Objective To compare the efficiency of epidermis cell culture between big graft method and small strip method. Methods The big graft method was to cut the skin tissue reticularly from dermis layer while the epidermis were not cut off. After it was digested fully in trypsin, theepidermis was separated from skin and was used to culture epidermal cells. The small strip method was routine. The time to cut the skin and to separate the epidermis was recorded, and the number and quality of cells were compared between two methods. Results It took 8-10 minutes to cut an area of 5 cm2 skin into small strips and 1-2 minutes into big grafts. It took 10-15 minutes to separate the epidermis from the same area skin by small strip method and 2 minutes by big graft method. The cells showed better vigor and its number was more by big grafts than by small strips.The chance of fibroblast contamination was reduced obviously. Conclusion The big graft method is simpler than the small strip method and can culture more epidermis cells with less chance of fibroblast contamination.
Surgical management of osteoarthritis of the knee: evidence based guideline contains 38 recommendations pertaining to the preoperative, perioperative, and postoperative care of patients with knee osteoarthritis (KOA) who are considering surgical treatment. Compared with the domestic consensus on diagnosis and treatment for KOA, this clinical practice guideline (CPG) prepared by the American Academy of Orthopedic Surgeons (AAOS) has some advantages in terms of methodology selection and recommendation. Therefore, it is necessary for us to interpret this CPG to speed up the understanding and dissemination of the CPG. The ultimate aims are to: ① strengthen the standardization and understanding of surgical treatment of KOA; ② enhance the understanding of clinicians for this CPG in treating KOA; ③ speed up the development of guideline development methodologies in China; ④ provide methodological guidance for the development of CPG based on the current situation in China.
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.
Objective To investigate the methodological characteristics of observational studies on the correlation between drug exposure during pregnancy and birth defects. Methods The PubMed database was searched from January 1, 2020 to December 31, 2020 to identify observational studies investigating the correlation between drug use during pregnancy and birth defects. Literature screening and data extraction were conducted by two researchers and statistical analysis was performed using R 3.6.1 software. Results A total of 40 relevant articles were identified, of which 8 (20.0%) were published in the four major medical journals and their sub-journals, 21 (42.5%) were conducted in Europe and the United States, and 4 were conducted (10.0%) in China. Cohort studies (30, 75.0%) and case-control studies (10, 25%) were the most commonly used study designs. Sixteen studies (40.0%) did not specify how the databases were linked. Sixteen studies (40.0%) did not report a clear definition of exposure, while 17 studies (42.5%) defined exposure as prescribing a drug that could not be guaranteed to have been taken by the pregnant women, possibly resulting in misclassification bias. Six studies (15.0%) did not report the diagnostic criteria for birth defects and 18 studies (45.0%) did not report the types of birth defects. In addition, 33 studies (82.5%) did not control for confounding factors in the study design, while only 19 studies (47.5%) considered live birth bias. Conclusion Improvements are imperative in reporting and conducting observational studies on the correlation between drug use during pregnancy and birth defects. This includes the methods for linking data sources, definition of exposure and outcomes, and control of confounding factors. Methodological criteria are needed to improve the quality of these studies to provide higher quality evidence for policymakers and researchers.
Currently, there is a lack of clarity and standardization regarding the implementation details of interventions in traditional Chinese medicine clinical practice guidelines (CPGs). This in methodological guidance for standardizing the implementation prescription adversely impacts the quality of implementation and hinders the clinical application rate of recommendations. Through in-depth analysis of implementation prescription of evidence-based CPGs in traditional Chinese medicine, we identified the challenges associated with standardization. In response, we propose enhancing the technical specifications of implementation prescriptions, advocating for improved formulation processes, diverse reporting approaches, and standardizedological guidelines. These recommendations aim to serve as a methodological reference and guidance for clinical practice guideline developers.
Objective To assess the methodological quality of systematic reviews/ meta-analysis of burden of illness, analyses the factors affecting it, so as to provide a reference basis for improving the methodological quality of related studies. Methods Systematic reviews/ meta-analysis of burden of illness were identified in PubMed, searching from its inception to 12 October 2024. Systematic reviews/ meta-analysis of burden of illness was included, the methodological quality of the included literature was evaluated using AMSTAR-2, and data were extracted using Excel 2021. Results A total of 308 systematic reviews/ meta-analysis were included, with a fluctuating upward trend in the number of publications from 2006 to 2024; of these, a total of 12 were rated as low quality. According to the AMSTAR-2 entries, the largest number of documents fully conformed to entry 16 (82.14%), followed by entry 5 (81.49%), and entry 8 (72.73%); one document conformed to entry 10 (0.32%), and relatively few conformed to entry 12 (68.83%), entry 13 (85.39%), and entry 15 (67.53%). ConclusionThe methodological quality of systematic reviews/ meta-analysis of burden of illness needs to be improved, and the main problems include the lack of pre-study protocols, the absence of a list of excluded literature, and the less than adequate explanation of heterogeneity and risk of bias, etc. There is still a need to further improve the methodological quality of the systematic reviews and to promote the long-term development of evidence based medicine.
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.
Indirect comparison refers to a comparison of different healthcare interventions using data from separate studies, and is often used because of a lack of, or insufficient evidence from head-to-head comparative trials. We aimed to summarize the definition, fundamental theory, type, relevant statistical contents, and to clarify some question on how to use indirect comparison, in order to attract more researchers' attention and promote methodological development of indirect comparison.
This article introduces development methods and notices about evidence-based clinical practice guidelines of ventilator-associated pneumonia (VAP) and discuss the similarities and differences between GRADE system and the methodological studies of other clinical guidelines, focusing on the analysis of literature retrieval, quality of evidence, formation of recommendation strength, and detailed measures on how to ensure correct understanding and rationally using the GRADE system. Applying the GRADE system to develop evidence-based clinical practice guidelines of VAP could clearly present the quality of evidence and make recommendations.