Department of Pediatric Immunology, Wilhelmina Children's Hospital, University Medical Centre Utrecht, Room KC 03.063.0, 3508 AB Utrecht, The Netherlands.
Rheumatology (Oxford). 2014 Feb;53(2):307-12. doi: 10.1093/rheumatology/ket310. Epub 2013 Oct 24.
The objectives of this study were to assess 27-joint Juvenile Arthritis Disease Activity Score (JADAS-27) responsiveness, JADAS-27 changes corresponding to clinically important differences and cut-off scores for low and high disease activity in a large prospective JIA cohort.
JADAS-27 responsiveness, using effect size and standardized response mean (SRM), and changes in the JADAS-27 corresponding to clinically important differences were determined for clinical improvement (ACRpedi30) and worsening (flare). To assess whether various degrees of change in the JADAS-27 could be used to demonstrate improvement or worsening in individual patients, diagnostic parameters were computed for cut-off score changes. Finally, cut-off scores for low and high disease activity and their diagnostic parameters were determined.
In 228 patients with 529 consecutive visits, ACRpedi30 was detected in 109 and flare in 111 visits. Regarding responsiveness, the effect size was 0.93 and SRM was 1.26 for clinical improvement, while for clinical worsening the effect size was 0.65 and SRM was 0.60. Changes in the JADAS-27 corresponding to clinically important difference were -5.5 for improvement and +1.7 for worsening. Cut-off score changes in the JADAS-27 had 65-90% sensitivity and 67-86% specificity for improvement, and 31-64% sensitivity and 89-97% specificity for worsening. The JADAS-27 cut-off score for low disease activity was ≤2.7 with 76% sensitivity and 62% specificity, and the cut-off score for high disease activity was ≥6 with 77% sensitivity and 77% specificity.
The JADAS-27 had moderate to good responsiveness and was changed by clinically important differences. The JADAS-27 cut-off scores differentiated between low and high disease activity. These JADAS-27 interpretations could be potentially applicable in clinical care and trials.
本研究旨在评估 27 关节幼年特发性关节炎疾病活动评分(JADAS-27)的反应性,以及 JADAS-27 的变化与临床重要差异的相关性,并确定用于低疾病活动和高疾病活动的 JADAS-27 截断值。
使用效应大小和标准化反应均值(SRM)评估 JADAS-27 的反应性,并确定 JADAS-27 的变化与临床改善(ACRpedi30)和恶化(flare)的临床重要差异相对应。为了评估 JADAS-27 的各种变化程度是否可用于显示个体患者的改善或恶化,计算了诊断参数以确定截断值变化。最后,确定了低疾病活动和高疾病活动的截断值及其诊断参数。
在 228 例患者的 529 次连续就诊中,109 次就诊检测到 ACRpedi30,111 次就诊检测到 flare。关于反应性,临床改善的效应大小为 0.93,SRM 为 1.26,而临床恶化的效应大小为 0.65,SRM 为 0.60。与临床重要差异相对应的 JADAS-27 变化为改善时为-5.5,恶化时为+1.7。JADAS-27 的截断值变化对改善的敏感性为 65-90%,特异性为 67-86%,对恶化的敏感性为 31-64%,特异性为 89-97%。低疾病活动的 JADAS-27 截断值为≤2.7,敏感性为 76%,特异性为 62%,高疾病活动的截断值为≥6,敏感性为 77%,特异性为 77%。
JADAS-27 具有中度至良好的反应性,且与临床重要差异相关。JADAS-27 的截断值可区分低疾病活动和高疾病活动。这些 JADAS-27 解释可能在临床护理和试验中具有潜在适用性。