Procedure

We conducted a single-centre, non-randomised, non-comparative pilot study in patients undergoing a spinal procedure at a National Health Service (NHS) spinal centre in the UK. A flowchart of the study procedure is outlined in figure 1. Prior to consenting to take part, all patients received a Participant Information Sheet (PIS). The PIS outlined that if patients agreed to take part, they would receive the ‘gold standard’ (verbal and written) in consent information. In addition to this, they would also receive a consent adjunct in the form of a personalised video.

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Figure 1

An overview of the Oxford Video Informed Consent Tool process.

All participants who agreed to take part were consented by fellowship trained Consultant Spinal Surgeons using verbal and written consenting methods in addition to a summary of the consent consultation being recorded. A researcher independent of the surgical team provided participants with patient information sheets prior to consenting. Participants were all informed that participation was voluntary and were free to withdraw at any time. The summary was conducted in a structured way and consisted of the following: a discussion around the patients reasoning for choosing surgery, followed by an overview of the surgical procedure, its intended benefits and associated risks ending with an opportunity for the patients to check their understanding by asking questions.

A password protected email and a hospital trust approved web transfer service was used to send the personalised consent videos to study participants. Participants reviewed their personalised consent consultations at home with their family or friends. Participants had the option to forward their personal consent videos to family members outside of the UK. All participants were invited to contact the spinal team to seek clarity or ask further questions regarding the video content (two participants used this service). The recorded consent was stored securely within the electronic health record, accessible only to the research team.

Participants were asked to contact the spinal team once they had reviewed the consent conversation, acknowledging the risks and benefits of the proposed treatment. Prospective patient data were obtained using a self-administered questionnaire regarding patient satisfaction with the use of a video consent tool as an adjunct to traditional consenting methods. Participants were invited to complete the measure following the consent consultation and after reviewing their personalised consent video.

Approximately 13 additional minutes were required compared with the traditional process to complete the video recording process. The mean recording time was 13 min and 15 s, with a range of 6 min and 21 s, to 20 min and 55 s. This was dependant of the complexity of the proposed treatment and its associated risks and benefits. Introduction of the video consent tool did not endure any significant costs as the technology already existed within the Trust.

Participants

Participants were recruited over a 4-month period (September to December 2017).

Twenty-two people were approached to take part, two declined and twenty volunteered (n=20). Participants did not receive an honorarium for taking part in the study. Study inclusion criteria were: over the age of 18 years of age; have capacity to make informed decisions; and have an active email address with access to the internet. Participants were excluded from the study if they had any visual or hearing impairments which may inhibit the ability to review the consent video.

Assessments

A researcher independent of the surgical team distributed electronic Self-Administered Questionnaires (SAQ) to participants who agreed to partake in the study, data were collected at one point, post consent consultation. Participant demographics, which included gender, age, number of times the video consent tool was viewed and who they watched the video with, were collected. In addition to this, participants completed the validated CSQ-8 tool. The CSQ-8 tool consists of eight self-report questions, each constructed with a four-point Likert scale reply.18 The minimum achievable satisfaction score is 8, indicating poor satisfaction, a maximum score of 32 would indicate high levels of satisfaction.19 20 The CSQ-8 tool has been extensively tested for reliability and validity19–21; to date, it has been translated into more than 30 languages since its first launch in the early 1980s.22 The CSQ-8 has been found to be acceptable for use in previous studies examining patient satisfaction with consenting methods.17 23

Data analysis

The data collection period finished once 20 completed SAQs were received. Normality of data was assessed using a Kolmogorov-Smirnov test. Descriptive, bivariate and inferential statistics were calculated and reported using two-tailed methods with the assistance a statistical programme from IBM, SPSS V.24 for Microsoft© Windows V.10.

Patient and public involvement

Patients were not involved in the development or design of this pilot study. However, following this preliminary pilot study, patient involvement will be included in the development of subsequent studies utilising OxVIC.

Descriptive information

Over a 4-month period, 20 participants (10:10, male:female) deemed suitable candidates for spinal procedures were recruited into the study. The mean age was 56 years (SD=16.26), range: 27 to 81 years. Participant demographics can been seen in table 1.

Patient satisfaction

CSQ-8 data were normally distributed. High patient satisfaction levels were reported across a broad range of spinal procedures. The mean patient satisfaction score (CSQ-8) was 30.2 out of a maximum 32, indicative of high patient satisfaction.

CSQ-8 scores by gender and age can be seen in table 2. A two-way between-groups analysis of variance was conducted to explore the impact of gender and age on patient satisfaction levels, as measured by the CSQ-8 scale. Participants were divided into five groups depending on their age (group 1: 25–34 years, group 2: 45–54 years, group 3: 55–64 years, group 4: 65–74 years and group 5: 75–99 years). The interaction effect between gender and age was not statistically significant (p=0.155).

CSQ-8 responses generated several significant trends, a strong positive relationship between meeting patients’ preoperative consenting needs and helping them to deal more effectively with their preoperative concerns was reported (p=0.028), with 80% reporting that the tool helped a great deal. All participants reported that they would recommend the video consent tool to others preparing for surgery. When asked ‘if future treatment were required, would you use the service again?’, all participants responded yes. A significant positive relationship between the quality of the service participants received versus the service they expected was observed (p=0.008).

Engagement with the tool

All participants watched the consent video at least once prior to consenting for surgery, with a mean number of viewings of 2–3 times. Eighty-five per cent of the participants watched the consent video with friends and family, which included next of kin, partners, children and other family members. Two participants sent the consent videos to their children living overseas. Fifteen per cent of participants reported watching their video alone. Those who watched the video four to five times on average reported higher satisfaction scores.

Clinical implications

This study indicates that a personalised video consent tool is feasible to administer during the preoperative consent process for spinal surgery procedures and that the intervention produced high satisfaction scores. Overall, we found that approximately 13 additional minutes was required compared with the traditional process to complete the video recording process.

This suggests that OxVIC would be acceptable for use, particularly in complex consultations where decision-making and communication might be more challenging for both the clinician and the patient.

While concerns over additional time, potential costs and practicality as to achieving this process are valid, they did not appear to be a significant barrier to delivering this service. Provided one has access to a good quality digital recording device, such as a smartphone that can transfer and store data securely, then the process can be straightforward.

We recognise that patients need to have access to the internet and may require help if not familiar using this sort of technology; however, as 85% of UK adults have a smartphone,30 access to the internet in this is not an insurmountable barrier. Future studies exploring clinician experiences of obtaining patient consent via OxVIC would also be useful to ensure that any concerns or barriers to use that were not identified in the present study are considered and acceptably addressed.

While we have not undertaken a cost analysis, for this pilot, there have been no significant costs as the technology already exists within the NHS Trust. Introducing OxVIC into clinical practice has numerous benefits such as documentary evidence of the clinician–patient consent conservation, which may reduce medicolegal cases. It may be used as an educational tool for medical teaching and could act as a patient resource/decision aid useful when analysing potential benefits and risks associated with surgery.

We would therefore suggest video consenting as a new benchmark in the consenting process. Based on this study, we recommend a large-scale study to evaluate the full impact of this process on outcome measures such as information retention, length of stay and litigation claims.

Strengths and limitations

This study has several strengths and weaknesses. Among the strengths was the development of a novel method to document the patient–clinician consent conversation. To our knowledge, this study is the first of its kind to provide preoperative patients with a personalised multimedia consent adjunct (OxVIC). Furthermore, OxVIC allows patients to review their consent conversation with family members and friends away from the clinical area, promoting shared decision making and patient autonomy.

Among the weaknesses is the limited diversity of the sample (eg, spinal surgery patients). Further studies could include the patient perspectives from other surgical specialities. In addition, quantitative data gathered within this pilot could be supported by the addition of qualitative research methods. While a standard NHS/Trust surgical consent form was used to promote surgeon adherence to standard information giving, the consent videos were not independently reviewed for validation purposes prior to patient access. The potential for standardisation should be considered in future studies of multimedia consenting.

Finally, concerns regarding cost and additional consenting time could be perceived as a potential limitation. However, the ability to document the patient–clinician conversation and its potential application to medicolegal practice may outweigh such concerns. This needs to be considered in future feasibility studies.

Future research

The findings from this pilot provide a foundation for potential future research projects.

A larger more diverse sample size to include younger (<25 years) and older (75 years+) people could add to the validity. Moreover, there is scope for the tool to be included in other specialities and further research should examine the acceptability of video consenting tool in multiple surgical disciplines. A larger study to definitively test the efficacy of OxVIC across different surgical specialities is in process.