ArticleBMJ open2026
Protocol RCT for active informed consent in spine and urologic surgery in the metropolitan city of Bologna: does an increased patient engagement improve satisfaction of complex surgical procedures?
Article in BMJ open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06059599 (Active Informed Consent), which is not on this map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Active Informed Consent: a New Solution to Improve and Objectively Test the Patient Understanding of Complex Surgical Procedures Proposals
Who cites it
1 citing paper in PubMed.
- The Role of Emotions in Health Literacy and Patient Education: Trends, Technologies, and Future Opportunities-A Scoping Review.Healthcare (Basel, Switzerland) · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionInformed consent is an essential component of surgical care; however, patients often struggle to fully understand procedures, associated risks and available alternatives. Factors such as preoperative anxiety, limited health literacy and the complexity of consent documents can further impair comprehension and information retention. The active informed consent (CIA) pathway, based on a Patient Educational Program that combines multimedia resources with a comprehension test, aims to enhance patient understanding, improve satisfaction and reduce medicolegal issues. METHODS AND ANALYSIS: The study will be conducted as a multicentre, non-pharmacological, randomised controlled trial in three hospitals in the Emilia-Romagna region (Italy). A total of 300 patients undergoing elective complex spinal surgery or robotic radical prostatectomy will be enrolled and randomised (1:1) to the experimental arm or to the standard informed consent arm, using block randomisation stratified by centre. Outcomes will include patient satisfaction (Client Satisfaction Questionnaire), comprehension, psychological distress (Depression Anxiety Stress Scales), pain (Numeric Rating Scale), functional recovery (Oswestry Disability Index/International Prostate Symptom Score/International Consultation on Incontinence Questionnaire Short Form/International Index of Erectile Function) and medicolegal complaints. Assessments will be performed at baseline (T0), discharge (T1), 2 months (T2) and 6 months (T3), with extended monitoring of medicolegal outcomes for up to 5 years. ETHICS AND DISSEMINATION: The study has been approved by the Regional Ethics Committee of Emilia-Romagna (protocol CIA21, V.1.3 dated 14 December 2022). Participation is voluntary and does not affect standard care. Results will be disseminated through peer-reviewed journals, conference presentations and communication with health authorities. If effective, the intervention may be implemented as a scalable model to improve patient empowerment and transparency in surgical consent. TRIAL REGISTRATION NUMBER: NCT06059599.
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Registered trials
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