REPORTING
|
1
|
Study hypothesis/aim/objective clearly described
|
1
|
1
|
1
|
1
|
1
|
0
|
2
|
Main outcomes in Introduction or Methods section
|
1
|
1
|
1
|
1
|
1
|
1
|
3
|
Patient characteristics clearly described
|
1
|
1
|
1
|
1
|
1
|
1
|
4
|
Relevant interventions including controls clearly described
|
1
|
1
|
1
|
1
|
1
|
NA
|
5
|
Distributions of principal confounders clearly described
|
0
|
0
|
1
|
0
|
0
|
2
|
6
|
Main findings (including outcomes) clearly described
|
1
|
1
|
1
|
1
|
1
|
1
|
7
|
Estimates of random variability in data for the main outcomes provided
|
1
|
1
|
1
|
1
|
1
|
1
|
8
|
All important adverse events related to intervention(s) reported
|
0
|
0
|
0
|
1
|
0
|
NA
|
9
|
Patient characteristics lost to follow-up described
|
1
|
1
|
1
|
1
|
0
|
0
|
10
|
Actual probability values for main outcomes reported
|
1
|
1
|
1
|
1
|
1
|
1
|
EXTERNAL VALIDITY
|
11
|
Subjects asked to participate were representative of target populations
|
1
|
1
|
1
|
1
|
1
|
1
|
12
|
Subjects prepared to participate were representative of target populations
|
1
|
1
|
1
|
1
|
1
|
1
|
13
|
Treatment facilities and delivery were representative of target populations
|
1
|
1
|
1
|
1
|
1
|
1
|
INTERNAL VALIDITY – bias
|
14
|
Study participants blinded to intervention administered
|
0
|
0
|
0
|
1
|
0
|
NA
|
15
|
Investigators blinded to assessment of main intervention outcomes
|
1
|
1
|
0
|
1
|
1
|
NA
|
16
|
Any data dredging was made clear at onset of study
|
0
|
0
|
1
|
1
|
1
|
0
|
17
|
Analyses adjust for different lengths of follow-up of participants
|
1
|
0
|
1
|
1
|
0
|
1
|
18
|
Statistical tests to assess the main outcomes were appropriate
|
1
|
1
|
1
|
1
|
1
|
1
|
19
|
Reliability of compliance with intervention(s)
|
1
|
1
|
1
|
1
|
0
|
NA
|
20
|
Main outcome measures used accurate in terms of validity and reliability.
|
1
|
1
|
1
|
1
|
1
|
1
|
INTERNAL VALIDITY - confounding (selection bias)
|
21
|
All participants were recruited from the same target population
|
1
|
1
|
1
|
1
|
1
|
1
|
22
|
All participants were recruited over the same period of time
|
1
|
1
|
0
|
1
|
1
|
1
|
23
|
Participants were randomised to intervention group(s)
|
1
|
1
|
0
|
1
|
1
|
NA
|
24
|
Randomised intervention assignment was concealed from both participants and investigators
|
0
|
0
|
0
|
1
|
0
|
NA
|
25
|
Adequate adjustment for confounding
|
0
|
0
|
0
|
0
|
0
|
1
|
26
|
Lost to follow-up considered
|
1
|
0
|
1
|
1
|
0
|
0
|
27
|
Statistical power- clinical meaningful effect or power calculation reported b
|
1~
|
1
|
1
|
1
|
1
|
1
|