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Willingness to Participate in Atopic Dermatitis Research Studies and Clinical Trials.

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Initial query of the GREAT database yielded 164 studies, 40 of which met inclusion criteria (Table 1). Included studies were geographically diverse, located in Europe (57.5%), North America (25%), Asia… Click to show full abstract

Initial query of the GREAT database yielded 164 studies, 40 of which met inclusion criteria (Table 1). Included studies were geographically diverse, located in Europe (57.5%), North America (25%), Asia (5%), Africa (2.5%), and transcontinentally (10%), and encompassed adult (42.5%), pediatric (37.5%), and combined (20%) populations. A total of 34 unique instruments were identified from the 40 included studies, with the following 3 instruments found in 1 or more studies: Patient Global Assessment (n = 3), Patient's Self-assessment (n = 2), and Patient's Assessment of Global Response (n = 4). The PtGA was reported as a secondary outcome in 100% of studies. Just more than half (52.5%) of PtGAs were static (Table 2). The scale used for patient responses varied greatly between studies. Many used a point-based format in which numerical values correlated with response options, ranging from 4 (37.5%) to 9 points (2.5%). Others were based on a 100-mm visual analog scale (10%). A distinguishing feature between PtGAs was a clear/no disease option, with 32.5% including a clear option, 47.5% without a clear option, and 20% without sufficient data (Table 2). This systematic review revealed significant heterogeneity of PtGA instruments used in AD studies. Key defining features between PtGAs were the inclusion of clear option and whether the instrument was static or dynamic. Levels of severity and recall periods also varied. Further work is needed in developing, standardizing, and validating a PtGA for AD for use in clinical practice.

Keywords: clear option; willingness participate; participate atopic; atopic dermatitis; option; dermatitis

Journal Title: Dermatitis
Year Published: 2019

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