PBM Module 4b Risk-of-bias-tabel

Risk of bias table for intervention studies (randomized controlled trials; based on Cochrane risk of bias tool and suggestions by the CLARITY Group at McMaster University)

Study reference

(first author, publication year)

Was the allocation sequence adequately generated?

Definitely yes
Probably yes
Probably no
Definitely no

Was the allocation adequately concealed?

Definitely yes
Probably yes
Probably no
Definitely no

Blinding: Was knowledge of the allocated interventions adequately prevented?

Were patients blinded?
Were healthcare providers blinded?
Were data collectors blinded?
Were outcome assessors blinded?

Were data analysts blinded?

Definitely yes
Probably yes
Probably no
Definitely no

Was loss to follow-up (missing outcome data) infrequent?

Definitely yes
Probably yes
Probably no
Definitely no

Are reports of the study free of selective outcome reporting?

Definitely yes
Probably yes
Probably no
Definitely no

Was the study apparently free of other problems that could put it at a risk of bias?

Definitely yes
Probably yes
Probably no
Definitely no

Overall risk of bias

If applicable/necessary, per outcome measure

LOW
Some concerns
HIGH

MacIntyre, 2011

Yes

Reason: Computer randomization at hospital level

No information

Reason: no information provided

Definitely no

Reason: Healthcare workers were not blinded, no information on outcome assessors

No information

Reason: no information was provided on loss to follow up (no loss to follow up was reported)

Probably yes

Reason: relevant outcomes were reported

Definitely no

Reason: There was a significant difference between the fit tested and non-fit tested group in influenza vaccination status

HIGH (infection)

Reason: high concerns regarding blinding and influenza vaccination status difference between groups