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The aim of this study is to evaluate the comprehension of the Informed consent with the Standard Verbal Communication (SVC) versus Portable Video Media (PVM).
The informed consent (IC) is a fully ethical and legal consolidated requirement. IC is the voluntary authorization by a patient for surgical treatment (MeSH). The IC has to include: 1. What is and for what is it, 2. How is it made, 3. What effect will produce, 4. which patients will benefit, 5. Alternatives, 6. Risks and special situations.
The standard IC is based in written and verbal information, but the information provided is insufficient, leading to misunderstanding and even litigation.
Technology plays an important role in the improvement of IC: the portable video media, tablet, with the application (app) iURO assists the procedure through videos and illustrations.
To evaluate and measure the comprehension of the information that patients received, we elaborated and validated a "Questionnaire to evaluate the comprehension of IC" (the process was mounted as "Questionnaire for urology IC validation" in the poster session at the 17th International European Association of Urology Nurses (EAUN) Meeting, Munich-Germany).
The patients undergoing to bladder or prostate transurethral resection were selected. Afterwards they were randomized previous the interview, into two groups: patients informed by PVM with the app iUro (experimental group) versus patients with an SVC (control group). The questionnaire was used to compare the comprehension of the surgery immediately and 15 days after the surgery. The items regarding questionnaire were: information, utility of the intervention, side effects, complications, comorbidity, usefulness of information, anxiety and risks.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care
Informed consent trough a portable video media, Written informed consent
Urology Department of the University Hospital of Puerto Real
Hospital Universitario Puerto Real
Published on BioPortfolio: 2016-07-28T03:38:21-0400
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Informed consent given by someone other than the patient or research subject.
Informed consent given by a parent on behalf of a minor or otherwise incompetent child.
Voluntary authorization, by a patient or research subject, with full comprehension of the risks involved, for diagnostic or investigative procedures, and for medical and surgical treatment.
Groups of persons whose range of options is severely limited, who are frequently subjected to COERCION in their DECISION MAKING, or who may be compromised in their ability to give INFORMED CONSENT.
Voluntary authorization by a person not of usual legal age for diagnostic or investigative procedures, or for medical and surgical treatment. (from English A, Shaw FE, McCauley MM, Fishbein DB Pediatrics 121:Suppl Jan 2008 pp S85-7).
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