Olivry Thierry, Mueller Ralf, Nuttall Tim, Favrot Claude, Prélaud Pascal
Department of Clinical Sciences and Center for Comparative Medicine and Translational Research, College of Veterinary Medicine, North Carolina State University, Raleigh, North Carolina, USA.
Vet Dermatol. 2008 Jun;19(3):115-9. doi: 10.1111/j.1365-3164.2008.00668.x.
To evaluate the extent and severity of skin lesions in clinical trials enrolling dogs with atopic dermatitis (AD), the International Task Force on Canine Atopic Dermatitis recently recommended the use of the third version of the CADESI. This version of the CADESI was found to exhibit acceptable content, construct, criterion, inter- and intraobserver reliability and sensitivity to change. The current study was aimed at determining optimal CADESI-03 cut-off points to separate AD severity categories for future clinical trials. One hundred and eight dogs with AD were selected based on current diagnosis standards. At one or more visits, clinicians subjectively rated the severity of AD as 'in remission', 'mild', 'moderate' or 'severe', and a CADESI-03 score was then determined. In all, 158 CADESI-03 values were recorded and divided among the four disease severity categories. Receiver-operating characteristics (ROC) curves were generated at increasing cut-off values to determine the benchmark that would offer optimal sensitivity and specificity between adjacent categories. Cut-offs of 16, 60 and 120 are proposed at the interface of remission, mild, moderate and severe categories, respectively. Proposed intervals therefore are: remission: 0-15; mild AD: 16-59; moderate AD: 60-119; and severe AD: >/= 120. This Task Force recommends that, whenever applicable and relevant, subgroup analyses of outcome measures, based on disease severity as determined with these cut-off CADESI-03 values, be preplanned for clinical trials enrolling dogs with AD. Such subgroup analyses could help determine whether specific interventions might be more effective in a particular subset of atopic dogs.
为评估在招募患有特应性皮炎（AD）犬只的临床试验中皮肤损伤的范围和严重程度，国际犬特应性皮炎特别工作组最近推荐使用第三版犬特应性皮炎严重程度指数（CADESI）。发现该版CADESI在内容、结构、标准、观察者间和观察者内信度以及对变化的敏感性方面均表现良好。本研究旨在确定最佳的CADESI - 03分界点，以便为未来的临床试验划分AD严重程度类别。根据当前诊断标准选取了108只患有AD的犬只。在一次或多次就诊时，临床医生主观地将AD严重程度评定为“缓解”“轻度”“中度”或“重度”，然后确定CADESI - 03评分。总共记录了158个CADESI - 03值，并将其分配到四个疾病严重程度类别中。通过提高分界值生成受试者工作特征（ROC）曲线，以确定能在相邻类别间提供最佳敏感性和特异性的基准。分别在缓解、轻度、中度和重度类别的分界处提出了16、60和120的分界点。因此，建议的区间为：缓解：0 - 15；轻度AD：16 - 59；中度AD：60 - 119；重度AD：≥120。该特别工作组建议，只要适用且相关，对于招募患有AD犬只的临床试验，应预先计划基于这些CADESI - 03分界值确定的疾病严重程度进行结局指标的亚组分析。此类亚组分析有助于确定特定干预措施在特定特应性犬只亚组中是否可能更有效。
