ObjectivesTo analyze patients’ values and preferences on individualized medication of high-dose methotrexate so as to support the development of the practice guideline for clinical medication of high-dose methotrexate.MethodsA multicenter cross-sectional study involving patients with osteosarcoma or hematological malignancy in 7 hospitals was conducted by questionnaires to evaluate the perception and willingness on detection of gene polymorphisms (MTHFR C677T, MTHFR A1298C, ABCB1 C3435T and RFC1 G80A) related to methotrexate (MTX) and therapeutic drug monitoring (TDM) of MTX. SPSS24.0 software was used to analyze the data.ResultsA total of 124 patients were involved, including 40 (32.26%) with osteosarcoma and 84 (67.74%) with hematological malignancy. 106 (85.48%) and 117 (94.35%) patients agreed on detection of gene polymorphisms and TDM, respectively. There was a significant difference on preference towards TDM between patients with risk factors for MTX and patients in which risk factors for MTX were not discovered (76.19% vs. 95.08%, P=0.003). The ranking of factors that contributed to the two decision-making was consistent (P<0.01), and specific orders of factors were identical. The clinical efficacy was the primary factor (mean rank 3.45 for detection of genetic polymorphisms and 3.52 for TDM), followed by safety (mean rank 3.01 and 3.16, respectively) and comfort (mean rank 1.73 and 1.79, respectively). Cost (mean rank 1.39 and 1.31, respectively) was the least important factor.ConclusionsThe preferences of patients toward detection of gene polymorphisms and TDM were generally similar, with well acceptance. No significant differences were found on the preferences toward detection of gene polymorphisms. However, patients with or without risk factors for MTX may differ significantly when making decisions on TDM, which may impact on clinical decision-making of clinicians and clinical pharmacists. The perception and willingness of patients should be considered adequately during the development of clinical practice guidelines and clinical practice.
Objectives To explore the characteristics of thrombosis in critically ill patients with Omicron infection and the therapeutic value of prophylactic low molecular weight heparin (LMWH) treatment. MethodsA single center, retrospective cohort study included critically ill adult patients with Omicron variant of SARS-CoV-2 admitted to Peking University Third Hospital from December 7, 2022, to February 8, 2023. The patients were categorized into two groups based prophylactic LMWH. Propensity score (PS) matching was used to match patients (1: 1 ratio) based on the predefined criteria. General clinical information and laboratory parameters were compared. This study was retrospectively registered at Chinese Clinical Trail Registry (ChiCTR2300067434). ResultsFour hundred and fifty-two patients and 360 patients were included before and after PS matching. There were no statistical differences in mortality, the incidence of pulmonary embolism, arterial thrombosis or bleeding between the anticoagulation group and non-coagulation group before and after PS matching. There were 91 thrombotic events in 82 patients (18.14%), of which 54 cases (59.34%) were lower limb intermuscular vein thrombosis, 3 cases (3.30%) were pulmonary embolism, 14 cases (15.38%) were acute myocardial infarction and 3 cases (3.30%) were acute cerebral infarction. The thrombotic event resulted in the death of 5 patients. D-dimer increased in 385 cases (85.56%). On the 1st, 3rd, 6th and 9th day, the concentration of D-dimer in the anticoagulant group was higher than that in the non-anticoagulant group (P=0.006, 0.001, 0.024 and 0.006, respectively). ConclusionsAlthough thrombosis and coagulation disorders are still common complications of COVID-19, it is not the direct cause of most death in COVID-19 patients caused by Omicron. The role of prophylactic anticoagulation treatment for Omicron-infected patients needs further study.
ObjectiveTo describe the current status of the evaluation index for the performance of diagnostic reagents compared with gold standards in systematic reviews and develop the list of evaluation indexes. MethodsPubMed, Embase (OVID), Cochrane Library (OVID), CBM, WanFang Data and CNKI databases were searched for systematic reviews about the performance of diagnostic reagents compared with gold standards from inception to 28th April, 2023. Two reviewers independently screened literature and extracted data. The frequency and ratio were used to describe the current status, while the qualitative synthesis was used to develop the list. ResultsA total of 133 systematic reviews were included. Sensitivity (133/133, 100.0%), specificity (131/133, 98.5%) and AUC (80/133, 60.2%) were used more frequently than 50%. Q index (6/133, 4.5%), false positive rate (3/133, 2.3%), Kappa value (2/133, 1.5%), false negative rate (1/133, 5%) and Youden's index were used less frequently than 5%. In order to evaluate the performance of diagnostic reagents compared with gold standards in systematic reviews comprehensively, a total of 14 index related to validity and predictability could be considered. ConclusionThe evaluation index for the performance of diagnostic reagents in systematic reviews are inconsistent and limited, so there is an urgent need to develop standardized evaluation indicators based on expert consensus.
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 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.
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.
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.