“Mixed Reality” in patient education prior to abdominal aortic aneurysm repair
A prospective, randomized, controlled pilot study
Abstract
Summary:Background: To investigate the usability of Mixed-Reality (MR) during patient education in patients scheduled for abdominal aortic aneurysm (AAA) repair. Patients and methods: Consecutive patients scheduled for elective AAA repair were block-randomized in either the Mixed-Reality group (MR group) or the conventional group (control group). Patients of both groups were educated about open and endovascular repair of their respective AAA. The MR group was educated using a head-mounted display (HMD) demonstrating a three-dimensional virtual reconstruction of the respective patient’s vascular anatomy. The control group was educated using a conventional two-dimensional monitor to display the patient’s vasculature. Outcomes were informational gain as well as patient satisfaction with the educational process. (DRKS-ID: DRKS00025174). Results: 50 patients were included with 25 patients in either group. Both groups demonstrated improvements in scores in the Informational Gain Questionnaire (IGQ) when comparing pre- and post-education scores. (MR group: 6.5 points (±1.8) versus 7.9 points (±1.5); Control group: 6.2 points (±1.8) versus 7.6 points (±1.6); p<0.01) There was no significant difference between the MR group and the control group either in informational gain (MR group: 1.4±1.8; Control group: 1.4±1.8; p=0.5) nor in patient satisfaction scores (MR group: mean 18.3 of maximum 21 points (±3.7); Control group: mean 17 of 21 points (±3.6); p=0.1) Multiple regression revealed no correlation between the use of MR and informational gain or patient satisfaction. Usability of the system was rated high, and patients’ subjective assessment of MR was positive. Conclusions: The use of MR in patient education of AAA patients scheduled for elective repair is feasible. While patients reported positively on the use of MR in education, similar levels of informational gain and patient satisfaction can be achieved with MR and conventional methods.
Introduction
“Mixed Reality” (MR) is an innovative technology that enables the projection of virtual objects into the physical environment and the users’ field of view by wearing a head-mounted display (HMD) [1] (Figure 1). The terms MR and Augmented Reality (AR) are often used synonymously. While in MR and AR the physical environment remains visually perceptible and is augmented with digital information, in Virtual Reality (VR) the user is in a completely simulated environment [2]. MR and AR can be utilized to display three-dimensional virtual objects based on cross-sectional imaging like computed tomography angiography (CTA) (Figure 1). Furthermore, MR allows the user to interact with the virtual object either via a manual controller, gesture and/or voice control (electronic supplementary material [ESM] 1). Thereby, a three-dimensional, interactive model of a patient’s individual anatomy can be created for a variety of applications. Among other areas, the use of MR in the field of patient education has recently been suggested [3, 4, 5, 6, 7, 8, 9]. A systematic review by Urlings et al. concluded with encouraging results regarding the potential of AR in patient education. It was also concluded however that evidence is limited and that existing studies often contain heterogenous applications and populations [10].
The use of MR in patient education prior to elective abdominal aortic aneurysm (AAA) repair might facilitate patient involvement in decision making in AAA management. A recent meta-analysis of available randomized, controlled trials has shown that EVAR is, despite its perioperative benefits, associated with an increased risk of AAA-related mortality, reintervention, and rupture in the long-term [11]. Additionally, comorbidity of patients complicates risk assessment. In this multifaceted context of management options, current guidelines recommend to also include the patient’s personal preference in decision making [12, 13].
This should make high quality patient education a priority. It can empower the patient to make an informed decision, improve compliance, reduce anxiety and increase overall quality of healthcare [3, 14, 15, 16, 17]. And even though patient preference is one of the corner stones of decision making and highlighted in current guideline recommendations for AAA management, optimization of patient education is an underrepresented topic in the research landscape.
This prospective, randomized controlled pilot study investigates the feasibility of MR technology during patient education in patients scheduled for AAA repair. Furthermore, it explores whether MR can increase informational gain and patient satisfaction during patient education for open and endovascular repair options when compared to a control group.
Patients and methods
Study population
All consecutive patients that were scheduled for either open or endovascular repair for juxtarenal or infrarenal abdominal aortic aneurysms at the Department of Vascular and Endovascular Surgery at the University Hospital Heidelberg were considered for inclusion. Exclusion criteria were Age >80, inability to understand German language, emergency procedures, or presence of a legal guardianship. Patients were 1:1 block-randomized in either the MR group or the control group in a parallel design using a randomization list with a block length of 4. After screening and the patients’ consent to participate, patients were allocated to a group according to the randomization list by a third person. Both groups were educated about open and endovascular AAA repair. Considering the pilot study design, sample size was set to 50 patients.
Patient education
In the MR group patient education was performed wearing an HMD (Magic Leap 1, Magic Leap, Florida, USA, Figure 2), by each the surgeon and the patient. Both were observing the same virtual, three-dimensional model of a patient-individual reconstruction of the vascular anatomy through the HMD (Mixed Reality Viewer, Brainlab AG, Munich, Germany, Figure 1). For the purposes of this study, only the surgeon was equipped with the manual controller and thereby enabled to interact with the model. The surgeon could zoom in and out of relevant structures as well as rotate the model. Additionally, using a pointer function, specific structures were highlighted for the patient. A video of operating the software is demonstrated in ESM 1.
In the control group, the pathology was visualized on a two-dimensional monitor using conventional viewing software (GE Centricity PACS RA1000 Workstation, Boston, Massachusetts, United States). The total duration of the process was timed. All education procedures were performed by the same surgeon to improve standardization of the procedure and increase comparability of results.
The surgeon educated all patients about the definition of an abdominal aortic aneurysm, the indication to repair, basic anatomical information including the location of the aneurysm relative to neighbouring organs and aortic branches, vascular access techniques including median laparotomy, femoral cut-down and percutaneous access, common complications following endovascular and open repair and follow-up protocols. The different methods of repair including endovascular, open, and as well as the distinct risks and benefits that are associated with each option were explained. Simultaneously, the patient-individual three-dimensional virtual object and important individual anatomical features such as for example the aneurysm neck, access vessels and other relevant structures were highlighted. Next, the steps of open and endovascular repair were explained. Patient education was performed in the hospital-setting prior to surgery.
MR workflow
The MR workstation consisted of a personal computer (PC) running the Elements Viewer software (Brainlab AG, Munich, Germany) as well as a Magic Leap 1 HMD. Based on a DICOM dataset of the preoperative computed tomography angiography an individual three-dimensional reconstruction of the patients’ vascular anatomy was produced for every individual patient in the MR group. This process took a maximum of 10 minutes per patient.
After wireless imaging transport from the Elements Viewer to the Mixed Reality Viewer by visually scanning a QR-code as well as a positional marker, that ensures that the object is on the same location in the room for both observers, the user can inspect and interact with the object. Up to four users can observe the same object simultaneously. The HMD furthermore allows the complete digital documentation of the educational process. The detailed workflow to create a three-dimensional virtual object is presented in Figure 3. No special training is required to operate the HMD as well as the Mixed Reality Viewer (Brainlab AG, Munich, Germany). Further technical specifications are presented in ESM 2.
Outcomes
Baseline demographics of all patients including age, gender, level of education and comorbidities are reported descriptively. All participants answered a questionnaire prior and after patient education about both the endovascular and open surgical repair options (Informational Gain Questionnaire (IGQ), 9 single-choice questions, maximum 9 points). Additionally, after patient education, the participants were asked to complete a questionnaire aimed at measuring the patients’ satisfaction with the educational process (Patient Satisfaction Questionnaire (PSQ), 7 questions, each with a six-point Likert Scale, each question with −3 to +3 points, maximum 21 points). The MR group additionally completed a questionnaire specifically about the experience with using the HMD and its usability (MR Usability Questionnaire (MRUQ), 6 questions, each with a Six-Point Likert Scale). Unanswered items on the questionnaires were counted as false answers. It was ensured that during the education process, all information that is necessary to correctly answer the IGQ were explained to all patients in detail.
The primary outcome measures were informational gain and patient satisfaction with the patient education process. Informational gain was defined as the difference in score prior and following the patient education process in the IGQ. Patient satisfaction was measured as the total score achieved on the PSQ. Secondary outcomes were the duration of the patient education process as well as results of the MRUQ. English translation of the IGQ, PSQ and MRUQ are presented in Table I. Detailed questionnaires in English translation are presented in ESM 3, 4 and 5.
Statistical analysis
The study protocol was registered at the German Clinical Trials Register (DRKS-ID: DRKS00025174). The study was performed according to the Declaration of Helsinki and in accordance with the CONSORT statement [18]. Ethical approval was provided for the study by the local ethics committee (S-728/2020). Statistical analysis was performed using R [19]. Demographics are presented as mean±standard deviation as well as absolute and relative frequencies. Scores on the informational gain questionnaires as well as the patient satisfaction questionnaire are presented as mean±standard deviation and graphically displayed as Box-Whisker-Plots. The Wilcoxon test for two paired samples was performed to test for differences between the scores on the informational gain questionnaire pre- and post-education within the MR and control group, respectively. The Mann-Whitney-U-test for two unpaired samples was used to test for statistically significant differences of informational gain scores as well as patient satisfaction scores and the duration of patient educations between the MR and control groups. Multiple regression analysis was conducted to examine the correlation of the use of MR-assisted education, age, sex, level of education, baseline IGQ score, duration of education and ASA class with informational gain as well as patient satisfaction. For multiple regression, the categorical variable ASA (ASA 2, 3 and 4) was dummy coded with reference category 2.
Results
Study population
Between June 2021 and July 2022, fifty-five consecutive patients fulfilled the inclusion criteria. Five patients declined participation in the study. Fifty patients (91%) were included with a mean age of 68 years (±7.7) years in the MR group and 69 years (±8.1) in the control group. 12% of participants were female in either group. The mean AAA diameter was 5.6 cm (±1.0) and 5.7 cm (±0.6) in the MR and control group, respectively. Nine patients in the MR group (36%) and 6 patients in the control group (24%) had undergone higher education in their respective biographies. Comorbidities were similar between groups. Details with regards to the patient population including comorbidities are presented in Table II.
Informational gain
The MR group scored 6.5 (±1.8) points on the informational gain questionnaire prior to patient education and 7.9 (±1.5) points following patient education. The control group scored 6.2 (±1.8) and 7.6 (±1.6), respectively. In the MR group 22 of 25 patients improved their score (88%) while in the control group 23 of 25 patients (92%) could improve. Both groups demonstrated a significant increase in the achieved score on the IGQ (p<0.01). However, there was no significant difference in the mean increase between both groups with a mean difference in score of 1.4 points (±1.8) in each group (p=0.5). Scores on the IGQ prior and following patient education are presented in Figure 4. Informational gain is presented in Figure 5. Multiple regression analysis demonstrated that only the baseline IGQ score correlated with informational gain. Patients with a lower baseline score showed a greater informational gain. The use of MR, age, sex, level of education, duration of education as well as ASA class showed no correlation with informational gain in multiple regression analysis. Results of the multiple regression analysis are demonstrated in Table III.
Patient satisfaction
The mean patient satisfaction score achieved by the MR group was 18.3 (±3.7) of a maximum of 21 points. The control group scored 17 (±3.6) points, respectively. There was no statistically significant difference in the scores achieved in the patient satisfaction questionnaire (p=0.1). Patient satisfactions scores are presented in Figure 6. Multiple regression analysis showed that patient satisfaction did not correlate with the use of MR, age, sex, duration, level of education as well as ASA class. Results of multiple regression are displayed in Table IV.
Duration of patient education
There were no significant differences in the duration of the patient education process with 22.5 (±9.3) min in the MR group and 21.6 (±5.7) min in the control group (p=0.69).
Subjective assessment of MR usability
In the subjective assessment questionnaire 92% of patients reported that they agree or strongly agree that the use of the HMD has helped them to understand the disease. 96% strongly agreed or agreed that it helped to better understand complications associated with the procedure. 84% strongly agreed or agreed that in the future they would prefer other specialties to use MR in patient education as well. No patients reported that they felt that MR in patient education was unnecessary. 90% of patients strongly disagreed or disagreed that the handling of the HMD felt impractical. And no patients reported any discomfort with using the HMD. One patient did not answer questions 1–5. Detailed results from the subjective assessment of MR in patient education is presented in Table V.
Discussion
Previous studies have indicated promising results with the use of MR and AR technologies during patient education [4, 8]. Shared decision making in AAA repair needs to consider individual patient preference and risk assessment based on an underlying understanding of the disease. Surgeons are tasked with informing an often elderly and comorbid patient population about increasingly complex therapeutic options [20]. High quality patient education at the preoperative stage has the potential to increase compliance, reduce anxiety and thereby improve the overall quality of care [3, 14, 15, 16, 17, 21].
A recent scoping review about the state of shared decision making in the management of AAA concluded that even though AAA patients generally prefer shared decision making and despite it being a corner stone in current guideline recommendations, it is still underutilized in clinical practice. It was furthermore suggested that there is a need for decision support tools and training to facilitate shared decision making [22, 23, 24, 25, 26].
The present study demonstrated the feasibility of MR technology in AAA patients for educational purposes. Even though patients had a mean age of approximately 70 years, they were open to the technology, which is also reflected in a 91% participation rate in this study of a consecutive cohort of AAA patients scheduled for elective repair. This is in line with a previous study reporting on the use of VR in AAA patient education [27, 28]. Additionally, patients reported no adverse side effects like dizziness, headache, nausea, or discomfort and only one patient (4%) reported that the device was impractical. The usability of MR systems was generally rated high in the literature as well [9, 29, 30, 31].
Subjectively, patients evaluated MR very positively. Over 90% of patients agreed that MR has helped them to understand their disease and potential complications with the procedure. 96% said they would prefer patient education in other specialties to also be performed using MR. This is in line with results from previous studies exploring AR-, MR- or VR-technology [4, 9, 21, 28, 30, 32, 33].
However, statistical analysis including multiple regression revealed no correlation of informational gain or patient satisfaction with using MR. The only significant correlation that was identified demonstrates that patients with a lower baseline knowledge naturally benefit more from patient education, as expected. Interestingly, a high level of informational gain and patient satisfaction could be achieved in both groups. This might imply that rather than the use of MR, the stimulation of patients’ involvement in the management decision was key, as was specified per protocol for both groups due to the study design. Similar observations were made previously in studies investigating the use of AR in education and teaching [9, 29, 30, 31, 34].
MR might be one way to keep patients engaged in their treatment. This is not necessarily exclusively true for MR and might as well apply for other kinds of decisional support tools. After all, high quality patient education needs to consider individual concerns and limitations as well. While patients and surgeons are tasked to reach a shared decision, it remains the surgeons’ responsibility to adjust communication style and supporting tools to individual needs [35, 36].
Limitations
There are several limitations that need to be addressed. First it must be stated that these are single center results with a patient education intervention using one specific MR software application performed by a single surgeon and that results might not be generalizable. Future modifications of the application, such as labeling of anatomic structures and demonstration of educational images or video sequences in the MR environment might improve the performance of the application. Furthermore, this study only included patients with juxta- and infrarenal AAAs to increase comparability between groups. Thereby, it remains unknown if with increasing complexity of the procedures the potential benefit of MR visualization could be revealed. Second, while the questions to assess informational gain and patient satisfaction in this study were carefully selected, there were no validated instruments available to measure informational gain during patient education for AAA repair. In the future, patient preference, shared decision making, and health literacy will become increasingly important and standardized and validated tools to measure the quality of different methodological approaches are needed. Furthermore, at the time of patient education in the hospital setting, patients were already pre-informed to varying degree from the out-patient setting. Different levels of prior knowledge could have introduced bias. Moreover, it was difficult to anticipate an adequate level of difficulty for the selected questions. Both limitations have led to relatively high baseline scores which left little room for improvement in either group. Third, the sample size of this pilot study was limited. While only one surgeon performed patient education interventions for both groups and informant bias was controlled, individual concerns and questions of patients leading to a deviation from the standard educational intervention could have resulted in information bias. Additionally, we did not include anxiety as well as mental status in our protocol, which could be confounding variables. For these reasons, the presented results must be interpreted as exploratory pilot study results. Despite the limitations, this is the largest series investigating MR education in a homogenous cohort of consecutive AAA patients with a respective control group and in a randomized setting.
Conclusions
The use of MR in patient education of AAA patients scheduled for elective repair is feasible. While patients reported very positively on MR-assisted education, similar levels of informational gain and patient satisfaction can be achieved with conventional methods.
Electronic supplementary material
The electronic supplementary material (ESM) is available with the online version of the article at https://doi.org/10.1024/0301-1526/a001062
References
1 Application and prospect of mixed reality technology in medical field. Curr Med Sci. 2019;39(1):1–6. https://doi.org/10.1007/s11596-019-1992-8
2 . Augmented reality: a class of displays on the reality-virtuality continuum. SPIE. 1995;2351. https://doi.org/10.1117/12.197321
3 . Effect of patient education on adherence to drug treatment for rheumatoid arthritis: a randomised controlled trial. Ann Rheum Dis. 2001;60(9):869–75.
4 Use of the mixed reality tool “VSI Patient Education” for more comprehensible and imaginable patient educations before epilepsy surgery and stereotactic implantation of DBS or stereo-EEG electrodes. Epilepsy Res. 2020;159:106247. https://doi.org/10.1016/j.eplepsyres.2019.106247
5 . Information recall in pre-operative consultation for Glioma surgery using actual size three-dimensional models. J Clin Med. 2020;9(11):3660. https://doi.org/10.3390/jcm9113660
6 . Interactive augmented reality systems: Aid for personalized patient education and rehabilitation. Unfallchirurg. 2018;121(4):286–92. https://doi.org/10.1007/s00113-018-0458-y
7 . The Cleft Lip Education with Augmented Reality (CLEAR) VR Phase 2 Trial: a pilot randomized crossover trial of a novel patient information leaflet. Cleft Palate Craniofac J. 2022;60(2). https://doi.org/10.1177/10556656211059709
8 . The first pilot study of an interactive, 360° augmented reality visualization platform for neurosurgical patient education: a case series. Oper Neurosurg. 2022;23(1):53–9. https://doi.org/10.1227/ons.0000000000000186
9 Patient-specific 3D printed and augmented reality kidney and prostate cancer models: impact on patient education. 3D Print Med. 2019;5(1):4. https://doi.org/10.1186/s41205-019-0041-3
10 The role and effectiveness of augmented reality in patient education: a systematic review of the literature. Patient Educ Couns. 2022;105(7):1917–27. https://doi.org/10.1016/j.pec.2022.03.005
11 . Editor’s choice – Endovascular vs. open repair for abdominal aortic aneurysm: systematic review and meta-analysis of updated peri-operative and long term data of randomised controlled trials. Eur J Vasc Endovasc Surg. 2020;59(3):385–97. https://doi.org/10.1016/j.ejvs.2019.11.030
12 . S3-leitlinie zum screening, diagnostik therapie und nachsorge des bauchaortenaneurysmas. Gefässchirurgie. 2018;23(6):402–3. https://doi.org/10.1007/s00772-018-0452-2
13 Editor’s choice – European Society for Vascular Surgery (ESVS) 2019 clinical practice guidelines on the management of abdominal aorto-iliac artery aneurysms. Eur J Vasc Endovasc Surg. 2019;57(1):8–93. https://doi.org/10.1016/j.ejvs.2018.09.020
14 . Approaches to patient education: emphasizing the long-term value of compliance and persistence. Am J Med. 2006;119(4 Suppl 1):S32–7. https://doi.org/10.1016/j.amjmed.2005.12.021
15 . A preoperative education intervention to reduce anxiety and improve recovery among Chinese cardiac patients: a randomized controlled trial. Int J Nurs Stud. 2012;49(2):129–37. https://doi.org/10.1016/j.ijnurstu.2011.08.008
16 . Strategies for improving the quality of verbal patient and family education: a review of the literature and creation of the EDUCATE model. Health Psychol Behav Med. 2014;2(1):482–95. https://doi.org/10.1080/21642850.2014.900450
17 . The relation between patient education, patient empowerment and patient satisfaction: a cross-sectional-comparison study. Appl Nurs Res. 2018;39:11–7. https://doi.org/10.1016/j.apnr.2017.10.008
18 . CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Ann Intern Med. 2010;152(11):726–32. https://doi.org/10.7326/0003-4819-152-11-201006010-00232
19 . RStudio: integrated development environment for R [computer software]. Boston, MA: RStudio, PBC; 2021.
20 The state of complex endovascular abdominal aortic aneurysm repairs in the vascular quality initiative. J Vasc Surg. 2019;70(2):369–80. https://doi.org/10.1016/j.jvs.2018.11.021
21 . Effects of preoperative virtual reality magnetic resonance imaging on preoperative anxiety in patients undergoing arthroscopic knee surgery: a randomized controlled study. Arthroscopy. 2019;35(8):2394–9. https://doi.org/10.1016/j.arthro.2019.02.037
22 . Shared decision making in and management of intact abdominal aortic aneurysm: a scoping review of the literature. Eur J Vasc Endovasc Surg. 2023. https://doi.org/10.1016/j.ejvs.2023.01.036
23 Improving shared decision making in vascular surgery: a stepped wedge cluster randomised trial. Eur J Vasc Endovasc Surg. 2022;64(1):73–81. https://doi.org/10.1016/j.ejvs.2022.04.016
24 Effect of a decision aid on agreement between patient preferences and repair type for abdominal aortic aneurysm: a randomized clinical trial. JAMA Surg. 2022;157(9):e222935. https://doi.org/10.1001/jamasurg.2022.2935
25 A decision aid regarding treatment options for patients with an asymptomatic abdominal aortic aneurysm: a randomised clinical trial. Eur J Vasc Endovasc Surg. 2014;48(3):276–83. https://doi.org/10.1016/j.ejvs.2014.04.016
26 . Development of three different decision support tools to support shared decision-making in vascular surgery. Patient Educ Couns. 2021;104(2):282–9. https://doi.org/10.1016/j.pec.2020.11.036
27 . The application of virtual reality in patient education. Ann Vasc Surg. 2019;59:184–9. https://doi.org/10.1016/j.avsg.2019.01.015
28 . The use of virtual reality in patient education related to medical somatic treatment: a scoping review. Patient Educ Couns. 2022;105(7):1828–41. https://doi.org/10.1016/j.pec.2021.12.015
29 . Evaluation of the effectiveness and usability of an educational portion size tool, ServARpreg, for pregnant women. J Hum Nutr Diet. 2019;32(6):719–27. https://doi.org/10.1111/jhn.12660
30 . The acceptability and impact of the Xploro digital therapeutic platform to inform and prepare children for planned procedures in a hospital: before and after evaluation study. J Med Internet Res. 2020;22(8):e17367. https://doi.org/10.2196/17367
31 Development and evaluation of an augmented reality education program for pediatric research. J Clin Transl Res. 2020;5(3):96–101.
32 . Towards a more user-friendly medication information delivery to people living with multiple sclerosis: a case study with Alemtuzumab. Adv Exp Med Biol. 2019;1120:67–82. https://doi.org/10.1007/978-3-030-06070-1_6
33 . Effect of an immersive preoperative virtual reality experience on patient reported outcomes: a randomized controlled trial. Ann Surg. 2017;265(6):1068–73. https://doi.org/10.1097/sla.0000000000002094
34 . The effectiveness of the use of augmented reality in anatomy education: a systematic review and meta-analysis. Sci Rep. 2021;11(1):15292. https://doi.org/10.1038/s41598-021-94721-4
35 . Health information needs and dissemination methods for individuals living with ischemic heart disease: a systematic review. Patient Educ Couns. 2023;108:107594. https://doi.org/10.1016/j.pec.2022.107594
36 . Therapeutic patient education: continuing education programmes for health care providers in the field of prevention of chronic diseases: report of a WHO working group. Copenhagen: World Health Organization; 1998.
