Background
Methods
Study | Country Countries Estimated | n (sample) for RR analysis | Method for RR | n (sample) for “outside of range” analysis | Population estimation source | Population estimation method | Calculation of attributable patient-years | Equation for calculating attributable patient-years^ |
---|---|---|---|---|---|---|---|---|
Port et al. 2004 [2] | US | Random sample (n = 17,245) from all 7 DOPPS I countries (N = 52,905) | 6 Cox proportional hazards models (one for each factor); a 7th Cox survival model was also used which adjusted for all six HD practices simultaneously. All models were adjusted for age, race, years of ESRD, country & 15 summary comorbid conditions (CAD, CHF, other cardiac disease, PVD, HTN, cerebrovascular disease, DM, lung disease, dyspnea, Hx cancer (active or inactive, excluding skin cancer), GI bleeding in past 12 months, neurologic disease, psychiatric disease, HIV/AIDS, and recurrent skin disease (including gangrene). | 1914 prevalent HD patients from US DOPPS II | 2001 US Renal Data System Annual Data Report | Estimation of the total US HD patient population in 2004 by extrapolation of 2001 data using a 6% annual growth rate | The expected gain in patient-years was calculated from the difference in the area under the 5-year survival curves between survival of the US haemodialysis population based on actual current death rates versus projected survival of the US haemodialysis population if all patients currently outside of the six practice guidelines were instead within them. | PY = [(N0/L) * FD] + [(N1/L) * (t – (FD/L))], Assumptions: • t = 5 years • L = 0.251 if all patients outside of the target ranges for the six HD practices are brought within these target ranges • L = 0.30 if there is no change from the current proportion of patients outside the six target ranges • N0 = 313,000 • N1 = 116,477 |
Jadoul et al. 2007 [13] | Belgium | > 20,000 (from all 12 DOPPS I and II countries) | Same as US study except: 1 modifiable practice differed (substituted albumin-corrected serum calcium for IDWG); did not adjust for dyspnea | 538 prevalent HD patients from Belgian DOPPS II | Outpatient HD patient population reported in the 2001 Flemish-speaking and French-speaking registries | Estimation of the total Belgian HD patient population in 2006 by extrapolation of 2001 data using a 7.5% annual growth rate | Same as US but on Belgian data | Same as US except: • L = 0.113 if all patients outside of the target ranges for the six HD practices are brought within these target ranges • L = 0.22 if there is no change from the current proportion of patients outside the six target ranges • N0 = 6373 • N1 = 1591 |
Piera et al. 2007 [14] | Spain | > 20,000 (from all 12 DOPPS I and II countries) | Same as US study except: 1 modifiable practice differed (substituted albumin-corrected serum calcium for IDWG); did not adjust for dyspnea | 613 from Spanish DOPPS II | Informe de la Sociedad Española de Nefrología de 2005 | Estimation of the total Spanish HD patient population in 2006 by extrapolation of 2005 data using a 5.1% annual growth rate | Same as US but on Spanish data | Same as US except: • L = 0.099 if all patients outside of the target ranges for the six HD practices are brought within these target ranges • L = 0.170 if there is no change from the current proportion of patients outside the six target ranges • N0 = 20,920 • N1 = 4902 |
Canaud et al. 2008 [15] | France | > 20,000 (from all 12 DOPPS I and II countries) | Same as US study except: 1 modifiable practice differed (substituted albumin-corrected serum calcium for IDWG); did not adjust for dyspnea | 532 from French DOPPS II | Bulletin Epidemiologique Hebdomadaire de 2005 | Estimation of the total French HD patient population in 2006 by extrapolation of 2005 data using a 5.3% annual growth rate | Same as US but on French data | Same as US except: • L = 0.157 if all patients outside of the target ranges for the six HD practices are brought within these target ranges • L = 0.223 if there is no change from the current proportion of patients outside the six target ranges • N0 = 31,987 • N1 = 6070 |
Wikström et al. 2010 [16] | Sweden | > 20,000 (from all 12 DOPPS I and II countries) | Same as US study except: 1 modifiable practice differed (substituted albumin-corrected serum calcium for IDWG); did not adjust for dyspnea | 547 prevalent HD patients from Swedish DOPPS II | 2003 Swedish Renal Registry | Estimation of the total Swedish HD patient population in 2006 by extrapolation of 2003 data using a 4.5% annual growth rate | Same as US but on Swedish data | Same as US except: • L = 0.180 if all patients outside of the target ranges for the six HD practices are brought within these target ranges • L = 0.274 if there is no change from the current proportion of patients outside the six target ranges • N0 = 2434 • N1 = 769 |
MONITOR-CKD5 | Austria France Germany Italy Poland Romania Slovenia Spain Switzerland United Kingdom* | Not applicable | Utilizes published RR rates from various DOPPS studies (see Table 2 for details) | 2023 from MONITOR-CKD5 | Austria, Poland, Romania, Spain, Switzerland, UK: ERA-EDTA Registry 2014; France: REIN Rapport Annuel 2014; Germany: QuaSi-Niere-Bericht 2006–2007; Italy: RIDT Report 2011–2013; Slovenia: ERA-EDTA Registry 2013 | Estimation of the HD patient population in 2017 in the 10 countries participating in the MONITOR-CKD5 study by extrapolation of 2014 data (except for Germany for which 2006 data were available, and Italy and Slovenia for which 2013 data were available) using a 5% annual growth rate | Same as US but on data from 10 European countries | Same as US except: L = 0.170 if all patients outside the target ranges for the six HD practices are brought within these target range L = 0.203 if there is no change from the current proportion of patients outside the six target ranges N0 = 303,517 N1 = 66,597 |
Definition and Selection of Target Ranges for Modifiable Practices
Estimation of “Out of Range”
Country | Kt/V | Phosphate | Hb | Inter-Dialytic Weight Gain | Albumin | Facility Catheter Use | All 6 Factors | ||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Target range | % outside range | RR if outside range | Target Range | % outside range | RR if outside range | Target Range | % outside range | RR if outside range | Target Range | % outside range | RR if outside range | Target Range | % outside range | RR if outside range | Target Range | % outside range | RR if outside range | % inside range on all 6 | % outside range on ≥1 | RR if outside range on ≥1 | |
US[2] | ≥1.2 | 12.1% | 1.16 | ≤5.5 mg/dL | 49.2% | 1.11 | ≥11 g/dL | 27.2% | 1.14 | ≤5.7% | 12.5% | 1.22 | ≥3.5 g/dL | 20.5% | 1.38 | ≤7% | 50.0% | 1.23 | 8.7% | 91.3% | 1.33 |
Belgium [13] | ≥1.2 | 30.3% | 1.13 | ≤1.5 mmol/L | 56.2% | 1.11 | ≥11 g/dL | 33.6% | 1.20 | ≥4.0 g/dL | 67.1% | 1.46 | ≤10% | 91.1% | 1.20 | ||||||
Spain [14] | ≥1.2 | 22.7% | 1.13 | ≤1.5 mmol/L | 63.5% | 1.11 | ≥11 g/dL | 30.4% | 1.20 | ≥4.0 g/dL | 71.4% | 1.46 | ≤10% | 42.8% | 1.20 | ||||||
France [15] | ≥1.2 | 15.5% | 1.13 | ≤1.8 mmol/L | 39.6% | 1.14 | ≥11 g/dL | 40.5% | 1.20 | ≥4.0 g/dL | 70.5% | 1.46 | ≤10% | 33.4% | 1.20 | ||||||
Sweden [16] | ≥1.2 | 20.1% | 1.13 | ≤1.8 mmol/L | 50.8% | 1.14 | ≥11 g/dL | 23.8% | 1.20 | ≥3.5 g/dL | 40.1% | 1.48 | ≤10% | 88.2% | 1.20 | ||||||
MONITOR-CKD5 * | ≥1.2 | 17.1% | 1.13 | ≤5.5 mg/dL | 38.5% | 1.14 | ≥10 g/dL | 14.0% | 1.22 | ≤5.7% | 7.8% | 1.22 | ≥4.0 g/dL | 56.8% | 1.46 | Pt-level: fistula (native or synthetic) vs. catheter | 16.6% | 1.32 | 15.5% | 84.5% | 1.33 |
Source of RR for MONITOR-CKD5 | Locatelli et al. 2004 [Ref 20] | Port et al. 2004 [Ref 2] | Pisoni et al. 2009 [Ref 21] | RR if outside range on ≥1 modifiable factor extrapolated from Port et al. 2004 [Ref. 1] Tables 1 and 2 where RR = (overall mortality / mortality rate of patients outside of range) / % of patients outside range − % of patients inside range; % of patients inside range on all 6 factors obtained through personal communication with Arbor Research 23Sep2016 |
Selection of Mortality Relative Risk Values
Population Estimation
Countries | Source | Year of Data | HD Prevalent Count | HD Incident Count | Extrapolation to 2017 | |
---|---|---|---|---|---|---|
HD Prevalent Count | HD Incident Count | |||||
Austria | ERA-EDTA Registry 20141 | 2014 | 3973 | 814 | 4599.24 | 942.31 |
France ° | ERA-EDTA Registry 20141 | 2014 | 41,314 | 8321 | 47,826.12 | 9632.60 |
Germany | Nierenersatztherapie in Deutschland 2006–20072 | 2006 | 63,413 | 16,260 | 108,457.11 | 27,809.96 |
Italy | Registro Italiano di Dialisi e Trapianto Report 2011–20133 | 2013 | 41,006 | 8241 | 49,843.22 | 10,017.40 |
Poland † | ERA-EDTA Registry 20141 (Section B, aggregated data)4 | 2014 | 19,345 | 3954 | 22,394.26 | 4577.25 |
Romania ^ | ERA-EDTA Registry 20141 | 2014 | 14,686 | 2538 | 17,000.88 | 2938.05 |
Slovenia †† | ERA-EDTA Registry 20135 | 2013 | 1349 | 209 | 1639.72 | 254.04 |
Spain ~ | ERA-EDTA Registry 20141 | 2014 | 21,517 | 4236 | 24,908.62 | 4903.70 |
Switzerland | ERA-EDTA Registry 20141 (Section B, aggregated data) | 2014 | 2636 | 663 | 3051.50 | 767.51 |
United Kingdom, England only ° * | ERA-EDTA Registry 20141 | 2014 | 20,556 | 4107 | 23,796.14 | 4754.37 |
Calculation of Attributable Patient-Years
Ethics
Consort
Results
Patients
Estimated Patient Life-Years Gained
Measure | Current statistics | Kt/V ≥ 1.2 | Phosphate ≤ 5.5 mg/dL | Hb ≥ 10 g/dL | IDWG ≤ 5.7% | Albumin ≥ 4.0 g/dl | AVF or graft v. catheter | All 6 Factors |
---|---|---|---|---|---|---|---|---|
Annual death rate | 0.150 1 | 0.1467 2 | 0.1423 2 | 0.1455 2 | 0.1475 2 | 0.1189 2 | 0.1424 2 | 0.1173 2 |
Annual rate of other loss3 | 0.053 | 0.053 | 0.053 | 0.053 | 0.053 | 0.053 | 0.053 | 0.053 |
L (Total loss rate) | 0.203 | 0.200 | 0.195 | 0.199 | 0.200 | 0.172 | 0.195 | 0.170 |
T | 5 | 5 | 5 | 5 | 5 | 5 | 5 | 5 |
N0 4 | 303,517 | 303,517 | 303,517 | 303,517 | 303,517 | 303,517 | 303,517 | 303,517 |
N1 5 | 66,597 | 66,597 | 66,597 | 66,597 | 66,597 | 66,597 | 66,597 | 66,597 |
FD | 0.63760 | 0.63164 | 0.62343 | 0.62938 | 0.63298 | 0.57668 | 0.62363 | 0.57321 |
PY | 1,563,221 | 1,572,540 | 1,585,273 | 1,576,047 | 1,570,443 | 1,655,565 | 1,584,967 | 1,660,650 |
Potential patient years gained | ||||||||
if 100% brought within target | 9319 | 22,052 | 12,826 | 7222 | 92,344 | 21,746 | 97,4296 | |
if 50% brought within target7 | 4501 | 10,651 | 6195 | 3488 | 44,601 | 10,503 | 47,057 |