| ObjectiveThe objective of this study was to explore the application evaluation technology of Clinical Practice Guidelines (CPGs) of Chinese medicines(CM) based on Analytic Hierarchy Process(AHP) and clinical cases. Two aims were involved.1. To establish the Evaluation Model for the Consistency between CPGs of CM and clinical cases. The model would be established by consulting clinicians based AHP, in order to explore the technology of evaluating the the consistency between CPGs of CM and clinical cases and the consistency of standards and objects, achieving the level of quantitative evaluation.2. To test the model based on the clinical cases. Two CM guidelines for Angina pectoris were selected to be evaluated, including Guidelines for Diagnosis and Treatment of Common Internal Diseases in Chinese Medicine Diseases of Modern Medicine (CPGs of DTCID) (ZYYXH/T50-135-2008) draw by China Association of Chinese Medicine and Evidence-based Guidelines of Clinical Practice in Chinese Medicine Internal Medicine(CPGs of EM) draw by China Academy of Chinese Medical Sciences. The model would be tested based on the clinical cases of Angina pectoris and in the purpose of analyzing the factors affecting the consistency and relations with clinical efficacy, which would contribute to promote the updating of CPGs of CM.Methods1. Establishing the Evaluation Model for the Consistency between CPGs of CM and clinical cases. According to preliminary research foundation, the key technical content were decomposed into 3 level, including 7 factors of Diagnosis of CM, Diagnosis of Modern Medicine, Syndrome of CM, Syndrome Differentiation, CM Recipe, Characteristics Therapy of CM and Prevention. Using the theory of AHP, the weight of factors which were calculated with Saaty fundamental scale by consulting clinicians and passed the consistency measurement required by AHP, were estimated and form the model.2. Testing the model based on the clinical cases. CPGs of DTCID and CPGs of EM for Angina pectoris were selected to be evaluated by the model. We quantitative evaluated the consistency between CPGs of DTCID and 150 Angina pectoris cases were, compared the superiority of consistency between CPGs of DTCID and CPGs of EM according to 85 cases of stable angina pectoris. The analysis was also executed to explore the causes of the consistency level and relation with clinical efficacy.ResultEstablishing the Evaluation Model for the Consistency between CPGs of CM and clinical cases. By calculating 59 consulting questionnaire passing the consistency measurement required by AHP, the weight of factors were estimated as follows:Diagnosis of CM 0.163026, Diagnosis of Modern Medicine0.13214, Syndrome of CM 0.115915, Syndrome Differentiation 0.142043, CM Recipe 0.211616, Characteristics Therapy of CM 0.079236 and Prevention 0.158458.The overall consistency between CPGs of DTCID and 150 Angina pectoris cases was 42.32±6.94% ranged from 35.21% to 63.37%, which reflected the relatively low consistency between them. The overall consistency was not effected by age, gender, type of Angina pectoris, condition of percutaneous coronary intervention(PCI), Angina Classification of Canadian Cardiovascular Society(CCS). The consistencies of the factors were Diagnosis of CM 100%, Diagnosis of Modern Medicine 100%, Syndrome of CM 38.25±4.40%, Syndrome Differentiation 34.17±8.15%, CM Recipe 31.08±23.64%, Characteristics Therapy of CM 7.92±19.13% and Prevention 0. The syndrome of qi-deficiency, turbid phlegm and blood stasis which 124 cases (82.7%) got was the most frequent syndrome. The overall consistency of the group with the syndrome of qi-deficiency, turbid phlegm and blood stasis was lower than the overall consistency of the group without that syndrome with a significant differences(P<0.05). The group with the syndrome of qi-deficiency, turbid phlegm and blood stasis had more white slimy fur than the group without the syndrome, which had a significant differences (P<0.05). In 150 cases,42 cases (28%) applied the CM recipe recommended by CPGs of DTCID, in which Gualouxiebaibanxia decoction was applied in 34 cases. According to CM recipe applications, the cases was divided into CM recipe guidelines recommended group, CM recipe not guidelines recommended group and CM recipe rejected group. The overall consistency and the CM-recipe consistency of CM recipe guidelines recommended group were the most highest among the groups with a significant differences (P<0.05). In 150 cases, Wendan decoction was applied in 64 cases (42.7%). According to Wendan decoction applications, the cases was divided into Wendan decoction group, not Wendan decoction group and CM recipe rejected group. The overall consistency and the CM-recipe consistency of Wendan decoction group were the most lowest among the groups with a significant differences (P<0.05). According to condition improvement degree, the cases was divided into 4 group, among which the overall consistencies were not significant different (P>0.05).Compare the superiority of consistency between CPGs of DTCID and CPGs of EM. The result showed that for 85 cases of stable angina pectoris CPGs of EM got a relative superiority consistency (62.97±4.96%), while CPGs of DTCID got 37.03±4.96%. On the factors "Diagnosis of CM" and "Diagnosis of Modern Medicine", two CPGs both got 100% showed equal consistency. On the factor "Syndrome of CM" and "Syndrome Differentiation", CPGs of EM got the relative superiority consistency 85.8% and 77.6%.73 cases got the syndrome of qi-def iciency, turbid phlegm and blood stasis and 8 cases got the syndrome of deficiency of both qi and yin. Compared to not syndrome of qi-deficiency, turbid phlegm and blood stasis group, the superiority of consistency for the syndrome of qi-deficiency, turbid phlegm and blood stasis group was higher with a significant differences (P<0.05). On the factor " CM Recipe", CPGs of EM just showed relative superiority on consistency in 24 case (28.2%) and on 59 cases two CPGs showed equal consistency.32 cases applied Wendan decoction, compared to the groups of not not Wendan decoction group and CM recipe rejected group, of which CPGs of EM superiority on consistency was higher with a significant differences(P<0.05). According to improvement degree of Angina Classification of CCS, CPGs of EM superiority on consistency was higher in improvement degree 0 and reduced by the improvement degree.ConclusionThe Evaluation Model for the Consistency based on AHP could achieve evaluation of consistency between CPGs of CM and clinical cases in a macro perspective, compare the relative superiority on consistency between two CPGs. On trend of consistency, evaluators could explore the factors affecting the consistency and obtain evidence to improve CPGs or clue to organize clinical trial. The technical methods using the evaluation model belongs to the consistency examination of standards and objects, might contribute to the exploration of consistency examination technical methods for standards.CPGs of DTCID for Angina pectoris recommending the syndromes of CM in single factor like turbid phlegm or blood stasis and two factors like deficiency of both qi and yin, show advantage on ease to realize and apply but not match complicated clinical condition of CM. The syndrome of qi-deficiency, turbid phlegm and blood stasis not prompted by the CPGs might be a frequent syndrome in Southern China which may causes the lower consistency of the CPGs. Also more study would be need to supplement the CM characteristics recommendation of prevention.CPGs of EM for Angina pectoris developed by method of evidence-based medicine getting relative superiority both in evaluation of Appraisal of Guidelines for Research and Evaluation Ⅱ (AGREEⅡ) and consistency, might indicate that for development of CM CPGs method of evidence-based gets better guidance in clinical practice than expert Consensus possibly. |
PDF Full Text Request