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Evaluation of an interactive multi-media device for delivering information on Le Fort I osteotomy
Journal of Cranio-Maxillo-Facial Surgery xxx (2014) 1e5
Contents lists available at ScienceDirect
Journal of Cranio-Maxillo-Facial Surgery journal homepage: www.jcmfs.com
Evaluation of an interactive multi-media device for delivering information on Le Fort I osteotomy Assem El Azem, Philip C.M. Benington, Balvinder S. Khambay, Ashraf F. Ayoub* Oral and Maxillofacial Surgery, The University of Glasgow Dental Hospital and School, 378 Sauchiehall Street, Glasgow G2 3JZ, UK
a r t i c l e i n f o
a b s t r a c t
Article history: Paper received 1 March 2013 Accepted 3 January 2014
This study was carried out on volunteers to evaluate a newly developed interactive software package aimed at informing prospective Le Fort I osteotomy patients regarding the surgical technique and possible complications. The aim of the study was to compare two methods of information delivery; a multi-media tablet device delivering both graphic and verbal information, and an audio device delivering essentially the same information in verbal form only. The null hypothesis was that there would be no difference between the efficiencies of the two methods. The subjects’ ability to recall the information delivered by both devices was assessed using a questionnaire. The tablet device participants scored an average of 15.48 points, while the audio device participants scored an average of 268 points. The difference was statistically significant (p < 0.001), suggesting that the multi-media tablet device was more effective method. Ó 2014 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.
Keywords: Le Fort I Consent Complications Orthognathic surgery Interactive media Questionnaire
1. Introduction Orthognathic surgery is carried out to correct skeletal and occlusal disharmonies that are beyond the scope of orthodontic treatment alone. The role of orthognathic surgery is to improve facial aesthetics as well as function including mastication, respiration and speech. Surgical correction of a maxillary discrepancy is a relatively safe procedure. It is well tolerated by the patient but complications do occur (Mcleod and Gruber, 2012). Therefore, patients have to be adequately informed of the potential risks and complications of osteotomies if they are to be able to give informed consent for surgery. As part of the informed consent procedure, patients must be made aware of the duration of treatment, including pre-and post-operative orthodontic preparation, the details of the surgical procedure itself and possible complications which might arise during and after surgery. The principle of informed consent is that a competent patient must be given sufficient information, in a manner which they can understand and recall, to make an informed choice about the planned treatment (General Medical Council, 2008). The use of
* Corresponding author. University of Glasgow Dental Hospital and School, 378 Sauchiehall Street, G2 3JZ, UK. Tel.: þ44 7710 413131. E-mail addresses: [email protected], [email protected] (A.F. Ayoub).
video media for informed consent and patient education has been reported in a variety of medical fields including surgery. This has been shown to increase patient knowledge of the procedure and satisfaction with the outcome, as well as decreasing anxiety (Rossi et al., 2005). Over the last 30 years several studies have investigated the use of computer assisted packages to deliver surgical information to a variety of patient populations. Unlike verbal communication, a computerised format can be accompanied by graphics and animation. A number of studies have found that the use of multimedia presentations containing questionnaires with a responsive feedback achieve higher knowledge scores than the use of conventional methods (Jones et al., 2001). Bulmer et al. (2001) asked 40 participants to answer 11 questions regarding lower urinary tract symptoms after having had the information about the condition presented through reading a leaflet or a touch-screen computer system. The participants in the “computer” group scored 4.3 out of possible 11 while the participants in the leaflet “group” scored 2.8 out of 11. Both methods of delivering information were well appreciated by all of the participants but 26 (65%) reported that they would prefer the computerized delivery of information if given the choice. One of the advantages of using an audio-visual format to deliver information regarding surgery and possible complications is to decrease the problem of readability and deliver the same information to all patients, regardless of their level of education and
1010-5182/$ e see front matter Ó 2014 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved. http://dx.doi.org/10.1016/j.jcms.2014.01.004
Please cite this article in press as: El Azem A, et al., Evaluation of an interactive multi-media device for delivering information on Le Fort I osteotomy, Journal of Cranio-Maxillo-Facial Surgery (2014), http://dx.doi.org/10.1016/j.jcms.2014.01.004
2
A. El Azem et al. / Journal of Cranio-Maxillo-Facial Surgery xxx (2014) 1e5
Fig. 1. A frontal and a lateral view of the skull with the bony cuts on the upper jaw.
literacy. Rossi et al. (2004) evaluated the effectiveness of using a videotape to inform patients about the risks, benefits and alternative treatments for ankle fracture surgery, before signing a consent form. Patients were then given a multiple-choice questionnaire to determine comprehension and retention of information. The video group outperformed the verbal group by 40.1%. In addition, the score of patients with educational levels less than or equal to the 12th grade was 67.8% greater after watching the video than after receiving the information verbally. It is a legal requirement to inform patients adequately about any surgical procedure and its risks. Information can be communicated verbally or in writing and is often repeated at several points during orthognathic planning (Layton and Korsen, 1994). Based on existing evidence, there appears to be an improved ability of patients to understand and retain information regarding their medical condition about the treatment that they were about to receive when it is presented to them graphically. No study appears to have been carried out to date to assess the possible benefits of interactive computer graphics in the delivery of information regarding orthognathic surgery. The Le Fort I osteotomy is one of the most common orthognathic surgical procedures to correct maxillary
Fig. 2. Graphic depicting swelling and redness of the left cheek region.
dysmorphology. It is well recognized that this procedure is associated with complications and patient’s awareness of these risks is essential (Van Otterlo et al., 1991). Several studies discussed the possible side effects after Le Fort I osteotomy. Rallis et al., (2006) studied the benefits of using titanium plates for fixation of the maxilla after the surgical procedure. The benefits included the stability of osteotomized segments, avoiding the need for intermaxillary fixation, patient’s comfort and less possibility of complications during immediate post-operative recovery in comparison with maxillomandibular fixation. However, his study found that the chief cause of plate removal was infection (46%). Bouletrau et al., (2008) studied the risk of severe vascular complications of Le Fort I osteotomy over 9 years and concluded that only 0.55% out of 916 patients suffered that complication. In this pilot study the research team developed multi-media software based on similar complications mentioned in the literature. The aim of this study was to compare the level of information retained by two groups of volunteer subjects on the risks associated with Le Fort I osteotomy communicated to them by using an interactive graphic multi-media tablet device in one group and using an audio verbal recording in the other group. 1.1. The null hypothesis There are no statistical differences in the levels of information retention between the participants in the multi-media tablet group and those in the audio verbal group. 2. Materials and methods An interactive computer program was developed to present an agreed package of information regarding Le Fort I osteotomy and its risks on the tablet device. This consisted of a series of novel graphic sequences accompanied by simple verbal descriptions as seen in Figs. 1e4. An audio recording was also prepared, aimed at presenting the same information verbally through headphones. The participants were then assigned in equal numbers to one or other mode of delivery through a pseudo-randomization process, which involved drawing sealed papers labelled “Tablet” and “Verbal” from a dispenser.
Fig. 3. Graphic depicting blood discharge from the nose.
Please cite this article in press as: El Azem A, et al., Evaluation of an interactive multi-media device for delivering information on Le Fort I osteotomy, Journal of Cranio-Maxillo-Facial Surgery (2014), http://dx.doi.org/10.1016/j.jcms.2014.01.004
A. El Azem et al. / Journal of Cranio-Maxillo-Facial Surgery xxx (2014) 1e5
3
Fig. 4. Graphic of the skull from a lateral view with the upper jaw fixed in its new position using 2 plates. The right hand image shows removal of the screws and plates in case of infection.
Table 1 Student t-test shows the statistical difference between group 1 (tablet) and group 2 (verbal). Group statistics
Total
Groups
N
Mean
Std. deviation
Std. error mean
1.00 2.00
25 25
15.48 10.72
5.19 3.37
1.0 .6
Independent samples test
Total
Equal variances assumed Equal variances not assumed
Levene’s test f or equality of variances
t-test for equality of means
F
t
3.854
Sig.
.055
3.841 3.841
Fifty volunteers were recruited on the main campus of Glasgow University after obtaining the appropriate local ethical approval. 22 participants were females (44%) and 28 were males (56%). The mean age of the participants at the time of completing the questionnaire was 27.04 years. Both groups had, surprisingly, the same average age of 27.04 years. 49 participants had already undertaken an educational degree or were studying at the time of the study and only one participant had a limited educational background. There was no difference between the two groups regarding the educational level. Individuals were approached and asked if they would be willing to take part in the study. A brief description about the research was given, including an explanation of why it is important for prospective patients to understand the basic information relating to jaw surgery and its possible complications. It was explained that, in most clinics, this information is given to patients verbally and that many of them may not fully understand or remember the details. The participants in the “tablet” group were asked to work through the animated program using the digital tablet in a quiet room with even lighting. The participants in the “verbal” group were asked to listen to the audio recording under the same conditions. The tablet device used in this study was a 10.100 touchscreen model. The specially developed software for the study was divided into sections, each of which was accompanied by a simple verbal explanation. The first section: “Surgery” explained the surgical technique of Le Fort I osteotomy. The bony cuts, the forward
df
Sig. (2-tailed)
48 41.171
.000 .000
Mean difference
4.76 4.76
Std. error difference
1.23914 1.23914
95% confidence interval of the difference Lower
Upper
2.26 2.25
7.25 7.26
movement and fixation of the maxilla using 4 plates and 16 screws, were illustrated graphically on a skull. The harvesting of a bonegraft from the iliac crest was depicted on a graphic representation of a full skeleton and the areas of possible swelling, numbness and nose bleeding were illustrated on a graphic representation of the face.
Fig. 5. Shows a summary of the results for the two groups. There was a clear tendency for the participants in the tablet group to achieve higher questionnaire scores, i.e, retain more information, than the verbal group. This was particularly evident in question eight which highlighted the possibility of relapse following Le Fort I osteotomy. This difference was statistically significant (p < 0.001).
Please cite this article in press as: El Azem A, et al., Evaluation of an interactive multi-media device for delivering information on Le Fort I osteotomy, Journal of Cranio-Maxillo-Facial Surgery (2014), http://dx.doi.org/10.1016/j.jcms.2014.01.004
4
A. El Azem et al. / Journal of Cranio-Maxillo-Facial Surgery xxx (2014) 1e5
In addition to the explanation of the surgery, ten possible complications were described using both the tablet and verbal media. These were classified as “immediate” and “late”. The immediate complications were: pain; swelling; numbness to the cheek nose and lip; nose bleeding; nose width increase; infection and limited mouth movement. The late complications were: relapse; plate removal and loss of tooth vitality. All participants were asked to complete a questionnaire immediately afterwards which consisted of 14 questions designed to assess the understanding and retention of the information presented (see Appendix). A Student t-test was applied to test for statistical differences between the two groups in providing the correct answers to the 14 questions. 3. Results Twenty five participants completed the study in each group. Table 1 shows the summary of the results. There was a highly significant difference between the means of the correct answers of the participants in the two groups (p < 0.001) .The mean for the “tablet” group was significantly higher than for the “verbal” group (p < 0.001). Regarding the duration of numbness, only a small percentage of the participants in the “verbal” group managed to retain this important piece of knowledge. Similarly, the possible complication of nose bleeding after surgery was remembered more readily by the participants in the “tablet” group. “Figure 5” shows the possible total score achieved for each question by each group of participants. There was a clear tendency for the “tablet” group to score higher marks than those in the “verbal” group except for question 13. This question did not reflect the superiority of one method over the other. The results for this question were coincidental as the answer was not provided in either method. A larger percentage of the participants in the “tablet” group retained the information regarding the hip bone-graft procedure, although the level of recall of this knowledge was poor for both groups. The responses to question four showed that none of the participants in the “verbal” group were able to recall the duration of possible numbness after Le Fort I osteotomy, compared to eight participants in the “tablet” group. 4. Discussion Informed consent is a process by which a well-informed patient can participate in the decision making process concerning his or her health care. Informed consent has significant importance for both clinicians and patients. There are no clear guidelines as to how much information should be disclosed as part of this process, although failure to provide sufficient information can be construed as negligence (Rossi et al., 2004). In some cases it may be difficult to obtain informed consent due to the unpredictable nature of unique surgical procedure (Pirnay et al., 2012) or the complexity of clinical environment (Bauser et al., 2012). Poor explanation of the proposed procedure was the reason of patients’ discontent and litigation (Krauser et al., 2001). Informed consent in orthognathic surgery is a lengthy process, which begins with the initial planning visit when treatment is being considered, and finishes when the patient is discharged at the end of post-operative follow-up period (Mcleod and Gruber, 2012). Information is usually given verbally on several occasions throughout the patient’s management, and in written
form as part of the signed consent process prior to surgery. The amount of information that patients should be given regarding the possible complications of surgery is debatable and the expectation varies from one medico-legal system to another. The current standard in the UK is to highlight the complications that are likely to occur (Layton and Korsen, 1994). Gasparini et al. (2004) proposed an informed consent model for orthognathic surgery in which it is recommended to divide the consent form into two parts. The first part concerns the diagnostic procedures, the therapeutic and surgical time frames, and the second part addresses the possible complications associated with the procedure. Muslow et al. (2012) identified 16 studies on the use of multimedia for patient education. In all studies the use of multi-media delivery was associated with a significant improvement in patient recall of information, which was objectively measured by a questionnaire. The use of multi-media education improved the score for understanding from 59% to 82%. The results of the present study support this finding. This pilot study used non-patient volunteers to test the efficacy of a multi-media tablet with animation software in enhancing delivery of information regarding the surgical procedure and possible complications of Le Fort I osteotomy. The null hypothesis was rejected, since the “tablet” device group demonstrated increased levels of certain information retention, compared with the “verbal” group. A similar study was carried out by Mladenovski and Klieser (2008) in relation to third molar surgery. They compared the effectiveness of an information leaflet with that of multi-media program in providing the patients with the necessary knowledge about the surgical procedure. In this study patients were randomly allocated either to the “leaflet” group or to the “multimedia” group. Thirty patients took part, of whom 29 completed the analysis. A pre-intervention and a post-intervention questionnaire were completed by the patients to assess their knowledge about third molar removal. The percentage of participants who found the three-dimensional animations helpful (93%) was significantly higher than the percentage who found the pictures in the leaflet helpful (15%). The multi-media option was rated significantly higher as a useful source of knowledge than the “leaflet” group (75% and 15% respectively). The findings of the present study are similar to these published data. This study showed the limitations of both methods in delivering the essential information on Le Fort I osteotomy and the associated potential complications. Refinements have to be made to the software to improve the understanding of surgery and the related complications. This has to be achieved before its routine use for clinical cases. The participants in this study were volunteers, who were not scheduled for surgery. This might have had a negative effect on their level of retention of surgical information. Patients would be more interested in knowing more about the complications of the surgical procedure that they are about to undergo. 5. Conclusion Using a graphic multi-media device to inform patients about Le Fort I osteotomy and its associated complications is more effective than verbal communication. Refinement of the multimedia device is required to improve the effectiveness of the method in delivering the required information. Patients should be involved in further studies once the software is ready for clinical application.
Please cite this article in press as: El Azem A, et al., Evaluation of an interactive multi-media device for delivering information on Le Fort I osteotomy, Journal of Cranio-Maxillo-Facial Surgery (2014), http://dx.doi.org/10.1016/j.jcms.2014.01.004
A. El Azem et al. / Journal of Cranio-Maxillo-Facial Surgery xxx (2014) 1e5
Appendix A
5
References Bouletrau P, Mortier J, Pierrillas P, Freidel M, Preton P: Severe vascular complications of Le Fort I osteotomy. J Craniomaxillofac Surg 36: 103e106, 2008 Bauser J, Beck N, Kiefer J: Awareness and education of patients receiving bisphosphonates. J Craniomaxillofac Surg 40: 277e282, 2012 Bulmer PJ, James M, Ellis-Jones J, Smith D, Timoney AG, Donovan J: A randomized trial comparing the effectiveness and preference of a touch-screen computer system with a leaflet for providing women with information on urinary symptoms suggestive of detrusor instability. BJU Int 88: 532e535, 2001 Gasparini G, Boniello R, Longobardi G, Pelo S: Orthognathic surgery: an informed consent model. J Craniofac Surg 15: 858, 2004 General Medical Council: Consent: patients and doctors making decisions together, www.gmc-uk.org; 2008 Jones JM, Nyhof-young J, Friedman A, Catton P: More than just a pamphlet: development of an innovative computer-based education program for cancer patients. Patient Educ Couns 44(3): 271e281. http://dx.doi.org/10.1016/S07383991(00)00204-4, 2001 Sep S0738399100002044 Krauser H, Bremerich A, Rustemeyer J: Reasons for patients’ discontent and litigation. J Cranio Maxillofac Surg 29: 181e183, 2001 Layton S, Korsen J: Informed consent in oral and maxillofacial surgery: a study of the value of written warnings. Br J Oral Maxillofac Surg 32: 34e36, 1994 Mcleod N, Gruber E: Consent for orthognathic surgery: a UK perspective. Br J Oral Maxillofac Surg 50: 17e21, 2012 Mladenovski A, Klieser JA: The efficacy of multimedia pre-operative information for patients: a pilot study. N Z Dent J 104: 36e43, 2008 Muslow J, Feeley M, Tierney S: Beyond consent: improving understanding in surgical patients. Am J Surg 203: 112e120, 2012 Pirnay P, Foo R, Herve C, Meningaud JP: Ethical questions raised by the first allotransplantations of the face: a survey of French surgeons. J Craniomaxillofac Surg 40: 402e407, 2012 Rallis G, Mourouzis C, Papakosta V, Papanastasiou G, Zachariades N: Reasons for miniplate removal following maxillofacial trauma: a 4-year study. J Craniomaxillofac Surg 34: 435e439, 2006 Rossi M, McClellan R, Chou L: Informed consent for ankle fracture surgery: patient comprehension of verbal and videotaped information. Foot Ankle Int 25: 756e762, 2004 Rossi MJ, Guttmann D, MacLennan MJ: Video informed consent improves knee arthroscopy patient comprehension. Arthroscopy 21: 739e743, 2005 Van Otterlo J, Tuinzing D, Greebe R, van der Kwast W: Intra and early postoperative complications of the Le Fort I osteotomy: a retrospective study on 410 cases. J Craniomaxillofac Surg 19: 217e222, 1991
Please cite this article in press as: El Azem A, et al., Evaluation of an interactive multi-media device for delivering information on Le Fort I osteotomy, Journal of Cranio-Maxillo-Facial Surgery (2014), http://dx.doi.org/10.1016/j.jcms.2014.01.004
Contents lists available at ScienceDirect
Journal of Cranio-Maxillo-Facial Surgery journal homepage: www.jcmfs.com
Evaluation of an interactive multi-media device for delivering information on Le Fort I osteotomy Assem El Azem, Philip C.M. Benington, Balvinder S. Khambay, Ashraf F. Ayoub* Oral and Maxillofacial Surgery, The University of Glasgow Dental Hospital and School, 378 Sauchiehall Street, Glasgow G2 3JZ, UK
a r t i c l e i n f o
a b s t r a c t
Article history: Paper received 1 March 2013 Accepted 3 January 2014
This study was carried out on volunteers to evaluate a newly developed interactive software package aimed at informing prospective Le Fort I osteotomy patients regarding the surgical technique and possible complications. The aim of the study was to compare two methods of information delivery; a multi-media tablet device delivering both graphic and verbal information, and an audio device delivering essentially the same information in verbal form only. The null hypothesis was that there would be no difference between the efficiencies of the two methods. The subjects’ ability to recall the information delivered by both devices was assessed using a questionnaire. The tablet device participants scored an average of 15.48 points, while the audio device participants scored an average of 268 points. The difference was statistically significant (p < 0.001), suggesting that the multi-media tablet device was more effective method. Ó 2014 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.
Keywords: Le Fort I Consent Complications Orthognathic surgery Interactive media Questionnaire
1. Introduction Orthognathic surgery is carried out to correct skeletal and occlusal disharmonies that are beyond the scope of orthodontic treatment alone. The role of orthognathic surgery is to improve facial aesthetics as well as function including mastication, respiration and speech. Surgical correction of a maxillary discrepancy is a relatively safe procedure. It is well tolerated by the patient but complications do occur (Mcleod and Gruber, 2012). Therefore, patients have to be adequately informed of the potential risks and complications of osteotomies if they are to be able to give informed consent for surgery. As part of the informed consent procedure, patients must be made aware of the duration of treatment, including pre-and post-operative orthodontic preparation, the details of the surgical procedure itself and possible complications which might arise during and after surgery. The principle of informed consent is that a competent patient must be given sufficient information, in a manner which they can understand and recall, to make an informed choice about the planned treatment (General Medical Council, 2008). The use of
* Corresponding author. University of Glasgow Dental Hospital and School, 378 Sauchiehall Street, G2 3JZ, UK. Tel.: þ44 7710 413131. E-mail addresses: [email protected], [email protected] (A.F. Ayoub).
video media for informed consent and patient education has been reported in a variety of medical fields including surgery. This has been shown to increase patient knowledge of the procedure and satisfaction with the outcome, as well as decreasing anxiety (Rossi et al., 2005). Over the last 30 years several studies have investigated the use of computer assisted packages to deliver surgical information to a variety of patient populations. Unlike verbal communication, a computerised format can be accompanied by graphics and animation. A number of studies have found that the use of multimedia presentations containing questionnaires with a responsive feedback achieve higher knowledge scores than the use of conventional methods (Jones et al., 2001). Bulmer et al. (2001) asked 40 participants to answer 11 questions regarding lower urinary tract symptoms after having had the information about the condition presented through reading a leaflet or a touch-screen computer system. The participants in the “computer” group scored 4.3 out of possible 11 while the participants in the leaflet “group” scored 2.8 out of 11. Both methods of delivering information were well appreciated by all of the participants but 26 (65%) reported that they would prefer the computerized delivery of information if given the choice. One of the advantages of using an audio-visual format to deliver information regarding surgery and possible complications is to decrease the problem of readability and deliver the same information to all patients, regardless of their level of education and
1010-5182/$ e see front matter Ó 2014 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved. http://dx.doi.org/10.1016/j.jcms.2014.01.004
Please cite this article in press as: El Azem A, et al., Evaluation of an interactive multi-media device for delivering information on Le Fort I osteotomy, Journal of Cranio-Maxillo-Facial Surgery (2014), http://dx.doi.org/10.1016/j.jcms.2014.01.004
2
A. El Azem et al. / Journal of Cranio-Maxillo-Facial Surgery xxx (2014) 1e5
Fig. 1. A frontal and a lateral view of the skull with the bony cuts on the upper jaw.
literacy. Rossi et al. (2004) evaluated the effectiveness of using a videotape to inform patients about the risks, benefits and alternative treatments for ankle fracture surgery, before signing a consent form. Patients were then given a multiple-choice questionnaire to determine comprehension and retention of information. The video group outperformed the verbal group by 40.1%. In addition, the score of patients with educational levels less than or equal to the 12th grade was 67.8% greater after watching the video than after receiving the information verbally. It is a legal requirement to inform patients adequately about any surgical procedure and its risks. Information can be communicated verbally or in writing and is often repeated at several points during orthognathic planning (Layton and Korsen, 1994). Based on existing evidence, there appears to be an improved ability of patients to understand and retain information regarding their medical condition about the treatment that they were about to receive when it is presented to them graphically. No study appears to have been carried out to date to assess the possible benefits of interactive computer graphics in the delivery of information regarding orthognathic surgery. The Le Fort I osteotomy is one of the most common orthognathic surgical procedures to correct maxillary
Fig. 2. Graphic depicting swelling and redness of the left cheek region.
dysmorphology. It is well recognized that this procedure is associated with complications and patient’s awareness of these risks is essential (Van Otterlo et al., 1991). Several studies discussed the possible side effects after Le Fort I osteotomy. Rallis et al., (2006) studied the benefits of using titanium plates for fixation of the maxilla after the surgical procedure. The benefits included the stability of osteotomized segments, avoiding the need for intermaxillary fixation, patient’s comfort and less possibility of complications during immediate post-operative recovery in comparison with maxillomandibular fixation. However, his study found that the chief cause of plate removal was infection (46%). Bouletrau et al., (2008) studied the risk of severe vascular complications of Le Fort I osteotomy over 9 years and concluded that only 0.55% out of 916 patients suffered that complication. In this pilot study the research team developed multi-media software based on similar complications mentioned in the literature. The aim of this study was to compare the level of information retained by two groups of volunteer subjects on the risks associated with Le Fort I osteotomy communicated to them by using an interactive graphic multi-media tablet device in one group and using an audio verbal recording in the other group. 1.1. The null hypothesis There are no statistical differences in the levels of information retention between the participants in the multi-media tablet group and those in the audio verbal group. 2. Materials and methods An interactive computer program was developed to present an agreed package of information regarding Le Fort I osteotomy and its risks on the tablet device. This consisted of a series of novel graphic sequences accompanied by simple verbal descriptions as seen in Figs. 1e4. An audio recording was also prepared, aimed at presenting the same information verbally through headphones. The participants were then assigned in equal numbers to one or other mode of delivery through a pseudo-randomization process, which involved drawing sealed papers labelled “Tablet” and “Verbal” from a dispenser.
Fig. 3. Graphic depicting blood discharge from the nose.
Please cite this article in press as: El Azem A, et al., Evaluation of an interactive multi-media device for delivering information on Le Fort I osteotomy, Journal of Cranio-Maxillo-Facial Surgery (2014), http://dx.doi.org/10.1016/j.jcms.2014.01.004
A. El Azem et al. / Journal of Cranio-Maxillo-Facial Surgery xxx (2014) 1e5
3
Fig. 4. Graphic of the skull from a lateral view with the upper jaw fixed in its new position using 2 plates. The right hand image shows removal of the screws and plates in case of infection.
Table 1 Student t-test shows the statistical difference between group 1 (tablet) and group 2 (verbal). Group statistics
Total
Groups
N
Mean
Std. deviation
Std. error mean
1.00 2.00
25 25
15.48 10.72
5.19 3.37
1.0 .6
Independent samples test
Total
Equal variances assumed Equal variances not assumed
Levene’s test f or equality of variances
t-test for equality of means
F
t
3.854
Sig.
.055
3.841 3.841
Fifty volunteers were recruited on the main campus of Glasgow University after obtaining the appropriate local ethical approval. 22 participants were females (44%) and 28 were males (56%). The mean age of the participants at the time of completing the questionnaire was 27.04 years. Both groups had, surprisingly, the same average age of 27.04 years. 49 participants had already undertaken an educational degree or were studying at the time of the study and only one participant had a limited educational background. There was no difference between the two groups regarding the educational level. Individuals were approached and asked if they would be willing to take part in the study. A brief description about the research was given, including an explanation of why it is important for prospective patients to understand the basic information relating to jaw surgery and its possible complications. It was explained that, in most clinics, this information is given to patients verbally and that many of them may not fully understand or remember the details. The participants in the “tablet” group were asked to work through the animated program using the digital tablet in a quiet room with even lighting. The participants in the “verbal” group were asked to listen to the audio recording under the same conditions. The tablet device used in this study was a 10.100 touchscreen model. The specially developed software for the study was divided into sections, each of which was accompanied by a simple verbal explanation. The first section: “Surgery” explained the surgical technique of Le Fort I osteotomy. The bony cuts, the forward
df
Sig. (2-tailed)
48 41.171
.000 .000
Mean difference
4.76 4.76
Std. error difference
1.23914 1.23914
95% confidence interval of the difference Lower
Upper
2.26 2.25
7.25 7.26
movement and fixation of the maxilla using 4 plates and 16 screws, were illustrated graphically on a skull. The harvesting of a bonegraft from the iliac crest was depicted on a graphic representation of a full skeleton and the areas of possible swelling, numbness and nose bleeding were illustrated on a graphic representation of the face.
Fig. 5. Shows a summary of the results for the two groups. There was a clear tendency for the participants in the tablet group to achieve higher questionnaire scores, i.e, retain more information, than the verbal group. This was particularly evident in question eight which highlighted the possibility of relapse following Le Fort I osteotomy. This difference was statistically significant (p < 0.001).
Please cite this article in press as: El Azem A, et al., Evaluation of an interactive multi-media device for delivering information on Le Fort I osteotomy, Journal of Cranio-Maxillo-Facial Surgery (2014), http://dx.doi.org/10.1016/j.jcms.2014.01.004
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A. El Azem et al. / Journal of Cranio-Maxillo-Facial Surgery xxx (2014) 1e5
In addition to the explanation of the surgery, ten possible complications were described using both the tablet and verbal media. These were classified as “immediate” and “late”. The immediate complications were: pain; swelling; numbness to the cheek nose and lip; nose bleeding; nose width increase; infection and limited mouth movement. The late complications were: relapse; plate removal and loss of tooth vitality. All participants were asked to complete a questionnaire immediately afterwards which consisted of 14 questions designed to assess the understanding and retention of the information presented (see Appendix). A Student t-test was applied to test for statistical differences between the two groups in providing the correct answers to the 14 questions. 3. Results Twenty five participants completed the study in each group. Table 1 shows the summary of the results. There was a highly significant difference between the means of the correct answers of the participants in the two groups (p < 0.001) .The mean for the “tablet” group was significantly higher than for the “verbal” group (p < 0.001). Regarding the duration of numbness, only a small percentage of the participants in the “verbal” group managed to retain this important piece of knowledge. Similarly, the possible complication of nose bleeding after surgery was remembered more readily by the participants in the “tablet” group. “Figure 5” shows the possible total score achieved for each question by each group of participants. There was a clear tendency for the “tablet” group to score higher marks than those in the “verbal” group except for question 13. This question did not reflect the superiority of one method over the other. The results for this question were coincidental as the answer was not provided in either method. A larger percentage of the participants in the “tablet” group retained the information regarding the hip bone-graft procedure, although the level of recall of this knowledge was poor for both groups. The responses to question four showed that none of the participants in the “verbal” group were able to recall the duration of possible numbness after Le Fort I osteotomy, compared to eight participants in the “tablet” group. 4. Discussion Informed consent is a process by which a well-informed patient can participate in the decision making process concerning his or her health care. Informed consent has significant importance for both clinicians and patients. There are no clear guidelines as to how much information should be disclosed as part of this process, although failure to provide sufficient information can be construed as negligence (Rossi et al., 2004). In some cases it may be difficult to obtain informed consent due to the unpredictable nature of unique surgical procedure (Pirnay et al., 2012) or the complexity of clinical environment (Bauser et al., 2012). Poor explanation of the proposed procedure was the reason of patients’ discontent and litigation (Krauser et al., 2001). Informed consent in orthognathic surgery is a lengthy process, which begins with the initial planning visit when treatment is being considered, and finishes when the patient is discharged at the end of post-operative follow-up period (Mcleod and Gruber, 2012). Information is usually given verbally on several occasions throughout the patient’s management, and in written
form as part of the signed consent process prior to surgery. The amount of information that patients should be given regarding the possible complications of surgery is debatable and the expectation varies from one medico-legal system to another. The current standard in the UK is to highlight the complications that are likely to occur (Layton and Korsen, 1994). Gasparini et al. (2004) proposed an informed consent model for orthognathic surgery in which it is recommended to divide the consent form into two parts. The first part concerns the diagnostic procedures, the therapeutic and surgical time frames, and the second part addresses the possible complications associated with the procedure. Muslow et al. (2012) identified 16 studies on the use of multimedia for patient education. In all studies the use of multi-media delivery was associated with a significant improvement in patient recall of information, which was objectively measured by a questionnaire. The use of multi-media education improved the score for understanding from 59% to 82%. The results of the present study support this finding. This pilot study used non-patient volunteers to test the efficacy of a multi-media tablet with animation software in enhancing delivery of information regarding the surgical procedure and possible complications of Le Fort I osteotomy. The null hypothesis was rejected, since the “tablet” device group demonstrated increased levels of certain information retention, compared with the “verbal” group. A similar study was carried out by Mladenovski and Klieser (2008) in relation to third molar surgery. They compared the effectiveness of an information leaflet with that of multi-media program in providing the patients with the necessary knowledge about the surgical procedure. In this study patients were randomly allocated either to the “leaflet” group or to the “multimedia” group. Thirty patients took part, of whom 29 completed the analysis. A pre-intervention and a post-intervention questionnaire were completed by the patients to assess their knowledge about third molar removal. The percentage of participants who found the three-dimensional animations helpful (93%) was significantly higher than the percentage who found the pictures in the leaflet helpful (15%). The multi-media option was rated significantly higher as a useful source of knowledge than the “leaflet” group (75% and 15% respectively). The findings of the present study are similar to these published data. This study showed the limitations of both methods in delivering the essential information on Le Fort I osteotomy and the associated potential complications. Refinements have to be made to the software to improve the understanding of surgery and the related complications. This has to be achieved before its routine use for clinical cases. The participants in this study were volunteers, who were not scheduled for surgery. This might have had a negative effect on their level of retention of surgical information. Patients would be more interested in knowing more about the complications of the surgical procedure that they are about to undergo. 5. Conclusion Using a graphic multi-media device to inform patients about Le Fort I osteotomy and its associated complications is more effective than verbal communication. Refinement of the multimedia device is required to improve the effectiveness of the method in delivering the required information. Patients should be involved in further studies once the software is ready for clinical application.
Please cite this article in press as: El Azem A, et al., Evaluation of an interactive multi-media device for delivering information on Le Fort I osteotomy, Journal of Cranio-Maxillo-Facial Surgery (2014), http://dx.doi.org/10.1016/j.jcms.2014.01.004
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Appendix A
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Please cite this article in press as: El Azem A, et al., Evaluation of an interactive multi-media device for delivering information on Le Fort I osteotomy, Journal of Cranio-Maxillo-Facial Surgery (2014), http://dx.doi.org/10.1016/j.jcms.2014.01.004