{
  "abstract": "Introduction Informed 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.",
  "authors": [
    {
      "affiliations": [
        "IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy"
      ],
      "name": "Luca Boriani"
    },
    {
      "affiliations": [
        "IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy"
      ],
      "name": "Irene Quattrini"
    },
    {
      "affiliations": [
        "Spine Surgery, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy"
      ],
      "name": "Bruna Maccaferri"
    },
    {
      "affiliations": [
        "IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy"
      ],
      "name": "Chiara Lima"
    },
    {
      "affiliations": [
        "IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy"
      ],
      "name": "Alice Benuzzi"
    },
    {
      "affiliations": [
        "IRCCS Azienda Ospedaliero-Universitaria di Bologna -Policlinico di Sant’Orsola, Bologna, Italy"
      ],
      "name": "Marco Salvador"
    },
    {
      "affiliations": [
        "Urology, Universita degli Studi di Bologna Dipartimento di Scienze Mediche e Chirurgiche, Bologna, Italy"
      ],
      "name": "Riccardo Schiavina"
    },
    {
      "affiliations": [
        "IRCCS Azienda Ospedaliero-Universitaria di Bologna -Policlinico di Sant’Orsola, Bologna, Italy"
      ],
      "name": "Eugenio Brunocilla"
    },
    {
      "affiliations": [
        "Ospedale Maggiore Carlo Alberto Pizzardi, Bologna, Italy"
      ],
      "name": "Federico Deiure"
    },
    {
      "affiliations": [
        "IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy"
      ],
      "name": "Vania Maselli"
    },
    {
      "affiliations": [
        "Ospedale Maggiore Carlo Alberto Pizzardi, Bologna, Italy"
      ],
      "name": "Roberta De Stefano"
    },
    {
      "affiliations": [
        "Spine Surgery, IRCCS Istituto Ortopedico Rizzoli, Bologna, Emilia-Romagna, Italy"
      ],
      "name": "Francesco Vommaro"
    },
    {
      "affiliations": [
        "Spine Surgery, IRCCS Istituto Ortopedico Rizzoli, Bologna, Emilia-Romagna, Italy"
      ],
      "name": "Alessandro Gasbarrini"
    }
  ],
  "title": "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?",
  "uid": "320eb043-34ab-5e42-83f1-a24c3957ffc3"
}