冠心病病人西雅图心绞痛量表最小临床重要性差值的制定及反应性对比研究

    Establishment of the minimum clinical importance difference of the Seattle Angina Qestionnaire in patients with coronary heart disease and reactivity comparison study

    • 摘要:
      目的 :确立西雅图心绞痛量表(seattle angina questionnaire,SAQ)在冠心病病人中的最小临床重要性差值并评价其反应性,构建本土化疗效评价标准。
      方法 :采用前瞻性队列研究,选取2024年5月至2025年11月于亳州市人民医院心内科收治的387例冠心病病人,按治疗方式分为药物治疗组和经皮冠状动脉介入治疗组。于基线及治疗后2 ~ 3个月收集SAQ、SF–36及病人总体变化印象量表数据。遵循COSMIN指南,综合锚定法与分布法测定最小临床重要性差值(minimally important difference,MCID),并对比SF–36的反应性。
      结果 :SAQ躯体受限、发作频率及疾病认知维度变化分与PGIC均呈强正相关(r = 0.671 ~ 0.693,P < 0.01),效标效度优于SF–36。确立躯体受限、发作频率及疾病认知维度的MCID最佳截断值取整后分别为11、10及8分,AUC分别为0.912、0.923和0.953,均>0.90,且阈值在药物治疗与经皮冠状动脉介入治疗组间保持稳定。反应性方面,SAQ各维度标准化反应均数(1.82 ~ 1.95)高于SF–36(0.55 ~ 0.61)(P < 0.01)。
      结论 :SAQ在冠心病病人中具有优异的纵向效度与反应性,其捕捉临床微小改善的灵敏度显著优于通用量表SF–36。本研究界定的本土化MCID阈值,为判定临床实质性改善提供了科学标尺,建议作为冠心病症状负担评价的核心工具。

       

      Abstract:
      Objective To establish the minimum clinical importance difference of the Seattle Angina Questionnaire (SAQ) in patients with coronary heart disease, evaluate its reactivity, and construct a localized efficacy evaluation standard. Methods: A prospective cohort study was conducted. A total of 387 patients with coronary heart disease admitted to the Department of Cardiology of Bozhou People's Hospital from May 2024 to November 2025 were selected, and divided into the drug treatment group and percutaneous coronary intervention group according to the treatment methods. The data of SAQ, SF-36 and Overall Impression of Change Scale for patients were collected at baseline and 2 to 3 months after treatment. In accordance with the COSMIN guidelines, the minimum clinical importance difference (MCID) was determined by combining the anchoring method and distribution method, and the reactivity of SF-36 was compared.
      Results The scores of physical limitation, attack frequency and changes in disease cognition dimension of SAQ were strongly positively correlated with PGIC (r = 0.671-0.693, P < 0.01), and the validity of the benchmark was better than that of SF-36. After rounding, the optimal cutoff values of MCID for the dimensions of physical limitation, attack frequency and disease cognition were 11, 10 and 8 points, respectively, and the AUCs were 0.912, 0.923 and 0.953, respectively, all >0.90, and the thresholds remained stable between the drug treatment group and percutaneous coronary intervention group. In terms of reactivity, the standardized response mean of each dimension of SAQ (1.82–1.95) was higher than that of SF-36 (0.55–0.61) (P < 0.01).
      Conclusions SAQ has excellent longitudinal validity and reactivity in patients with coronary heart disease, and its sensitivity in capturing minor clinical improvements is significantly better than that of the general scale SF-36. The localized MCID threshold defined in this study provides a scientific yardstick for determining substantial clinical improvement, and is recommended as the core tool for evaluating the symptom burden of coronary heart disease.

       

    /

    返回文章
    返回