Evaluation of the Simplified Diagnosis Tool for Chinese IBS-C (Irritable Bowel Syndrome With Constipation) Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- the sensitivity and specificity of the Simplified Diagnosis Tool for Chinese IBS-C patients
研究概览
简要总结
The study is a multi-centre, observational study which enrolls 150 IBS-C patients and 150 non-IBS-C patients in China.
详细描述
The potential study subject will be identified by the investigators by face-to-face visit, and there will be only 1 visit in this study. Every patient will complete both ROME IV and the Simplified Diagnosis Tool during the visit, and in the same day.
The study will collect results of the ROME IV and the Simplified Diagnosis Tool. Sensitivity and specificity of simplified diagnosis methodology compared with ROME IV will be analysed after all the data has been collected.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Group 1 (IBS-C)
- •≥18 years old
- •Decrease of frequency of bowel movement (<3 time per week), change of stool consistency (stool that is hard and difficult to pass, Bristol Types 1 to 3), or other 'constipation symptoms' judged by investigators.
- •With abdominal symptoms such as abdominal pain, bloating, and abdominal discomfort, or other 'constipation symptoms' judged by investigators.
- •Result of ROME VI marked as 'IBS-C'.
- •Group 2 (non-IBS-C)
- •≥18 years old
- •Decrease of frequency of bowel movement (<3 time per week), change of stool consistency (stool that is hard and difficult to pass, Bristol Types 1 to 3), or other 'constipation symptoms' judged by investigators.
- •With abdominal symptoms such as abdominal pain, bloating, and abdominal discomfort, or other 'constipation symptoms' judged by investigators.
- •Result of ROME VI marked as 'Non IBS-C'.
排除标准
- •Individuals with a cognitive condition and unable to finish the questionnaire.
- •Individuals have an acute or chronic non-GI condition that can be associated with constipation; e.g., central nervous system cause (Parkinson's disease, spinal cord injury, and multiple sclerosis), pseudo-obstruction, colonic inertia, megacolon, megarectum, bowel obstruction, descending perineum syndrome, solitary rectal ulcer syndrome, systemic sclerosis.
- •Individuals who had been diagnosed with the following organic health problems likely to affect GI symptoms:
- •Inflammatory bowel disease (Crohn's disease or ulcerative colitis)
- •cancer anywhere in the GI tract or current infection of the GI tract.
- •Pelvic floor dysfunction. (i.e., disease that is not adequately treated or stable with therapy.)
- •Any history of colon surgeries.
- •Individuals who participate in any interventional study currently.
- •Not suitable for the study judged by investigators.
结局指标
主要结局
the sensitivity and specificity of the Simplified Diagnosis Tool for Chinese IBS-C patients
时间窗: 14 months
Sensitivity (%)=(number of patients judged as IBS-C based on both the Simplified Diagnosis Tool and the ROME IV)/( number of patients judged as IBS-C based on ROME IV) ×100% Specificity (%)=(number of patients judged as non-IBS-C based on both the Simplified Diagnosis Tool and ROME IV)/( number of patients judged as non-IBS-C based on The ROME IV) ×100%
次要结局
- the accuracy of the Simplified Diagnosis Tool(14 month)
- the Kappa coefficient of the Simplified Diagnosis Tool(14 months)
- the positive predictive value, and negative predictive value of the Simplified Diagnosis Tool(14 months)