New microsatellite markers for Ellipse, Venustaconcha ellipsiformis (Bivalvia: Unionidae), with notes on optimal sample size and cross-species amplification.

Venustaconcha ellipsiformis (Unionidae) is a freshwater mussel species inhabiting small to medium streams of the Midwestern United States; however, its occurrence is rather sporadic and populations are often isolated. Due to anthropogenic habitat degradation and water pollution, this species is designated as some sort of conservation status in many states. To prioritize conservation strategies, highly variable genetic markers are necessary to assess population genetic structure and potential genetic erosion of V. ellipsiformis. Using whole genome sequence data, we developed and characterized microsatellite markers for V. ellipsiformis. Among 23 tetranucleotide loci tested, 14 loci were consistently amplified and showed polymorphism. Analyses performed on three populations in the upper Mississippi River basin showed that the number of alleles per locus ranged from 2 to 11 and the observed heterozygosity varied from 0.15 to 0.75. Based on genotypic and allelic rarefaction curves, these loci had adequate statistical power to genetically discriminate between individuals and the sample size was large enough to capture most alleles available in the populations at most loci. Finally, cross-species screening of the loci successfully amplified and showed polymorphism in six species in the tribe Lampsilini. The microsatellite loci developed in this study provide a valuable addition to extant genetic markers for freshwater mussels and can be useful to provide high-level resolution of population genetic parameters for V. ellipsiformis. Such information will be of great value for resource managers developing and prioritizing conservation strategies for imperiled mussel species.

The fight against diabetes: how the kidney care community is taking action.

More than nine percent of the US population--or 29.1 million people--has diabetes. Of this group, more than eight million are undiagnosed, and one in three people who have been diagnosed also have kidney disease. Minority groups, including American Indians, Hispanics, and African Americans, continue to be the most at risk for diabetes and kidney disease. Community partnerships and physician education play major roles in awareness and education efforts. At DaVita Kidney Care, clinicians created the StepAhead program to address diabetes care management among its patients.

ESRD special needs plans: a proof of concept for integrated care.

Since the completion of the Centers for Medicare and Medicaid Services' end-stage renal disease (ESRD) demonstration projects, passage of the Affordable Care Act, and announcement of ESRD Seamless Care Organizations (ESCOs) by CMS' Innovation Center, it seems that ESRD-centered accountable care organizations will be the future model for kidney care of Medicare beneficiaries. Regardless of what you call it--managed care organization, special needs plan, ESCO--balancing quality of health care with costs of health care will continue to be the primary directive for physicians and institutions using integrated care management (ICM) strategies to manage their ESRD patients' health. The renal community has had previous success with ICM, and these experiences could help to guide our way.

Toward population management in an integrated care model.

Under the Patient Protection and Affordable Care Act of 2010, accountable care organizations (ACOs) will be the primary mechanism for achieving the dual goals of high-quality patient care at managed per capita costs. To achieve these goals in the newly emerging health care environment, the nephrology community must plan for and direct integrated delivery and coordination of renal care, focusing on population management. Even though the ESRD patient population is a complex group with comorbid conditions that may confound integration of care, the nephrology community has unique experience providing integrated care through ACO-like programs. Specifically, the recent ESRD Management Demonstration Project sponsored by the Centers for Medicare & Medicaid Services and the current ESRD Prospective Payment System with it Quality Incentive Program have demonstrated that integrated delivery of renal care can be accomplished in a manner that provides improved clinical outcomes with some financial margin of savings. Moving forward, integrated renal care will probably be linked to provider performance and quality outcomes measures, and clinical integration initiatives will share several common elements, namely performance-based payment models, coordination of communication via health care information technology, and development of best practices for care coordination and resource utilization. Integration initiatives must be designed to be measured and evaluated, and, consistent with principles of continuous quality improvement, each initiative will provide for iterative improvements of the initiative.

An assessment of the relation between metal contaminated sediment and freshwater mussel populations in the Big River, Missouri.

The Big River in southeast Missouri drains the largest historical lead mining area in the United States. Ongoing releases of metal contaminated sediments into this river are well documented and are suspected of suppressing freshwater mussel populations. We characterized the spatial extent of metal contaminated sediments and evaluated its relationship with mussel populations in the Big River. Mussels and sediments were collected at 34 sites with potential metal effects and 3 reference sites. Analysis of sediment samples showed that lead (Pb) and zinc (Zn) concentrations were 1.5 to 65 times greater than background concentrations in the reach extending 168 km downstream from Pb mining releases. Mussel abundance decreased acutely downstream from these releases where sediment Pb concentrations were highest and increased gradually as Pb sediment concentrations attenuated downstream. We compared current species richness with historical survey data from three reference rivers with similar physical habitat characteristics and human effects, but without Pb-contaminated sediment. Big River species richness was on average about one-half that expected based on reference stream populations and was 70-75 % lower in reaches with high median Pb concentrations. Sediment Zn and cadmium, and particularly Pb, had significant negative correlations with species richness and abundance. The association of sediment Pb concentrations with mussel community metrics in otherwise high-quality habitat indicates that Pb toxicity is likely responsible for depressed mussel populations observed within the Big River. We used concentration-response regressions of mussel density verses sediment Pb to determine that the Big River mussel community is adversely affected when sediment Pb concentrations are above 166 ppm, the concentration associated with 50 % decreases in mussel density. Based on this assessment of metals concentrations sediment and mussel fauna, our findings indicate that sediment in approximately 140 km of the Big River with suitable habitat has a toxic effect to mussels.

Impacts of acute and chronic suspended solids exposure on juvenile freshwater mussels.

Construction activities may affect adjacent water systems by introducing increased levels of suspended solids into the water body and may subsequently affect the survival and growth of freshwater mussels. We tested three sediment types from sites in Missouri, including Spring River sediment (SRS), Osage River bank clay soil (ORC), and quarried limestone from Columbia (LMT). We prepared series of suspensions of each sediment with total suspended solids concentrations ranging from 0 to 5000 mg/L. Juveniles from three mussel species, Fatmucket (Lampsilis siliquoidea), Arkansas Brokenray (Lampsilis reeveiana), and Washboard (Megalonaias nervosa) were exposed to these suspensions in both acute (96-h) and chronic (28-d) tests. No clear impact on survival was observed from the acute or chronic exposures, but chronic test showed that juvenile mussels' growth was strongly affected. Interestingly, growth was enhanced at lower levels of SRS and ORC (≤500 mg/L, p < 0.05), and the juvenile mussels exposed to 500 mg/L SRS exhibited approximately 60 % more dry weight than those reared in the control. LMT did not enhance growth. Growth was slowed by high concentrations (>1000 mg/L) of all three sediments, implying that high suspended solids levels could reduce survival in the long term. Our findings may help to inform regulations and guidelines for construction activities to minimize adverse effects on juvenile mussels.

Association of Chronic Condition Special Needs Plan With Hospitalization and Mortality Among Patients With End-Stage Kidney Disease.

Importance: While several studies have demonstrated the benefit of enrollment in chronic condition special needs plans (C-SNPs) for other chronic diseases (eg, diabetes), there is no evaluation of the association of C-SNPs with outcomes among patients with end-stage kidney disease (ESKD). Objective: To examine whether and to what degree C-SNP enrollment was associated with improved clinical outcomes and quality of life in patients with ESKD. Design, Setting, and Participants: This multicenter cohort study included 2718 patients who were newly enrolled in an ESKD C-SNP between January 1, 2013, and September 30, 2017, and receiving dialysis from DaVita Kidney Care. Patients were followed up until death, loss to follow-up, or end of study (ie, December 31, 2018). Enrollees in C-SNP were matched via multiple clinical and demographic characteristics with 2 different control populations, as follows: (1) those in the same facilities (n = 2545) or (2) those in similar counties (n = 1986). Patients enrolled in CareMore C-SNPs (n = 206) were excluded from the study. Data analysis was conducted June to December 2019. Exposures: Standard ESKD care with dialysis plus access to an integrated care team who worked with the patient and the dialysis team, comprehensive health assessments done by the integrated care team, and access to select benefits (such as vision and dental care) as a C-SNP enrollee. Main Outcomes and Measures: Hospitalizations, mortality, laboratory values indicative of metabolic control, and Kidney Disease Quality of Life 36-item (KDQOL-36) survey scores. Results: The 2545 C-SNP enrollees in the facility-matched analysis had a mean (SD) age of 57.2 (12.9) years, and included 968 (38.0%) women, 1328 (52.2%) Hispanic individuals, and 553 (21.7%) African American individuals. The 1986 C-SNP enrollees in the county-matched analysis had a mean (SD) age of 57.8 (12.2) years, with 705 (35.5%) women, 1085 (54.6%) Hispanic individuals, and 472 (23.8%) African American individuals. Compared with patients not enrolled in C-SNP, enrollees had lower hospitalization rates, with incidence rate ratios of 0.90 (95% CI, 0.84-0.97; P = .006) in the facility-matched analysis and 0.76 (95% CI, 0.70-0.83; P < .001) in the county-matched analysis. Compared with patients not enrolled in C-SNP, enrollees had decreased mortality risk in the same facilities (hazard ratio, 0.77; 95% CI, 0.68-0.88; P < .001) and in the same counties (hazard ratio, 0.77; 95% CI, 0.66-0.88; P < .001). No significant differences were observed between C-SNP enrollees and matched patients in metabolic laboratory values or KDQOL-36 survey scores. Conclusions and Relevance: This cohort study found a positive association of C-SNP enrollment with lower rates of hospitalization and mortality. The findings suggest that the additional services and benefits C-SNPs provide may improve outcomes compared with standard of care for patients with ESKD.

A payer-provider partnership for integrated care of patients receiving dialysis.

OBJECTIVES: Patients with end-stage renal disease (ESRD) are clinically complex, requiring intensive and costly care. Coordinated care may improve outcomes and reduce costs. The objective of this study was to determine the impact of a payer-provider care partnership on key clinical and economic outcomes in enrolled patients with ESRD. STUDY DESIGN: Retrospective observational study. METHODS: Data on patient demographics and clinical outcomes were abstracted from the electronic health records of the dialysis provider. Data on healthcare costs were collected from payer claims. Data were collected for a baseline period prior to initiation of the partnership (July 2011-June 2012) and for two 12-month periods following initiation (April 2013-March 2014 and April 2014-March 2015). RESULTS: Among both Medicare Advantage and commercial insurance program members, the rate of central venous catheter use for vascular access was lower following initiation of the partnership compared with the baseline period. Likewise, hospital admission rates, emergency department visit rates, and readmission rates were lower following partnership initiation. Rates of influenza and pneumococcal vaccination were higher than 95% throughout all 3 time periods. Total medical costs were lower for both cohorts of members in the second 12-month period following partnership initiation compared with the baseline period. CONCLUSIONS: Promising trends were observed among members participating in this payer-provider care partnership with respect to both clinical and economic outcomes. This suggests that collaborations with shared incentives may be a valuable approach for patients with ESRD.

Diabetes education and care management significantly improve patient outcomes in the dialysis unit.

BACKGROUND: The incidence of diabetes mellitus, particularly type 2, is increasing in the general population. Similarly, the incidence of patients with diabetes mellitus who develop end-stage renal disease has increased concomitantly in the dialysis facility to 44% of patients starting dialysis therapy with diabetes mellitus as their primary diagnosis. The aim of this study is to determine whether intensive education and care management of diabetes could improve glycemic control, alter patient behavior, and reduce complications in the setting of the dialysis unit. METHODS: Eighty-three patients were allocated to either the control group or study group based on their day of dialysis treatment. All patients were followed up for a year. Patients in the study group underwent a diabetes education program and were followed up by a care manager who provided self-management education, diabetes self-care monitoring/management, motivational coaching, and foot checks. RESULTS: The control group baseline foot risk category worsened from 2.7 to 3.3 (P < 0.05), whereas it was unchanged in the study group (2.2 to 2.0). There were no amputations in the study group versus five amputations in the control group (P < 0.05). Ten patients in the control group were hospitalized with diabetes- or vascular-related admissions versus one patient in the study group (P < 0.002). Hemoglobin A(1c) levels declined from 6.9 to 6.3 in the study group, whereas results of the control group were unchanged (P < 0.005). Diabetes-related quality-of-life scores increased in the study group from 76 to 86 (P < 0.001 versus the control group). There was a significant improvement in self-management behavior in all six categories evaluated in the study group versus the control group. Dialysis centers were recognized by the American Diabetes Association to provide diabetes education. CONCLUSION: A program of intensive diabetes education and care management in a dialysis unit is effective in providing significant improvements in patient outcomes, glycemic control, and better quality of life in patients with diabetes mellitus.

Toward population management in an integrated care model.

Under the Patient Protection and Affordable Care Act of 2010, accountable care organizations (ACOs) will be the primary mechanism for achieving the dual goals of high-quality patient care at managed per capita costs. To achieve these goals in the newly emerging health care environment, the nephrology community must plan for and direct integrated delivery and coordination of renal care, focusing on population management. Even though the ESRD patient population is a complex group with comorbid conditions that may confound integration of care, the nephrology community has unique experience providing integrated care through ACO-like programs. Specifically, the recent ESRD Management Demonstration Project sponsored by the Centers for Medicare & Medicaid Services and the current ESRD Prospective Payment System with it Quality Incentive Program have demonstrated that integrated delivery of renal care can be accomplished in a manner that provides improved clinical outcomes with some financial margin of savings. Moving forward, integrated renal care will probably be linked to provider performance and quality outcomes measures, and clinical integration initiatives will share several common elements, namely performance-based payment models, coordination of communication via health care information technology, and development of best practices for care coordination and resource utilization. Integration initiatives must be designed to be measured and evaluated, and, consistent with principles of continuous quality improvement, each initiative will provide for iterative improvements of the initiative.

Preference for monthly darbepoetin alfa dosing in patients with chronic kidney disease not receiving dialysis.

OBJECTIVE: To determine patient preference for once-weekly Epoetin alfa versus once-monthly (QM) darbepoetin alfa in patients with chronic kidney disease (CKD) not receiving dialysis. METHODS: AMPS (Aranesp Monthly Preference Study) consisted of two studies of similar design, each with a 2-week screening/baseline period, a 20-week QM darbepoetin alfa dosing period, and an 8-week follow-up period. Patients aged > or = 18 years had a nephrologist-reported diagnosis of CKD but were not receiving dialysis, and were required to have at least two hemoglobin levels within 10-12 g/dL and to have been receiving a stable dose (< 25% change) of once-weekly or once-every-other-weekly Epoetin alfa for at least 8 weeks. At week 21, patients could continue on QM darbepoetin alfa or revert back to their previous Epoetin alfa regimen. The primary analysis assessed patient preference at week 21 for QM darbepoetin alfa versus previous once-weekly Epoetin alfa. RESULTS: AMPS enrolled 442 patients: 54% were female, 67% were Caucasian, and mean (SD) age was 68.3 (13.5) years. At week 21, 346 patients remained on study. Of the patients converted from once-weekly Epoetin alfa, 86% (138/161) preferred darbepoetin alfa QM, and of all patients who expressed a preference, regardless of previous Epoetin alfa dosing frequency, 96% (305/319) preferred QM darbepoetin alfa. Mean (SD) hemoglobin at week 29 of the study was similar to mean hemoglobin at baseline (for those who completed the study and were receiving QM darbepoetin alfa at week 29: 11.2 [1.1] g/dL at week 29 versus 11.4 [0.7] g/dL at baseline). QM darbepoetin alfa was well tolerated. CONCLUSION: These data show that the majority of study patients preferred QM darbepoetin alfa to more frequent Epoetin alfa, and that QM darbepoetin alfa maintained hemoglobin levels at week 29 and was well tolerated over the study period. The single-item questionnaire could be a potential limitation of this study and further investigation with a multi-question instrument may be helpful in confirming these results.

A randomized, controlled trial comparing IV iron sucrose to oral iron in anemic patients with nondialysis-dependent CKD.

BACKGROUND: Although iron deficiency frequently complicates anemia in patients with nondialysis-dependent CKD (ND-CKD), the comparative treatment value of IV iron infusion and oral iron supplementation has not been established. METHODS: In a randomized, controlled multicenter trial, we compared the efficacy of iron sucrose, given as 1 g in divided IV doses over 14 days, with that of ferrous sulfate, given 325 mg orally thrice daily for 56 days in patients with ND-CKD stages 3 to 5, Hb < or =11 g/dL, TSAT < or =25%, and ferritin < or =300 ng/mL. Epoetin/darbepoetin therapy, if any, was not changed for eight weeks prior to or during the study. RESULTS: The proportion of patients achieving the primary outcome (Hb increase > or =1 g/dL) was greater in the IV iron treatment group than in the oral iron treatment group (44.3% vs. 28.0%, P= 0.0344), as was the mean increase in Hb by day 42 (0.7 vs. 0.4 g/dL, P= 0.0298). Compared to those in the IV iron group, patients in the oral iron treatment group showed a greater decline in GFR during the study (-4.40 vs. -1.45 mL/min/1.73m2, P= 0.0100). No serious adverse drug events (ADE) were seen in patients administered IV iron sucrose as 200 mg IV over two to five minutes, but drug-related hypotension, including one event considered serious, occurred in two females weighing less than 65 kg after 500 mg doses were given over four hours. CONCLUSION: IV iron administration using 1000 mg iron sucrose in divided doses is superior to oral iron therapy in the management of ND-CKD patients with anemia and low iron indices.

The challenges of diabetes care in the dialysis unit.

Nephrologists, dialysis facilities, and payers are confronted with a new and more difficult set of challenges to effectively care for the steadily increasing number of patients with diabetes mellitus (DM) developing end-stage renal disease (ESRD). U.S. Renal Data System (USRDS) data suggest that the current care of patients with DM on dialysis is suboptimal. Recently published reports have confirmed the value of HbA1C measurements in the diabetic dialysis population, that control of blood glucose lowers mortality, and that a program of care management and diabetes education can have a significant impact on patient outcomes. As leader of the nephrology team, the nephrologist should, at a minimum, be accountable for defining who is managing the diabetes. A more systematic and educated approach to DM and its complications needs to be developed by the renal community.