1 ObjectiveTo develop a self-reported Postprandial Distress Syndrome Symptom Scale(PDSS)by patients with postprandial distress syndrome(PDS),the reliability and validity of the scale will be assessed.2 MethodsThe development of the PDSS consisted of three parts:the development of the original scale,the pre-testing of the scale language,and the pre-survey of the scale.(ⅰ)the original scale was developed by literature research and modified Delphi method;(ⅱ)the scale language pre-testing was done by semi-structured interview and questionnaire;(ⅲ)in the pre-survey part of the scale,40 healthy individuals and 40 patients with PDS were included in the survey,and the scale entries were further screened and revised to form the final official version of the scale.For the reliability and validity assessment part of the PDSS,100 healthy individuals and 100 patients with PDS were included for scale assessment,and the data were statistically analyzed using validated factor analysis methods,Pearson’s correlation coefficient,Cronbach’s alpha coefficient,and nonparametric tests to evaluate the reliability,validity,and discrimination of the scale.The PDSS was then used to measure the change in symptom scores of 100 PDS patients before and after treatment(1 week).The paired t-test was used to evaluate the scale’s responsiveness.3 Results3.1 Development of the scalePDSS is a single-dimensional symptom scale in the form of question and answer.PDSS was self-assessed daily by PDS patients using visual analog scores.The scale has eight entries,each with a total of 2 sub-entries,recording the presence or absence of symptoms and the severity of symptoms,respectively.The items include postprandial fullness,early satiety,nausea,acid reflux,hiccups,lack of appetite for meals,bloating,and burning sensation in the stomach.The scoring method used was visual analog scoring.3.2 Reliability and validity assessment of the scaleFeasibility:In the formal survey of the scale,three rounds of PDSS were distributed to PDS patients in this research:at the time of enrollment(first round),24-48 hours after enrollment(second round),and on the 7th day after enrollment(third round).The effective recall rate was 80.65%in the first round,89%in the second round,and 96.63%in the third round.The average filling time of PDSS was 94.6±101.045 seconds.The above shows that PDSS has good feasibility.Reliability:The internal consistency of Cronbach’s a of the PDSS was 0.822.The retest reliability was 0.88,indicating that the PDSS has good reliability and stability.Validity:The structural validity fit index of the PDSS was 0.876,and the content validity index at the scale level was 0.7375.There was a good association between the PDSS and the LDQ and SFNDI(p<0.001),indicating the extent to which the scale truly reflects the characteristics of the object it is intended to measure.Distinguishability:PDSS can distinguish between healthy people and PDS patients better,and the difference is statistically significant(P<0.001).It indicates that the PDSS has a good differentiation degree.Responsiveness:There was a statistically significant difference in the change of PDSS scores at the time of enrollment and on the 7th day of enrollment(P<0.001).It indicates that the PDSS can better detect minimal clinically important differences in the respondents.4 ConclusionsPDSS is a single-dimensional symptom scale in the form of question and answer.PDSS was self-assessed daily by PDS patients using visual analog scores.The PDSS has eight entries,each with a total of 2 sub-entries,recording the presence or absence of symptoms and the severity of symptoms,respectively.The items include postprandial fullness,early satiety,nausea,acid reflux,hiccups,lack of appetite for meals,bloating,and burning sensation in the stomach.It can be used to evaluate the clinical efficacy of postprandial distress syndrome. |