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.
ObjectiveTo systematically review the clinical applicability of the global guidelines evaluation index system, and to provide some foundation for the evidence-based establishment of the clinical applicability evaluation index system in China. MethodsThe PubMed, Embase, Cochrane Library, CNKI, WanFang and VIP databases were electronically searched to collect literature on the clinical applicability evaluation index system of guidelines from inception to November 2022. Two reviewers independently screened literature, extracted data and then organized the data to form the evaluation items pool through qualitative systematic review and thematic synthesis. ResultsA total of 82 articles were finally included, and 141 clinical applicability evaluation indicators were obtained, including 5 third-level topics, 14 analytical topics and 141 descriptive topics. The third-level topics were availability, readability, feasibility, acceptability and overall evaluation. Influencing factors in the feasibility field were summarized as medical staff factors, patient/patient family factors, environmental factors and guideline factors. ConclusionThis study systematically sort out the applicability evaluation items of the guidelines, which provide an evidence-based reference for the construction of relevant evaluation index systems in China.
直接证据来自直接比较我们关注的干预措施用于我们关注的患者人群，并测量患者重要结局的研究。间接证据可由以下4种方式之一产生。第一，患者可能与我们关注的患者不同（适用性一词常用于这类间接性）。第二，所检验的干预措施可能与我们关注的干预措施不同。有关患者和干预措施间接性的决策取决于对生物或社会因素差异是否大到可能使效应尺度出现预期的较大差异的考虑。第三，结果可能有别于最初设定的结局指标——如替代结果本身不重要，但测量之是基于替代结果的变化反映患者重要结局变化这一假设。第四类间接性在概念上与前三类不同，发生于临床医生必须在未经直接比较的两种干预措施间做出选择时。这种情况下比较治疗方案需要特定的统计方法，并根据患者人群、联合干预措施、结局测量指标及备选干预措施试验方法的差异程度，将证据级别降低1或2级。
ObjectivesTo establish statistical analysis and result reporting model for evaluation of the applicability of the clinical guidelines. We conducted an empirical study for clinical guidelines for the prevention and treatment of type 2 diabetes in China.MethodsA cross-sectional survey was conducted to select 6 to 8 doctors in geriatric, endocrinology, nephrology or related departments from medical institutions. The questionnaire was filled by doctors at a conference and electronic questionnaires were sent to those who did not attend the conference. Descriptive analysis was carried out for characteristics of evaluators, scores of each dimension, access to guidelines and factors affecting implementation. The Kruskal-Wallis rank-sum test and Nemenyi test were used for multi-group comparison and pairwise comparison. Multiple linear regressions with the stepwise strategy were used to screen out the association factors.ResultsA total of 725 questionnaires were collected in this survey. There were 722 valid questionnaires with an active recovery rate of 99.6%. The results showed the accessibility score was lowest and the acceptability score was highest. The results of multi-group comparison and multiple linear regression analysis showed that familiarity with the guidelines was the influencing factor of each score (P<0.05). The guidelines were primarily obtained from academic conferences (52.1%), WeChat (45.4%), and biomedical literature databases (43.5%). Among the evaluators, 44 (41.9%) believed that there were implementation obstacles in the guidelines, among which 136 (18.8%), 134 (18.5%) and 133 (18.4%) believed that implementation obstacles were medical personnel factor, patient factor and environmental factor.ConclusionsIn this study, a data analysis and result report model for the assessment of the applicability of the guidelines is established to provide evidence for the development/revision of the guidelines.
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.
ObjectiveTo explore impact factors related to the clinical applicability of guidelines, and provide suggestions for better development and implementation of guidelines. MethodsThe CNKI database was electronically searched to collect clinical guidelines issued by the Chinese Medical Association and the Chinese Medical Doctor Association from 2015 to 2020. Sixty-one guidelines were randomly selected from included guidelines and each guideline was evaluated by medical staff from three regions using the instrument for evaluating clinical applicability of guidelines (version 2.0). Statistical data were described, and t-test or rank sum test or chi-square test were used for comparison between groups. The impact factors were screened by stepwise logistic regression analysis. ResultsA total of 6 904 valid questionnaires were collected from 119 medical institutions in 26 provinces of China. The more familiar with the guidelines and the more consistent with the wishes of patients or their families, the overall standardized score of the clinical applicability of guidelines would be higher. In addition, the more familiar with the guidelines, the standardized scores in each field would be higher. The higher emphasis on guidelines compliance, the higher the feasibility standardized score. ConclusionIn order to improve the clinical applicability of guidelines, developers should pay attention to whether the recommendations are consistent with the wishes of patients or their families. Then, medical institutions should pay attention to the compliance of guidelines. Finally, medical personnel should be familiar with the recommendations.
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.
Objective To evaluate the clinical applicability of clinical practice guidelines in China in the past 5 years, and to provide suggestions for better development and implementation of guidelines. Methods A cross-sectional study was conducted. A total of 61 guidelines issued by the Chinese Medical Association and the Chinese Medical Doctor Association from 2015 to 2020 were selected randomly based on CNKI database. Each guideline was evaluated by medical staff from three regions using the instrument for evaluating clinical applicability of guidelines (version 2.0). Quantitative data were described by mean, standard deviation, median and interquartile range, while qualitative data were described by frequency and composition ratio. Results A total of 6 904 valid questionnaires were collected from 119 medical institutions in 26 provinces of China. The results showed that the standardized scores ranged from 54.4% to 72.7% (median 64.3%) for accessibility, from 66.1% to 83.3% (median 74.9%) for readability, from 53.7% to 94.7% (median 86.0%) for acceptability, and ranged from 61.4% to 81.0% (median 72.5%) for feasibility. Approximately 4.3% of the medical staff considered that there were obstacles to implement the guidelines, including environmental factors (32.1%), medical staff factors (26.5%), guidelines factors (22.5%), and patients or family factors (18.9%). Conclusion The overall clinical applicability of the guidelines selected in this study is satisfactory. However, it is necessary to improve the accessibility of clinical guidelines. In addition, to improve the clinical applicability, it is suggested that medical staff should be trained and provided with supporting resources.
Methodological quality and transferability will be important issues for the credibility and usefulness of both published studies and administrative methods for evaluating the socio-economic value of marketed medicines in China. This paper critically examines factors commonly contributing to, or inhibiting, the quality and transferability of socio-economic evidence of the value of medicines, with specific reference to the Chinese community. It discusses appropriate approaches to design, performance, and reporting of published economic evaluation studies, as well as guides on assessment of quality of economic evaluations and recommends two internationally established methods that may be suitable for training in this setting.
Clinical practice guidelines are decision-making tools for bridging the gap between current best evidence and clinical practice. Studies have shown poor clinical applicability of existing guidelines, which may not be solved by improving the quality of guidelines alone. National medical management service guidance center is developing clinical practice guidelines of clinical evaluation system of construction projects, based on evidence-based method formulated by the target users of clinical guidelines evaluators’ applicability evaluation system of clinical practice guidelines. It aims to identify guidelines with high clinical applicability and provide the evaluation results of clinical applicability to developers and revisers of clinical guidelines, and then optimize the development and update, eventually improving the clinical applicability of guides and promote Chinese clinical guidelines in clinical application.