New interventions are rapidly progressing into clinical practice through the preclinical study stage. The animal experiments should be comprehensive and critically evaluated for their pivotal role in this process. To integrate the evidence of animal studies by systematic review throws light on intervention outcomes and could decrease risk of participants in human trials. The methodological weakness of animal studies is easy to highlight but robust methods to synthesize evidence is essential. Here, we discuss some problems in systematic review of animal experiments and whether animal models of diverse species contribute to bias of meta-analysis conclusions.
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.
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.
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.
This article mainly introduced the purpose and scope relating to the 11 Cochrane methods groups for Cochrane systematic reviews and encourage more people to contribute to the research on methodology.
High-quality randomized controlled trials can balance between-group confounding factors and are an important source of comprehensive information on benefits and harms. The CONSORT (consolidated standards of reporting trials) working group released the CONSORT Harms 2022 statement to further improve the harm reporting quality in randomized controlled trials. Traditional Chinese medicine formulas have unique characteristics such as compatibility taboos and using toxic herbs. The harms of traditional Chinese medicine formulas need to be reported in a standard. This study suggests that researchers should pay attention to enhancing the professional competence of research teams, developing suitable standards for reporting the harm of traditional Chinese medicine formulas in randomized controlled trials, and incorporating relevant guidelines into journal publication requirements. These efforts are essential for laying the necessary groundwork for the global dissemination and promotion of traditional Chinese medicine.
Primary economic evaluations are needed in the case that the systematic review of existing economic evidence is not capable of informing economic profiles of marketed medicines. Following the first section of this programs, we presented the principles of designing a study, measuring costs and outcomes, and performing sensitivity analyses. Generally, four designs of economic evaluations are available to perform economic evaluations, each of which has specific strengths and weaknesses. Valuation of outcomes and costs may differ in methods, mainly based on the requirements and applicability of study. The possible factors leading to variation of results should be analyzed using analytic methods with different techniques.
ObjectiveTo evaluate the methodological quality of animal experiments published in high impact journals, in order to provide references for improving the quality of animal experiments.MethodsCSCD and Web of Science databases were electronically searched to collect intervening primordial animal experiments from 2014 to August, 2016. Four reviewers independently screened literatures, extracted data and assessed the methodological quality of included studies by using SYRCLE tool.ResultsA total of 1 999 animal experiments were included. The cited frequency of more than 90% studies were ≤5 times, and of which 52.53% studies were zero. The results of SYRCLE evaluation showed that 54.55% of sub items rated as "low risk" were less than 30%. And 84.62% of them were less than 10%.ConclusionThere are defeet in methodological quality of animal experiments either domestic or abroad. The problems of domestic researches in implementation bias, measurement bias and loss of access bias are particularly obvious. The coincidence rates of "low risk" are much lower than those of abroad studies. Therefore, we suggest that it is necessary to take specific measures to popularize SYRCLE tool to effectively guide the development of animal experiments and improve the design and implementation of animal experiments.
ObjectiveTo study the development of methods assessing donor liver viability in liver transplantation.MethodsThe literature in the recent years on the methods of assessing donor liver viability was reviewed.ResultsFrom donor liver morphology to function,there have being developed many methods which assess donor liver viability,including:①donor liver appearance; ②intraoperative biopsies; ③donor liver microcirculation; ④portal pressure; ⑤enzymes levels in liver; ⑥lidocainemetabolizing activity; ⑦energy metabolism of donor liver; ⑧fat content in donor liver.ConclusionThere are many methods to assess the viability of donor liver. Each has its supericrity and defect respectively. Intraoperative biopsies, 31Pmagnetic resonance spectroscopy and portal pressure have more importance in clinical application.
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.