| 杨雪,杨素琴,王荣华,孙学东,刘建平,廖星,李赞华,李尚蔚,杜时春,常秦.对糖尿病患者进行科研教育的多中心随机干预试验[J].,2011,31(10):1359-1363 |
| 对糖尿病患者进行科研教育的多中心随机干预试验 |
| A Multi-center,Randomized Control Trial on Clinical Research Education to Diabetes Patients |
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| DOI： |
| 中文关键词: 糖尿病 随机对照试验 临床科研 教育 |
| 英文关键词:diabetes randomized control trial clinical research education |
| 基金项目:国家重点基础研究发展计划(973计划)资助项目(No.2006CB504602);2010年度山东省优秀中青年科学家奖励基金项目(No.BS2010YY016) |
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| 中文摘要: |
| 目的评价实施科研教育对于改变患者对临床科研认识和态度的效果。方法对6家医院符合糖尿病诊断的258例患者开展随机教育干预试验,干预组129例,给予临床科研知识教育;对照组129例,不进行干预。结局指标为患者干预前后及组间对临床科研的认识、态度的变量。结果两组均无退出及失访病例。就19个题目答案赋值内容进行组间和组内比较,差异有统计学意义(P<0.05),经教育后患者对临床科研的认识、对知情同意、安慰剂、随访、随机分配以及伦理学等方面的认识水平有了明显提高,对参加科研的态度、看法、信心、期望等方面都有明显转变,证明该干预方法简便易行。受教育程度与教育效果呈正相关。结论本研究证实了对即将参与临床试验的患者进行临床科研教育的必要性,以及开展科研教育工作的有效性和可行性。 |
| 英文摘要: |
| Objective To assess the effect of implementing education about clinical research in changing the awareness and attitudes of diabetic patients.Methods A randomized control trial was implemented in 258 patients with diabetes from 6 hospitals.The participants were assigned to the intervention group(129 cases,who received education about the clinical research) and the control group(129 cases,who received no intervention).The outcome indicators were the variables on knowledge,attitude for the clinical research between before and after intervention in the same group and between the two groups.Results There was no withdrawal or lost in the two groups.Comparing the contents between inter-groups and intra-group for 19 assignment questions,it showed statistical significance(P<0.05).After the patients received education,their knowledge about and attitude towards clinical research,informed consent,placebo,follow-up,random allocation,and ethics,etc.were markedly improved.Their attitudes for the participants to join in scientific research,opinion,confidence were obviously changed,and it also showed that the method was feasible.The patients’ education level was positively correlated with the clinical research educated outputs.Conclusion This study proved the necessity for patients participating in future clinical trials to receive education,as well as its feasibility and effectiveness. |
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