ObjectiveTo evaluate the methodological quality of cross-sectional surveys about Chinese medicine syndrome in a population at potential risk of cerebrovascular diseases. Methods The CNKI, WanFang Data, CBM and PubMed databases were electronically searched to collect cross-sectional surveys about Chinese medicine syndromes in a population at potential risk of cerebrovascular diseases from inception to December, 2022. The methodological quality was assessed using the JBI scale. Results A total of 105 studies were included. The average reporting rate of JBI was 52.06%, and the items with the highest scores included "sufficient coverage of the identified sample in data analysis" (100%), "description of study subjects and setting" (92.38%), and "using valid methods for the identification of the condition" (86.67%). Items with the lowest scores included "adequate sample size" (13.33%), "adequate response rate or low response rate managed appropriately" (14.29%), and "study participants recruited in an appropriate way" (20.95%). Subgroup analysis suggested that type of publication and number of implementation centers were potential factors influencing methodology quality (P<0.05). Conclusion The methods essential to a cross-sectional survey such as sampling, sample size calculation and handling with the response rate, and the syndrome diagnosis scales specific to Chinese medicine require further improvement.
ObjectiveTo systematically review the application status of Delphi method in clinical research of traditional Chinese medicine (TCM).MethodsPubMed, EMbase, CNKI, WanFang Data and VIP databases were electronically searched to collect original research and methodological research on Delphi method in TCM from inception to August 30th, 2020. Two reviewers independently screened literature, extracted data, and then, descriptive analysis was performed by using qualitative methods.ResultsA total of 612 articles involving 573 original studies and 39 methodological studies were included, which involved 167 types of diseases. The primary research purposes were disease diagnosis and treatment, syndrome research, scale development, evaluation research, index research, clinical investigation, methodology research, and other 8 categories. 487 papers reported the implementation process and results of Delphi method in varying degrees.ConclusionsDelphi method is widely used in clinical research of TCM, however, there are deficiencies in the specific implementation process.
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.
Adapting the existing guidelines in the context of specific regions can improve the efficiency of guidelines development, and reduce cost and time for developing guidelines. ADOLOPMENT is a methodological tool for guidelines adaptation, which was developed by the GRADE Working Group based on the standardized international guidelines making process. With ADOLOPMENT, developers can effectively use existing guidelines and evidence, avoid duplication of the evidence evaluation, and record the process from evidence to recommendations, which will ensure the transparency of adaptation, help users to understand the process, and improve the acceptability and credibility of guideline adaptation. This paper aims to introduce the ADOLOPMENT and its application.
World Federation of Acupuncture-Moxibustion Societies (WFAS) standard Norms for Formulation and Evaluation of the Clinical Practice Guidelines of Acupuncture and Moxibustion (Hereinafter referred to as Norms) is the first methodological specification for the development of guidelines of acupuncture and moxibustion (Acup-Mox) issued by an international academic organization. The Norms stipulates the principles, procedures, review process and requirements of the development of WFAS guidelines of Acup-Mox. It also proposes the development method, evaluation method, and reporting standards of WFAS guidelines of Acup-Mox. This article introduces the development process of the Norms and provides an interpretation of the methodological supplementary requirements for key links such as "formulation of clinical questions", "evidence retrieval, evaluation and synthesis", and "consensus decision-making", as well as the "framework and contents of recommendation" to provide relevant references for users in learning and using the Guidelines.
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.
ObjectiveTo understand the current status of research methods in disease burden systematic reviews, identify limitations and shortcomings of existing research methods, and provide suggestions to address relevant issues. MethodsA computer search of the PubMed database was conducted to collect systematic reviews on disease burden, with search limits set from database inception to December 21, 2023. Two independent researchers utilized Endnote 20 for literature screening and Excel 2019 for data extraction and descriptive analysis. ResultsA total of 216 articles were included in the review, revealing a year-on-year increase in the number of systematic reviews on disease burden since 2004. The journal PharmacoEconomics published the most articles (n=22), while research on certain infectious diseases and parasitic infections was the most prevalent (n=51). Only 31 articles provided a complete account of the entire systematic review process. The reporting rates for inclusion/exclusion criteria, information retrieval, literature screening, and statistical analysis steps were all 100%. However, the rate of protocol registration was relatively low at 19%. Eighty-eight percent of the articles utilized software such as Excel and Epidata for data extraction, yet only 32% adhered to the reproducibility principles outlined in AMSTAR-2. In terms of quality assessment, 105 articles underwent evaluation, with the Joanna Briggs Institute checklist and Newcastle-Ottawa scale being the most commonly used quality assessment tools for epidemiological studies, while economic studies preferred the Drummond checklist (n=9). Regarding the details of inclusion/exclusion criteria, only 53% of studies reported their study design in detail, and less than one-sixth provided a comprehensive description of the interventions and control measures. Statistical analyses predominantly employed qualitative methods (80%), with quantitative analyses comprising a minority (20%), all of which were conducted using meta-analysis techniques, primarily utilizing R software (n=15). ConclusionThe number of systematic reviews on disease burden has shown a yearly increasing trend; however, most studies have failed to comprehensively adhere to the fundamental processes of systematic reviews, significantly limiting their quality. Currently, the primary issues include a lack of protocol registration, incomplete supplementary searches, mismatched quality assessment tools, and insufficiently comprehensive outcome measures. To address these challenges, it is essential to develop a methodological guideline for systematic reviews on disease burden that incorporates these concerns. Such a guideline would standardize researchers' practices and ensure strict adherence to systematic review methodologies, thereby enhancing the scientific rigor of the research and its support for clinical decision-making.
Evidence-based medicine advocates to support clinical decision-making with the best evidence, which is useful to objectively evaluate the clinical efficacy of traditional Chinese medicine and optimize clinical diagnosis and treatment. However, significant individualized characteristics identified from syndrome differentiation and treatment are incompatible with evidence-based clinical decision-making, which highlights population-level evidence, to some extent. In recent years, a number of new methods and technologies have been introduced into individualized clinical efficacy evaluation research of traditional Chinese medicine to assist managing and processing complex and multivariate information. These methods and technologies share similarities with evidence-based medicine, and are expected to link the clinical practice of traditional Chinese medicine with evidence-based clinical decision-making. They will guide the development of evidence-based clinical decision-making in traditional Chinese medicine.
Methodological quality and transferability will be important issues for the credibility and usefulness of both published studies and administrative methods for evaluating the socio-economic value of marketed medicines in China. This paper critically examines factors commonly contributing to, or inhibiting, the quality and transferability of socio-economic evidence of the value of medicines, with specific reference to the Chinese community. It discusses appropriate approaches to design, performance, and reporting of published economic evaluation studies, as well as guides on assessment of quality of economic evaluations and recommends two internationally established methods that may be suitable for training in this setting.
As precision medicine continues to gain momentum, the number of predictive model studies is increasing. However, the quality of the methodology and reporting varies greatly, which limits the promotion and application of these models in clinical practice. Systematic reviews of prediction models draw conclusions by summarizing and evaluating the performance of such models in different settings and populations, thus promoting their application in practice. Although the number of systematic reviews of predictive model studies has increased in recent years, the methods used are still not standardized and the quality varies greatly. In this paper, we combine the latest advances in methodologies both domestically and abroad, and summarize the production methods and processes of a systematic review of prediction models. The aim of this study is to provide references for domestic scholars to produce systematic reviews of prediction models.