A significant obstacle in guiding evidence-based management of bullous pemphigoid (BP) is the lack of a standardised, validated scoring system for the condition. The aim of this study is to evaluate the suitability of the Bullous Pemphigoid Disease Area Index (BPDAI) and the Autoimmune Bullous Skin disorder Intensity Score (ABSIS) as outcome measures for BP in clinical trials. Thirty-two BP patients were repeatedly assessed over four years using Physician Global Assessment (PGA), anti-BP180 ELISA titres, BPDAI, ABSIS, BPDAI-Pruritus, Autoimmune Bullous Disease Quality of Life (ABQOL) and Treatment of Autoimmune Bullous Disease Quality of Life (TABQOL) questionnaires. The reliability, validity, responsiveness, and minimal clinically important differences (MCIDs) were calculated. For inter-rater reliability, the intraclass correlation coefficients (95% CI) were: BPDAI 0.957 (0.901-0.982) and ABSIS 0.881 (0.736-0.949). Compared to ABSIS, BPDAI was better correlated with PGA(r = 0.875, p < 0.001), BPDAI-Pruritus (r=0.632, p = 0.004), ABQOL (r = 0.521, p = 0.011) and TABQOL (r=0.538, p = 0.008). MCIDs for BPDAI were 4-points for assessing clinical improvement and 3-points for deterioration. ABSIS demonstrated less responsiveness with MCIDs at 8.6-points for improvement and 4-points for deterioration. These results indicate that BPDAI demonstrated excellent reliability, validity and responsiveness, while ABSIS had moderate to good reliability, validity and responsiveness.
BackgroundOutcome measures for atopic dermatitis (AD) patients with pigmented skin have neither been developed nor validated.ObjectiveTo compare the reliability and validity of four common AD outcome measures in patients with various levels of skin darkness.MethodThe inter- and intra-rater reliability and construct validity of the EASI (Eczema Area and Severity Index), objective-SCORing Atopic Dermatitis (oSCORAD), Three Items Severity index (TIS) and Six Areas, Six Sites Atopic Dermatitis (SASSAD) were evaluated in 18 patients of various levels of skin darkness, using their full body photographs, by five trained clinicians.ResultsThe inter-rater reliability intraclass coefficient (ICCs) and 95% confidence intervals were poor for highly pigmented patients: EASI -.054(-.200 to .657), oSCORAD -.089(-.206 to .598), TIS -.21(-.24 to .147), SASSAD -.071(-.200 to .631); fair for mildly pigmented patients: EASI .464(.140-.839), oSCORAD .588(.265-.89), TIS.524(.200-.865), SASSAD .41(.045-.775); and fair to good for non-pigmented patients: EASI .64(.330-.908), oSCORAD .586(.263-.889), TIS .403(.09-.809), SASSAD .667(.358-.916). Erythema likely contributed to the inter-rater variability. Construct validity had significant correlations across all measures in non-pigmented patients, but no correlations in highly pigmented patients.ConclusionAD outcome measures have poor reliability and validity in highly pigmented patients, with variations in erythema perception being a contributor.
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