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。
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.
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.
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.
ObjectivesThis study aimed to evaluate the validity and reliability of the clinical practice guidelines (CPGs) applicability evaluation tool, a preliminary revised tool, by using it to appraise specific clinical guidelines.MethodsMedical staffs were sampled from relevant departments in domestic medical institutions to use tool to evaluate the two guidelines. Spearman-Brown coefficient of odd-even split-half method and Cronbach's alpha coefficient were used to evaluate the split-half reliability and internal consistency reliability. The convergent and discriminant validity were evaluated by correlation analysis and correlation coefficient comparison hypothesis test, and the structural validity was investigated by confirmatory factor analysis based on structural equation.ResultsThe split-half reliability of the evaluation tool was 0.86, and the Cronbach's coefficient of the whole tool and each dimension were greater than 0.7 for two guidelines. The success rates of tool convergent and discriminant validity calibration were 100%. In the second-order confirmatory factor analysis model, the χ2 and df were 3.38 and 2.46, the comparative fit index (CFI) were 0.872 and 0.974, the goodness of fit index (GFI) were 0.954 and 0.983, and the adjusted goodness of fit index (AGFI) were 0.846 and 0.959 for two guidelines respectively. Both standard root mean square residual (SRMR) and root mean square error of approximation (RMSEA) were less than 0.09. Both P values of RMSEA hypothesis test were greater than 0.05.ConclusionsThe evaluation scale is a valid and reliable instrument for assessing the applicability of CPGs, which should be further evaluated in practical applications in the future.
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.
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.
In the process of evidence-based practice, the evaluation of evidence applicability relied on the subjective judgment of clinicians, while the systematic method of which was still in lack. The complex clinical information of traditional Chinese medicine (TCM) enhanced the uncertainty and risk of applying evidence. Based on the analysis of the process of evidence-based practice, this paper introduced the method of TCM evidence applicability evaluation and used the raw data of clinical trials to develop a clinical prediction model to enable the assessment of the evidence applicability on individual patients. The establishment of individual evidence applicability evaluation method could promote the rational application of TCM evidence in the long term.