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Domain
Support for judgement
Selection bias.
Random sequence
Describe the method used to
generation.
generate the allocation
sequence
in sufficient detail to allow an
assessment of whether it should
produce comparable groups.
Allocation
Describe the method used to
concealment.
conceal the allocation sequence
in sufficient
detail
to
determine
whether intervention
allocations
could have been foreseen in
advance of,
or during,
enrolment.
Performance bias.
Blinding of
Describe all measures used, if
participants and
any, to blind study participants
personnel
and personnel from knowledge of
Assessments
which intervention
a participant
should be madefor
received. Provide any
each main outcome
information relating to whether
(or class of
the intended blinding was
outcomes).
effective.
Detection bias.
Blinding of
Describe all measures used, if
outcome
any, to blind outcome assessors
assessment
from knowledge of which
Assessments
intervention a participant
should be madefor
received. Provide any
each main outcome
information relating to whether
(or class of
the intended blinding was
outcomes) .
effective.
Attrition bias.
Incomplete
Describe the completeness of
outcome data
outcome data for each main
Assessments
outcome, including
attrition
and
should be madefor
exclusions from the analysis.
each main outcome
State whether attrition and
(or class of
exclusions were reported, the
outcomes).
numbers in each intervention
group (compared with total
randomized participants),
Review authors ’ judgement
Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence.
Selection bias (biased
allocation to
interventions) due to
inadequate concealment
of allocations prior to
assignment.
Performance bias due to knowledge of the allocated interventions by participants and personnel during the study.
Detection bias due to knowledge of the allocated interventions by outcome assessors.
Attrition bias due to amount, nature or handling of incompl
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