Guigui P, Rillardon L, Veil-Picard A, Blamoutier A, Heissler P, Benoist M, Deburge A
Service de Chirurgie Orthopédique, Hôpital Beaujon, 100, boulevard du Général-Leclerc, 92110 Clichy,
Rev Chir Orthop Reparatrice Appar Mot. 2002 Oct;88(6):601-12.
The main aim of this prospective, multicentric, observational study was to validate a self-administered quality-of-life questionnaire for patients with lumbar spine stenosis treated surgically.
The self-administered questionnaire was composed of eight questions exploring three dimensions: lumbalgia, radiculalgia, radicular ischemia. This questionnaire was associated with an index of neurological involvement (to take into account objective neurological data), and with an index of patient satisfaction (to assess the patient's perception of the impact of surgery on lumbalgia, radiculalgia, and gait disorders). The scoring scale was validated by studying the structure of the questionnaire (to ascertain the pertinence of the proposed three dimensions), by determining the questionnaire's reproducibility (intraobserver variability) and sensitivity to change, and by examining the contents of the questions (to assess the capacity of the scale to effectively measure the parameters it was designed to measure). Cronbach's alpha coefficient and principal component analysis were used to assess the questionnaire's structure. Reproducibility was tested on 49 patients who completed the self-administered questionnaire twice at a 15-day interval; intraclass correlation coefficients were determined. Sensibility was tested by correlating variation in the scores obtained pre- and postoperatively with the index of satisfaction; mean standard responses were determined. The validity of the questionnaire's content was assessed by correlating the scores obtained with the questionnaire to those obtained with three other self-administered questionnaires: SF36, EIFEL2 and GHA38.
This work included 104 patients, 96 of whom were reviewed at consultations 6 and 12 months after surgery. The principal components analysis confirmed the presence of the three dimensions. The global Cronbach alpha coefficient was 0.86. The global intraclass coefficient of correlation was 0.95, varying from 0.86 to 0.97 depending on the dimension studied. There was a good correlation (0.82) between changes in the score studied and the index of satisfaction. All the mean standardized responses were higher than 1, indicating good sensitivity to change. There was also a good correlation between the questionnaire tested and the EIFEL2 self-administered questionnaire and the following dimensions of the SF36: physical activity, physical pain, vitality, and limitation due to physical pain.
Associating a simple 8-question self-administered questionnaire with an index of satisfaction (4 questions) and an objective index of neurological involvement provided a reliable, sensitive, and reproducible assessment of the changes in functional disorders resulting from lumber stenosis before and after surgical treatment.
这项前瞻性、多中心、观察性研究的主要目的是验证一份用于接受手术治疗的腰椎管狭窄症患者的自我管理生活质量问卷。
这份自我管理问卷由八个问题组成，涉及三个维度：腰痛、神经根痛、神经根缺血。该问卷与一个神经受累指数（用于考虑客观神经学数据）以及一个患者满意度指数（用于评估患者对手术对腰痛、神经根痛和步态障碍影响的感知）相关联。通过研究问卷结构（以确定所提出的三个维度的相关性）、确定问卷的可重复性（观察者内变异性）和对变化的敏感性，以及检查问题内容（以评估该量表有效测量其设计旨在测量的参数的能力）来验证评分量表。使用克朗巴哈系数和主成分分析来评估问卷结构。对49名患者进行可重复性测试，这些患者每隔15天完成两次自我管理问卷；确定组内相关系数。通过将术前和术后获得的分数变化与满意度指数相关联来测试敏感性；确定平均标准反应。通过将问卷获得的分数与其他三份自我管理问卷（SF36、EIFEL2和GHA38）获得的分数相关联来评估问卷内容的有效性。
这项研究纳入了104名患者，其中96名在术后6个月和12个月的会诊中接受了复查。主成分分析证实了三个维度的存在。总体克朗巴哈系数为0.86。总体组内相关系数为0.95, 根据所研究的维度，该系数在0.86至0.97之间变化。所研究的分数变化与满意度指数之间存在良好的相关性（0.82）。所有平均标准反应均高于1，表明对变化具有良好的敏感性。所测试的问卷与EIFEL2自我管理问卷以及SF36的以下维度：身体活动、身体疼痛、活力和身体疼痛导致的限制之间也存在良好的相关性。
将一份简单的8个问题的自我管理问卷与一个满意度指数（4个问题）和一个客观的神经受累指数相结合，为手术治疗前后腰椎管狭窄导致的功能障碍变化提供了可靠、敏感且可重复的评估。
