Informed Consent in Neurosurgery
Conditions
Keywords
Informed consent, neurosurgery, Randomized controlled trial, video-assisted consent, Patient satisfaction, Patient comprehension
Brief summary
This single-center randomized controlled trial addresses a critical gap in neurosurgical practice by evaluating the effectiveness of video-assisted informed consent compared to standard consent procedures.
Detailed description
Importance: Informed consent in neurosurgery faces unique challenges due to procedural complexity and limited clinical time, with traditional methods often resulting in suboptimal patient comprehension. Objective: To determine whether preoperative educational videos improve patient comprehension and satisfaction compared to standard consent procedures in neurosurgical patients. Design: Single-center, non-blinded randomized controlled trial. Patients are randomized (1:1) using opaque envelope methods. Setting: Department of Neurosurgery, Kantonsspital St. Gallen, Switzerland. Intervention: Video group receives individualized educational videos plus standard consent. Control group receives standard consent only. Videos coveres surgical indication, anatomy, procedural details, and risks. Main Outcomes and Measures: Primary outcomes: patient comprehension via standardized questionnaires, satisfaction with consent process, psychological distress (Patient Health Questionnaire-4). Assessments conducted preoperatively and postoperatively.
Interventions
PROCEDUREStandard informed consent
Standard informed consent, consisting of an in-person verbal consultation with the responsible neurosurgeon supplemented by written documentation and cranial models when applicable
PROCEDUREEducational Informed Consent Video
Individualized procedure-specific educational video. Videos are developed by a multidisciplinary collaboration of neurosurgeons, medical educators, and patient advocates. Each video is tailored based on location of the pathology, surgical approach, positioning, anticoagulation intake, and intraoperative adjuncts such as electrophysiology. Each video followes a standardized format covering anatomical considerations, preoperative care, the surgical procedure, and postoperative care including potential complications, expected recovery process, and post-surgery instructions.
Sponsors
Cantonal Hospital of St. Gallen
Felix C. Stengel, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The study population comprises adult patients scheduled for elective neurosurgical intracranial tumor resection
Exclusion criteria
* Patients requiring emergency surgery * Patients with cognitive impairments preventing informed consent * Patients with significant language barriers impeding effective communication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Comprehension | Measurement at two timepoints: - preoperative: within 24 hours after consenting - postoperative: within 72 hours after surgery | The investigators assess patients' comprehension through standardized questionnaires developed for neurosurgical procedures. Comprehension is evaluated by dichotomized responses: patients answering all questions correctly versus those who did not. |
| Patient Satisfaction | Measurement at two timepoints: - preoperative: within 24 hours after consenting - postoperative: within 72 hours after surgery | The investigators assess patients' satisfaction through standardized questionnaires developed for neurosurgical procedures. To measure satisfaction with consent and information delivery we use a visual analogue scale (0-100, higher scores indicating greater satisfaction). |
| Psychological Distress | Measurement at two timepoints: - preoperative: within 24 hours after consenting - postoperative: within 72 hours after surgery | The investigators evaluate psychological distress using the Patient Health Questionnaire 4 (PHQ-4). The PHQ-4 (Patient Health Questionnaire-4) is a brief, self-administered questionnaire used to screen for both anxiety and depression. It combines the PHQ-2 (a 2-item depression screener) and the GAD-2 (a 2-item anxiety screener). The PHQ-4 is designed to be a quick and easy way to identify individuals who may be experiencing symptoms of anxiety or depression, prompting further evaluation if needed. Scoring: Each item is scored on a 4-point Likert scale (0-3), and the scores are summed for each subscale (GAD-2 and PHQ-2) and the overall PHQ-4. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction with hospital stay | Measurement at two timepoints: - preoperative: within 24 hours after consenting - postoperative: within 72 hours after surgery | We measure satisfaction with the hospital stay and information delivery using a visual analogue scale (0-100, higher scores indicating greater satisfaction) |
Countries
Switzerland
Outcome results
None listed