Gastrointestinal Endoscopy, Informed Consent
Conditions
Brief summary
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.
Interventions
BEHAVIORALReading of informed consent form
Patients that adequately read informed consent forms
Sponsors
Centro Hospitalar Tondela-Viseu
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adult patients able to autonomously give informed consent * Patients refered to elective endoscopic procedures (upper digestive endoscopy and/or colonoscopy) without deep sedation.
Exclusion criteria
* Patients refered to urgent endoscopic procedures * Patients refered for endoscopic procedures with deep sedation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessing the percentage of patients who adequate read informed consent forms | 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. |
Countries
Portugal
Outcome results
None listed