1

Appendix 3 – Bias risk (Cochrane)

Author and Year Question Judgment support Bias Risk

Insufficient information about the random sequence

Random sequence generation UNCLEAR
generation process to allow judgment.

Insufficient information about the random sequence

Allocation concealment UNCLEAR
generation process to allow judgment

Blinding of participants and Blinding of participants and professionals ensured, and it is LOW
Herkenrath et al. professionals unlikely that blinding has been broken.
2017
Blinding of the outcome assessment was performed, LOW
Blinding of outcome assessors
and it is unlikely that the blinding was broken.

Data loss was balanced across groups, with similar LOW

Incomplete outcomes
reasons for data loss across groups;

The study protocol is available and all pre-specified primary and

Selective outcome report secondary outcomes that are of interest LOW

to the review have been reported as proposed;

Insufficient information about the random sequence

Random sequence generation
Kuo et al., 2017
Allocation concealment
UNCLEAR
generation process to allow judgment
Insufficient information about the random sequence
UNCLEAR
generation process to allow judgment
 2

Blinding of participants and Blinding of participants and professionals ensured,

LOW
professionals and it is unlikely that blinding has been broken.

Blinding of outcome assessors The study does not report this information. UNCLEAR

Incomplete outcomes There was no loss of outcome data; LOW

The study protocol is not available, but it is clear that LOW

Selective outcome report
the published study included all the desired

outcomes.

Geração da sequência aleatória Raffle LOW

Insufficient information about the random sequence UNCLEAR

Ocultação de alocação
generation process to allow judgment

Cegamento de participantes e The study does not report this information. UNCLEAR

Lin et al, 2019 profissionais

Cegamento de avaliadores de The study does not report this information. UNCLEAR

desfecho

Desfechos incompletos There was no loss of outcome data; LOW

The study protocol is available and all pre-specified LOW

Relato de desfecho seletivo primary and secondary outcomes that are of interest to the review have

been reported as proposed;

Random sequence generation Computer random number generation; LOW

Puhan et al., 2006
Any other procedure that does not hide the
Allocation concealment HIGH
allocation.
 3

Unblinded study or incomplete blinding, and the

Blinding of participants and HIGH
outcome is likely to be influenced by the lack of blinding;
professionals

Blinding of the outcome assessment was performed, LOW

Blinding of outcome assessors
and it is unlikely that the blinding was broken.

Incomplete outcomes There was no loss of outcome data; LOW

The study protocol is available and all pre-specified LOW

Selective outcome report primary and secondary outcomes that are of interest to the review

have been reported as proposed;

Random sequence generation Computer random number generation; LOW

Allocation concealment Sequential numbered opaque and sealed envelopes. LOW

Blinding of participants and Blinding of the outcome assessment was performed, LOW

professionals and it is unlikely that the blinding was broken.

Souza et al., 2018 Blinding of the outcome assessment was performed, LOW
Blinding of outcome assessors
and it is unlikely that the blinding was broken.

Incomplete outcomes There was no loss of outcome data; LOW

The study protocol is available and all pre-specified LOW

Selective outcome report primary and secondary outcomes that are of interest to the review

have been reported as proposed;

Vranish et al., Insufficient information about the random sequence UNCLEAR

Random sequence generation
2016 generation process to allow judgment
 4

Insufficient information about the random sequence UNCLEAR

Allocation concealment
generation process to allow judgment

Unblinded study or incomplete blinding, but review

Blinding of participants and LOW
authors believe that the outcome does not change due to lack of
professionals
blinding

Insufficient information to judge as high risk and low

Blinding of outcome assessors UNCLEAR
risk of bias;

Incomplete outcomes There was no loss of outcome data; LOW

The study protocol is not available, but it is clear that

LOW
Selective outcome report the published study included all of the desired outcomes