCV; antiviral therapy
8.  Metabolic Syndrome, Components, and Cardiovascular Disease Prevalence in Chronic Kidney Disease: Findings from the Chronic Renal Insufficiency Cohort (CRIC) Study 
American Journal of Nephrology  2011;33(6):477-484.
Metabolic syndrome may increase the risk for incident cardiovascular disease (CVD) and all-cause mortality in the general population. It is unclear whether, and to what degree, metabolic syndrome is associated with CVD in chronic kidney disease (CKD). We determined metabolic syndrome prevalence among individuals with a broad spectrum of kidney dysfunction, examining the role of the individual elements of metabolic syndrome and their relationship to prevalent CVD.
We evaluated four models to compare metabolic syndrome or its components to predict prevalent CVD using prevalence ratios in the Chronic Renal Insufficiency Cohort (CRIC) Study.
Among 3,939 CKD participants, the prevalence of metabolic syndrome was 65% and there was a significant association with prevalent CVD. Metabolic syndrome was more common in diabetics (87.5%) compared with non-diabetics (44.3%). Hypertension was the most prevalent component, and increased triglycerides the least prevalent. Using the bayesian information criterion, we found that the factors defining metabolic syndrome, considered as a single interval-scaled variable, was the best of four models of metabolic syndrome, both for CKD participants overall and for diabetics and non-diabetics separately.
The predictive value of this model for future CVD outcomes will subsequently be validated in longitudinal analyses.
PMCID: PMC3095834  PMID: 21525746
Cardiovascular disease; Chronic kidney disease; Chronic Renal Insufficiency Cohort (CRIC) Study; Metabolic syndrome
9.  Symptoms Characteristic of Heart Failure among CKD Patients without Diagnosed Heart Failure 
Journal of cardiac failure  2011;17(1):17-23.
Epidemiological studies typically diagnose heart failure (HF) at the time of hospitalization, and have not evaluated the prevalence of HF symptoms in CKD patients without a prior HF diagnosis.
Methods and Results
We modified the Kansas City Cardiomyopathy Questionnaire (KCCQ) to detect and quantify symptoms characteristic of HF (dyspnea, edema, and fatigue) among 2,883 CKD patients without diagnosed heart failure in the Chronic Renal Insufficiency Cohort (CRIC). The KCCQ is a 23-item instrument that quantifies the impact of dyspnea, fatigue and edema on physical, social, and emotional functions (scored 0–100). The median KCCQ score was 92, and 25% had KCCQ scores < 75. Compared with cystatin C-based eGFR >50ml/min/1.73m2 (reference), eGFR 40–50, 30–40, and <30 were independently associated with lower KCCQ scores (<75); adjusted odds ratios and (95% CI): 1.38 (1.06–1.78), 1.39 (1.09–1.82), and 2.15 (1.54–3.00), respectively. Lower hemoglobin (Hb) levels also had independent associations with KCCQ <75: Hb > 14 g/dL (reference), Hb 13–14 g/dL (1.03; 0.76–1.40), Hb 12–13 g/dL (1.41; 1.04–1.91), Hb 11–12 g/dL (1.56; 1.12–2.16); and Hb<11 g/dL (1.65; 1.15–2.37).
CKD patients without diagnosed HF have a substantial burden of symptoms characteristic of HF, particularly among those with lower eGFR and hemoglobin levels.
PMCID: PMC3011973  PMID: 21187260
hemoglobin; glomerular filtration rate
10.  Association of Metabolic Syndrome with Development of New Onset Diabetes After Transplantation 
Transplantation  2010;90(8):861-866.
New-onset diabetes after transplantation (NODAT) is a major post-transplant complication associated with lower allograft and recipient survival. Our objective was to determine if metabolic syndrome pre-transplant is independently associated with NODAT development.
We recruited 640 consecutive incident non-diabetic renal transplant recipients from 3 academic centers between 1999 and 2004. NODAT was defined as use of hypoglycemic medication, a random plasma glucose >200 mg/dL, or 2 fasting glucose levels ≥126 mg/dL beyond 30 days post-transplant.
Metabolic syndrome was common pre-transplant (57.2 %). NODAT developed in 31.4% of recipients one year post-transplant. Participants with metabolic syndrome were more likely to develop NODAT compared to recipients without metabolic syndrome (34.4% v. 27.4%, p=0.057). Recipients with increasing number of positive metabolic syndrome components were more likely to develop NODAT (metabolic syndrome score-prevalence at 1 year: 0-0.0%, 1-24.2, 2-29.3%, 3-31.0%, 4-34.8%, and 5-73.7%, p=0.001). After adjustment for demographics, age by decade (HR-1.34 (1.20-1.50), p<0.0001), African American race (HR-1.35 (1.01-1.82), p=0.043), cumulative prednisone dosage (HR-1.18 (1.07-1.30), p=0.001), and metabolic syndrome (HR-1.34 (1.00-1.79), p=0.047) were independent predictors of development of NODAT at 1 year post-transplant. In a multivariable analysis incorporating the individual metabolic syndrome components themselves as covariates, the only pre-transplant metabolic syndrome component to remain an independent predictor of NODAT was low HDL (HR-1.37 (1.01-1.85), p=0.042).
Metabolic syndrome is an independent predictor for NODAT and is a possible target for intervention to prevent NODAT. Future studies to evaluate if modification of metabolic syndrome factors pre-transplant reduces NODAT development are needed.
PMCID: PMC2959139  PMID: 20724958
Renal Transplant; NODAT; Metabolic Syndrome
11.  Hypertension Awareness, Treatment, and Control in Adults With CKD: Results From the Chronic Renal Insufficiency Cohort (CRIC) Study 
A low rate of blood pressure control has been reported among patients with chronic kidney disease (CKD). These data were derived from population-based samples with a low rate of CKD awareness.
Study Design
Setting & Participants
Data from the baseline visit of the Chronic Renal Insufficiency Cohort (CRIC) study (n=3612) were analyzed. Participants with an estimated glomerular filtration rate of 20 to 70 ml/min/1.73m2 were identified from physician offices and review of laboratory databases.
Prevalence and awareness of hypertension, treatment patterns, control rates and factors associated with hypertension control.
Following a standardized protocol, blood pressure was measured three times by trained staff and hypertension was defined as systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg and/or self-reported antihypertensive medication use. Patients’ awareness and treatment of hypertension were defined using self-report and two levels of hypertension control were evaluated: systolic/diastolic blood pressure <140/90 mmHg and <130/80 mmHg.
The prevalence of hypertension was 85.7%, and 98.9% of CRIC participants were aware of this diagnosis, 98.3% were treated with medications while 67.1% and 46.1% had their hypertension controlled to <140/90 mmHg and <130/80 mmHg, respectively. Of CRIC participants with hypertension, 15%, 25%, 26% and 32% were taking one, two, three and four or more antihypertensive medications, respectively. After multivariable adjustment, older patients, blacks, those with higher urinary albumin excretion were less likely while participants taking ACE-inhibitors and angiotensin receptor blockers were more likely to have controlled their hypertension to <140/90 mmHg and <130/80 mmHg.
Data were derived from a single study visit.
Despite almost universal hypertension awareness and treatment in this cohort of patients with CKD, rates of hypertension control were sub-optimal.
PMCID: PMC2866514  PMID: 19962808
12.  Extended Follow-up of interstitial cystitis patients Responsive to Treatment with Intravesical Bacillus Calmette Guerin or Placebo 
The Journal of urology  2007;179(2):552-555.
To evaluate longer-term response in subjects with interstitial cystitis (IC) who initially responded to intravesical bacillus Calmette-Guerin (BCG) or placebo in a randomized clinical trial.
Materials and Methods
Subjects with IC, who responded positively to treatment with either BCG or placebo after 34 weeks of follow-up in a double-blind clinical trial, were followed for an additional 34 weeks in an observational study to assess the durability of response. Outcomes at 68 weeks included a patient-reported global response assessment, a 24-hour voiding diary, pain, urgency, and validated IC symptom indices.
Thirty-eight of the responders to BCG or placebo in the clinical trial continued extended follow-up in the observational study. Twelve (75%) responders who received placebo and 19 (86%) responders who received BCG considered themselves to remain moderately or markedly improved at Week 68. Improved symptom outcomes were also generally maintained for the duration of follow-up in both groups.
The majority of subjects who respond to therapy with intravesical BCG or placebo maintain improved symptoms for up to 68 weeks after the initiation of therapy. However, initial response rates are low and placebo responders demonstrate essentially the same durability of response as BCG responders. These results argue against the routine use of BCG in this patient group.
PMCID: PMC2694727  PMID: 18082224
bacillus Calmette Guerin; BCG; interstitial cystitis; pain; quality of life
13.  Adherence to Hepatitis C Virus Therapy and Early Virologic Outcomes 
Suboptimal drug exposure attributable to physician-directed dosage reductions of pegylated interferon and/or ribavirin are associated with decreased sustained virologic response rates. However, data are limited with regard to suboptimal drug exposure that is attributable to missed doses by patients with chronic hepatitis C virus (HCV) infection. We examined the relationship between adherence to pegylated interferon and ribavirin therapy, measured by pharmacy refill, and HCV suppression during the initial 12 weeks of therapy.
We conducted a cohort study involving 188 patients with chronic HCV infection who were treated with pegylated interferon plus ribavirin. Adherence was calculated using pharmacy refill data and could exceed 100%. The primary outcome was decrease in HCV load at 12 weeks; early virologic response was a secondary outcome. Mixed-effects regression models estimated the association between adherence and HCV suppression during the initial 12 weeks. Subanalyses were performed among patients who received optimal weight-based dosages.
The mean decrease in HCV load at 12 weeks was 0.66 log IU/mL greater for patients with ⩾85% adherence than for those with <85% adherence (3.23 vs. 2.57 log IU/mL; P = 04). When patients who received a suboptimal ribavirin dosage were excluded, the decrease in viral load was 1.00 log IU/mL greater for persons with <85% adherence (3.32 vs. 2.32 log IU/mL; P = 01). Early virologic response was more common among patients with ⩾85% adherence than it was among those with <85% adherence to treatment with pegylated interferon (73% vs. 29%; P = 02) and ribavirin (73% vs. 55%; P = 08).
Adherence of ⩾85% to pegylated interferon and ribavirin treatment was associated with increased HCV suppression. Decreases in HCV load became greater when patients with ⩾85% adherence to their regimen continued to receive their recommended weight-based ribavirin dosage.
PMCID: PMC2668718  PMID: 19086908

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