This is the second paper in the evidence-based medicine glossary series. It provides information on the principles for evidence-based medicine through definitions, criteria for inclusion and screening, regular flow-sheet, reporting format and the establishment of databases.
Objective To form the list of methodological quality evaluation and explanation for the selection of objective performance criteria in single arm trial, and initially construct a methodological guiding tool for the selection and evaluation of target value, so as far to provide a research basis for improving the system of single-arm trial quality evaluation by objective performance criteria method. Methods Combining the bias risk assessment method of observational study, interventional trails, domestic and foreign policy documents, and systematically collecting the common bias and evaluation key points, preliminarily proposing the list of methodological quality evaluation and explanation for the selection of objective performance criteria in single-arm trial, via two rounds of expert consensus voting using nominal group method, finally formulating the list based on the voting results and expert opinions. Results Through two rounds of discussion, sorting, comprehensive expert opinions, we improved the corresponding items in the list and finally formed the list of methodological quality evaluation and explanation for the selection of objective performance criteria in single-arm trial, which included four areas: authority, traceability, comparability, and reliability, including 10 items. The entries in each field considered both design and implementation throughout the clinical trial. Conclusion The methodology list developed in this study provides methodological guidance for the selection of objective performance criteria and quality evaluation, and provides a solid theoretical basis for the establishment of a complete methodological system of quality evaluation for objective performance criteria single arm trails.
Objective To observe the differentiation effect of rabbit amnion-derived stem cells (ADSC) induced into neural cells.Methods ADSC of New Zealand female rabbits were isolated and cultured. Its mRNA level of Fibronectin, Nestin and Vimentin were detected by real-time quantitative polymerase chain reaction. The selfreplication ability of ADSC was confirmed by monoclonal formation experiments. These ADSC were further induced into neural cells in vitro. Five days after induced differentiation, the expression of -tubulin and glial fibrillary acidic protein (GFAP) were detected by immunofluorescent staining. Results ADSC were separated from amnion tissue gradually after 24 hours. There were polygonal cells gathered around the amnion tissue at 72 hours, and were distributed compactly around the amnion at 120 hours. The morphology of cleavage daughter cells was basically the same as parent cells. ADSC has the ability of self-replication. The Nestin, Vimentin, Fibronectin mRNA expressions in ADSC were 15.79, 1.91, 7.65 times those in spleen cells. The differences were statistically significant(Z=-5.243, -3.972, -2.524; P＜0.05). The beta;-tubulin expression was found in cytoplasm of most cells. The GFAP expression was found in cytoplasm in some cells. Conclusions ADSC has self-replication ability. It can be induced into neurons and neuroglial cells under the right conditions.
Objective To assess the evidence of Cochrane systematic reviews on the treatment of temporomandibular disorders (TMD) as well as the methodological quality of all randomized controlled trials (RCTs) of the included systematic reviews. Methods The Cochrane Library (Issue 3, 2008) was searched for systematic reviews on the treatment of temporomandibular disorders. The risk of bias was assessed independently by two authors. Results Three systematic reviews involving 25 RCTs were included. The methods of 23 studies were rated as of lower quality with high risk of various biases. Only 2 studies were of high quality. Conclusion There is insufficient or inconsistent evidence to support the use of hyaluronate, occlusal adjustment, and stabilization splint therapy for the treatment of TMD. The overall quality of RCTs about the treatment of TMD is generally low. Analysis of the included trials showed that some trials had no clear description of randomization methods, allocation concealment, sample size calculation, and intention-to-treat analysis. To improve the quality of the reporting of RCTs, clinical trial registration and the revised Consolidated Standards of Reporting Trials (CONSORT) statement should be introduced into the trial design and strictly followed.
ObjectivesTo assess the methodological and reporting quality of surgical meta-analyses published in English in 2014.MethodsAll meta-analyses investigating surgical procedures published in 2014 were selected from PubMed and EMbase. The characteristics of these meta-analyses were collected, and their reporting and methodological quality were assessed by the PRISMA and AMSTAR, respectively. Independent predictive factors associated with these two qualities were evaluated by univariate and multivariate analyses.ResultsA total of 197 meta-analyses covering 10 surgical subspecialties were included. The mean PRISMA and AMSTAR score (by items) were 22.2±2.4 and 7.8±1.2, respectively, and a positive linear correlation was found between them with a R2 of 0.754. Those meta-analyses conducted by the first authors who had previously published meta-analysis was significantly higher in reporting and methodological quality than those who had not (P<0.001). Meanwhile, there were also significant differences in these reporting (P<0.001) and methodological (P<0.001) quality between studies published in Q1 ranked journals and (Q2+Q3) ranked jounals. On multivariate analyses, region of origin (non-Asiavs. Asia), publishing experience of first authors (ever vs. never), rank of publishing journals (Q1 vs. Q2+Q3), and preregistration (presence vs. absence) were associated with better reporting and methodologic quality, independently.ConclusionThe reporting and methodological quality of current surgical meta-analyses remained suboptimal, and first authors' experience and ranking of publishing journals were independently associated with both qualities. Preregistration may be an effective measure to improve the quality of meta-analysis, which deserves more attention from future meta-analysis reviewers.
Clinical practice guidelines need to be based on evidence, but traditional Chinese medicine, especially integration of traditional Chinese and Western medicine guidelines, inevitably need to combine clinical research evidence, ancient literature, and expert experience and consensus. In the process of formulating, there are deviations in understanding and application of the expert consensus method and expert experience, resulting in opaque of the recommendations, unclear of the details of the diagnosis and treatment strategy, less prominent of the advantages and value of traditional Chinese medicine, which affects the scientificity, transparency, applicability, promotion and application of the guidelines of traditional Chinese medicine or integration of traditional Chinese and Western medicine. This study discusses the guiding principle of "evidence as a core, consensus as a supplement, and experience as a reference" that was generally followed and puts forward detailed methodological suggestions to the formulation of guidelines for traditional Chinese medicine and integration of traditional Chinese and Western medicine.
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.
Objective To assess the methodological quality and reporting quality of meta-analysis published in Chinese Acupuncture & Moxibustion. Methods We searched CNKI database to collect meta-analysis published in Chinese Acupuncture & Moxibustion up to 2015. Methodological quality assessment was carried out using AMSTAR tool, and quality assessment was carried out by PRISMA checklist. Data analysis was performed by using SPSS 19.0 software. Results A total of 31 meta-analyses were enrolled. Among all the 31 meta-analyses, the first authors came from 19 institutions, and 21 meta-analysis were supported by fundings. All meta-analyses were about the evaluations of acupuncture intervention, involving 10 disease systems (ICD-10) and sub-health. The mean score of the methodological assessment was 7.42±1.13. In addition, the mean score of reporting quality was 18.79±2.04. Conclusion The meta-analyses published in Chinese Acupuncture & Moxibustion have high quality on methodology as well as reporting. Due to the limited quality and quantity of included studies, the above results are needed to be further assessed by more studies.
In the clinical evidence-based decision-making process, factors including benefits and harms, evidence certainty, cost and feasibility of interventions should be considered based on the best evidence. The development of decision threshold of effect size (DTES) for patient health outcomes can help stakeholders understand the benefits and harms of interventions, assess evidence certainty, and interpret research results. Based on international experience, the MERGE Working Group through group discussions, semi-structured interviews, expert consensus, and pilot application developed a set of 8-step guidelines for the development of DTES for health outcomes. These steps included necessity assessment, formation of working groups, selection of patient important outcomes, creation of scenarios based on the best evidence, design of expert consultation questionnaires, analysis of expert consultation results, face-to-face expert consensus, dissemination of the application and reevaluation. The DTES guideline development is intended to provide methodological guidance for stakeholders to develop DTES for health outcome indicators in different domains.
ObjectiveTo evaluate the developing methodologies of Essential Medicines Lists for Children (EMLcs) in global, in order to provide reference in developing EMLc of China. MethodsWe searched ProQuest, ScienceDirect, SpringerLink and MEDLINE databases, World Health Organization (WHO) official website, and 67 websites of National Ministry of Health and Drug Administration Section, to collect literature about selection methodology of children and/or adult essential medicines list (EML). A descriptive analysis was conducted. ResultsA total of fourteen literatures were included. Of which, 6 were about the essential medicines selection methodology in children, and the other 8 were about the essential medicines selection methodology in adult. The WHO had established independent EMLc selection committee. Paediatricians were involved in the selection of EMLc in the WHO and India. There was no selection criteria and process for EMLc globally. The WHO, India, and South Africa selected their EMLcs referring to the WHO EML selection criteria. The WHO and South Africa had their own updating time, period and process for EMLc. The WHO EMLc was updated per 2 years, which in high frequency and conducts in rigorous process. However, the EMLc of India had not been updated yet. ConclusionIt is suggested that China could build a national EMLc selection committee involving paediatricians and evidence-based medicine experts etc. in referring to the framework of the WHO Child Health Working Group. The EMLc selection criteria and process of China could be established referring to the one of the WHO, based on the disease burden, drug accessibility and medical insurance of children of China. The EMLc of China should be simultaneously updated with the adult EML of China.