Diagnosis and Management of Infantile Hemangioma

Table 39. Strength of evidence for harms of laser modalities
Outcome
Intervention
PDL
Study Design
Quality and Number of
Studies (N Total)
Pigmentation changes
RCT: 1 good, 1 poor 211,212
(173)
Study
Limitations
Consistency Directness Precision
Reporting
Bias
Finding
Strength of Evidence Grade
Low Consistent Direct Precise Undetected Hypo- or hyper-pigmentation
consistently reported, with
hypopigmentation reported more
frequently.
Cohort studies: 1 good, 1
poor 213,215 (73)
Case series: 1 fair, 4
poor 221,224,225,228,230 (1017)
Bleeding
RCT: 1 good 212 (121)
Pain
RCT: 1 good 212 (121)
Scarring
Cohort studies: 1 good 215
(50)
Case series: 2 fair, 1
poor 227,228,230 (769)
Moderate SOE for association of
PDL with skin pigmentation
complications based on relatively
few participants in studies.
Low Unknown Direct Imprecise Undetected No significant difference in
bleeding between short pulse
PDL and observation groups.
Low SOE for association of
bleeding with PDL based on one
study with low limitations,
unknown consistency, and
imprecision.
Low Unknown Indirect Imprecise Undetected 13% of parents reported pain for
their children after PDL.
Insufficient SOE for pain
following PDL given few
occurrences of outcome. Pain is
also difficult to assess in infant
population.
Medium Inconsistent Direct Imprecise NA 1/25 children receiving PDL in
one study 7/769 children in case
series had scarring.
Insufficient SOE due to few
occurrences of the outcome
reported in studies.
98