Objective To study the relationship between the expression of p53，bcl-2 and nm23 and clinicopathology in the patients with gastric cancer and to probe the correlation among the expression of three kinds of oncogene.Methods Eighty cases of different differentiated gastric cancer, 37 cases of peri-tumor atypical mucosa hyperplasia and 20 cases of normal gastric mucosa were stained by immunohistochemistry (SP method).The expression of p53,bcl-2 and nm23 was analyzed with their relation to histologic type，differentiation，lymph node metastasis and prognosis of gastric carcinoma.Results The positive rates of bcl-2 protein expression in mild,middle and severe peritumor atypical hyperplasia were 7.1%, 18.1% and 25.0%. There was no obvious difference among 3 groups (Pgt;0.05). The bcl-2 positive rates of welldifferentiated and poordifferentiated gastric cancer were 78.2% and 48.5% respectively, the difference was obvious (P＜0.05). The positive expression rate of p53 protein in welldifferentiated gastric cancer was 72.5%, obviously lower than that of poordifferentiated gastric cancer (86.2%,P＜0.05). The positive rate of nm23 in welldifferentiated gastric cancer was 84.3%, obviously higher than that of poordifferentiated (17.2%),and the expression rate of nonlymph node metastasis group was higher than that of lymph node metastasis group (P＜0.05). The expression rate of nm23 protein was closely correlated to tumor differentiation and lymph node metastasis (P＜0.05). There was a negative correlation between p53 and bcl-2 expression. Conclusion bcl-2 and p53 can be important indices for tumor differentiation and prognosis. nm23 protein plays an important inhibiting role in the process of gastric cancer metastasis and may be a molecular biological basis for the evaluation of patients prognosis in gastric cancer.
Objective To understand the feasibility of application of objective performance criteria single arm trial in clinical efficacy evaluation of traditional Chinese medicine, and put forward theoretical countermeasures for the difficulties in application, so as to provide references for promoting the application of objective performance criteria single arm trial in clinical efficacy evaluation of traditional Chinese medicine in the future. Methods Semi-structured qualitative interviews were conducted among clinical experts and methodologists who were involved in objective performance criteria single arm trials using purposive sampling combined with snowball sampling and a preset interview outline. To explore the application situations, influencing factors and difficulties in the application process of objective performance criteria single arm trial in the clinical efficacy evaluation of traditional Chinese medicine, and put forward theoretical countermeasures. Results A total of 12 respondents were interviewed, including 7 clinical experts and 5 methodologists. The interview content was summarized and formed into 216 codes. After category analysis, 5 categories were formed, including the applicable situations, advantages, limitations, difficulties in the application process and theoretical countermeasures. The respondents believed that objective performance criteria single arm trial could be used as an alternative plan when controlled trials could not be carried out, or as a preliminary exploration or evidence supplement. It had the advantages of reducing sample size, good patient compliance, saving resource input, and relatively rigorous design. However, its application was limited due to low awareness and unclear level of evidence. The application difficulties included the setting of objective performance criteria, sample size calculation, quality control and statistical analysis. It was suggested to form a standard to promote its application in the efficacy evaluation of traditional Chinese medicine. Conclusion The design of objective performance criteria single arm trial is consistent with the characteristics of clinical research of traditional Chinese medicine. However, because there is no control group, the validity of objective performance criteria single arm trial is challenged, which hinders its further application in the clinical efficacy evaluation of traditional Chinese medicine. By standardizing the selection of objective performance criteria, calculation of sample size, statistical analysis methods and research implementation steps, the strength of its demonstration and the recognition can be improved to a certain extent, but attention should be paid to avoid its misuse. In the future, the objective performance criteria single arm trial may be used as a basis to further explore the new direction of scientific research methods for clinical efficacy evaluation of traditional Chinese medicine.
In the formulation of the clinical question of traditional Chinese medicine clinical practice guidelines, even if the intervention elements (intervention or control) have an appropriate scope, guideline developers are still faced with a variety of interventions. By analyzing the difficulty and necessity of priority selection of intervention interventions, we propose the approach of extending expert evidence to the process of priority selection of intervention interventions, and further provide the methodology of expert evidence data collection table design, application, data presentation and expert decision-making method to provide references and guidance for guideline developers.
Clinical practice guidelines will be incorporated in different evidence sources and evidence types, the research and exploration of multiple sources of evidence at China and foreign, this paper advocates the construction of both characteristics of multi-source evidence of traditional Chinese medicine, by combing 70 guide manuals, analyze the necessity and advantages of multi-source evidence construction, and further from the multi-source evidence source and evidence logic theory interpretation and application, in order to provide methodological references for the formulation of evidence-based clinical practice guidelines of traditional Chinese medicine.
Currently, the recommendations of the clinical practice guidelines related to acupuncture in China and abroad are opaque to the source of the acupuncture prescription, there is a lack of comprehensive evaluation of the rationality of the acupuncture prescription, and the standards for the selection of the acupuncture prescription are opaque and nonstandard, and the writing and reporting details are insufficient, thus affecting the clinical applicability of the guidelines. To a certain extent, the utilization rate of the recommendations of the guidelines is low. This paper discusses the origin, rationality comprehensive evaluation, priority selection, writing and reporting of acupuncture prescriptions, and puts forward detailed methodological suggestions, to provide guidance makers of methodological optimization thoughts and suggestions for the evaluation, selection and writing of acupuncture prescriptions in the recommendations.
When prioritizing clinical questions in the development of the clinical practice guidelines, clinical questions with high recognition and low variability, or high score and less disagreement among experts were often prioritized, while questions with high recognition but high variability were excluded. By this approach, clinical questions with practical value but also showed high variability due to different causes were not accepted as priorities. There were some methodological and clinical limitations by doing so. By summarizing the causes and connotations of expert opinion variability in terms of clinical experience, expertise and values, this paper analyzed the advantages of the variability quantification application, and proposed corresponding methodological recommendations, so as to provide references for guideline developers in the priority selection of clinical questions.
In the process of formation of recommendations of clinical practice guidelines, experts have many difficult problems of lack of transparency and high subjectivity in making final decisions, such as incomplete comprehensive consideration of dimensions and great heterogeneity in the evaluation of importance between dimensions, etc. As a decision-making tool, multi-criterion decision analysis improves the decision-making level of recommendation by adding the combination of qualitative and quantitative methods. By analyzing the challenges facing the formation of recommendations, this paper introduces the decision assistance of multi-criterion decision, and analyzes and summarizes the advantages and methods of the application of multi-criterion decision, so as to provide reference and guidance for guide makers to solve the difficulties in the formation of recommendations.
In the process of formulation, traditional Chinese medicine clinical practice guidelines are often faced with the dilemma of lack of evidence. Guidelines development groups tend to make final decisions based on expert experience or expert opinion, but the limitations of cognitive bias reduce the credibility and transparency of the guidelines. By clarifying the difference between the expert experience and expert opinion and expert evidence, the expert evidence of traditional Chinese medicine discipline advantages and necessity, providing the recommendation form link using expert evidence methodology design and implementation details, retaining the empirical characteristics of traditional Chinese medicine and improving the lack of evidence, has certain practical application value.
After the completion of a clinical trial, its conclusion generally depends on the results of statistical analysis of the main outcome, that is, whether the P-value in the hypothesis test is less than the α level of the hypothesis test, usually α=0.05. The size of the P-value indicates the sufficient degree of reason for making the hypothesis judgment, and can be interpreted as to determine whether a conclusion is statistically significant but does not involve the difference in the degree of drug effects or other effects. Fragility index, which is, the minimum number of patients required to change the occurrence of a target outcome event to a non-target outcome event from a statistically significant outcome to a non-significant outcome, can be used to assist in understanding of clinical trial statistical inference results and assisting in clinical decision making This paper discusses the concept, calculation method and clinical application of the fragility index, and recommends that the fragility index be routinely reported in all future randomized controlled trials to help patient clinicians and policymakers make appropriate and optimal decisions.