The study is a multi-centre, observational study which enrolls 150 IBS-C patients and 150 non-IBS-C patients in China.
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.
Study Type
OBSERVATIONAL
Enrollment
300
Research Site
Beijing, China
Research Site
Guangzhou, China
Research Site
Guangzhou, China
Research Site
Nanchang, China
the sensitivity and specificity of the Simplified Diagnosis Tool for Chinese IBS-C patients
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%
Time frame: 14 months
the accuracy of the Simplified Diagnosis Tool
Accuracy (%)=(number of patients judged as IBS-C based on both the Simplified Diagnosis Tool and The ROME IV + number of patients judged as non-IBS-C based on both Simplified Diagnosis Tool and The ROME IV) / (total number of patients in the FAS) ×100%
Time frame: 14 month
the Kappa coefficient of the Simplified Diagnosis Tool
The Kappa coefficient will be calculated according to the following formula: Kappa coefficient=(P0-Pe)/(1-Pe)
Time frame: 14 months
the positive predictive value, and negative predictive value of the Simplified Diagnosis Tool
Positive predictive value (%)=(number of patients judged as IBS-C based on both Simplified Diagnosis Tool and The ROME IV)/(number of patients judged as IBS-C based on Simplified Diagnosis Tool) ×100% Negative predictive value (%)=(number of patients judged as non-IBS-C based on both Simplified Diagnosis Tool and The ROME IV)/( number of patients judged as non-IBS-C based on Simplified Diagnosis Tool) ×100%
Time frame: 14 months
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Research Site
Nanjing, China
Research Site
Shanghai, China
Research Site
Shenyang, China
Research Site
Wenzhou, China
Research Site
Wuhan, China
Research Site
Zhengzhou, China