本文選題：臨床研究　切入點：慢性胃炎　出處：《中醫(yī)雜志》2017年19期

【摘要】：目的以臨床研究中運用量化評價標(biāo)準(zhǔn)為例,探討建立量化評價指標(biāo)并應(yīng)用于臨床研究過程質(zhì)量控制中的可行性及意義。方法建立慢性胃炎中醫(yī)藥防治臨床研究質(zhì)量控制量化評價指標(biāo),包括研究藥物管理、隨機化執(zhí)行、數(shù)據(jù)記錄、受試者依從性、受試者保護、實驗室檢測等臨床研究關(guān)鍵環(huán)節(jié),并將其應(yīng)用于國家中醫(yī)藥管理局中醫(yī)藥行業(yè)科研專項"慢性胃炎中醫(yī)藥防治技術(shù)及規(guī)范的轉(zhuǎn)化應(yīng)用研究"中每個環(huán)節(jié)的質(zhì)量評價,實現(xiàn)臨床研究質(zhì)量的管理。結(jié)果臨床研究啟動初期、啟動中期和結(jié)題前的三次質(zhì)量控制量化評價顯示,啟動初期"研究記錄及時"標(biāo)化分值最低,為0.6;研究中期"數(shù)據(jù)記錄"和"研究用藥的依從性"方面標(biāo)化分值最低,均為0.8;結(jié)題前的評價仍然是研究記錄的規(guī)范性和完整性方面表現(xiàn)欠缺,標(biāo)化分值均為0.8。三次量化評價總分值分別為91.3、94.6、96.7,呈逐漸升高趨勢,表明研究質(zhì)量總體情況良好。結(jié)論在對影響研究質(zhì)量的風(fēng)險進(jìn)行識別的基礎(chǔ)上,建立臨床研究質(zhì)量控制與評價量化指標(biāo),并在研究過程中實施質(zhì)量控制評價,有助于對研究課題質(zhì)量及時進(jìn)行管理,可有效促進(jìn)研究質(zhì)量的提升。
[Abstract]:Objective to study the feasibility and significance of establishing quantitative evaluation index and applying it to quality control in clinical research.Methods the quantitative evaluation indexes of quality control in the clinical study of prevention and treatment of chronic gastritis were established, including drug management, randomization execution, data recording, subject compliance, subject protection, laboratory test, and other key links of clinical research.It is applied to the quality evaluation of every link in the special scientific research project of Chinese medicine industry of the State Administration of traditional Chinese Medicine, "Research on the Prevention and treatment of chronic gastritis by traditional Chinese Medicine and its Standard Transformation and Application", so as to realize the quality management of clinical research.Results at the beginning of clinical study, the quantitative evaluation of three times of quality control showed that the standardized score of "research record in time" was the lowest in the early stage of the clinical study.The standardized scores of "data record" and "compliance of research drugs" were the lowest (0.8) in the middle period of the study, and the evaluation before the conclusion was still lack of standardization and integrity of the research record, the standardized score was 0.8.The total score of the third quantitative evaluation was 91.3 / 94.6 / 96.7, which showed a trend of increasing gradually, indicating that the overall quality of the study was good.Conclusion on the basis of identifying the risk that affects the quality of the research, the quantitative index of quality control and evaluation of clinical research is established, and the quality control evaluation is carried out in the course of the research, which is helpful to the management of the quality of the research subject in time.It can effectively promote the quality of research.
【作者單位】： 中國中醫(yī)科學(xué)院西苑醫(yī)院;北京中醫(yī)藥大學(xué)東方醫(yī)院;
【基金】：國家中醫(yī)藥管理局中醫(yī)藥行業(yè)科研專項(201107006)
【分類號】：R24
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本文編號：1716646