患者报告结局评价技术在针灸疗效评价中的适用性研究

【目的】探讨患者报告结局(PRO)评价技术在评价针灸临床疗效中的适用性。【方法】引入NPQ颈痛量表作为主要疗效指标,应用PRO模式评价针灸干预颈椎病颈痛的疗效,以麦吉尔疼痛量表(MPQ)和SF-36生存质量量表为参照,对一项多中心(9个中心)随机对照临床试验中896例患者治疗前后和随访中所测量的NPQ评分进行信度、效度、反应度评价。【结果】信度分析提示:NPQ量表的克朗巴赫α系数为0.769(95%CI∶0.761～0.804)。内容效度分析提示:NPQ评分与MPQ量表各个领域是一般到中等强度的相关,与SF-36量表中的躯体疼痛领域为中到强相关,与其他6个领域为一般相关,与精神健康为弱相关。结构效度提示:NPQ颈痛量表共可筛选出3个因子,累计方差贡献率为59.3%。反应度分析提示:患者在治疗结束时和随访3个月后的NPQ评分与治疗前的NPQ评分差异均有统计学意义(P<0.001)。【结论】以NPQ颈痛量表评价针灸治疗颈椎病颈痛的临床疗效,具有良好的信度、效度和反应度。PRO评估技术适用于针灸临床疗效评价,能够准确测量临床结局,值得在各类针灸临床研究中推广应用。

Study of Applicability of Patient-reported Outcomes for Evaluation of Therapeutic Effect of Acupuncture and Moxibustion on Neck Pain Induced by Cervical Spondylosis

Objective To explore the applicability of patient-reported outcomes(PRO) for the evaluation of therapeutic effect of acupuncture and moxibustion for neck pain induced by cervical spondylosis.Methods A multiple randomized control clinical trial was carried out in 896 qualified patients.With Nape Pain Questionnaire(NPN) items as the main indexes of therapeutic effect,PRO mode was used to evaluate the therapeutic effect of acupuncture and moxibustion for the patients with neck pain induced by cervical spondylosis.With McGill Pain Questionnaire(MPQ) and SF-36 life quality questionnaire as reference,we evaluated the reliability,validity and responsiveness of NPQ scores of 896 patients before treatment,after treatment and during follow-up.Results The results of reliability analysis showed that the Cronbach’s α coefficient of NPQ scores was 0.769(95% CI:0.761-0.804).The results of content validity analysis showed that NPQ scores were moderately correlated with each dimensions of MPQ,and were moderately or strongly correlated with the somatic pain in SF-36.NPQ scores were mildly correlated with 6 dimensions of SF-36,and were weakly correlated with mental health.The results of structure validity analysis showed that 3 factors selected from NPQ had an accumulative variance contribution rate of 59.3%.The results of the analysis of responsiveness showed that NPQ scores at the end of treatment and 3 months after the follow-up differed from those before treatment(P<0.001).Conclusion PRO shows good reliability,validity and responsiveness for the evaluation of therapeutic effect of acupuncture and moxibustion for neck pain induced by cervical spondylosis,which is expected to be extensively used for the clinical research of acupuncture and moxibustion.