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Table 5 Evidence profile

From: Peritoneal Dialysis Guidelines 2019 Part 2: Main Text (Position paper of the Japanese Society for Dialysis Therapy)

Certainty assessment

Number of patients

Effect

Certainty

Importance

No. of studies

Study design

Bias risk

Inconsistency

Indirectness

Inaccuracy

Other

Icodextrin dialysis solution

Glucose dialysis solution monotherapy

Relative [95% CI]

Absolute (95% CI)

Overall survival rate (number of deaths due to events)

 10

RCT

Serious a

Not serious

Not serious

Serious b

None

10/592 (1.7%)

14/514 (2.7%)

RR 0.75 [0.33–1.71]

7 patients decreased per 1000 patients (18 patients decreased to 19 patients increased)

Low

Critical

Technical survival (PD continuation period/PD withdrawal)

 5

RCT

Serious a

Not serious

Not serious

Serious c

None

10/239 (4.2%)

17/231 (7.4%)

RR 0.57 [0.29–1.12」

32 patients decreased per 1000 patients (52 patients decreased to 9 patients increased)

Low

Critical

Peritoneal clearance volume (episodes of poor body fluid management)

 4

RCT

Serious a

Not serious

Not serious

Not serious

None

3/129 (2.3%)

12/111 (10.8%)

RR 0.31 [0.12–0.82]

73 patients decreased per 1000 patients (93 patients decreased to 19 patients decreased)

Moderate

Critical

Peritoneal clearance volume (total daily clearance)

 6

RCT

Serious a

Not serious

Not serious

Serious d

None

133

119

-

MD 186.76 mL increase (47.08 mL decrease to- 420.59 mL increase)

Low

Critical

Urine volume

 4

RCT

Serious a

Not serious

Not serious

Serious d

None

75

61

-

MD 106.08 mL increase (173.29 mL decrease to 385.45 mL increase)

Low

Critical

Residual renal function (GFR/CCr)

 5

RCT

Serious a

Not serious

Not serious

Not serious

None

97

84

-

MD 0.56 increase (0.37 decrease to 1.49 increase)

Moderate

Critical

Peritoneal function (creatinine level, etc.) (D/P Cr value)

 2

RCT

Serious a

Serious e

Not serious

Serious f

None

55

50

-

MD 0.00 (0.07 decrease to 0.07 increase)

Very low

Important

Complications (peritonitis)

 8

RCT

Serious a

Not serious

Not serious

Serious b

None

128/551 (23.2%)

108/483 (22.4%)

RR 0.95 [0.79–1.15]

11 patients decreased per 1000 patients (47 patients decreased to 34 patients increased)

Low

Critical

Complications (rash)

 4

RCT

Serious a

Not serious

Not serious

Serious c

None

56/392 (14.3%)

17/334 (5.1%)

RR 1.84 [0.48–7.09]

43 patients increased per 1000 patients (26 patients decreased to 310 patients increased)

Low

Critical

Occurrence rate of impaired glucose tolerance—not reported

-

-

-

-

-

-

-

-

-

-

-

-

Critical

  1. CI, confidence interval; RR, risk ratio; MD: mean difference
  2. a.Many high-risk elements
  3. bWith a 1% difference, selection of the intervention differs, 95% CI straddles the threshold
  4. cWith a 2% difference, selection of the intervention differs, 95% CI straddles the threshold
  5. dWith a 100 mL difference, selection of the intervention differs, 95% CI straddles the threshold
  6. eI2 (degree of inter-study variance) was 65%, meaning that the directionality of effects differs between studies
  7. fWith a 0.05 difference, selection of the intervention differs, 95% CI straddles the threshold