Development And Assessment Of The Chinese Clinician Reported Outcome Scales Of Chronic Spleen And Stomach Disease Based On Delphi Method

ObjectiveThrough literature research,group discussion,Delphi method and other methods,signs and symptoms’ items of chronic gastritis(CG),gastro-esophageal reflux disease(GERD)and ulcerative colitis(UC)were investigated to form the Clinician Reported Outcome(CRO)scales of chronic diseases of spleen and stomach and also tested through the clinic.The scales will be used for the evaluation of chronic gastrointestinal disease in Traditional Chinese Medicine and Western Medicine,to enrich the evaluation outcome of chronic gastrointestinal diseases,and to provide an effective tool for the promotion of the construction of Chinese medicine clinical effect evaluation system,fully reflects the characteristics of Chinese medicine.MethodsThrough consulting books and searching database(2007-2017 years),we collected symptoms and signs of CG,GERD and UC,merged the same items,and initially formed entry pools.After studying,screening by the research group formed by doctors,post-graduates,nurses,Delphi method questionnaires for chronic spleen and stomach diseases were formed.After three circles Delphi method,conducted a questionnaire survey to a number of famous experts throughout the spleen and stomach disease,mainly on symptoms and signs to clinical importance and frequency,3 primary CRO scales were formed.The preliminary scales were sent to many experts of the spleen and stomach diseases around the country for review,and a preliminary revision was carried out in combination with the opinions.The feasibility,reliability,validity and responsiveness were evaluated for clinical performance assessment on the revised scales,forming 3 perfect and feasible scales,including Chronic Gastritis CRO scale,Gastro-esophageal Reflux Disease CRO scale,Ulcerative Colitis CRO scale.ResultsThe three rounds of expert consultation have been actively answered by the experts,and all the experts participating in the consultation have good authority,subject representation and regional representation.After three rounds of expert consultation,upper abdominal pain,anorexia,early satiety and postprandial fullness,tongue and pulse,stomach pain,bloating,belching,noisy stomach,abdominal discomfort 10 items are the main symptoms and signs of chronic gastritis entry,the coefficient of variation was between 0.09-0.18,Kendall W 0.606,P < 0.05;pantothenic acid,retrosternal swelling stuffy,putrid,nocturnal cough,tunsuan,tongue and pulse,pharyngeal foreign body sensation,substernal burning pain,belching,acid regurgitation,heartburn and retrosternal pain 12 items are the main symptoms and items of gastro-esophageal reflux disease,the coefficient of variation between 0.05-0.20,Kendall W 0.514,P < 0.05;bowel,abdominal distension,tongue and pulse,abdominal discomfort,abdominal pain,diarrhea,mucus,pus and blood stool,defecation,hematochezia,anal tenesmus,uncomfortable burning,abdominal tenderness 13 items are composed of ulcerative colitis’ s main symptoms and signs items,the coefficient of variation between 0.05-0.21,Kendall W 0.646,P < 0.05.A total of 109 patients with chronic spleen and stomach diseases were selected for clinical performance assessment,and 40 healthy people were included.The feasibility,reliability,validity and responsiveness of the final scale were evaluated.Chronic gastritis(weiwantong / weipi)in 40 cases,the average completion time is 278.95 seconds,the completion rate of 100%;the test-retest reliability between 0.86-0.99,Cronbach coefficient between 0.86-0.99,with a good internal consistency reliability,inter rater reliability between 0.86-0.99,evaluation of internal reliability between 0.86-0.99,the reliability evaluation is good;each item between high and low group discrimination index between 0.41-0.94,with a good discriminant validity;change ratio(CR)in 0.57-0.83,effectsize(ES)between 0.7-1.9,patients group compared with healthy group,P < 0.05,in good reaction.Gastro-esophageal reflux disease(tusuan / esophagus)in 34 cases,average completion time is 161.10 seconds,the completion rate of 100%;the test-retest reliability between 0.87-0.99,Cronbach coefficient between the items is 0.87-0.99,with a good internal consistency reliability,inter rater reliability between 0.89-0.98,reliability evaluation in 0.87-0.99,the reliability evaluation is good;each item between the high and low group discrimination index between 0.56-0.82,has a good discriminant validity;the CR was between 0.39-0.91 and ES in 0.39-1.00,the patients group compared with healthy group,P < 0.05,the reaction is good.Ulcerative colitis(dysentery / diarrhea)in 35 cases,the average completion time is 183.26 seconds,the completion rate of 100%;the test-retest reliability was 0.82-1.00,Cronbach coefficient between the items in 0.87-1.00,with a good internal consistency reliability,inter rater reliability between 0.86-1.00,evaluation of internal reliability was 0.82-1.00.Evaluation of the reliability is good;each item between high and low end group discrimination index was between 0.52-0.96,has good discriminant validity;the CR was between 0.4-0.86 and ES in 0.38-1.08,the patients group compared with healthy group,P < 0.05,the reaction is good.The final formation of 3 chronic diseases of spleen and stomach CRO scales: Chronic Gastritis(CG)–CRO,Gastro-esophageal reflux disease(GERD)–CRO,Ulcerative colitis(UC)-CRO.ConclusionThree chronic spleen and stomach diseases CRO have good feasibility,reliability,validity and responsiveness,which can be used for clinical evaluation of Chinese and Western medicine in chronic spleen and stomach diseases.