选择与选择退出常规记录的健康数据的二次使用:一个随机对照试验
Merel Hermus1, Celinde H Scharloo-Karels1, M Arfan Ikram2
1Department of Pathology, Erasmus MC University Medical Center, Rotterdam, the Netherlands.
European journal of internal medicine
|January 30, 2025
概括
与opt-in相比,选择退出健康数据的同意程序显著增加了患者数据的研究可用性. 患者必须得到充分的信息,以保持对其健康信息的控制.
科学领域:
- 医疗信息学 医疗信息学
- 生物伦理学生物伦理学
- 医疗保健服务研究 医疗服务研究
背景情况:
- 健康数据的二次使用对于改善医疗保健至关重要.
- 在数据可用性与患者隐私和控制之间取得平衡至关重要.
- 知情同意程序是道德数据共享的关键.
研究的目的:
- 为了比较健康数据的二次使用的选择与选择退出同意程序.
- 确定同意方法对数据可用性和潜在偏差的影响.
- 为医疗研究中的患者同意提供最佳实践信息.
主要方法:
- 在第三级医院进行的随机对照试验.
- 在16个门诊诊所招募2228名新患者.
- 分配到选择加入或选择退出同意组.
主要成果:
- 选择退出程序的同意率高于选择加入的同意率.
- 同意率因患者的性别,社会经济地位和出生国而异.
- 研究期间为2022年12月至2023年9月.
结论:
- 选择退出同意更有效地最大限度地提高了健康数据的可用性,减少了偏见.
- 患者知情同意对于保持患者自主性至关重要.
- 这有助于在研究中使用道德和高效的二次数据.
相关概念视频
Randomized Experiments
6.7K
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...
6.7K
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
114
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,...
114
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
Data Collection by Experiments
23.8K
Data collection is a systematic method of obtaining, observing, measuring, and analyzing accurate information. An experimental study is a standard method of data collection that involves the manipulation of the samples by applying some form of treatment prior to data collection. It refers to manipulating one variable to determine its changes on another variable. The sample subjected to treatment is known as “experimental units.”
An example of the experimental method is a public...
An example of the experimental method is a public...
23.8K
What is an Experiment?
10.3K
An experiment is a planned activity carried out under controlled conditions. The purpose of an experiment is to investigate the relationship between two variables. When one variable causes change in another, we call the first variable the explanatory or independent variable. The affected variable is called the response or dependent variable. In a randomized experiment, the researcher manipulates values of the explanatory variable and measures the resulting changes in the response variable. The...
10.3K


