2014年至2023年间眼科临床试验中的结果报告偏差
Xiaole Li1, Marko Tien1, Ryan S Huang1
1Faculty of Medicine, University of Toronto Temerty, Toronto, Ontario, Canada.
The British journal of ophthalmology
|February 26, 2026
概括
结果报告偏差在眼科试验中很常见,不良结果更有可能被省略. 改善协议的遵守和透明度对于准确的医学研究至关重要.
科学领域:
- 眼科医生 眼科 眼科
- 临床试验 临床试验
- 研究诚信研究诚信
背景情况:
- 结果报告偏差 (ORB) 可以扭曲干预的有效性和安全数据.
- 临床试验结果的选择性报告会损害基于证据的医学.
- 在眼科随机对照试验 (RCT) 中ORB的患病率需要调查.
研究的目的:
- 确定眼科RCT中结果报告偏差的流行率和程度.
- 确定与眼科研究中不完整或未报告的结果相关的因素.
- 检查眼科试验中预先规定的和公布的结果之间的差异.
主要方法:
- 在Embase,MEDLINE和CENTRAL系统搜索眼科RCT (2014-2023年).
- 定义不完全报告的结果 (缺少元分析数据) 和未报告的结果 (没有发表).
- 使用后勤回归和元分析来评估ORB患病率,相关因素和结果不利性.
主要成果:
- 在260个眼科RCT中,有64.2%的结果不完全报告;47.7%的结果未报告.
- 未报告的结果与较低的期刊影响因子和行业资金有关.
- 不利的结局是不完全报告的3.31倍 (p<0.001).
结论:
- 结果报告偏差在眼科RCT中非常普遍.
- 不完整的报告与不利的结果和特定试验特征有关.
- 加强对协议的遵守和报告透明度对于可靠的眼科研究至关重要.
更多相关视频
相关概念视频
Clinical Trials
10.9K
Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
There are four phases in a clinical trial. A phase one...
10.9K
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
503
Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
503
Open Angle Glaucoma: Treatment
1.1K
In open-angle glaucoma, the iridocorneal angle remains open, but the trabecular meshwork becomes stiff, slowing down the outflow of aqueous humor. This causes a buildup of aqueous humor in the anterior chamber, leading to a sudden increase in intraocular pressure. The treatment for open-angle glaucoma focuses on reducing the elevated intraocular pressure by either decreasing the secretion of aqueous humor or increasing its outflow.
Drugs such as carbonic anhydrase inhibitors, α2- and...
Drugs such as carbonic anhydrase inhibitors, α2- and...
1.1K
Clinical Trials: Overview
5.1K
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
5.1K
Angle Closure Glaucoma: Treatment
1.4K
Angle-closure glaucoma, or closed-angle glaucoma, is an eye condition where the iris bulges out and blocks the iridocorneal angle, resulting in a buildup of aqueous humor and increased intraocular pressure. Immediate medical attention is necessary due to the sudden onset of symptoms. The treatment for angle-closure glaucoma includes short-term and long-term approaches. Short-term treatment involves using eye drops like pilocarpine to lower intraocular pressure by increasing aqueous humor...
1.4K
Glaucoma: Overview
1.5K
Glaucoma is an eye condition characterized by increased intraocular pressure that damages the retina and optic nerve, leading to irreversible blindness if left untreated. The human eye has various components, including the cornea, iris, pupil, lens, and optic nerve. Aqueous humor is secreted by the epithelium of the ciliary body in the posterior chamber and flows through the trabecular meshwork and canal of Schlemm, maintaining normal intraocular pressure. The trabecular meshwork and the canal...
1.5K


