随机对照试验的报道质量,用于垂体腺瘤的药物治疗
Hongmei Yan1, Daiyan Wang2, Yujing Zhao1
1Department of Neurosurgery, Weifang People's Hospital, Weifang, China.
Medicine
|March 15, 2024
概括
关于垂体腺瘤 (PA) 药物治疗的随机对照试验 (RCT) 的报告质量很差. 虽然一些领域有所改善,但样本大小和分配隐藏等关键因素往往被低估,这需要研究人员提高意识.
科学领域:
- 内分泌学 在内分泌学.
- 临床试验 临床试验
- 医学研究质量 医疗研究质量
背景情况:
- 由于改善的多学科护理,对垂体腺瘤 (PAs) 进行医疗治疗至关重要.
- 评估PA药物治疗随机对照试验 (RCT) 的报告质量至关重要.
研究的目的:
- 评估对垂体腺瘤药物治疗的RCT的报告质量.
- 识别随着时间的推移影响报告质量的趋势和因素.
主要方法:
- 在PubMed和MEDLINE系统搜索关于PA药物治疗的RCT (1974-2022).
- 评估报告质量使用28项2010年综合标准测试报告 (CONSORT) 声明整体质量评分 (OQS).
主要成果:
- 分析了27个RCT (1816名患者),OQS的中位数为12/28.
- 核心报告项目 (背景,目标,参与者,干预措施,结果) 在100%的试验中是完整的.
- 在试验识别,样本大小,分配隐藏和辅助分析 (11-4%报告) 发现报告不足.
- 自2010年以来,总体报告质量 (OQS) 显著提高.
- 较高的OQS与2010年后的出版物和招募超过100名患者的研究相关.
结论:
- 根据2010年CONSORT声明,PA药物治疗RCT的总体报告质量不足于最佳水平.
- 报告质量的上升趋势和与更好的报告相关的因素被观察到.
- 作者,审稿人和编辑需要加大努力,以改善RCT报告标准.
相关概念视频
01:11Clinical Trials: Overview
2.9K
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...
2.9K
01:12Hazard Ratio
120
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...
120
01:23Types 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
01:19Pharmacovigilance
830
Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
830
01:28Drug Therapy
43
The advent of drug therapy has profoundly shaped modern mental health care, providing targeted treatments for a range of psychological disorders. Psychotherapeutic drugs, classified into antianxiety, antidepressant, and antipsychotic medications, address symptoms across anxiety disorders, mood disorders, and schizophrenia. While these medications have transformed patient outcomes, they require careful management due to their potential side effects and limitations.
Antianxiety Medications
Antianxiety Medications
43
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