The Study Of The Recommended Items Of Clinician-Reported Outcomes Of Functional Gastrointestinal Disorders Based On The Theory Of Delphi Method

ObjectiveThis study aimed to set up recommended items of Clinician-Reported outcomes (CRO) of functional gastrointestinal disorders by literature research based on the theory of Delphi method.And through the clinical investigation, we test the discrimination validity, reliability, and responsibility of the four CRO scales. The scale is going to be used for evaluation of traditional and western medicine therapy of functional gastrointestinal disorders, finally contribute to build the diagnosis and therapeutic evaluation system, and strengthen the promotion and modernization of Chinese medicine.Methodswe checked and read clinical search medical literatures from CNKI and CQCIP(from2002to2012), Refer ing to Clinical Guides of functional dyspepsia (FD) and irritable bowel syndrome (IBS), obtained the main symptoms of functional gastrointestinal disorders.According to Delphi’s investigation questionnaire design and organization principle, we carried on two rounds of the expert investigation aimed at the symptom’s primary, importance to syndrome, clinical incidence. And to set up recommended items of Clinician-Reported outcomes (CRO) of functional gastrointestinal disorders.Through the clinical investigation,we test the discrimination validity, reliability and responsibility of the scales. And to develop four CRO scales, including Weipi(FD-PDS)-CRO,Weitong(FD-EPS)-CRO, Xiexie(IBS-D)-CRO, Bianmi (IBS-C)-CRO.ResultsTwo rounds of expert advisory all got positive responses. Participating experts had good regional representative, representative and authoritative discipline. Weipi (FD-PDS)-CRO was composed of6items, which are Bloating, burning sensation, early satiety, belching, loss of appetite and acid reflux. The coefficient of variation was0.06-0.30, coordination coefficient was0.620, P<0.05;Weitong(FD-EPS)-CR0was composed of7items, which are stomachache, bloating, burning sensation, early satiety, belching, loss of appetite and acid reflux. The coefficient of variation was0.04-0.26, coordination coefficient was0.708, R0.05;Xiexie(IBS-D)-CRO was composed of8items, which are abdominal distension, abdominal pain, diarrhea, tongxie, unsmooth defecate, mucous stool, borborygmus and flatus. The coefficient of variation was0.09-0.29, coordination coefficient was0.660, P<0.05; Bianmi (IBS-C)-CRO was composed of4items, which are abdominal pain, abdominal distension, unsmooth defecate and constipation. The coefficient of variation was0.00-0.21,coordination coefficient was0.665, P<0.05.And through the clinical investigation, we would test the reliability, discriminant validity and responsibility of the scale. A sample of130cases was taken.A sample of30cases was taken with Weipi (FD-PDS), Weipi (FD-PDS)-CRO had good finish rate, the median of the complete time was2minutes. The identification index D of total points and each item was0.36-0.75, the discriminant validity was good;The ICC of total points and each item was0.81-1.00(P<0.05), Intro-rater reliability was excellent;The ICC of total points and each item was0.94-0.99(P<0.05), Inter-rater reliability was excellent, the Bland-Altman analysis both revealed no systematic errors;ES of total points and each item was0.49-1.53, SRM was0.64-1.82, CR was43-58%, with a highly responsiveness.A sample of34cases was taken with Weitong(FD-EPS), Weitong(FD-EPS)-CRO had good finish rate, the median of the complete time was2.50minutes. The identification index D of total points and each item was0.35-0.70, the discriminant validity was good;The ICC of total points and each item was0.90-1.00(P<0.05), Intro-rater reliability was excellent;The ICC of total points and each item was0.84-0.99(P<0.05), Inter-rater reliability was excellent, the Bland-Altman analysis both revealed no systematic errors;ES of total points and each item was0.53-3.34, SRM was0.51-1.95, CR was39-61%, with a highly responsiveness. A sample of40cases was taken with Xiexie(IBS-D), Xiexie(IBS-D)-CRO had good finish rate, the median of the complete time was5.25minutes. The identification index D of total points and each item was0.33-0.70, the discriminant validity was good;The ICC of total points and each item was0.89-1.00(P<0.05), Intro-rater reliability was excellent;The ICC of total points and each item was0.84-1.00(P<0.05), Inter-rater reliability was excellent,the Bland-Altman analysis both revealed no systematic errors;ES of total points and each item was0.58-1.33, SRM was0.74-1.94, CR was41-75%, with a highly responsiveness.A sample of26cases was taken with Bianmi(IBS-C),Bianmi(IBS-C)-CRO had good finish rate, the median of the complete time was1.25minutes. The identification index D of total points and each item was0.48-0.72, the discriminant validity was good;The ICC of total points and each item was0.84-0.99(R<0.05), Intro-rater reliability was excellent;The ICC of total points and each item was0.93-1.00(P<0.05), Inter-rater reliability was excellent,the Bland-Altman analysis both revealed no systematic errors;ES of total points and each item was0.74-1.03, SRM was0.53-1.62, CR was36-54%, with a highly responsiveness.ConelusionThe four CRO scales of functional gastrointestinal disorders are reliable and valid instrument used for measuring the curative effect.