With the dissemination and popularization of EBM around the world, the evidence-based laboratory medicine has boomed gradually. However, the substantial researches in tbe field are still inadequale now. Based on the facts of hospital laboratory medicine, this article discussed the feasibility that apply the rationale and methods to orient the laboratory quality control.
While proposing evidence-based medical decision, we analyzed the existing problems in laboratory medicine, discussed the necessity and probability and explored the practicing way of evidence-based laboratory medicine, in order to follow the latest developing of clinical medicine and provide the best clinical laboratory technique and clinical laboratory service for good patient care.
Objective To seek the statistical solution in the comparison of different effects from multi-center randomized controlled trials （RCTs）. Methods The data collected from a multi-center RCT were used as the examples and processed by CMH test and meta-analysis. Results The result of CMH test indicated that the significant difference of the effect values existed among centers （P 〈0. 05 ）. While meta-analysis showed no significant difference （P 〉0.05 ） by heterogeneity test. However, when using fixed effect model, inter-group significant difference of merged effect values was observed （P 〈0.05 ）. Conclusions In the clinical research based on the method of multi-center RCT, met.a-analysis can be applied if the difference of inclination of the inter-group therapeutic effect is found among different centers. The proper mathematical model should be selected based on the result of heterogeneity test to merge and compare the effect values. The conclusions should be drawn from the results of both meta-analysis and CMH test.
Objective To investigate an evaluation method of medical literature applicability to clinical work， and provide a convenient way for physicians to search for the best evidence. Methods Delphi method was used to choose appropriate evaluating indexes， analytic hierarchy process was performed to determine the weighing of each index， and the formula to calculate medical literature applicability was formed. The practicability of this formula was evaluated by consistency checking between the formula’s results and experts’ opinions on literature applicability. Results Five evaluating indexes were determined， including literature’s publishing year （X1）， whether the target questions were covered （X2）, sample size （X3）， trial category （X4）， and journal level （X5）. The formula to calculate medical literature applicability was Y=3.93 X1＋11.78 X2＋14.83 X3＋44.53 X4＋24.93 X5. The result of consistency checking showed that the formula’s results were highly consistent with experts’ opinions （Kappa=0.75， P＜0.001）. Conclusion The applicability formula is a valuable tool to evaluate medical literature applicability.
This paper is to discuss the research of heterogeneity in Meta-analysis, including the definition of the heterogeneity in Meta-analysis and classification it into clinical heterogeneity, methodological heterogeneity and statistical heterogeneity, the strategies for diminishing clinical heterogeneity and methodological heterogeneity, the five testing methods in statistical heterogeneity (Q statistic, I2 statistic, H statistic, Galbraith plot and L’Abbe plot) and the examples and applying conditions of the five testing methods, classification of meta-analysis into exploratory meta-analysis and analytic meta-analysis according if the meta-analysis has heterogeneity, and the strategies and the flowchart when existing the heterogeneity in meta-analysis.
The conclusions of meta-analyses are susceptible to various of biases, and publication bias is one of such main bias. Therefore, Checking for evidence of publication bias should be undertaken routinely at the preliminary stage of a meta-analysis. Begg’s test, Egger’s test, and Macaskill’s test are usually used to objectively identify publication bias in meta-analyses. In order to conveniently use these methods, the SAS program of these three tests was designed in this paper. In order test practical data, the fact that the output of this program of SAS software was consisted with the output of STATA software was validated. So, this program is an alternative way to do such hypothesis tests to identify the publication bias in meta-analyses.
To show that a new drug is better than, as good as, or no worse than that of a known effective drug. Theoretically, it is necessary to confirm the efficacy of a treatment, but the current practice of clinical trial suggests that there exists many problems in its confirmation including the objectives of clinical investigation vary based on the fact that more and more clinical trials use active controls. Applied statistical methods have to adapt to these changes. In this paper, we illustrated some statistical issues of confirming efficacy in clinical trials, including its conditions, the determination of clinical margin, the forms of the null and alternative hypothesis and confidence intervals, the choice of endpoints and some miscellaneous considerations. We bly suggests that it is necessary to make biostatisticians and clinical trialists understand the importance of using the right statistical methods when investigating clinical trials. We also think these methods introduced in the paper may provide some help in trial design and evaluation.
Objective To evaluate the efficacy and safety of safflower yellow pigment lyophilized power amp; dripping solution in the treatment of patients with angina, by using parenteral solution of Dan-shen root extraction as control, we designed the nonferiority clinical trial phase Ⅲ. Method 784 patients with stable angina pectoris Ⅰ, Ⅱ, Ⅲ degree and occurred more than twice per week were selected. They were randomly, stratified and blindly assigned into 5 parallel groups including one control. They were treated by using safflower yellow pigment lyophilized power (SYPLP) 80 mg + 0.9% NS 250ml, intravenously guttae, daily (trial group 1); SYPLP 160 mg + 0.9% NS 250 ml, intravenously guttae, daily (trial group 2); safflower yellow pigment lyophilized dripping solution (SYPLDS) 200 ml (160 mg), intravenously guttae, daily (trial group 3); SYPLDS 100 ml (80 mg), intravenously guttae, daily (trial group 4) and parenteral solution of Dan-shen root extraction 20 ml + 0.9% NS 250 ml, intravenously guttae, daily (control group) respectively. Efficacy and safety were evaluated after 14 days of continuous treatment. Results The angina efficacy (per-protocol population, PP): The notable effective rates of trial groups 1 to 4 and control group were 53.27%，69.44%，70.09%，55.09% and 26.00% respectively, and the effective rates were 88.79%，92.59%，93.46%，89.81% and 73.00% respectively。There was significant differences between trial group 1 and 2, trial group 3 and 4. All trial groups showed significant different effect when compared with control (P＜0.05). The effect of trial group 2 was better than those of trial group 1, and trial group 3 better than trial group 4, the four trial groups better than control group. The intention-to-treat (ITT) analysis result was almost the same to PP analysis, but trial group 3 showed no significant difference to trial group 4. In trial group 2, 3 and 4, each occurred one adverse effect, while the number was 10 in control group.Conclusion SYPLP amp; SYPLDS have certain effect on angina. They are more effective than parenteral solution of Dan-shen root extraction. No toxic side effect has been found in clinic tests.
目的 促进医学生化检验课程理论与实验的结合，提高学生学习实验兴趣，增强学生临床对话的能力。 方法 通过创建问题情景和病例，在医学检验专业本科班中应用以问题为导向教学法（PBL），结合病例教学方法进行临床生化检验实验教学改革。 结果 问卷调查显示，学生在教学内容掌握、学习的主动性、综合分析能力、创新能力、团队协作等方面均得到明显提高。92.6%的学生认为PBL结合病例教学法优于传统实验教学法。 结论 PBL结合病例教学法值得在生化检验实验教学中加以推广。