Formulation And Evaluation Of Diagnostic Criteria Of Kidney Yang Deficiency Syndrome Based On Mixed Methods Research

1 ObjectiveAdopting a mixed-method research model,establishing the "Diagnostic Criteria for Kidney Yang Deficiency Syndrome" with reasonable entries,clear definitions,strong operability,and accurate diagnosis,and conducting clinical evaluations,providing a standardized and reliable diagnostic criteria of Kidney Yang deficiency syndrome for clinical work and research on new Chinese medicines with syndromes.2 MethodsThe formulation of the "Diagnosis Criteria for Kidney Yang Deficiency Syndrome" adopts the design of explanatory sequence and exploratory sequence.Among them,quantitative research methods include literature research,on-site Delphi method and expert questionnaire survey;qualitative research methods include expert meeting method and qualitative interview method.In the evaluation part of the "Diagnostic Criteria for Kidney Yang Deficiency Syndrome",111 subjects were included,the criteria and the doctors were discriminated to collect symptoms information.Project analysis method,cross analysis method,multiple response analysis,linear regression analysis,discrimination analysis and other methods were used to analyze the data statistically,and the accuracy of standard discrimination,the sensitivity and specificity of items were evaluated.3 Results3.1 Establishment of diagnostic criteria entry pool for Kidney Yang deficiency syndromeA total of 41 relevant literatures related to the diagnostic criteria of Kidney Yang deficiency syndrome from 1962 to 2016 were retrieved,and 21 common diagnostic criteria were included as the source of symptom entries.There are 2 national standards,1 institutional standard,8 monographs,5 textbooks,and 5 journal articles.Through the division and standardization,the number of existing diagnostic items of Kidney Yang deficiency syndrome was reduced from 252 to 131,and a standard diagnostic item pool of Kidney Yang deficiency syndrome was established.The items pool contains 53 localized items,25 qualitative items,19 tongue items,and 10 pulse items,which has laid a good literature research foundation for the development of diagnostic criteria for kidney-yang deficiency syndrome.3.2 Preliminary screening of diagnostic items for Kidney Yang deficiency syndromeIn this study,Delphi method and brainstorming method were used to complete the preliminary screening of the diagnosis items of Kidney Yang deficiency syndrome,and the main items in the diagnosis of Kidney Yang deficiency syndrome were basically determined.4 localized items,including soft waist and knees,frequent nocturia,clear urine and nocturia;3 qualitative items,including aversion to cold,cold pain in the waist and knees,and morning diarrhea;5 tongue items,including pale tongue,fat tongue,tender tongue,white fur and slippery fur;7 pulse items,including deep pulse,weak pulse,late pulse,fine pulse,micro-pulse,insufficient ulnar vein,especially ulnar,2 other items,including Tired and debilitated.Expert discussions reached a consensus and determined that the type of diagnostic criteria for Kidney Yang deficiency syndrome established in this study is a common diagnostic criterion.This study provides a reference for the design of subsequent questionnaires and the selection of items.3.3 Optimization of diagnostic items for Kidney Yang deficiency syndromeThe explanatory sequence design was used in this study,through the integration of quantitative and qualitative data,determined that nocturia,soreness of waist,and aversion to cold can basically be the main items for diagnosis of Kidney Yang deficiency syndrome.The determination of clear urine,morning diarrhea and anaphrodisia,as well as the identification of tongue and pulse items require further screening.This interview preliminarily determined the principles of quantitative or qualitative diagnosis that can be used in the diagnosis of Kidney Yang deficiency syndrome,and provided valuable opinions and suggestions for the design of expert questionnaires(research tools)and the definition and classification of items3.4 Determination of diagnosis items and their weight of kidney Yang deficiency syndrome based on large sample questionnaireThis study Through exploratory sequence design,the results of qualitative interviews were incorporated into the design of the questionnaire,and the questionnaire was optimized through expert demonstration.A total of 220 experts from 35 hospitals in 15 provinces and cities participated in the survey.This survey has good reliability,consistency and effectiveness.In this study,the quantitative screening of Kidney Yang deficiency syndrome was completed,and the diagnostic basis of Kidney Yang deficiency syndrome was initially determined.5 localized items:nocturia,soreness of waist,anaphrodisia,clear urine and erectile dysfunction;6 qualitative items:aversion to cold,edema,morning diarrhea,pale complexion,coldness,and thinning leukorrhea;1 tongue item:pale white tongue;3 pulse image items:deep pulse,weak pulse and obviously in chi pulse3.5 Deep optimization of diagnosis basis and principles of Kidney Yang deficiency syndromeThis study uses a study design of explanatory sequences.Through in-depth interviews and expert review meetings,the applicability and feasibility of the diagnostic criteria for kidney-yang deficiency syndrome were demonstrated,and the diagnostic basis and principles were further optimized.The diagnostic basis of the "Diagnosis Criteria of Kidney Yang Deficiency Syndrome" was determined:4 localized items were nocturia,soreness of waist,morning diarrhea,and anaphrodisia;3 qualitative items were aversion to cold/aversion to cold and cold limbs,edema and bright pale complexion;1 tongue item,which is pale and tender tongue;1 pulse item,which is deep and weak pulse,obviously in chi pulse.The diagnostic principle of the "Diagnosis Criteria for Kidney Yang Deficiency Syndrome":at least 1 localized item,at least 1 qualitative item,and 1 of the tongue or pulse(The weight score can be used as a reference for the classification of light,medium,and heavy syndromes).3.6 Clinical Evaluation of "Diagnostic Criteria for Kidney Yang Deficiency Syndrome"A total of 111 subjects with no abnormalities in physical and chemical examination indexes were included in this study to evaluate the applicability of the diagnostic criteria for Kidney Yang deficiency syndrome and the consistency of doctor's judgment.The 2 doctors jointly determined the kidney-yang deficiency syndrome as the gold standard.The diagnostic accuracy of the "Diagnosis Criteria for Kidney Yang Deficiency Syndrome" is 85.71%,and the Cohen's kappa coefficient of the consistency test is 0.81(P<0.001).Consistency can accurately diagnose Kidney Yang deficiency syndrome.Item multiple response analysis and linear regression analysis suggested that the three items of "soreness of waist","anaphrodisia" and"aversion to cold/aversion to cold and colds" are of great significance in the diagnosis of Kidney Yang deficiency syndrome.ROC curve analysis and item analysis suggest that the diagnostic basis and diagnostic principles of the "Diagnostic Criteria for Kidney Yang Deficiency Syndrome" are reasonable.The specificity of each item of "Diagnosis Criteria of Kidney Yang Deficiency Syndrome" is relatively high,which is suitable for scientific research.4 ConclusionThe inconsistency of diagnostic criteria for TCM syndromes and irregular terminology have affected the accuracy of TCM clinical syndrome differentiation and the standardization of research on new Chinese medicines with syndromes.Kidney Yang Deficiency Syndrome is one of the basic syndromes of traditional Chinese medicine.It involves many diseases such as urinary system,digestive system,respiratory system,cardiovascular and cerebrovascular system and reproductive system.The common diagnostic criteria for Kidney Yang deficiency syndromes is of great significance for guiding the clinical research,scientific research and the research of new drugs for syndromes of Chinese medicine.This study takes the formulation of the diagnostic criteria for kidney-yang deficiency syndrome as an example and adopts a mixed-method research model to establish the "Diagnostic Criteria for Kidney-yang Deficiency Syndrome" with the characteristics of reasonable item setting,clear interpretation,strong operability,and accurate diagnosis.It is expected to provide standardized diagnostic criteria for kidney-yang deficiency syndromes for clinical and scientific research in TCM,and to provide a reference for the research of syndrome criteria.This study reached the following conclusions:4.1 This study established the "Diagnostic Criteria for Kidney Yang Deficiency Syndrome".The diagnostic criteria include 9 items.This criteria uses a combination of localized items,qualitative items,tongue or pulse.The diagnosis principle of Kidney Yang deficiency syndrome:at least 1 localized item,at least 1 qualitative item,and 1 of the tongue or pulse(the weighted score can be used as the reference basis for the classification of light,medium,and severe syndromes).4.2 The mixed methods research is suitable for the research of the formulation of syndrome diagnosis criteria,which can improve the quality of the research of syndrome diagnosis criteria.Quantitative research and qualitative research both play an important role in the formulation of criteria.In this study,two research methods and their results are used to explanatory sequence and exploratory sequence design in mixed methods research.By formulating good quality control measures,standardizing the research process,mixed methods research has improved research quality in terms of interpretation of survey results,formulation of questionnaires,optimization of diagnostic basis and diagnostic principles.4.3 The clinical evaluation study provides a basis for the application of the standard.After the establishment of the "Diagnosis Criteria for Kidney Yang Deficiency Syndrome",clinical verification is needed.This study passed the clinical evaluation study of "Diagnosis Criteria of Kidney Yang Deficiency Syndrome",and evaluated the diagnostic basis and diagnostic principles from the angles of sensitivity,specificity,and discrimination of the items.Clinical evaluation studies have confirmed that the "Diagnosis Criteria for Kidney Yang Deficiency Syndrome" formulated in this study has the characteristics of reasonable item setting,clear interpretation,simple operation and accurate dialectics.The "Diagnostic Criteria for Kidney Yang Deficiency Syndrome" is suitable for scientific research in TCM.This study laid the foundation for the popularization and application of the standard.