This study is a micro-costing study of the consent pathways when consent is obtained using paper or digital forms. A CHEERS Checklist has been completed and can be found in Supplementary Material Table 2.

2.1 Model Overview

The model consisted of two pathways, one for the digital consent pathway the other for paper consent pathway, using a decision tree structure. Figure 1 shows the paper consent pathway with five stages including printing, consent ahead of the day of surgery, storage before surgery, consent on the day of surgery and the pre op checklist. Figure 2 shows the digital consent pathway which only has three steps, consent ahead of the day of surgery, consent on the day of surgery and the pre op checklist. The process-steps in obtaining informed consent for surgical procedures were modelled in MS Excel®. The costs per consent episode attributed to each pathway were compared to identify a preferred consent pathway.

Fig. 1

Paper consent pathway. TSA theatre surgical admissions, DSU day surgery unit, WHO World Health Organization. This figure illustrates an example of the paper consent pathway separated into stages 1–5. It is important to note that parts of this pathway occur with each consent episode and other parts happen irregularly. In the base case the forms are not scanned by admin as this step depends on Trust policy for storing consent forms. The impact of forms being scanned into electronic health records is considered in a scenario analysis

Fig. 2

Digital consent pathway. WHO World Health Organization. This figure illustrates an example of the digital consent pathway separated into stages 1–3. It is important to note that parts of this pathway occur with each consent episode and other parts happen irregularly

The model was based on the experience of the breast surgery department at Portsmouth Hospital National Health Service (NHS) Trust which acted as a representative surgical department with 110 consent procedures completed per month. Costs were provided in Great British Pounds (GBP).

Portsmouth Hospital NHS Trust were in the process of adopting the Concentric digital health system and therefore well placed to consider the process steps required in consent gained both using a paper-based or digital-based system. Interviews were conducted with clinicians (Senior nurses from breast, urology, ENT, colorectal, an orthopaedic plaster technician and breast clinicians—consultant, trainee and fellow) and non-clinicians (senior manager medical information/photography; breast services administrators, Waiting list co-ordinator, ENT outpatient supervisor, orthopaedic secretary, urology secretary, theatre admission administrators and a deputy coding manager), mean times were used to reach consensus. To better understand the paper-based and digital consent pathways by department and hospital setting, the elements of resource use, patient care, best practice and healthcare professional and patient preferences were discussed.

To apply the insight gained from the interview, a micro-costing study approach was adopted to measure healthcare costs from the UK NHS perspective and considered: staff time, and operational resources needed [15]. The assumptions around each task, its duration and the staff member completing each task are provided in Supplementary Table 1.

Sensitivity analysis was performed to identify cost drivers and scenario analyses explored consent timing, digital readiness and any scanning requirements. Discounting was not applied as the time horizon per consent episode was assumed to be less than 12 months.

2.2 Resource Utilization and Cost Data2.2.1 Consent Procedure Pathway

The staff member responsible for the task, the duration of the task, and the frequency of the task (per week/month or per consent form) were deduced, through the interview process. UK-specific cost data were identified from the Personal Social Services Research Unit 2022/23 (PSSRU 2022/23) which include the cost to the NHS (including employer pension contributions and training costs) [15].

In the model, there were two types of paper consent forms that could be used: pre-printed (including pre-determined procedure specific risks and benefits) and blank template, both with different costs; the rates at which each of these were used would impact the cost of the pathway and was therefore also discussed in the interview process.

2.2.2 Consultation Time

A clinic consultation with the patient includes both a discussion about diagnosis, prognosis and the risks and benefits of all treatment options (including surgical, non-surgical and no treatment), and can also include the completion of the consent form. A surgical consultation costs the NHS approximately £141.00 per hour as identified in the PSSRU. Consultation times were determined by interrogation of allotted clinic times (the time scheduled for clinicians to see a patient) and comparisons between paper and digital pathways investigated with a time and motion study by determining the duration of consent, recorded by an independent observer (health care professional or researcher). The average clinic time allocated for explaining the diagnosis, treatment options, consenting and booking the patient for an operation was 25 min. Consent is then reconfirmed on the day of surgery, which involves a discussion between the surgeon and the patient to ensure understanding, and this process took approximately 5 min. However, significant variation exists owing to factors including the complexity of the diagnosis, a requirement for more investigations and patient preference to take more time to consider treatment options. The average consultation times used for consent in a cohort of patients undergoing breast surgery within the Portsmouth Hospitals University NHS Trust breast unit were found to be the same for both paper (6.9 min, n = 12) and digital consent (6.8 min, n = 19); therefore, the same times were used as inputs into the model for both pathways, thus not impacting the cost difference.

2.2.3 Fixed Costs of Digital Consent Pathway

The cost of change management will depend on the level of digital infrastructure already in use, and staff training already completed within the hospital settings. In the base case, we assume the equipment required for digital consent is present and already regularly used in clinics and the long-term costs attributed to the initial setup would be minimal or that consent can be performed through personal devices. Therefore, only ongoing fixed costs of digital consent, such as the licensing fee for use of the digital consent software (Concentric Health Ltd, Cardiff, UK) and any updates that may be required over time were obtained. Scenario analysis was performed where the cost of implementation was considered based on the digital maturity of the hospital.

2.2.4 Litigation

A reduction in consent form error and unintentional omission of core risks could be a key benefit to digital consent. To determine the current scope and cost to the NHS of using paper consent processes, a freedom of information (FOI) request was made to NHS Resolution to establish the number of claims and the damages paid for claims where the primary cause is ‘Fail to warn-informed consent’ [11]. The freedom of information request was made in August 2022 being fulfilled in September 2022. It covered all of England’s ‘failure to warn-informed consent’ claims that were closed in an 11-year period between 2011 and 2022. These data on total value and number of ‘informed consent’ claims were used to estimate an average cost per claim of £201,590. The impact on litigation is not included within the micro-costing study but forms part of the CCA.

2.3 Base Case Assumptions

The parameter and cost inputs included in the model base case are described in Table 2, respectively. Guidance from the Royal College of Surgeons states that consent should be obtained in advance of surgery to ‘ensure that the patient has sufficient time and information to make an informed decision’ [16]. In the base case, all patients provided consent prior to the day of surgery and consent was confirmed on the day of surgery. An equal clinical consultation duration (including consent) of 25 min and reconfirmation of consent on the day of surgery taking 5 min was assumed for both pathways.

The extent to which hospitals use electronic healthcare records (EHR), tablets and mobile devices varies across healthcare providers. In the base case, it is assumed that the digital consent software is accessed through devices which already exist within the hospital (or via the user’s mobile phone) and therefore there are no additional fixed costs related to the purchase of hardware. The digital consent web-application works via an internet connection (Ethernet, WiFi, mobile data) on computers, tablets and smartphone devices with all mainstream browsers supported. The costs of using the software and any maintenance costs are included in the licence costs. The digital consent provider acts as a data processor for the Trust and therefore the Trust has control and ownership of the consent content. Scenario analysis estimates the impact of additional fixed costs of hardware based on the level of hospital digital maturity.

All resource use parameters used in the base case were based on observations and estimations of the breast surgery department at Portsmouth Hospital NHS Trust. In the base case, 80% of the consent forms were pre-printed and 20% were blank templates, examples of both are in the supplementary materials. The costs of ordering and moving forms to and from storage are process steps that are not necessary with digital consent. An example of the digital consent framework is also in the supplementary material. Some completed consent forms are placed in storage for more than 3 months whilst the patient waited for an operation, and we determined this occurred in approximately 10% of consent episodes. In a centre with 110 consented procedures per month (Portsmouth Hospital NHS Trust breast surgery department), we identified a paper consent form would have to be collected from storage by a porter every other day.

The costs of retrieving paper health records from archives (including a paper consent form) were restricted to costs of the staff transporting the health records to and from the medical records storage facility within the hospital. This was estimated to take approximately 15 min per day. This does not however consider the transportation of records to an external storage venue which would take significantly longer (or require vehicle transport from the archived records team). There were no assumed costs for storage, nor costs borne by medical records staff who would file the paper consent form, and therefore these costs may be under-estimated.

2.4 Sensitivity Analysis

One-way sensitivity analysis (OWSA) was performed by varying parameter estimates by 20% to identify those parameters which had the greatest influence on the total cost difference. In the absence of published estimates 20% variation was chosen to provide adequate variation to estimate the most influential parameters. Probabilistic sensitivity analysis (PSA) was also conducted (10,000 simulations) to explore overall uncertainty in the estimated costs. Gamma distributions were applied for cost and resource use parameters. For the proportion variables, a beta distribution was applied. NHS hourly rates were not varied in PSA as these are not subject to change; however, the time each healthcare staff member spends on each task was varied in the PSA.

2.5 Scenario Analysis2.5.1 Consent Timing

To explore the cost impact of consent timing, a scenario of on the day consent was conducted, although this does not fulfil the General Medical Council (UK) requirements of allowing patients time to consider treatment options, on-the-day consent is commonplace in the NHS [4]. The total consultation time (prior and on the day of surgery) was assumed to be the same (30 min) as in the prior consent base case; however, the distribution was different: 20 min for the initial consultation prior to the day of surgery and 10 min for the on the day consultation, which includes obtaining consent. In this scenario 80% of the consent forms used were blank and 20% were pre-printed forms based on estimates of current practice from the interviews where it was stated that mostly blank forms rather than pre-printed forms are used for consent obtained on the day of surgery.

2.5.2 Digital Maturity

To explore the cost impact of digital maturity, changes to the consent process and the hardware required were explored. In each scenario, the cost of digital consent software licensing was included (£1.08 per consent episode) [17]. Some digital consent platforms do not require any additional hardware as they can be accessed via mobile devices, others may need a separate device, or the preference of the user may warrant the purchase of hardware, such as electronic tablets or signature trackpads. As such, scenarios considered cost impacts for hardware to obtain digital consent. The expected lifetime of the hardware, and the resale value were used to calculate the depreciation value. On the basis of a department performing 110 consented procedures a month, three scenarios were explored that included:

1.

A semi-digitally mature hospital department where only one tablet was needed.

2.

An immature hospital department where four trackpads and one tablet were needed.

3.

A digitally naive hospital department where six track pads and two tablets were required.

2.5.3 Scanning

Some hospital departments have digital aspects to the recording of healthcare episodes and managing patient notes. Therefore, three additional scenarios were explored:

1.

A paper consent form completed prior to the day of surgery and was immediately scanned into the EHR for use on the day of surgery.

2.

A paper consent form was completed and stored until the day of surgery when it was used to confirm the consent and after the surgical procedure the paper consent form was scanned into the EHR.

3.

Paper-based consent was obtained and documented on the day of surgery, it was scanned into the EHR after the surgical procedure was completed.

To ensure the project was patient focussed, we worked with the Patient-Public Involvement (PPI) group at Portsmouth Hospitals University NHS Trust and set up a regular focus group for impact assessment. During study design and implementation, we offered a stabilising, reflective space for development and critique. This study aligns with the PPI group’s vision of improving the quality and accessibility of consent for healthcare treatments.