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Analysis of the quality of clinical trials about therapeutic research using the standard of Evidence-Based Medicine
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- Author:
- No author available
- Journal Title:
- CHINESE JOURNAL OF OPHTHALMOLOGY
- Issue:
- 9
- DOI:
- 10.3760/j:issn:0412-4081.2004.09.009
- Key Word:
- 证据医学;随机对照试验;对照临床试验;论文,学位;质量控制
Abstract： 目的探讨我国眼科领域的临床疗效研究水平,为循证医学(EBM)研究提供可靠证据.方法按照EBM标准,对中华眼科杂志1983～2002年间,发表的全部涉及临床疗效的论文进行检索和分析.结果临床疗效研究论文共152篇;其中属于随机对照试验35篇,临床对照试验8篇,共计43篇,占临床疗效研究论文的28.1%,且在随机分组、对照设置、盲法、基线资料、随访、失访、并发症报告及统计分析等方面均存在较多问题.在属于对照实验的论文中,有10篇(23.3%)论文描述了随机或半随机分组的具体方法;采用安慰剂对照和开放对照的文章分别是3篇(7.0%)和9篇(20.9%);盲法研究性论文7篇(16.3%);有随访结果,并提供较为详细随访资料的论文25篇(58.1%);未见分析混杂、偏倚、干扰和沾染等因素影响临床疗效研究质量的论文;未见在项目设计时进行了样本含量估算的论文;15篇(34.9%)论文中的部分或全部数据未标明显著性检验方法,仅有P值.结论我国眼科领域的部分临床科研设计方法不够严谨,从而影响研究结果的真实性和可靠性.重视对眼科医师进行临床科研设计方法的培训,严格控制研究质量,对提高我国的临床疗效研究水平至关重要.(中华眼科杂志,2004,40:609-613)
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