Abstract
Introduction
The integration of novel electronic informed consent platforms in healthcare has undergone significant growth over the last decade. Adoption of uniform, accessible, and robust electronic online consenting applications is likely to enhance the informed consent process and improve the patient experience and has the potential to reduce medico-legal ramifications of inadequate consent. A systematic review and meta-analysis was conducted to evaluate the utility of novel electronic means of informed consent in surgical patients and discuss its application to neurosurgical cohorts.
Methods
A review of randomised controlled trials, non-randomised studies of health interventions, and single group pre-post design studies in accordance with the PRISMA statement. Random effects modelling was used to estimate pooled proportions of study outcomes. Patient satisfaction with the informed consent process and patients’ gain in knowledge were compared for electronic technologies versus non-electronic instruments. A sub-group analysis was conducted to compare the utility of electronic technologies in neurosurgical cohorts relative to other surgical patients in the context of patient satisfaction and knowledge gain.
Results
Of 1042 screened abstracts, 63 studies were included: 44 randomised controlled trials (n = 4985), 4 non-randomised studies of health interventions (n = 387), and 15 single group pre-post design studies (n = 872). Meta-analysis showed that electronic technologies significantly enhanced patient satisfaction with the informed consent process (P < 0.00001) and patients’ gain in knowledge (P < 0.00001) compared to standard non-electronic practices. Sub-group analysis demonstrated that neurosurgical patient knowledge was significantly enhanced with electronic technologies when compared to other surgical patients (P = 0.009), but there was no difference in patient satisfaction between neurosurgical cohorts and other surgical patients with respect to electronic technologies (P = 0.78).
Conclusions
Novel electronic technologies can enhance patient satisfaction and increase patients’ gain in knowledge of their surgical procedures. Electronic patient education tools can significantly enhance patient knowledge for neurosurgical patients. If used appropriately, these modalities can shorten and/or improve the consent discussion, streamlining the surgical process and improving satisfaction for neurosurgical patients.
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Introduction
Providing patients with easy-to-understand information about a recommended procedure, and subsequently requesting permission from them, is the ethical and legal obligation of the modern-day clinician [22]. This protocol, defined as informed consent (IC), enables patients to exercise autonomy and participate in their medical care [32]. IC seeks to balance the doctor-patient relationship by providing a legal framework to protect both the patient from harm and the doctor from litigation [41]. It is an explicit authorisation provided by the patient to assent (consent) or dissent (refuse) a healthcare intervention offered by their physician. Empowering patients to participate in the IC process and engage in shared decision-making has become the gold standard of patient care in recent years [19, 73].
According to the UK Department of Health’s guidance on eliciting consent, a valid IC process includes not only the disclosure of information to patients but also its comprehension by them [21, 67]. However, there are concerns that the current IC process in surgical cases may be suboptimal [35, 40, 47, 53, 81]. In one study, only a third of participants demonstrated sufficient understanding of their operative risks [30]. Although suboptimal patient engagement can be a direct cause for this, it is largely due to poor disclosure of information by healthcare providers, which reduces patient understanding and hinders satisfaction [36, 44]. This leads to lower confidence in healthcare providers and affects treatment adherence, postoperative recovery, and ultimately clinical outcomes [31, 62, 93].
Due to limited time and in the interest of efficient workflow, the IC process can be truncated from a robust patient education event to a mere signature on a form [13]. Standardised information sheets can lead to some patients being neglected, especially in the presence of low health literacy or language barriers, resulting in poor comprehension and, thereby, an inadequate IC process [17]. The nature of the complex procedures comprising the practice of neurosurgery makes the challenge of achieving adequate informed consent even greater for neurosurgical patients. Further, in neurosurgery decisions regarding surgery, its risks and benefits need to be fully understood and weighed up by the patient, as it can have life-changing consequences. Neurosurgical patients can also have complex communication needs. Electronic consent offers another avenue to ensure that informed consent is established, allowing patients to take their time to fully understand and acknowledge the consent process.
Patient knowledge and patient satisfaction are the two predominant metrics used in the existing literature to assess the adequacy of the informed consent process. Both depend on the instruments utilised to disclose information [48]. The tools for information disclosure have evolved in the modern digital era. Legacy methods such as written instruments (leaflets, brochures) remain in use, but there is increasing adoption of novel electronic interventions in the form of interactive and non-interactive decision aid software, and multimedia aids such as audio recordings, videos, and compact discs (CDs) [15, 26]. Electronic tools encourage patients to listen and engage with information in their own time. The COVID-19 pandemic has been an unexpected impetus for the adoption of digital dissemination of clinically related information in health services around the world [8]. Substantial evidence has emerged suggesting that these digital modalities have enhanced the patient experience and that the value of these electronic tools can be greater in certain surgical specialties (such as neurosurgery) over others [35].
The purpose of this systematic review and meta-analysis is to report on the value of electronic technologies for the IC process in surgical patients, with a focus on neurosurgical cohorts.
Methods
For the purposes of this systematic review, standardised definitions for the interventions and comparators were used (see Table 1).
Search strategy
The study adhered to the PRISMA and AMSTAR guidelines for the design, conduct, and reporting of systematic reviews and meta-analyses [68]. A search of original publications from the following online bibliographic databases was conducted to find suitable studies: OVID MEDLINE, PubMed, Embase, Global Health, and APA PsycInfo.
The PubMed search strategy consisted of MeSH headings and keywords for “digital interventions”, “consent”, and “surgery”, along with related terms linked by the Boolean operator “AND”. This strategy was adapted for other databases (see supplemental Table A).
Two reviewers (AKK, FA) independently screened titles and abstracts of identified papers in accordance with predefined selection criteria. The second stage consisted of full-text retrieval to confirm inclusion eligibility. Reference lists of identified articles were manually searched for additional relevant publications. Studies were eligible for inclusion if they satisfied the criteria listed in Table 2.
Registration and protocol
The review was registered on PROSPERO (International Prospective Register of Systematic Reviews) with the identification number CRD42022314812.
Data extraction
Based on the Cochrane Review Group Data Extraction template [77], a data extraction form (DEF) was designed to collect information relevant to the study outcomes. This was tested before use. Variables collected are listed in Table 3. Missing/unclear data were noted, and no assumptions about the data were made. Three researchers (AKK, FA, and ABS) independently implemented the DEF for each study. Discrepancies were resolved through discussions with senior authors (ABM, ARS).
Outcomes and outcome measures
The study outcomes, their standardised definitions, and outcome measures are listed in Table 4. As electronic IC interventions are primarily designed for patients to use outside the standard consultation with their physicians, the study outcomes were purposefully patient-centred, while other possible outcomes (e.g., uptake of procedures, complaints, and adverse clinical outcomes) were excluded.
Risk of bias assessment
The quality of the included studies was evaluated using the National Heart, Lung, and Blood Institute (NHLBI) quality assessment tools [37]. Three reviewers (AKK, FA, ABS) independently assessed each study using the appropriate quality assessment tool and calculated a score for each study, scoring them as “good”, “fair”, or “poor” quality. “Good quality” studies had the least risk of bias, and the results were considered valid. “Fair quality” studies were susceptible to bias but not deemed sufficient to invalidate results. “Poor quality” studies had a significant risk of bias that likely invalidated the findings. If ratings differed, reviewers discussed the article to reach a consensus and, if necessary, discussed with senior authors (ABM, ARS).
Data analyses
A table summarising relevant data for each included RCT was generated using Review Manager (Cochrane Collaboration: Version 5.4) [83]. Studies with unclear/missing data for the outcomes of interest were excluded from meta-analysis. The processes used for data analysis for the outcomes are listed in Table 3.
A random effects model was selected for the analysis due to the heterogeneity observed in the studies during the preliminary research. Studies were grouped according to the format of data recorded for patient satisfaction (primary outcome) in order to minimise heterogeneity. Forest plots were generated for each outcome to illustrate the results. Alpha values < 0.05 were considered statistically significant.
The sub-group analyses investigated whether neurosurgical cohorts experienced greater satisfaction and gained more knowledge when compared to patients of other surgical specialties, in the context of digital modalities of information disclosure. Studies reporting their findings for patient satisfaction in continuous data format were not eligible for the sub-group analyses as all neurosurgical studies reported this outcome in categorical data form.
Sensitivity analyses were also conducted to determine the potential sources of heterogeneity. To assess the robustness of the findings, each study was excluded one-by-one, and all poor-quality studies were removed. Publication bias was assessed via funnel plot analysis for outcomes with a sample size > 10.
Results
Study selection
The search yielded 1042 studies, 625 of which were screened after duplicates were removed. Some 182 potentially eligible abstracts were identified, and a full review led to 44 RCTs, 4 non-randomised studies (NRSI), and 15 single group pre-post design (PPD) studies. Figure 1 presents a PRISMA flow chart of this process.
Study characteristics
Tables 5, 6, 7, and 8 summarise the characteristics of the included studies (including surgical disciplines, digital modalities tested, and outcome measures used). All articles included participants with competence to consent.
RCTs
A total of 4985 patients were randomised across 44 RCTs. Individual studies ranged from 11 to 393 participants. Forty-two articles [1, 6, 7, 9, 11, 12, 18, 20, 23,24,25, 27, 33, 39, 40, 42, 46, 52, 55, 58, 61,62,63, 65, 72, 75, 76, 78, 79, 82, 85, 86, 90, 91, 94, 95] included participants who could consent for themselves. The rest (n = 2) [10, 16] included parents who consented on behalf of their children who were undergoing surgical procedures. Most studies used a two-arm parallel RCT design (n = 39) [1, 6, 7, 9, 13, 14, 16, 20, 23, 24, 33, 39, 40, 46, 52, 55, 59, 62, 63, 65, 72, 75, 76, 78, 79, 82, 85, 86, 90, 91, 94, 95] to compare a purpose-built digital intervention for the IC process with control groups receiving traditional non-electronic IC practice. Two of these 39 RCTs implemented a cross-over design where participants served as their own controls [61, 91]. The remaining five studies were three-arm parallel RCTs [18, 25, 27, 42, 58], four of which compared their digital intervention against two different forms of non-electronic traditional means, namely standard verbal discussions, written brochures, and simple 3D diagrams/models [18, 27, 42, 58]. The remaining three-arm study compared two different electronic technologies for IC, namely an interactive video program and a non-interactive pre-recorded video, against standard verbal discussion.
Non-randomised studies of healthcare interventions (NRSIs)
A total of 387 patients participated in the included 4 NRSIs. Individual studies ranged from 40 to 187 participants.
One group pre-post design (PPD) studies
A total of 872 patients participated in the 15 PPD studies. Individual studies ranged from 10 to 278 participants.
Interventions
The electronic interventions used in the studies included pre-recorded videos (n = 30), menu-driven videodiscs (n = 4), computer programs (n = 25), iPad applications (n = 2), PowerPoint® presentations (n = 2), patient information websites (n = 2), virtual reality (VR) (n = 1), and an interactive storybook (n = 1). The interventions were divided into interactive (n = 31) and non-interactive (n = 32). Interactive electronic interventions were predominantly self-paced computer programs with high-quality videos and animated graphics. Some studies used more advanced software, such as Tait et al., who used advanced 2-dimensional (2D) and 3-dimensional (3D) graphic technology to simulate various physiologic functions to aid patient-specific education on their conditions and planned procedures. Heller et al. integrated patient testimonials with before-and-after photos, while Wollinger et al. used a program developed on a touchscreen monitor with headphones, with animated 3D figures and modules to divide the information provided.
Non-interactive electronic interventions included pre-recorded videos and PowerPoint presentations, which did not require active patient participation, but still included images, animations, and authentic surgical footage.
Consenting modalities used in the control arms included the standard verbal discussion with the surgeon and written materials (n = 59), but in three studies, written information was provided alone. One study used physical models during consultation with the surgeon to facilitate discussion.
Risk of bias assessment
Tables 6, 7, and 8 illustrate the results of the risk of bias assessment.
RCTs
Of the included RCTs, 30 (68.2%) had adequate random-sequence generation, 16 (36.4%) had satisfactory allocation concealment, four (9.1%) double-blinded, 16 (36.4%) blinded outcome assessors, 38 (86.4%) had low risk of attrition bias, and 20 (45.5%) reported sample size calculations and recruited sufficiently to detect differences in outcomes. Many items (n = 57, 9.7%) were recorded as unclear due to insufficient information reported.
Overall, studies were divided into good (n = 5) [6, 24, 27, 38, 96], fair (n = 36) [1, 9, 13, 14, 16, 18, 20, 23, 33, 39, 42, 46, 52, 55, 58, 59, 61, 63, 69, 71, 75, 76, 78, 79, 82, 85, 86, 90, 91, 94, 95], and poor (n = 3) [25, 60, 65] quality.
Same group PPD studies
Of the 15 PPD studies, ten (66.7%) reported pre-defined eligibility criteria and recruited representative participants from a defined clinical population. Only three (20.0%) enrolled participants met the predetermined eligibility criteria, while seven (46.7%) reported a sample size calculation and recruited the required number of participants to give confidence in the results. Only one study [67] blinded outcome assessors. All 15 studies had an attrition rate of < 20%, but five (33.3%) did not consider lost-to-follow-up in their analysis. Overall, studies were divided into those with fair (n = 12) [2, 6, 43, 45, 49, 54, 57, 66, 88] and poor (n = 3) [5, 29, 34] quality.
Synthesis of results
Findings of the qualitative and quantitative syntheses are summarised in Tables 5 and 9, respectively. Sixty-one of 63 included studies reported the primary outcome, patient satisfaction. Forty-eight publications (76.1%) measured the secondary outcome, patient knowledge gain [1, 2, 4, 5, 9, 13, 14, 16, 18, 20, 24, 25, 27, 28, 33, 34, 39, 42, 46, 52, 54, 55, 59, 62, 63, 65, 66, 71, 75, 76, 78, 79, 82, 85,86,87,88,89,90,91, 94, 95]. Of the 109 outcomes measured across the 63 publications, only 10 (9.2%) were assessed using validated instruments.
Primary outcome: patient satisfaction with the IC process
Questionnaires used to measure patient satisfaction included validated instruments, such as the Client Satisfaction Questionnaire-8 (CSQ-8) [81] (n = 7) [33, 43, 57, 61, 69, 91, 95]. This is an instrument used to assess patient satisfaction in most clinical settings, in which patients are asked to rate the services received from their healthcare provider. It contains 8 items relating to patient satisfaction, with a maximum of 4 points per item, leading to a maximum score of 32. One study [6] used a scale adapted from the validated 26-item Evaluation du Vecu de l’Anesthesie Generale (EVAN-G) [84].
On the other hand, most studies utilised purpose-built measures, such as Likert scales (n = 37) [1, 6, 7, 10, 11, 16, 18, 20, 23, 25, 27, 34, 39, 40, 42, 45, 46, 49, 51, 54, 55, 58, 61, 63, 65, 75, 78, 79, 85, 87, 89, 90, 94, 96], 10-cm visual analogue scales (n = 9) [2, 6, 7, 71, 76, 86, 88, 92], and linear numerical rating scales (n = 6) [9, 12, 24, 28, 51, 82]. The 10-cm visual analogue scales instructed patients to put a dash on a line that was then quantified and tallied by computer software.
In contrast, two studies used a single dichotomous question aimed at overall satisfaction: “Are you satisfied with the IC process?” [29, 66].
Assessments of patient satisfaction were carried out at different times, ranging from before the operation to 6 weeks, 3 months, and 1 year after the operation. The number of items in the questionnaires to assess patient satisfaction ranged from one to 18, with individual items relating to various aspects of electronic interventions, such as appeal, comprehensibility, convenience, usefulness, information quantity, and duration of intervention.
Secondary outcome: patient knowledge
Outcome measures for patient knowledge were predominantly comprehension-based assessments that evaluated information retention and recall. These ranged in composition from 5 to 28 questions and included various formats, such as multiple-choice questions (MCQs), true/false items, and dichotomous (yes/no) questions. They were conducted before and after the IC intervention at various time points, ranging from pre-procedure (baseline) to 3 months and a year after the operation.
Results of quantitative synthesis
For patient satisfaction with the IC process (continuous data), meta-analysis showed that electronic IC technologies significantly improved patient satisfaction compared to standard IC practices (P < 0.0001) (Fig. 2).
Meta-analysis of patient satisfaction with the IC process (categorical data) demonstrated that electronic IC technologies resulted in significantly greater satisfaction compared to standard IC practices (OR 1.90; P < 0.00001) (Fig. 3). In other words, surgical patients undergoing the IC process via electronic tools were 1.9 times more likely to be satisfied with their medical procedure and care than those that received the traditional IC process.
The studies that reported categorical data for patient satisfaction were also significantly more homogeneous in methodology as demonstrated by an I2 value of 0%. Sub-group analysis demonstrated that this significant enhancement of patient satisfaction prevailed for neurosurgical studies (OR 1.84; P < 0.0001) and for non-neurosurgical studies (OR 1.95; P < 0.00001) (Fig. 3). There were no statistically significant differences between the sub-groups (P = 0.78).
For patient knowledge gain (continuous data), meta-analysis demonstrated that electronic IC technologies were significantly superior to traditional IC practices (SMD 0.63; P < 0.00001) (Fig. 4). Sub-group analysis showed that this significant improvement in patient knowledge through electronic technologies prevailed for neurosurgical studies (SMD 0.91; P < 0.00001) and for non-neurosurgical studies (SMD 0.59; P < 0.00001) (Fig. 4). Further, there was a statistically significant difference between neurosurgical and non-neurosurgical studies (P = 0.009), indicating that neurosurgical patients benefitted more in knowledge gain through digital informed consent modalities when compared to non-neurosurgical patients.
Results of qualitative synthesis
For patient satisfaction with the IC process, all studies (100%) reported improved satisfaction after electronic IC intervention (Table 5). Twenty-two out of 46 studies with control groups (47.8%) showed significantly greater satisfaction in electronic IC intervention groups than in controls. None of the studies showed greater satisfaction in control groups than in intervention groups. Of 45 studies that reported knowledge gain, 38 studies (84.4%) reported improved understanding following IC interventions. Thirty-four of these 38 studies (89.5%) reported significantly greater understanding after electronic IC intervention. Of the 47 studies with control groups, 39 (83.0%) reported patient knowledge gain as an outcome. Of these 39 studies, 18 (46.2%) reported significantly higher test scores in electronic IC intervention groups than in control.
Results of publication bias and sensitivity analyses
Funnel plot analysis did not demonstrate the presence of publication bias, with the spread of effect narrowing as the size of the study increased. Sensitivity analyses were performed for each outcome by removing each study one by one, and then excluding poor-quality studies. The removal of any of the studies did not have a disruptive effect on the findings, indicating that the pooled results were robust.
Discussion
With the progressive digitalization of healthcare, traditional means of consent have slowly been replaced by multimedia-aided consent, which can include informative videos, interactive animations, and consent-specific platforms. The results show that this ‘e-consent’ significantly improves patient satisfaction with the IC process and patients’ knowledge gain compared to standard consent methods (e.g., patient-surgeon discussion, brochures). These outcomes are interlinked, as increased knowledge gained during the IC process and greater general understanding of the procedure, risks, and treatment options leads to greater satisfaction. Increased understanding can also reduce preoperative anxiety, which directly influences satisfaction. Although these are qualitative factors, they were assessed on numerical scales, which enabled quantitative analysis of the outcomes.
The aim of this study was to investigate how electronic technologies impact the surgical patient’s experience to better inform and design a suitable IC process, which is necessary due to current suboptimal IC procedures prevalent across surgical practice [30]. To design the optimal IC process for neurosurgical patients, various patient and non-patient-related factors must be considered. Patient-related factors include age, gender, educational level, previous medical knowledge, and neurocognition. There is evidence that younger patients with greater baseline educational or medical knowledge are more likely to understand information presented via electronic means [82, 92].
The biggest non-patient factor influencing patient satisfaction and understanding is the format in which information is presented. Services must decide which electronic tools should be used, such as animated video explanations, novel interactive or non-interactive multimedia, or simple consent platforms. For objective knowledge gain, the format in which information is presented is crucial, because traditional IC means lengthy documents and brochures with medical terminology that are too advanced for most patients. This process is not inclusive for patients with lower medical literacy, or who are unable to read and digest large amounts of text. Video and animations, on the other hand, are easy to understand and inclusive for all patients. However, it is important to be careful when adopting advanced technologies in a widespread service to ensure that they do not act as an obstacle for patients who are inexperienced with technology, do not have access to technology, or patients with disabilities [35].
Ultimately, it will be a challenge to implement e-consent in low- and middle-income countries (LMIC), with widespread unsuitable infrastructure and different cultural views on medical practice. Different approaches to providing information would be needed, and differences in language, literacy rates, and health education must be considered. The UK (a high-income country (HIC)) is home to a prominent multicultural society that can face its own challenges, such as different attitudes to technology use and health care, language issues, and possibly compliance with reading material. This can lead to insufficient knowledge gain, which could be misinterpreted as inability to understand, rather than because of cultural barriers. Therefore, additional steps must be taken to fully integrate e-consent platforms into LMICs and HICs alike.
When considering vulnerable populations, such as patients with mental health problems, the disabled and the elderly, e-consenting technologies can unintentionally act as an obstacle to understanding. Knowledge gain may become compromised, and this can be misconstrued as a patient not competent to consent.
On the other hand, the greatest advantage of using e-consent is its flexibility, which is useful in situations such as during the COVID-19 pandemic [8], where physical interaction was limited, so information must be communicated effectively and safely via alternative methods. Ensuring that patients receive the relevant information to make a truly informed decision is vital in neurosurgery where patients consent to complex procedures. The reproducibility of e-consent mitigates for time pressures associated with standard verbal IC and has been shown to improve patient comprehension [7].
IC satisfaction
The results demonstrated that patient satisfaction improved using electronic IC technologies for surgical patients. This was also apparent when used as an adjunct to standard practice (verbal discussion) [2], and during a cross-over study in which participants experienced both processes [91]. Although there are some studies that do not show a significant increase in patient satisfaction after the intervention when examined individually, there is a significant combined effect, as shown by the meta-analysis [1, 9, 10, 16, 20, 23, 27, 42, 46, 63, 69, 71, 75, 78, 82, 86, 87, 89, 90, 92, 95]. Furthermore, as this is a minority of studies, we believe that the non-significant results could be due to various factors, such as patient demographics (baseline understanding, education level, gender), type of surgery, and individual experience with technology. Nevertheless, it is important to consider personal preferences, as some people may be more suited to traditional-personalised consultations with the surgeon. Satisfaction can be subjective, but when used to supplement IC, technology can lead to a greater patient experience. This strengthens patients’ confidence in their healthcare providers and influences treatment adherence, postoperative recovery, and ultimately clinical outcomes.
Knowledge and understanding
Increased knowledge leads to greater patient autonomy and contributes to a shift towards patient-centred care. In the past, the comprehensiveness of information disclosed to patients was determined by the doctor’s professional judgement. However, the Montgomery ruling [64] challenged this notion and stated that doctors should provide their patients with all relevant information so that they can make an informed decision. This has since influenced British IC practice [50, 80]. For this reason, maximum information provision is crucial to ensure that details (including risks that may or may not be relevant) have been communicated to the patient in a comprehensible and clear way.
In most cases, electronic IC technologies were more effective than standard IC practices in improving patient knowledge, understanding, and retention. However, there were numerous studies that did not show any significant difference [1, 16, 27, 42, 71, 76, 95]. This may be due to small educational differences in patients. As Rossi et al. [75] reported, patients with higher education levels achieved higher test scores. Increased baseline knowledge has previously been shown to increase understanding, which supports the idea that those with higher education, previous surgical experience, or independent research on their surgery would influence the observed results. More complex surgeries would have more content and information to comprehend and retain, posing another challenge to the patient. Therefore, the procedure itself and the volume of information relating to it can influence patient understanding, with more complex surgeries potentially having lower understanding scores. In this case, personal consultations are cardinal, as surgeons can identify concerns and work with the patient sequentially to clarify information. Although digital platforms may not address patient-specific issues if used alone, it was clear in studies where electronic IC technologies were used, in addition to standard practices, that surgeons rated patients in electronic IC intervention arms as more knowledgeable (asked more relevant questions, etc.) [82, 89]. This creates a setting where clinicians must fill gaps in understanding, rather than start from scratch during patient-surgeon discussions, saving time and resources.
Nevertheless, there is an argument to be made about the use of electronic IC technologies instead of the standard oral discussion, as various reports have shown that these interventions performed similar or even better than the input of the healthcare provider [5, 66]. We believe this may be due to the repeatability of electronic IC technologies, which allow patients to re-watch the same information several times until they understand. This cannot be replicated in time-limited surgeon–patient discussions. If electronic methods can match the role of the doctor in preoperative consultations, this would be an invaluable help to replace consent discussions. If used appropriately, digitalization of consent can make health lists more efficiently managed.
Application to neurosurgery
Ten studies which satisfied inclusion criteria featured neurosurgical patients. These included randomised studies [6, 7, 23, 70], non-randomised studies [51], and single group pretest–posttest design studies [14, 34, 56, 57, 66]. All studies demonstrated either improved patient/surgeon satisfaction and/or patient comprehension with the use of novel information technology adjuncts as part of the consent process. The use of such adjuncts in neurosurgical practice could help standardize and optimize the consent process, ensuring that patients receive the relevant information to make a truly informed decision. The sub-group meta-analysis of these neurosurgical studies outperformed other surgical studies in patient comprehension. This is a testament to the need and usefulness of such a communication platform to exist. In practise, face-to-face clinics are still an important part of the consent process; however, ensuring that patients are not rushed and feel limited by the clinic time is part of our duty to our patients. Electronic consent allows other avenues of communication both visual and audio, to provide the neurosurgical patient with the information they require for the potentially life-changing decision they will make, in the comfort of their own homes. Translation services and multilingual software can have a great impact via electronic consent, to allow patients to read up and understand the risks and benefits of the neurosurgical procedure, which often is complex, that they are about to consent for. It allows the patients to truly understand the pathology, the surgery, and the expected outcome, in their own environment.
Future directions and recommendations
Research into the use of e-consent provides valuable information to guide future directions to improving the efficiency of surgical consent. It is an important part of the surgical process to ensure patient safety and understanding and to promote patient confidence in the health system, and it has shown promising results so far. Patient satisfaction is generally high through e-consent but can be more effective in certain patient groups or types of operations. Due to differences in literature and variable factors, the most appropriate type of electronic consent technology will vary according to the surgical procedure and the circumstances of the patients. It is important to clarify that the same electronic technology cannot apply to all cases and that individual health services must design their own consenting intervention tailored to their patient’s preferences and resources. This information can be used to improve current practices.
Limitations
The use of descriptive analysis was a limitation used to review and summarise the advantages, disadvantages, and value of e-consent in surgical practice. The papers included investigated e-consent in elective surgeries, so the results cannot be applied to emergency situations. The studies used various electronic modalities, from videos, computer programmes, and apps to PowerPoint presentations. This is reflected in the high I2 values for outcomes reporting continuous data in the meta-analysis. The grouping of heterogeneous studies can be attributed to the lack of studies in this area, which itself is the product of the novelty of electronic technologies for information disclosure in clinical practice. Nevertheless, this study cements the substantial value of electronic modalities in IC in surgery and forms the basis for future studies to further investigate this area.
Conclusions
This is the only meta-analysis regarding the use of electronic consent in surgery and its application to neurosurgery. It has shown both the benefits it withholds and the common usage amongst the worldwide surgical population including neurosurgical cohorts. Alongside streamlining the consent process, e-consent has been shown to improve satisfaction and baseline knowledge in patients undergoing surgical procedures.
Data Availability
The data used to support the findings of this study are included in the article tables. Raw data files can be accessed upon request to corresponding author.
Abbreviations
- CDs:
-
Compact discs
- DEF:
-
Data extraction form
- HIC:
-
High-income country
- IC:
-
Informed consent
- LMIC:
-
Low- and middle-income countries
- MCQs:
-
Multiple-choice questions
- NHLBI:
-
National Heart, Lung, and Blood Institute
- NSRIs:
-
Non-randomised studies of healthcare interventions
- PPD:
-
Pre-post design
- PRISMA:
-
Preferred Reporting Items for Systematic Reviews and Meta-Analyses
- RCTs:
-
Randomised controlled trials
- SM:
-
Supplementary materials
- SMD:
-
Standardised mean difference
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Mirza, A.B., Khoja, A.K., Ali, F. et al. The use of e-consent in surgery and application to neurosurgery: a systematic review and meta-analysis. Acta Neurochir 165, 3149–3180 (2023). https://doi.org/10.1007/s00701-023-05776-3
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DOI: https://doi.org/10.1007/s00701-023-05776-3