Informed Consent in Endoscopy: Read, Understood or Merely Signed?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 232
- 试验地点
- 1
- 主要终点
- Assessing the percentage of patients who adequate read informed consent forms
研究概览
简要总结
Informed consent form is a legal document that, ethically, should be obtained before any endoscopic procedure is performed.
The main purpose of this research study is to assess the readability, comprehensibility and applicability of the new informed consent proposed by the Portuguese Society of Digestive Endoscopy as a way to standardize the information provided to patients prior to endoscopic exams.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients able to autonomously give informed consent
- •Patients refered to elective endoscopic procedures (upper digestive endoscopy and/or colonoscopy) without deep sedation.
排除标准
- •Patients refered to urgent endoscopic procedures
- •Patients refered for endoscopic procedures with deep sedation
结局指标
主要结局
Assessing the percentage of patients who adequate read informed consent forms
时间窗: 12 months
Assess if patients "adequately read" informed consent forms - "adequate reading" was defined by checking all of the following: signing of informed consent form; fulfilment of a questionnaire regarding medical history and drugs; underlining a small sentence added to the orignial version of informed consent form. Patients not meeting all the defined criteria were considered not to have adequately read the informed consent.
次要结局
未报告次要终点
研究者
Ana Carvalho
Principal Investigator
Centro Hospitalar Tondela-Viseu