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Table 4 Methodological characteristics of test-treatment trials

From: Test-treatment RCTs are susceptible to bias: a review of the methodological quality of randomized trials that evaluate diagnostic tests

Trial Quality Item

Trials, n

(%)

Randomized sequence allocation

 Adequate

59

(57)

 Inadequate

2

(2)

 Unclear

42

(41)

Allocation concealment

 Adequate

38

(37)

 Inadequate

3

(3)

 Unclear

62

(60)

Blinding

 Patients

5

(5)

 Care-providers

4

(4)

 Outcome assessors

22

(21)

  aSingle-blind

20

(19)

  bDouble-blind

5

(5)

 No blinding

78

(76)

Reporting of primary outcome assessment

 Complete

53

(51)

 Partial

33

(32)

 Absent

17

(17)

Reporting of participant flow

 Complete

44

(43)

 Partial

58

(56)

 Absent

1

(1)

Missing data

 Complete

41

(40)

 Attrition ≤10%

30

(29)

 Attrition >10%

25

(24)

 Incomplete, cannot calculate

4

(4)

 Unclear if complete

3

(3)

Differential attrition

 ≥ 5% between arms

16

(16)

 ≥ 20% between arms

1

(1)

Intention-to-treat (ITT)

 Patients analyzed as randomized

72

(70)

 Complete or imputed data and analyzed as randomized

30

(29)

 Not conducted

31

(30)

Inconsistent outcome assessment

21

(20)

Inappropriate subgroup analysis

9

(9)

Sample size

 Power calculation reported

81

(79)

  cMedian trial sample size [IQR]

309

[153–731]

  cMedian study arm sample size [IQR]

166

[72–297]

  1. ablinding either patients or care-providers or outcome assessors; bblinding at least two of: patients, care-providers or outcome assessors; cbased on numbers randomized in all 103 trials