Dosing Dialysis: Is More Better ? “ Dialysis in the 21st Century”  Chicago, Illinois September 19, 2004 Robert S. Lockridg...
"Thinking Outside the Box"
Dosing Dialysis: Is More Better ? <ul><ul><ul><li>Demographics of the ESRD population  </li></ul></ul></ul><ul><ul><ul><li...
Dosing Dialysis: Is More Better ? <ul><ul><ul><li>Demographics of the ESRD population   </li></ul></ul></ul>
Cardiovascular Disease Mortality General Population vs ESRD Patients Foley RN, et al.  Am J Kidney Dis . 1998;32:S112-S119...
Growth of U.S. Dialysis Patients  Source:  USRDS 2000 Annual Data Report Networks 2000 Annual Report
Modalities of U.S. Dialysis Patients Source:  USRDS 2000 Annual Data Report Networks 2000 Annual Report 1990   1992  1994 ...
Dialysis Patients E mployed or Students Source:  Networks 2000 Annual Report Employed or Students
ESRD Population
Cost Centers for Dialysis Patients <ul><li>Hospitalization </li></ul><ul><li>$23,000 </li></ul>$7,000
Fewer Nursing Candidates  Total Enrollments and Graduations, All RN Programs   1988  1994  2000
Nephrology Manpower Issues Source:Abt Report 1995
Dosing Dialysis: Is More Better ? <ul><ul><ul><li>Efforts of renal community and CMS to improve quality of care of dialysi...
“ Quality Care for Our Patients” <ul><li>1990-1999 </li></ul><ul><ul><ul><li>Major Network initiative to monitor anemia, n...
“ Quality Care for Our Patients” <ul><li>2000-2003 </li></ul><ul><ul><ul><li>Quality improvement by K/DOQI standards 2000 ...
Dosing Dialysis: Is More Better ? <ul><ul><ul><li>Results from USRDS 2002 Annual Report concerning Core Indicators, hospit...
Hemoglobin-Epogen Trend USRDS  2002 ADR 1991 1992 1993 1994 1995 1996 1997 1 998 1999 2000 2 001 Mean wee k l y E P O dose...
Urea Reduction Rate USRDS  2002 ADR 1998 1999 2000 Pe rcent of pa ti ent s 1998 1999 2000 Pe rcent of pa ti ent s 0 20 40 ...
Urea Reduction Rate USRDS  2002 ADR 1993 1994 1995 1996 1997 1998 1999 P e rce n t o f pati e n ts 0 20 40 60 80 100 1998 ...
Adjusted Admission Rates per 1000 Patient Years for Prevalent ESRD Population USRDS  2002 ADR
Adjusted Hospital Admission Rate per 1000 Patient Years  <ul><ul><ul><li>Medicare patients (1998-2000)   500 admissions pe...
Adjusted One Year Death Rate per 1000 Patient Years for Incident ESRD Patients USRDS  2002 ADR
Adjusted One Year Death Rate per 1000 Patient Years for Prevalent ESRD Patients USRDS  2002 ADR
Annual Death Rates per 1000 Patient Years at Risk Prevalent Patients Adjusted 2000 <ul><li>ESRD Population     177.6 </li>...
Dosing Dialysis: Is More Better ? <ul><ul><ul><li>Does three times per week affect adequacy? </li></ul></ul></ul>
Three Times per Week Dialysis Source : Gotch et al,  Kidney International , Vol. 58, Suppl. 76 (2000), pp S3-18
Hemo Study 2002 Why No Significant Change? Short Group Long Group NHHD
Dosing Dialysis: Is More Better ? <ul><ul><ul><li>Overview of Lynchburg’s NHHD Data   </li></ul></ul></ul>
Demographics of  51 NHHD Patients as of 7-31-04 <ul><li>Average Age 54.4 years (Range 26.7-82.7 years) </li></ul><ul><li>A...
Demographics of NHHD Program  9-4-97 to 7-31-04 <ul><li>Completed Training    52 </li></ul><ul><li>Currently in Program at...
Demographics of NHHD Program   9-4-97 to 7-31-04 <ul><li>Patient months on NHHD   1,566.4   </li></ul><ul><li>Total treatm...
Treatment Parameters as of 8-17-04 <ul><li>Treatment time 5-9 hours, five or six nights or days/week </li></ul><ul><li>BFR...
Longitudinal Study of NHHD  from 9-1-97 to 5-31-03  <ul><ul><ul><li>25 patients at one year </li></ul></ul></ul><ul><ul><u...
SF-36 PCS and MCS
Quality of Life Improvements Physical Component Summary Score p = 0.007 Mental Component Summary Score p = 0.002
Hospital Days and Admissions
60% Reduction in Hospital Days 42% Reduction in Hospital Admissions Admissions p = 0.008 Days p = 0.002
Systolic and Diastolic BP Pre  NHHD 1 Year  N=25 Pre  NHHD 2 Year  N=19 Pre  NHHD 3 Year  N=14 Pre  NHHD 4 Year  N=6 Pre  ...
Hypertension - Improved BP control  p=0.0003 p=0.0001
Blood Pressure Categories Pre  NHHD 1 Year  N=25 Pre  NHHD 2 Year  N=19 Pre  NHHD 3 Year  N=14 Pre  NHHD 4 Year  N=6 Pre  ...
Blood Pressure Medications p=0.001
Phosphate Binder Usage  (number of tablets/day-includes ALL binders)
CA/PO4 Product on NHHD
CA/PO4 Product on NHHD p=0.001
Dry Weight
Dry Weight p=0.07
Hemogloblin 1 Year  N=25 2 Year  N=19 3 Year  N=14 4 Year  N=6 5 Year  N=4
Mortality  <ul><li>Mortality rate calculated on 35 out of 40 patients in the program </li></ul><ul><li>2 patients not incl...
Internal Jugular Tunneled Catheters  Used in NHHD Program as of  4-30-04 <ul><ul><ul><li>Total Patients with Catheters    ...
Interlink Device and Injection Caps
Catheter Locking Device
Catheter with Wings Removed and Dressing on
Catheter Infection Rate for NHHD Program as of 4-30-04 <ul><ul><ul><li>1120.5 Months on NHHD at home </li></ul></ul></ul><...
Fistula Data in NHHD Program as of 4-30-04 <ul><ul><ul><li>Patients who used Fistula    17 </li></ul></ul></ul><ul><ul><ul...
Graft Data in NHHD Program as of 4-30-04 <ul><ul><ul><li>Patients who used Graft    3 </li></ul></ul></ul><ul><ul><ul><li>...
Conclusions  <ul><li>By the Year 2010 the ESRD population and the cost to the Medicare ESRD Program will double </li></ul>...
Conclusions <ul><ul><ul><li>Daily Dialysis improves:  </li></ul></ul></ul><ul><ul><ul><ul><li>Quality of life </li></ul></...
Conclusions <ul><ul><ul><li>Daily Dialysis improves outcomes because this new modality offers a higher Renal Replacement D...
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  • * Another interesting way to look at mortality is to compare CV disease mortality in the general population vs. ESRD patients. As you can see, a 25-34 yr. old ESRD patient has the same mortality rate of an 80 yr old in the general population. This is frightening.
  • Rationale for the linear mixed model – the best model for normally distributed, multi-patient, longitudinal data For each patient, many longitudinal (time series) observations exist Good analysis needs to take into account all of these data points Intra-patient data points are highly, but not completely, correlated and an analysis needs to take these considerations into account Traditional t-tests, ANOVA models don’t work We can use the linear mixed model because the data is distributed normally
  • Rationale for the linear mixed model – the best model for normally distributed, multi-patient, longitudinal data For each patient, many longitudinal (time series) observations exist Good analysis needs to take into account all of these data points Intra-patient data points are highly, but not completely, correlated and an analysis needs to take these considerations into account Traditional t-tests, ANOVA models don’t work We can use the linear mixed model because the data is distributed normally
  • Explanation of Statistical Methods Poisson is the best model to handle count data Correction for overdispersion is necessary because patients have such a large range in their hospitalization days per time period (larger than would have been expected by Poisson) in their days on HD before NHHD
  • Explanation of Statistical Methods Poisson is the best model to handle count data Correction for overdispersion is necessary because patients have such a large range in their hospitalization days per time period (larger than would have been expected by Poisson) in their days on HD before NHHD
  • Dialysis21stCentury.ppt

    1. 1. Dosing Dialysis: Is More Better ? “ Dialysis in the 21st Century” Chicago, Illinois September 19, 2004 Robert S. Lockridge Jr. MD Lynchburg Nephrology Physicians
    2. 2. &quot;Thinking Outside the Box&quot;
    3. 3. Dosing Dialysis: Is More Better ? <ul><ul><ul><li>Demographics of the ESRD population </li></ul></ul></ul><ul><ul><ul><li>Efforts of renal community and CMS to improve quality of care of dialysis patients </li></ul></ul></ul><ul><ul><ul><li>Results from USRDS 2002 Annual Report concerning Core Indicators, hospitalizations and mortality </li></ul></ul></ul><ul><ul><ul><li>Does three times per week affect adequacy? </li></ul></ul></ul><ul><ul><ul><li>Overview of Lynchburg’s NHHD data </li></ul></ul></ul>
    4. 4. Dosing Dialysis: Is More Better ? <ul><ul><ul><li>Demographics of the ESRD population </li></ul></ul></ul>
    5. 5. Cardiovascular Disease Mortality General Population vs ESRD Patients Foley RN, et al. Am J Kidney Dis . 1998;32:S112-S119. GP: General Population. Dialysis Female Dialysis Black Dialysis White Age (years) Annual CVD Mortality (%) 0.001 0.01 0.1 1 10 100 25-34 35-44 45-54 55-64 66-74 75-84 >85 GP Male GP Female GP Black GP White Dialysis Male
    6. 6. Growth of U.S. Dialysis Patients Source: USRDS 2000 Annual Data Report Networks 2000 Annual Report
    7. 7. Modalities of U.S. Dialysis Patients Source: USRDS 2000 Annual Data Report Networks 2000 Annual Report 1990 1992 1994 1996 1998 2000
    8. 8. Dialysis Patients E mployed or Students Source: Networks 2000 Annual Report Employed or Students
    9. 9. ESRD Population
    10. 10. Cost Centers for Dialysis Patients <ul><li>Hospitalization </li></ul><ul><li>$23,000 </li></ul>$7,000
    11. 11. Fewer Nursing Candidates Total Enrollments and Graduations, All RN Programs 1988 1994 2000
    12. 12. Nephrology Manpower Issues Source:Abt Report 1995
    13. 13. Dosing Dialysis: Is More Better ? <ul><ul><ul><li>Efforts of renal community and CMS to improve quality of care of dialysis patients </li></ul></ul></ul>
    14. 14. “ Quality Care for Our Patients” <ul><li>1990-1999 </li></ul><ul><ul><ul><li>Major Network initiative to monitor anemia, nutrition, and adequacy in the 90’s </li></ul></ul></ul><ul><ul><ul><li>End Stage Renal Disease Managed Care Demonstration Project of 1996 </li></ul></ul></ul><ul><ul><ul><li>Quality improvement by DOQI standards 1997 </li></ul></ul></ul>
    15. 15. “ Quality Care for Our Patients” <ul><li>2000-2003 </li></ul><ul><ul><ul><li>Quality improvement by K/DOQI standards 2000 </li></ul></ul></ul><ul><ul><ul><li>Hemo Study completed 2002 </li></ul></ul></ul><ul><ul><ul><li>Network Access (Fistula First) initiative 2003 </li></ul></ul></ul><ul><ul><ul><li>Proposed ESRD Disease Management Demonstration Project of 2003 ending 2008 </li></ul></ul></ul><ul><ul><ul><li>NIH/CMS Daily Dialysis Study ending 2008 </li></ul></ul></ul>
    16. 16. Dosing Dialysis: Is More Better ? <ul><ul><ul><li>Results from USRDS 2002 Annual Report concerning Core Indicators, hospitalizations and mortality </li></ul></ul></ul>
    17. 17. Hemoglobin-Epogen Trend USRDS 2002 ADR 1991 1992 1993 1994 1995 1996 1997 1 998 1999 2000 2 001 Mean wee k l y E P O dose ( t housands of uni t s) 5 7 9 11 13 15 17 19 Hem o g l obi n ( g /dl ) 9.0 9.5 10.0 10.5 11.0 11.5 12.0 H e mo gl o b i n W e e k ly EP O do s e
    18. 18. Urea Reduction Rate USRDS 2002 ADR 1998 1999 2000 Pe rcent of pa ti ent s 1998 1999 2000 Pe rcent of pa ti ent s 0 20 40 60 80 100 1998 1999 2000 All patients Female Male 75+ 70-<75 65-<70 60-<65 <60
    19. 19. Urea Reduction Rate USRDS 2002 ADR 1993 1994 1995 1996 1997 1998 1999 P e rce n t o f pati e n ts 0 20 40 60 80 100 1998 1999 2000 CPM Claims 75+ 70-<75 65-<70 60-<65 <60
    20. 20. Adjusted Admission Rates per 1000 Patient Years for Prevalent ESRD Population USRDS 2002 ADR
    21. 21. Adjusted Hospital Admission Rate per 1000 Patient Years <ul><ul><ul><li>Medicare patients (1998-2000) 500 admissions per 1000 patient years </li></ul></ul></ul><ul><ul><ul><li>Prevalent ESRD patients (2000) 1900 admissions per 1000 patient years </li></ul></ul></ul><ul><ul><ul><li>Prevalent transplant patients (2000) 807 admissions per 1000 patient years </li></ul></ul></ul>
    22. 22. Adjusted One Year Death Rate per 1000 Patient Years for Incident ESRD Patients USRDS 2002 ADR
    23. 23. Adjusted One Year Death Rate per 1000 Patient Years for Prevalent ESRD Patients USRDS 2002 ADR
    24. 24. Annual Death Rates per 1000 Patient Years at Risk Prevalent Patients Adjusted 2000 <ul><li>ESRD Population 177.6 </li></ul><ul><li>Dialysis Patients 234.1 </li></ul><ul><li>Hemodialysis Patients 236.7 </li></ul><ul><li>Peritoneal Patients 219.9 </li></ul><ul><li>Transplant Patients 34.7 </li></ul>
    25. 25. Dosing Dialysis: Is More Better ? <ul><ul><ul><li>Does three times per week affect adequacy? </li></ul></ul></ul>
    26. 26. Three Times per Week Dialysis Source : Gotch et al, Kidney International , Vol. 58, Suppl. 76 (2000), pp S3-18
    27. 27. Hemo Study 2002 Why No Significant Change? Short Group Long Group NHHD
    28. 28. Dosing Dialysis: Is More Better ? <ul><ul><ul><li>Overview of Lynchburg’s NHHD Data </li></ul></ul></ul>
    29. 29. Demographics of 51 NHHD Patients as of 7-31-04 <ul><li>Average Age 54.4 years (Range 26.7-82.7 years) </li></ul><ul><li>Average Weight 81.3 kg (Range 38-156 kg) </li></ul><ul><li>23 Black Patients, 29 White Patients </li></ul><ul><li>33 Men, 19 Women </li></ul><ul><li>Education: < HS 10, HS 25, HS+College 14, Undergraduate 1, Graduate 2 </li></ul>
    30. 30. Demographics of NHHD Program 9-4-97 to 7-31-04 <ul><li>Completed Training 52 </li></ul><ul><li>Currently in Program at Home 32 </li></ul><ul><li>Left Program During Training 3 </li></ul><ul><li>Deaths 4 </li></ul><ul><li>Left Program After Completing Training Transplanted 7 </li></ul><ul><li>For Medical Reasons 6 </li></ul><ul><li>For Compliance 2 </li></ul><ul><li>Personal Choice 1 </li></ul><ul><li> </li></ul>
    31. 31. Demographics of NHHD Program 9-4-97 to 7-31-04 <ul><li>Patient months on NHHD 1,566.4 </li></ul><ul><li>Total treatments at home 34,586 </li></ul><ul><li>Longest patient time in months 81.7 </li></ul><ul><li>Shortest patient time in months 0.3 </li></ul><ul><li>Average patient time in months 30.1 </li></ul>
    32. 32. Treatment Parameters as of 8-17-04 <ul><li>Treatment time 5-9 hours, five or six nights or days/week </li></ul><ul><li>BFR 200-250 cc/minute </li></ul><ul><li>DFR 200-300 cc/minute </li></ul><ul><li>Dialysate K 2.0 mEq/L, HC03 35 mEq/L, Na 137 mEq/L, Ca 3.0-3.5 mEq/L </li></ul><ul><li>Machine - Fresenius 2008 H, Fresenius 2008 K, Fresenius 2008 Home K </li></ul><ul><li>F60 Reusable Dialyzer </li></ul>
    33. 33. Longitudinal Study of NHHD from 9-1-97 to 5-31-03 <ul><ul><ul><li>25 patients at one year </li></ul></ul></ul><ul><ul><ul><li>19 patients at two years </li></ul></ul></ul><ul><ul><ul><li>14 patients at three years </li></ul></ul></ul><ul><ul><ul><li>6 patients at four years </li></ul></ul></ul><ul><ul><ul><li>4 patients at five years </li></ul></ul></ul>
    34. 34. SF-36 PCS and MCS
    35. 35. Quality of Life Improvements Physical Component Summary Score p = 0.007 Mental Component Summary Score p = 0.002
    36. 36. Hospital Days and Admissions
    37. 37. 60% Reduction in Hospital Days 42% Reduction in Hospital Admissions Admissions p = 0.008 Days p = 0.002
    38. 38. Systolic and Diastolic BP Pre NHHD 1 Year N=25 Pre NHHD 2 Year N=19 Pre NHHD 3 Year N=14 Pre NHHD 4 Year N=6 Pre NHHD 5 Year N=4
    39. 39. Hypertension - Improved BP control p=0.0003 p=0.0001
    40. 40. Blood Pressure Categories Pre NHHD 1 Year N=25 Pre NHHD 2 Year N=19 Pre NHHD 3 Year N=14 Pre NHHD 4 Year N=6 Pre NHHD 5 Year N=4
    41. 41. Blood Pressure Medications p=0.001
    42. 42. Phosphate Binder Usage (number of tablets/day-includes ALL binders)
    43. 43. CA/PO4 Product on NHHD
    44. 44. CA/PO4 Product on NHHD p=0.001
    45. 45. Dry Weight
    46. 46. Dry Weight p=0.07
    47. 47. Hemogloblin 1 Year N=25 2 Year N=19 3 Year N=14 4 Year N=6 5 Year N=4
    48. 48. Mortality <ul><li>Mortality rate calculated on 35 out of 40 patients in the program </li></ul><ul><li>2 patients not included because they were transplanted within 14 days of starting NHHD </li></ul><ul><li>3 patients not included because they were in the program less than 3 months </li></ul><ul><li>2 patients died from 10-5-97 to 4-30-03 </li></ul><ul><li>2.4% deaths per patient-year </li></ul>
    49. 49. Internal Jugular Tunneled Catheters Used in NHHD Program as of 4-30-04 <ul><ul><ul><li>Total Patients with Catheters 42 </li></ul></ul></ul><ul><ul><ul><li>Total Catheters 124 </li></ul></ul></ul><ul><ul><ul><li>Average Catheter Life (months) 9.0 </li></ul></ul></ul><ul><ul><ul><li>Longest Catheter Life (months) 74.7 </li></ul></ul></ul><ul><ul><ul><li>Shortest Catheter Life (months) 0.2 </li></ul></ul></ul>
    50. 50. Interlink Device and Injection Caps
    51. 51. Catheter Locking Device
    52. 52. Catheter with Wings Removed and Dressing on
    53. 53. Catheter Infection Rate for NHHD Program as of 4-30-04 <ul><ul><ul><li>1120.5 Months on NHHD at home </li></ul></ul></ul><ul><ul><ul><li>0.35 Exit Site Infections per 1000 Patient Days </li></ul></ul></ul><ul><ul><ul><li>0.53 Catheter Sepsis per 1000 Patient Days </li></ul></ul></ul><ul><ul><ul><li>0.88 Total Infections per 1000 Patient Days </li></ul></ul></ul>
    54. 54. Fistula Data in NHHD Program as of 4-30-04 <ul><ul><ul><li>Patients who used Fistula 17 </li></ul></ul></ul><ul><ul><ul><li>Patients attempting to use Fistula 5 </li></ul></ul></ul><ul><ul><ul><li>Patients that went home with Fistula 10 </li></ul></ul></ul><ul><ul><ul><li>Clotted Fistula requiring revision 2 </li></ul></ul></ul><ul><ul><ul><li>Fistula Months on NHHD at home 243.9 </li></ul></ul></ul><ul><ul><ul><li>Exit Site Infections 1 </li></ul></ul></ul><ul><ul><ul><li>Sepsis from Fistula 0 </li></ul></ul></ul>
    55. 55. Graft Data in NHHD Program as of 4-30-04 <ul><ul><ul><li>Patients who used Graft 3 </li></ul></ul></ul><ul><ul><ul><li>Patients attempting to use Graft 2 </li></ul></ul></ul><ul><ul><ul><li>Patients that went home with Graft 1 </li></ul></ul></ul><ul><ul><ul><li>Clotted Graft requiring revision 0 </li></ul></ul></ul><ul><ul><ul><li>Graft Months on NHHD at home 27.3 </li></ul></ul></ul><ul><ul><ul><li>Exit Site Infections 0 </li></ul></ul></ul><ul><ul><ul><li>Sepsis from Graft 0 </li></ul></ul></ul>
    56. 56. Conclusions <ul><li>By the Year 2010 the ESRD population and the cost to the Medicare ESRD Program will double </li></ul><ul><li>Pushing the Core Indicators in a three time per week treatment schedule does not appear to affect hospital admissions and mortality </li></ul><ul><li>Tunneled IJ catheters are effective and safe permanent access for NHHD patients </li></ul><ul><li>AV fistula and AV grafts are effective and safe permanent access for NHHD patients </li></ul>
    57. 57. Conclusions <ul><ul><ul><li>Daily Dialysis improves: </li></ul></ul></ul><ul><ul><ul><ul><li>Quality of life </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Hospital admissions and hospital days </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Blood pressure control with fewer medications </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Calcium/phosphorus product with no phosphate binders </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Nutritional status </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Mortality </li></ul></ul></ul></ul>
    58. 58. Conclusions <ul><ul><ul><li>Daily Dialysis improves outcomes because this new modality offers a higher Renal Replacement Dose </li></ul></ul></ul><ul><ul><ul><ul><li>Standard three times per week dialysis provides about 10 ml/min creatinine clearance </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Short daily dialysis provides about 20 ml/min creatinine clearance </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Nocturnal dialysis provides greater than 30 ml/min creatinine clearance </li></ul></ul></ul></ul>

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