IC is a mandatory prerequisite prior to medical procedure. It is performed to protect patients' legal rights and guide the ethical practices of medicine, safeguarding the patient's autonomy, self-determination, and inviolability (2, 5). This process includes a comprehensive dialogue between the physician and the patient or their guardian, covering four essential components: risks, benefits, alternative treatments, and general information about the proposed procedure (1, 6). Failing to obtain valid informed consent not only puts the patient's autonomy at risk but also poses possible danger to their safety, potentially constituting medical negligence or battery (3, 4, 6). To ensure compliance, a signed IC document serves as system-level proof to confirm that an appropriate consent process has taken place (5). By providing comprehensive information about potential risks, complications, and alternative treatments available, a valid IC process allows patients to make informed choices and take an active role in their healthcare (4). This is fundamental to making informed decisions that align with the patient's values and preferences, reducing the likelihood of misunderstandings or dissatisfaction.

The CMPA ascribes to the Oxford Dictionary definition of consent as a “voluntary agreement to or acquiescence in what another person proposes or desires; agreement to a course of action.” Deficient or inadequate surgical consent has at times been claimed by patients against physicians and can lead to allegations of assault and battery, when no consent was given at all, when the treatment provided was not the one discussed in the consent, or when the information provided by the physician to the consenter results in misrepresentation or lack of comprehension of the surgical procedure (6).

In pediatric settings, multiple steps must be considered to ensure that the consent obtained is valid and legal. The individual providing consent must be considered mature to provide consent (which is not always equivalent to the legal age of maturity of 18), and a determination of capacity as the ability to understand the information given regarding the proposed treatment, as well as its alternatives and possible consequences of a decision or lack of decision must be performed. In pediatric surgical setting, such capacity is either lacking, difficult to determine or varies with age, maturity, and specific situation (7–10). In cases involving complex procedures, such as pediatric spine surgeries, the parent or legal guardian of the patient often authorizes consent on behalf of the minor, acting in the best interest of the patient (6).

However, the matter of the patient's assent complementing the IC process should also be considered. The involvement of children and adolescents in medical decisions ought to align with their developmental capacity to comprehend the nature and implications of their medical condition, along with the risks and benefits associated with the proposed treatment and available alternatives. Physicians should respect expressions of assent or dissent, and recognize and assess instances of lack of capacity, minimizing potential harm while upholding the patient's best interests (9, 10).

For elective procedures, it is recommended to request valid IC in the clinic prior to the day of the surgery. This allows the patient and/or their guardian sufficient time to process the information received, reducing the likelihood of feeling pressure to proceed with a procedure that might not be fully understood (11).

Valid informed consent relies on the consenter's understanding of the provided information (1, 4). A prospective qualitative study on spinal surgery in adults highlighted key concerns expressed by patients regarding the IC process, including a desire for more detailed information on the procedure, its associated risks, benefits, and alternative treatments (12). Patients also demonstrated difficulty recalling potential risks and alternatives, suggesting that the availability of a video of the procedure might assist with their understanding (12).

Assessing a consenter's true understanding can be a complex task. Individuals may inaccurately report full comprehension due to factors like overestimating their understanding of the information, a desire to appear competent, or reluctance to admit confusion (13). Kreps (13) and Taherdoost (14) recommends the use of tests and questionnaires to directly and objectively determine patients' comprehension of the information provided. Validated questionnaires can assist with obtaining relevant, reliable, and valid information from patients and guardians submitted to IC processes (13, 14).

Schenker et al. presented a systematic review supporting the idea of including additional communication methods to improve comprehension of the written IC (3). This was supported by a systematic review by Glaser et al. in 2020, also mentioning the use of test/posttest components as a superior way of measuring consenter comprehension (1). Both publications emphasized the need for further studies in vulnerable populations.

In pediatric cases, generally an adult who holds guardianship of the pediatric patient is the one responsible for signing the consent, but often the patient is also involved in this process. Assessing both the guardian's and the pediatric patient's comprehension and satisfaction is crucial. The literature reveals that both tend to understand only a portion of the content presented, indicating a potential gap in the IC process.

Theologis et al. conducted a study evaluating the comprehension of pediatric spine patients and their guardians regarding the traditional verbal surgical consent process for Adolescent Idiopathic Scoliosis (15). Using a validated questionnaire, they measured understanding of the risks, benefits, expected outcomes, and overall comprehension of the process. The study revealed that both patients and guardians only understood approximately 60% of the content presented in the surgical consent, implying a potential gap in achieving a fully informed consent prior to pediatric spine surgeries.

Traditional informed consent involves a discussion with a member of the medical team and a written consent form, and recent studies have focused on finding more patient-friendly approaches to IC delivery. Studies have suggested that additional information sources, beyond verbal or written communication, could enhance patients' understanding of surgical procedures, risks, and benefits (12, 16).

Video-assisted IC has emerged as a promising method to improve satisfaction and comprehension. A pilot study supported by The British Association of Spinal Surgeons found that the use of a video resource as a compliment to traditional preoperative consent (oral or written) significantly increased spinal patient satisfaction (17). Similarly, a study involving 142 patients showed that those who viewed an educational video as part of the IC process demonstrated higher knowledge scores and reported better comprehension and satisfaction compared to the control group receiving conventional consent (18).

IC plays a critical role in patient safety and care quality. Patient-centered approaches, like multimedia tools, have emerged as valuable tools to enhance IC processes and mitigate associated risks.

Abujarad et al. developed a patient-centered virtual multimedia IC tool, incorporating virtual coaching, multimedia library, and automated quizzes. Patient engagement was integral to its design and evaluation, resulting in a usable and meaningful tool (19, 20). Studies demonstrated the effectiveness and patient satisfaction with multimedia patient education tools and video consent, by improving comprehension and addressing patient concerns (17, 21).

The use of multimedia tools in pediatric settings has shown promising results in enhancing comprehension and reducing anxiety in guardians during the IC process.

Tait et al. found that interactive multimedia programs significantly improved children's understanding of clinical trial information compared to traditional paper formats. Participants also reported finding the multimedia tool more effective and easier to follow (22). Additionally, a randomized controlled trial demonstrated that multimedia tools for pediatric surgical consent effectively reduced parental anxiety, leading to improved comprehension and overall satisfaction (23).

The CMPA and CPSA provide a “standard of practice” to its members to ensure proper informed consent is obtained prior to medical procedures. It states that consent can be given in multiple ways, depending on the nature of the treatment or procedure. Written consent, in particular, is recommended for surgical and invasive procedures, and it should be documented in the patient's records (6, 24).

A report by Hanson & Pitt in 2017, based on a 5-year period, revealed that 65% of medical legal actions related to informed consent were related to surgery, and only 21% of these cases were decided in favor of the surgeon (25). The Supreme Court of Canada, in cases like Reibl v Hughes and Ciarlariello v Schacter, placed the responsibility of ensuring patient understanding on the physicians, confirming the duty outlined by professional organizations (26, 27). Physicians not only have to provide information about risks, benefits, and alternative treatments, but they also have a legal obligation to ensure patient comprehension (28).

Burningham et al. highlighted a significant gap between legal requirements and actual practice in surgical discussions and IC processes. Physicians are mandated to ensure full patient understanding, but both physicians and patients often struggle to recognize when comprehension is lacking. The study suggested that interventions, such as the use of multimedia resources, could enhance patients' knowledge of risks and help physicians fulfill their professional obligations (28).

Adopting a patient-centered approach and SDM during the informed consent process improves collaboration and patient autonomy (2, 29). This approach considers evidence-based practices along with the patient's values and preferences. This process empowers patients to take an active and meaningful role in their healthcare decisions, along with their medical team (29, 30).