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This is an interventional, non-pharmacological, randomized controlled superiority study (RCT), multicenter, open label, parallel group.
The aim is to evaluate the effectiveness of a new preoperative information method, based on multimedia tools and on the objective control of understanding by the patient candidate for spinal or urological surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| active informed consent | Experimental | The experimental group will be prepared for the surgery through the new information tools, a video will be administered with information about the various surgical possibilities, graphics and animations in order to direct the patient toward a more informed choice. Next, an interview with the surgeon will be arranged for the patient and care givers to be listened to and guided through the use of 3D-printed models into the best decision for the individual case (Shared Decision Making - SDM). Having decided on the surgery, patients with similar surgical programs will be guided in educational programs to reinforce information, understanding and long-term retention of the concepts learned. The course will conclude with a second interview with the surgeon and the signing of the standard informed consent. |
|
| Traditional informed consent | No Intervention | The control group of patients will be informed about the surgery according to standard practices. As per standard practice, the patient will meet with the physician before surgery for an explanatory interview and subsequent signing of informed consent. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| active informed consent | Other | new preoperative information method, based on multimedia tools and on the objective control of understanding by the patient candidate for vertebral or urological surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Client Satisfaction Questionnaire | The primary outcome of the study will be measured: - by means of the Client Satisfaction Questionnaire, which provides a patient satisfaction score with a range from a minimum of 8 points (completely dissatisfied) to a maximum of 32 points (completely satisfied). | baseline (T0), discharge (T1), 2 months follow-up (T2) and 6 months follow-up (T3) |
| Measure | Description | Time Frame |
|---|---|---|
| Comprehension Questionnaire | procedure-specific assessment tool designed ad-hoc to evaluate a patient's knowledge and understanding of the planned procedure and associated risks/alternatives. | baseline (T0), discharge (T1), 2 months follow-up (T2) and 6 months follow-up (T3) |
| Depression Anxiety Stress Scales (DASS-21) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luca Boriani, MD | Contact | 0516366233 | luca.boriani@ior.it | |
| Bruna Maccaferri, MD | Contact | 0516366163 | bruna.maccaferri@ior.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Ortopedico Rizzoli | Recruiting | Bologna | 40136 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23832767 | Result | Kinnersley P, Phillips K, Savage K, Kelly MJ, Farrell E, Morgan B, Whistance R, Lewis V, Mann MK, Stephens BL, Blazeby J, Elwyn G, Edwards AG. Interventions to promote informed consent for patients undergoing surgical and other invasive healthcare procedures. Cochrane Database Syst Rev. 2013 Jul 6;2013(7):CD009445. doi: 10.1002/14651858.CD009445.pub2. | |
| 31948345 |
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is a 21-item self-report questionnaire designed to assess the severity of depression, anxiety, and stress symptoms over the past week |
| baseline (T0), discharge (T1), 2 months follow-up (T2) and 6 months follow-up (T3) |
| Numeric Rating Scale (NRS) | is a simple self-report measure in which patients rate their current pain intensity on an scale from 0 ("no pain") to 10 ("worst imaginable pain"). | baseline (T0), discharge (T1), 2 months follow-up (T2) and 6 months follow-up (T3) |
| Oswestry Disability Index (ODI) | self-administered questionnaire that assesses the degree of disability and functional impairment across ten daily-activity domains. | baseline (T0), discharge (T1), 2 months follow-up (T2) and 6 months follow-up (T3) |
| International Prostate Symptom Score (IPSS) | Only for Urology patients: 7-item questionnaire that evaluates the severity of lower urinary tract symptoms and their impact on quality of life. | baseline (T0), discharge (T1), 2 months follow-up (T2) and 6 months follow-up (T3) |
| International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) | Only for Urology patients: short, patient-completed questionnaire that measures the frequency, severity, and impact of urinary incontinence on quality of life. | baseline (T0), discharge (T1), 2 months follow-up (T2) and 6 months follow-up (T3) |
| International Index of Erectile Function (IIEF-5 ) | Only for Urology patients: brief, 5-item self-report measure used to assess erectile function and screen for erectile dysfunction severity | baseline (T0), discharge (T1), 2 months follow-up (T2) and 6 months follow-up (T3) |
| Rate of Patients Declining Spine Surgery (Opt-Out Rate) | The proportion of patients in spine surgery population, who, after receiving full information, choose not to proceed with the planned surgery. | baseline (T0) |
| Medico-Legal Outcomes | For each group, we will track through hospital records the number of medicolegal complaints or claims filed by patients, specifically those alleging inadequate informed consent or unexpected outcomes, related to their surgery within the follow-up period. The outcome will be reported as the count (or proportion of patients) with such complaints in each arm. | baseline (T0), discharge (T1), 2 months follow-up (T2) and 6 months follow-up (T3). |
| Glaser J, Nouri S, Fernandez A, Sudore RL, Schillinger D, Klein-Fedyshin M, Schenker Y. Interventions to Improve Patient Comprehension in Informed Consent for Medical and Surgical Procedures: An Updated Systematic Review. Med Decis Making. 2020 Feb;40(2):119-143. doi: 10.1177/0272989X19896348. Epub 2020 Jan 16. |
| 30944886 | Result | Nathe JM, Krakow EF. The Challenges of Informed Consent in High-Stakes, Randomized Oncology Trials: A Systematic Review. MDM Policy Pract. 2019 Mar 28;4(1):2381468319840322. doi: 10.1177/2381468319840322. eCollection 2019 Jan-Jun. |
| 29932049 | Result | Luhnen J, Muhlhauser I, Steckelberg A. The Quality of Informed Consent Forms-a Systematic Review and Critical Analysis. Dtsch Arztebl Int. 2018 Jun 1;115(22):377-383. doi: 10.3238/arztebl.2018.0377. |
| 41806994 | Derived | Boriani L, Quattrini I, Maccaferri B, Lima C, Benuzzi A, Salvador M, Schiavina R, Brunocilla E, Deiure F, Maselli V, De Stefano R, Vommaro F, Gasbarrini A. 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? BMJ Open. 2026 Mar 10;16(3):e108286. doi: 10.1136/bmjopen-2025-108286. |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D014570 | Urologic Diseases |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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