Study reference

Study characteristics

Patient characteristics

Prognostic factor(s)

Follow-up

Outcome measures and effect size

Comments

Robinson 2012

Type of study:

Prospective cohort

Setting:

Multi-center

Countries:

France, Germany, Italy, Japan, Spain, United Kingdom, and United States, Australia, Belgium, Canada, New Zealand and Sweden.

Source of funding:

The DOPPS is administered by Arbor Research Collaborative for Health and is supported by scientific research grants from Amgen (since 1996), Kyowa Hakko Kirin (since 1999, in Japan), Genzyme (since 2009), and Abbott (since 2009), without restrictions on publications.

Dr. Akizawa receives consulting fees from Chugai, Kirin, and Abbott; grants/funds from Chugai and Kirin.

Dr. Kerr is on clinical advisory boards for Amgen, Fresenius, and Baxter.

Inclusion criteria:

Included in the DOPPS studies.

- HD initiated;

Exclusion criteria:

- pre-dialysis SBP <110 mm Hg;

N= 24525

mean SBP mm Hg: 147 ± 24

mean DBP mm Hg: 77 ± 14

Characteristics (confounders and effect modifiers):

None mentioned.

Describe prognostic factor(s) and method of measurement:

Measurement of bloodpressure, both systolic blood pressure (SBP) and diastolic blood pressure (DBP)

Endpoint of follow-up:

Average 21 months.

For how many participants were no complete outcome data available?

N (%):

For missing data, missing indicators were used. In confirmatory

analyses, multiple imputation of missing data was performed using IVEware, and mortality

analyses were repeated using the imputed data.

Outcome measures and effect size:

Only categorical HR presented.

Compared with the reference category 130–139 mm Hg, all-cause mortality was elevated for patients with SBP 110–119 mm Hg (hazard ratio [HR]=1.14, 95% confidence interval [CI]=1.01–1.28, p=0.03)

and 120–129 mm Hg (HR=1.11, 95% CI=1.00–1.23, p=0.04), and lower for patients with SBP 150–159 mm Hg (HR=0.90, 95% CI=0.81–0.99, p=0.03). For patients with SBP ≥160 mm Hg, there was no consistent difference in mortality from the reference category.

Systolic 120–129 mm Hg (HR=1.11, 95% CI=1.00–1.23, p=0.04)

Pan 2012

Type of study:

Systematic Review + meta-analysis.

Setting:

N/A

Country:

N/A

Source of funding:

Not mentioned.

Inclusion criteria:

- initiation of dialysis;

- outcome mortality;

Exclusion criteria:

- not human;

- narrative review;

N= 1.285.747

Mean age ± SD:

Sex: 56% M / 44% F

Describe prognostic factor(s) and method of measurement:

estimated  glomerular  filtration  rate  (eGFR) at initiation of dialysis.

MDRD equation (eGFR = 186 !  (SCr)  –1.154    X  (age)  –0.203    X  (0.742 if female)  X  (1.212 if black)) or the Cockcroft-Gault equation (eGFR = (140 – age)  X  mass  X  (0.85 if female)  X  (72  X  SCr)^-1 ), with correction  for  body  surface  area.  Average  eGFR  was  >  10.97 ml/min/1.73 m2   in patients who started dialysis early  and  was  <  5.98  ml/min/1.73  m2    in  patients  who

started dialysis late.

Early vs. late initiation. Definition differed between studies.

Early: average > 7-10 ml/min/1.73 m 2

Late: < 5-7 ml/min/1.73 m 2

Endpoint of follow-up:

Minimum of two years.

For how many participants were no complete outcome data available?

Not mentioned

Outcome measures and effect size:

Mortality

Early vs. late initiation

OR  1.33;  95%  CI:  1.18–1.49,  p<0,001

Foote 2012

Type of study:

Cohort

Setting:

Database inquiry

Country:

Australia & New Zealand.

Source of funding:

C.F. was supported by a National Health and Medical Research Council (NHMRC) Medical and Dental Postgraduate Scholarship. A.C. was supported by an NHMRC Principal Research Fellowship. V.P. was supported by an Australian Heart Foundation Career Development Award. M.J. and M.G. were supported by Jacquot Research Establishment Awards & Jacquot Research Fellowship Awards respectively. M.J. was also supported by a Royal Australasian College of Physicians Servier Staff Post Doctoral Fellowship.

Inclusion criteria:

- Aged 75 years or over;

- Initiated chronic RRT;

Exclusion criteria:

N=1781

Mean age (IQR): 79 (77-81)

Sex: 62% M / 38% F

Describe prognostic factor(s) and method of measurement:

Age, BMI, Late referral, gender, ethnicity, comorbidity.

Endpoint of follow-up:

Median 28 months

For how many participants were no complete outcome data available?

N=21 (2%):

Outcome measures and effect size (include 95%CI and p-value if available):

Mortality

Age (5yr increment)

HR Crude 1,27 (1,17 – 1,38) p<0,001

HR adjusted 1,24 (1,13 – 1,36) p<0,001

Underweight (< 18,5)

HR Crude 1,56 (1,21 – 2,01) p=0,001

HR adjusted 1,78 (1,33 – 2,38) p<0,001

Other comorbid conditions

HR Crude 1,43 (1,19 – 1,70) p=0,001

HR adjusted 1,38 (1,13 – 1,69) p<0,001.

Not associated:

Gender 1,04 (0,91-1,19)

Ethnicity 1,22 (0,96 – 1,55)

Overweight 0,96 (0,83 – 1,12)

Bao 2012

Type of study:

Prospective cohort

Setting:

Multicentre database

Country:

US

Source of funding:

This work was supported through contracts N01-DK-7-0005 from the National Institute of

Diabetes and Digestive and Kidney Diseases (NIDDK). Dr Bao’s effort was supported by grant No. 69734 from the

Graduate Medical Education funding through the VA and by T32 2T32DK007418-31 from the National Institutes

of Health. Dr Dalrymple’s effort was supported by grant No. UL1 RR024146 from the National Center for

Research Resources. A portion of Dr Johansen’s effort was supported by 1K24DK085153 from the NIDDK.

Inclusion criteria:

- incident patients receiving maintenance dialysis;

- adults;

Exclusion criteria:

-incomplete outcome data

N=1576

Mean age ± SD: 59 ± 14,2

Sex: 55% M / 45% F

Other important characteristics (confounders and effect modifiers):

eGFR: 10 ± 4,45

Describe prognostic factor(s) and method of measurement:

We obtained data on age; sex; race/ethnicity; smoking status; Medicaid coverage at the start of dialysis; comorbid conditions, including the inability to transfer or ambulate; use of erythropoietin; selected laboratory values (serum albumin, creatinine, and haemoglobin levels) within 45 days of dialysis initiation; and whether patients were under the care of a nephrologist before initiation of dialysis from the Medical Evidence Report (CMS form No.

2728)

Frailty definition:

The phenotype of frailty was established using criteria similar to the earlier modification of

Fried’s criteria

Endpoint of follow-up:

Median 2,9 years

For how many participants were no complete outcome data available?

N=102 (9%):

Reasons for incomplete outcome data described?

Outcome measures and effect size:

Mortality

Age per 10yrs

HR adjusted 1,38 (1,27 – 1,50) p<0,001.

Smoking (current)

HR adjusted 1,48 (1,05 – 2,08) p=0,03.

Frailty

HR adjusted 1,57 (1,25 – 1,97) p<0,001.

Albumin (< 2,5 g/dL)

HR adjusted 1,47 (1,01 – 1,15) p=0,03.

Hospitalisation

Age per 10yrs

HR adjusted 1,12 (1,06 – 1,18) p<0,001.

Frailty

HR adjusted 1,26 (1,09 – 1,45) p<0,001.

eGFR

HR adjusted 1,08 (1,01 – 1,15) p=0,03.

Albumin (< 2,5 g/dL)

HR adjusted 1,26 (1,03 – 1,53) p=0,02.

Congestive heart failure

HR adjusted 1,15 (1,00 – 1,31) p=0,04.

Not associated mortality: gender, 1,00 (0,85 – 1,18)

eGFR 1,08 (0,98 – 1,19)

Hb N/A

DM 1,00 (0,83 – 1,20)

Congestive heart failure 1,11 (0,91 – 1,35)

Heart disease 1,19 (0,97 – 1,46)

CVA 0,87 (0,63 – 1,21)

PAV 1,27 (0,97 – 1,55)

COPD 1,32 (0,97 – 1,81)

Cancer 1,04 (0,74 – 1,46)

EPO use (1,02 (0,70 – 1,22)

Not associated hospitalisation:

Gender 0,94 (0.83 – 1.07)

Smoking 1,23 (0.97 – 1.56)

Hb N/A

DM 1.00 (0.89-1.13)

Heart disease 1.05 (0.90 – 1.23)

CVA 1.22 (0.97 – 1.54)

PAV 1.12 (0.95 – 1.32)

COPD 1.00 (0.78- 1.29)

Cancer 1.02 (0.77 – 1.35)

EPO 1.01 (0.87 – 1.17)

Wagner 2011

Type of study:

Prospective cohort

Setting:

Nationwide multicentre

Country:

UK

Source of funding:

Dr Wagner receives funding from the fellowship training program of the National Kidney Foundation

Center for Clinical Practice Guideline Development and Implementation at Tufts Medical Center. Dr Kent is

supported by a grant of the National Institute of Health (NIH/NCRR 1UL1 RR025752). Dr Tangri is supported by the KRESCENT postdoctoral fellowship award, a joint initiative of the Kidney Foundation of Canada, the Canadian

Institute of Health Research and the Canadian Society of Nephrology. The UK Renal Registry is funded by an

annual capitation charge to UK renal units and is independent of industry and government.

Inclusion criteria:

- adults;

- incident dialysis;

Exclusion criteria:

N=3631

Mean age (25^th & 75^th percentile): 64 ( 49-73

Sex: 62% M / 38% F

Describe prognostic factor(s) and method of measurement:

At initiation of dialysis treatment, the UKRR collects information about diabetes, smoking status, and history of CVD according to ischemic heart disease (angina, previous myocardial infarction, coronary artery bypass graft or angioplasty), cerebrovascular disease and peripheral vascular disease (claudication, ischemic or neuropathic ulcers, non coronary angioplasty, vascular graft or aneurysm, amputation for peripheral vascular disease)

Endpoint of follow-up:

36 months

For how many participants were no complete outcome data available?

N (%): not possible to asses

Outcome measures and effect size (include 95%CI and p-value if available):

Mortality (within 3 years)

Age

HR adjusted 1,04 (1,03 – 1,04) Wald X² – 99.3

DM

HR adjusted 1,77 (1,28 – 2,44) Wald X² – 11,8

CVD

HR adjusted 1,56 (1,28 – 1,90) Wald X² – 19,8

Smoking

HR adjusted 1,38 (1,14 – 1,68) Wald X² – 11,1

Hb (> per 1 g/L)

HR adjusted 0,93 (0,89 – 0,98) Wald X² – 8,2

Albumin ( per log   g/L)

HR adjusted 0,14 (0,09 – 0,21) Wald X² – 95,9

SCr ( per 1mg/DL)

HR adjusted 0,96 (0,93 – 0,99) Wald X² – 4,1

calcium ( per log  mg/dL)

HR adjusted 2,72 (1,13 – 6,58) Wald X² – 4,9

Not associated:

Gender 0.95 (0.80-1.12)

Couchoud 2009

Type of study:

Prospective cohort

Setting:

Multicenter database REIN

Country:

France

Source of funding:

Not mentioned

Inclusion criteria:

- aged 75 years or older;

- Started dialysis.

Exclusion criteria:

- Acute renal failure;

N=2500

Mean age ± SD:80,9 ± 4,1

Sex: 61% M / 39% F

Describe prognostic factor(s) and method of measurement:

Baseline information at dialysis initiation included age, gender, primary renal disease, comorbidities, mobility sta-

tus (walks without help, needs assistance for transfers or totally dependent for transfers), body mass index (BMI) and

context of first dialysis.

Endpoint of follow-up:

Median 12 months

For how many participants were no complete outcome data available?

N (%): 17%

Outcome measures and effect size:

Mortality (within 6 months)

BMI ( <18,5 kg/m2)

OR adjusted 1,3 (1,1 – 1,6)

Diabetes

OR adjusted 1,2 (1,1 – 1,3)

Congestive heart failure

OR adjusted 1,3 (1,2 – 1,5)

PAV

OR adjusted 1,3 (1,1 – 1,5)

Dysrhythmia

OR adjusted 1,2 (1,1 – 1,3)

Cancer

OR adjusted 1,3 (1,1 – 1,5)

Severe behavioural disorder

OR adjusted 1,5 (1,2 – 1,8)

Totally dependent for tranfer

OR adjusted 1,7 (1,4 – 2,0)

Not associated:

Gender (male) 1,11 ( 0.91 - 1.25)

Age 1,2 (0.9 – 1.6)

ischeamic heart disease  1.1 (0.9-1.5)

impaired vision 0.9 (0.4-1.9) Haemiplegia or paraplegia 1.5 (0.7-3.1)

Plantinga 2007

Type of study:

Prospective cohort

Setting:

Multicentre

Country:

US

Source of funding:

This work was supported by grant no. RO1 DK 59616 from the National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, grant no. R01-HS-08365 from the Agency for Health Care Research and Quality, Rockville, MD, and grant no. R01 HL 62985 from the National Heart, Lung, and Blood Institute, Bethesda,MD. N.R.P is supported by grant no. K24DK02643 andM.J.K. by grant no. K24 DK02856 from the National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD

Inclusion criteria:

- aged 18 years or older;

- Speaking English or Spanish;

Exclusion criteria:

N=1041

Mean age ± SD: 57,9 ± 15

Describe prognostic factor(s) and method of measurement:

All-cause mortality information was obtained from clinic report, medical records, and data from the Centers for

Medicare & Medicaid Services (CMS; death notification forms and Social Security records), United States Renal

Data System, and the National Death Index.

Endpoint of follow-up:

Mean 37 months

For how many participants were no complete outcome data available?

N (%):

Not mentioned

Outcome measures and effect size:

Survival (4 years)

Age (10 yr increment)

RR adjusted 0,77 (0,66 – 0,91)

Inverse 1,29 (1,10 – 1,51)

Unemployed

RR adjusted 0,48 (0,27 – 0,86)

Inverse 2,08 (1,16 – 3.70)

Decreases albumin (-1 g/dL)

RR adjusted 0,30 (0,20 – 0,45)

Inverse 3.33 (2,22 – 5,00)

Not associated:

Smoking 1,27 (0,97- 1,6)

decreases systolic blood pressure 1,06 (0.98 – 1,16)

Fernandez 2007

Type of study:

Prospective cohort

Setting:

Single center

Country:

Spain

Source of funding:

Not mentioned

Inclusion criteria:

- patients with ESRD;

- incident dialysis patients;

Exclusion criteria:

Not mentioned

N=304

Mean age ± SD: 64 ± 15

Sex: 63% M / 37% F

Other important characteristics (confounders and effect modifiers):

Describe prognostic factor(s) and method of measurement:

The prognostic index was constructed in relation to age and 11 diseases. Diseases were cardiopathy, including ischemic heart disease (IHD) with or without previous his- tory of chronic heart failure (CHF) and CHF without ischemic heart disease; chronic atrial fibrillation (AF); peripheral vascular disease (PVD), including intermittent claudication, aorto-femoral-popliteal surgery, aortic aneurysm or aneurysm surgery, amputation due to arterial ischemia; cerebral vascular disease (CVD) including acute ischemic or hemorrhagic cerebral vascular stroke, or carotid endarterectomy; diabetes mellitus (DM); arterial hypertension (HT) defined as blood pressure >140/90 mm Hg, recorded a mean of 3 times each year in the last 3 years; chronic obstructive pulmonary disease (COPD); chronic hepatopathy (CH), including hepatitis C, hepatitis B, alcoholism, unspecified liver disease, liver transplantation and Caroli’s disease; gastrointestinal disease (GI) including chronic pancreatitis, diverticulosis, malabsorption syndrome and inflammatory bowel disease; neoplasia (N) including solid malignancies, multiple myeloma, lymphomas, leukemias; systemic diseases (S) including systemic lupus erythematosus, vasculitis, amyloidosis,rheumatoid arthritis.

Endpoint of follow-up:

Median follow-up 19 months

For how many participants were no complete outcome data available?

N (%):

Not mentioned

Outcome measures and effect size:

Peripheral vascular diseases

HR adjusted 1,86 (1,03 – 3,37)

Diabetes

HR adjusted 1,72 (1,04 – 3,0)

Malignancy

HR adjusted 3,85 (1,87 – 7,99)

Not associated:

noncontrolled hypertension 1.38 (0.83-2.27)

Chronic atrial fibrillation 1.33 (0.74-2.32)

Chronic pulmonary disease 1.48 (0.80-2.38)

Chronic liver disease 1.83 (0.96-3.57)

Gastrointestinal disease  1.33 (0.65-2.60)

Systemic diseases 1.77 (0.86-2.82)