Items | Criteria | Bale (2019) | Hsieh (2018) | Revivo (2018) | Pacey (2013) | Kemp (2010) | Scheper (2017) |
---|---|---|---|---|---|---|---|
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 |