Patient selection |
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A: Were the eligibility criteria specified |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
B1: Was a method of randomization performed |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
B2: Was the treatment allocation concealed |
Yes |
Yes |
Yes |
No |
No |
No |
No |
C: Were the groups similar at baseline regarding the most important prognostic indicators |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
Intervention |
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|
|
|
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D: Were the index and control interventions explicitly described |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
E: Was the care provider blinded to the intervention |
No |
No |
No |
No |
No |
No |
No |
F: Were co-interventions avoided or comparable |
Yes |
No |
No |
Yes |
No |
Yes |
Yes |
G: Was the compliance acceptable in all groups |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
H: Was the patient blinded to intervention |
No |
No |
Yes |
No |
No |
No |
No |
Outcome measurement |
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|
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I: Was the outcome assessor blinded to the intervention |
Yes |
Yes |
Yes |
No |
No |
Yes |
Yes |
J: Were the outcome measures relevant |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
K: Were adverse effects described |
Yes |
Yes |
No |
No |
No |
No |
No |
L: Was the withdrawal/drop-out rate described and acceptable |
Yes |
Yes |
Yes |
Yes |
No |
Yes |
Yes |
M1: Was a short-term follow-up measurement performed |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
M2: Was a long-term follow-up measurement performed |
No |
Yes |
No |
No |
No |
No |
Yes |
N: Was the timing of the outcome measurement in both groups comparable |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
Statistics |
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|
|
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O: Was the sample size for each group described |
Yes |
Yes |
No |
Yes |
Yes |
No |
No |
P: Did the analysis include an intention-to-treat analysis |
Yes |
Yes |
No |
No |
No |
No |
No |
Q: Were point estimates and measures of variability presented for the primary outcome measures |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
No |
Total quality score |
16/19 |
16/19 |
13/19 |
12/19 |
10/19 |
12/19 |
12/19 |
|
(84%) |
(84%) |
(68%) |
(63%) |
(53%) |
(63%) |
(63%) |