RÉSUMÉ
OBJECTIVE To evaluate the global cancer-associated thromboembolism risk assessment tools based on evidence- based methods， and to provide methodological reference and evidence-based basis for constructing a specific tool in China. METHODS A comprehensive search was conducted on 6 databases， including CNKI， Wanfang data， VIP， CBM， PubMed， and Embase， as well as on the websites of NCCN， ASCO， ESMO and so on with a deadline of June 30， 2022. Furthermore， a supplementary search was conducted in January 2023. The essential characteristics and methodological quality of included risk assessment tools were described and analyzed qualitatively， focusing on comparing each assessment stratification ability. RESULTS Totally 14 risk assessment tools were included in the study， with a sample size of 208-18 956 cases and an average age distribution of 53.1-74.0 years. The applicable population included outpatient cancer student@sina.com patients， lymphoma patients， and multiple myeloma patients，etc. The common predictive factors were body mass index， venous thromboembolism history， and tumor site. All tools had undergone methodological validation， with 9 presented in a weighted scoring format. Only seven tools were used simultaneously for specificity， sensitivity， negative predictive value （NPV）， positive predictive value （PPV） and area under the curve （AUC） or C statistical analysis. CONCLUSIONS The risk of bias in constructing existing tools is high， and the heterogeneity of tool validation results is significant. The overall methodological quality must be improved， and its risk stratification ability must also be investigated. There are still certain limitations in clinical practice in China.
RÉSUMÉ
Risk assessment of clinical trials is of great significance to improve the quality of clinical trials. Through systematic comparative analysis of risk assessment tools for clinical trials in Britain, Germany and France, this paper found that the three countries’ risk assessment tools were consistent in terms of legal system guarantee and assessment process, but there were obvious differences in the basic risk classification and risk grading standards of clinical trials. Based on the experience of Britain, France and Germany, this paper proposed to improve the relevant regulations and documents of clinical trial risk management in China from the perspective of Chinese national conditions, further explore the factors affecting clinical trial risk, and develop and design clinical trial risk assessment tools with different discipline characteristics according to the specialties of the discipline to improve the quality and level of clinical trials.
RÉSUMÉ
Objective To explore risk factors of neurosurgical patients in bed with deep vein thrombosis (DVT) and to compare the Autar Scale with the Caprini Scale for predicting DVT formation. Methods Retrospective analysis of DVT risk factors was conducted on sixty-eight cases neurosurgical patients in bed of three hospitals. In addition, used two kinds of risk assessment scales to assess patient′s level of DVT risk. Results Coma (OR=9.410,95%CI=1.689-52.423), paralysis (OR=4.950,95%CI=1.432-17.105) , infection (OR=2.927,95%CI=1.162-7.373), lower limb central venous catheterization (OR=6.072,95%CI=2.187-16.858) may be risk factors for DVT in neurosurgical patients in bed. The two risk assessment tools were used within 24 hours after admission (χ2=34.861) and within 24 hours after surgery (χ2=52.869) to predict differences in neurosurgical patients with thrombosis risk level, with statistical significance (P < 0.01). Conclusions Nurses should identify risk factors of DVT every day and take preventive measures early to reduce the risks. The Caprini Scale is better than the Autar Scale for predicting DVT formation.