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Diagnosis and Management of Infantile Hemangioma

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Grey Literature<br />

In response to 21 requests for Scientific Information Packets, we received four documents,<br />

all <strong>of</strong> which addressed medications (becaplermin gel, recombinant interferon alfa-2b) that were<br />

not evaluated in studies meeting our criteria. The documents yielded no citations <strong>of</strong> relevance for<br />

this review, <strong>and</strong> the documents themselves did not meet criteria for inclusion in the review (one<br />

case series <strong>of</strong> 8 individuals, one addendum to an article, two files <strong>of</strong> prescribing information).<br />

Our search <strong>of</strong> ClinicalTrials.gov did not yield any results not identified in our other searches,<br />

<strong>and</strong> our searches <strong>of</strong> the web sites <strong>of</strong> relevant organizations yielded background information for<br />

informing our contextual questions.<br />

Key Question 1. Effectiveness <strong>and</strong> Harms <strong>of</strong> Imaging<br />

Modalities<br />

Key Points<br />

• Strength <strong>of</strong> the evidence (SOE) for the effectiveness <strong>of</strong> imaging for IH was insufficient<br />

given few studies assessing varied outcomes.<br />

• Studies assessed IH in different anatomic locations <strong>and</strong> reported differing findings for the<br />

sensitivity <strong>of</strong> ultrasound <strong>and</strong> effectiveness <strong>of</strong> imaging modalities depending on location<br />

or subtype.<br />

Overview <strong>of</strong> the Literature<br />

Two poor quality diagnostic accuracy studies—one prospective 68 <strong>and</strong> one retrospective 70 —<br />

addressed imaging modalities. Both studies were conducted in tertiary care settings with care<br />

settings in the United States, Canada, <strong>and</strong> Spain. One study enrolled patients from nine centers<br />

<strong>and</strong> included patients less than18 years old with IH in the lumbosacral area measuring greater<br />

than 2.5 cm. 68 The retrospective cohort study reported chart review data from two tertiary care<br />

centers <strong>and</strong> included 55 patients (mean age <strong>of</strong> 30 days) with liver IH. 70<br />

Overall, studies were limited by the size <strong>of</strong> cohorts, lack <strong>of</strong> st<strong>and</strong>ard processes, <strong>and</strong> lack <strong>of</strong><br />

direct comparison at the same time point using the various imaging modalities. We considered<br />

the SOE for all imaging modalities to be insufficient given single, small studies addressing<br />

different approaches, using weaker study designs <strong>and</strong> precluding a meta-analysis. The studies did<br />

not address harms.<br />

Detailed Analysis<br />

In one prospective cohort study, seven out <strong>of</strong> 26 (26.9%) children who underwent ultrasound<br />

had an abnormality compared with 21 <strong>of</strong> the 41 (51.2%) patients who received MRI <strong>and</strong> were<br />

noted to have a spinal abnormality. 68 Nineteen <strong>of</strong> these patients underwent both ultrasound <strong>and</strong><br />

MRI. In five cases ultrasound did not reveal an abnormality later found on MRI. Agreement<br />

between ultrasound <strong>and</strong> MRI was 0.27 (95% CI: -0.15 to 0.7, p=0.21), which was consistent with<br />

chance. Ultrasound had a sensitivity <strong>of</strong> 50 percent (95% CI: 18.7% to 81.3%) <strong>and</strong> specificity <strong>of</strong><br />

77.8 percent (95% CI: 40% to 97.2%) for identifying anomalies including tethered cords <strong>and</strong><br />

intraspinal IH. We calculated the sensitivity <strong>of</strong> both modalities for identifying intraspinal IH<br />

specifically: assuming a false positive value <strong>of</strong> 0, ultrasound, which missed 4 intraspinal IH in 26<br />

21

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