Abstract：
OBJECTIVE: To evaluate the psychometric properties of the Diary for Irritable Bowel Syndrome Symptoms-Constipation (DIBSS-C), which was developed to support primary and secondary endpoints in irritable bowel syndrome (IBS) with predominant constipation (IBS-C) clinical trials.
METHODS: Observational data were collected from 108 adults with IBS-C using a smartphone-type device for 17 days. DIBSS-C data regarding bowel movements (BMs) were collected for each event (along with the Bristol Stool Form Scale); abdominal symptoms were rated each evening. Global status items and the Gastrointestinal Symptom Rating Scale-IBS were completed on day 10 and day 17 and the IBS-Symptom Severity Scale on day 17. Item-level performance, internal consistency reliability, test-retest reliability, and construct validity were evaluated.
RESULTS: The Abdominal Symptoms Domain score demonstrated high internal consistency reliability (Cronbach\'s alpha week 1 = 0.98; week 2 = 0.96) and test-retest reliability (intraclass correlation coefficient [ICC] = 0.93). Test-retest reliability was stronger for abdominal symptoms (ICC = 0.91-0.94) than for the frequency-based BM-related outcomes (ICC = 0.54-0.66). Key construct validity hypotheses were supported by moderate to strong correlations with the corresponding Gastrointestinal Symptom Rating Scale-IBS, IBS-Symptom Severity Scale, and Bristol Stool Form Scale items. All known-groups comparisons were statistically significant for the abdominal symptom items and domain score; evidence for known-groups validity of BM-related outcomes was supportive when based on constipation severity.
CONCLUSIONS: The results of this study provided key psychometric evidence for the DIBSS-C, ultimately contributing to its qualification by the US Food and Drug Administration for use in IBS-C clinical trials.
METHODS: Observational data were collected from 108 adults with IBS-C using a smartphone-type device for 17 days. DIBSS-C data regarding bowel movements (BMs) were collected for each event (along with the Bristol Stool Form Scale); abdominal symptoms were rated each evening. Global status items and the Gastrointestinal Symptom Rating Scale-IBS were completed on day 10 and day 17 and the IBS-Symptom Severity Scale on day 17. Item-level performance, internal consistency reliability, test-retest reliability, and construct validity were evaluated.
RESULTS: The Abdominal Symptoms Domain score demonstrated high internal consistency reliability (Cronbach\'s alpha week 1 = 0.98; week 2 = 0.96) and test-retest reliability (intraclass correlation coefficient [ICC] = 0.93). Test-retest reliability was stronger for abdominal symptoms (ICC = 0.91-0.94) than for the frequency-based BM-related outcomes (ICC = 0.54-0.66). Key construct validity hypotheses were supported by moderate to strong correlations with the corresponding Gastrointestinal Symptom Rating Scale-IBS, IBS-Symptom Severity Scale, and Bristol Stool Form Scale items. All known-groups comparisons were statistically significant for the abdominal symptom items and domain score; evidence for known-groups validity of BM-related outcomes was supportive when based on constipation severity.
CONCLUSIONS: The results of this study provided key psychometric evidence for the DIBSS-C, ultimately contributing to its qualification by the US Food and Drug Administration for use in IBS-C clinical trials.
摘要：
目的：评估肠易激综合征症状-便秘（DIBSS-C）日记的心理测量学特性，该研究旨在支持伴有便秘的肠易激综合征(IBS-C)临床试验的主要和次要终点.
方法：使用智能手机型设备从108名患有IBS-C的成年人中收集17天的观察数据。收集每个事件的关于排便(BMs)的DIBSS-C数据(连同布里斯托尔大便形式量表[BSFS]);每天晚上对腹部症状进行评级。在第10天和第17天完成总体状态项目和胃肠道症状评定量表-IBS（GSRS-IBS），在第17天完成IBS-症状严重程度量表（IBS-SSS）。项目级性能，内部一致性可靠性，测试-重测可靠性，并对结构效度进行了评价。
结果：腹部症状领域评分显示出较高的内部一致性可靠性（Cronbach的α第1周=0.98；第2周=0.96）和重测可靠性（组内相关系数[ICC]=0.93）。腹部症状（ICC=0.91-0.94）的重测可靠性强于基于频率的BM相关结果（ICC=0.54-0.66）。关键的结构效度假设得到了与相应GSRS-IBS的中强相关性的支持，IBS-SSS,和BSFS项目。所有已知组的腹部症状项目和领域评分比较均具有统计学意义；当基于便秘严重程度时，已知组的BM相关结果有效性的证据具有支持性。
结论：这项研究的结果为DIBSS-C提供了关键的心理测量证据，最终有助于其被美国食品和药物管理局用于IBS-C临床试验的资格。
方法：使用智能手机型设备从108名患有IBS-C的成年人中收集17天的观察数据。收集每个事件的关于排便(BMs)的DIBSS-C数据(连同布里斯托尔大便形式量表[BSFS]);每天晚上对腹部症状进行评级。在第10天和第17天完成总体状态项目和胃肠道症状评定量表-IBS（GSRS-IBS），在第17天完成IBS-症状严重程度量表（IBS-SSS）。项目级性能，内部一致性可靠性，测试-重测可靠性，并对结构效度进行了评价。
结果：腹部症状领域评分显示出较高的内部一致性可靠性（Cronbach的α第1周=0.98；第2周=0.96）和重测可靠性（组内相关系数[ICC]=0.93）。腹部症状（ICC=0.91-0.94）的重测可靠性强于基于频率的BM相关结果（ICC=0.54-0.66）。关键的结构效度假设得到了与相应GSRS-IBS的中强相关性的支持，IBS-SSS,和BSFS项目。所有已知组的腹部症状项目和领域评分比较均具有统计学意义；当基于便秘严重程度时，已知组的BM相关结果有效性的证据具有支持性。
结论：这项研究的结果为DIBSS-C提供了关键的心理测量证据，最终有助于其被美国食品和药物管理局用于IBS-C临床试验的资格。
