Digital informed consent for paediatric spinal surgery: a patient-centric evaluation of eConsent utilization
Original Article

Digital informed consent for paediatric spinal surgery: a patient-centric evaluation of eConsent utilization

Daniel Fontannaz1, Aaditya Dravid2 ORCID logo, Mark Harris1, Aman Sharma1

1Great Ormond Street Children’s Hospital, London, UK; 2Imperial College London School of Medicine, London, UK

Contributions: (I) Conception and design: D Fontannaz, A Sharma; (II) Administrative support: None; (III) Provision of study materials or patients: None; (IV) Collection and assembly of data: D Fontannaz; (V) Data analysis and interpretation: A Dravid, D Fontannaz; (VI) Manuscript writing: All authors; (VII) Final approval of manuscript: All authors.

Correspondence to: Dr. Aaditya Dravid, MBBS, BSc. Imperial College London School of Medicine, Reynolds Building, St Dunstan’s Road, London W6 8RP, UK. Email: Aaditya.dravid1@nhs.net.

Background: Informed consent is a fundamental aspect of surgical care, ensuring that patients comprehend the nature, risks, and benefits of their procedures. With the growing adoption of digital healthcare solutions, electronic consent (eConsent) has emerged as an alternative to traditional paper-based consent. This study evaluates patient experiences with eConsent in the context of paediatric scoliosis surgery at our institution.

Methods: A prospective review of 46 patient responses to eConsent surveys was conducted. Data collected included the likelihood of recommending eConsent, the perceived ease of the process (rated 0–10, with 0 being the easiest), preferred method of consent (paper vs. eConsent), adequacy of information provided (yes/no), and overall satisfaction with the consent process (rated 1–10). Descriptive statistical analysis was performed.

Results: Among the 46 respondents, 97.8% preferred eConsent over traditional paper-based consent, while none explicitly favored paper. Most patients selected “Extremely Likely” or “Likely” when asked if they would recommend eConsent. The quality and quantity of information provided were deemed adequate by 97.8% of patients. The average overall process rating was 9.0/10, indicating a high level of patient satisfaction. Notably, the difficulty rating averaged 0.76/10, indicating greater ease, demonstrating that patients found the digital process highly user-friendly.

Conclusions: This study highlights a possible preference for eConsent in spinal surgery, with high satisfaction ratings and widespread agreement on information adequacy. The low difficulty scores (indicating a smooth and simple process) suggest that eConsent is well-received and accessible to patients. However, the lack of strong recommendations in survey responses warrants further investigation into potential areas of improvement, including how patient satisfaction metrics are assessed and interpreted. Future work should explore strategies to further optimize digital consent workflows and address any remaining barriers to adoption.

Keywords: Electronic consent (eConsent); spinal surgery; electronic; informed consent

Submitted Oct 29, 2025. Accepted for publication Mar 22, 2026. Published online May 27, 2026.

doi: 10.21037/jss-2025-aw-206

Introduction

Informed consent is an integral part of patient-centred care and is the foundation for building trust in the physician-patient relationship. Not only is this a legal and ethical requirement for doctors, but it also gives patients autonomy for their healthcare decisions (1,2). This is perhaps more relevant for surgeons as the interventions that are prescribed have a more prolonged and pronounced effect. The Royal College of Surgeons (RCS) indicates that informed consent comprises a non-coerced conversation between physician and patient regarding the natural course of the illness with/without surgery, an explanation of the benefits, the material risks involved and the alternatives to surgery (3,4). It has been shown that only 1/3rd of patients had sufficient understanding of their operative risk with the current consent practices (5).

Current consent documentation in the United Kingdom is done through a pre-filled paper form. While it may be formatted differently at various healthcare trusts, it covers the same fields as outlined by the Department of Health and Social Care (6). Though this process is acceptable, there are several aspects which can hamper the process of informed consent. It has been reported that forms do not have enough free text space to outline alternatives to surgery that may have been discussed, as well as not having enough space to outline the risks of the procedure, leading to legibility issues. Furthermore, there is an inherent risk of variability, omission and human error (6,7). The British Orthopaedic Society endorsed operation-specific templates to prevent omissions and legibility issues (6,8,9). However, these are not tailored to the material risks of each individual patient, and there is a discrepancy between what the orthopaedic clinician recalls as risks versus what is documented (10).

Furthermore, it can neglect certain patients due to varying health literacy or language barriers, resulting in poor comprehension (11).

Providing informed consent is medico-legal obligation as it is a source of litigation and distrust for patients. A study conducted by Nancy Epstein examined medicolegal suits involving spine surgery. She found that of the 78 cases, 63 (80%) involved spine surgeons, with 44 cases occurring due to lack of informed consent (56%) (12). Makhni et al. found in their research that 23% of all medicolegal cases involving spine surgeries were due to issues around informed consent (13). Epstein also calculated that the average settlement for spine surgery cases was $2.4 million, with 53% of patients suffering from quadriplegia (12).

Although conducted in the US where litigation rates are high, it clearly shows not only the financial burden these cases have but also the clinical risks and side-effects surgery has, emphasising the need for an appropriate consent strategy, and an understanding by both stakeholders of the risks and benefits of undertaking surgery (14).

The digital era has impacted various aspects of healthcare (15-18). Electronic consent (eConsent) offers another avenue for ensuring that informed consent is sustained (19). It comprises multimedia systems, interactivity, and signature capture features to aid with understanding and comprehension of procedures (20). While it has been used for 15 years, its prevalence was scarce and its adoption into modern medical practice has been accelerated by the coronavirus disease 2019 (COVID-19) pandemic (15-18,21).

Preliminary orthopaedic studies show that electronic supplements during the consent process improved knowledge of material risk, along with patient satisfaction (22,23). However, not much research has been conducted analysing the efficiency and patient experience of eConsent in a paediatric orthopaedic population.

We aim to evaluate patient experience in providing eConsent for surgery, evaluating the perceived ease, assessing the patients’ perspective on the adequacy of information provided and their overall satisfaction with the consenting process. We present this article in accordance with the STROBE reporting checklist (available at https://jss.amegroups.com/article/view/10.21037/jss-2025-aw-206/rc).

Methods

A prospective review of 46 patient responses to eConsent surveys was randomly conducted in our institution over a 3-month period. Clinical data, including patient demographics, type of operation and level of fusion, were obtained from medical records. Our inclusion criteria were children aged <18 years with radiographically confirmed lumbar or thoracic scoliosis deformity requiring elective fusion surgery.

Patients were excluded if they had unconfirmed diagnoses, did not require fusion surgery or those with no follow-up available (last follow-up was 26/4/2025).

Informed consent was given by patients’ legal guardian (in all cases, it was the parents) in accordance to clinical practice. Survey responses were completed by parents/legal guardians following the eConsent process pre-operatively on the day of the surgery, with patient involvement in consent discussions where age-appropriate. The questionnaire assessed the likelihood of recommending eConsent, perceived ease of use, preferred consent modality (paper versus electronic), adequacy of information provision, and overall satisfaction with the consent process. Ease of use was scored on a 0–10 scale (0 indicating easiest), and overall satisfaction on a 1–10 scale (Table S1).

Data were stored on encrypted institutional servers with access restricted to the clinical team and descriptive analyses were performed using Microsoft Excel.

Results

Descriptive analysis showed the average age of patients in our study was 12 years (range, 6.75–17.5 years) with a female-to-male ratio of 1.64. The most common condition that was eConsented was “Late onset idiopathic scoliosis” with the most common levels fused being T3–L3. Among the 46 patients, post-operation nausea and vomiting were the most common complications (Table 1). A proportion of 97.8% preferred eConsent over traditional paper-based consent, while none explicitly favored paper. All patients selected “Extremely Likely” or “Likely” when asked if they would recommend eConsent, which may reflect limitations in question phrasing or interpretation rather than dissatisfaction. The quality and quantity of information provided were deemed adequate by 97.8% of patients. The average overall process rating was 9.0/10, indicating a high level of patient satisfaction. Notably, the ease-of-use rating averaged 0.76/10, where lower scores represented greater ease, demonstrating that patients found the digital process highly user-friendly.

Table 1

Descriptive analysis for patients who were eConsented, including gender, average age, diagnoses, level of fusion, post-operation complication, likelihood to eConsent, process difficulty, and overall process score

Characteristics Values
Gender
   Male 19
   Female 28
Age (years) 12.21
Diagnoses
   Idiopathic scoliosis
    Early onset idiopathic scoliosis (0–10 years) 10
    Late onset idiopathic scoliosis (10–18 years) 22
   Congenital scoliosis 3
   Neuromuscular scoliosis 6
   Atlantoaxial scoliosis 1
   Kyphosis with scoliosis 4
Levels operated (for posterior spinal fusion)
   T2–L5 1
   T3–L3 9
   T2–L2 1
   T2–L3 3
   T6–L4 1
   T2–L5 3
   C2–3 1
   T2–pelvis-L4/L5/ALIF 1
   T2–L4 1
   T3–L2 2
   T4–L3 1
   T3–L1 1
   T4–L1 1
Post operation complication
   Nausea 4
   Vomiting 5
   Extravasation 1
   CSF leak 1
   Wound fluid leak 1
   Atelectasis 1
   Lung consolidation 1
   UTI 1
   Desaturation 1
Likely to recommend eConsent
   Likely 20
   Extremely likely 25
   Difficulty [1–10] 0.76
   Overall process [1–10] 9

ALIF, anterior lumbar interbody fusion; CSF, cerebrospinal fluid; eConsent, electronic consent; UTI, urinary tract infection.

Discussion

In a paediatric population, gaining valid and legal informed consent is imperative. Individuals giving consent must be considered mature (which is not always the legal age of maturity of 18 years) as well as having capacity (24-28). In paediatric spine surgery, parents authorize consent on behalf of the patient (24,29). Therefore, the understanding of both the patient and their parents should be gauged.

Theologis et al. conducted a study estimating the comprehension of paediatric spine patients and their guardians regarding the traditional verbal surgical process for adolescent idiopathic scoliosis. They found that only 60% of the information that was mentioned during the consent process was appreciated, highlighting a gap in achieving full informed consent (30).

The findings of this study aimed to evaluate the experience of econsenting in a tertiary paediatric spine surgery department with particular emphasis on the ease of the process and their overall satisfaction. To our knowledge, our study is the first to explore this topic in a complex paediatric spine department. Our study highlighted the profound preference of eConsent over paper-based consent (97.8%), with it being very easy to use (0.76/10). Studies assessing the efficacy of eConsent have discovered that patients reported eConsent to be better and easier to understand than the traditional paper-based approach (20,31). Tait et al found increased understanding by both parents and children when eConsenting (32).

A major benefit of digital informed consent is the decreased omission of core risks. A research study conducted by Dyke et al. found that errors in core risk delivery was decreased in eConsenting versus traditional paper-based consenting (6). Another key benefit of eConsent is that it allows patients to have a deeper understanding into the consenting process. This reinforces shared decision-making within the doctor-patient dynamic, correcting the inherent inequality due to the varied medical literacy (33). In a complex field such as paediatric spine surgery, it is therefore critical for both patients and parents to understand what they are consenting to. Finally, eConsent may reduce the administrative burden for consent, allowing for meaningful dialogue between the doctor and the patient (6,34).

Haussen et al. used a smartphone-based e-Consent platform for a trial for cerebral thrombectomy, and found that it “streamlined the process” in a trial of patients with large vessel occlusive stroke (35). In adult neurosurgery, Ramsay et al. found that eConsenting reduced the time given to receive informed consent at major neurosurgical centres, a result echoed by the majority of respondents (36).

A paediatric pilot study during COVID-19, aiming to improve recruitment for newborn screening, found that with hybrid recruitment through emailed eConsent links, the proportion of enrolled babies increased significantly. At a primary care level, eConsent has been successfully piloted for human papilloma virus 1 vaccination in children across multiple schools and has promoted “more informed and easier collaborations… and has reduced operation cost” (37).

Whilst eConsent has ameliorated the entire process, there are some challenges and drawbacks with eConsent that need to be addressed. With all forms of consent, there may be a cultural or language barrier that can imped with the process (38).

Furthermore, there is always a risk of data confidentiality, breach and or identity theft. Finally, there is an initial cost to setup eConsent system within each trust (39).

Although eConsent has not been widely implemented, there have been other digital tools to aid with consenting process. When utilising video presentations and other interactive methods, information is easier to understand than text-based (40,41).

The British Association of Spinal Surgeons found that video-assisted consenting as a complement to traditional paper-based preoperative consent showed increased spinal patient satisfaction (42).

In a paediatric setting, digitalised consent and multimedia tools for surgical consent effectively reduce parental anxiety, leading to improved comprehension and overall satisfaction (43).

Several limitations of this study warrant consideration. The sample size was small (n=46), limiting both the statistical robustness and wider generalisability of the findings. While the near-unanimous positive ratings across several domains may indicate a favourable experience, it also introduces the possibility of response bias and reduces the ability of the survey to discriminate between varying levels of satisfaction.

Furthermore, the wording of some questions may have further encouraged positively skewed responses. In addition, Hawthorne bias cannot be excluded, as participants’ awareness of being studied may have influenced their evaluations. The study also did not capture quantitative data regarding the specific components of consent discussed for individual procedures, nor did it assess discrepancies between risks explained during the consent discussion and those documented in the consent record.

Such information would have provided additional insight into the quality and completeness of the consent process.

Finally, the absence of a paper-consent comparator group represents a major limitation, as it precludes direct assessment of whether the observed satisfaction is specific to the electronic consent format. As such, the findings support the acceptability of eConsent within this setting, but should not be over-interpreted as evidence of its superiority over traditional consenting approaches.

Future research should directly compare paper versus digital consenting in a prospective randomised research trial. As discussed, methods of delivering information to supplement the informed consent process are a preliminary step that should be established. Examples such as videos, eBooks and more traditional methods such as leaflets or diagrams may help (24,44,45). Bethune et al. supplemented the informed consent discussion for spinal neurosurgery with an eBook. When patient knowledge was reviewed following a retrospective brief questionnaire, they found significant increases in understanding of the procedures (1). Mirza et al.’s landmark meta-analysis found similar results showing enhanced patient satisfaction scores and patient understanding with the use of electronic technologies (19).

The use of eConsent and supplementary electronic material is notably vital in the paediatric spine surgery domain, as these procedures can have a profound effect on an inherently vulnerable population.

Finally, research into barriers for the implementation of eConsent tools should be conducted; financial and bureaucratic aspects of implementing digitalised consent need to be understood to accelerate pre-, peri- and post-operative care, and enhance shared decision making.

Conclusions

Electronic consenting appears to be a promising, feasible and acceptable modality in paediatric spinal surgery, with participants reporting high levels of satisfaction and positive perceptions of information adequacy and process quality. Nevertheless, the lack of a parallel paper-consent comparator represents an important limitation and prevents attribution of these findings specifically to the electronic consent process itself. Thus, further prospective comparative studies are required to evaluate its added value over conventional consenting and to define its place in standard paediatric spinal surgery pathways.

Acknowledgments

None.

Footnote

Reporting Checklist: The authors have completed the STROBE reporting checklist. Available at https://jss.amegroups.com/article/view/10.21037/jss-2025-aw-206/rc

Data Sharing Statement: Available at https://jss.amegroups.com/article/view/10.21037/jss-2025-aw-206/dss

Peer Review File: Available at https://jss.amegroups.com/article/view/10.21037/jss-2025-aw-206/prf

Funding: None.

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://jss.amegroups.com/article/view/10.21037/jss-2025-aw-206/coif). The authors have no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. Informed consent was given by patients’ legal guardian (in all cases, it was the parents) in accordance to clinical practice.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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Cite this article as: Fontannaz D, Dravid A, Harris M, Sharma A. Digital informed consent for paediatric spinal surgery: a patient-centric evaluation of eConsent utilization. J Spine Surg 2026;12(5):71. doi: 10.21037/jss-2025-aw-206

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