Diagnosis and Management of Infantile Hemangioma

Infantile Hemangioma CER: Risk of Bias for RCTs Form
Reviewer Initials: _____ Ref ID: __________
Risk of
Bias
Selection
bias
Performa
nce bias
Attrition
bias
Detection
bias
Criterion Yes No Unclear COMMENTS
Was the allocation sequence generated adequately (e.g., random number table,
computer-generated randomization)?
Was the allocation of treatment adequately concealed (e.g., pharmacycontrolled
randomization or use of sequentially numbered sealed envelopes)?
Were participants analyzed within the groups they were originally assigned to?
Does the design or analysis control account for important confounding and
modifying variables through matching, stratification, multivariable analysis, or
other approaches?
Did researchers rule out any impact from a concurrent intervention or an
unintended exposure that might bias results?
Did the study maintain fidelity to the intervention protocol?
If attrition (overall or differential nonresponse, dropout, loss to follow-up, or
exclusion of participants) was a concern, were missing data handled
appropriately (e.g., intention-to-treat analysis and imputation)?
Was the length of follow-up different between the groups?
Were the outcome assessors blinded to the intervention or exposure status of
participants?
Reporting
bias
Other
Were interventions/exposures assessed/defined using clearly defined measures,
implemented consistently across all study participants?
Were outcomes assessed using clearly defined measures, implemented
consistently across all study participants?
Were the potential outcomes prespecified by the researchers?
Are all prespecified outcomes reported?
List outcomes of interest assessed:
______________________________________________________________
Would answers to any of these questions vary by the specific outcome
assessed? If yes, please explain in Comments box.
OUTCOMES OF INTEREST FOR REVIEW
Imaging: Ability to identify presence, number, and extent of hemangiomas and associated structural anomalies (sensitivity and specificity)
Treatment: Size / volume of hemangioma; Impact on vision; Aesthetic appearance as assessed by clinician or parent; Degree of ulceration; Quality of life
B-7