Association of residual urine output with mortality, quality of life, and inflammation in incident hemodialysis patients: the Choices for Healthy Outcomes in Caring for End-Stage Renal Disease (CHOICE) Study.

BACKGROUND: Residual kidney function (RKF) is associated with improved survival in peritoneal dialysis patients, but its role in hemodialysis patients is less well known. Urine output may provide an estimate of RKF. The aim of our study is to determine the association of urine output with mortality, quality of life (QOL), and inflammation in incident hemodialysis patients. STUDY DESIGN: Nationally representative prospective cohort study. SETTING & PARTICIPANTS: 734 incident hemodialysis participants treated in 81 clinics; enrollment, 1995-1998; follow-up until December 2004. PREDICTOR: Urine output, defined as producing at least 250 mL (1 cup) of urine daily, ascertained using questionnaires at baseline and year 1. OUTCOMES & MEASUREMENTS: Primary outcomes were all-cause and cardiovascular mortality, analyzed using Cox regression adjusted for demographic, clinical, and treatment characteristics. Secondary outcomes were QOL, inflammation (C-reactive protein and interleukin 6 levels), and erythropoietin (EPO) requirements. RESULTS: 617 of 734 (84%) participants reported urine output at baseline, and 163 of 579 (28%), at year 1. Baseline urine output was not associated with survival. Urine output at year 1, indicating preserved RKF, was independently associated with lower all-cause mortality (HR, 0.70; 95% CI, 0.52-0.93; P = 0.02) and a trend toward lower cardiovascular mortality (HR, 0.69; 95% CI, 0.45-1.05; P = 0.09). Participants with urine output at baseline reported better QOL and had lower C-reactive protein (P = 0.02) and interleukin 6 (P = 0.03) levels. Importantly, EPO dose was 12,000 U/wk lower in those with urine output at year 1 compared with those without (P = 0.001). LIMITATIONS: Urine volume was measured in only a subset of patients (42%), but agreed with self-report (P < 0.001). CONCLUSIONS: RKF in hemodialysis patients is associated with better survival and QOL, lower inflammation, and significantly less EPO use. RKF should be monitored routinely in hemodialysis patients. The development of methods to assess and preserve RKF is important and may improve dialysis care.

Inpatient hemodialysis initiation: reasons, risk factors and outcomes.

BACKGROUND/AIMS: Inpatient initiation of chronic hemodialysis is considered undesirable because of cost and possible harms of hospitalization. We examined the patient characteristics and outcomes associated with inpatient initiation. METHODS: In a prospective cohort study of incident dialysis patients, the independent association of inpatient hemodialysis initiation with patient outcomes was assessed in multivariable analyses with adjustment for patient characteristics and propensity for inpatient initiation. RESULTS: A total of 410 of 652 (63%) hemodialysis patients began as inpatients; uremia and volume overload were the most commonly documented reasons. Compared to outpatients, inpatients were more likely to be unmarried, report less social support, have multiple comorbidities and be referred to a nephrologist 4 months or less prior to initiation. Inpatient initiation was protective for subsequent all-cause hospitalization (incidence rate ratio (IRR) = 0.92, confidence interval (CI) 0.89-0.94); this was most pronounced among those who had the highest propensity for inpatient initiation (IRR = 0.66, CI 0.56-0.78), including those referred late to nephrology. Similar results were found for infectious hospitalization. Mortality [hazard ratio = 1.03, CI 0.82-1.30] and cardiovascular events were not significantly different for inpatients versus outpatients. CONCLUSION: Inpatient hemodialysis initiation has a protective association with hospitalization among those patients referred late to nephrology, with multiple comorbidities and/or little social support.

Spoken language development in children following cochlear implantation.

CONTEXT: Cochlear implantation is a surgical alternative to traditional amplification (hearing aids) that can facilitate spoken language development in young children with severe to profound sensorineural hearing loss (SNHL). OBJECTIVE: To prospectively assess spoken language acquisition following cochlear implantation in young children. DESIGN, SETTING, AND PARTICIPANTS: Prospective, longitudinal, and multidimensional assessment of spoken language development over a 3-year period in children who underwent cochlear implantation before 5 years of age (n = 188) from 6 US centers and hearing children of similar ages (n = 97) from 2 preschools recruited between November 2002 and December 2004. Follow-up completed between November 2005 and May 2008. MAIN OUTCOME MEASURES: Performance on measures of spoken language comprehension and expression (Reynell Developmental Language Scales). RESULTS: Children undergoing cochlear implantation showed greater improvement in spoken language performance (10.4; 95% confidence interval [CI], 9.6-11.2 points per year in comprehension; 8.4; 95% CI, 7.8-9.0 in expression) than would be predicted by their preimplantation baseline scores (5.4; 95% CI, 4.1-6.7, comprehension; 5.8; 95% CI, 4.6-7.0, expression), although mean scores were not restored to age-appropriate levels after 3 years. Younger age at cochlear implantation was associated with significantly steeper rate increases in comprehension (1.1; 95% CI, 0.5-1.7 points per year younger) and expression (1.0; 95% CI, 0.6-1.5 points per year younger). Similarly, each 1-year shorter history of hearing deficit was associated with steeper rate increases in comprehension (0.8; 95% CI, 0.2-1.2 points per year shorter) and expression (0.6; 95% CI, 0.2-1.0 points per year shorter). In multivariable analyses, greater residual hearing prior to cochlear implantation, higher ratings of parent-child interactions, and higher socioeconomic status were associated with greater rates of improvement in comprehension and expression. CONCLUSION: The use of cochlear implants in young children was associated with better spoken language learning than would be predicted from their preimplantation scores.

Cerebrovascular disease incidence, characteristics, and outcomes in patients initiating dialysis: the choices for healthy outcomes in caring for ESRD (CHOICE) study.

BACKGROUND: Stroke is the third most common cause of cardiovascular disease death in patients on dialysis therapy; however, characteristics of cerebrovascular disease, including clinical subtypes and subsequent consequences, have not been well described. STUDY DESIGN: Prospective national cohort study, the Choices for Healthy Outcomes in Caring for End-Stage Renal Disease (CHOICE) Study. SETTINGS & PARTICIPANTS: 1,041 incident dialysis patients treated in 81 clinics enrolled from October 1995 to July 1998, followed up until December 31, 2004. PREDICTOR: Time from dialysis therapy initiation. OUTCOMES & MEASUREMENTS: Cerebrovascular disease events were defined as nonfatal (hospitalized stroke and carotid endarterectomy) and fatal (stroke death) events after dialysis therapy initiation. Stroke subtypes were classified by using standardized criteria from the Trial of ORG 10172 in Acute Stroke Treatment (TOAST) system. The incidence of cerebrovascular event subtypes was analyzed by using time-to-event analyses accounting for competing risk of death. Clinical outcomes after stroke were abstracted from medical records. RESULTS: 165 participants experienced a cerebrovascular event with an overall incidence of 4.9 events/100 person-years. Ischemic stroke was the most common (76% of all 200 events), with cardioembolism subtype accounting for 28% of the 95 abstracted ischemic events. Median time from onset of symptoms to first stroke evaluation was 8.5 hours (25th and 75th percentiles, 1 and 42), with only 56% of patients successfully escaping death, nursing home, or skilled nursing facility. LIMITATIONS: Relatively small sample size limits power to determine risk factors. CONCLUSIONS: Cerebrovascular disease is common in dialysis patients, is identified late, and carries a significant risk of morbidity and mortality. Stroke etiologic subtypes on dialysis therapy are multifactorial, suggesting risk factors may change the longer one has end-stage renal disease. Additional studies are needed to address the poor prognosis through prevention, early identification, and treatment.

Predicting behavior problems in deaf and hearing children: the influences of language, attention, and parent-child communication.

The development of language and communication may play an important role in the emergence of behavioral problems in young children, but they are rarely included in predictive models of behavioral development. In this study, cross-sectional relationships between language, attention, and behavior problems were examined using parent report, videotaped observations, and performance measures in a sample of 116 severely and profoundly deaf and 69 normally hearing children ages 1.5 to 5 years. Secondary analyses were performed on data collected as part of the Childhood Development After Cochlear Implantation Study, funded by the National Institutes of Health. Hearing-impaired children showed more language, attention, and behavioral difficulties, and spent less time communicating with their parents than normally hearing children. Structural equation modeling indicated there were significant relationships between language, attention, and child behavior problems. Language was associated with behavior problems both directly and indirectly through effects on attention. Amount of parent-child communication was not related to behavior problems.

Timing, causes, predictors and prognosis of switching from peritoneal dialysis to hemodialysis: a prospective study.

BACKGROUND: The use of peritoneal dialysis (PD) has declined in the United States over the past decade and technique failure is also reportedly higher in PD compared to hemodialysis (HD), but there are little data in the United States addressing the factors and outcomes associated with switching modalities from PD to HD. METHODS: In a prospective cohort study of 262 PD patients enrolled from 28 peritoneal dialysis clinics in 13 U.S. states, we examined potential predictors of switching from PD to HD (including demographics, clinical factors, and laboratory values) and the association of switching with mortality. Cox proportional hazards regression was used to assess relative hazards (RH) of switching and of mortality in PD patients who switched to HD. RESULTS: Among 262 PD patients, 24.8% switched to HD; with more than 70% switching within the first 2 years. Infectious peritonitis was the leading cause of switching. Patients of black race and with higher body mass index were significantly more likely to switch from PD to HD, RH (95% CI) of 5.01 (1.15-21.8) for black versus white and 1.09 (1.03-1.16) per 1 kg/m2 increase in BMI, respectively. There was no difference in survival between switchers and non-switchers, RH (95% CI) of 0.89 (0.41-1.93). CONCLUSION: Switching from PD to HD occurs early and the rate is high, threatening long-term viability of PD programs. Several patient characteristics were associated with the risk of switching. However, there was no survival difference between switchers and non-switchers, reassuring providers and patients that PD technique failure is not necessarily associated with poor prognosis.

Association of peritoneal dialysis clinic size with clinical outcomes.

OBJECTIVE: Very few studies have addressed the relationship between number of peritoneal dialysis (PD) patients treated at a clinic (PD clinic size) and clinical outcomes. In a national prospective cohort study of incident PD patients (n = 236, from 26 clinics), we examined whether being treated at a larger PD clinic [>50 PD patients (n = 3 clinics) vs 50 patients was associated with fewer switches to hemodialysis (RH = 0.13, 95% CI 0.06 - 0.31) and fewer cardiovascular events (RH = 0.62, 95% CI 0.06 - 0.98). No associations of PD clinic size with cardiovascular or all-cause mortality were seen. CONCLUSION: PD patients treated at clinics with greater numbers of PD patients may have better outcomes in terms of technique failure and cardiovascular morbidity. PD clinic size may act as a proxy of greater PD experience, more focus on the modality, and better PD practices at the clinic, resulting in better outcomes.

The association of sudden cardiac death with inflammation and other traditional risk factors.

Despite the frequency of cardiovascular death in dialysis patients, few studies have prospectively measured sudden cardiac death in these individuals. Here, we sought to determine the frequency of sudden cardiac death and its association with inflammation and other risk factors among the CHOICE (Choices for Healthy Outcomes In Caring for ESRD) cohort of 1,041 incident dialysis patients. Sudden cardiac death was defined as that occurring outside of the hospital with an underlying cardiac cause from death certificate data. Over a median 2.5 years of follow-up, 22% of all mortality in this cohort was due to sudden cardiac death. Using Cox proportional hazards, we found that the highest tertiles of high-sensitivity C-reactive protein and of IL-6 were each associated with twice the risk of sudden cardiac death compared to their lowest tertiles when adjusted for demographics, comorbidities and laboratory factors. A decrement in serum albumin was associated with a 1.35 times increased risk for sudden cardiac death in the highest compared to the lowest tertile. These findings were robust and consistent when accounting for competing risks of death from other causes. Hence, we found that sudden cardiac death is common among patients with end stage renal disease and that inflammation and malnutrition significantly increased its occurrence independent of traditional cardiovascular risk factors.

Heparin-induced antibodies and cardiovascular risk in patients on dialysis.

The clinical relevance of heparin-induced antibodies (HIA) in the absence of thrombocytopenia remains to be defined. The aims of this study were (i) to determine the prevalence of HIA in patients treated by dialysis, (ii) to determine the prevalence of thrombocytopenia and heparin-induced thrombocytopenia (HIT), and (iii) to test whether HIA are associated with adverse outcomes. Sera from 740 patients treated by hemodialysis (HD, n=596) and peritoneal dialysis (PD, n=144) were tested for HIA (IgG, IgA or IgM) by masked investigators at approximately six months after enrolment in the Choices for Healthy Outcomes in Caring for End-Stage Renal Disease (CHOICE) study. We assessed, with time-to-event Cox proportional hazards models, whether the presence of HIA predicted any of four clinical outcomes: arterial cardiovascular events, venous thromboembolism, vascular access occlusion and mortality. HIA prevalence was 10.3% overall. HIA positivity did not predict development of thrombocytopenia or any of the four clinical outcomes over a mean follow-up of 3.6 years, with hazard ratios for arterial cardiovascular events of 0.98 (95% confidence interval 0.70-1.37), venous thromboembolism 1.39 (0.17-11.5), vascular access occlusion 0.82 (0.40-1.71), and mortality 1.18 (0.85-1.64). Chronic intermittent heparin exposure was associated with a high seroprevalence of HIA. In dialysis patients these antibodies were not an independent risk factor for cardiovascular events and mortality. Our data do not suggest that dialysis patients should be monitored for HIA antibodies in the absence of thrombocytopenia.

Accuracy of patients' reports of comorbid disease and their association with mortality in ESRD.

BACKGROUND: Patient awareness of chronic diseases is low. Unawareness may represent poor understanding of chronic illness and may be associated with poor outcomes in patients with end-stage renal disease (ESRD). STUDY DESIGN: Concurrent prospective national cohort study. SETTING & PARTICIPANTS: Incident hemodialysis and peritoneal dialysis patients enrolled in the Choices for Healthy Outcomes in Caring for ESRD Study and followed up until 2004. PREDICTOR: Inaccurate patient self-report of 8 comorbid diseases compared with the medical record. OUTCOMES & MEASUREMENTS: All-cause mortality was the primary outcome. Cox proportional hazard models were used to assess the contribution of demographics and clinical measures in the relation of inaccurate self-report to mortality. RESULTS: In 965 patients, the proportion of inaccurate self-reporters ranged from 3% for diabetes mellitus to 35% for congestive heart failure. Generally, inaccurate self-reporters were older and had more chronic diseases. Greater risk of death was found for inaccurate self-reporters of ischemic heart disease (hazard ratio [HR], 1.34; 95% confidence interval, 1.12 to 1.59; P = 0.001), coronary intervention (HR, 1.46; 95% confidence interval, 1.08 to 1.97; P = 0.01), and chronic obstructive pulmonary disease (HR, 1.40; 95% confidence interval, 1.14 to 1.70; P = 0.001). The greater risk of death remained significant for chronic obstructive pulmonary disease (HR, 1.36; 95% confidence interval, 1.11 to 1.66; P = 0.003) after adjustment for age, sex, and race. In patients receiving peritoneal dialysis, greater risk of death (HR, 2.06; 95% confidence interval, 1.34 to 3.15; P = 0.001) was found for inaccurate self-reporters of ischemic heart disease. LIMITATIONS: Includes potential for residual confounding, medical record error, misclassification of patient accuracy of self-report, and low inaccurate self-report of some chronic diseases, reducing the power to measure associations. CONCLUSIONS: Accuracy of self-report depends on the specific comorbid disease. Patients with ESRD, especially those receiving peritoneal dialysis, who inaccurately report heart disease may be less aware of their chronic comorbid disease and may be at greater risk of mortality compared with those who accurately report their comorbid disease.

Third-generation parathyroid hormone assays and all-cause mortality in incident dialysis patients: the CHOICE study.

BACKGROUND: There has been controversy about the utility of new third-generation parathyroid hormone (PTH) assays measuring only 1-84 PTH, with few large studies comparing second- and third-generation PTH measurements in patients with ESRD. METHODS: We measured 1-84 PTH ('biointact' or 'whole' PTH) and total PTH ('intact' PTH) in a national cohort of 515 incident dialysis patients from banked frozen EDTA plasma (median follow-up, 35 months) and examined the accuracy of estimating 1-84 PTH from total PTH and the associations of these levels with patient characteristics and mortality. RESULTS: The 1-84 PTH and total PTH levels were closely correlated. Higher 1-84 PTH was associated with African-American race and higher serum phosphate and lower calcium levels. The percentage of total PTH represented by 1-84 PTH was, on average, 53%, but with a wide range (25-89%). Calculating 1-84 PTH from total PTH using a proposed standard conversion factor (54%) led to misclassification of 8% of the population compared with measured 1-84 PTH. In a multivariate Cox proportional hazards model for all-cause mortality, a 1-84 PTH value >160 pg/ml was associated with increased risk of mortality (HR = 1.62, 95% CI, 1.03-2.54) compared to a level of 80-160 pg/ml. Elevated total PTH, 7-84 PTH and the 1-84 PTH/7-84 PTH ratio were not significantly associated with mortality. CONCLUSIONS: The 1-84 PTH and total PTH are highly correlated. Elevated 1-84 PTH was significantly associated with increased mortality, whereas total PTH did not reach statistical significance. Thus, although in other respect they are similar, there may be utility in measuring 1-84 PTH for its associations with mortality.

Lipoprotein(a) level as a predictor of cardiovascular disease and small apoliprotein(a) isoforms in dialysis patients: assay-related differences are important.

BACKGROUND: Lipoprotein(a) assays sensitive to apolipoprotein(a) size may underestimate associations of lipoprotein(a) with cardiovascular disease (CVD) and low molecular weight (LMW) apolipoprotein(a) isoforms. This study among 629 dialysis patients compares the value of two lipoprotein(a) assays in predicting CVD events and small isoforms. METHODS: Lipoprotein(a) level was measured by an apolipoprotein(a) size-insensitive ELISA and apolipoprotein(a) size-sensitive immunoturbidometric (IT) assay; and apolipoprotein(a) size by Western blot. Positive/negative predictive values (PPV/NPV) for small isoforms were calculated, and CVD events ascertained prospectively. RESULTS: The ELISA assay predicted CVD more strongly [Relative Hazard, RH=1.8; p=0.045, at the 85th Lipoprotein(a) percentile] than the IT assay (RH=1.3; p=0.37). The PPV for LMW isoforms using the ELISA (Whites, 98%; Blacks, 90%) were much higher than the IT assay (Whites, 75%; Blacks, 68%). Relative to the ELISA assay values, a positive bias in the IT assay values was seen for participants with larger apolipoprotein(a) isoforms, which may explain these findings. CONCLUSIONS: When measured by an apolipoprotein(a) size-insensitive ELISA assay, but not a size-sensitive IT assay, high lipoprotein(a) levels predict both incident CVD and LMW isoforms in dialysis patients. Clinicians ordering lipoprotein(a) levels and research studies of lipoprotein(a) should determine if an apolipoprotein(a)-size related bias is present in the assay they use.

Electric charge requirements of pediatric cochlear implant recipients enrolled in the Childhood Development After Cochlear Implantation study.

OBJECTIVE: To evaluate mapping characteristics of children with cochlear implants who are enrolled in the Childhood Development After Cochlear Implantation (CDACI) multicenter study. STUDY DESIGN: Longitudinal evaluation during 24 months of speech processor maps of children with cochlear implants prospectively enrolled in the study. SETTING: Six tertiary referral centers. SUBJECTS: One hundred eighty-eight children enrolled in the CDACI study who were 5 years old or younger at the time of enrollment. Of these children, 184 received unilateral implants, and 4 received simultaneous bilateral implants. INTERVENTION: Children attended regular mapping sessions at their implant clinic as part of the study protocol. Maps were examined for each subject at 4 different time intervals: at device activation and 6, 12, and 24 months postactivation. MAIN OUTCOME MEASURES: Mean C/M levels (in charge per phase) were compared for 4 different time intervals, for 3 different devices, for 6 different implant centers, and for children with normal and abnormal cochleae. RESULTS: All 3 types of implant devices demonstrate significant increases in C/M levels between device activation and the 24-month appointment. Significant differences in mean C/M levels were noted between devices. Children with cochlear anomalies demonstrate significantly greater C/M levels than children with normal cochleae. CONCLUSION: The CDACI study has enabled us to evaluate the mapping characteristics of pediatric patients who use 3 different devices and were implanted at a variety of implant centers. Analysis of such data enables us to better understand the mapping characteristics of children with cochlear implants.

Assessing the use of speech and language measures in relation to parental perceptions of development after early cochlear implantation.

OBJECTIVE: Clinicians and investigators use multiple outcome measures after early cochlear implantation (CI) to assess auditory skills, speech, and language effects. Are certain outcome measures better associated with optimal childhood development from the perspective of parents? We studied the association between several commonly used outcome instruments and a measure of parental perceptions of development to gain insight into how our clinical tests reflect parental perceptions of a child's developmental status. STUDY DESIGN: Cross-sectional analysis. SETTING: Six academic centers. PATIENTS: One hundred eighty-eight deaf children (<6 yr) 1 year after CI activation enrolled in the longitudinal Childhood Development after CI study. MAIN OUTCOME MEASURES: Measures of auditory skills, speech, and language. Parental perceptions of development quantified with a visual analogue scale (visual analogue scale-development). METHODS: Nonparametric and parametric regression methods were used to model the relationship between outcome measures and visual analogue scale-development scores. RESULTS: All outcome measures were positively associated with parental perceptions of development, but more robust associations were observed with language measures and a parent-report scale of auditory skills than with a selected measure of closed-set speech. For speech and language data, differences were observed in the trajectories of associations among younger (2-3 yr) versus older (4-5 yr) children. CONCLUSION: Our results demonstrate the importance of measuring multiple outcome measures after early pediatric CI. The degree to which an outcome measure reflects childhood development as perceived by parents may be affected by the child's age. Measures that are based on parental report and broader outcome measures focused on verbal language offer the potential for a fuller understanding of the true effectiveness of early implantation.

Surgical factors in pediatric cochlear implantation and their early effects on electrode activation and functional outcomes.

OBJECTIVE: To assess the impact of surgical factors on electrode status and early communication outcomes in young children in the first 2 years of cochlear implantation. STUDY DESIGN: Prospective multicenter cohort study. SETTING: Six tertiary referral centers. PATIENTS: Children 5 years or younger before implantation with normal nonverbal intelligence. INTERVENTION: Cochlear implant operations in 209 ears of 188 children. MAIN OUTCOME MEASURES: Percent active channels, auditory behavior as measured by the Infant Toddler Meaningful Auditory Integration Scale/Meaningful Auditory Integration Scale and Reynell receptive language scores. RESULTS: Stable insertion of the full electrode array was accomplished in 96.2% of ears. At least 75% of electrode channels were active in 88% of ears. Electrode deactivation had a significant negative effect on Infant Toddler Meaningful Auditory Integration Scale/Meaningful Auditory Integration Scale scores at 24 months but no effect on receptive language scores. Significantly fewer active electrodes were associated with a history of meningitis. Surgical complications requiring additional hospitalization and/or revision surgery occurred in 6.7% of patients but had no measurable effect on the development of auditory behavior within the first 2 years. Negative, although insignificant, associations were observed between the need for perioperative revision of the device and 1) the percent of active electrodes and 2) the receptive language level at 2-year follow-up. CONCLUSION: Activation of the entire electrode array is associated with better early auditory outcomes. Decrements in the number of active electrodes and lower gains of receptive language after manipulation of the newly implanted device were not statistically significant but may be clinically relevant, underscoring the importance of surgical technique and the effective placement of the electrode array.

Tracking development of speech recognition: longitudinal data from hierarchical assessments in the Childhood Development after Cochlear Implantation Study.

OBJECTIVE: To develop a speech recognition index that summarizes data collected through an array of age-appropriate hierarchical speech recognition tests in a longitudinal study. STUDY DESIGN: Prospective cohort. SETTING: Six tertiary referral centers in the Childhood Development after Cochlear Implantation (CDaCI) Study. PATIENTS: One hundred eighty-eight children implanted at age 5 years or younger and 97 age-comparable normal-hearing controls. INTERVENTION: Cochlear implantation. MAIN OUTCOME MEASURES: Outcome measures were the following: Infant-Toddler Meaningful Auditory Integration Scale, Meaningful Auditory Integration Scale, Early Speech Perception Test, Pediatric Speech Intelligibility Test, Multisyllabic Lexical Neighborhood Test, Lexical Neighborhood Test, and Hearing in Noise Test, obtained before implantation and at 6, 12, 18, and 24 months postimplant. RESULTS: A speech recognition cumulative index, speech recognition index in quiet (SRI-Q), was created to combine information from tests administered in quiet. This index allows simultaneous display of data from all tests in the speech recognition hierarchy and is sensitive to improvements in performance over time as a function of age. SRI-Q also provides a composite of performance on multiple tests, allowing both the tracking of "growth curve" in speech recognition across a wide age range over an extended follow-up period and the comparison of normal-hearing and implanted children on multiple measures. The data range for individual tests is also preserved for ease of interpretation. CONCLUSION: SRI-Q allows tracking of global development of speech recognition over time as children progress through a hierarchy of speech perception measures and complements the more detailed assessments obtained from individual tests within the hierarchy.

Early, intermediate, and long-term risk factors for mortality in incident dialysis patients: the Choices for Healthy Outcomes in Caring for ESRD (CHOICE) Study.

BACKGROUND: Knowing whether risk factors for mortality differ in dialysis patients who survive longer and the strengths of these risk factors for mortality change over time would assist physicians in making better prognostic judgments. STUDY DESIGN: Prospective cohort study. SETTING & PARTICIPANTS: 1,041 incident dialysis patients treated in 81 clinics (mean follow-up, 3.1 years). PREDICTOR: A parsimonious set of risk factors (older age, white race, unemployed status, comorbidity, ever smoking, decreased systolic blood pressure, and decreased serum albumin level) chosen from several available demographic, clinical, and laboratory variables. OUTCOMES & MEASUREMENTS: Long-term (4+ years) survival and mortality over yearly intervals of follow-up, examined in logistic regression and Cox proportional hazards analyses. RESULTS: All baseline risk factors were associated with a decreased chance of surviving 4+ years, even after adjustment for confounders. Increased age was a strong and independent risk factor for mortality over all yearly intervals; comorbidity, smoking, and decreased blood pressure were early risk factors; low albumin level and unemployed status were intermediate risk factors; and white race was a late risk factor. When risk factors were updated with time, low albumin level and severe comorbidity became significant risk factors over most intervals. LIMITATIONS: Lack of some follow-up data and inability to rule out residual confounding or make causal inference based on results. CONCLUSION: Long-term survivors on dialysis therapy may have different risk factors for mortality than patients in earlier phases of end-stage renal disease (eg, race versus blood pressure); other risk factors may be constant over time (eg, age, comorbidity, and albumin level). Such information may help guide physicians in making prognostic judgments for individual patients with particular dialysis vintages.

Agreement of self-reported comorbid conditions with medical and physician reports varied by disease among end-stage renal disease patients.

OBJECTIVE: To compare self-report of eight diseases with review of medical records and physician reports. STUDY DESIGN AND SETTING: In a cohort of 965 incident end-stage renal disease (ESRD) patients (Choices for Healthy Outcomes in Caring for End-stage renal disease study), data on existing medical conditions were obtained from medical record abstraction, physician report (CMS Form 2728), and self-report in a baseline questionnaire. We evaluated agreement with kappa statistics (k) and sensitivity of self-report. Regression models were used to examine characteristics associated with agreement. RESULTS: The results showed excellent or substantial agreement between self-report and the medical record for diabetes (k=0.93) and coronary artery intervention (k=0.79), and poor agreement for chronic obstructive pulmonary disease (k=0.20). Physician-reported prevalence for all diseases was equal or lower than that by self-report. Male patients were more likely to inaccurately report hypertension. Compared to white patients, African American patients were more likely to inaccurately report cardiovascular diseases. CONCLUSION: In ESRD patients, self-report agreement with the medical record varies with the specific disease. Awareness of diseases of the cardiovascular system appears to be low. African American and male ESRD patients are at risk of low awareness of disease and educational interventions are needed in this high-risk population.

Attainment of clinical performance targets and improvement in clinical outcomes and resource use in hemodialysis care: a prospective cohort study.

BACKGROUND: Clinical performance targets are intended to improve patient outcomes in chronic disease through quality improvement, but evidence of an association between multiple target attainment and patient outcomes in routine clinical practice is often lacking. METHODS: In a national prospective cohort study (ESRD Quality, or EQUAL), we examined whether attainment of multiple targets in 668 incident hemodialysis patients from 74 U.S. not-for-profit dialysis clinics was associated with better outcomes. We measured whether the following accepted clinical performance targets were met at 6 months after study enrollment: albumin (> or =4.0 g/dl), hemoglobin (> or =11 g/dl), calcium-phosphate product (<55 mg2/dl2), dialysis dose (Kt/V> or =1.2), and vascular access type (fistula). Outcomes included mortality, hospital admissions, hospital days, and hospital costs. RESULTS: Attainment of each of the five targets was associated individually with better outcomes; e.g., patients who attained the albumin target had decreased mortality [relative hazard (RH) = 0.55, 95% confidence interval (CI), 0.41-0.75], hospital admissions [incidence rate ratio (IRR) = 0.67, 95% CI, 0.62-0.73], hospital days (IRR = 0.61, 95% CI, 0.58-0.63), and hospital costs (average annual cost reduction = 3,282 dollars, P = 0.002), relative to those who did not. Increasing numbers of targets attained were also associated, in a graded fashion, with decreased mortality (P = 0.030), fewer hospital admissions and days (P < 0.001 for both), and lower costs (P = 0.029); these trends remained statistically significant for all outcomes after adjustment (P < 0.001), except cost, which was marginally significant (P = 0.052). CONCLUSION: Attainment of more clinical performance targets, regardless of which targets, was strongly associated with decreased mortality, hospital admissions, and resource use in hemodialysis patients.

Statin use and sepsis events [corrected] in patients with chronic kidney disease.

CONTEXT: Patients with chronic kidney disease are at high risk for sepsis and sepsis-related mortality. OBJECTIVE: To assess whether statin use is associated with a reduction in sepsis events [corrected] in dialysis patients. DESIGN, SETTING, AND PATIENTS: National prospective cohort study that enrolled 1041 incident dialysis patients at 81 US not-for-profit outpatient dialysis clinics from October 1995 to June 1998, with follow-up to January 2005. Statin use was determined by medical record review. Rates of sepsis events [corrected] between statin users and control patients were compared using multivariate regression models, with adjustment for potential confounders in the overall cohort and in a subcohort in which control patients were matched to statin users according to their likelihood (propensity) to have been prescribed a statin. MAIN OUTCOME MEASURE: Sepsis events [corrected] were determined through hospital records from the United States Renal Data System (mean follow-up, 3.4 years). RESULTS: There were 303 sepsis events [corrected] Rates of sepsis events [corrected] were significantly lower in patients receiving statins (crude incidence rate, 41/1000 patient-years) than in those not receiving statins (crude incidence rate, 110/1000 patient-years) (P<.001). With adjustment for demographics and dialysis modality, statin users were substantially less likely to be subsequently hospitalized for sepsis (incidence rate ratio, 0.41; 95% confidence interval [CI], 0.25-0.68). Further adjustment for comorbidities and laboratory values continued to show this protective association (incidence rate ratio, 0.38; 95% CI, 0.21-0.67). In the propensity-matched subcohort, statin use was even more protective (incidence rate ratio, 0.24; 95% CI, 0.11-0.49). CONCLUSIONS: Use of statins was strongly and independently associated with a reduction in the risk of sepsis events [corrected] in patients who had chronic kidney disease and were receiving dialysis. Randomized trials of statins in patients with chronic kidney disease should examine the prevention of sepsis as a potentially important benefit.