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.
【摘要】 目的 评价亚洲骨质疏松自我评价工具（OSTA）和我国妇女骨质疏松筛选工具（OSTC）与四川地区围绝经期和绝经后汉族妇女骨密度的关系，比较两种工具对骨质疏松症的筛检能力，探讨其临床应用价值。 方法 2010年7—10月筛选获得356名45岁以上妇女的双能X线骨密度仪腰椎、股骨颈和全髋骨密度数据，利用体重和年龄分别计算OSTA指数与OSTC指数，并进行比较。 结果 OSTA指数与OSTC指数和各部位骨密度值均呈正相关（r=0.458~0.593和r=0.440~0.599，Plt;0.001），两种筛选指数之间呈正相关（r=0.956，Plt;0.001）。按两级危险程度分类界值进行判定，OSTA和OSTC的灵敏度分别为78.2%、93.5%，特异度为67.2%、43.0%，受试者工作特征曲线下面积为0.792、0.798，Kappa系数为0.452、0.357。 结论 OSTA与OSTC应用于四川地区围绝经期和绝经后妇女骨质疏松症的筛查效果均不理想，临床应用价值受限。【Abstract】 Objective To evaluate the relationship between osteoporosis self-assessment tool for asians (OSTA), osteoporosis self-assessment tool for Asians (OSTC) and bone mineral density in Sichuan perimenopausal and postmenopausal women of Han nationality, and discuss the value of their clinical application through comparison of the screening ability of the two tools in predicting osteoporosis and low bone mass. Methods With the data of bone mineral density at lumbar spine, femoral neck and total proximal femur measured by DXA of 356 women aged 45 years old and above, OSTA and OSTC risk indexes of each subject were calculated based on their weight and age, and were then compared. Results The bone mineral density of above-mentioned locations were positively correlated with OSTA and OSTC indexes (r=0.458-0.593 and r=0.440-0.599,Plt;0.001), and these two indexes were also correlated positively (r=0.956, Plt;0.001). According to the two risk levels by these cutoffs, OSTA and OSTC indexes could diagnose osteoporosis with the sensitivity of 78.2% and 93.5%, the specificity of 67.2% and 43%, the area under ROC curve of 0.792 and 0.798, and the Kappa value of 0.452 and 0.357, respectively. Conclusion Both OSTA and OSTC were not ideal tools for screening osteoporosis in perimenopausal and postmenopausal women in Sichuan province.
ObjectiveTo acquaint the development process and item composition of the appraisal tools and reporting standards of clinical pathways worldwide, in order to improve the development and evaluation of clinical pathways. MethodsWe searched databases including PubMed, EMbase, Web of Science, CBM, CNKI and WanFang Data for articles about the appraisal tools and reporting standards of clinical pathways from inception to Jan, 2014. Two reviewers independently screened literature according to the inclusion and exclusion criteria, extracted data, and compared the difference in development process and item composition among included appraisal tools and reporting standards of clinical pathways. ResultsA total of 7 appraisal tools and reporting standards were included. Among them, 3 were from UK, 1 from China, 1 from Australia, 1 from Belgium, and 1 from Saudi Arabia. All included appraisal tools contained 4 to 15 domains and 14 to 99 items. Based on the comparison of different domains and items of included appraisal tools, "Clinical Pathway Management Guidelines" published by the National Health and Family Planning Commission of the People's Republic of China and the research of Vannhaecht, we identified 17 key elements of clinical pathway as follows:organizational commitment, pathway project management, format of doc, content of pathway, multidisciplinary involvement, variance management, EBM/guidelines, maintenance of pathway, accountability, patient involvement, development of pathway, additional support systems & documents, operational arrangement, implementation, outcome management, safety and organization of the care process. ConclusionCurrently, the appraisal tools and reporting standards of clinical pathways are rudimentary, so we desperately needs to establish mature appraisal tool and reporting standard of clinical pathways to guide the development and implementation of clinical pathway, so as to improve their application effects in clinical practice and medical quality.
The AMSTAR 2, a critical appraisal tool, was developed for assessing systematic reviews which included randomized or non-randomized studies of healthcare interventions, or both. It was recently published in BMJ. This paper introduces AMSTAR 2 and interprets its usage by a published systematic review.
ObjectivesTo compare and analyze existing pharmaceutical economic evaluations quality assessment instruments, and to provide suggestions on how to choose the most appropriate instrument.MethodsPubMed, EMbase, ScienceDirect, Web of Science, CNKI, WanFang Data and VIP databases were electronically searched to collect studies on existing pharmaceutical economic evaluations quality assessment instruments from inception to December, 2017. Two reviewers independently screened literature, extracted data and analyzed studies in terms of items, design methods, scopes and characteristics.ResultsTwelve original checklists with good reliability and validity were found. The first quality assessment method was designed in 1987 and the latest one was published in 2013. The number of checklist items ranged from 11 to 61.ConclusionThere is no consolidated method for assessing the quality of pharmaceutical economics evaluations. Evaluators can choose appropriate evaluation tools according to the purpose, type and operability of evaluation.
ObjectivesTo investigate the current status of the clinical applicability evaluation tools, and to provide some foundation for establishment of the clinical applicability evaluation index system.Methods7 databases, 6 guideline databases and 16 academic institutions and the administrative department of health website were systematically searched from inception to April 2019. Two reviewers independently screened literature, extracted data and then included the literature related to the applicability of clinical guidelines. The CPG clinical applicability evaluation index was initially prepared through the subject comprehensive method.ResultsA total of 19 articles were finally included. Among them, there were 4 evaluation tools for the clinical applicability of the guidelines, and 15 evaluation tools for the guideline clinical applicability evaluation items. Through combing and comparison, we found that these tools had differences in evaluators, evaluation fields and items.ConclusionsThe global guidelines for clinical applicability assessment tools have different kinds of problems, such as that the tools are not targeted, the indicators are not well-formed, and the methodological knowledge requirement of the evaluators is high. There is still a lack of guidelines for clinical applicability assessment tools from target users’ view.
ObjectivesTo establish a tool for evaluating clinical applicability of guidelines with the users of the guidelines as evaluators.MethodsThe research group formed a multidisciplinary team to establish an evidence- based tool for evaluating clinical applicability of guidelines through systematic evaluation and two rounds of Delphi expert consultation and external audit.ResultsThe established tool consisted: evaluator basic information (12 items); clinical applicability evaluation (12 items, including availability, readability, acceptability, feasibility and overall evaluation); and scoring scheme.ConclusionsThis study has established a tool for evaluating clinical applicability of guidelines with the users of the guidelines as evaluators and provides criteria and methods for evaluating clinical applicability of guidelines.
RoB2 (revised version 2019), an authoritative tool for assessing the risk of bias in randomized controlled trials, has been updated and improved based on the original version. This article elaborated and interpreted the background and main content of RoB2 (revised version 2019), as well as the operation process of the new software. Compared with the previous version of RoB2 (revised version 2018), RoB2 (revised version 2019) has the advantages of rich content, complete details, accurate questions, and simple operation, etc. Additionally, it is more user-friendly for researchers and beginners. The risk bias assessment of randomized controlled trials is more comprehensive and accurate, and it is an authoritative, trustworthy, and popular tool for evaluating the risk of bias in randomized controlled studies in medical practice.
ObjectiveTo develop a transparent evaluation tool for the transparency of clinical practice guidelines.MethodsLiterature, books and policy documents related to the transparency of guidelines were retrieved from PubMed, EMbase, Web of Science, WanFang Data and CNKI databases to form a pool of items. After two rounds of Delphi expert consultation, the items were modified and scored to determine whether to be included in the final evaluation system. Expert consensus would determine the organization and evaluation method of the final tool.ResultsA total of 77 references were included, and 399 items related to transparency of guidelines were extracted. The items pool containing 53 items was formed after normalization and de-duplication. After two rounds of Delphi consultation, the evaluation tool for transparency of clinical practice guidelines covering 32 items in 6 areas was formed. The established tool consisted of planning (5 items), personnel selection (6 items), conflict of interest management (6 items), recommendation formation process (8 items), external review process (3 items), and guide reporting process (4 items).ConclusionsThe developed evaluation tool for transparency of clinical practice guidelines can provide a standard for the formulation, evaluation and utilization of guidelines from the perspective of transparency.