The background and status of the quality assessment instruments of clinical trials, and several frequently used instruments both domesticly and abroad were introduced, and the problems in this field were discussed.
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.
Since the concept of core outcome set (COS) was introduced into clinical trials of traditional Chinese medicine (TCM), researchers have paid much more attention to develop COS for specific diseases. Although researchers believe that the characteristics of TCM, such as syndromes, should be considered in the COS of TCM, it was insufficiently addressed. In addition, the naming of TCM syndromes has not been standardized, and the classification and diagnostic criteria for specific diseases have been inconsistent. Thus, it is difficult to include TCM syndromes in the COS. Different diseases may show similar TCM syndromes which makes research difficult. Based on previous studies, this paper provided methods of developing core TCM syndromes set according to the model of combination of disease and syndrome and the model of syndrome dominating disease to provide references for future researches.
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.
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.
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 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.
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.
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.
Objectives To explore the quality of the reporting of randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) for chronic fatigue syndrome (CFS).Methods We searched the Cochrane Central Register of Controlled Clinical Trials (CENTRAL) (The Cochrane Library, Issue 4, 2006), PubMed, EMbase, the Chinese Biomedical Database (CBMdisc), VIP Information, and China National Knowledge Infrastructure (CNKI) (from establishment to February 2007). We also checked the reference lists of included studies. The quality of the reporting of RCTs was assessed using the 22-item checklist of the CONSORT Statement and other self-established criteria. Results Thirty-eight RCTs were included. The word “randomization” was not present in any of the trials, and only 17 reports used a structured abstract. All trials did not report the scientific background and the rational for the trial, the estimation of the necessary sample size, the methods of allocation concealment and blinding, participant flow chart, ITT analysis, and ancillary analyses. Some authors misunderstood the diagnostic criteria and inclusion criteria, some selected inappropriate control interventions, and some did not clearly describe their statistical methods or used incorrect methods. All 38 trials reported positive outcomes, few reported adverse effects. No report included a general interpretation of the new trial’s results in the context of current evidence in their discussion section, and none mentioned the limitations of the study, the clinical and research implications or the external validity of the trial findings. Conclusion The overall reporting quality of RCTs of TCM for CFS is poor. Defects are found in each section of the reports. Researchers and journal editors should learn and use the principles and methods of evidence-based medicine—especially the use of a transparent prospective clinical trial register and the CONSORT Statement—to improve the design, conduct and report TCM trials.