Study |
Bias |
Randomisation process |
Deviations from intended interventions |
Missing outcome data |
Measurement of the outcome |
Selection of the reported results |
Overall |
Authors' judgement |
Support for judgement |
Authors' judgement |
Support for judgement |
Authors' judgement |
Support for judgement |
Authors' judgement |
Support for judgement |
Authors' judgement |
Support for judgement |
Authors' judgement |
Support for judgement |
Hill 2006 |
Some concerns |
No information about allocation concealment. |
Low risk of bias |
All participants were analysed according to their initial allocation. |
Low risk of bias |
The data of only two participants (5%) were missing. |
Low risk of bias |
Outcome assessors were blinded. |
Low risk of bias |
Only the journal article is avaible. |
Some concerns |
Lack of details about allocation concealment, and only the journal article is available. |
Koppers 2006 |
Some concerns |
Randomisation was reported only as a sentence, the two groups had similar baseline characteristics. |
Low risk of bias |
All participants were analysed according to their initial allocation. |
Low risk of bias |
7% of the data are missing (3 participants out of 39). |
Low risk of bias |
Observer reported outcome that do not involve judgements. |
Some concerns |
Only the journal article is available. |
Some concerns |
Lack of details about the randomisation process and only the journal article is available. |
Larson 1999 |
Some concerns |
Randomisation was reported only as a sentence. |
High risk of bias |
59% of the participants were excluded. |
High risk of bias |
Missingness is likely to be dependent on its true value. |
Low risk of bias |
Observer reported outcome that do not involve judgement. |
Some concerns |
Only the journal article is available. |
High risk of bias |
Lack of details about the randomisation process, and only the trial register is available. There is some concern with ITT and missingness is likely to be dependant on the outcome. |
Lisboa 1997 |
Some concerns |
Randomisation was reported only as a sentence, and the two groups had similar baseline characteristics. |
Low risk of bias |
All participants were analysed according to their initial allocation. |
Low risk of bias |
No missing data. |
Low risk of bias |
Outcome assessors were blinded. |
Some concerns |
Only the journal article is available. |
Some concerns |
Lack of details about allocation concealment and only the journal article is available. |
Ramirez Sarmiento 2002 |
Some concerns |
Randomisation was reported only as a sentence, and no differences between the groups at visual inspection. |
High risk of bias |
serious concern with ITT analysis. |
Low risk of bias |
Missingness is independent on its true value. |
Low risk of bias |
Observer reported outcome that do not involve judgement. |
Some concerns |
Only the journal article is available. |
High risk of bias |
Lack of details about the randomisation process, only the journal article is available and ITT analysis was not conducted appropriately. |
Sanchez Riera 2001 |
Some concerns |
Randomisation was reported only as a sentence, and baseline characteristics were similar between the groups. |
Low risk of bias |
All participants were analysed according to their initial allocation. |
Low risk of bias |
No missing data. |
Low risk of bias |
Outcome assessors were blinded. |
Some concerns |
Only the journal article is available. |
Some concerns |
Lack of details about the randomisation process and only the journal article is available. |
Wu 2017 |
Some concerns |
Randomisation was reported only as a sentence, and both groups had similar baseline characteristics. |
Low risk of bias |
All participants were analysed according to their initial allocation. |
Low risk of bias |
No missing data. |
Low risk of bias |
Observer‐reported outcome that do not involves judgements. |
Some concerns |
Some differences between the trial register and the journal article in blinding. |
Some concerns |
Lack of details about the randomisation process and there are differences in reporting blinding between the trial register and journal article. |
Wu 2017 |
Some concerns |
Randomisation was reported only as a sentence, and both groups had similar baseline characteristics. |
Low risk of bias |
All participants were analysed according to their initial allocation. |
Low risk of bias |
No missing data. |
Low risk of bias |
Observer‐reported outcome that do not involves judgements. |
Some concerns |
Some differences between the trial register and the journal article in blinding. |
Some concerns |
Lack of details about the randomisation process and there are differences in reporting blinding between the trial register and journal article. |