使用CONSORT陈述和随机试验报告的质量:比较前后评估
1Thomas C. Chalmers Centre for Systematic Reviews, Children's Hospital of Eastern Ontario Research Institute, 401 Smyth Rd, Ottawa, Ontario, K1H 8L1 Canada.
JAMA
|April 20, 2001
概括
综合试验报告标准 (CONSORT) 声明改善了随机对照试验 (RCT) 报告. 采用CONSORT的期刊显示,报告质量显著提高,未明确的分配隐藏率下降.
科学领域:
- 医学研究方法学 医学研究方法学
- 临床试验报告标准 临床试验报告标准
背景情况:
- 综合试验报告标准 (CONSORT) 声明是为了提高随机对照试验 (RCT) 报告的质量而开发的.
- 关于CONSORT声明在实现其目标方面有效性的数据有限.
研究的目的:
- 评估是否采用CONSORT声明与RCT报告的质量提高有关.
- 为了比较RCT报告在CONSORT指南实施之前和之后.
主要方法:
- 采用了比较的前后研究设计.
- 1994年的报告 (前CONSORT) 与1998年的报告 (后CONSORT) 在四个著名的医学期刊中进行了比较.
- 两个期刊采用了CONSORT,另外两个期刊作为对比期刊,其中一个期刊没有采用指南.
主要成果:
- 采用CONSORT的期刊的报告显示,包含在CONSORT检查清单中的项目数量在统计上显著增加.
- 在采用者期刊中观察到,关于分配隐的不清楚报告频率显著下降.
- 使用Jadad规模评估的总体试验质量得分在采用CONSORT声明的期刊中显著改善.
结论:
- 这些发现表明,使用CONSORT声明与公布的RCT报告质量的可证明改进有关.
- 遵守CONSORT指南对临床试验报告的清晰度和完整性产生了积极的影响.
相关概念视频
02:07Blind Procedures
10.8K
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...
10.8K
01:15Study Design in Statistics
7.5K
A study design is a set of techniques that allow a researcher to collect and analyze data from different variables defined for a specific research problem. Statistics is commonly for effective study design and more robust experiments,
Does aspirin reduce the risk of heart attacks? Is one brand of fertilizer more effective at growing roses than another? Is fatigue as dangerous to a driver as the influence of alcohol? Questions like these are answered using randomized experiments with proper...
Does aspirin reduce the risk of heart attacks? Is one brand of fertilizer more effective at growing roses than another? Is fatigue as dangerous to a driver as the influence of alcohol? Questions like these are answered using randomized experiments with proper...
7.5K
01:13Randomized Experiments
6.3K
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...
6.3K
01:16Clinical 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
01:11Blinding
2.9K
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.
2.9K
01:23Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
627
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,...
627