ABSTRACT
Evidence and value：impact on DEcisionMaking （EVIDEM） framework was developed by EVIDEM collaboration. Its core is the combination of multiple criteria decision analysis （MCDA） model and standardized health technology assessment （HTA） report， which aims to evaluate the overall value of medical interventions. It has been tested and implemented in the real-world evaluation environments. After more than 10 years of development， EVIDEM framework has been updated to version 10， and the relevant operation manuals have been published. More than 40 countries have joined the collaboration and more than 20 countries have carried out relevant studies. The framework is constructed with patients， population and sustainability as the overall goals， combing the evidence and value， forming a relatively complete decision-making framework system composed of 2 levels， 7 dimensions and 20 criteria. The two levels include normative universal criteria and contextual criteria. The normative universal criteria， namely EVIDEM core model， is the quantitative evaluation， consisting of 5 dimensions and 13 criteria. Contextual criteria， namely contextual tools， are qualitative evaluation， consisting of 2 dimensions and 7 criteria. The specific operation steps of EVIDEM framework include selecting and constructing criteria， assigning weights， integrating and evaluating evidence， quantitative and qualitative evaluation of value， comprehensive value estimation and ranking based on value estimation. EVIDEM framework is applicable to disease diagnosis， treatment， management and other fields. Its application scope includes medical insurance reimbursement， clinical practice decision-making， drug selection and so on， which can provide a method for more systematic， transparent and scientific healthcare decision-making. At present， the framework has been introduced into the field of traditional Chinese medicine and can provide a scientific and feasible evaluation tool and methodology system for the clinical comprehensive evaluation of Chinese patent medicine.
ABSTRACT
Traditional Chinese medicine （TCM） health technology assessment （HTA） provides scientific information and decision-making basis for decision-makers at all levels to choose TCM health technology reasonably. However， it is still in its infancy. In the future， it is necessary to strengthen top-level design， improve cognition and attention， enhance talent training and cooperation， and speed up the development of evaluation criteria in line with the characteristics of TCM， so as to promote the development of HTA in TCM. Therefore， it is imperative to create a method system and tools suitable for TCM HTA. Evidence and value impact on decisionmaking （EVIDEM） framework is developed by EVIDEM collaboration. It combines evidence and value to form a relatively complete decision-making framework system， which can provide methodological support for medical insurance reimbursement， clinical practice decision-making， drug selection and so on. The introduction of EVIDEM framework into the field of TCM has methodological feasibility and practical operability， but it is still necessary to further integrate and optimize the TCM characteristics. On the basis of theoretical research， pilot studies are carried out with Chinese patent medicine as the breakthrough point， forming a preliminary framework and implementation path for the research of TCM HTA， in order to promote healthcare decision-making and achievement transformation.
ABSTRACT
This study systematically evaluated the effectiveness and safety of Dingkundan combined with conventional western medicine in the treatment of female infertility. Four Chinese databases，three English databases， and two clinical trial registration platforms were retrieved from inception to April 2021. Two researchers independently carried out literature screening，data extraction，risk assessment of bias，and grading of evidence quality. RevMan 5.4.1 was used for data analysis. A total of 216 research articles were retrieved and 21 randomized controlled trials （RCTs） were included，involving 2 172 cases. The risks of bias in the included RCTs were high. As unraveled by Meta-analysis results， Dingkundan combined with western medicine for ovulation stimulation was superior to western medicine for ovulation stimulation alone in improving pregnancy rate and progesterone level ［relative risk（RR）pregnancy rate=1.67，95% confidence interval（CI）（1.44，1.93）；standardized mean difference （SMD）progesterone=1.21，95% CI（0.82，1.60）］. Dingkundan combined with western medicine for improving the endometrium was superior to western medicine for improving the endometrium alone in improving the pregnancy rate ［RRpregnancy rate=1.35，95% CI（1.23，1.48）］. Dingkundan combined with clomiphene was more effective than clomiphene alone in regulating endometrial thickness and reducing follicle-stimulating hormone and estradiol levels ［MDendometrial thickness=3.34，95% CI（3.27，3.41）， MDfollicle-stimulating hormone=-0.42，95% CI（-0.65，-0.19）， MDestradiol=-4.33，95% CI （-8.18，-0.48）］. Dingkundan combined with letrozole was superior to letrozole alone in increasing the follicle-stimulating hormone level and reducing the estradiol level ［MD follicle-stimulating hormone=1.14，95% CI（0.49，1.78）， MDestradiol =-33.65，95% CI（-59.13，-8.17）］. The single-study results showed that Dingkundan combined with conventional western medicine had certain advantages in regulating endometrial thickness，reducing follicle-stimulating hormone，luteinizing hormone，and estradiol levels，and increasing progesterone levels. The Grading of Recommendations， Assessment， Development， and Evaluation（GRADE）system was used for the evaluation of outcome indicators. The results showed that the quality of the evidence was graded moderate or low. Based on the existing evidence，Dingkundan combined with western medicine for infertility treatment had certain advantages in increasing the pregnancy rate， improving endometrial thickness， regulating hormone levels， and reducing adverse reactions. However，affected by the quality of the included trials，the results may have limitations，and high-quality RCTs are needed for verification in the future.
ABSTRACT
The present study systematically evaluated the efficacy and safety of Pushen capsule （PC） in the treatment of hyperlipidemia （HPL） to provide the basis for its clinical application in the future. The randomized controlled trials （RCTs） of PC in treating HPL were comprehensively retrieved from four Chinese databases and three English databases. The included RCTs were evaluated using the Cochrane risk-of-bias tool， followed by the Meta-analysis by RevMan 5.3. Twenty-four RCTs were included， with 2 634 patients involved. The patients in the experimental group were treated with PC， PC combined with conventional therapy，or PC combined with other Chinese patent medicine. The cases in the control group were treated conventionally or by other Chinese patent medicine. Meta-analysis results showed that PC alone or in combination was superior to the treatment in the control group in improving total cholesterol （TC），triglyceride （TG），high-density lipoprotein cholesterol （HDL-C），low-density lipoprotein cholesterol （LDL-C），and total response rate. Fourteen trials reported adverse reactions， including seven reporting specific results. The adverse reactions were dominated by epigastric discomfort， but the difference was not statistically significant. However， affected by the quality of the included trials，the evidence strength of the conclusion of this study is graded low. More high-quality RCTs reported in detail are needed for further confirmation.