书面知情同意的要求和在图表复习前列腺癌研究中的选择偏差
Renning Zheng1,2, Sanjay K Das1,3, Trung Duong Tran4
1Department of Urology, Cedars-Sinai Medical Center, Los Angeles, CA.
American journal of epidemiology
|March 4, 2026
概括
放弃对未来图表审查的知情同意至关重要. 如果不这样做,就会引入选择偏见,因为同意的患者年轻,前列腺癌风险较低,影响研究有效性.
科学领域:
- 医学研究方法论医学研究方法论.
- 在瘤学瘤学.
- 临床试验中的临床试验.
背景情况:
- 回顾性图表审查经常使用放弃知情同意.
- 对图表审查的潜在招生可能会面临机构审查委员会 (IRB) 对同意豁免的限制.
- 这可能导致选择偏见,影响研究的代表性和有效性.
研究的目的:
- 通过要求在图表审查研究中对潜在招生提供书面知情同意来确定引入的选择偏差.
- 评估同意要求如何影响前列腺癌研究中的参与者特征和结果.
主要方法:
- 使用了IRB批准的图表审查协议,并放弃了对潜在招募的书面知情同意.
- 在达勒姆VA医疗保健系统确定了2202名预定进行初始前列腺活检的患者 (2007-2021年).
- 提供书面同意单独采血协议的患者 (1,238) 和未提供书面同意的患者 (964) 之间的特征和前列腺癌风险的比较.
主要成果:
- 提供书面同意的患者年轻,但与非同意者相比,种族分布相似.
- 最重要的是,同意组的前列腺癌风险明显降低 (OR=0.41,p<0.001).
- 这些差异表明,同意要求可能会扭曲研究群体.
结论:
- 要求在图表审查研究中对潜在招生提供书面知情同意,引入了显著的选择偏差.
- 由于年龄和疾病风险的差异,同意的群体可能不能准确地代表更广泛的合格人口.
- 建议允许对未来图表审查的书面同意豁免,以最大限度地减少选择偏差并提高研究有效性.
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