在2014年至2023年间的眼科临床试验中使用患者报告的结果
Xiaole Li1, Natalie Chen1, Han Hsiao2
1Faculty of Medicine, University of Toronto Temerty, Toronto, Ontario, Canada.
The British journal of ophthalmology
|July 10, 2025
概括
患者报告结果 (PROs) 和PRO措施 (PROMs) 在眼科试验中提供了宝贵的患者见解,但未得到充分利用. 未来的研究应该优先考虑它们的整合和解释,以进行全面的治疗评估.
科学领域:
- 眼科医生 眼科 眼科
- 临床试验 临床试验
- 患者报告的结果
背景情况:
- 患者报告结果 (PROs) 评估健康状况和功能健康.
- 产品价值测量 (PROM) 是量化产品价值的标准化工具.
- 专家提供了超越传统临床终点的洞察力,这对于治疗评估至关重要.
研究的目的:
- 调查眼科随机对照试验 (RCT) 中的PRO和PROM的利用,解释和报告.
- 评估在高影响力眼科研究中PROs遵守报告准则.
主要方法:
- 在顶级期刊 (2014-2023) 中发表的眼科RCT的系统综述.
- 评估PRO的入选,主要结果的状态,以及遵守CONSORT PRO的指导方针.
- 多变量回归用于探索影响PRO利用的因素.
主要成果:
- 在26.1%的RCT中,PRO被纳入其中,只有8.4%作为主要结局.
- 大多数研究 (95.4%) 使用PROM,主要是眼科专用工具.
- 最少重要的差异 (MID) 很少报告 (2.3%),并且遵守CONSORT PRO指南是不理想的 (33.3%).
- 在具有较低日志影响因子和药物干预因素的试验中,PRO使用的可能性较小.
结论:
- 在高影响眼科RCT中整合和解释PROs是有限的.
- 对于未来的试验,建议使用经过验证的,特定条件的PROM和已建立的MID.
- 提高PRO利用率可以提供对治疗疗效和患者体验的更全面的理解.
更多相关视频
06:29Comparing Objective Conjunctival Hyperemia Grading and the Ocular Surface Disease Index Score in Dry Eye Syndrome During COVID-19
Published on: May 25, 2022
2.4K
07:44In vivo Structural Assessments of Ocular Disease in Rodent Models using Optical Coherence Tomography
Published on: July 24, 2020
3.0K
相关概念视频
Clinical Trials
8.6K
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...
8.6K
Clinical Trials: Overview
3.4K
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...
3.4K
Open Angle Glaucoma: Treatment
583
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...
583
Glaucoma: Overview
777
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...
777
Angle Closure Glaucoma: Treatment
702
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...
702
