Delgado-Herrera Leticia, Lasch Kathryn, Zeiher Bernhardt, Lembo Anthony J, Drossman Douglas A, Banderas Benjamin, Rosa Kathleen, Lademacher Christopher, Arbuckle Rob
Astellas Pharma Global Development, Inc., One Astellas Way, Northbrook, IL 60062, USA.
Pharmerit International, Newton, MA, USA.
Therap Adv Gastroenterol. 2017 Sep;10(9):673-687. doi: 10.1177/1756283X17726018. Epub 2017 Aug 24.
To evaluate the psychometric properties of the newly developed seven-item Irritable Bowel Syndrome - Diarrhea predominant (IBS-D) Daily Symptom Diary and four-item Event Log using phase II clinical trial safety and efficacy data in patients with IBS-D. This instrument measures diarrhea (stool frequency and stool consistency), abdominal pain related to IBS-D (stomach pain, abdominal pain, abdominal cramps), immediate need to have a bowel movement (immediate need and accident occurrence), bloating, pressure, gas, and incomplete evacuation.
Psychometric properties and responsiveness of the instrument were evaluated in a clinical trial population [ClinicalTrials.gov identifier: NCT01494233].
A total of 434 patients were included in the analyses. Significant differences were found among severity groups ( < 0.01) defined by IBS Patient Global Impression of Severity (PGI-S) and IBS Patient Global Impression of Change (PGI-C). Severity scores for each Diary and Event Log item score and five-item, four-item, and three-item summary scores were calculated. Between-group differences in changes over time were significant for all summary scores in groups stratified by changes in PGI-S ( < 0.05), two of six Diary items, and three of four Event Log items; a one-grade change in PGI-S was considered a meaningful difference with mean change scores on all Diary items -0.13 to -0.86 [standard deviation (SD) 0.79-1.39]. Similarly, for patients who reported being 'slightly improved' (considered a clinically meaningful difference) on the PGI-C, mean change scores on Diary items ranged from -0.45 to -1.55 (SD 0.69-1.39). All estimates of clinically important change for each item and all summary scores were small and should be considered preliminary. These results are aligned with the previous standalone psychometric study regarding reliability and validity tests.
These analyses provide evidence of the psychometric properties of the IBS-D Daily Symptom Diary and Event Log in a clinical trial population.
利用肠易激综合征腹泻型（IBS-D）患者的II期临床试验安全性和有效性数据，评估新开发的七项IBS-D每日症状日记和四项事件日志的心理测量特性。该工具可测量腹泻（大便频率和大便稠度）、与IBS-D相关的腹痛（胃痛、腹痛、腹部绞痛）、立即需要排便（立即需要和意外发生情况）、腹胀、压力、气体和排便不尽。
在一个临床试验人群中评估该工具的心理测量特性和反应性[ClinicalTrials.gov标识符：NCT01494233]。
共有434名患者纳入分析。在由IBS患者总体严重程度印象（PGI-S）和IBS患者总体变化印象（PGI-C）定义的严重程度组之间发现了显著差异（<0.01）。计算了每个日记和事件日志项目得分的严重程度分数以及五项、四项和三项汇总分数。在按PGI-S变化分层的组中，所有汇总分数随时间变化的组间差异均显著（<0.05），六项日记项目中的两项以及四项事件日志项目中的三项；PGI-S的一级变化被认为是有意义的差异，所有日记项目的平均变化分数为-0.13至-0.86[标准差（SD）0.79-1.39]。同样，对于在PGI-C上报告“略有改善”（被认为是临床上有意义的差异）的患者，日记项目的平均变化分数范围为-0.45至-1.55（SD 0.69-1.39）。每个项目和所有汇总分数的所有临床重要变化估计值都很小，应视为初步结果。这些结果与之前关于信效度测试的独立心理测量研究一致。
这些分析提供了IBS-D每日症状日记和事件日志在临床试验人群中的心理测量特性的证据。
