Development and validation of standardized severity rating scale to assess the consistency of drug-drug interaction severity among various drug information resources

BackgroundThe consistency in reporting the severity of drug interactions across the drug information resources is important in guiding the appropriate clinical use of drug-pairs, to minimize the associated adverse events. This necessitates the need of a standardized severity rating scale, that can accommodate the different severity ratings of the same interacting drug-pair into a reasonable severity category, that can ease the consistency assessment among different drug information resources.ObjectiveTo develop and validate a standardized severity rating scale that can ease the consistency assessment among the various drug information resources.MethodsThe definitions of various severity rating categories as documented in the eight drug information resources was consolidated to develop a standardized severity rating scale. Thus developed rating scale was validated using twenty commonly used drug-pairs. Fleiss' kappa score was used as an indicator for assessing overall consistency among various drug information resources, whereas, Cohen's kappa was used as an indicator of level of consistency between two drug information resources and between individual drug information resource and newly developed standardized severity rating scale.ResultsThe newly developed standardized severity rating scale classifies the severity of drug-drug interactions into three categories namely mild, moderate and major. The Fleiss' kappa score was improved from 0.047 to 0.176, indicating improved strength of agreement [Average pairwise agreement: 16% Vs 36.7%] among various drug information resources. The average pairwise Cohen's kappa was 0.082 [Strength of agreement: poor] in original severity ratings whereas it was improved to 0.198 [Strength of agreement: almost equal to fair] in standardized severity rating scale.ConclusionThe newly developed standardized severity rating scale can be used as a tool to assess the consistency of severity rating categories among the various drug information resources.     

HPLC法与化学发光微粒子免疫法测定癫痫患者血浆中卡马西平浓度的一致性评价

目的 评价两种方法[高效液相色谱法(HPLC法)和化学发光微粒子免疫法(CMIA法)]测定患者血浆中卡马西平浓度的一致性。方法 采用Bland-Altman法和Passing-Bablok回归法分析两种检测方法的测定值,并进一步分析两种方法的一致性。结果 Bland-Altman法分析表明测定患者血浆中卡马西平浓度的两种方法(HPLC法和CMIC法)一致性良好;两种方法的回归方程为Y=0.9912X-0.1083(R2=0.970,n=117),显示两种方法相关性良好。结论 测定患者血浆中卡马西平浓度的两种方法(HPLC法和CMIA法)具有较好的相关性与一致性,两种测定方法可以相互替代。     

中医精准医学的理论形成和内涵剖析

预测性、预防性、个体化和精准医疗是近年来医学界讨论的重要焦点,随着人类健康意识的提升,预防性、个体化和精准化显得更加重要,三者的核心是精准医学。中医学的发展离不开寒热温凉的气候轴、地理特征的方位轴、时序变化的时间轴和四维内容的空间轴,离不开"天人合一"和"五运六气"思想,而这些正是中医精准医学的理论源流,中医学标准化是观天、观地、察物和察人事宏观大实验的背景下产生的,天地物人之间的趋同性和自身的一致性是中医精准医学核心内涵。     

超声自动全容积扫描与弹性成像对乳腺病变的鉴别诊断

目的评价观察者间超声自动全容积扫描(ABVS)和弹性成像鉴别乳腺病变的可信度,以及ABVS、弹性成像及两者结合在乳腺病变鉴别诊断中的价值。方法 41例患者分别接受ABVS和弹性成像检查,分析ABVS和弹性成像在两位医师中的诊断一致性,ABVS、弹性成像及ABVS结合弹性成像与病理结果的一致性,比较三种方法的诊断价值。结果两位医师的ABVS诊断结果(K=0.620)和弹性成像诊断结果(K=0.654)均具有良好的一致性;ABVS诊断结果(K=0.810)、弹性成像诊断结果(K=0.765)、ABVS与弹性成像结合的诊断结果(K=0.901)均与病理结果具有良好或极好的一致性,其对乳腺病变的诊断准确率分别为91.30%、89.13%及95.65%,敏感性分别为100%、96.42%及100%,特异性分别为77.78%、77.78%及87.50%,阳性预测值分别为87.50%、87.10%及93.75%,阴性预测值分别为100%、93.33%及100%。结论 ABVS和弹性成像在观察者间具有良好的一致性,与病理结果有良好的一致性,在乳腺病变的鉴别诊断中具有较高的应用价值,ABVS和弹性成像结合更有助于提高诊断准确率。     

罗氏e602不同仪器间乙肝标志物检测结果的一致性

目的对罗氏cobas 8000 e602乙肝标志物的试剂在Au1和Au2检测两仪器间检测结果的一致性进行评价。方法参照CLSI EP9A3方案,各取40例样本同时在Au1和Au2间单次检测,对其结果进行一致性分析,计算医学决定水平处的偏移值,以≤1/2室间质评(±10%)作为可接受标准。结果罗氏e602 Au1和Au2间乙肝标志物结果 95%在Bland-Altman一致性界限内,Passing-Bablok回归方程分别为HBsAg:Y=-0.0036+1.0458X,HBsAb:Y=0.6364+1.0043X;HBeAg:Y=-0.0096+1.0063X;HBeAb:Y=-0.0011+1.0203X;HBcAb:Y=-0.0002+0.9160X。医学决定水平的偏移值分别为4.13%、6.57%、-0.33%、1.88%、-8.79%,比对结果可接受。结论罗氏cobas 8000 e602Au1和Au2检测乙肝标志物的比对结果一致,检测结果无差异。     

Assessing the Consistency of Traditional Chinese Medicine with Multiple Correlative Active Components

The problem of controlling the quality of raw materials and/or final product of traditional Chinese medicine (TCM) has been studied. Earlier proposed consistency index to assess the consistency of quality of raw materials and/or final product processed or manufactured from different locations or sites has only focused on a single (i.e., the most active) component assuming that the most active component can be quantitatively identified among multiple active components. In this paper, we extend such results to the case of two correlative components. Sampling plans (sample sizes) are obtained for various combinations of study parameters. An example concerning a TCM for treating patients with rheumatoid arthritis is presented to illustrate the use of the proposed method. Some concluding remarks are also provided.     

一贯制责任护理模式对提高孕产妇满意度的影响研究

Objective The purpose of this study is to find the influence of conducting the consistency primary nursing model in obstetrics department for improving patients' satisfaction to nursing work.Methods A quantitative research was conducted by an investigation of two groups of subjects,with one group being given the model of nursing and the other group not being given the same model of nursing.The investigation was to investigate the degree of satisfaction of patients to nursing work.And the total score of satisfaction and each score of each item investigated were analyzed and compared.Qualitative research:to abstract the related subject issues of pregnant and postpartum women to satisfaction degree to nursing work,by using the method of visiting and discussing of focuses of the pregnant and postpartum women groups.Results Patients' overall and sub-item satisfaction with invention of new model in the research group was higher than that of the control group,and had a statistical significance (P＜0.01).And the Results from visiting and discussing the groups of patients also reflected the research group had a good satisfaction.Conclusions The consistency primary nursing model improves pregnant and postpartum women's satisfaction to nursing work,and it is worthy of extending.     

Panel discussion does not improve reliability of peer review for medical research grant proposals

Objective

Peer review is the gold standard for evaluating scientific quality. Compared with studies on inter-reviewer variability, research on panel evaluation is scarce. To appraise the reliability of panel evaluations in grant review, we compared scores by two expert panels reviewing the same grant proposals. Our main interest was to evaluate whether panel discussion improves reliability.

Methods

Thirty reviewers were randomly allocated to one of the two panels. Sixty-five grant proposals in the fields of clinical medicine and epidemiology were reviewed by both panels. All reviewers received 5-12 proposals. Each proposal was evaluated by two reviewers, using a six-point scale. The reliability of reviewer and panel scores was evaluated using Cohen's kappa with linear weighting. In addition, reliability was also evaluated for the panel mean scores (mean of reviewer scores was used as panel score).

Results

The proportion of large differences (at least two points) was 40% for reviewers in panel A, 36% for reviewers in panel B, 26% for the panel discussion scores, and 14% when the means of the two reviewer scores were used. The kappa for panel score after discussion was 0.23 (95% confidence interval: 0.08, 0.39). By using the mean of the reviewer scores, the panel coefficient was similarly 0.23 (0.00, 0.46).

Conclusion

The reliability between panel scores was higher than between reviewer scores. The similar interpanel reliability, when using the final panel score or the mean value of reviewer scores, indicates that panel discussions per se did not improve the reliability of the evaluation.     

快速精子浓度检测试剂盒的临床实验室检测评价

目的:探讨快速精子浓度检测试剂盒的准确性、灵敏性和特异性,以评价其临床应用价值。方法:应用快速精子浓度检测试剂盒和世界卫生组织推荐的显微镜计数法分别测定临床500例不育症患者的精子浓度,并进行两种方法的kappa一致性检验。结果:快速检测精子浓度检测试剂盒和显微镜计数法比较的准确性为97.6%,特异性为97.4%,敏感性为97.8%,Kappa值为0.956,两种检测方法的结果有很好的一致性。结论:运用快速精子浓度检测试剂盒能够基本满足临床需求,其标本处理简便,有良好的应用前景。