Dougados Maxime, Luo Michelle P, Maksymowych Walter P, Chmiel Joseph J, Chen Naijun, Wong Robert L, Davis John C, van der Heijde Désirée
Hôpital Cochin and University of Paris, Paris, France.
Arthritis Rheum. 2008 Apr 15;59(4):553-60. doi: 10.1002/art.23527.
To evaluate the feasibility/acceptability, reliability, external validity, and discriminant capacity of the Patient Acceptable Symptom State (PASS) concept in patients with active ankylosing spondylitis (AS).
PASS was assessed by asking patients to respond yes or no to a single question: "Considering all the different ways your disease is affecting you, if you would stay in this state for the next months, do you consider that your current state is satisfactory?" during the 24-week, randomized (2:1 ratio), double-blind, placebo-controlled portion of an adalimumab study of 315 patients.
PASS reliability was high (kappa = 0.86) in patients with stable disease. Significantly more patients who answered yes to PASS than patients who answered no to PASS were responders based on the ASsessment in Ankylosing Spondylitis (ASAS) International Working Group criteria for 20% improvement (75% who answered yes versus 29% who answered no), the ASAS criteria for 40% improvement (61% versus 16%), the ASAS partial remission criteria (37% versus 3%), and > or =50% improvement on the Bath Ankylosing Spondylitis Disease Activity Index (65% versus 19%; P < 0.001 for all comparisons), demonstrating external validity of the PASS concept. More adalimumab-treated than placebo-treated patients achieved PASS at week 12 (42.3% versus 22.4%; P < 0.001), and more adalimumab-treated than placebo-treated patients achieved sustained PASS through week 20 (34.6% versus 12.3%; P < 0.001), indicating excellent discriminant capacity.
PASS is a feasible, acceptable, reliable, and valid assessment of satisfactory health state in patients with AS.
评估患者可接受症状状态（PASS）概念在活动性强直性脊柱炎（AS）患者中的可行性/可接受性、可靠性、外部效度和判别能力。
在一项有315例患者参与的阿达木单抗研究的24周随机（2:1比例）、双盲、安慰剂对照阶段，通过让患者对一个单一问题回答“是”或“否”来评估PASS：“考虑到疾病影响你的所有不同方式，如果你在接下来的几个月里保持这种状态，你认为你目前的状态令人满意吗？”
病情稳定的患者中，PASS的可靠性较高（kappa = 0.86）。根据强直性脊柱炎评估（ASAS）国际工作组20%改善标准，回答PASS为“是”的患者中应答者显著多于回答“否”的患者（回答“是”的患者中有75%，回答“否”的患者中有29%）；根据ASAS 40%改善标准（61%对16%）、ASAS部分缓解标准（37%对3%）以及巴斯强直性脊柱炎疾病活动指数改善≥50%（65%对19%；所有比较P < 0.001），这表明PASS概念具有外部效度。在第12周时，接受阿达木单抗治疗的患者达到PASS的比例高于接受安慰剂治疗的患者（42.3%对22.4%；P < 0.001），并且在第20周时，接受阿达木单抗治疗的患者中持续达到PASS的比例高于接受安慰剂治疗的患者（34.6%对12.3%；P < 0.001），表明判别能力良好。
PASS是对AS患者健康满意状态的一种可行、可接受、可靠且有效的评估。
