| Background:In recent years,with more and more large-scale multi-center clinical research studies,the importance of quality management more and more revealed. How to measure and to ensure that accuracy and precision of different observation(or evaluation) method among different researchers becomes a major clinical research topics.Observation of clinical symptoms is a key step to obtain information in clinical practices or clinical research process. Observation of clinical symptoms has also played an important role in all aspects and links of the clinical research process.In order to improve the quality of clinical research and the veracity of the findings for clinical studies,agreement of quality management in clinical research of TCM is not only of great significance,but also very necessary.At present,there are very few clinical studies about agreement of clinical observation in our country.To explore agreement and related factors of observation of clinical symptoms in TCM clinical research has an important practical significance.Objective:In this study,through evaluation agreement of observed symptoms of the same patients by different physicians of TCM,it is easy to show the agreement of observed symptoms among researchers,and to analyze the reasons for inconsistencies and its possible links.The method has been proposed for improving the quality and reliability of results in clinical research of TCM.Methods:The site investigation and a direct inquiry were performed in the study. A total of 2 pairs of 4 physicians of TCM,who were as researchers in the study projects of difficult diseases in the National Science and Technology Supported Program during the Eleventh Five-Year Plan Period,investigated the subjects respectively at the same time from January 13,2009 to February 5, 2009 in Department of Nephropathy Endocrinology in the Beijing University of Traditional Chinese Medicine,Dongzhimen Hospital and Department of Respiratory in the First Affiliated Hospital of the Henan College of Traditional Chinese Medicine.The baseline information of all the patients and doctors were collected. Syndromes of TCM,clinical symptoms,tongue and pulse signs observed by two doctors respectively.The agreement of clinical observed items were evaluated by the method of Kappa,weighted Kappa,and intraclass correlation coefficient (ICC).Results:The results indicated that the agreement of two doctors was very good (Kappa values＞0.80).Among the 34 items of main TCM symptoms indicators of diabetic nephropathy,the agreement assessment of listlessness and fatigue, swollen tongue with scalloped edges,pale swollen tongue,deep,thready and slow pulse,and oscitancy was unsatisfactory(Kappa value＜0.60).The agreement was moderate(0.6＜Kappa value＜0.8) in items of thready and weak pulse,sallow complexion,aversion to heat,sweat or night sweat,dysphoria with feverish sensation chest,palmsand soles,red and thin tongue with cracks,thin and rapid pulse,night pollakiuria,swollen tongue with white moss and hyperspasmia.The agreement of the rest symptoms were all very good(Kappa value＞0.80).Among the 15 items of observed main COPD symptoms,tongue coating and pulse had a lower consistence(Kappa value＜0.60),tongue material and tongue shape had appropriate consistence(0.6＜Kappa value＜0.8),the rest were observed with higher level consistency.Total of 49 symptoms observed in two diseases were unsatisfactory agreement assessment(14.3%of total symptoms). Moderate agreement can be accounted for 24.5%,and good agreement for 61.2%.Conclusion:This study showed that the symptoms,which could achieved our expected agreement(correlation coefficient＞0.6),were up to 85.7%.This demonstrated that the agreement between the investigated doctors is very high.The results indicated that the doctors who participate in clinical research of TCM have revealable professional quality.In addition,it make out that different doctors had an unreliable agreement in tongue and pulse,which account for a large proportion inconsistency.With analyzing of inconsistent reasons,it can be summarized as three reasons including investigated doctors, investigated patient,external factors and so on. |
PDF Full Text Request