Marant Claire, Arnould Benoit, Marrel Alexia, Spizak Céderic, Colombel Jean-Frédéric, Faure Patrick, Hagege Hervé, Lemann Marc, Nahon Stéphane, Tucat Gilbert, Vandromme Luc, Thibout Emmanuel, Goldfarb Gérard
Mapi Values, Patient-Reported Outcomes, 27 rue de la Villette, Lyon, France;
Clin Exp Gastroenterol. 2011;4:173-80. doi: 10.2147/CEG.S18585. Epub 2011 Jul 27.
To develop a self-administered questionnaire assessing patients' satisfaction with treatments in Crohn's disease for use in clinical research and epidemiological studies.
Semi-directive interviews (16) were conducted with patients with severe Crohn's disease treated with anti-tumor necrosis factor alpha (anti-TNFα). Transcripts were analyzed and concepts related to satisfaction with treatment were extracted and organized into a model. Items were generated using patients' words. The resulting test version was tested for relevance and comprehension with 7 patients and revised accordingly; the new version was tested with 5 other patients and revised to provide the pilot version. A clinician advisory board was involved at each milestone of the development.
The test questionnaire assessed treatment satisfaction through 67 items, organized into 5 sections: treatment efficacy, side-effects, convenience and constraints, overall impact, and satisfaction. Conceptual content of the questionnaire includes comparison with prior state and with expectations, satisfaction, acceptability, and intentions. The questionnaire was generally well accepted and understood by patients; few modifications were made in the structure and item formulation. After the second round of comprehension tests, the pilot version contained 62 items; the questionnaire was named Satisfaction of PAtients in Crohn's diseasE (SPACE(©)).
The questionnaire is a unique tool to assess treatment satisfaction in patients with Crohn's disease. A scoring and validation study is currently being performed to finalize and establish its scoring, as well as its psychometric properties.
开发一份用于临床研究和流行病学研究的自我管理问卷，以评估克罗恩病患者对治疗的满意度。
对接受抗肿瘤坏死因子α（抗TNFα）治疗的重度克罗恩病患者进行了16次半指导性访谈。对访谈记录进行分析，提取与治疗满意度相关的概念并组织成一个模型。使用患者的原话生成问卷项目。将生成的测试版本与7名患者一起测试其相关性和可理解性，并据此进行修订；新版本再与另外5名患者一起测试，并再次修订以提供试点版本。在问卷开发的每个阶段都有一个临床顾问委员会参与。
测试问卷通过67个项目评估治疗满意度，这些项目分为5个部分：治疗效果、副作用、便利性和限制、总体影响以及满意度。问卷的概念内容包括与先前状态和预期的比较、满意度、可接受性和意愿。该问卷总体上被患者很好地接受和理解；在结构和项目表述方面几乎没有修改。第二轮理解测试后，试点版本包含62个项目；该问卷被命名为克罗恩病患者满意度问卷（SPACE(©)）。
该问卷是评估克罗恩病患者治疗满意度的独特工具。目前正在进行一项评分和验证研究，以最终确定并建立其评分方法以及心理测量特性。
