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.
ObjectiveTo evaluate the current status and trend of methodological quality of multi-center randomized controlled trials (RCTs) of stroke treatments in Chinese Mainland.MethodsMulti-center RCTs of stroke treatments conducted in Chinese Mainland published in Chinese or English language from January 2000 to December 2019 were retrieved from seven databases including PubMed, Cochrane Central Registry of Controlled Trials, Embase, China Biology Medicine, China National Knowledge Infrastructure, Chinese Science and Technique Journals Database, and Wanfang Database. The basic information was collected. Methodological items were referred to the Cochrane Collaboration’s tool for assessing risk of bias. The definitions of Wade were used to assess the outcome measure.ResultsA total of 90 multi-center RCTs were included, of which 39 were published from 2000 to 2009, and 51 were published from 2010 to 2019. The total number of trials published from 2010 to 2019 was 1.31 times of that published from 2000 to 2009. The research subjects were ischemic stroke patients in 58.9% (53/90) of the RCTs, intracerebral hemorrhage patients in 14.4% (13/90) of the RCTs, and ischemic stroke patients as well as hemorrhagic stroke patients in 26.7% (24/90) of the RCTs. There were 55.6% (50/90) drug trials, and 44.4% (40/90) non-drug trials. There were statistically significant differences in the loss of visit report (P=0.005), primary and secondary outcome indicators report (P=0.027), and adverse reaction report (P=0.007) between the two periods; there was no statistically significant difference in reported adequate randomized methods (P=0.341), allocation concealment (P=0.611), blindness (P=0.551), used intentionality analysis (P=0.573), or follow-up time (P=0.061) between the two periods.ConclusionIn the past 20 years in Chinese Mainland, the quality of stroke treatment RCTs improves slowly, and more attention should be paid to develop the RCTs of true randomization, blinding, and better patient outcome measures.
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.
In the absence of large trials, it is important for us to discuss whether a well-conducted meta-analysis of smaller randomized controlled trial (RCT) can replace large trials or not. We have evaluated the quality of original literature and methodological quality. The difference between meta-analysis of smaller RCT and the largest randomized trials have also discussed.
背景与目的 对卫生保健干预措施进行决策权衡需要有不良和有益的可靠证据,然而绝大多数系统评价针对的是研究方法非常成熟的随机对照试验及其有效性评价,系统地评价不良反应的方法尚未完善,对研究者而言,能作为相关指南的资源很少.为此,作者在文中报告了对不良反应进行系统评价的新近体会,同时提出进一步实践和研究的建议.方法 描述并比较3个包含不良反应评价的药物干预的系统评价的方法学,重点评价其研究问题、研究设计和质量评价.结果 1个研究关注于如何根据提供的特殊不良反应数据建立卫生经济学模式,而其它两个研究涉及更广泛的问题.尽管每个评价对纳入标准的定义不同,但它们均纳入了随机和观察性数据.对研究质量的评价采用了标准方法.由于研究设计不良、报告不充分和现有研究工具有限,在运用纳入标准和评估研究质量时,研究者遇到了各种问题.最终发现,3个评价都做了大量的工作,但对卫生保健决策者有用的资料不多.研究者确认,改善的关键在于如何提出系统评价的问题和发展不良反应研究的质量评价方法学.结论 若不良反应的系统评价只专注于一个中心问题,那么它会提供与临床决策更相关的资料,也有利于明确纳入系统评价研究的类型.系统评价中不良反应的质量评估的方法学需要进一步完善.
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.
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.