在手术随机试验中与安慰剂对照对比非手术对照的参与者招募和退出:一个元流行病学研究和元分析
Pragadesh Natarajan1, Spiro Menounos2, Laura Harris2,3
1St George and Sutherland Clinical Campuses, School of Clinical Medicine, UNSW Medicine & Health, Sydney, New South Wales, Australia pragadeshnat9@hotmail.com sam.adie@gmail.com.
BMJ open
|April 18, 2024
概括
与安慰剂对照组进行的手术试验显示,与非手术对照组相比,类似的招募,但与非手术对照组相比,参与者 attrition 较高. 增加随访时间点可以减少安慰剂控制的手术研究中的磨损.
科学领域:
- 临床试验 临床试验
- 手术研究的研究.
- 超流行病学 超流行病学
背景情况:
- 招募和消耗是随机对照试验 (RCT) 的关键因素.
- 在手术RCT中将安慰剂对照与非手术对照进行比较对于了解试验进行至关重要.
- 之前的研究还没有全面评估这些控制类型之间的招聘和 attrition 差异.
结论:
- 使用安慰剂对照的手术试验面临着类似的招聘挑战,但与非手术对照相比,其 attrition 率显著更高.
- 手术RCT的研究设计应战略性地包括诸如增加后续时间等措施,以尽量减少参与者学和后续损失.
相关概念视频
Blinding
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
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
126
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,...
126
Blind Procedures
10.6K
Ideally, the people who observe and record the children’s behavior are unaware of who was assigned to the experimental or control group, in order to control for experimenter bias. Experimenter bias refers to the possibility that a researcher’s expectations might skew the results of the study. Remember, conducting an experiment requires a lot of planning, and the people involved in the research project have a vested interest in supporting their hypotheses. If the observers knew which...
10.6K
Randomized 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
Hazard Ratio
116
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...
116
Observational Studies
8.5K
Observational studies are a type of analytical study where researchers observe events without any interventions. In other words, the researcher does not influence the response variable or the experiment's outcome.
There are three types of observational studies – Prospective, retrospective, and cross-sectional.
Prospective Study
Prospective studies, also known as longitudinal or cohort studies, are carried out by collecting future data from groups sharing similar characteristics. One...
There are three types of observational studies – Prospective, retrospective, and cross-sectional.
Prospective Study
Prospective studies, also known as longitudinal or cohort studies, are carried out by collecting future data from groups sharing similar characteristics. One...
8.5K


