<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01717989</url>
  </required_header>
  <id_info>
    <org_study_id>20080234</org_study_id>
    <nct_id>NCT01717989</nct_id>
  </id_info>
  <brief_title>Study to Evaluate the Prospective Payment System</brief_title>
  <acronym>STEPPS™</acronym>
  <official_title>Study to Evaluate the Prospective Payment System Impact on Small Dialysis Organizations</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Amgen</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Amgen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To describe trends in treatment patterns of Small Dialysis Organizations (SDOs) prior to and&#xD;
      during the implementation of the Centers for Medicare and Medicaid Services' (CMS') policy&#xD;
      [End Stage Renal Disease (ESRD) Prospective Payment System (PPS)] to bundle reimbursement for&#xD;
      all dialysis services. Specifically, to describe CMS ESRD PPS quality performance measures&#xD;
      for dialysis centers over time.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2010</start_date>
  <completion_date type="Actual">September 2012</completion_date>
  <primary_completion_date type="Actual">September 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants Per Facility With Hemoglobin &lt; 10 g/dL</measure>
    <time_frame>Data were collected monthly from June 2010 until September 2012</time_frame>
    <description>The percentage of participants within each small dialysis organization (SDO) facility with hemoglobin &lt; 10 g/dL over time. Percentage of participants meeting the criteria at the facility-level were calculated for each facility first and then summarized across facilities as a continuous variable, weighted by the number of participants in a facility.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Per Facility With Hemoglobin &gt; 12 g/dL</measure>
    <time_frame>Data were collected monthly from June 2010 until September 2012</time_frame>
    <description>The percentage of participants within each small dialysis organization (SDO) facility with hemoglobin &gt; 12 g/dL over time. Percentage of participants meeting the criteria at the facility-level were calculated for each facility first and then summarized across facilities as a continuous variable, weighted by the number of participants in a facility.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%</measure>
    <time_frame>Data were collected monthly from June 2010 until September 2012</time_frame>
    <description>The percentage of participants within each small dialysis organization (SDO) facility with a urea reduction ratio ≥ 65% over time. URR is calculated as:&#xD;
Baseline urea level - post-baseline urea level/baseline urea level * 100. Percentage of participants meeting the criteria at the facility-level were calculated for each facility first and then summarized across facilities as a continuous variable, weighted by the number of participants in a facility.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Treated by Each Dialysis Modality</measure>
    <time_frame>Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.</time_frame>
    <description>The percentage of participants treated with peritoneal, hemodialysis (in center) or home hemodialysis over the course of the study. For participants who switched modalities within a quarter, the last current modality is reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants in Each Vascular Access Type Category</measure>
    <time_frame>Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.</time_frame>
    <description>The percentage of participants in each vascular access type category out of all enrolled participants on hemodialysis over the course of the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Per Facility Receiving Erythropoietin Stimulation Agents (ESA)</measure>
    <time_frame>Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.</time_frame>
    <description>The percentage of participants who received erythropoietin stimulation agents (ESA) in a facility over the course of the study. Mean and confidence interval (CI) are calculated across facilities and by using total number of participants actively receiving chronic dialysis in each facility per month as weight.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Receiving Cinacalcet</measure>
    <time_frame>Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.</time_frame>
    <description>The percentage of participants receiving cinacalcet (Sensipar) over time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Receiving Phosphate Binding Agents</measure>
    <time_frame>Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.</time_frame>
    <description>The percentage of participants receiving phosphate binding agents over time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Receiving a Vitamin D Sterol</measure>
    <time_frame>Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.</time_frame>
    <description>The percentage of participants receiving a vitamin D sterol (ie, calcitriol, alfacalcidol, paricalcitol or doxercalciferol) over time. Note that participants could receive more than one type of vitamin D sterol.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Hemoglobin Concentration by Quarter</measure>
    <time_frame>Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of Facilities With Percentage of Participants With Hemoglobin &lt; 10 g/dL Over Time</measure>
    <time_frame>December 2010, March 2011, June 2011, September 2011, December 2011</time_frame>
    <description>Facilities were categorized over time based on the percentage of participants at the facility with hemoglobin &lt; 10 g/dL: Faciities with 0 to &lt;5% of participants with hemoglobin &lt; 10 g/dL; Facilities with 5 to &lt; 10% of participants with hemoglobin &lt; 10 g/dL; Facilities with 10 to &lt; 15% participants with hemoglobin &lt; 10 g/dL; Facilities with 15 to &lt; 20% of participants with hemoglobin &lt; 10 g/dL; Facilities with ≥ 20% of participants with hemoglobin &lt; 10 g/dL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Per Facility With Transferrin Saturation &lt; 20% and Ferritin Level &lt; 100 ng/mL</measure>
    <time_frame>December 2010, March 2011, June 2011, September 2011, December 2011</time_frame>
    <description>The mean percentage of participants per facility with transferrin saturation &lt; 20% and ferritin level &lt; 100 ng/mL. Mean and CI are calculated across facilities and by using number of participants with non-missing transferrin saturation and ferritin in each facility as weight.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative Monthly Dose of Epoetin Alfa Administered</measure>
    <time_frame>December 2010, March 2011, June 2011, September 2011, December 2011</time_frame>
    <description>The cumulative monthly intravenous epoetin alfa dose in participants on hemodialysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Taking Epoetin Alfa by Month</measure>
    <time_frame>December 2010, March 2011, June 2011, September 2011, December 2011</time_frame>
    <description>The number of participants who took epoetin alfa only, by month, in participants on hemodialysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Transfusions, Hospitalizations, Mortality, and Transfers Out</measure>
    <time_frame>June to December 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">2248</enrollment>
  <condition>Chronic Kidney Disease</condition>
  <arm_group>
    <arm_group_label>Cohort</arm_group_label>
    <description>Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs).</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The study population will consist of approximately 50 SDOs selected to participate in the&#xD;
        registry. All efforts will be made to select a diversified group of facilities by&#xD;
        evaluating geography, facility size (i.e., number of patients treated) and setting (i.e.,&#xD;
        rural and urban settings) and potentially, dialysis modalities offered as well as payor&#xD;
        mix.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Patient Inclusion Criteria:&#xD;
&#xD;
          -  Adults ≥ 18 years of age who have given written informed consent&#xD;
&#xD;
          -  Documented physician diagnosis of ESRD requiring dialysis and receiving care at a&#xD;
             participating dialysis center&#xD;
&#xD;
          -  Undergoing dialysis on the dialysis schedule assigned to the site&#xD;
&#xD;
        Patient Exclusion Criteria:&#xD;
&#xD;
          -  Patients will be ineligible for the study if they do not consent to have their data&#xD;
             collected for research purposes.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>MD</last_name>
    <role>Study Director</role>
    <affiliation>Amgen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Gulf Shores</city>
        <state>Alabama</state>
        <zip>36542</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Siloam Springs</city>
        <state>Arkansas</state>
        <zip>72761</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Springdale</city>
        <state>Arkansas</state>
        <zip>72764</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Azusa</city>
        <state>California</state>
        <zip>91702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bakersfield</city>
        <state>California</state>
        <zip>93309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Covina</city>
        <state>California</state>
        <zip>91723</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Glendale</city>
        <state>California</state>
        <zip>91205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hacienda Heights</city>
        <state>California</state>
        <zip>91745</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Inglewood</city>
        <state>California</state>
        <zip>90301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lancaster</city>
        <state>California</state>
        <zip>93534</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Northridge</city>
        <state>California</state>
        <zip>91324</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>San Dimas</city>
        <state>California</state>
        <zip>91773</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>West Covina</city>
        <state>California</state>
        <zip>91790</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Whittier</city>
        <state>California</state>
        <zip>90606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Pembroke Pines</city>
        <state>Florida</state>
        <zip>33028</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Blairsville</city>
        <state>Georgia</state>
        <zip>30512</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>East Point</city>
        <state>Georgia</state>
        <zip>30344</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96816</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Quincy</city>
        <state>Illinois</state>
        <zip>62301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Columbia</city>
        <state>Mississippi</state>
        <zip>39429</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Pachuta</city>
        <state>Mississippi</state>
        <zip>39347</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68512</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68521</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Livingston</city>
        <state>New Jersey</state>
        <zip>07039</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10461</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Maspeth</city>
        <state>New York</state>
        <zip>11378</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>King</city>
        <state>North Carolina</state>
        <zip>27021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Yadkinville</city>
        <state>North Carolina</state>
        <zip>27055</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Arlington</city>
        <state>Texas</state>
        <zip>76015</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77074</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Fairfax</city>
        <state>Virginia</state>
        <zip>22030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>South Charleston</city>
        <state>West Virginia</state>
        <zip>25015</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>San Juan</city>
        <zip>00936</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Puerto Rico</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.amgentrials.com</url>
    <description>AmgenTrials clinical trials website</description>
  </link>
  <verification_date>November 2013</verification_date>
  <study_first_submitted>September 12, 2012</study_first_submitted>
  <study_first_submitted_qc>October 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 31, 2012</study_first_posted>
  <results_first_submitted>November 25, 2013</results_first_submitted>
  <results_first_submitted_qc>November 25, 2013</results_first_submitted_qc>
  <results_first_posted type="Estimate">January 14, 2014</results_first_posted>
  <last_update_submitted>November 25, 2013</last_update_submitted>
  <last_update_submitted_qc>November 25, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 14, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Dialysis</keyword>
  <keyword>Prospective Payment System</keyword>
  <keyword>Center for Medicare and Medicaide Services</keyword>
  <keyword>End Stage Renal Disease</keyword>
  <keyword>Concomitant Medications Dosage /Treatment patterns</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>From 16 June 2010 through 02 July 2012, 2248 participants were enrolled in the study. A total of 51 small dialysis organization facilities enrolled in the study, of these, 45 (88.2%) facilities reported completing the study, 5 (9.8%) discontinued and 1 site was unaccounted for.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Cohort</title>
          <description>Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2248"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1182"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1066"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Ineligibility determined</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol deviation</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="439"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol-specified criteria</title>
              <participants_list>
                <participants group_id="P1" count="551"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Cohort</title>
          <description>Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs).</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="2248"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61.1" spread="15.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="966"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1282"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>American Indian or Alaska Native</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian/Pacific Islander</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="258"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="557"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1246"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="171"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="646"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neither Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1602"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Dialysis modality at enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Peritoneal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="125"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemodialysis (in center)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2107"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Home hemodialysis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Per Facility With Hemoglobin &lt; 10 g/dL</title>
        <description>The percentage of participants within each small dialysis organization (SDO) facility with hemoglobin &lt; 10 g/dL over time. Percentage of participants meeting the criteria at the facility-level were calculated for each facility first and then summarized across facilities as a continuous variable, weighted by the number of participants in a facility.</description>
        <time_frame>Data were collected monthly from June 2010 until September 2012</time_frame>
        <population>Facilities with at least one non-missing hemoglobin record for participants included in the primary analysis set (all enrolled participants) at each time point (indicated by n).</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort</title>
            <description>Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Per Facility With Hemoglobin &lt; 10 g/dL</title>
          <description>The percentage of participants within each small dialysis organization (SDO) facility with hemoglobin &lt; 10 g/dL over time. Percentage of participants meeting the criteria at the facility-level were calculated for each facility first and then summarized across facilities as a continuous variable, weighted by the number of participants in a facility.</description>
          <population>Facilities with at least one non-missing hemoglobin record for participants included in the primary analysis set (all enrolled participants) at each time point (indicated by n).</population>
          <units>percentage of participants per facility</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2248"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>SDO facilities</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>June 2010 (n=39)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.5" lower_limit="9.4" upper_limit="13.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>July 2010 (n=45)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.0" lower_limit="8.3" upper_limit="13.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>August 2010 (n=50)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.1" lower_limit="10.9" upper_limit="15.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>September 2010 (n=51)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.0" lower_limit="10.0" upper_limit="13.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>October 2010 (n=51)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.7" lower_limit="11.1" upper_limit="14.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>November 2010 (n=51)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.2" lower_limit="11.3" upper_limit="15.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>December 2010 (n=51)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.3" lower_limit="11.9" upper_limit="16.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>January 2011 (n=50)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.5" lower_limit="11.6" upper_limit="15.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>February 2011 (n=50)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.3" lower_limit="15.6" upper_limit="21.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>March 2011 (n=50)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.4" lower_limit="13.7" upper_limit="19.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>April 2011 (n=50)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.9" lower_limit="13.8" upper_limit="19.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>May 2011 (n=50)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.4" lower_limit="12.7" upper_limit="18.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>June 2011 (n=50)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.7" lower_limit="14.0" upper_limit="19.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>July 2011 (n=50)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.0" lower_limit="11.9" upper_limit="16.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>August 2011 (n=50)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.5" lower_limit="13.2" upper_limit="17.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>September 2011 (n=50)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.3" lower_limit="16.6" upper_limit="22.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>October 2011 (n=50)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.7" lower_limit="18.7" upper_limit="25.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>November 2011 (n=50)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.2" lower_limit="18.8" upper_limit="25.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>December 2011 (n=48)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.8" lower_limit="18.7" upper_limit="25.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>January 2012 (n=48)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.0" lower_limit="18.2" upper_limit="26.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>February 2012 (n=48)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.5" lower_limit="15.9" upper_limit="23.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>March 2012 (n=48)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.3" lower_limit="19.7" upper_limit="27.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>April 2012 (n=48)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.0" lower_limit="20.8" upper_limit="27.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>May 2012 (n=48)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.1" lower_limit="21.1" upper_limit="28.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>June 2012 (n=45)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.6" lower_limit="20.7" upper_limit="29.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>July 2012 (n=45)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.1" lower_limit="20.2" upper_limit="26.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>August 2012 (n=45)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.6" lower_limit="19.2" upper_limit="26.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>September 2012 (n=45)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.2" lower_limit="17.8" upper_limit="26.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Treated by Each Dialysis Modality</title>
        <description>The percentage of participants treated with peritoneal, hemodialysis (in center) or home hemodialysis over the course of the study. For participants who switched modalities within a quarter, the last current modality is reported.</description>
        <time_frame>Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.</time_frame>
        <population>Primary Analysis Set participants on study at each time point</population>
        <group_list>
          <group group_id="O1">
            <title>Q4 2010</title>
            <description>Fourth quarter (Q4) 2010</description>
          </group>
          <group group_id="O2">
            <title>Q1 2011</title>
            <description>First quarter (Q1), 2011</description>
          </group>
          <group group_id="O3">
            <title>Q2 2011</title>
            <description>Second quarter (Q2), 2011</description>
          </group>
          <group group_id="O4">
            <title>Q3 2011</title>
            <description>Third quarter (Q3) 2011</description>
          </group>
          <group group_id="O5">
            <title>Q4 2011</title>
            <description>Fourth quarter, 2011</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Treated by Each Dialysis Modality</title>
          <description>The percentage of participants treated with peritoneal, hemodialysis (in center) or home hemodialysis over the course of the study. For participants who switched modalities within a quarter, the last current modality is reported.</description>
          <population>Primary Analysis Set participants on study at each time point</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1819"/>
                <count group_id="O2" value="1810"/>
                <count group_id="O3" value="1701"/>
                <count group_id="O4" value="1646"/>
                <count group_id="O5" value="1554"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Peritoneal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0"/>
                    <measurement group_id="O2" value="2.2"/>
                    <measurement group_id="O3" value="3.6"/>
                    <measurement group_id="O4" value="2.8"/>
                    <measurement group_id="O5" value="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemodialysis (in center)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.4"/>
                    <measurement group_id="O2" value="93.0"/>
                    <measurement group_id="O3" value="93.0"/>
                    <measurement group_id="O4" value="92.6"/>
                    <measurement group_id="O5" value="93.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Home hemodialysis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5"/>
                    <measurement group_id="O2" value="0.7"/>
                    <measurement group_id="O3" value="0.6"/>
                    <measurement group_id="O4" value="0.7"/>
                    <measurement group_id="O5" value="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0"/>
                    <measurement group_id="O2" value="4.2"/>
                    <measurement group_id="O3" value="2.8"/>
                    <measurement group_id="O4" value="3.9"/>
                    <measurement group_id="O5" value="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Per Facility With Hemoglobin &gt; 12 g/dL</title>
        <description>The percentage of participants within each small dialysis organization (SDO) facility with hemoglobin &gt; 12 g/dL over time. Percentage of participants meeting the criteria at the facility-level were calculated for each facility first and then summarized across facilities as a continuous variable, weighted by the number of participants in a facility.</description>
        <time_frame>Data were collected monthly from June 2010 until September 2012</time_frame>
        <population>Facilities with at least one non-missing hemoglobin record for participants included in the primary analysis set (all enrolled participants) at each time point (indicated by n).</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort</title>
            <description>Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Per Facility With Hemoglobin &gt; 12 g/dL</title>
          <description>The percentage of participants within each small dialysis organization (SDO) facility with hemoglobin &gt; 12 g/dL over time. Percentage of participants meeting the criteria at the facility-level were calculated for each facility first and then summarized across facilities as a continuous variable, weighted by the number of participants in a facility.</description>
          <population>Facilities with at least one non-missing hemoglobin record for participants included in the primary analysis set (all enrolled participants) at each time point (indicated by n).</population>
          <units>percentage of participants per facility</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2248"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>SDO facilities</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>June 2010 (n=39)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.2" lower_limit="25.4" upper_limit="35.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>July 2010 (n=45)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.3" lower_limit="25.1" upper_limit="31.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>August 2010 (n=50)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.2" lower_limit="25.2" upper_limit="31.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>September 2010 (n=51)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.6" lower_limit="27.7" upper_limit="34.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>October 2010 (n=51)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.7" lower_limit="26.4" upper_limit="31.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>November 2010 (n=51)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.8" lower_limit="24.9" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>December 2010 (n=51)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.5" lower_limit="22.1" upper_limit="27.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>January 2011 (n=50)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.6" lower_limit="22.7" upper_limit="29.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>February 2011 (n=50)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.5" lower_limit="21.4" upper_limit="28.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>March 2011 (n=50)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.8" lower_limit="19.6" upper_limit="26.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>April 2011 (n=50)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.8" lower_limit="18.7" upper_limit="25.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>May 2011 (n=50)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.2" lower_limit="20.2" upper_limit="26.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>June 2011 (n=50)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.5" lower_limit="15.5" upper_limit="22.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>July 2011 (n=50)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.2" lower_limit="17.3" upper_limit="23.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>August 2011 (n=50)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.0" lower_limit="16.3" upper_limit="22.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>September 2011 (n=50)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.2" lower_limit="15.6" upper_limit="21.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>October 2011 (n=50)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.3" lower_limit="12.3" upper_limit="16.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>November 2011 (n=50)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.5" lower_limit="9.8" upper_limit="13.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>December 2011 (n=48)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.8" lower_limit="9.8" upper_limit="13.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>January 2012 (n=48)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.7" lower_limit="11.8" upper_limit="15.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>February 2012 (n=48)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.5" lower_limit="10.4" upper_limit="15.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>March 2012 (n=48)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.2" lower_limit="9.4" upper_limit="13.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>April 2012 (n=48)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.3" lower_limit="8.7" upper_limit="12.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>May 2012 (n=48)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.6" lower_limit="9.6" upper_limit="13.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>June 2012 (n=45)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.1" lower_limit="10.1" upper_limit="14.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>July 2012 (n=45)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.9" lower_limit="9.4" upper_limit="14.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>August 2012 (n=45)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.6" lower_limit="9.4" upper_limit="13.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>September 2012 (n=45)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.1" lower_limit="10.9" upper_limit="15.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%</title>
        <description>The percentage of participants within each small dialysis organization (SDO) facility with a urea reduction ratio ≥ 65% over time. URR is calculated as:&#xD;
Baseline urea level - post-baseline urea level/baseline urea level * 100. Percentage of participants meeting the criteria at the facility-level were calculated for each facility first and then summarized across facilities as a continuous variable, weighted by the number of participants in a facility.</description>
        <time_frame>Data were collected monthly from June 2010 until September 2012</time_frame>
        <population>Facilities with at least one non-missing URR record for participants included in the primary analysis set (all enrolled participants) at each time point (indicated by n).</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort</title>
            <description>Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%</title>
          <description>The percentage of participants within each small dialysis organization (SDO) facility with a urea reduction ratio ≥ 65% over time. URR is calculated as:&#xD;
Baseline urea level - post-baseline urea level/baseline urea level * 100. Percentage of participants meeting the criteria at the facility-level were calculated for each facility first and then summarized across facilities as a continuous variable, weighted by the number of participants in a facility.</description>
          <population>Facilities with at least one non-missing URR record for participants included in the primary analysis set (all enrolled participants) at each time point (indicated by n).</population>
          <units>percentage of participants per facility</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2248"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>SDO facilities</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>June 2010 (n=37)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.8" lower_limit="81.4" upper_limit="88.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>July 2010 (n=44)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85.0" lower_limit="81.5" upper_limit="88.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>August 2010 (n=49)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85.0" lower_limit="82.5" upper_limit="87.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>September 2010 (n=50)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.9" lower_limit="84.3" upper_limit="89.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>October 2010 (n=50)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87.9" lower_limit="85.2" upper_limit="90.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>November 2010 (n=50)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87.8" lower_limit="85.2" upper_limit="90.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>December 2010 (n=50)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.9" lower_limit="84.3" upper_limit="89.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>January 2011 (n=49)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85.5" lower_limit="82.1" upper_limit="88.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>February 2011 (n=49)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.7" lower_limit="83.9" upper_limit="89.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>March 2011 (n=49)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.4" lower_limit="86.1" upper_limit="90.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>April 2011 (n=49)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87.8" lower_limit="85.5" upper_limit="90.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>May 2011 (n=49)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.8" lower_limit="85.9" upper_limit="91.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>June 2011 (n=49)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.2" lower_limit="88.3" upper_limit="92.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>July 2011 (n=49)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.0" lower_limit="87.0" upper_limit="90.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>August 2011 (n=49)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.0" lower_limit="86.9" upper_limit="91.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>September 2011 (n=49)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.5" lower_limit="87.6" upper_limit="91.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>October 2011 (n=49)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.4" lower_limit="88.1" upper_limit="92.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>November 2011 (n=49)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.2" lower_limit="86.0" upper_limit="91.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>December 2011 (n=47)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.3" lower_limit="88.0" upper_limit="92.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>January 2012 (n=47)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.7" lower_limit="86.1" upper_limit="91.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>February 2012 (n=47)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.3" lower_limit="86.9" upper_limit="91.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>March 2012 (n=48)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.4" lower_limit="87.0" upper_limit="91.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>April 2012 (n=47)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.9" lower_limit="88.4" upper_limit="93.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>May 2012 (n=47)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91.1" lower_limit="89.1" upper_limit="93.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>June 2012 (n=44)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91.1" lower_limit="89.0" upper_limit="92.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>July 2012 (n=44)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91.3" lower_limit="88.9" upper_limit="93.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>August 2012 (n=44)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91.4" lower_limit="88.8" upper_limit="94.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>September 2012 (n=44)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.3" lower_limit="91.6" upper_limit="95.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants in Each Vascular Access Type Category</title>
        <description>The percentage of participants in each vascular access type category out of all enrolled participants on hemodialysis over the course of the study.</description>
        <time_frame>Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.</time_frame>
        <population>Primary Analysis Set participants on study and on hemodialysis at each time point</population>
        <group_list>
          <group group_id="O1">
            <title>Q4 2010</title>
            <description>Fourth quarter, 2010</description>
          </group>
          <group group_id="O2">
            <title>Q1 2011</title>
            <description>First quarter 2011</description>
          </group>
          <group group_id="O3">
            <title>Q2 2011</title>
            <description>Second quarter, 2011</description>
          </group>
          <group group_id="O4">
            <title>Q3 2011</title>
            <description>Third quarter, 2011</description>
          </group>
          <group group_id="O5">
            <title>Q4 2011</title>
            <description>Fourth quarter, 2011</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants in Each Vascular Access Type Category</title>
          <description>The percentage of participants in each vascular access type category out of all enrolled participants on hemodialysis over the course of the study.</description>
          <population>Primary Analysis Set participants on study and on hemodialysis at each time point</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1718"/>
                <count group_id="O2" value="1683"/>
                <count group_id="O3" value="1582"/>
                <count group_id="O4" value="1524"/>
                <count group_id="O5" value="1445"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Arteriovenous fistula</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.8"/>
                    <measurement group_id="O2" value="63.2"/>
                    <measurement group_id="O3" value="63.5"/>
                    <measurement group_id="O4" value="63.8"/>
                    <measurement group_id="O5" value="63.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Arteriovenous graft</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.2"/>
                    <measurement group_id="O2" value="16.8"/>
                    <measurement group_id="O3" value="16.2"/>
                    <measurement group_id="O4" value="16.0"/>
                    <measurement group_id="O5" value="15.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Venous catheter</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.9"/>
                    <measurement group_id="O2" value="20.0"/>
                    <measurement group_id="O3" value="20.2"/>
                    <measurement group_id="O4" value="20.1"/>
                    <measurement group_id="O5" value="20.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1"/>
                    <measurement group_id="O2" value="0.1"/>
                    <measurement group_id="O3" value="0.1"/>
                    <measurement group_id="O4" value="0.1"/>
                    <measurement group_id="O5" value="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Per Facility Receiving Erythropoietin Stimulation Agents (ESA)</title>
        <description>The percentage of participants who received erythropoietin stimulation agents (ESA) in a facility over the course of the study. Mean and confidence interval (CI) are calculated across facilities and by using total number of participants actively receiving chronic dialysis in each facility per month as weight.</description>
        <time_frame>Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.</time_frame>
        <population>Primary Analysis Set facilities / participants on study at each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Q4 2010</title>
            <description>Fourth quarter, 2010</description>
          </group>
          <group group_id="O2">
            <title>Q1 2011</title>
            <description>First quarter 2011</description>
          </group>
          <group group_id="O3">
            <title>Q2 2011</title>
            <description>Second quarter, 2011</description>
          </group>
          <group group_id="O4">
            <title>Q3 2011</title>
            <description>Third quarter, 2011</description>
          </group>
          <group group_id="O5">
            <title>Q4 2011</title>
            <description>Fourth quarter, 2011</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Per Facility Receiving Erythropoietin Stimulation Agents (ESA)</title>
          <description>The percentage of participants who received erythropoietin stimulation agents (ESA) in a facility over the course of the study. Mean and confidence interval (CI) are calculated across facilities and by using total number of participants actively receiving chronic dialysis in each facility per month as weight.</description>
          <population>Primary Analysis Set facilities / participants on study at each time point.</population>
          <units>percentage of participants per facility</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1819"/>
                <count group_id="O2" value="1810"/>
                <count group_id="O3" value="1701"/>
                <count group_id="O4" value="1646"/>
                <count group_id="O5" value="1554"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Facilities</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="48"/>
                <count group_id="O3" value="49"/>
                <count group_id="O4" value="49"/>
                <count group_id="O5" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91.2" lower_limit="87.0" upper_limit="94.5"/>
                    <measurement group_id="O2" value="92.0" lower_limit="89.1" upper_limit="94.5"/>
                    <measurement group_id="O3" value="90.9" lower_limit="87.7" upper_limit="93.7"/>
                    <measurement group_id="O4" value="91.2" lower_limit="88.5" upper_limit="94.0"/>
                    <measurement group_id="O5" value="89.4" lower_limit="86.4" upper_limit="92.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Receiving Cinacalcet</title>
        <description>The percentage of participants receiving cinacalcet (Sensipar) over time</description>
        <time_frame>Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.</time_frame>
        <population>Primary Analysis Set participants on study at each time point</population>
        <group_list>
          <group group_id="O1">
            <title>Q4 2010</title>
            <description>Fourth quarter (Q4) 2010</description>
          </group>
          <group group_id="O2">
            <title>Q1 2011</title>
            <description>First quarter (Q1), 2011</description>
          </group>
          <group group_id="O3">
            <title>Q2 2011</title>
            <description>Second quarter (Q2), 2011</description>
          </group>
          <group group_id="O4">
            <title>Q3 2011</title>
            <description>Third quarter (Q3) 2011</description>
          </group>
          <group group_id="O5">
            <title>Q4 2011</title>
            <description>Fourth quarter, 2011</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Receiving Cinacalcet</title>
          <description>The percentage of participants receiving cinacalcet (Sensipar) over time</description>
          <population>Primary Analysis Set participants on study at each time point</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1819"/>
                <count group_id="O2" value="1810"/>
                <count group_id="O3" value="1701"/>
                <count group_id="O4" value="1646"/>
                <count group_id="O5" value="1554"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.3"/>
                    <measurement group_id="O2" value="26.2"/>
                    <measurement group_id="O3" value="29.3"/>
                    <measurement group_id="O4" value="30.0"/>
                    <measurement group_id="O5" value="31.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Receiving Phosphate Binding Agents</title>
        <description>The percentage of participants receiving phosphate binding agents over time</description>
        <time_frame>Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.</time_frame>
        <population>Primary Analysis Set participants on study at each time point</population>
        <group_list>
          <group group_id="O1">
            <title>Q4 2010</title>
            <description>Fourth quarter (Q4) 2010</description>
          </group>
          <group group_id="O2">
            <title>Q1 2011</title>
            <description>First quarter (Q1), 2011</description>
          </group>
          <group group_id="O3">
            <title>Q2 2011</title>
            <description>Second quarter (Q2), 2011</description>
          </group>
          <group group_id="O4">
            <title>Q3 2011</title>
            <description>Third quarter (Q3) 2011</description>
          </group>
          <group group_id="O5">
            <title>Q4 2011</title>
            <description>Fourth quarter, 2011</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Receiving Phosphate Binding Agents</title>
          <description>The percentage of participants receiving phosphate binding agents over time</description>
          <population>Primary Analysis Set participants on study at each time point</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1819"/>
                <count group_id="O2" value="1810"/>
                <count group_id="O3" value="1701"/>
                <count group_id="O4" value="1646"/>
                <count group_id="O5" value="1554"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.9"/>
                    <measurement group_id="O2" value="66.0"/>
                    <measurement group_id="O3" value="70.4"/>
                    <measurement group_id="O4" value="74.2"/>
                    <measurement group_id="O5" value="73.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Receiving a Vitamin D Sterol</title>
        <description>The percentage of participants receiving a vitamin D sterol (ie, calcitriol, alfacalcidol, paricalcitol or doxercalciferol) over time. Note that participants could receive more than one type of vitamin D sterol.</description>
        <time_frame>Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.</time_frame>
        <population>Primary Analysis Set participants on study at each time point</population>
        <group_list>
          <group group_id="O1">
            <title>Q4 2010</title>
            <description>Fourth quarter (Q4) 2010</description>
          </group>
          <group group_id="O2">
            <title>Q1 2011</title>
            <description>First quarter (Q1), 2011</description>
          </group>
          <group group_id="O3">
            <title>Q2 2011</title>
            <description>Second quarter (Q2), 2011</description>
          </group>
          <group group_id="O4">
            <title>Q3 2011</title>
            <description>Third quarter (Q3) 2011</description>
          </group>
          <group group_id="O5">
            <title>Q4 2011</title>
            <description>Fourth quarter, 2011</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Receiving a Vitamin D Sterol</title>
          <description>The percentage of participants receiving a vitamin D sterol (ie, calcitriol, alfacalcidol, paricalcitol or doxercalciferol) over time. Note that participants could receive more than one type of vitamin D sterol.</description>
          <population>Primary Analysis Set participants on study at each time point</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1819"/>
                <count group_id="O2" value="1810"/>
                <count group_id="O3" value="1701"/>
                <count group_id="O4" value="1646"/>
                <count group_id="O5" value="1554"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any Vitamin D sterol</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80.6"/>
                    <measurement group_id="O2" value="76.2"/>
                    <measurement group_id="O3" value="77.5"/>
                    <measurement group_id="O4" value="77.7"/>
                    <measurement group_id="O5" value="79.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intravenous</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.0"/>
                    <measurement group_id="O2" value="68.0"/>
                    <measurement group_id="O3" value="66.5"/>
                    <measurement group_id="O4" value="62.6"/>
                    <measurement group_id="O5" value="62.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Oral - activated</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.6"/>
                    <measurement group_id="O2" value="10.3"/>
                    <measurement group_id="O3" value="15.3"/>
                    <measurement group_id="O4" value="16.2"/>
                    <measurement group_id="O5" value="17.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Oral - not activated</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3"/>
                    <measurement group_id="O2" value="5.9"/>
                    <measurement group_id="O3" value="6.7"/>
                    <measurement group_id="O4" value="9.1"/>
                    <measurement group_id="O5" value="9.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Hemoglobin Concentration by Quarter</title>
        <time_frame>Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.</time_frame>
        <population>Primary Analysis Set participants on study at each time point and with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Q4 2010</title>
            <description>Fourth quarter (Q4) 2010</description>
          </group>
          <group group_id="O2">
            <title>Q1 2011</title>
            <description>First quarter (Q1), 2011</description>
          </group>
          <group group_id="O3">
            <title>Q2 2011</title>
            <description>Second quarter (Q2), 2011</description>
          </group>
          <group group_id="O4">
            <title>Q3 2011</title>
            <description>Third quarter (Q3) 2011</description>
          </group>
          <group group_id="O5">
            <title>Q4 2011</title>
            <description>Fourth quarter, 2011</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Hemoglobin Concentration by Quarter</title>
          <population>Primary Analysis Set participants on study at each time point and with available data.</population>
          <units>g/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1797"/>
                <count group_id="O2" value="1773"/>
                <count group_id="O3" value="1675"/>
                <count group_id="O4" value="1610"/>
                <count group_id="O5" value="1525"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.28" spread="1.35"/>
                    <measurement group_id="O2" value="11.17" spread="1.35"/>
                    <measurement group_id="O3" value="11.06" spread="1.25"/>
                    <measurement group_id="O4" value="11.00" spread="1.32"/>
                    <measurement group_id="O5" value="10.78" spread="1.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Distribution of Facilities With Percentage of Participants With Hemoglobin &lt; 10 g/dL Over Time</title>
        <description>Facilities were categorized over time based on the percentage of participants at the facility with hemoglobin &lt; 10 g/dL: Faciities with 0 to &lt;5% of participants with hemoglobin &lt; 10 g/dL; Facilities with 5 to &lt; 10% of participants with hemoglobin &lt; 10 g/dL; Facilities with 10 to &lt; 15% participants with hemoglobin &lt; 10 g/dL; Facilities with 15 to &lt; 20% of participants with hemoglobin &lt; 10 g/dL; Facilities with ≥ 20% of participants with hemoglobin &lt; 10 g/dL.</description>
        <time_frame>December 2010, March 2011, June 2011, September 2011, December 2011</time_frame>
        <population>Facilities with at least one non-missing hemoglobin record, for participants included in the primary analysis set who were on study and with available data at each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>December 2010</title>
          </group>
          <group group_id="O2">
            <title>March 2011</title>
          </group>
          <group group_id="O3">
            <title>June 2011</title>
          </group>
          <group group_id="O4">
            <title>September 2011</title>
          </group>
          <group group_id="O5">
            <title>December 2011</title>
          </group>
        </group_list>
        <measure>
          <title>Distribution of Facilities With Percentage of Participants With Hemoglobin &lt; 10 g/dL Over Time</title>
          <description>Facilities were categorized over time based on the percentage of participants at the facility with hemoglobin &lt; 10 g/dL: Faciities with 0 to &lt;5% of participants with hemoglobin &lt; 10 g/dL; Facilities with 5 to &lt; 10% of participants with hemoglobin &lt; 10 g/dL; Facilities with 10 to &lt; 15% participants with hemoglobin &lt; 10 g/dL; Facilities with 15 to &lt; 20% of participants with hemoglobin &lt; 10 g/dL; Facilities with ≥ 20% of participants with hemoglobin &lt; 10 g/dL.</description>
          <population>Facilities with at least one non-missing hemoglobin record, for participants included in the primary analysis set who were on study and with available data at each time point.</population>
          <units>percentage of facilities</units>
          <param>Number</param>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1789"/>
                <count group_id="O2" value="1661"/>
                <count group_id="O3" value="1592"/>
                <count group_id="O4" value="1511"/>
                <count group_id="O5" value="1420"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Facilities</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="50"/>
                <count group_id="O3" value="50"/>
                <count group_id="O4" value="50"/>
                <count group_id="O5" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>0%-&lt;5% of participants with hemoglobin &lt; 10 g/dL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.8" spread="1.36"/>
                    <measurement group_id="O2" value="10.0" spread="1.33"/>
                    <measurement group_id="O3" value="10.0" spread="1.23"/>
                    <measurement group_id="O4" value="4.0" spread="1.29"/>
                    <measurement group_id="O5" value="6.3" spread="1.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5%-&lt;10% of participants with hemoglobin &lt;10 g/dL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.6"/>
                    <measurement group_id="O2" value="22.0"/>
                    <measurement group_id="O3" value="20.0"/>
                    <measurement group_id="O4" value="16.0"/>
                    <measurement group_id="O5" value="8.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>10%-&lt;15% of participants with hemoglobin &lt;10 g/dL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.4"/>
                    <measurement group_id="O2" value="24.0"/>
                    <measurement group_id="O3" value="20.0"/>
                    <measurement group_id="O4" value="18.0"/>
                    <measurement group_id="O5" value="16.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15%-&lt;20% of participants with hemoglobin &lt;10 g/dL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.8"/>
                    <measurement group_id="O2" value="18.0"/>
                    <measurement group_id="O3" value="10.0"/>
                    <measurement group_id="O4" value="20.0"/>
                    <measurement group_id="O5" value="16.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥20% of participants with hemoglobin &lt;10 g/dL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.5"/>
                    <measurement group_id="O2" value="26.0"/>
                    <measurement group_id="O3" value="40.0"/>
                    <measurement group_id="O4" value="42.0"/>
                    <measurement group_id="O5" value="52.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Per Facility With Transferrin Saturation &lt; 20% and Ferritin Level &lt; 100 ng/mL</title>
        <description>The mean percentage of participants per facility with transferrin saturation &lt; 20% and ferritin level &lt; 100 ng/mL. Mean and CI are calculated across facilities and by using number of participants with non-missing transferrin saturation and ferritin in each facility as weight.</description>
        <time_frame>December 2010, March 2011, June 2011, September 2011, December 2011</time_frame>
        <population>Facilities / participants with at least one non-missing transferrin saturation or ferritin record at each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>December 2010</title>
          </group>
          <group group_id="O2">
            <title>March 2011</title>
          </group>
          <group group_id="O3">
            <title>June 2011</title>
          </group>
          <group group_id="O4">
            <title>September 2011</title>
          </group>
          <group group_id="O5">
            <title>December 2011</title>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Per Facility With Transferrin Saturation &lt; 20% and Ferritin Level &lt; 100 ng/mL</title>
          <description>The mean percentage of participants per facility with transferrin saturation &lt; 20% and ferritin level &lt; 100 ng/mL. Mean and CI are calculated across facilities and by using number of participants with non-missing transferrin saturation and ferritin in each facility as weight.</description>
          <population>Facilities / participants with at least one non-missing transferrin saturation or ferritin record at each time point.</population>
          <units>percentage of participants per facility</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1399"/>
                <count group_id="O2" value="1132"/>
                <count group_id="O3" value="1160"/>
                <count group_id="O4" value="1128"/>
                <count group_id="O5" value="1064"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Facilities</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="43"/>
                <count group_id="O3" value="44"/>
                <count group_id="O4" value="43"/>
                <count group_id="O5" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4" spread="1.36" lower_limit="1.5" upper_limit="3.5"/>
                    <measurement group_id="O2" value="0.6" spread="1.33" lower_limit="0.2" upper_limit="1.1"/>
                    <measurement group_id="O3" value="1.4" spread="1.23" lower_limit="0.2" upper_limit="3.0"/>
                    <measurement group_id="O4" value="1.0" spread="1.29" lower_limit="0.4" upper_limit="1.7"/>
                    <measurement group_id="O5" value="0.7" spread="1.21" lower_limit="0.3" upper_limit="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cumulative Monthly Dose of Epoetin Alfa Administered</title>
        <description>The cumulative monthly intravenous epoetin alfa dose in participants on hemodialysis.</description>
        <time_frame>December 2010, March 2011, June 2011, September 2011, December 2011</time_frame>
        <population>Primary Analysis Set participants on study and on hemodialysis and receiving epoetin alfa at each time point and with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>December 2010</title>
          </group>
          <group group_id="O2">
            <title>March 2011</title>
          </group>
          <group group_id="O3">
            <title>June 2011</title>
          </group>
          <group group_id="O4">
            <title>September 2011</title>
          </group>
          <group group_id="O5">
            <title>December 2011</title>
          </group>
        </group_list>
        <measure>
          <title>Cumulative Monthly Dose of Epoetin Alfa Administered</title>
          <description>The cumulative monthly intravenous epoetin alfa dose in participants on hemodialysis.</description>
          <population>Primary Analysis Set participants on study and on hemodialysis and receiving epoetin alfa at each time point and with available data.</population>
          <units>units</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1172"/>
                <count group_id="O2" value="1188"/>
                <count group_id="O3" value="1105"/>
                <count group_id="O4" value="1096"/>
                <count group_id="O5" value="984"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39000.0" lower_limit="19100.0" upper_limit="71500.0"/>
                    <measurement group_id="O2" value="35000.0" lower_limit="16650.0" upper_limit="66000.0"/>
                    <measurement group_id="O3" value="33800.0" lower_limit="15400.0" upper_limit="65000.0"/>
                    <measurement group_id="O4" value="28000.0" lower_limit="13000.0" upper_limit="52000.0"/>
                    <measurement group_id="O5" value="32900.0" lower_limit="16000.0" upper_limit="60000.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Taking Epoetin Alfa by Month</title>
        <description>The number of participants who took epoetin alfa only, by month, in participants on hemodialysis.</description>
        <time_frame>December 2010, March 2011, June 2011, September 2011, December 2011</time_frame>
        <population>Primary Analysis Set participants on study and on hemodialysis at each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>December 2010</title>
          </group>
          <group group_id="O2">
            <title>March 2011</title>
          </group>
          <group group_id="O3">
            <title>June 2011</title>
          </group>
          <group group_id="O4">
            <title>September 2011</title>
          </group>
          <group group_id="O5">
            <title>December 2011</title>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Taking Epoetin Alfa by Month</title>
          <description>The number of participants who took epoetin alfa only, by month, in participants on hemodialysis.</description>
          <population>Primary Analysis Set participants on study and on hemodialysis at each time point.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1645"/>
                <count group_id="O2" value="1566"/>
                <count group_id="O3" value="1499"/>
                <count group_id="O4" value="1421"/>
                <count group_id="O5" value="1342"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1269" spread="57684.5"/>
                    <measurement group_id="O2" value="1299" spread="52423.4"/>
                    <measurement group_id="O3" value="1244" spread="51344.7"/>
                    <measurement group_id="O4" value="1212" spread="48175.3"/>
                    <measurement group_id="O5" value="1140" spread="47792.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Transfusions, Hospitalizations, Mortality, and Transfers Out</title>
        <time_frame>June to December 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.</time_frame>
        <population>Primary Analysis Set participants on study at each time point</population>
        <group_list>
          <group group_id="O1">
            <title>2010</title>
            <description>From June through December 2010</description>
          </group>
          <group group_id="O2">
            <title>Q1 2011</title>
            <description>First quarter (Q1), 2011</description>
          </group>
          <group group_id="O3">
            <title>Q2 2011</title>
            <description>Second quarter (Q2), 2011</description>
          </group>
          <group group_id="O4">
            <title>Q3 2011</title>
            <description>Third quarter (Q3) 2011</description>
          </group>
          <group group_id="O5">
            <title>Q4 2011</title>
            <description>Fourth quarter, 2011</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Transfusions, Hospitalizations, Mortality, and Transfers Out</title>
          <population>Primary Analysis Set participants on study at each time point</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1873"/>
                <count group_id="O2" value="1810"/>
                <count group_id="O3" value="1701"/>
                <count group_id="O4" value="1646"/>
                <count group_id="O5" value="1554"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Participants with transfusions</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54"/>
                    <measurement group_id="O2" value="56"/>
                    <measurement group_id="O3" value="50"/>
                    <measurement group_id="O4" value="39"/>
                    <measurement group_id="O5" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants who died</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71"/>
                    <measurement group_id="O2" value="67"/>
                    <measurement group_id="O3" value="52"/>
                    <measurement group_id="O4" value="55"/>
                    <measurement group_id="O5" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with hospitalizations</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="574"/>
                    <measurement group_id="O2" value="445"/>
                    <measurement group_id="O3" value="354"/>
                    <measurement group_id="O4" value="296"/>
                    <measurement group_id="O5" value="275"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants who transferred out</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63"/>
                    <measurement group_id="O2" value="51"/>
                    <measurement group_id="O3" value="31"/>
                    <measurement group_id="O4" value="47"/>
                    <measurement group_id="O5" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 28 months</time_frame>
      <desc>As this was a non-interventional observational study, only serious adverse drug reactions (SADRs) relating to Amgen products were reported. An adverse drug reaction (ADR) was defined for this study as any undesirable experience or worsening of a pre-existing medical condition associated with the use of a medicine in a clinical study participant.</desc>
      <group_list>
        <group group_id="E1">
          <title>Cohort</title>
          <description>Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs).</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA version 15.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2248"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2248"/>
              </event>
              <event>
                <sub_title>Convulsion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2248"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results aftercompletion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Study Director</name_or_title>
      <organization>Amgen Inc.</organization>
      <phone>866-572-6436</phone>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01717989
org study id: 20080234
nct id: NCT01717989
lead sponsor: 
has dmc: No
To describe trends in treatment patterns of Small Dialysis Organizations (SDOs) prior to and
      during the implementation of the Centers for Medicare and Medicaid Services' (CMS') policy
      [End Stage Renal Disease (ESRD) Prospective Payment System (PPS)] to bundle reimbursement for
      all dialysis services. Specifically, to describe CMS ESRD PPS quality performance measures
      for dialysis centers over time.
observational model: Cohort
time perspective: Prospective
measure: Percentage of Participants Per Facility With Hemoglobin < 10 g/dL
time frame: Data were collected monthly from June 2010 until September 2012
description: The percentage of participants within each small dialysis organization (SDO) facility with hemoglobin < 10 g/dL over time. Percentage of participants meeting the criteria at the facility-level were calculated for each facility first and then summarized across facilities as a continuous variable, weighted by the number of participants in a facility.
measure: Percentage of Participants Per Facility With Hemoglobin > 12 g/dL
time frame: Data were collected monthly from June 2010 until September 2012
description: The percentage of participants within each small dialysis organization (SDO) facility with hemoglobin > 12 g/dL over time. Percentage of participants meeting the criteria at the facility-level were calculated for each facility first and then summarized across facilities as a continuous variable, weighted by the number of participants in a facility.
measure: Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%
time frame: Data were collected monthly from June 2010 until September 2012
description: The percentage of participants within each small dialysis organization (SDO) facility with a urea reduction ratio ≥ 65% over time. URR is calculated as:
Baseline urea level - post-baseline urea level/baseline urea level * 100. Percentage of participants meeting the criteria at the facility-level were calculated for each facility first and then summarized across facilities as a continuous variable, weighted by the number of participants in a facility.
measure: Percentage of Participants Treated by Each Dialysis Modality
time frame: Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.
description: The percentage of participants treated with peritoneal, hemodialysis (in center) or home hemodialysis over the course of the study. For participants who switched modalities within a quarter, the last current modality is reported.
measure: Percentage of Participants in Each Vascular Access Type Category
time frame: Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.
description: The percentage of participants in each vascular access type category out of all enrolled participants on hemodialysis over the course of the study.
measure: Percentage of Participants Per Facility Receiving Erythropoietin Stimulation Agents (ESA)
time frame: Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.
description: The percentage of participants who received erythropoietin stimulation agents (ESA) in a facility over the course of the study. Mean and confidence interval (CI) are calculated across facilities and by using total number of participants actively receiving chronic dialysis in each facility per month as weight.
measure: Percentage of Participants Receiving Cinacalcet
time frame: Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.
description: The percentage of participants receiving cinacalcet (Sensipar) over time
measure: Percentage of Participants Receiving Phosphate Binding Agents
time frame: Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.
description: The percentage of participants receiving phosphate binding agents over time
measure: Percentage of Participants Receiving a Vitamin D Sterol
time frame: Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.
description: The percentage of participants receiving a vitamin D sterol (ie, calcitriol, alfacalcidol, paricalcitol or doxercalciferol) over time. Note that participants could receive more than one type of vitamin D sterol.
measure: Mean Hemoglobin Concentration by Quarter
time frame: Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.
measure: Distribution of Facilities With Percentage of Participants With Hemoglobin < 10 g/dL Over Time
time frame: December 2010, March 2011, June 2011, September 2011, December 2011
description: Facilities were categorized over time based on the percentage of participants at the facility with hemoglobin < 10 g/dL: Faciities with 0 to <5% of participants with hemoglobin < 10 g/dL; Facilities with 5 to < 10% of participants with hemoglobin < 10 g/dL; Facilities with 10 to < 15% participants with hemoglobin < 10 g/dL; Facilities with 15 to < 20% of participants with hemoglobin < 10 g/dL; Facilities with ≥ 20% of participants with hemoglobin < 10 g/dL.
measure: Percentage of Participants Per Facility With Transferrin Saturation < 20% and Ferritin Level < 100 ng/mL
time frame: December 2010, March 2011, June 2011, September 2011, December 2011
description: The mean percentage of participants per facility with transferrin saturation < 20% and ferritin level < 100 ng/mL. Mean and CI are calculated across facilities and by using number of participants with non-missing transferrin saturation and ferritin in each facility as weight.
measure: Cumulative Monthly Dose of Epoetin Alfa Administered
time frame: December 2010, March 2011, June 2011, September 2011, December 2011
description: The cumulative monthly intravenous epoetin alfa dose in participants on hemodialysis.
measure: Number of Participants Taking Epoetin Alfa by Month
time frame: December 2010, March 2011, June 2011, September 2011, December 2011
description: The number of participants who took epoetin alfa only, by month, in participants on hemodialysis.
measure: Number of Participants With Transfusions, Hospitalizations, Mortality, and Transfers Out
time frame: June to December 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.
arm group label: Cohort
description: Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs).
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: MD
role: Study Director
affiliation: Amgen
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country: Puerto Rico
country: United States
url: http://www.amgentrials.com
description: AmgenTrials clinical trials website
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 