Transcript Goal of DOPPS:

Goal of DOPPS:
To increase longevity for HD
patients by identifying practice
patterns associated with
improved patient outcomes
“live longer -- live better”
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DOPPS
Framework for Hypotheses
Patient Demographics
+
Patient Comorbidities
Patient Outcomes
Practice Patterns
+
Mortality
Hospitalization
Vascular access
Quality of life
Dialysis Outcomes and Practice Patterns
Study (DOPPS)
• Longitudinal study of hemodialysis patients and HD unit practices
DOPPS I: 7 countries,1996-2001
• DOPPS II: 12 countries, 2002-2004
• DOPPS III: 12 Countries, 2005-2008
• Representative units (>300), random patients (>17,000)
• Uniform international data collection
• Supported by Amgen, Inc. and (for Japan) Kirin Brewery, Ltd. without
restriction on publication
• Coordinated by University Renal Research & Education Association
(URREA), Ann Arbor, MI USA
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A Nationally Representative
International Study
• Facilities randomly selected to represent all geographic
regions and all types of facilities in each country
• Within each facility, a random sample of patients is
selected
Some call it the Framingham Study of Dialysis
DOPPS II
Japan
(60 facilities)
(randomly selected sites stratified by
unit type and region)
Europe
(140 facilities)
Australia &
New Zealand
(20 facilities)
Canada & US
(120 facilities)
Inclusion of Multiple Countries
Increases Observable Variability
Probability Distribution
1.0
0.8
0.6
0.4
0.2
0.0
0
2
4
6
8
Practice Pattern or Outcome
10
12
The Dialysis Outcomes and Practice Patterns
Study (DOPPS):
An International Hemodialysis Study
Young EW, Goodkin DA, Mapes DL, Port FK,
Keen ML, Chen K, Maroni BL, Wolfe RA, Held PJ
Kidney International 17 (Suppl. 74): S74-S81, 2000
Young EW et al. Kidney Int 17 (Suppl. 74):S74-S81, 2000
Introduction
(1)
• The Dialysis Outcomes and Practice Patterns Study
(DOPPS) is a prospective, longitudinal, observational
study of hemodialysis patients and facilities in seven
countries (France, Germany, Italy, Japan, Spain, United
Kingdom, United States)
• Primary goal of DOPPS is to improve the understanding of
dialysis practices that are associated with better
outcomes for patients
• Primary study endpoints: mortality, hospitalization, quality
of life and vascular access outcomes
Young EW et al. Kidney Int 17 (Suppl. 74):S74-S81, 2000
Introduction (2)
• Technical design and analysis was contributed by investigators
from:
– University Renal Research and Education Association (URREA)
– Amgen, Inc. Thousand Oaks, CA
– all seven countries
• World-wide Coordinating Center: URREA
• Supported by scientific grants from Amgen and Kirin without
restrictions on publications
Young EW et al. Kidney Int 17 (Suppl. 74):S74-S81, 2000
Introduction (3)
• Data collection began in 1996 in the US, 1997 in Europe and 1999
in Japan, and continued through 2001
• Facility sample in DOPPS I includes 327 hemodialysis centers
treating an approximate total of 24,392 patients
• Detailed longitudinal data collection has begun on a random
sample of 10,332 patients (Sept. 1999)
Young EW et al. Kidney Int 17 (Suppl. 74):S74-S81, 2000
Summary of Hemodialysis Facilities in Sampling Frame
for Each Country (1)
Country
Total Facilities
Total HD patients
France
316
20,106
Germany
790
43,747c
Italy
599
30,963c
Japan
2653
158,222d
Spain
476
15,427c
United Kingdom
146
7,528d
United States
2894
159,349e
HD=hemodialysis; c Data obtained directly from European Dialysis and Transplant Association (EDTA)
for 1995; d Data from Japanese Society for Dialysis Therapy for 1997; e Data from United States Renal
Data System (USRDS) for 1995
Young EW et al. Kidney Int 17 (Suppl. 74):S74-S81, 2000
Summary of Hemodialysis Facilities in Sampling
Frame for Each Country (2)
Country
No. of Geographic
regions a
No. of Facility
types b
France
22
4
General, private, university,
association
Germany
10
3
Clinics (medical centers), nonprofit,
free-standing, private practice
Italy
19
2
Public, private
Japan
47
2
Hospital, clinic
Spain
83
2
Academic, non-academic
United Kingdom
11
2
Center, satellite
United States
1
3
Free-standing profit, free-standing
non-profit, hospital
Facility Types
b
Number of regions in each country’s sample frame used in sampling plan. U.S. sample was not stratified
by geographic region; b Number of facility types used in sampling plan. U.S. sample was not stratified by
facility type although facility strata in common use are shown for comparison with other countries
a
Young EW et al. Kidney Int 17 (Suppl. 74):S74-S81, 2000
Geographic Distribution of DOPPS Dialysis Units in the
U.S. (A), Europe (B) and Japan (C)
C
B
A
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Young EW et al. Kidney Int 17 (Suppl. 74):S74-S81, 2000
DOPPS Data Collection
• DOPPS data collection instruments were designed to
gather detailed information characterizing:
–
–
–
–
Dialysis unit practices
Individual patient prescriptions
Laboratory values
Medical background/pre-existing comorbid conditions of
participating patients
• This longitudinal study entails prospective observation of
outcomes among thousands of subjects around the
world
Young EW et al. Kidney Int 17 (Suppl. 74):S74-S81, 2000
Patient Level Data Collection Items
• A study coordinator at each dialysis facility collects
baseline (Medical Questionnaire, or “MQ”) and
longitudinal (Interval Summary, or “IS”) patient data
abstracted primarily from the patients’ medical record
• Patients are asked to complete a questionnaire (Patient
Questionnaire, or “PQ”) that includes the Kidney Disease
Quality of Life (KDQOL) survey and modules concerning
pre-ESRD care, economic aspects of ESRD, employment
and rehabilitation
Young EW et al. Kidney Int 17 (Suppl. 74):S74-S81, 2000
Facility Level Data Collection Items
• The medical director and nurse manager at each
facility completed a comprehensive questionnaire
addressing a wide range of practice and
management issues, including:
–
–
–
–
Anemia and iron therapy
Continuing education policies/practice
Dialysis dose
Dietician and nutrition practices
Young EW et al. Kidney Int 17 (Suppl. 74):S74-S81, 2000
Characteristics of DOPPS Dialysis
Facilities by Country, 1996-1999
Number of hemodialysis patients
Type of facility
Country
Enrolled
facilities
Mean
Median
Min a
Max
Freestanding
(%) b
Institutional
(%) c
France
20
64
59
32
111
40
60
Germany
20
60
55
30
110
80
20
Italy
20
65
54
25
219
40
60
Japan
66
96
71
26
426
56
44
Spain
20
53
50
25
90
50
50
United
Kingdom
20
62
58
26
160
50
50
United
States
161
81
70
15
369
71
29
a
Small units excluded from study
Freestanding includes clinics, private and other non-institutionally based facilities
c Institutional includes hospital-based, university, academic and other public facilities
Young EW et al. Kidney Int 17 (Suppl. 74):S74-S81, 2000
b
Comparison of DOPPS Patient Characteristics by
Country
Age (years)
Diabetes Mellitus as cause of
ESRD (%)
Male (%)
Country
Mean a
P-valueb
% ptsa
AORc
P-valuec
% ptsa
AORd
P-valued
France
60.4
0.3569
57.8
1.18
0.0087
10.4
0.16
0.0001
Germany
60.1
0.8847
54.3
1.04
0.5292
25.0
0.48
0.0001
Italy
62.2
0.0001
55.1
1.07
0.2496
10.7
0.17
0.0001
Japan
58.8
0.0001
61.1
1.36
0.0001
23.9
0.46
0.0001
Spain
60.9
0.0541
56.8
1.15
0.0362
19.5
0.34
0.0001
United
Kingdom
58.1
0.0001
62.0
1.39
0.0001
14.6
0.25
0.0001
United
States
60.0
ref
52.9
ref
ref
40.9
ref
ref
AOR= adjusted odds ratio
a Unadjusted
b Adjusted for sex and diabetes
c Adjusted for age and diabetes
d Adjusted for age and sex
Young EW et al. Kidney Int 17 (Suppl. 74):S74-S81, 2000
Results
• Large variation in facility size (number of patients
treated) was found in all countries
• The average patient age is lowest in the United Kingdom
and Japan and highest in Italy and Spain
• Diabetes mellitus as the attributed cause of ESRD was
much higher in the United States than in the other
countries
• Racial variation was much higher in the U.S. than in the
other countries
Young EW et al. Kidney Int 17 (Suppl. 74):S74-S81, 2000
Conclusions
• At this early phase, the DOPPS has demonstrated its
technical feasibility and revealed basic differences in
hemodialysis facilities such as:
– Dialysis facilities vary widely in size and type (freestanding
vs. institutionally based) across countries
– Variation is also seen in patient age, sex distribution, and
diabetes mellitus as the attributed cause of ESRD
Young EW et al. Kidney Int 17 (Suppl. 74):S74-S81, 2000
Acknowledgements
• We wish to thank the DOPPS study coordinators and medical
directors for their dedication and hard work, and we are grateful to
the patients who completed questionnaires
• DOPPS is supported by scientific grants from Amgen and Kirin
without restrictions on publications
Young EW et al. Kidney Int 17 (Suppl. 74):S74-S81, 2000