the dialysis outcomes and practice patterns study (dopps) practice monitor: rationale and methods...
TRANSCRIPT
Special Article
The Dialysis Outcomes and Practice Patterns Study (DOPPS)Practice Monitor: Rationale and Methods for an Initiative to
Monitor the New US Bundled Dialysis Payment System
Bruce Robinson, MD,1 Douglas Fuller, MS,1 Dawn Zinsser, BA,1 Justin Albert, BA,1
Brenda Gillespie, PhD,2 Francesca Tentori, MD,1 Marc Turenne, PhD,1
Friedrich Port, MD,1 and Ronald Pisoni, PhD1
A new initiative of the US Dialysis Outcomes and Practice Patterns Study (DOPPS), the DOPPS PracticeMonitor (DPM), provides up-to-date data and analyses to monitor trends in dialysis practice during implemen-tation of the new Centers for Medicare & Medicaid Services (CMS) end-stage renal disease ProspectivePayment System (PPS; 2011-2014). We review DPM rationale, design, sampling approach, analytic methods,and facility sample characteristics. Using stratified random sampling, the sample of �145 US facilities providesresults representative nationally and by facility type (dialysis organization size, rural/urban, free standing/hospital based), achieving coverage similar to the CMS sample frame at average values and tails of thedistributions for key measures and patient characteristics. A publicly available web report (www.dopps.org/DPM) provides detailed trends, including demographic, comorbidity, and dialysis data; medications; vascularaccess; and quality of life. Findings are updated every 4 months with a lag of only 3-4 months. Baseline data arefrom mid-2010, before the new PPS. In sum, the DPM provides timely representative data to monitor effects ofthe expanded PPS on dialysis practice. Findings can serve as an early warning system for possible adverseeffects on clinical care and as a basis for community outreach, editorial comment, and informed advocacy.Am J Kidney Dis. 57(6):822-831. © 2011 by the National Kidney Foundation, Inc.
INDEX WORDS: End-stage renal disease; prospective payment system; quality incentive program; DialysisOutcomes and Practice Patterns Study.
Payment for US dialysis services has changedfundamentally with the new Centers for Medi-
care & Medicaid Services (CMS) end-stage renaldisease (ESRD) prospective payment system (PPS;implemented over 2011-2014) and the Quality Incen-tive Program (QIP; implemented in 2012).1,2 Thesepayment reforms establish new financial incentivesand constraints for dialysis facilities. Because of thesealtered incentives, there is potential for substantialchanges in a broad range of clinical dialysis practices,and the need to promptly monitor access to andquality of dialysis care under the expanded PPS hasbeen highlighted.3-5 The Dialysis Outcomes and Prac-tice Patterns Study (DOPPS) Practice Monitor (DPM)is a new initiative to monitor trends in dialysis prac-tice during both PPS and QIP implementation. To ourknowledge, no other nationally representative data
From the 1Arbor Research Collaborative for Health; and 2Uni-versity of Michigan Department of Biostatistics, Ann Arbor, MI.
Received December 10, 2010. Accepted in revised form March2, 2011. Originally published online April 29, 2011.
Address correspondence to Bruce Robinson, MD, 315 WestHuron, Ste 360, Ann Arbor, MI 48103. E-mail: [email protected]
© 2011 by the National Kidney Foundation, Inc.0272-6386/$36.00
doi:10.1053/j.ajkd.2011.03.001822
source currently exists to fulfill this role in a timelymanner.
To achieve DPM aims, the DOPPS has increasedUS enrollment from 85 to 137 dialysis facilities, witha final target sample of 145 facilities. Stratified ran-dom sampling has ensured that the sample is represen-tative nationally and by facility type (dialysis organi-zation size, rural/urban location, etc). A key feature ofthe DPM is a detailed publicly available web report todescribe trends in clinical practice, including achieve-ment of CMS quality measures and clinical practiceguidelines. The web site was launched in November2010 with baseline data from mid-2010, before imple-mentation of the expanded PPS. Findings are pre-sented for the nation overall and by facility type andare updated every 4 months, with a lag of only 3-4months for most data.
By providing timely nationally representative datafor US dialysis patients and facilities, the DPM is animportant independent data source to report trends indialysis practice, evaluate the impact on clinical out-comes, and serve as a basis for informed advocacy. Inthis article, we review the DPM rationale, design,sampling approach, and analytic methods. We alsoshow that the DPM facility sample is representative ofUS dialysis facilities overall, facility subtypes thatmay respond differently to reimbursement policychange, and patient groups with higher dialysis costs
that may be most vulnerable to these changes in care.Am J Kidney Dis. 2011;57(6):822-831
The DOPPS Practice Monitor: Rationale and Methods
METHODS
DOPPSandDPMSampling
Begun in 1996, the DOPPS is a prospective cohort study that hasstudied hemodialysis patients and practices during 4 study phasesin 12 countries. The most recent phase, DOPPS 4, began in 2009.Detailed study methods have been published previously.6,7 Thesemethods have been applied by the DOPPS since its beginning toprovide nationally representative statistics for many different typesof hemodialysis practice measures, patient characteristics, andoutcomes. Informed patient consent is obtained as indicated inaccordance with local requirements.
Facility Sample Frame
In each DOPPS country, facilities are randomly selected from alist of all dialysis facilities treating at least 20 adult (aged �18years) in-center maintenance hemodialysis patients. For the USDPM, the sample frame is based on the 2008 Dialysis FacilityCompare (DFC) database8 created from CMS data obtained througha data use agreement. This database provides demographic andquality-of-care measures for all Medicare-certified dialysis facili-ties in the United States through the end of 2007. Data from theDFC are augmented with facility patient counts obtained from theJuly 2008 Annual Facility Survey database.9 Of 4,959 facilities,4,343 (88%) served at least 20 adult in-center hemodialysis pa-tients and constituted the final sample frame of facilities eligiblefor DPM participation. The restriction to facilities treating at least 20patients was chosen because these facilities served 97% of UShemodialysis patients. From this sample frame, �145 dialysis unitswere targeted for DPM recruitment.
Facility Sampling Strata
Random facility selection was performed within prespecifiedstrata of different facility types. Prior DOPPS experience hasshown that data from 20 randomly selected facilities yield reliableestimates to accurately represent practices within a particularfacility grouping. Therefore, targets were set to select a minimumof 20 facilities per category in the following 3 strata.
(1) Dialysis organization size: free-standing dialysis units wereclassified as part of a large (LDO; �500 dialysis facilities),medium (MDO; 11-500 facilities), or independent/small dialysisorganization (SDO; �10 dialysis facilities). Currently, the LDOstratum is composed of only the 2 largest US dialysis organiza-tions, each having more than 1,000 facilities. Because there are nostandard definitions to distinguish an SDO from an MDO, thecutoff at 10 facilities was used to meet the needs of the DPMsampling design.
(2) Hospital based/non–hospital based: all dialysis units werecategorized as hospital-based or free-standing non–hospital-baseddialysis units. All hospital-based units in CMS data were SDO/independent facilities.
(3) Rural/nonrural location: based on zip code, dialysis unitswere grouped into 3 categories according to the 2004 censustract–based rural-urban commuting area (RUCA) codes,10 aswell as approximate travel time from the center of each zip codeto the nearest urbanized area. Facilities were grouped into the 3categories of: (A) remote rural, population �10,000 with atleast 45 minutes’ travel time to the nearest urbanized area; (B)nonremote rural, population �10,000 with less than 45 min-utes’ travel time, and (C) nonrural, population �10,000. Be-cause there is no standard method of combining RUCA codes,we chose our definition of rurality to be consistent with com-
mon applications.Am J Kidney Dis. 2011;57(6):822-831
Patient Sampling
Data are collected from 20-40 randomly selected in-centerhemodialysis patients enrolled in the study at each participatingstudy site. An algorithm selects a larger number of patients withincreasing size of the dialysis unit to yield an overall average of�30 study patients per facility. Patients departing the study (eg,because of death, transfer to other facilities, switch to peritonealdialysis or home hemodialysis therapy, transplant, or recovery ofkidney function) are replaced at 4-month intervals. Replacementsare determined using random selection of patients new to thefacility since the prior selection, providing prevalent cross-sections that are representative of patients in each facility at every4-month interval.6
SamplingWeights
Facility sampling weights, patient sampling weights, and poststrati-fication weights are applied to report data that are representative at thenational and facility stratum levels.11 To obtain 20 or more facilities ineach stratum category, oversampling of facilities occurs in somecategories (Table 1). The fraction of facilities within each stratum istermed the facility sampling fraction. The reciprocal of the facilitysampling fraction serves as the facility sampling weight. Within eachfacility, data are collected on a random sample of 20-40 adultmaintenance hemodialysis patients. The fraction of all the facility’sadult maintenance hemodialysis patients that participates in the studyat a sampling selection time point is termed the patient samplingfraction. The reciprocal of the patient sampling fraction serves as thepatient sampling weight. Additionally, poststratification weights arecomputed for each patient to correct for disproportionate consent ratesamong basic demographic variables, years with ESRD, and diabetesas ESRD cause, which are collected for all facility patients.
Data Elements andReporting
DOPPSDataElements
Patient-level study data are limited to routinely collected clinicaldata. Data are collected using manual entry and/or electronic extrac-tion from patient medical records. At study entry, data include demo-graphics, detailed comorbid conditions, vascular access, medicationprescription and dose, and laboratory values. Patient-level data up-dated every 4 months include laboratory values (recorded monthly);medication prescription and dose (prescription and dose for mineralmetabolism and anemia-related medications are updated monthly);vascular access procedures, other clinical procedures, and hospitaliza-tions (with cause and procedures); date and causes of death; andreason for study departure. Patient self-reported data (eg, quality of life,depression symptoms, satisfaction with care, and others) are collectedyearly. Facility survey data related to practice preferences, servicesoffered, and staffing are collected yearly from the facility medical directorand nurse study manager. DOPPS data collection instruments are updatedor refined annually.
DPMWebReports
Data for the DPM web site are updated every 4 months with alag of 3-4 months from the time of data collection to appearance onthe web report. The DPM provides national and stratum-specificdescriptive statistics and trends in the following 9 clinical areas:demographics, comorbid conditions, anemia, mineral and bonedisorder (MBD), dialysis prescription and dose, vascular access,cardiovascular medications, nutrition, and quality of life. Demo-graphic and comorbidity data are reported annually. Vascularaccess use is reported every 4 months. Medication use is reportedmonthly for anemia and MBD medications and once every 4months for other medications. Erythropoiesis-stimulating agents
(ESAs) and intravenous iron dose also are reported. Laboratory823
Robinson et al
data are reported for each month as the mean of the last 2-3monthly values, except for less frequently measured laboratorytests, such as parathyroid hormone (PTH). Quality of life isreported annually as physical and mental component summaryscores. Examples of detailed data reported are provided for anemiaand MBD measures in Box 1. Sample graphical presentations forDPM data are shown in Fig 1. Altogether, more than 1,300 chartsand tables are provided on the DPM web site; graphics of the typeshown in Fig 1 are available for download.
Trends are monitored for variables reported on the DPM web site.Tests of location (t tests and quantile regression) that account forrepeated measures are used to assess significant differences betweenbaseline (ie, before 2011) values and post-PPS implementation values(ie, 2011-2014). After sufficient data are obtained in 2011 to establishpost-PPS trends, additional modeling techniques, including longitudi-nal mixed models and spline regression, will be used to quantify theeffect of PPS implementation on trends in monitored variables. Anexecutive summary provided with each DPM will highlight notablefindings.
Specific clinical data that are not provided on the web sitewill form the basis for multivariable analyses and peer-reviewed publications. These include deaths, hospitalizations,clinical procedures and other events, facility survey data, andselected patient self-reported data.
Evaluating theDPMSample
To assess the extent to which the sample of DPM facilities isrepresentative of US hemodialysis facilities overall, 2007 CMS datafor the 137 DPM facilities are compared with 2007 CMS data for all
Table 1. Distribution of DPM
Categories
TotalFacility Characteristics Used for
Dialysis organization size LDO
MDO
SDO
Rurality Nonrural
Rural(nonremote)
Rural (remote)
Hospital based Hospital based
Free standing
Facility Characteristics Not Us
Profit status For profit
Nonprofit
Geographic region Central
East
South
West
Note: Values shown as number (percentage). Some strata wexception of hospital-based facilities (19 recruited to date), theachieved in all sampling strata.
Abbreviations and definitions: CMS, Centers for Medicare & MStudy; DPM, DOPPS Practice Monitor; LDO, large dialysis orgunits); SDO, small or independent dialysis organization (�10 uni
aAs of September 2010.
remaining US hemodialysis facilities treating at least 20 in-center
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hemodialysis patients (N � 4,206).8 Analyses are limited to mainte-nance hemodialysis patients 18 years or older. Comparisons areperformed for 8 patient characteristics or laboratory measures. Theseitems were chosen because they are part of the 2012 CMS QIP, areidentified as important in a recent Government Accountability Office(GAO) report,3 or otherwise are expected to be potentially affected by thenew PPS. Comparisons are tested using a weighted t test.
Additionally, we sought to show the reliability of DOPPS dataversus the CMS database. Baseline data from a prevalent cross-section of patients in all 66 DOPPS phase 3 US facilities (studyinitiation dates, 2005-2007) are expressed at the facility level usingsummary methods similar to the CMS. To form the comparisongroup, we selected a record from the CMS dialysis facility reportsdatabase that most closely matched the date the facility was recruitedinto the DOPPS. Group-wise comparisons (DOPPS phase 3 vs CMS)are conducted using 2-sample t test and Wilcoxon rank-sum test.
RESULTS
Descriptionof theUSDOPPSFacility Sample
As of September 2010, a total of 291 US hemodialy-sis facilities had been contacted for participation inthe DOPPS as part of the DPM initiative, of which137 (47%) had agreed and were actively participating.The distribution of these units by facility characteris-tics is listed in Table 1. The distribution illustrates thepurposive oversampling method used to monitor clini-
ties by Facility Characteristics
CMS FacilitiesFacilities in US
DOPPSa
4,343 137ified Sampling of DPM Facilities
2,704 (62.3) 68 (49.6)
633 (14.6) 22 (16.1)
1,006 (23.2) 47 (34.3)
3,923 (90.3) 82 (59.9)
180 (4.1) 26 (19.0)
240 (5.5) 29 (21.2)
235 (5.4) 19 (13.9)
4,108 (94.6) 118 (86.1)
or Sampling of DPM Facilities
3,574 (83.0) 91 (67.4)
732 (17.0) 44 (32.6)
1,010 (23.3) 43 (31.4)
951 (21.9) 39 (28.5)
1,205 (27.8) 27 (19.7)
1,177 (27.1) 28 (20.4)
intentionally oversampled. Rurality is defined in text. With theum study target of 20 facilities per selection stratum has been
aid Services; DOPPS, Dialysis Outcomes and Practice Patternstion (�500 units); MDO, medium dialysis organization (11-500
Facili
Strat
ed f
ereminim
edicanizats).
cal practice in certain facility types that are less
Am J Kidney Dis. 2011;57(6):822-831
n the
The DOPPS Practice Monitor: Rationale and Methods
common in the United States, including SDO/indepen-dent, hospital-based, and rural units. The stratifiedrandom selection scheme also resulted in a sufficientnumber of participating units in other (nonsampling)facility strata, including profit status and geographicregion, to provide meaningful practice data in thesefacility strata.
Comparison to FacilitiesDecliningParticipation
For the 53% of sampled facilities declining partici-pation, burden to facility staff was the most commonreason cited. Weighted comparisons of 2007 CMSdata between the facilities declining (declined) andactively participating (DPM) are listed in Table 2.
Figure 1. Examples of graphics used in the Dialysis Outcom(A) Sample box-and-whisker chart (modified). At each time poindistribution, the vertical line below the central dot connects the 1dot connects the 75th and 90th percentile values. Additional staseparate data table (not shown). Values at each month are basedmonths. (B) Sample “stacked” column chart. Segment heights rpoint indicated on the x-axis. Values for each month are based omonths.
Facilities that declined participation had a mean facil-
Am J Kidney Dis. 2011;57(6):822-831
ity standardized mortality ratio 0.06 points higherthan DPM participating facilities (0.95 vs 0.89; P �0.2), as well as a higher percentage of African Ameri-can patients (35.9% vs 26.1%; P � 0.03).
Comparison toUSDialysisUnitsOverall
We analyzed 2007 CMS data to compare the distri-bution of 8 variables in DPM facilities (DPM) withtheir distribution in the CMS non-DPM sample frame(N � 4,206). The DPM sample did not differ apprecia-bly from the CMS sample frame (P � 0.1) for 6 of the8 selected variables. DPM facilities have fewer Afri-can American patients than the CMS non-DPM sample(26.1% vs 35.8%; P � 0.001). The mean standardized
d Practice Patterns Study Practice Monitor web-based reports.wn on the x-axis, the central dot represents the median of the
nd 25th percentile values, and the vertical line above the centrals (mean, standard deviation sample size, etc) are provided in ae average of at least 2 measurements obtained during the prior 3ent the proportion of observations in each category at the timeaverage of at least 2 measurements obtained during the prior 3
es ant sho
0th atisticon thepres
mortality ratio was lower for the DPM sample (0.89
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Robinson et al
vs 0.95 in the CMS non-DPM sample), although thisdifference was not statistically significant (P � 0.1).
Weighted distributions of facility variables in the
Box 1. Examples of Data Elements Reported in the DPM
Anemia Measures
ESA use
- Any use (%)- By type (% epoetin, % darbepoetin)- By route (% IV, % subcutaneous)
ESA dose
- Mean and categories (�5,000, 5,000-�10,000, 10,000-�25,000,25,000-�50,000, �50,000 U/wk), overall and by type
Hemoglobin- Mean and categories (�10, 10-�11, 11-�12, �12 g/dL)
Iron use- Any IV use (%)- By type of IV preparation (%)- By route (% IV, % oral)
IV iron dose- Mean and categories (�250, 250-�500, �500 mg/mo)
Serum ferritin- Mean and categories (�200, 200-�500, 500-�800, �800 ng/mL)
Serum TSAT- Mean and categories (�20, 20-�30, 30-�50, �50%)
Mineral and Bone Disorder Measures
Serum calcium, total- Mean and categories (�8.4, 8.4-9.5, 9.6-10.2, �10.2 mg/dL)
Serum calcium, albumin-corrected- Mean and categories (�8.4, 8.4-9.5, 9.6-10.2, �10.2 mg/dL)
Serum phosphorus- Mean and categories (�3.5, 3.5-4.5, 4.6-5.5, 5.6-7.0,
�7.0 mg/dL)
Serum PTH- Mean and categories (�150, 150-300, 301-600, �600 pg/mL)
PTH measurement- % Patients with PTH measurement over prior 3 mo
Phosphate binder- Any use (%)- By type (%)
Vitamin D analogue- Any use (%)- By route (% IV, % oral, % both)- By type (%)
Cinacalcet- Any use (%)
Note: Shown here for anemia and MBD only (2 of 9 clinicalareas). Specifications of variables for reporting purposes are re-ported in the DPM Methods section. Each item will be reported onthe web site for the nation overall and by facility type. Conversionfactors for units: serum calcium in mg/dL to mmol/L, �0.2495serum phosphorus in mg/dL to mmol/L, �0.3229; hemoglobin ing/dL to g/L, �10; iron in �g/dL to �mol/L, �0.179. No conversionnecessary for ferritin in ng/mL and �g/L or PTH in pg/mL and ng/L.
Abbreviations: DPM, Dialysis Outcomes and Practice PatternsStudy Practice Monitor; ESA, erythropoiesis-stimulating agent; IV,intravenous; PTH, parathyroid hormone; TSAT, transferrin saturation.
DPM sample and CMS non-DPM sample are shown in
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Fig 2. The DPM achieves sampling coverage similar tothat in the CMS sample frame at the tails of each of thedistributions, in addition to similar mean values (Table2). This is important because practice changes in re-sponse to the new PPS may have different effects onpractice at the tails of the distribution of a particularpatient characteristic or practice area. Evaluation ofunweighted distributions shows that for the 8 facilityvariables, the DPM sample provides at least 24 facilitiesbelow the 20% percentile and at least 19 facilities abovethe 80% percentile of each variable’s distribution. Thus,the DPM has an adequate facility sample (�20 facilities)to report trends in care and test auxiliary hypothesesspecifically in facilities in the lowest and highest 20% ofoverall CMS distribution.
Two key differences between the DPM and CMSsample frames are worth comment. First, the overallfraction of African American patients is lower and thefraction of facilities with �10% of African Americanpatients is higher in the DPM facility sample than inthe CMS sample frame. This result is attributable inpart to purposely oversampling remote rural facilities,although DPM facilities also show a lower prevalenceof African American patients in the rural (nonremote)and nonrural facility strata. However, nearly one-fourth of DPM facilities have at least 50% AfricanAmerican patients (Fig 2C). Thus, the DPM canreadily report trends in care for African Americanpatients, as well as for facilities with a high propor-tion of African American patients. The overall frac-tions of Asian and Native American patients in theDPM facilities (3.7% and 2.4%, respectively) aresimilar to the overall CMS sample frame (3.6% and1.8%, respectively). Second, the mean standardizedmortality ratio for the DPM sample is lower than forthe CMS sample frame. However, the DPM facilitysample provides representation across the range ofstandardized mortality ratios in the CMS sample frame(Fig 2).
Reliability ofUSDOPPSData
To test the assumption that data from the DOPPSsample of 20-40 patients per facility are representa-tive of these facilities overall, we compared the DOPPSdata with CMS data in the 66 facilities participating inthe US DOPPS phase 3 from 2005-2007 (Table 3).Differences in patient characteristics (age �65 years,African American, and catheter use) were small andnot statistically significant (P � 0.1). The small differ-ences between DOPPS and CMS data for hemoglobinlevel and urea reduction ratio targets (P � 0.1 andP � 0.07, respectively) likely are caused by differ-ences in measure specification. CMS data are ex-pressed as patient-annualized averages, whereas
DOPPS estimates are based on 2 monthly valuesAm J Kidney Dis. 2011;57(6):822-831
The DOPPS Practice Monitor: Rationale and Methods
obtained approximately 4 months apart for each pa-tient in the facility cross-sectional sample.
DISCUSSION
On January 1, 2011, the CMS fundamentallychanged payment for dialysis services for Medicarepatients with ESRD by making a single bundledpayment (the expanded PPS) for each dialysis treat-ment to cover dialysis-related items and services.1
This has replaced the prior system that made a singlepayment for dialysis and other composite rate ser-vices, but paid separately for most drugs, laboratorytests, and other services provided by dialysis facili-ties. An option was provided to allow for a 4-yeartransition period to the new PPS by 25% per yearfrom 2011 to 2014. However, 2 separate surveysindicated that �90% of facilities were planning tochoose 100% transition to the new PPS in January
Table 2. Comparisons of DPM
SampleNo. of
Facilities SMR Age >65 y A
All facilitytypesa
DPM 137 0.89 45.6
Declined 154 0.95 44.0
Non-DPM 4,206 0.95 45.1
LDO DPM 68 0.88 44.3
Non-DPM 2,636 0.96 44.3
MDO DPM 22 0.98 50.7
Non-DPM 611 0.92 45.4
SDO DPM 28 0.83 45.5
Non-DPM 743 0.94d 47.3
Nonrural DPM 69 0.89 45.0
Non-DPM 3638 0.95 44.9
Rural(nonremote)
DPM 25 0.82 48.4
Non-DPM 150 0.97d 46.8
Rural (remote) DPM 24 0.89 50.2
Non-DPM 202 0.88 45.3
Free standing DPM 118 0.87 45.4
Non-DPM 3990 0.95d 45.0
Hospital based DPM 19 0.88 48.2
Non-DPM 216 0.86 47.0
Note: DPM includes participating DPM facilities as of Septparticipate or left the study before September 2010; non-DPM incDPM participation as of September 2010. Values shown as meancolumns) of non-DPM with DPM and declined with DPM. P � 0.�10.
Abbreviations and definitions: CMS, Centers for Medicare &Study Practice Monitor; Hb, hemoglobin; LDO, large dialysis orgunits); PD, peritoneal dialysis; SDO, small or independent dialysurea reduction ratio.
aMean DPM values are weighted to provide national or stratumbP � 0.01-�0.05; cP � 0.01; dP � 0.05-�0.10.
2011.12,13 The CMS also will implement a QIP in
Am J Kidney Dis. 2011;57(6):822-831
January 2012, initially based on claims-based qualitymeasures (hemoglobin �10 g/dL, hemoglobin �12g/dL, urea reduction ratio �65%).2 Together, theexpanded PPS and QIP are intended to encouragefacilities to operate efficiently while ensuring high-quality care.
The DPM is a new US DOPPS initiative designedto provide the community contemporary data andanalyses that will monitor trends in dialysis practicesfrom before to after PPS and QIP implementation.Facility recruitment for the DPM has been highlysuccessful, with nearly 50% of contacted facilitiesparticipating in the study. As of September 2010, atotal of 137 facilities were participating, with a finalstudy goal of 145 facilities. The target of at least 20facilities for each of the DPM facility strata has beenrecruited (with the exception of hospital-based facili-ties, at 19 to date; Table 1). The DPM facility sam-
ple With CMS Sample Frame
Percentage of Patients in Facility
ancan
Hb � 10-12g/dL URR >65%
>90 d WithCatheter Medicaid PD
55.0 95.5 11.7 21.1 5.9b 54.8 93.5 10.2 22.9 4.6c 53.5 95.7 11.5 23.8 5.0
47.0 96.5 10.8 21.7 6.0b 47.5 96.5 11.0 23.8 4.9
67.4 92.9 13.1 16.0 0.1c 63.5 94.2 12.2 24.3d 4.8c
71.3 94.9 12.9 22.5 9.0
63.5b 94.2 12.0 23.7 4.4
54.6 95.9 11.5 20.6 6.2b 53.1 95.6 11.4 23.4 5.1
51.2 96.7 13.1 26.0 1.4d 50.7 96.9 11.1 27.4 0.9
54.3 91.1 10.8 25.0 2.3c 49.6 96.4 10.2 29.3 2.0
54.4 95.7 11.5 21.1 5.8c 52.9 95.7 11.4 23.9 4.8
65.9 91.6 14.7 22.2 8.7
65.5 94.7d 14.5 23.1 8.1
r 2010; declined includes sampled facilities that declined tofacilities in the CMS sample frame that had not been selected for
MS facility-level data. P values are for t tests comparisons (withinot indicated otherwise. Conversion factor for: Hb in g/dL to g/L,
caid Services; DPM, Dialysis Outcomes and Practice Patternsation (�500 units); MDO, medium dialysis organization (11-500anization (�10 units); SMR, standardized mortality ratio; URR,
cific estimates.
Sam
Africmeri
26.1
35.9
35.8
29.1
38.1
8.7
37.4
29.8
28.8
27.1
35.9
29.2
42.4
15.5
38.5
26.5
36.3
18.6
27.2
embeludesof C
10 if n
Medianizis org
-spe
pling approach has yielded a recruited sample that is
827
Robinson et al
representative of US dialysis facilities overall, keyfacility subtypes, and particular patient groups. Thesedistributions illustrate the capacity of the DPM toreport trends in care for not only average facilities, butalso for facilities performing at the tails of the distribu-tion for particular patient characteristics or clinicalpractices.
The value of the DPM sample is that it meets theimperative to closely monitor trends in practice withthe implementation of the new PPS and upcomingQIP. This payment reform undoubtedly will changedialysis practice, but many of the effects are difficultto predict because of the variety of financial incen-tives in the final rule (and upcoming rules).3,14 On onehand, financial constraints may place pressures tolimit care, perhaps by favoring staffing reductions tothe extent possible or shifting time-consuming careaway from the dialysis unit (eg, to the emergencydepartment or hospital). On the other hand, pressureto operate at capacity may motivate programs toimprove care by decreasing skipped treatments (eg,patient education and coordination of transportation)and avoidable high-cost hospitalizations (eg, replac-ing central catheters with arteriovenous fistulae). In-centives also may increase training for and use ofhome dialysis therapies. Although the DPM is a studyof in-center hemodialysis, it will monitor trends inpatients switching from in-center hemodialysis toperitoneal dialysis or home hemodialysis and viceversa. Additionally, the QIP provides a mechanism forrewarding quality of care, initially based on measuresof anemia and dialysis adequacy that have been pro-posed for 2012.2 However, there also is a risk thatsuch programs may divert attention from other clini-
Table 3. Comparison
SampleNo. of
Facilities Age >65 y
DOPPS phase 3 66 44.0
CMS 2005-2007 66 45.6
Note: Comparison is restricted to 66 US facilities participating inCMS data for the year in which the DOPPS facility began participacollected for a prevalent cross-section of study patients in each Ucollection. Conversion factor for Hb in g/dL to g/L, �10.
Abbreviations: CMS, Centers for Medicare & Medicaid Servicerythropoiesis-stimulating agent; Hb, hemoglobin; URR, urea red
aHb level for Medicare patients with either ESA reimbursemeCMS results are expressed as percentage of patient-months duvalues obtained approximately 4 months apart.
bURR for Medicare patients only. CMS results are expressedbased on the mean of 2 monthly values obtained approximately 4
cCMS results are expressed as percentage of patient-months dstudy entry.
dP � 0.05-�0.10 for 2-sample t test (P � 0.10 if not shown).
cal areas that are not being measured or rewarded.15
828
Specific areas of clinical care initially will facegreater pressures than others. As examples, we summa-rize possible changes in the management of anemiaand MBD. Box 1 lists many of the data elements inanemia and MBD that the DPM web site will report.Regarding anemia management, average hemoglobinlevels have decreased during the past several yearsafter the publication of multicenter clinical trials andupdated US Food and Drug Administration guid-ance,16-18 and may decrease even further. SeveralDOPPS observations support the probability that aver-age ESA doses will decrease, while iron dosing mayincrease. First, ESA doses (for the same hemoglobinlevels) have been consistently higher in the UnitedStates than in other DOPPS countries.19,20 However,some of this difference is accounted for by measur-able differences in patient case-mix and the extent towhich the remaining difference is discretionary andtherefore modifiable (ie, not due to patient factors) isunclear. Second, the DOPPS recently reported effectsof the 2006 change in ESA reimbursement in dialysispatients in Japan from a separately billable item toinclusion in a bundled dialysis treatment payment.With bundling, average ESA dose decreased by 12%,intravenous iron use per 4 months increased from32% to 41% of patients, and hemoglobin levels essen-tially were unchanged.21 Although it is tempting tospeculate that changing incentives in the United Statesmay drive practice changes similar to those in Japan,anemia management practices differ substantially be-tween the United States and Japan, with much lowerESA and iron dosing, substantially lower intravenousiron use, and lower hemoglobin levels and target
OPPS and CMS Data
Percentage of Patients in Facility
Africanmerican
Hb � 10-12g/dLa
URR>65%b
WithCatheterc
37.3 50.4 91.9 25.8
34.3 52.9 94.7d 28.2
PPS phase 3 (2005-2007). CMS 2005-2007 results are based onn US DOPPS phase 3; DOPPS phase 3 results use DOPPS dataPPS phase 3 facility at the time of initiating DOPPS phase 3 data
OPPS, Dialysis Outcomes and Practice Patterns Study; ESA,n ratio.ims (CMS result) or reported ESA prescription (DOPPS result).the year. DOPPS results are based on the mean of 2 monthly
rcentage of patient-months during the year. DOPPS results areths apart.the year; DOPPS results are based on vascular access in use at
of D
A
DOting i
S DO
es; Ductio
nt claring
as pemon
uring
ranges in Japan versus the United States.
Am J Kidney Dis. 2011;57(6):822-831
The DOPPS Practice Monitor: Rationale and Methods
Figure 2. (A-H) Distributions of the Centers for Medicare & Medicaid Services (CMS) data for facilities in the Dialysis Outcomes and PracticePatternsStudy (DOPPS)samplecomparedwith theCMSfacility sample frame.Valueswerecalculated for8patient/clinicalmeasures inaprevalentcross-section of hemodialysis patients 18 years or older in the 2008 Dialysis Facility Compare database, based on 2007 CMS data. Each panelshows the distribution of values for the indicated measure across dialysis facilities in the DPM facility sample (N � 137 facilities) and the CMS facilitysample frame (N � 4,206) of facilities treating 20 or more in-center hemodialysis patients. Abbreviations: SMR, standardized mortality ratio; URR,
urea reduction ratio.Am J Kidney Dis. 2011;57(6):822-831 829
Robinson et al
MBD management also likely will change, but inways that are less predictable at this time becausefinancial incentives regarding MBD management areless apparent and the 2012 QIP will not include MBDmeasures.2,22 Inclusion in the new PPS of all intrave-nous renal medications and their oral equivalents maychange vitamin D analogue prescription practices,such as switching to other vitamin D analogues and/orto other medication classes (eg, calcimimetics) formanaging PTH levels.1 Additionally, bundling of di-alysis-related laboratory tests may result in less fre-quent measurement of PTH and use of other assays.Yet more dramatic practice changes can be expectedcloser to the time that payments for ESRD-relatedoral-only drugs, including phosphate binders and cal-cimimetics, are incorporated into the PPS in January2014.
The DPM is responsive to identified priorities in theGAO report.3 As stated in that report, the CMS shouldmonitor access to and quality of dialysis care promptlyafter the new PPS is implemented. Preliminary CMSplans for monitoring the new PPS build on existinginitiatives (eg, the ESRD Networks, surveyors, andDFC). The DPM complements these efforts by provid-ing more timely and detailed information about trendsin dialysis practices and quality of care. The GAOreport also highlighted groups of beneficiaries withabove-average dialysis costs, including patients withMedicaid, African American race, and/or youngerage, and cautioned that these patients may be mostvulnerable. The DPM provides ample facility represen-tation across the full spectrum of facilities treatingthese patient groups (Table 2; Fig 2) and thus theDPM is a resource to readily follow trends in theircare.
The DPM also will monitor access to care. Rel-evant data (not all available on the web site) includetrends in total census size, patient case-mix, medicalcoverage, and home modality use in the representativesample of DPM facilities, as well as trends possiblyreflecting access to care, such as changes in “adher-ence to care” (eg, skipped treatments), use of medicalprocedures, and outcomes such as withdrawal fromdialysis therapy. The DPM is not designed to monitorother aspects of access to care, including overall orregional trends in ESRD incidence/prevalence andnumber of dialysis facilities.
A hypothesis motivating the DPM design is thatresponses to the new PPS will vary by facility type,potentially affecting patient care. For example, SDOand independent facilities may be at different risk thanLDO facilities because of smaller volumes of patientsand treatments, disadvantages in negotiating withpharmacy and laboratory vendors, and new adminis-
trative burdens.23,24 In addition, previous research has830
identified differences in anemia management prac-tices by for-profit status and organizational affilia-tion.25-27 Hospital-based long-term dialysis facilities,most of which are independently owned, could faceadditional challenges. Choice among dialysis facili-ties for rural-area patients often is limited. Thus,closure of rural facilities or “cherry picking” of pa-tients could limit access to care for these patients.Twenty-nine of the 240 facilities defined as rural-remote in the CMS sample are participating in theDPM, providing a unique opportunity to monitorpractices and outcomes in this facility stratum. TheDPM will report clinical trends in each of these andother facility types.
To evaluate effects of the new PPS on clinicaloutcomes and their costs, the DOPPS will capturedetailed clinical event data. These include outpatient(eg, vascular access) procedures, elective hospitaliza-tions (eg, blood transfusions and parathyroidectomy),urgent hospital admissions, and patient survival. Theweb site will not report on trends in most clinicalevents because many are relatively uncommon andrequire a longer observation period and detailed statis-tical adjustment for carefully assessing whetherchanges over time may not be due to random error.Patient-reported outcomes, including quality of lifeand detailed satisfaction with care, also will be col-lected. The DPM will serve as a unique source forfollowing these quality-of-life measures. The DPMalso will be a source for facility-level survey data,such as trends in facility services, staffing, etc, as thePPS is implemented.
Because the DPM is based on a sample of facilitiesand patients, it will require eventual confirmation withnational CMS data. However, a great strength of theDPM sample is that it has been selected to providenational representation (unlike LDO data). The DPMis an efficient means to serve as an early warningsystem, as well as a reliable source for many data thatwill not be captured across the population throughother data sources (eg, patient-reported outcomes,vascular access care, and facility services). Althoughthe DOPPS previously has observed close agreementof its data with those reported by the US Renal DataSystem and Fistula First Initiative, linkage with CMSdata is planned for the DPM as a means to providelater confirmation of DPM findings. A potential limita-tion is that practices may already have changed some-what during 2010 in anticipation of the new PPS.National CMS data for comparisons of 2009 to 2010will become available for analysis in late 2011, whenDPM data from both 2010 and 2011 are available onthe DPM web site.
In sum, the DPM will fill an important need,
providing a source of timely representative data andAm J Kidney Dis. 2011;57(6):822-831
The DOPPS Practice Monitor: Rationale and Methods
tracking effects of the expanded PPS on dialysispractice. Findings from the DPM reports can serveas an early warning system for possible adverse ef-fects on clinical care and as a basis for patient anddialysis community outreach, editorial comment, andinformed advocacy. Similar efforts are being consid-ered for the international DOPPS to monitor practicechanges in other countries.
ACKNOWLEDGEMENTSThe authors acknowledge editorial assistance by Shauna Leighton
of Arbor Research Collaborative for Health.Support: The DOPPS is supported by scientific research grants
from Amgen (since 1996), Kyowa Hakko Kirin (since 1999, inJapan), Genzyme (since 2009), and Abbott (since 2009) withoutrestrictions on publications. The DOPPS Practice Monitor is sup-ported by Amgen.
Financial Disclosure: Aside from those reported in the previoussection, the authors declare that they have no relevant financialinterests.
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