Patient and Caregiver Priorities for Outcomes in CKD: A Multinational Nominal Group Technique Study.

RATIONALE & OBJECTIVE: Patients with chronic kidney disease (CKD) are at an increased risk for premature death, cardiovascular disease, and burdensome symptoms that impair quality of life. We aimed to identify patient and caregiver priorities for outcomes in CKD. STUDY DESIGN: Focus groups with nominal group technique. SETTING & PARTICIPANTS: Adult patients with CKD (all stages) and caregivers in the United States, Australia, and United Kingdom. ANALYTICAL APPROACH: Participants identified, ranked, and discussed outcomes that were important during the stages of CKD before kidney replacement therapy. For each outcome, we calculated a mean importance score (scale, 0-1). Qualitative data were analyzed using thematic analysis. RESULTS: 67 (54 patients, 13 caregivers) participated in 10 groups and identified 36 outcomes. The 5 top-ranked outcomes for patients were kidney function (importance score, 0.42), end-stage kidney disease (0.29), fatigue (0.26), mortality (0.25), and life participation (0.20); and for caregivers, the top 5 outcomes were life participation (importance score, 0.38), kidney function (0.37), mortality (0.23), fatigue (0.21), and anxiety (0.20). Blood pressure, cognition, and depression were consistently ranked in the top 10 outcomes across role (patient/caregiver), country, and treatment stage. Five themes were identified: re-evaluating and reframing life, intensified kidney consciousness, battling unrelenting and debilitating burdens, dreading upheaval and constraints, and taboo and unspoken concerns. LIMITATIONS: Only English-speaking participants were included. CONCLUSIONS: Patients and caregivers gave highest priority to kidney function, mortality, fatigue, life participation, anxiety, and depression. Consistent reporting of these outcomes in research may inform shared decision making based on patient and caregiver priorities in CKD.

Patient and Caregiver Perspectives on Terms Used to Describe Kidney Health.

BACKGROUND AND OBJECTIVES: The language used to communicate important aspects of kidney health is inconsistent and may be conceptualized differently by patients and health professionals. These problems may impair the quality of communication, care, and patient outcomes. We aimed to describe the perspectives of patients on terms used to describe kidney health. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: Patients with CKD (n=54) and caregivers (n=13) from the United States, United Kingdom, and Australia participated in ten focus groups to discuss terms for kidney health (including kidney, renal, CKD, ESKD, kidney failure, and descriptors for kidney function). We analyzed the data using thematic analysis. RESULTS: We identified four themes: provoking and exacerbating undue trauma (fear of the unknown, denoting impending death, despair in having incurable or untreatable disease, premature labeling and assumptions, judgment, stigma, and failure of self); frustrated by ambiguity (confused by medicalized language, lacking personal relevance, baffled by imprecision in meaning, and/or opposed to obsolete terms); making sense of the prognostic enigma (conceptualizing level of kidney function, correlating with symptoms and effect on life, predicting progression, and need for intervention); and mobilizing self-management (confronting reality, enabling planning and preparation, taking ownership for change, learning medical terms for self-advocacy, and educating others). CONCLUSIONS: The obscurity and imprecision of terms in CKD can be unduly distressing and traumatizing for patients, which can impair decision making and self-management. Consistent and meaningful patient-centered terminology may improve patient autonomy, satisfaction, and outcomes.

Kidney Function and Cardiovascular Events in Postmenopausal Women: The Impact of Race and Ethnicity in the Women's Health Initiative.

BACKGROUND: Kidney disease disproportionately affects minority populations, including African Americans and Hispanics; therefore, understanding the relationship of kidney function to cardiovascular (CV) outcomes within different racial/ethnic groups is of considerable interest. We investigated the relationship between kidney function and CV events and assessed effect modification by race/ethnicity in the Women's Health Initiative. STUDY DESIGN: Prospective cohort study. SETTING & PARTICIPANTS: Baseline serum creatinine concentrations (assay traceable to isotope-dilution mass spectrometry standard) of 19,411 postmenopausal women aged 50 to 79 years who self-identified as either non-Hispanic white (n=8,921), African American (n=7,436), or Hispanic (n=3,054) were used to calculate estimated glomerular filtration rates (eGFRs). PREDICTORS: Categories of eGFR (exposure); race/ethnicity (effect modifier). OUTCOMES: The primary outcome was the composite of 3 physician-adjudicated CV events: myocardial infarction, stroke, or CV-related death. MEASUREMENTS: We evaluated the multivariable-adjusted associations between categories of eGFR and CV events using proportional hazards regression and formally tested for effect modification by race/ethnicity. RESULTS: During a mean follow-up of 7.6 years, 1,424 CV events (653 myocardial infarctions, 627 strokes, and 297 CV-related deaths) were observed. The association between eGFR and CV events was curvilinear; however, the association of eGFR with CV outcomes differed by race (P=0.006). In stratified analyses, we observed that the U-shaped association was present in non-Hispanic whites, whereas African American participants had a rather curvilinear relationship, with lower eGFR being associated with higher CV risk, and higher eGFR, with reduced CV risk. Analyses among Hispanic women were inconclusive owing to few Hispanic women having very low or high eGFRs and very few events occurring in these categories. LIMITATIONS: Lack of urinary albumin measurements; residual confounding by unmeasured or imprecisely measured characteristics. CONCLUSIONS: In postmenopausal women, the patterns of association between eGFR and CV risk differed between non-Hispanic whites and African American women.

Correlates of poor glycemic control among patients with diabetes initiating hemodialysis for end-stage renal disease.

BACKGROUND: Maintaining tight glycemic control is important for prevention of diabetes-related outcomes in end-stage renal disease patients with diabetes, especially in light of their poor prognosis. This study aimed to determine factors associated with poor glycemic control among U.S. patients with diabetes mellitus initiating hemodialysis for end-stage renal disease. METHODS: Using data from the U.S. Renal Data System, electronic health records of a large national dialysis provider, and U.S. Census data, we performed a cross-sectional multivariable Poisson regression analysis to characterize risk factors associated with poor glycemic control, defined as glycated hemoglobin (HbA1c) > 7 vs. ≤ 7 %, in adult patients with diabetes who initiated hemodialysis at an outpatient facility between 2006 and 2011. RESULTS: Of 16,297 patients with diabetes, 21.2 % had HbA1c >7 %. In multivariable analysis, younger patients, patients of Native American race, and those of Hispanic ethnicity had higher prevalence of poor glycemic control. Independent correlates of poor glycemic control further included higher platelet count, white blood cell count, and ferritin; higher body mass index, systolic blood pressure, total cholesterol and triglyceride concentrations; lower HDL and albumin concentrations; lower normalized protein catabolic rate; and higher estimated glomerular filtration rate at initiation of dialysis (all P < 0.05). No independent associations were found with area-level socioeconomic indicators. Occurrence of diabetes in patients < 40 years of age, a proxy for type 1 diabetes, was associated with poor HbA1c control compared with that in patients ≥ 40 years of age, which was classified as type 2 diabetes. These findings were robust to the different outcome definitions of HbA1c > 7.5 % and > 8 %. CONCLUSION: In this cohort of incident end-stage renal disease patients with diabetes, poor glycemic control was independently associated with younger age, Native American race, Hispanic ethnicity, higher body mass index, and clinical risk factors including atherogenic lipoprotein profile, hypertension, inflammation, and markers indicative of malnutrition and a more serious systemic disease.

Differences in access to kidney transplantation between Hispanic and non-Hispanic whites by geographic location in the United States.

BACKGROUND AND OBJECTIVES: Hispanic patients undergoing chronic dialysis are less likely to receive a kidney transplant compared with non-Hispanic whites. This study sought to elucidate disparities in the path to receipt of a deceased donor transplant between Hispanic and non-Hispanic whites. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: Using the US Renal Data System, 417,801 Caucasians who initiated dialysis between January 1, 1995 and December 31, 2007 with follow-up through 2008 were identified. This study investigated time from first dialysis to first kidney transplantation, time from first dialysis to waitlisting, and time from waitlisting to kidney transplantation. Multivariable Cox regression estimated cause-specific hazard ratios (HRCS) and subdistribution (competing risk) hazard ratios (HRSD) for Hispanics versus non-Hispanic whites. RESULTS: Hispanics experienced lower adjusted rates of deceased donor kidney transplantation than non-Hispanic whites (HRCS, 0.77; 95% confidence interval [95% CI], 0.75 to 0.80) measured from dialysis initiation. No meaningful differences were found in time from dialysis initiation to placement on the transplant waitlist. Once waitlisted, Hispanics had lower adjusted rates of deceased donor kidney transplantation (HRCS, 0.66; 95% CI, 0.64 to 0.68), and the association attenuated once accounting for competing risks (HRSD, 0.79; 95% CI, 0.77 to 0.81). Additionally controlling for blood type and organ procurement organization further reduced the disparity (HRSD, 0.99; 95% CI, 0.96 to 1.02). CONCLUSIONS: After accounting for geographic location and controlling for competing risks (e.g., Hispanic survival advantage), the disparity in access to deceased donor transplantation was markedly attenuated among Hispanics compared with non-Hispanic whites. To overcome the geographic disparities that Hispanics encounter in the path to transplantation, organ allocation policy revisions are needed to improve donor organ equity.

Trends in relative mortality between Hispanic and non-Hispanic whites initiating dialysis: a retrospective study of the US Renal Data System.

BACKGROUND: Hispanic patients undergoing long-term dialysis experience better survival compared with non-Hispanic whites. It is unknown whether this association differs by age, has changed over time, or is due to differential access to kidney transplantation. STUDY DESIGN: National retrospective cohort study. SETTING & PARTICIPANTS: Using the US Renal Data System, we identified 615,618 white patients 18 years or older who initiated dialysis therapy between January 1, 1995, and December 31, 2007. PREDICTORS: Hispanic ethnicity (vs non-Hispanic whites), year of end-stage renal disease incidence, age (as potential effect modifier). OUTCOMES: All-cause and cause-specific mortality. RESULTS: We found that Hispanics initiating dialysis therapy experienced lower mortality, but age modified this association (P < 0.001). Compared with non-Hispanic whites, mortality in Hispanics was 33% lower at ages 18-39 years (adjusted cause-specific HR [HRcs], 0.67; 95% CI, 0.64-0.71) and 40-59 years (HRcs, 0.67; 95% CI, 0.66-0.68), 19% lower at ages 60-79 years (HRcs, 0.81; 95% CI, 0.80-0.82), and 6% lower at 80 years or older (HRcs, 0.94; 95% CI, 0.91-0.97). Accounting for the differential rates of kidney transplantation, the associations were attenuated markedly in the younger age strata; the survival benefit for Hispanics was reduced from 33% to 10% at ages 18-39 years (adjusted subdistribution-specific HR [HRsd], 0.90; 95% CI, 0.85-0.94) and from 33% to 19% among those aged 40-59 years (HRsd, 0.81; 95% CI, 0.80-0.83). LIMITATIONS: Inability to analyze Hispanic subgroups that may experience heterogeneous mortality outcomes. CONCLUSIONS: Overall, Hispanics experienced lower mortality, but differential access to kidney transplantation was responsible for much of the apparent survival benefit noted in younger Hispanics.

Trends in the incidence of atrial fibrillation in older patients initiating dialysis in the United States.

BACKGROUND: One sixth of US dialysis patients 65 years of age have been diagnosed with atrial fibrillation/flutter (AF). Little is known, however, about the incidence of AF in this population. METHODS AND RESULTS: We identified 258 605 older patients (≥67 years of age) with fee-for-service Medicare initiating dialysis in 1995 to 2007, who had not been diagnosed with AF within the previous 2 years. Patients were followed for newly diagnosed AF. Multivariable proportional hazard regression was used to examine temporal trends and associations of race and ethnicity with incident AF. We also studied temporal trends in the mortality and risk of ischemic stroke after new AF. Over 514 395 person-years of follow-up, 76 252 patients experienced incident AF for a crude AF incidence rate of 148/1000 person-years. Incidence of AF increased by 11% (95% confidence interval, 5-16) from 1995 to 2007. Compared with non-Hispanic whites, blacks (-30%), Asians (-19%), Native Americans (-42%), and Hispanics (-29%) all had lower rates of incident AF. Mortality after incident AF decreased by 22% from 1995 to 2008. Even more pronounced reductions were seen for incident ischemic stroke during these years. CONCLUSIONS: The incidence of AF is high in older patients initiating dialysis in the United States and has been increasing over the 13 years of study. Mortality declined during that time but remained >50% during the first year after newly diagnosed AF. Because data on warfarin use were not available, we were unable to study whether trends toward better outcomes could be explained by higher rates of oral anticoagulation.

Hispanic ethnicity and vascular access use in patients initiating hemodialysis in the United States.

BACKGROUND AND OBJECTIVES: Hispanics are the largest minority in the United States (comprising 16.3% of the US population) and have 1.5 times the age-, sex-, and race-adjusted incidence of ESRD compared with non-Hispanics. Poor health care access and low-quality care generally received by Hispanics are well documented. However, little is known regarding dialysis preparation of Hispanic patients with progressive CKD. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: Using data from Medical Evidence Report form CMS-2728-U3, 321,996 adult patients of white or black race were identified who initiated hemodialysis (HD) between July 1, 2005 and December 31, 2008. The form captures Hispanic ethnicity, vascular access use at first outpatient HD, sociodemographic characteristics, and comorbidities. This study also examined whether use of an arteriovenous fistula (AVF) or graft (AVG) was reported. RESULTS: AVF/AVG use was reported in 14.5% of Hispanics and 17.6% in non-Hispanics (P<0.001). The unadjusted prevalence ratio (PR) was 0.85 (95% confidence interval [95% CI], 0.83-0.88), indicating that Hispanics were 15% less likely to use AVG/AVF for their first outpatient HD. Adjustment for age, sex, and race, as well as a large number of comorbidities and frailty indicators, did not change this association (PR, 0.85; 95% CI, 0.83-0.88). Further adjustment for timing of first predialysis nephrology care, however, attenuated the PR by two-thirds (PR, 0.94; 95% CI, 0.92-0.97). CONCLUSIONS: Hispanics are less likely to use arteriovenous access for first outpatient HD compared with non-Hispanics, which seems to be explained by variation in the access to predialysis nephrology care.

Construct validity of the incontinence severity index.

AIMS: To assess the construct validity of the incontinence severity index (ISI) by testing its correlation with two health-related quality of life measures, the short forms of the Urogenital Distress Inventory (UDI-6) and the Incontinence Impact Questionnaire (IIQ-7), in women with urodynamic stress incontinence. MATERIALS AND METHODS: A cohort of 170 women with the urodynamic stress incontinence who underwent corrective surgery completed the ISI, IIQ-7, and the UDI-6 both pre- and post-treatment. We correlated the pre- and post-treatment responses between the ISI, the IIQ-7, the UDI-6 and their subscales. We also assessed the sensitivity of the ISI to change by correlating the percent change in score between the three instruments. The results were analyzed using a non-parametric test of correlation, the Spearman's rho. RESULTS: The ISI scores were generally not well correlated with the pre-treatment IIQ-7 and UDI-6 scores (r < 0.40). The post-treatment scores and percent change from pre- to post-treatment of the ISI, however, were highly correlated with that of the IIQ-7 and UDI-6 (r's > 0.70, P < 0.001). The ISI was most highly correlated with the UDI-6 stress symptoms subscale and most poorly correlated with the UDI-6 obstructive/discomfort subscale. CONCLUSIONS: This study provides valuable insight into the construct validity of the ISI. Evidence of its convergent validity is found in the high correlation with the stress symptoms subscales of the UDI-6, while the poorer correlation with the obstructive subscale provides evidence of its divergent validity. These data also suggest that the ISI is highly sensitive to change seen with treatment.

Is the cough-stress test necessary when placing the tension-free vaginal tape?

OBJECTIVE: To estimate whether the mode of anesthesia (and the resultant ability or inability to perform the cough-stress test) used during the tension-free vaginal tape (TVT) procedure affects postoperative continence. METHODS: A cohort of 170 women who underwent the TVT procedure without any other concomitant surgery completed the short form of the Urogenital Distress Inventory (UDI-6) to assess their continence status preoperatively and postoperatively. Chi-squared, t, and Mann-Whitney U tests were used to determine the association between these data and anesthesia type during univariate analysis. RESULTS: Both anesthesia groups showed significant improvement from their preoperative UDI-6 scores to their postoperative scores. However, when comparing the change from pre- to postoperative UDI-Stress Symptoms subscale scores between the 2 groups, we found a significant difference. Mean improvement in the local group was 58.3 (+/- 33.8) compared with 41.7 (+/- 39.4) in the general group (P = .02). CONCLUSION: Women who undergo TVT show significant improvements in incontinence severity regardless of anesthesia type. However, greater improvements in stress incontinence, as measured by the UDI-Stress Symptoms subscale, are seen when the TVT is placed while using the cough-stress test under local analgesia. LEVEL OF EVIDENCE: II-2.