A Clinic Reseach Of Processing A Standardized Gastrointestinal Heat Retention Syndrome Diagnostic Scale Combining With Reliability And Validity Evaluation

Objective:It is meaningful to develop a Gastrointestinal Heat Retention syndrome diagnostic scale which should be critically appraised with reliability, validity, sensitivity, specificity and diagnostic accuracy, based on principles and methodologies of making a scientific scale, which will contribute to the development of clinical diagnosis and treatment for Gastrointestinal Heat Retention syndrome-related disease. We focused on processing Gastrointestinal Heat Retention syndrome diagnostic scale for adults and children, and original Gastrointestinal Heat Retention syndrome and facultative Gastrointestinal Heat Retention syndrome are involved.Methods:Literature analysisand expert consensus were used before data collecting, we conducted a multi-center clinical study to develop a scientific Gastrointestinal Heat Retention syndrome’s diagnosis standardized scale according to the principles of DME, then questionnaire was used to evaluate the reliability and validity by medical statistics methods. The study was based on a set of procedures and methods of scale development, preparation the syndrome diagnosis standard belong to Gastrointestinal Heat Retention independently. The specific methods and steps are as follows:(1) determine research objective and research objects;(2) establish a working group, preliminary adopt the scale items and normalize them. the initial scale entry into the results of the analysis based on the literature, and for standardized treatment;(3) based on Delphi technique select scale items subjectively;(4) based on clinical data, combined with statistical methods select scale items objectively;(5) empower the scale items and determine diagnostic thresholds with statistical methods (6) evaluate the reliability and validity of the diagnostic scale.Results:This study developed two Gastrointestinal Heat Retention syndrome diagnostic scales, specifically for adult and children, and the original Gastrointestinal Heat Retention syndrome and facultative Gastrointestinal Heat Retention syndrome are involved. We determined the Gastrointestinal Heat Retention syndrome’s quantized diagnosis standard, original syndrome, facultative phlegm-heat syndrome, facultative Qi deficiency syndrome and facultative Yin deficiency syndromes’diagnostic thresholds for children are98.5,20.5,34,31.5, Original syndrome, facultative phlegm-heat syndrome, facultative Qi deficiency syndrome and facultative Yin deficiency syndromes’diagnostic thresholds for adults are64.5, 19.5,30.5,23.5. The scale has been critical appraised for achieving good reliability and validity. ROC curve has been used to confirm the corresponding diagnostic thresholds.The quantized diagnosis standard which is determined at has been validated by, the results showed that this diagnosis standard could have a good sensitivity, specificity and diagnostic accuracy.Conclusion:The study developed a Gastrointestinal Heat Retention syndrome diagnostic scale which has been considered as a subjective and scientific scale with good reliability and validity. The scale raised a diagnosis standard with a proper threshold which is sensitive, specific and accurate. The scale would contribute to the diagnose of gastrointestinal heat retention syndrome, and the weight would make sense to reflect the essence of the patient The study not only determined Gastrointestinal Heat Retention syndrome’s quantized diagnosis standard, but also a meaningful exploring to standardize the methodology of how to construct a TCM syndromes’ diagnosis standard.