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.
Assessment of Real World Observational Studies (ArRoWS) is a tool developed by the Leicester Real World Evidence (LRWE) Unit of the Diabetes Research Centre of the University of Leicester in the United Kingdom to assess the quality of real world evidence research, and has been reported to have good practicability. ArRoWS can be used to quickly and specifically assess the quality of real world evidence research that uses electronic health record information. The tool contains 16 items, nine of which are common items, and seven of which are related to specific research designs. The current study introduces the development background, development process, assessment items, assessment criteria, and application methods of ArRoWS and other related aspects, to provide references for real world researchers in China.
ObjectiveTo evaluate the reliability and validity of the instrument of clinical applicability of guidelines (version 2.0). MethodsThe experts of domestic medical institutions were investigated by questionnaire, and the instrument of clinical applicability of guidelines (version 2.0) were evaluated the guidelines for the diagnosis and treatment of tinea mantis and tinea pedis (revised edition 2017) and the guidelines for the diagnosis and treatment of cerebral hemorrhage in China (2019). Using Cronbach's α coefficient and Spearman-Brown coefficient to evaluate the inherent reliability and split-half reliability. The content validity was evaluated by calculating the content validity index of the item level and the adjusted Kappa value. The correlation coefficient between each item and the dimension and the hypothesis test were used to evaluate the convergent and discriminant validity. The structural validity was evaluated by using structural equation model to evaluate the structural validity of the tool. ResultsThe Cronbach's α coefficient and Spearman-Brown coefficient of the instrument of clinical applicability of guidelines (version 2.0) were both greater than 0.7, the content validity index (S-CVI/Ave) were more than 0.8, the success rates of convergent were 100%, and the success rates of discriminant validity calibration were 100% and 96%. In the second-order confirmatory factor analysis model, the χ2/ df were less than 3, the fitting index (CFI), the goodness of fit index (GFI) and the adjustment goodness of fit index (AGFI) were all greater than 0.9. The root mean square residual (RMR) were all less than 0.05, and approximate error root mean square (RMSEA) were less than 0.09. The P value of RESEA hypothesis test were more than 0.05. ConclusionThe instrument of clinical applicability of guidelines (version 2.0) has good reliability and validity, which can be further verified in practical application in the future.
The current issue of air pollution has pushed the development of the corresponding observational air pollution studies. The World Health Organization has developed a new risk of bias (RoB) assessment instrument and a related guideline for assessing the risk of potential bias in observational air pollution studies. This study introduced the background, methods, uses, advantages and disadvantages, precautions, and usage scenarios of the RoB instrument. It is expected to provide researchers with corresponding quality evaluation tools when writing related systematic review and meta-analysis, which will also help provide reporting standards for observational air pollution studies, thereby improving the quality of studies.
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.
Objective The ultimate goal of developing guidelines is for using them in clinical practice. In this study, an implementation evaluation tool was developed to promote the overall evaluation of guidelines and to improve their promotion and implementation. Methods The research group set up a team to formulate and establish a guideline implementation evaluation tool, through preliminary research, interviews, a systematic review of relevant literature, two expert consensus meetings and two Delphi expert consensus meetings to evaluate the guideline implementation tool. Experts were invited to give opinions and grades on the fields, items and overall implementation evaluation method of the tool. Results The evaluation tool for the implementation of guidelines included 5 fields, accessibility, communicability, performability, recognizability and applicability, with a total of 7 items. The scale-level CVIs in two rounds of Delphi expert consensus were 0.91 and 0.93. We collected opinions and suggestions and made some revisions and insertions without deleting any items based on the parameter that no items fulfilled the standard if mean <3.5, coefficient of variation >15% and I-CVI<0.78. Conclusion In this study, in order to provide a standard and method for the evaluation of guideline implementation, a guideline implementation evaluation tool has been developed and evaluated by clinically-related physicians and guideline formulation methodology experts. The guideline implementation evaluation tool presents satisfactory face and content validity. Empirical research is needed to verify the tool’s performance in evaluating guideline implementation.
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 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.
The instrument for evaluating clinical applicability of guidelines (version 2.0) is designed to evaluate the clinical applicability of guidelines quantitatively. It is helpful to select guidelines with high clinical applicability and provide suggestions for revision. The evaluators are consistent with the target users of guidelines. The instrument consists of basic information, evaluation items and scoring scheme. The evaluation items are related to accessibility, readability, acceptability, feasibility and overall evaluation. Therefore, this article provides a detailed interpretation of the instrument and references for future users.