Objective To provide methodological guidance for the application of matching-adjusted indirect comparison (MAIC). Methods The methodology literature on MAIC was examined to clarify key steps and methodological points, and MAIC application literature in the non-small cell lung cancer field published after January 2016 was systematically reviewed to compare and analyze the current status and problems of MAIC. Results MAIC consisted of five key steps: data source and sample selection, matching variable screening, individual weight calculation, matching validity evaluation, and relative efficacy calculation. The systematic review revealed that studies primarily employed literature reviews to screen data sources, used statistical analysis and other scientific methods to screen matching variables, employed software for individual weight calculation, evaluated matching validity by reporting effective sample size (ESS), calculated relative efficacy using Cox, logistic, and other models, conducted sensitivity analyses to evaluate the uncertainty caused by different data sources and matching variable combinations, and the studies demonstrated good overall reporting standardization but significant differences in particular aspects. Concerning the connection between MAIC and pharmacoeconomic research, studies included mainly used target drugs as the reference group of survival data extrapolation, and proportional hazards (PH) assumptions were considered when utilizing hazard ratios (HR) in extrapolation. Conclusion There are some deficiencies in the method application and reporting standards of MAIC research, such as lack of explanation of data source selection criteria and matching variable screening criteria, insufficient reporting of weight distribution, and inadequate consideration of PH assumptions. It is recommended that future MAIC research systematically screen data sources and report covariate distribution evaluation, covariate status evaluation, weight distribution, uncertainty measurement, etc. Additionally, considering PH assumptions after calculating HR is suggested.
Retrospective chart review (RCR) is a type of research that answers specific research questions based on the existing patient medical records or related databases through a series of research processes including data extraction, data collation, statistical analysis, etc. Relying on the development of medical big data, as well as the relatively simple implementation process and low cost of information acquisition, RCR is increasingly used in the medical research field. In this paper, we conducted the visual analysis of high-quality RCR published in the past five years, and explored and summarized the current research status and hotspots by analyzing the characteristics of the number of publications, national/regional and institutional cooperation networks, author cooperation networks, keyword co-occurrence and clustering networks. We further systematically combed the methodological core of this kind of research from eight aspects: research question and hypothesis, applicability of chart, study design, data collecting, statistical analysis, interpretation of results, and reporting specification. By summarizing the shortcomings, unique advantages and application prospects of RCR, providing guidance and suggestions for the standardized application of RCR in the medical research field in the future.
ObjectivesTo assess the methodological quality and reporting quality of meta-analysis published on The Chinese Journal of Nursing.MethodsCNKI and WanFang Data databases were electronically searched to collect meta-analysis which published on The Chinese Journal of Nursing from inception to December 2017. Two reviewers independently screened literature, extracted data and assessed the methodological quality and the reporting quality by AMSTAR scale and PRISMA statement. Statistical analysis was then performed by using SPSS 19.0 software.ResultsA total of 53 meta-analyses were included, which involved 7 disease systems and sub-health status. The mean score of the methodological assessment by AMSTAR was 7.75±1.32, including 9 high-quality papers (17.0%), 41 middle-quality papers (77.4%), and 3 low-quality papers (5.6%). The mean score of the reporting quality assessment by PRISMA was 22.5±3.08, including 39 relatively complete papers (73.6%), 11 papers with certain defects (20.8%), and 3 papers with serious defects (5.6%).ConclusionsThe methodological and reporting quality of meta-analysis published on The Chinese Journal of Nursing deserves further improvement.
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.
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.
Rapid, living evidence-based points, as a new model promoting the rapid translation of evidence, aim to integrate the current best evidence, clinical status, public/patient preferences and values, and provide concise and practical guidance rapidly to important questions concerned in clinical medicine and public health. This paper introduces the methodological framework for the development of "Rapid, Living Evidence-Based Points" from 4 aspects: initiation and planning, evidence search and review, development, update, publication and dissemination of evidence-based points, in order to provide a reference for domestic scholars in developing rapid, living evidence-based points.
Intensive discussions and debates concerning whether we should and how to apply evidence-based medicine (EBM) research in traditional Chinese medicine (TCM) have arisen worldwide. We always hold the opinion: TCM needs EBM; the evidence from EBM is not limited to randomized controlled trials and systematic reviews; innovative methodological studies are urged based on the characteristics of TCM theoretically and clinically. Based on the methodological training and studies in this area, the authors discussed how to promote the evidence based TCM from five aspects including completing clinical trial procedure, reporting clinical trials according to international standards, reviewing the current clinical studies on TCM systematically, promoting the methodological research and academic exchange and better evidence (knowledge) management.
Objective To explore the methods used for developing evidence-based clinical practice guidelines for acupuncture. Methods Based on the characteristics of acupuncture in traditional Chinese medicine,and principles of evidence-based medicine, this article introduces and summarizes the processes and methods for developing an evidence-based clinical practice guideline for acupuncture. We analyzed similarities and differences between clinical practice guidelines for acupuncture and for other interventions. We used an evidence-based clinical practice guideline of acupuncture for depression as an example to illustrate the methods of literature search, grading of evidence and recommendations, evidence evaluation and consensus formation. Results Preliminary recommendations on the methods for developing evidence-based clinical practice guidelines for acupuncture were made. Conclusion Based on the optimized rational methodology for developing clinical guidelines, evidence-based high-quality clinical practice guidelines for acupuncture could be established.
Objective To improve the sensitivity and broaden the applicability of N-of-1 trials in traditional Chinese medicine (TCM), the clinical application and methodology of single-case experimental designs (N-of-1trials, multiple-baseline designs; MBDs) were expounded, compared, and discussed. Methods This paper introduced the current utility of N-of-1 trials in TCM research, introduced MBDs, and compared the methodologies of N-of-1 trials, MBDs and crossover design. Finally, two design schemes to improve the sensitivity and applicability of N-of-1 trials were illustrated. Results N-of-1 trials conformed to the TCM concept of treatment based on syndrome differentiation; however, due to the complex composition of TCM, the results were easily affected by carryover effect. In MBDs, the intervention was introduced in a staggered way, no washout period was needed, and the required sample size was small. MBDs were generally used to preliminarily indicate the effect of intervention; however, the statistical analysis was relatively complicated, and there were few MBDs used in clinical trials of TCM at present. Compared with crossover trials, single-case experimental designs had advantages and disadvantages. N-of-1 trials might best reflect the individualized treatment of TCM and a suitable statistical model (e.g., hierarchical Bayesian statistical method) was expected to improve the sensitivity and applicability of N-of-1 trials in TCM. Combining clinical trial designs (e.g., the combination of N-of-1 trials and MBDs) would complement the limitations of N-of-1 trials, and expand the scope of conditions applicable for study. Conclusion N-of-1 trials have both advantages and disadvantages in TCM research. Improved statistical models or combined study designs will improve the sensitivity and broaden the applicability of N-of-1 trials in TCM.