Desinfectie huid en slijmvliezen Module 1.2 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

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
P
robably yes
Probably no
Definitely no

Was the study apparently free of another 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

 

Martinez, 2017

Definitely yes

Reason:
use of sealed, shuffled cards from which a card was randomly selected

Definitely yes

Reason:
use of sealed, shuffled cards

Probably yes

Reason:
- Patients: not relevant for the outcome blood culture contamination
- Healthcare workers: probably not blinded (could possibly recognize disinfectants by color, smell)
- Outcome assessor blinded

No information

Reason:
not reported

Definitely yes

Reason:
all relevant outcomes were reported

Definitely yes

Reason:
no another problems

SOME Concerns

Reason:
healthcare workers probably not blinded, loss to follow up not reported

 

Story-Roller, 2016

Probably no

Reason:
unclear

Probably no

Reason:
unclear

Definitely no

Reason:
Patients: not relevant for the outcome blood culture contamination
- Healthcare workers not blinded (disinfectants are recognized by color)
- Outcome assessor not blinded

No information

Reason:
not reported

Definitely yes

Reason:
all relevant outcomes were reported

Definitely yes

Reason:
Information about order- and carry-over effect not reported

HIGH

Reason:
randomisation proces unclear, no blinding, loss to follow up not reported

Washer, 2013

Definitely yes

Reason:
sequence was randomly assigned via computer

Definitely yes

Reason:
computer generated and concealed from clinical investigators.

Probably yes

Reason:
- Patients: not relevant for the outcome blood culture contamination
- Healthcare workers not blinded (different method for different antiseptic agents, color);
- Outcome assessors: blinded

No information

Reason:
not reported

Definitely yes

Reason:
all relevant outcomes were reported

Probably yes

Reason:
25 cultures from 16 patients with iodine allergy may have been included in the analysis even though they did not undergo all interventions

SOME Concerns

Reason:
due to another problem mentioned, loss to follow up not reported

Suwanpimolkul, 2008

Probably yes

Reason:
computer generated in blocks of four and stratified by unit. For ER, alternate 1-week schedule

 

Definitely yes

Reason:
computer generated

Probably yes

Reason:
- Patients: not relevant for the outcome blood culture contamination
- Healthcare workers not blinded (disinfectants are recognized by color)
- Outcome assessor blinded

No information

Reason:
not reported

Definitely yes

Reason:
all relevant outcomes were reported

Probably yes

Reason:
No contamination rates reported per medical ward, no distinction between medical wards and ICUs

SOME Concerns

Reason:
allocation sequence, healthcare workers not blinded, another problem mentioned, loss to follow up not reported

Calfee, 2002

Probably no

Reason:
initially, groups were formed based on geographic location and subspecialty of hospital units. Allocation sequences unclear

Probably no

Reason: concealment of allocation sequences not reported

Probably yes

Reason:
- Patients: not relevant for the outcome blood culture contamination
- Healthcare workers not blinded (1 of 4 disinfectant was recognized by color anyway)
- Outcome assessor blinded

Probably yes

Reason:
there was loss to follow up, distribution among groups not reported

Definitely yes

Reason:
all relevant outcomes were reported

Probably yes

Reason:
information about order- and carry-over effect not reported. No contamination rates reported per units, only distinction between the groups which was based on geographic location and subspecialty

HIGH

Reason:
randomisation process unclear, blinding healthcare workers, distribution in loss to follow up not reported, another problem mentioned

Mimoz, 1999

Definitely yes

Reason:
computer generated by block randomization of four and stratified by unit

 

Definitely yes

Reason:
computer randomization

Probably yes

Reason:
- Patients: not relevant for the outcome blood culture contamination
- Healthcare workers not blinded (disinfectants are recognized by color)
 -Outcome assessor blinded

No information

Reason:
not reported

Definitely yes

Reason:
all relevant outcomes were reported

Definitely yes

Reason:
no another problems

SOME Concerns

Reason:
healthcare workers not blinded, loss to follow up not reported

Little, 1999

Definitely yes

Reason:
computer generated by block randomization

Definitely yes

Reason:
computer randomization and opaque envelopes

Probably yes

Reason:
- Patients: not relevant for the outcome blood culture contamination
- Healthcare workers could probably recognize disinfectant by smell (disinfectant with or without alcohol)
- Outcome assessor blinded

No information

Reason:
not reported

Definitely yes

Reason:
all relevant outcomes were reported

Definitely no

Reason:
difference in contamination rates between ER and ICU not reported

SOME Concerns

Reason:
due to another problem mentioned