腰腿痛患者报告结局量表的初步研制

Preliminary Development of Patient Reported Outcome Instrument for Low Back and Leg Pain

目的:初步研制腰腿痛患者报告结局量表。方法:通过对前期量表修订、典型病例访谈、核心小组讨论、专家咨询、借鉴国内外相关量表等方法,形成初步量表。于2010年6月-2011年2月间,纳入住院患者100例:男性44例,女性56例;年龄22～65岁,平均51.8岁;腰椎间盘突出症66例,腰椎管狭窄症34例。应用该量表对患者进行测评,并对其进行认知性、信度和效度分析。结果:形成一个由3个域16个条目组成的腰腿痛患者报告结局量表。32例病情无变化患者两次评分比较差异无统计学意义(P>0.05),且有显著相关性(r>0.9);该量表总体克朗巴赫α系数为0.936;每个条目得分与其所在域得分的相关系数均大于0.5;该量表同Oswestry功能障碍指数问卷表对患者的评分结果具有显著相关性(r>0.9)。结论:该量表有较好的认知性、信度和效度,可尝试作为腰腿痛患者临床疗效的评价工具,但仍需进一步的评价和修订。

Objective：To develop a patient reported outcome instrument for low back and leg pain preliminarily. Methods： The primary instrument was formed by revising early scale, interviewing typical cases, focus group discussion, expert consuiting,referring to related instrument,and etc. 100 inpatients（44 males and 56 females）were analyzed from June 2010 to February 2011. They aged from 22 to 65 years old（mean,51.8 years）,including 66 lumbar disc herniation and 34 lumber spinal stenosis. They were tested by the instrument, and then analyzed the cognition, reliability and validity of the scale. Results： A 3-domain, 16-item instrument was developed. For 32 patients with no changes in illness, there was no statistical significant difference between two scores（P）0.05）and it showed significant correlation （r）0.9）. The total Cronbachrs Alpha of the instrument was 0. 936. The correlation coefficients of the score of each item and its corresponding domain were more than 0.5. Measurement result of the instrument had significant correlation （r〉0.9）with Oswestry disability index （ODD. Conclusion：The instrument has a good cognition, reliability and validity, which can try to be applied for the therapeutic evaluation of low back and leg pain, but still need further evaluation and modification.