Centre for Family and Community Medicine, Karolinska Institutet, Nobels Allé 12, 141 52 Huddinge, Sweden.
Health Qual Life Outcomes. 2009 Dec 29;7:106. doi: 10.1186/1477-7525-7-106.
Questionnaires are used in research and clinical practice. For gastrointestinal complaints the Rome II questionnaire is internationally known but not validated. The aim of this study was to validate a printed and a computerized version of Rome II, translated into Swedish. Results from various analyses are reported.
Volunteers from a population based colonoscopy study were included (n = 1011), together with patients seeking general practice (n = 45) and patients visiting a gastrointestinal specialists' clinic (n = 67). The questionnaire consists of 38 questions concerning gastrointestinal symptoms and complaints. Diagnoses are made after a special code. Our validation included analyses of the translation, feasibility, predictability, reproducibility and reliability. Kappa values and overall agreement were measured. The factor structures were confirmed using a principal component analysis and Cronbach's alpha was used to test the internal consistency.
Translation and back translation showed good agreement. The questionnaire was easy to understand and use. The reproducibility test showed kappa values of 0.60 for GERS, 0.52 for FD, and 0.47 for IBS. Kappa values and overall agreement for the predictability when the diagnoses by the questionnaire were compared to the diagnoses by the clinician were 0.26 and 90% for GERS, 0.18 and 85% for FD, and 0.49 and 86% for IBS. Corresponding figures for the agreement between the printed and the digital version were 0.50 and 92% for GERS, 0.64 and 95% for FD, and 0.76 and 95% for IBS. Cronbach's alpha coefficient for GERS was 0.75 with a span per item of 0.71 to 0.76. For FD the figures were 0.68 and 0.54 to 0.70 and for IBS 0.61 and 0.56 to 0.66. The Rome II questionnaire has never been thoroughly validated before even if diagnoses made by the Rome criteria have been compared to diagnoses made in clinical practice.
The accuracy of the Swedish version of the Rome II is of doubtful value for clinical practice and research. The results for reproducibility and reliability were acceptable but the outcome of the predictability test was poor with IBS as an exception. The agreement between the digital and the paper questionnaire was good.
问卷在研究和临床实践中被广泛使用。对于胃肠道投诉，国际上已知的是罗马 II 问卷，但尚未得到验证。本研究的目的是验证一个已翻译成瑞典语的罗马 II 的印刷版和计算机版。报告了各种分析的结果。
从一项基于人群的结肠镜检查研究中招募志愿者（n=1011），同时招募普通科医生就诊的患者（n=45）和胃肠科专家诊所就诊的患者（n=67）。问卷包含 38 个有关胃肠道症状和投诉的问题。诊断是根据特殊代码做出的。我们的验证包括翻译、可行性、可预测性、可重复性和可靠性分析。测量了 Kappa 值和总体一致性。使用主成分分析确认了因子结构，并用 Cronbach's alpha 检验了内部一致性。
翻译和回译显示出良好的一致性。问卷易于理解和使用。重复性测试显示，GERS 的 Kappa 值为 0.60，FD 的 Kappa 值为 0.52，IBS 的 Kappa 值为 0.47。当问卷诊断与临床医生诊断进行比较时，GERS 的可预测性的 Kappa 值和总体一致性分别为 0.26 和 90%，FD 的 Kappa 值和总体一致性分别为 0.18 和 85%，IBS 的 Kappa 值和总体一致性分别为 0.49 和 86%。印刷版和电子版之间的一致性的相应数字分别为 GERS 的 0.50 和 92%，FD 的 0.64 和 95%，以及 IBS 的 0.76 和 95%。GERS 的 Cronbach's alpha 系数为 0.75，项目间跨度为 0.71 至 0.76。FD 的相应数字为 0.68 和 0.54 至 0.70，IBS 的相应数字为 0.61 和 0.56 至 0.66。即使将罗马标准做出的诊断与临床实践中的诊断进行了比较，罗马 II 问卷也从未经过全面验证。
罗马 II 瑞典语版本对于临床实践和研究的准确性价值值得怀疑。可重复性和可靠性的结果可以接受，但可预测性测试的结果较差，IBS 是一个例外。数字问卷和纸质问卷之间的一致性良好。
