相关实验视频
在已注册的糖尿病试验中,患者重要的结果
Gunjan Y Gandhi1, M Hassan Murad, Akira Fujiyoshi
1Division of Endocrinology, Diabetes, Metabolism and Nutrition, College of Medicine, Mayo Clinic, Rochester, Minnesota 55905, USA.
JAMA
|June 5, 2008
概括
大多数糖尿病临床试验没有优先考虑患者重要的结果. 仅有18%的注册随机临床试验 (RCT) 使用患者重要结果作为其主要重点,影响安全性和疗效评估.
科学领域:
- 临床研究方法论临床研究方法论
- 糖尿病干预措施 糖尿病干预措施
- 患者为中心的研究结果研究.
背景情况:
- 对糖尿病干预措施的安全性和有效性仍然存在担忧.
- 随机临床试验 (RCT) 往往缺乏对患者重要结果的测量,例如死亡率和生活质量.
研究的目的:
- 系统地评估在正在进行和未来的糖尿病RCT中纳入患者重要结果的情况.
- 确定糖尿病RCT中测量患者重要结果的比例.
主要方法:
- 搜索了主要的RCT注册表 (ClinicalTrials.gov,ISRCTN,ANZCTR) 寻找符合条件的试验.
- 鉴定并采样了436个2至4期RCT,注册了糖尿病患者,重点关注自2004年以来注册的RCT.
- 独立的审查员提取了研究特征和结果类型 (患者重要,代孕,生理) 的数据.
主要成果:
- 在分析的436个RCT中,只有18%使用患者重要结局作为主要结局.
- 代孕结果在61%的试验中是主要的,而生理结果在16%是主要的.
- 在46%的试验中,患者重要的结局被报告为主要或次要. 较大,较长的试验更有可能包括它们,而并行设计和2型糖尿病试验的可能性较小.
结论:
- 大多数注册的糖尿病RCT没有优先考虑患者重要的结果.
- 这种代表性不足可能会限制对真正干预有效性和患者福祉的评估.
- 未来的研究和试验设计应强调包括患者重要的结果.
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