Arbor Research
 

Arbor Research Collaborative for Health News 

 
July 2013
In This Issue
2013 Annual Report
DPM Web Conference
DOPPS Guide for Researchers
LURN Expands
Contributions to Kidney Allocation Policy
DOPPS Training in Russia
Project News in Brief
Recent Publications

   

2013 Arbor Research Annual Report
 
The 2013 Arbor Research annual report is now available at ArborResearch.org. This report highlights the research we conduct to achieve our biggest goal: reducing the burden of chronic disease and improving the delivery of care to patients.  

 

As our organization grows, we seek opportunities to make meaningful improvements in patient lives and health care practices. You can read about our progress and project developments by clicking here.

 

                                     


 

Save the Date: DPM Web Conference

   

The DOPPS will host a free, public Web conference to discuss the latest data available from the DOPPS Practice Monitor (DPM) on Thursday, September 5, 2013. Registration will be available on the DOPPS.org website as the date approaches. 

 

 

                                     


 

Job Openings

  

 

Arbor Research is growing. We currently offer excellent opportunities for candidates with skills in biostatistics, health economics, health services research, and project support. 

 

Please click here to view a full list of current openings.

 

                                     


 

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If you have a question or a comment, please send it to Communications@ArborResearch.org 

 

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Tel: +1 (734) 665-4108

 

                                     


 

Quick Links

 

Greetings! 

Welcome to the July issue of the Arbor Research newsletter. In this issue, we highlight new resources and recent publications.

 

                                     


 

 

   

The Dialysis Outcomes and Practice Patterns Study (DOPPS) has a long history of successful collaborations with investigators outside of Arbor Research Collaborative for Health. New information for researchers has been added to DOPPS.org to promote new partnerships. Past activities have allowed scientists to explore a very broad range of topics of interest to the dialysis community. To continue the tradition of providing unique opportunities for scientific investigation, the DOPPS invites interested researchers to learn more about opportunities for collaboration with us. Please click here to learn more about research collaborations with DOPPS.   

 

                                     


 

 

      

 

Arbor Research was awarded a grant to expand existing work as the data coordinating center for the Symptoms of Lower Urinary Tract Dysfunction Network (LURN). The LURN project's goals are to develop and test patient-reported tools and conduct phenotypic studies to quantitatively describe the symptoms of lower urinary tract dysfunction in women and men. It is hoped that these efforts will inform strategies to prevent and/or manage disease and improve the lives of patients who suffer from lower urinary tract dysfunction.  

 

The new funds allow us to provide data coordinating services to three new clinical sites (in addition to the three existing sites that were funded in the original grant). The funding also provides additional effort for project, analytic, and monitoring staff, as well as supporting two additional face-to-face Steering Committee meetings.

 

                                     


 

 

patients    

The OPTN/UNOS Board of Directors approved substantial revisions to the national policy for deceased donor kidney allocation at their June 24-25 meeting. As the SRTR contractor from 2000 to 2010, Arbor Research performed many of the early analyses supporting these policy changes. Please click here to learn more about our contributions to kidney allocation policy.

 

                                     


 

 

DOPPS Training in Russia

 

On June 28, 2013, the DOPPS held a training session in Moscow. The training was presented in Russian by the local supporting organization and investigators. Three members of the Arbor Research staff attended: Ron Pisoni, Justin Albert, and Chris Pustulka. The training focused primarily on study procedures and was attended by staff from dialysis facilities that were randomly selected and agreed to participate in DOPPS in Russia. The session was well-attended and generated thoughtful discussion about the study. DOPPS data collection will begin in Russia in August, 2013.

 

                                     


 

 

 Project News in Brief
   

The pilot phase of the Chronic Kidney Disease Outcomes and Practice Patterns Study (CKDopps) in Brazil is now complete. Longitudinal data collection will begin later this year. For more information about the CKDopps, please click here.

 

The Empowering Patients on Choices for Renal Replacement Therapy (EPOCH) study has begun interviewing patients. To learn more about EPOCH, please click here.

 

Under the ESRD Quality Measures Development and Maintenance contract, Arbor Research convened three Technical Expert Panels (TEP) in April 2013 to consider information in the areas of mineral bone disorder, dialysis adequacy, preventive care, and pediatric peritoneal dialysis adequacy. The TEP Summary Report summarizes the proceedings and recommendations of these panels. It will be available for download on the CMS website.

 

New ESRD quality measures were developed and existing measures were updated as a result of the Clinical TEP Meeting held in April 2013. These measures will be available for public comment from July 26, 2013 until August 9, 2013. The supporting documentation and TEP Report for the measures will be available for download on the CMS website. The public is encouraged to submit comment on the measures to ESRD_Quality_Measures@arborresearch.org.

 

The Payment Year 2014 QIP Preview Period will begin Monday, July 29 and close on Thursday, August 29 at 5:00PM EDT. Dialysis facilities will have the opportunity to preview and comment on their PY2014 ESRD QIP Performance Score Reports through DialysisReports.org. The PY2014 QIP includes six quality measures, three clinical measures, and three reporting measures, which will be used to determine a Total Performance Score and a resulting payment reduction for each eligible facility.

  

The Dialysis Facility Compare quarterly preview will run from August 15 to August 29.

  

Click here to view our complete portfolio of projects. 

 

 

 

                                     


 

 

Recent Publications  

 

 

Worldwide, mortality risk is high soon after initiation of hemodialysis

Robinson BM, et al; Kidney Int. click to view abstract

 

Computerized assessment of competence-related abilities in living liver donors: the Adult-to-Adult Living Donor Liver Transplantation Cohort Study

Freeman J, et al; Clinical Transplantation click to view abstract

 

Association of Dialysate Bicarbonate Concentration with Mortality in the Dialysis Outcomes and Practice Patterns Study

Tentori F, et al; Am J Kidney Dis. click to view abstract

 

Major bleeding events and risk stratification of antithrombotic agents in hemodialysis: results from the DOPPS

Sood MM, et al; Kidney Int. click to view abstract

 

Changes in dialysis treatment modalities during institution of flat rate reimbursement and quality assurance programs

Kleophas W, et al; Kidney Int. click to view abstract

 

Hemodialysis patient preference for type of vascular access: variation and predictors across countries in the DOPPS

Fissell RB, et al; J Vasc Access. click to view abstract

  

worldwideWorldwide, mortality risk is high soon after initiation of hemodialysis

Robinson BM, et al; Kidney Int.

 

Mortality rates for maintenance hemodialysis patients are much higher than the general population and are even greater soon after starting dialysis. Here we analyzed mortality patterns in 86,886 patients in 11 countries focusing on the early dialysis period using data from the Dialysis Outcomes and Practice Patterns Study, a prospective cohort study of in-center hemodialysis. The primary outcome was all-cause mortality, using time-dependent Cox regression, stratified by study phase adjusted for age, sex, race, and diabetes. The main predictor was time since dialysis start as divided into early (up to 120 days), intermediate (121-365 days), and late (over 365 days) periods. Mortality rates (deaths/100 patient-years) were 26.7 (95% confidence intervals 25.6-27.9), 16.9 (16.2-17.6), and 13.7 (13.5-14.0) in the early, intermediate, and late periods, respectively. In each country, mortality was higher in the early compared to the intermediate period, with a range of adjusted mortality ratios from 3.10 (2.22-4.32) in Japan to 1.15 (0.87-1.53) in the United Kingdom. Adjusted mortality rates were similar for intermediate and late periods. The ratio of elevated mortality rates in the early to the intermediate period increased with age. Within each period, mortality was higher in the United States than in most other countries. Thus, internationally, the early hemodialysis period is a high-risk time for all countries studied, with substantial differences in mortality between countries. Efforts to improve outcomes should focus on the transition period and the first few months of dialysis. For more information about this paper, please click here.

computerizedComputerized assessment of competence-related abilities in living liver donors: the Adult-to-Adult Living Donor Liver Transplantation Cohort Study

Freeman J, et al; Clinical Transplantation

 

BACKGROUND: Despite its importance, determination of competence to consent to organ donation varies widely based on local standards. We piloted a new tool to aid transplant centers in donor assessment. METHODS: We assessed competence-related abilities among potential living liver donors (LDs) in the nine-center A2ALL study. Prospective LDs viewed an educational video and were queried to assess Understanding, Appreciation, Reasoning, and ability to express a Final Choice using the MacArthur Competence Assessment Tool for Clinical Research, adapted for computerized administration in LDs ("MacLiver"). Videotaped responses were scored by a clinical neuropsychologist (JF). RESULTS: Ninety-three LDs were assessed. Mean (standard deviation; domain maximum) scores were as follows: Understanding: 18.1 (2.6; max = 22), Appreciation: 5.1 (1.0; max = 6), Reasoning: 3.1 (0.8; max = 4), and Final Choice: 3.8 (0.5; max = 4). Scores did not differ by demographics, relationship to the recipient, eligibility to donate, or eventual donation (p > 0.4). Higher education was associated with greater Understanding (p = 0.004) and Reasoning (p = 0.03). CONCLUSION: Standardized, computerized education with independent ratings of responses may (1) alert the clinical staff to potential donors who may not be competent to donate and (2) highlight areas needing further assessment and education, leading to better informed decision making. For more information about this paper, please click here.

associationofdialysateAssociation of Dialysate Bicarbonate Concentration with Mortality in the Dialysis Outcomes and Practice Patterns Study

Tentori F, et al; Am J Kidney Dis.

 

BACKGROUND: Most hemodialysis patients worldwide are treated with bicarbonate dialysis using sodium bicarbonate as the base. Few studies have assessed outcomes of patients treated with different dialysate bicarbonate levels, and the optimal concentration remains uncertain. STUDY DESIGN: The Dialysis Outcomes and Practice Patterns Study (DOPPS) is an international prospective cohort study. SETTING & PARTICIPANTS: This study included 17,031 patients receiving thrice-weekly in-center hemodialysis from 11 DOPPS countries (2002-2011). PREDICTOR: Dialysate bicarbonate concentration. OUTCOMES: All-cause and cause-specific mortality and first hospitalization, using Cox regression to estimate the effects of dialysate bicarbonate concentration, adjusting for potential confounders. MEASUREMENTS: Demographics, comorbid conditions, laboratory values, and prescriptions were abstracted from medical records. RESULTS: Mean dialysate bicarbonate concentration was 35.5 ± 2.7 (SD) mEq/L, ranging from 32.2 ± 2.3 mEq/L in Germany to 37.0 ± 2.6 mEq/L in the United States. Prescription of high dialysate bicarbonate concentration (=38 mEq/L) was most common in the United States (45% of patients). Approximately 50% of DOPPS facilities used a single dialysate bicarbonate concentration. 3,913 patients (23%) died during follow-up. Dialysate bicarbonate concentration was associated positively with mortality (adjusted HR, 1.08 per 4 mEq/L higher [95% CI, 1.01-1.15]; HR for dialysate bicarbonate =38 vs 33-37 mEq/L, 1.07 [95% CI, 0.97-1.19]). Results were consistent across levels of pre-dialysis session serum bicarbonate and between facilities that used a single dialysate bicarbonate concentration and those that prescribed different concentrations to individual patients. The association of dialysis bicarbonate concentration with mortality was stronger in patients with longer dialysis vintage. LIMITATIONS: Due to the observational nature of the present study, we cannot rule out that the reported associations may be biased by unmeasured confounders. CONCLUSIONS: High dialysate bicarbonate concentrations, especially prolonged exposure, may contribute to adverse outcomes, likely through the development of postdialysis metabolic alkalosis. Additional studies are warranted to identify the optimal dialysate bicarbonate concentration. For more information about this paper, please click here.

MajorbleedingMajor bleeding events and risk stratification of antithrombotic agents in hemodialysis: results from the DOPPS.

Sood MM, et al; Kidney Int. 

 

Benefits and risks of antithrombotic agents remain unclear in the hemodialysis population. To help clarify this we determined variation in antithrombotic agent use, rates of major bleeding events, and factors predictive of stroke and bleeding in 48,144 patients in the Dialysis Outcomes and Practice Patterns Study (DOPPS) phases I-IV. Antithrombotic agents including oral anticoagulants (OACs), aspirin (ASA), and anti-platelet agents (APAs) were recorded along with comorbidities at study entry, and clinical events including hospitalization due to bleeding were then collected every 4 months. There was wide variation in OAC (0.3-18%), APA (3-25%), and ASA use (8-36%), and major bleeding rates (0.05-0.22 events/year) among countries. All-cause mortality, cardiovascular mortality, and bleeding events requiring hospitalization were elevated in patients prescribed OACs across adjusted models. The CHADS2 score predicted the risk of stroke in atrial fibrillation patients. Gastrointestinal bleeding in the past 12 months was highly predictive of major bleeding events; for patients with previous gastrointestinal bleeding, the rate of bleeding exceeded the rate of stroke by at least twofold across all categories of CHADS2 score, including patients at high stroke risk. Appropriate risk stratification and a cautious approach should be considered before OAC use in the dialysis population. For more information about this paper, please click here.  

 

ChangesinChanges in dialysis treatment modalities during institution of flat rate reimbursement and quality assurance programs.

Kleophas W, et al; Kidney Int.
 
Dialysis procedure rates in Germany were reduced in 2002, changing from per-session payment to weekly flat rate (FR). Quality assurance (QA) was introduced in 2009 with defined treatment targets for spKt/V, dialysis frequency, treatment time (TT) and hemoglobin (Hgb). The Dialysis Outcomes and Practice Patterns Study (DOPPS) observed practice patterns before, during and after introduction of FR and QA. Data from 14-21 dialysis centers included 407-618 prevalent patients with hemodialysis (HD) vintage >90 days based on cross-sections in DOPPS 1-4 (1998-2011). Descriptive statistics were used to report differences over time in 4 QA parameters (TT, spKt/V, dialysis frequency, Hgb), erythropoietin-stimulating agents (ESA), and intravenous (IV) iron doses. Time trends were analyzed using linear mixed models adjusted for patient demographics and comorbidities. The proportion of patients with low TT (4-6% of patients <4 hours) and low spKt/V (9-12% <1.2) was lowest after implementation of QA. Hgb levels increased since 1998, remaining consistent from 2005 (8-10% <10 g/dL). ESA prescription was around 90%. ESA dosing declined since peaking in 2006 at 8706 units/week. IV iron use was highest in 2011 (78%; mean dose 293 mg/month). Since 1998, trends to improve quality metrics for HD have been seen in Germany even after implementation of a reimbursement FR. Facility practice patterns can be useful for understanding the ability to maintain quality of care in a cost-containment environment. For slides and more information about this paper, please click here.   
  

HemodialysisHemodialysis patient preference for type of vascular access: variation and predictors across countries in the DOPPS.

Fissell RB, et al; J Vasc Access. 

 

Purpose: Catheters are associated with worse clinical outcomes than fistulas and grafts in hemodialysis (HD) patients. One potential modifier of patient vascular access (VA) use is patient preference for a particular VA type. The purpose of this study is to identify predictors of patient VA preference that could be used to improve patient care. Methods: This study uses a cross-sectional sample of data from the Dialysis Outcomes and Practice Patterns Study (DOPPS 3, 2005-09), that includes 3815 HD patients from 224 facilities in 12 countries. Using multivariable models we measured associations between patient demographic and clinical characteristics, previous catheter use and patient preference for a catheter. Results: Patient preference for a catheter varied across countries, ranging from 1% of HD patients in Japan and 18% in the United States, to 42% to 44% in Belgium and Canada. Preference for a catheter was positively associated with age (adjusted odds ratio per 10 years=1.14; 95% CI=1.02-1.26), female sex (OR 1.49; 95% CI=1.15-1.93), and former (OR=2.61; 95% CI=1.66-4.12) or current catheter use (OR=60.3; 95% CI=36.5-99.8); catheter preference was inversely associated with time on dialysis (OR per three years=0.90; 95% CI=0.82-0.97). Conclusions: Considerable variation in patient VA preference was observed across countries, suggesting that patient VA preference may be influenced by sociocultural factors and thus could be modifiable. Catheter preference was greatest among current and former catheter users, suggesting that one way to influence patient VA preference may be to avoid catheter use whenever possible. For more information about this paper, please click here.