14个随机对照试验的数据完整性
Ben W Mol1, Esmee M Bordewijk2, Ewelina Rogozińska3
1Department of Obstetrics and Gynecology, Monash University, Clayton, Australia.
概括
对贫血孕妇用铁治疗的随机对照试验 (RCT) 的调查揭示了潜在的研究完整性问题. 一些研究显示重复数据和不可信的发现,质疑他们的结果的有效性.
科学领域:
- 医学研究的完整性 医学研究的完整性
- 临床试验方法论 临床试验方法论
- 基于证据的医学是基于证据的医学.
背景情况:
- 对怀孕期间缺铁性贫血的铁治疗方法的审查发现,在同一研究人员撰写的单独随机对照试验 (RCT) 中,重复表.
- 这种重复引起了人们对公布数据可靠性的担忧.
研究的目的:
- 严格评估由Dr.进行的随机临床试验的研究完整性. 阿姆·达尔维什 (AM Darwish) 来自埃及阿苏特大学.
- 评估在多项研究中提供的数据的一致性和有效性.
主要方法:
- 在14个已识别的RCT中对基线和结果表进行系统比较.
- 对基线特征的p值分布进行分析,以检测与预期随机分配的偏差.
- 在研究之间识别重复内容和潜在的抄袭行为.
主要成果:
- 分析了14个涉及1,405名参与者的RCT.
- 两对研究在基线特征上表现出显著的相似性.
- 一对研究被发现是窃的,p值分析表明所有研究中适当随机化的概率很低.
结论:
- 分析表明,与Darwish博士相关的RCT中存在潜在的完整性问题.
- 建议在将研究结果应用于临床实践之前,对这些研究进行批判性调查.
- 在进一步审查之前,这些研究不应该为患者的护理决策提供信息.
更多相关视频
06:13Author Spotlight: Exploring the Impact of Reduced Resistance Exercise Volume on Metabolic Health
Published on: December 1, 2023
1.1K
06:55Inverse Probability of Treatment Weighting Propensity Score using the Military Health System Data Repository and National Death Index
Published on: January 8, 2020
14.5K
相关概念视频
01:16Clinical Trials
6.7K
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...
6.7K
01:23Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
125
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,...
125
01:12Hazard Ratio
115
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...
115
01:11Blinding
2.4K
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.
2.4K
01:13Randomized Experiments
6.9K
The randomization process involves assigning study participants randomly to experimental or control groups based on their probability of being equally assigned. Randomization is meant to eliminate selection bias and balance known and unknown confounding factors so that the control group is similar to the treatment group as much as possible. A computer program and a random number generator can be used to assign participants to groups in a way that minimizes bias.
Simple randomization
Simple...
Simple randomization
Simple...
6.9K
01:52Regression Toward the Mean
6.3K
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...
6.3K