Preliminary Research And Assessment Of Patients Reported Outcomes For Functional Dyspepsia

Objective: Functional dyspepsia (FD) refers to postprandial fullness,early satiety, abdominal pain and symptom/or burning sensation, thesesymptoms derived from gastric and duodenal region, and exclusion organic,systemic and metabolic diseases may cause these symptoms. RomeⅢstandardput FD into postprandial distress syndrome (PDS) and epigastric painsyndrome (EPS). FD is one of the common diseases of the gastrointestinaltract, its pathogenesis is not yet fully clear. Modern medical treatment stays inthe symptomatic treatment of stage. Due to the lack of effective means of cure,resulting in FD recurrent, repeated clinical examination found no obviousabnormalities, but there are still many symptoms seriously affect their qualityof life.Traditional Chinese Medicine(TCM) has the advantage of individualizedtherapy in the treatment of the FD. TCM treatment of FD achieve efficacy, thepurpose is not easily repeated with the whole concept and diagnosis andtreatment characteristics. However, TCM is lack of complete clinical medicinetreatment efficacy evaluation system, and more doctors to determine theclinical efficacy by improving symptoms, tongue and pulse and otherindicators, this approach depends on personal experience,it’s too subjective.Or some physicians evaluate the efficacy of direct copying Modern medicalmethod, and this method is unable to reflect the characteristics of TCM. Sohow to establish clinical efficacy evaluation system in line with Chinesecharacteristics, has become the focus of the development of Chinese medicine,the introduction of scale evaluation is necessary.Patient reportedoutcomes(PRO) is an important evaluation tool to measure the patient’ssubjective symptoms.PRO claims clinical efficacy should be closelyassociated with the patient’s own feelings. PRO scale can be quantified TCM diagnosis, is a new method of evaluation of the efficacy of TCM.This paper follows the international scale production standards, on thebasis of the FD studies abroad trying to develop more mature, scientific PRO,to evaluate the efficacy of TCM for FD provides a new idea.Methods: Formulate the FD-PRO according to the U.S. Food and DrugAdministration(FDA) published guidelines for the PRO. Select the145patients who meet the criteria of Rome Ⅲ of FD to complete thequestionnaire. Develop the database with Epidata3.1and analyze data usingSPSS18.0. Scale analysis of the feasibility, reliability, validity to determine itsscientific.The experts importance rating method, missing value method,entrydistribution method,discrete trend method, correlation coefficient method forentry selection to form the final scale.Results:1Scale of assessment1.1Feasibility analysis: Clinical investigation of145questionnaires weredistributed,145were recovered, recovery rate100%,91.03%completion rate.97.2%of respondents completed the scale of time within20minutes.(PROproduction requirements: the recovery rate and completion rate reached morethan85%, the completion time within20minutes of the scale is easy to accept,is scientific.)1.2Reliability Analysis1.2.1Split-half reliability analysis: Guttman Split-Half coefficient of the scaleis0.829.(PRO production requirements: Guttman Split-Half coefficient of thescale of more than0.7shows good reliability.)1.2.2Internal consistency reliability analysis: The Scale overall Cronbach’s αcoefficient was0.958; somatic physiological field Cronbach’s α coefficientwas0.901; areas of daily life Cronbach’s α coefficient was0.910;psychological field Cronbach’s α coefficient was0.880; social communicationfield Cronbach’s α coefficient was0.748; satisfaction Cronbach’s α coefficient0.710.(PRO production requirements: Cronbach’s α coefficient of the scale ofmore than0.6shows good reliability.) 1.3Validity Analysis1.3.1Face validity: the core group and focus group for mading and screeningentrys repeated discussions and arguments in order to ensure the quality.1.3.2Structure validity: The scale exploratory factor analysis to evaluate thescale.Factor analysis using principal component analysis. The results showedthat KMO=0.840, P=0.000, suitable for factor analysis. According tocharacteristic root value＞1extracted factor, the results obtained16commonfactors, the cumulative variance contribution rate of72.307%.16commonfactors describe the feelings of patients with FD from five aspects ofphysiological, psychological, social, life, satisfaction. This scale wasoriginally designed physiological body areas, areas of daily life, thepsychological field, the field of social communication, satisfaction fivedimensions similar to16common factors. This shows that the theoreticalmodel of this structure is consistent with the scale, FD-PRO scale has goodconstruct validity.Through the above evaluation, show that scale’s reliability, validity,feasibility and science are better.2Entry Screening2.1Experts importance rating method: Delete the experts scoring average isless than or equal to2.6points of entry:10、11、18、19、20、21、60.2.2missing value method: Entries24,25,62missing values were6.2%,5.5%,2.1%, because of missing values higher so deleting.2.3entry distribution method: The scale has no one answer selection rate ofmore than80%, therefore no entries deleted.2.4discrete trend method:This method deletes the entry standard deviation ofless than0.8:10、11、20、22、31.2.5correlation coefficient method: The scale merger or delete entries Pearsoncorrelation coefficient greater than0.65:18、19、38、39、40、41、42、43、44、45、46、48、50、52、53、58、59.Through the above method, the final table form consists of45items ofFD-PRO. Conclusions:1According to international scale production standards, research on thediagnosis and treatment of FD reference of TCM and Modern medicine,preliminary made the FD-PRO scale.2FD-PRO through scientific item selection and evaluation, have certainscience. It can be used to assess the clinical research and the effect of TCMand Modern medicine on FD, and can be used for further popularization andapplication.3This topic for TCM clinical evaluation provides new ideas andreference.