CLINICAL IMPLICATION S Only SCORAD , EASI , and POEM currently perform adequately .
BACKGROUND Valid and reliable outcome measurements are a prerequisite for evidence -based practice .
The comparative validity and reliability of outcome measurements for assessing atopic eczema ( AE ) severity is unclear .
OBJECTIVE We sought to assess the validity , reliability , sensitivity to change , and ease of use of outcome measurements for AE .
We also sought to give recommendations on which outcomes to use in clinical research and for clinical monitoring .
Tacrolimus Ointment 0.03% Is Safe and Effective for the Treatment of Mild to Moderate Atopic Dermatitis in Pediatric Patients: Results From a Randomized, Double-Blind, Vehicle-Controlled Study
Objective . This study was design ed to compare the safety and efficacy of tacrolimus ointment 0.03 % with vehicle ointment for the treatment of mild to moderate atopic dermatitis ( AD ) in pediatric patients . Methods . A total of 317 patients ( 2–15 years of age ) with mild to moderate AD were r and omized to receive tacrolimus ointment or vehicle ointment twice daily in a 6-week , multicenter , double-blind study . Efficacy evaluations , including the Investigators ' Global Atopic Dermatitis Assessment , eczema area and severity index , percentage of total body surface area affected , and patient assessment of itch occurred at baseline , day 4 , and weeks 2 , 4 , and 6 . Cutaneous adverse events were recorded to evaluate safety . Results . At the end of study , 50.6 % ( 80 of 158 ) of the patients were treated successfully with tacrolimus ointment based on Investigators ' Global Atopic Dermatitis Assessment scores , a significant improvement compared with patients treated with vehicle ointment ( 25.8 % [ 41 of 159 ] ) . The percent improvement from baseline in eczema area and severity index scores was also significantly greater in tacrolimus-treated patients ( 54.8 % ) compared with vehicle-treated patients ( 20.8 % ) . There was also a significant improvement in the percentage of total body surface area affected of tacrolimus-treated patients ( 50.5 % reduction from baseline ) compared with vehicle-treated patients ( 16.4 % ) . Patient itch scores were significantly lower in tacrolimus-treated patients ( 2.1 ) versus vehicle-treated patients ( 3.7 ) . Overall , the incidence of cutaneous adverse events reported was similar for both treatment groups . There was no significant difference in the incidence of burning or stinging between treatment groups . Significantly fewer tacrolimus-treated patients prematurely discontinued from the study because of a cutaneous adverse event in the treatment area or experienced increased itching and erythema at the application site . Conclusion . Monotherapy with tacrolimus ointment 0.03 % is a safe and effective treatment alternative for pediatric patients with mild to moderate AD
CLINICAL IMPLICATION S Only SCORAD , EASI , and POEM currently perform adequately .
BACKGROUND Valid and reliable outcome measurements are a prerequisite for evidence -based practice .
The comparative validity and reliability of outcome measurements for assessing atopic eczema ( AE ) severity is unclear .
OBJECTIVE We sought to assess the validity , reliability , sensitivity to change , and ease of use of outcome measurements for AE .
We also sought to give recommendations on which outcomes to use in clinical research and for clinical monitoring .