ObjectivesTo establish statistical analysis and result reporting model for evaluation of the applicability of the clinical guidelines. We conducted empirical study for clinical guidelines for diagnosis and treatment of renal transplantation rejection in China.MethodsA cross-sectional survey was conducted to select 16 medical institutions in China which had carried out kidney transplantations. In each medical institution, 6 to 8 clinicians from the kidney transplantation department or related departments were selected to complete the questionnaire. 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 regression with stepwise strategy were used to screen out the association factors.ResultsIn this survey, 128 questionnaires were distributed, in which 105 valid questionnaires were collected, and the recovery rate was 82.03%. The subjects of this survey were all kidney transplant clinicians from public tertiary hospitals, with an average 10.95 years of working time. 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 biomedical literature database (73.3%), academic journals (55.2%) and academic conferences (55.2%). Among the evaluators, 44 (41.9%) believed that there were implementation obstacles in the guidelines, among which 40 (38.1%) believed that implementation obstacles were environmental factors.ConclusionsThe applicability of clinical guidelines for diagnosis and treatment of renal transplantation rejection in China is adequate. However, the publicity of the guideline requires improvement. As the guideline is updated, consideration should be given to including access to the guideline, adding free public information promotion, and familiarizing clinicians with the guidelines through training programs to promote application of the guideline.
ObjectiveTo verify the existing domestic and foreign formulas of normal predictive value indicator for adult pulmonary diffusion capacity’s applicability at current stage in Kunming.MethodsBased on the pulmonary diffusion capacity parameters determination of diffusion capacity for carbon monoxide of the lung (DLCO) collected from one-breath breathing test completed by 680 adults with healthy lung function and without any disease which may cause pulmonary diffusion dysfunctions in Kunming, the regression equation of adult DLCO normal predicted value in Kunming was initially established; the fitting degree of DLCO predicted value and measured value was verified; and the correlation between European adults (instrument-inherent ECCS93) and the normal predicted values of adult DLCO in Shanghai, Chongqing and Lhasa were calculated and contrasted.ResultsThe regression equation of adult DLCO normal predicted value in Kunming was initially established: for male, 0.483+0.063×height (cm)+0.041×weight (kg)–0.071×age (years); for female, 1.679+0.055×height (cm)+0.018×weight (kg)–0.060×age (years). The data collected from the one-breath breathing test were similar to the predicted values obtained from the normal adult male and female DLCO prediction formulas in Kunming, the difference was not statistically significant (tM=–0.167, tF=–0.436, both P>0.05), suggesting that the formula for predicting the value established in this study was valid and well fitted. The predicted value of adult DLCO in Kunming area was statistically significant compared with the adult DLCO estimates of European adults and Lhasa, Chongqing and Shanghai in China (FM=713.4, FF=1 442.2, both P<0.001). Lhasa had the highest value; Kunming was the second highest; instrument-inherent European area and Chongqing came to third and fourth; and Shanghai had the lowest predicated adult DLCO value (all P<0.001).ConclusionThe current predictive formulas for adult pulmonary diffusion capacity indicators in China and worldwide are not suitable for the populations in Kunming.
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 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.
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.
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.
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.
Objective To update and form an instrument for evaluating clinical applicability of guidelines (version 1.0). Methods We updated the systematic review of global guideline clinical applicability evaluation instruments to form the initial item list and carried out Delphi expert consultation to establish the instrument for evaluating clinical applicability of guidelines (version 2.0). Results The general structure of version 2.0 was consistent with that of version 1.0, which included 12 evaluation items belonging to five domains covering accessibility, readability, acceptability, feasibility, and an overall evaluation. Moreover, some new items were added in version 2.0, such as "The guideline does not provide supporting tools or resources and the operation is poor", "After the guideline implementation, the expected effects of diagnosis and treatment do not be achieved", " Medical staff in your workplace believe that the guideline is not necessary because they have sufficient medical experience, etc.", "Lack of authority of the organizations and personnel that developed the guideline" and "Medical staff in your workplace are reluctant to change the original medical practice". Conclusion This study updated and formed an instrument for evaluating clinical applicability of guidelines (version 2.0), which is able to better assess the applicability of new clinical guidelines and greatly promote more appropriate guidelines into practice.
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.
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.