数据共享和评估产妇诱导宫成熟的试验的可靠性:对随机对照试验的元流行病学研究
Malitha Patabendige1,2, Daniel Lorber Rolnik1,2, Wanlin Li1
1Department of Obstetrics and Gynaecology, Monash University, Monash Medical Centre, Clayton, Victoria, 3168, Australia.
EClinicalMedicine
|July 21, 2025
概括
随机对照试验 (RCT) 分享个人参与者数据 (IPD) 劳动诱导具有更高的质量和可靠性. 鼓励IPD共享可以加强证据综合,以改善临床实践.
科学领域:
- 产科和妇科 产科和妇科
- 临床流行病学 临床流行病学
- 医学研究方法学 医学研究方法学
背景情况:
- 诱导分娩是一种常见的产科干预,在全球范围内采用率不尽相同.
- 评估随机对照试验 (RCT) 的可靠性通常包括检查个人参与者数据 (IPD),但数据共享仍然是一个挑战.
- 数据共享和非数据共享RCT之间的试验特征,可信度,效果大小和证据确定性的差异尚未得到充分理解.
研究的目的:
- 为了比较共享IPD的RCT的特征,可信度和证据确定性,与不共享IPD的RCT相比.
- 评估IPD共享对劳动诱导研究结果可靠性的影响.
主要方法:
- 一个对9个IPD关于产业诱导的元分析的元流行病学研究.
- 基于试验特征,注册,可信度 (使用TRACT检查清单),基线数据的一致性和统计结果的可重复性来评估RCT.
- 随机效应元分析和GRADE方法被用来比较共享和非共享IPD组之间的效应估计.
主要成果:
- 在265个RCT中,只有24.2%共享数据. 共享RCT显示显著更好的试验注册率 (44.0%与14.1%) 和可信度 (84.4%与49.1%).
- 非共享的RCT显示了夸大效果估计的可能性更高 (1.29至2.36的ROR) 和基线特征不那么一致.
- 与非共享组相比,共享IPD组的证据确定性更高,特别是对于没有可信度问题的RCT.
结论:
- 不分享IPD的劳动诱导的RCT更有可能具有较低的质量,可信度问题和夸张的效果估计.
- 鼓励IPD共享和进行IPD元分析对于强有力的证据综合至关重要.
- 优先考虑RCT的可信性和质量评估对于开发可靠的临床指南和告知实践至关重要.
相关概念视频
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
177
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,...
177
Clinical Trials
8.5K
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...
8.5K
Regression Toward the Mean
6.5K
Regression toward the mean (“RTM”) is a phenomenon in which extremely high or low values—for example, and individual’s blood pressure at a particular moment—appear closer to a group’s average upon remeasuring. Although this statistical peculiarity is the result of random error and chance, it has been problematic across various medical, scientific, financial and psychological applications. In particular, RTM, if not taken into account, can interfere when...
6.5K
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
Blinding
2.6K
Blinding is a commonly used method of not telling participants which treatment a subject is receiving. Blinding is a critical part of a randomized control trial or RCT. It reduces the bias that affects the results. In an RCT, blinding is used in the form of a placebo. A placebo effect occurs when untreated subjects falsely believe they have received the treatment and report improved symptoms. A placebo or a dummy treatment is administered to subjects to negate the bias caused by such an effect.
2.6K
Hazard Ratio
255
The hazard ratio (HR) is a widely used measure in clinical trials to compare the risk of events, such as death or disease recurrence, between two groups over time. It reflects the ratio of hazard rates—the instantaneous risk of the event occurring—between a treatment group and a control group. This measure provides valuable insights into the relative effectiveness of a treatment by assessing how the risk of an event differs between the two groups.
For example, in a clinical trial...
For example, in a clinical trial...
255


