[目的]在脾胃系疾病患者报告结局(PRO)量表的基础上研制具有中医特色的肠易激综合征(IBS)专属PRO量表,用于IBS的临床疗效评价,丰富和发展PRO量表体系。[方法]遵照国际通用量表研制的程序化方式,在中医理论指导下,结合PRO的相关概念和内涵,以脾胃系疾病PRO量表为基础,建立量表的理论结构模型、建立条目池,编制初选量表。通过对181例样本的临床调查数据进行探索性因子、逐步回归、离散趋势、克朗巴赫系数、频数分布和专家重要性评分等分析方法进行条目筛选。[结果]在脾胃系疾病PRO量表基础上,补充了23个条目,优化后剩下18个条目,加上原脾胃系疾病PR()量表的条目形成IBS初选量表,合计62个条目,经筛选后形成终表,由4个领域、8个方面、43个条目构成。[结论]脾胃系疾病PRO量表之IBS子量表是严格按照国际量表的步骤和方法进行研制的系统,结论可信、科学性强,适用于IBS的临床疗效评价。
[Objective]To develop the irritable bowel syndrome (IBS) sub-scale based on the gastroen- terological diseases patient reported outcomes (PRO) Scale (GED-PRO) to evaluate the clinical efficacy of IBS and to enrich the PRO scale system. [Methods]According to the international guideline of the PRO concept and the global general method of developing a scale, we set up the theory structure model, established item pools,completed the pilot survey and developed the initial scale on the basis of the GED-PRO scale. The items of the scale were screened by multivariate statistical techniques such as exploratory factor analysis, stepwise regression, discrete trend method, cronbach's coefficient, frequency distribution and ex- perts grading method. EResults~The theory structure model included physical, level of independent, psycho- logical and social domains. 23 items were added and 18 items were kept after screening. The initial IBS sub-scale included 62 items in total,which contained the 18 new items and the original items of the GEDPRO scale. The pilot survey covered 181 samples (99 healthy people and 82 patients). The final scale was formed after screening. It was composed of 4 domains, 8 facets and 43 items. [Conclusion]The IBS subscale of the GED-PRO scale was made based on the general international principle of PRO scale develop ment. It is scientific and reliable and can be used to evaluate the clinical efficacy of the treatment for IBS.