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research-article2014
FAIXXX10.1177/1071100714543644Foot & Ankle InternationalWang et al
Article
The Use of Multimedia as an Adjunct to the Informed Consent Process for Morton’s Neuroma Resection Surgery
Foot & Ankle International® 2014, Vol. 35(10) 1037–1044 © The Author(s) 2014 Reprints and permissions: sagepub.com/journalsPermissions.nav DOI: 10.1177/1071100714543644 fai.sagepub.com
Calvin Wang, MD, FRCSC1, Peter Ammon, MBBS, FRACS2, and Andrew D. Beischer, MBBS, MD, FRACS1
Abstract Background: The purpose of this study was to assess if a computer-based multimedia education module (MEM) improved patients’ comprehension when used as an adjunct to the standard verbal consent process for Morton’s neuroma resection surgery. Methods: Nineteen patients (15 females and 4 males) considered candidates for Morton’s neuroma resection surgery were prospectively recruited. A standardized verbal discussion was had with each patient regarding risks and benefits of surgery, alternative treatments, and the usual postoperative course. Patient understanding was then assessed with a questionnaire. Each patient subsequently viewed the MEM and the questionnaire was repeated. Patients also rated ease of understanding and satisfaction with both methods of patient education. Results: Patients answered a significantly greater proportion of correct answers after viewing the MEM module (85%), compared to verbal discussion alone (61%) (P = .002). Patients rated both the ease of understanding of the module and amount of information provided by the module as a mean of 9.3 cm on a 10 cm Visual Analog Scale (VAS). The majority of patients (76%) rated the multimedia tool as having answered their questions about surgery as well or better than the treating surgeon. Conclusion: An interactive multimedia educational tool was a useful adjunct to the informed consent process for patients considering Morton’s neuroma resection surgery. Levels of Evidence: Level II, prospective cohort study. Keywords: Morton’s neuroma, surgery, multimedia, patient education, informed consent Informed consent is a prerequisite prior to any operative procedure and forms the basis of the doctor-patient relationship by promoting patient autonomy and protecting the patient from potential harms.13 By providing patients with information regarding the risks and benefits, expected outcomes, and alternatives of a proposed treatment, it allows an individual to make a “reasonable” decision regarding treatment. The British Orthopaedic Association guide to good practice in forefoot surgery states that this information should be “explained [to patients] in understandable language … [and] the surgeon should try to verify that the patient has understood the information.”8 In the current medical climate, obtaining proper informed consent also has significant medicolegal implications.27 Typically the process of obtaining operative consent from a patient has involved physician-led discussion with the patient. To enhance patient education and understanding during the informed consent process, multiple aids have been used.23 These include information pamphlets, videos,
and anatomical models. Studies have shown that despite these aids, patient recollection remains variable, and often very poor.12,17,25,29 With the advent of newer technologies, multimedia audiovisual tools are increasingly being used to improve patient education.2,3,5-7,10,11,24 The goal of this study was to evaluate the impact of a computer-based, interactive multimedia education module (MEM) on patient learning regarding Morton’s neuroma resection surgery. The primary aim was to assess the effect of using the multimedia tool when used in sequence after the 1
Victorian Orthopaedic Foot and Ankle Clinic, Richmond, Victoria, Australia 2 Murdoch Orthopaedic Clinic, Murdoch, WA, Australia Corresponding Author: Andrew D. Beischer, MBBS, MD, FRACS, Victorian Orthopaedic Foot and Ankle Clinic, Suite 6.3, The Epworth Centre, 32 Erin St, Richmond, Victoria 3121, Australia. Email: [email protected]
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Table 1. Educational Objectives of Multimedia Education Model. Morton’s neuroma pathophysiology Nonoperative treatment • Shoe-wear modifications and orthotics • Role of NSAIDs, corticosteroid injection • Works in up to 80% of patients Details of operative procedure • Local anesthesia • Incision • Resection of Morton’s neuroma • Sutures, dressing, and postoperative shoe Postoperative period • Day care surgery • Usual postoperative medications, including pain relief • Weight-bearing in rigid sole postop shoe • Elevation of foot for first 2 weeks • Keep dressing intact and dry for first 2 weeks Likely outcome • 80% successful in pain relief • Permanent numbness in affected toes Possible complications • Wound breakdown and infection • Nerve injury • Recurrent Morton’s neuroma • Clawing of the toes • Deep vein thrombosis • Other medical complications ○ Anesthetic ○ Cardiovascular ○ Allergic reactions
traditional surgeon–patient verbal interaction. The secondary aim was to evaluate patient satisfaction with using the MEM as an adjunct in the informed-consent process.
Methods Development of Educational Objectives A literature review on the etiology, natural history, and treatment of Morton’s neuroma was performed.1,15,20,28,30 A group of patients previously treated for Morton’s neuroma resection by the senior author was surveyed to determine their educational priorities or deficiencies that they had experienced with regard to their past surgery. This information was used to form a list of educational objectives (Table 1) for development of the MEM.
Development of the MEM The MEM was developed based on the educational objectives. A script was developed by the senior author which was then reviewed by 2 linguists who removed unnecessary
medical terminology. Three-dimensional (3D) computer animations illustrating the educational objectives were created using 3D Studio Max (Autodesk, San Rafael, CA) and integrated with an audio track and text into an interactive linear program in QuickTime (Apple, Cupertino, CA)18 and Macromedia Flash (Adobe Systems Inc, San Jose, CA). The program allowed patients to progress and review information at their own pace (see Figure 1).
Development of the Questionnaire A knowledge questionnaire (Q1) was designed to assess patients’ understanding of information that had been presented to them. The design of the questionnaire was based on those used in previously published studies.2,4-6 A total of 12 questions were used (Table 2), with 9 specifically related to possible complications of Morton’s neuroma resection surgery. Answer options included the following: “true,” “false,” and “unsure.” The last option was provided so that patients would not guess the correct response. A second questionnaire (Q2) was designed to assess patient satisfaction with the MEM and to also assess patients’ expectation of the likely success of surgery (Table 3).
Study Design This study was approved by the Human Research Ethics Committee of our institution. The same fellowship-trained orthopaedic foot and ankle surgeon saw all patients in a private practice setting during the period of June 2006 to June 2012. The inclusion criteria for patients recruited into the study were patients (1) considered appropriate candidates for Morton’s neuroma resection surgery, (2) whose primary language was English, (3) who could read the questionnaire, and (4) who could use the multimedia presentation. Exclusion criteria included poor vision, poor hearing, and English not being the patient’s primary language Once the patient was considered a candidate for Morton’s neuroma surgery, each then received a standardized comprehensive discussion concerning the nature and treatment of his or her condition, including treatment options. Details of the proposed operative procedure, postoperative course, and potential complications were explained by the senior author. Patients were then asked if they would agree to participate in the study. Those who consented to participate in the study were then asked to complete the initial knowledge questionnaire (Q1). Patients then observed the MEM, and then completed Q1 for a second time. Patients were also asked to complete the satisfaction questionnaire (Q2) at this time. Upon completion of this process, if patients had further questions or incorrect responses in the postmodule Q1, the treating surgeon discussed these issues further with them. Demographic data were collected from the medical charts of participating patients. Nineteen consecutive
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Figure 1. A multimedia module representative shot. A menu on the right of the animation screen allows the patient to follow his or her progression through the module and enables each patient to review any section of the module that has already been viewed. Three buttons at the bottom of the screen allow the patient to review any section already completed, but do not allow the patient to advance to the next section until the current section is completed. Table 2. Knowledge Assessment Questionnaire (Q1). 1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8 1.9 1.10 1.11 1.12
Smoking does not affect the outcome of the operation. A Morton’s neuroma cannot recur after surgery. Morton’s neuroma surgery relieves pain in approximately 9 in 10 patients. I do not need to use a special shoe on the operative foot after surgery. To reduce bleeding and pain I need to keep the foot elevated as much as possible. 5 out of 10 people will have a surgical complication. Infection never occurs after Morton’s neuroma surgery. I will have normal sensation in the toes following Morton’s neuroma surgery. Getting the dressings wet after surgery is safe. Swelling of the foot never occurs after Morton’s neuroma surgery. Clots in the leg never occur after Morton’s neuroma surgery. Clawing of the toes can occur Morton’s neuroma surgery.
TRUE TRUE TRUE TRUE TRUE TRUE TRUE TRUE TRUE TRUE TRUE TRUE
UNSURE UNSURE UNSURE UNSURE UNSURE UNSURE UNSURE UNSURE UNSURE UNSURE UNSURE UNSURE
FALSE FALSE FALSE FALSE FALSE FALSE FALSE FALSE FALSE FALSE FALSE FALSE
patients assessed as candidates for Morton’s neuroma resection were prospectively recruited into the study. The mean age was 48 years. There were 15 females and 4 males. All patients spoke English as their primary language and consented to participate in the study. All patients completed the premodule and postmodule questionnaires.
biostatistician. “Unsure” and incorrect responses were grouped together as “not correct” and compared with correct responses. Student’s paired t test was used to test the null hypothesis that there would be no change in the correct and incorrect response rates, premodule and postmodule. Statistical significance was set at P < .05.
Data Analysis
Results
Results from the knowledge questionnaire were analyzed by the junior author using Microsoft Excel (Microsoft Corp, Redmond, WA) in consultation with the institution’s
After the standardized surgeon consultation and before observing the MEM, of 228 questions (19 subjects × 12 questions) answered by patients, 139 (61%) were answered
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Table 3. Module Performance Survey (Q2). 2. Expected result of surgery 2.1. The chance of having a good outcome following surgery is: I————————————————————————————I 0% 100% No patients have good outcome All patients have good outcome 3. Satisfaction with computer consent module 3.1. I found the consent module easy to understand: I————————————————————————————I Strongly disagree Strongly agree 3.2. The computer module had the appropriate amount of information to help me make my decision about surgery: I————————————————————————————I Strongly disagree Strongly agree For the following questions please tick the box that most closely reflects your response. 3.3. The duration of the module was: 1. Too long 2. Too short 3. Just right 4. Unsure 3.4. The questions that I had about the problem with my foot was better answered by: 1. My surgeon 2. The computer program 3. My surgeon/computer the same 3.5. Comments you would like to make about the computer module:
correctly, 54 (24%) were answered “unsure,” and 35 (15%) were answered incorrectly. Therefore 139 (61%) responses were correct, and 89 (39%) were not correct. After viewing the MEM, 194 (85%) were answered correctly, 15 (7%) “unsure,” and 19 (8%) incorrectly. This represented a 24% increase in correct responses, which was statistically significant (P = .002). The majority of this increase was due to a 17% decrease in “unsure” responses. Figure 2 illustrates the percentage of correct responses for each specific question premodule and postmodule. There were 2 questions in which the correct response rate more than doubled from premodule to postmodule. Regarding the risk of blood clots, the number of correct responses increased from 7 (37%) to 17 (90%) postmodule. Regarding the risk of claw toes, the number of correct responses increased from 4 (21%) to 17 (90%) postmodule. Similarly, questions on the risk of recurrence of Morton’s neuroma, and expected benefit from surgery also had large improvement in correct responses postmodule. Both had an additional 7 (37%) more correct responses, from 10 (53%) and 6 (32%) premodule, respectively. On the 10-cm Visual Analog Scale (VAS) relating the chance of having a good outcome following surgery—where a measurement of 10 cm corresponds to a 100% chance—a median score of 80% was obtained. This was identical to that proposed by the module (80%). For ease of understanding of the module, patients gave a median rating of 93% on the VAS. When asked how appropriate the amount of information was provided by the module, patients again gave a
median score of 93%. All patients rated the duration of the module as “just right”; 76% rated the multimedia tool as having answered their questions about surgery as well (59%) or better (17%) than the treating surgeon; 24% of subjects preferred the surgeon’s verbal explanation.
Discussion The consent process is an essential journey for the patient and their treating clinician to travel together to ensure that each patient makes an informed decision about their treatment options.8,13 If a well-informed patient elects to undergo a proposed operative procedure, he or she should have realistic expectations about the likely outcome and risks of such a decision.16 Unfortunately many studies have indicated that despite careful preoperative verbal discussion with their treating clinicians, many patients appear to have a poor comprehension of the issues central to their decision to have surgery.9,12,17,25,29 In an effort to improve the informed consent process, pamphlets, videos, and multimedia presentations have been introduced into the informed consent process with variable success. Our group has previously reported on a prospective, randomized 3-way comparison of a standardized verbal discourse with the patient to either pamphlet or MEM methods of educating patients regarding issues central to the decision making process regarding knee arthroscopy surgery.10 The results of this particular study provided level II evidence that as an isolated method of information delivery the MEM was significantly and substantially superior to
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Figure 2. A comparison of the percentage of correct responses for each item in the knowledge questionnaire premodule and postmodule. Note questions 2, 3, 11, and 12 showed a marked improvement in the percentage of correct answers following completion of the multimedia education module.
both a standardized verbal consent process and pamphletbased patient education. Although the MEM can be effective for assisting patients making an informed decision regarding surgery, it is not clinically acceptable to use this technology as a substitute for the surgeon–patient relationship.19 Indeed, in this study we observed that 24% of patients preferred the educational experience provided by the surgeon to that provided by the MEM. Therefore, in the current study our primary aim was to investigate whether the MEM was a useful adjunct to the usual verbal surgeon–patient discourse regarding informed consent for patients considering Morton’s neuroma resection surgery. A secondary goal was to determine patients’ assessment of the value and usability of the MEM when incorporated into the informed consent process. The MEM significantly and substantially improved patient recall of information relevant to Morton’s neuroma and the proposed surgery. This suggested that the module presented information in a clear, understandable manner that allowed patients to better answer the questionnaire. Some of this improvement may be due to reinforcement by the module of information discussed by the surgeon. However, the audiovisual nature of the module was likely to also have had an effect, as illustrated by some of the following examples.7,14,23 There were 4 questions that patients answered poorly after the standardized surgeon discussion. These were regarding the risk of recurrence (53% correct), likelihood of
pain relief (32% correct), risk of blood clots (37%), and risk of claw toes (21%). The question on which patients performed most poorly was related to the risk of developing claw toes postoperatively (21% correct premodule). The consultant surgeon always mentioned the potential outcome of claw toes in his standard patient discussion of potential operative complications. Despite this discussion, few patients indicated they were aware of this complication. Within the MEM, patients observed an animation that demonstrated the process of toes clawing (Figure 3), and this graphical representation likely had a greater impact on patients’ awareness of this complication than when this risk was mentioned by the surgeon. This was evident in the fact that postmodule there were 90% correct responses to this particular question. The second question that patients answered poorly was regarding the risk of blood clots (37% correct premodule). Despite being uncommon, there is a small incidence of patients developing a deep vein thrombosis (DVT) or pulmonary embolism (PE) following forefoot surgery.21,26 As this can have grave medical implications, we believe it is important for patients to be aware of this potential complication. One possible reason for patients overlooking this potential complication is the fact that the surgeon did not mention needing DVT prophylaxis, as he does not regularly use it in this group of patients. In comparison, the patients appeared more aware and cognizant of the risk of infection (79% correct premodule) because the surgeon
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Figure 3. Module animation illustrating the risk of developing claw toe deformities postoperatively.
stated the need for perioperative antibiotics. However, the module specifies that there is a very small chance of getting a DVT/PE postoperatively, and shows a graphical representation of a DVT forming in the calf vein. Correspondingly, the correct response rate increased to 89% postmodule. Although all patients were advised by their treating surgeon that the chance of successful relief of pain by surgery was 80%, less than a third of patients correctly answered question 1.3, which stated that there was a 90% chance of pain relief with surgery. Perhaps this indicated that patients believed that there was little material difference between what was mentioned by the surgeon and that what was stated by the question. After viewing the module more than twothirds of patients answered the same question correctly. Patient understanding of the chance of success from surgery was also evaluated by question 3.1, which patients completed after viewing the MEM. The mean response to this VAS type question was 8.0 cm, which equated to an 80% chance of success from surgery. This result reflected the mean patient perception of the likely success rate of surgery after education by the surgeon and the patient multimedia education module. This observation suggested that using a continuous measurement scale such as the VAS could be a better tool to assess patient perception of the likelihood of a successful outcome with surgery rather than a true/false-type question design. Before consenting to a operative procedure patients must be given a balanced and unbiased understanding of the likelihood of success and have a clear understanding of
what the surgery involves, including postoperative recovery and what the likely outcome of surgery will be. Patients must also comprehend the material risks associated with a operative procedure.22 It is the personal view of the senior author that all patients considering a operative intervention must also clearly understand that any surgery carries a chance of failure, which includes the risk of being made worse by surgery. Question 1.2 dealt with acknowledgment by the patient of the possibility of failure or of being made worse by surgery (ie, that the Morton’s neuroma could recur). Patients were advised by the surgeon and by the MEM that the neuroma could recur at the resected stump of the nerve and this could be as or possibly more symptomatic than the original lesion. Only half of all patients correctly answered this question after the consultation with the surgeon. The correct response rate improved to 90% after viewing the module. We believe this significant and substantial improvement was due to the clear depiction of an incisional neuroma forming following initial resection using 3-D animation. Patients in this study reported a high level of satisfaction with the format, ease of understanding, and duration of the MEM. The study was undertaken in a facility containing 3 or 4 consulting rooms for the use of the senior author. After having consulted with the surgeon, patients were left alone in the consulting room where they had seen the surgeon to view the module and complete the questionnaires on their own. Only if they had further questions after completing this process did the surgeon return to the patient. In this setting,
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Wang et al introduction of the MEM did not negatively impact on patient flow through the clinic as patients rarely had further questions after having completed this process. In a clinic with less consulting rooms available to be used for viewing of the MEM by patients it is possible that its use could negatively impact on patient flow. Consequently our group is developing MEMs that would perform better on tablet-type devices, which could potentially be used in a greater number of clinical environments such as the waiting room. When these multimedia education modules are available online in a format that can be viewed on a tablet type device, patients will be able to access the educational content when they wish. At this point we intend to explore if repeated viewing of the content by patients further improves their comprehension of issues related to a pending surgery. A potential criticism of this study is that the questionnaires that were used have not been formally validated as an assessment tool. The question items were, however, carefully constructed and reviewed by 2 fellowship-trained foot and ankle surgeons. Patients were also able to answer “unsure” if they did not understand the question clearly. Another potential criticism is the study design that was chosen. As patients were tested twice it is possible that this methodology introduced a potential bias where patients were primed by the initial questionnaire to information that they were to receive when they viewed the MEM. Consequently the increased proportion of correct responses observed in Q2 could have been due to the priming phenomenon. We do not believe that this phenomenon is the cause for the observed difference in this study as our group has previously undertaken studies using different randomized experimental designs. These studies have demonstrated that the priming effect did not appear to be a major factor influencing patients’ responses to the knowledge questionnaires.11,24 In the current study we wished to explore the effect of the MEM when used as an adjunct to the usual verbal consent provided by a consultant foot and ankle surgeon in a busy clinical setting. We also aimed to determine patient satisfaction regarding the utility of the MEM when incorporated into the senior authors informed consent process. The true/false/unsure and VAS design of questions used in this study appeared easy for patients to use, as it was rare for a patient to seek help regarding how to complete them. A statistical analysis of the performance of the questionnaires was outside the scope of this study but the results of this pilot study have lead our group to now investigate the optimization of questionnaire design and the process of questionnaire validation. The purpose of this research was to potentially develop simple, reproducible, and useful tools to assess patient comprehension of issues central to making an informed decision regarding surgery. It is possible that the significant improvement in patient understanding that was observed after viewing the MEM was that the surgeon had performed poorly as an educator.
We contend that this was not the case as not only does the senior author has a particular interest and enthusiasm for patient education but many others have reported on the failure of the traditional verbal consent process to reliably convey to patients the information they need to make an informed decision.9,12,16,17,29 General barriers for patients not retaining information include lack of time in a busy clinic, poor communication techniques, and patient comprehension and anxiety. This study has shown that use of a multimedia tool can allow patients to process and review information at their own pace, and reinforce relevant information previously discussed by the surgeon. As the patients in this group varied from 28 to 65 years of age, it showed that the general population could use the program without difficulty. The majority of patients felt that the module provided as much or more information than the surgeon, indicating its usefulness as an adjunct to the traditional informed consent process.
Conclusion The use of an MEM as an adjunct to the usual informed consent process significantly improved patient understanding regarding Morton’s neuroma resection surgery. Patients of both sexes and all age groups felt the module was easy to understand, and provided as much or better information than the surgeon consultation alone. We contend that multimedia tools can be used effectively in the clinical setting to better prepare patients for surgery. Declaration of Conflicting Interests The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: The multimedia patient education module (MEM) examined in this study was created by Surgical Multimedia Services (SMS). SMS received a grant from MRFWB to create and study the Morton’s neuroma MEM. SMS is a private research company. Andrew Beischer is a director and shareholder of SMS but has not received nor expects to receive any financial reward for this association with SMS.
Funding The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The authors would like to acknowledge the generous financial support of this research project by the Medical Research Foundation for Women and Babies.
References 1. Adams SB Jr, Peters PG, Schon LC. Persistent or recurrent interdigital neuromas. Foot Ankle Clin. 2011;16:317-325. 2. Batuyong E, Birks C, Beischer AD. The use of multimedia as an adjunct to the informed consent process for ankle ligament reconstruction surgery. Foot Ankle Spec. 2012;5: 150-159.
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3. Batuyong ED, Jowett AJ, Wickramasinghe N, Beischer AD. Using multimedia to enhance the consent process for bunion correction surgery. ANZ J Surg. 2014;84:249-254. 4. Beamond BM, Beischer AD, Brodsky JW, Leslie H. Improvement in surgical consent with a preoperative multimedia patient education tool: a pilot study. Foot Ankle Int. 2009;30:619-626. 5. Beischer AD, Clarke A, de Steiger RN, et al. The practical application of multimedia technology to facilitate the education and treatment of patients with plantar fasciitis: a pilot study. Foot Ankle Spec. 2008;1:30-38. 6. Beischer AD, Corniou A, de Steiger RN, Cohn J, Graves S. The role of multimedia in patient education for total hip replacement surgery. J Bone Joint Surg Br. 2002;84B:290. 7. Bollschweiler E, Apitzsch J, Obliers R, et al. Improving informed consent of surgical patients using a multimediabased program? Results of a prospective randomized multicenter study of patients before cholecystectomy. Ann Surg. 2008;248:205-211. 8. British Orthopaedic Association. Elective Forefoot Surgery: A Guide to Good Practice. 2010. Available at: https://www. boa.ac.uk/Publications/Documents/Elective_Forefoot_ Surgery_Blue_Book.pdf. 9. Cassileth BR, Zupkis RV, Sutton-Smith K, March V. Informed consent—why are its goals imperfectly realized? N Engl J Med. 1980;302:896-900. 10. Cornoiu A, Beischer AD, Donnan L, Graves S, de Steiger R. Multimedia patient education to assist the informed consent process for knee arthroscopy. ANZ J Surg. 2011;81:176-180. 11. Ellett L, Villegas R, Beischer A, Ong N, Maher P. The use of a multimedia module to aid the informed consent process in patients undergoing gynecological laparoscopy for pelvic pain—a randomized controlled trial [published online ahead of print January 23, 2014]. J Minim Invasive Gynecol. doi:10.1016/j.jmig.2014.01.002. 12. Hutson MM, Blaha JD. Patients’ recall of preoperative instruction for informed consent for an operation. J Bone Joint Surg Am. 1991;73:160-162. 13. Jefford M, Moore R. Improvement of informed consent and the quality of consent documents. Lancet Oncol. 2008;9:485-493. 14. Karunaratne AS, Korenman SG, Thomas SL, Myles PS, Komesaroff PA. Improving communication when seeking informed consent: a randomised controlled study of a computer-based method for providing information to prospective clinical trial participants. Med J Aust. 2010;192:388-392.
15. Kay D, Bennett GL. Morton’s neuroma. Foot Ankle Clin. 2003;8:49-59. 16. Leclercq WK, Keulers BJ, Scheltinga MR, Spauwen PH, van der Wilt GJ. A review of surgical informed consent: past, present, and future. A quest to help patients make better decisions. World J Surg. 2010;34:1406-1415. 17. Madan AK, Tichansky DS. Patients postoperatively for get aspects of preoperative patient education. Obes Surg. 2005;15:1066-1069. 18. Maffulli N, Papalia R, Palumbo A, Del Buono A, Denaro V. Quantitative review of operative management of hallux rigidus. Br Med Bull. 2011;98:75-98. 19. Maheu MM, Pulier ML, Wilhelm FH, McMenamin JP, Brown-Connolly NE. Online clinical practice management: referrals, client education, and consent. In: Milmoe S, ed. The Mental Health Professional and the New Technologies. Mahwah, NJ: Lawrence Erlbaum; 2005:336-337. 20. Peters PG, Adams SB Jr, Schon LC. Interdigital neuralgia. Foot Ankle Clin. 2011;16:305-315. 21. Radl R, Kastner N, Aigner C, et al. Venous thrombosis after hallux valgus surgery. J Bone Joint Surg Am. 2003;85A:1204-1208. 22. Rogers v Whitaker. Commonwealth Law Reports, Australia, 1992; 479. 23. Ryan RE, Prictor MJ, McLaughlin KJ, Hill SJ. Audio-visual presentation of information for informed consent for participation in clinical trials. Cochrane Database Syst Rev. 2008;CD003717. 24. Shadur B. Multimedia based patient education. An addition to the informed consent process for rotator cuff surgery. In: Department of Surgery. Melbourne: University of Melbourne; 2006:89. 25. Shurnas PS, Coughlin MJ. Recall of the risks of forefoot surgery after informed consent. Foot Ankle Int. 2003;24:904-908. 26. Solis G, Saxby T. Incidence of DVT following surgery of the foot and ankle. Foot Ankle Int. 2002;23:411-414. 27. Suk M, Udale AM, Helfet DL. Orthopaedics and the law. J Am Acad Orthop Surg. 2005;13:397-406. 28. Thomson CE, Gibson JN, Martin D. Interventions for the treatment of Morton’s neuroma. Cochrane Database Syst Rev. 2004;CD003118. 29. Turner P, Williams C. Informed consent: patients listen and read, but what information do they retain? N Z Med J. 2002;115:U218. 30. Weinfeld SB, Myerson MS. Interdigital neuritis: diagnosis and treatment. J Am Acad Orthop Surg. 1996;4:328-335.
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research-article2014
FAIXXX10.1177/1071100714543644Foot & Ankle InternationalWang et al
Article
The Use of Multimedia as an Adjunct to the Informed Consent Process for Morton’s Neuroma Resection Surgery
Foot & Ankle International® 2014, Vol. 35(10) 1037–1044 © The Author(s) 2014 Reprints and permissions: sagepub.com/journalsPermissions.nav DOI: 10.1177/1071100714543644 fai.sagepub.com
Calvin Wang, MD, FRCSC1, Peter Ammon, MBBS, FRACS2, and Andrew D. Beischer, MBBS, MD, FRACS1
Abstract Background: The purpose of this study was to assess if a computer-based multimedia education module (MEM) improved patients’ comprehension when used as an adjunct to the standard verbal consent process for Morton’s neuroma resection surgery. Methods: Nineteen patients (15 females and 4 males) considered candidates for Morton’s neuroma resection surgery were prospectively recruited. A standardized verbal discussion was had with each patient regarding risks and benefits of surgery, alternative treatments, and the usual postoperative course. Patient understanding was then assessed with a questionnaire. Each patient subsequently viewed the MEM and the questionnaire was repeated. Patients also rated ease of understanding and satisfaction with both methods of patient education. Results: Patients answered a significantly greater proportion of correct answers after viewing the MEM module (85%), compared to verbal discussion alone (61%) (P = .002). Patients rated both the ease of understanding of the module and amount of information provided by the module as a mean of 9.3 cm on a 10 cm Visual Analog Scale (VAS). The majority of patients (76%) rated the multimedia tool as having answered their questions about surgery as well or better than the treating surgeon. Conclusion: An interactive multimedia educational tool was a useful adjunct to the informed consent process for patients considering Morton’s neuroma resection surgery. Levels of Evidence: Level II, prospective cohort study. Keywords: Morton’s neuroma, surgery, multimedia, patient education, informed consent Informed consent is a prerequisite prior to any operative procedure and forms the basis of the doctor-patient relationship by promoting patient autonomy and protecting the patient from potential harms.13 By providing patients with information regarding the risks and benefits, expected outcomes, and alternatives of a proposed treatment, it allows an individual to make a “reasonable” decision regarding treatment. The British Orthopaedic Association guide to good practice in forefoot surgery states that this information should be “explained [to patients] in understandable language … [and] the surgeon should try to verify that the patient has understood the information.”8 In the current medical climate, obtaining proper informed consent also has significant medicolegal implications.27 Typically the process of obtaining operative consent from a patient has involved physician-led discussion with the patient. To enhance patient education and understanding during the informed consent process, multiple aids have been used.23 These include information pamphlets, videos,
and anatomical models. Studies have shown that despite these aids, patient recollection remains variable, and often very poor.12,17,25,29 With the advent of newer technologies, multimedia audiovisual tools are increasingly being used to improve patient education.2,3,5-7,10,11,24 The goal of this study was to evaluate the impact of a computer-based, interactive multimedia education module (MEM) on patient learning regarding Morton’s neuroma resection surgery. The primary aim was to assess the effect of using the multimedia tool when used in sequence after the 1
Victorian Orthopaedic Foot and Ankle Clinic, Richmond, Victoria, Australia 2 Murdoch Orthopaedic Clinic, Murdoch, WA, Australia Corresponding Author: Andrew D. Beischer, MBBS, MD, FRACS, Victorian Orthopaedic Foot and Ankle Clinic, Suite 6.3, The Epworth Centre, 32 Erin St, Richmond, Victoria 3121, Australia. Email: [email protected]
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Table 1. Educational Objectives of Multimedia Education Model. Morton’s neuroma pathophysiology Nonoperative treatment • Shoe-wear modifications and orthotics • Role of NSAIDs, corticosteroid injection • Works in up to 80% of patients Details of operative procedure • Local anesthesia • Incision • Resection of Morton’s neuroma • Sutures, dressing, and postoperative shoe Postoperative period • Day care surgery • Usual postoperative medications, including pain relief • Weight-bearing in rigid sole postop shoe • Elevation of foot for first 2 weeks • Keep dressing intact and dry for first 2 weeks Likely outcome • 80% successful in pain relief • Permanent numbness in affected toes Possible complications • Wound breakdown and infection • Nerve injury • Recurrent Morton’s neuroma • Clawing of the toes • Deep vein thrombosis • Other medical complications ○ Anesthetic ○ Cardiovascular ○ Allergic reactions
traditional surgeon–patient verbal interaction. The secondary aim was to evaluate patient satisfaction with using the MEM as an adjunct in the informed-consent process.
Methods Development of Educational Objectives A literature review on the etiology, natural history, and treatment of Morton’s neuroma was performed.1,15,20,28,30 A group of patients previously treated for Morton’s neuroma resection by the senior author was surveyed to determine their educational priorities or deficiencies that they had experienced with regard to their past surgery. This information was used to form a list of educational objectives (Table 1) for development of the MEM.
Development of the MEM The MEM was developed based on the educational objectives. A script was developed by the senior author which was then reviewed by 2 linguists who removed unnecessary
medical terminology. Three-dimensional (3D) computer animations illustrating the educational objectives were created using 3D Studio Max (Autodesk, San Rafael, CA) and integrated with an audio track and text into an interactive linear program in QuickTime (Apple, Cupertino, CA)18 and Macromedia Flash (Adobe Systems Inc, San Jose, CA). The program allowed patients to progress and review information at their own pace (see Figure 1).
Development of the Questionnaire A knowledge questionnaire (Q1) was designed to assess patients’ understanding of information that had been presented to them. The design of the questionnaire was based on those used in previously published studies.2,4-6 A total of 12 questions were used (Table 2), with 9 specifically related to possible complications of Morton’s neuroma resection surgery. Answer options included the following: “true,” “false,” and “unsure.” The last option was provided so that patients would not guess the correct response. A second questionnaire (Q2) was designed to assess patient satisfaction with the MEM and to also assess patients’ expectation of the likely success of surgery (Table 3).
Study Design This study was approved by the Human Research Ethics Committee of our institution. The same fellowship-trained orthopaedic foot and ankle surgeon saw all patients in a private practice setting during the period of June 2006 to June 2012. The inclusion criteria for patients recruited into the study were patients (1) considered appropriate candidates for Morton’s neuroma resection surgery, (2) whose primary language was English, (3) who could read the questionnaire, and (4) who could use the multimedia presentation. Exclusion criteria included poor vision, poor hearing, and English not being the patient’s primary language Once the patient was considered a candidate for Morton’s neuroma surgery, each then received a standardized comprehensive discussion concerning the nature and treatment of his or her condition, including treatment options. Details of the proposed operative procedure, postoperative course, and potential complications were explained by the senior author. Patients were then asked if they would agree to participate in the study. Those who consented to participate in the study were then asked to complete the initial knowledge questionnaire (Q1). Patients then observed the MEM, and then completed Q1 for a second time. Patients were also asked to complete the satisfaction questionnaire (Q2) at this time. Upon completion of this process, if patients had further questions or incorrect responses in the postmodule Q1, the treating surgeon discussed these issues further with them. Demographic data were collected from the medical charts of participating patients. Nineteen consecutive
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Figure 1. A multimedia module representative shot. A menu on the right of the animation screen allows the patient to follow his or her progression through the module and enables each patient to review any section of the module that has already been viewed. Three buttons at the bottom of the screen allow the patient to review any section already completed, but do not allow the patient to advance to the next section until the current section is completed. Table 2. Knowledge Assessment Questionnaire (Q1). 1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8 1.9 1.10 1.11 1.12
Smoking does not affect the outcome of the operation. A Morton’s neuroma cannot recur after surgery. Morton’s neuroma surgery relieves pain in approximately 9 in 10 patients. I do not need to use a special shoe on the operative foot after surgery. To reduce bleeding and pain I need to keep the foot elevated as much as possible. 5 out of 10 people will have a surgical complication. Infection never occurs after Morton’s neuroma surgery. I will have normal sensation in the toes following Morton’s neuroma surgery. Getting the dressings wet after surgery is safe. Swelling of the foot never occurs after Morton’s neuroma surgery. Clots in the leg never occur after Morton’s neuroma surgery. Clawing of the toes can occur Morton’s neuroma surgery.
TRUE TRUE TRUE TRUE TRUE TRUE TRUE TRUE TRUE TRUE TRUE TRUE
UNSURE UNSURE UNSURE UNSURE UNSURE UNSURE UNSURE UNSURE UNSURE UNSURE UNSURE UNSURE
FALSE FALSE FALSE FALSE FALSE FALSE FALSE FALSE FALSE FALSE FALSE FALSE
patients assessed as candidates for Morton’s neuroma resection were prospectively recruited into the study. The mean age was 48 years. There were 15 females and 4 males. All patients spoke English as their primary language and consented to participate in the study. All patients completed the premodule and postmodule questionnaires.
biostatistician. “Unsure” and incorrect responses were grouped together as “not correct” and compared with correct responses. Student’s paired t test was used to test the null hypothesis that there would be no change in the correct and incorrect response rates, premodule and postmodule. Statistical significance was set at P < .05.
Data Analysis
Results
Results from the knowledge questionnaire were analyzed by the junior author using Microsoft Excel (Microsoft Corp, Redmond, WA) in consultation with the institution’s
After the standardized surgeon consultation and before observing the MEM, of 228 questions (19 subjects × 12 questions) answered by patients, 139 (61%) were answered
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Table 3. Module Performance Survey (Q2). 2. Expected result of surgery 2.1. The chance of having a good outcome following surgery is: I————————————————————————————I 0% 100% No patients have good outcome All patients have good outcome 3. Satisfaction with computer consent module 3.1. I found the consent module easy to understand: I————————————————————————————I Strongly disagree Strongly agree 3.2. The computer module had the appropriate amount of information to help me make my decision about surgery: I————————————————————————————I Strongly disagree Strongly agree For the following questions please tick the box that most closely reflects your response. 3.3. The duration of the module was: 1. Too long 2. Too short 3. Just right 4. Unsure 3.4. The questions that I had about the problem with my foot was better answered by: 1. My surgeon 2. The computer program 3. My surgeon/computer the same 3.5. Comments you would like to make about the computer module:
correctly, 54 (24%) were answered “unsure,” and 35 (15%) were answered incorrectly. Therefore 139 (61%) responses were correct, and 89 (39%) were not correct. After viewing the MEM, 194 (85%) were answered correctly, 15 (7%) “unsure,” and 19 (8%) incorrectly. This represented a 24% increase in correct responses, which was statistically significant (P = .002). The majority of this increase was due to a 17% decrease in “unsure” responses. Figure 2 illustrates the percentage of correct responses for each specific question premodule and postmodule. There were 2 questions in which the correct response rate more than doubled from premodule to postmodule. Regarding the risk of blood clots, the number of correct responses increased from 7 (37%) to 17 (90%) postmodule. Regarding the risk of claw toes, the number of correct responses increased from 4 (21%) to 17 (90%) postmodule. Similarly, questions on the risk of recurrence of Morton’s neuroma, and expected benefit from surgery also had large improvement in correct responses postmodule. Both had an additional 7 (37%) more correct responses, from 10 (53%) and 6 (32%) premodule, respectively. On the 10-cm Visual Analog Scale (VAS) relating the chance of having a good outcome following surgery—where a measurement of 10 cm corresponds to a 100% chance—a median score of 80% was obtained. This was identical to that proposed by the module (80%). For ease of understanding of the module, patients gave a median rating of 93% on the VAS. When asked how appropriate the amount of information was provided by the module, patients again gave a
median score of 93%. All patients rated the duration of the module as “just right”; 76% rated the multimedia tool as having answered their questions about surgery as well (59%) or better (17%) than the treating surgeon; 24% of subjects preferred the surgeon’s verbal explanation.
Discussion The consent process is an essential journey for the patient and their treating clinician to travel together to ensure that each patient makes an informed decision about their treatment options.8,13 If a well-informed patient elects to undergo a proposed operative procedure, he or she should have realistic expectations about the likely outcome and risks of such a decision.16 Unfortunately many studies have indicated that despite careful preoperative verbal discussion with their treating clinicians, many patients appear to have a poor comprehension of the issues central to their decision to have surgery.9,12,17,25,29 In an effort to improve the informed consent process, pamphlets, videos, and multimedia presentations have been introduced into the informed consent process with variable success. Our group has previously reported on a prospective, randomized 3-way comparison of a standardized verbal discourse with the patient to either pamphlet or MEM methods of educating patients regarding issues central to the decision making process regarding knee arthroscopy surgery.10 The results of this particular study provided level II evidence that as an isolated method of information delivery the MEM was significantly and substantially superior to
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Figure 2. A comparison of the percentage of correct responses for each item in the knowledge questionnaire premodule and postmodule. Note questions 2, 3, 11, and 12 showed a marked improvement in the percentage of correct answers following completion of the multimedia education module.
both a standardized verbal consent process and pamphletbased patient education. Although the MEM can be effective for assisting patients making an informed decision regarding surgery, it is not clinically acceptable to use this technology as a substitute for the surgeon–patient relationship.19 Indeed, in this study we observed that 24% of patients preferred the educational experience provided by the surgeon to that provided by the MEM. Therefore, in the current study our primary aim was to investigate whether the MEM was a useful adjunct to the usual verbal surgeon–patient discourse regarding informed consent for patients considering Morton’s neuroma resection surgery. A secondary goal was to determine patients’ assessment of the value and usability of the MEM when incorporated into the informed consent process. The MEM significantly and substantially improved patient recall of information relevant to Morton’s neuroma and the proposed surgery. This suggested that the module presented information in a clear, understandable manner that allowed patients to better answer the questionnaire. Some of this improvement may be due to reinforcement by the module of information discussed by the surgeon. However, the audiovisual nature of the module was likely to also have had an effect, as illustrated by some of the following examples.7,14,23 There were 4 questions that patients answered poorly after the standardized surgeon discussion. These were regarding the risk of recurrence (53% correct), likelihood of
pain relief (32% correct), risk of blood clots (37%), and risk of claw toes (21%). The question on which patients performed most poorly was related to the risk of developing claw toes postoperatively (21% correct premodule). The consultant surgeon always mentioned the potential outcome of claw toes in his standard patient discussion of potential operative complications. Despite this discussion, few patients indicated they were aware of this complication. Within the MEM, patients observed an animation that demonstrated the process of toes clawing (Figure 3), and this graphical representation likely had a greater impact on patients’ awareness of this complication than when this risk was mentioned by the surgeon. This was evident in the fact that postmodule there were 90% correct responses to this particular question. The second question that patients answered poorly was regarding the risk of blood clots (37% correct premodule). Despite being uncommon, there is a small incidence of patients developing a deep vein thrombosis (DVT) or pulmonary embolism (PE) following forefoot surgery.21,26 As this can have grave medical implications, we believe it is important for patients to be aware of this potential complication. One possible reason for patients overlooking this potential complication is the fact that the surgeon did not mention needing DVT prophylaxis, as he does not regularly use it in this group of patients. In comparison, the patients appeared more aware and cognizant of the risk of infection (79% correct premodule) because the surgeon
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Figure 3. Module animation illustrating the risk of developing claw toe deformities postoperatively.
stated the need for perioperative antibiotics. However, the module specifies that there is a very small chance of getting a DVT/PE postoperatively, and shows a graphical representation of a DVT forming in the calf vein. Correspondingly, the correct response rate increased to 89% postmodule. Although all patients were advised by their treating surgeon that the chance of successful relief of pain by surgery was 80%, less than a third of patients correctly answered question 1.3, which stated that there was a 90% chance of pain relief with surgery. Perhaps this indicated that patients believed that there was little material difference between what was mentioned by the surgeon and that what was stated by the question. After viewing the module more than twothirds of patients answered the same question correctly. Patient understanding of the chance of success from surgery was also evaluated by question 3.1, which patients completed after viewing the MEM. The mean response to this VAS type question was 8.0 cm, which equated to an 80% chance of success from surgery. This result reflected the mean patient perception of the likely success rate of surgery after education by the surgeon and the patient multimedia education module. This observation suggested that using a continuous measurement scale such as the VAS could be a better tool to assess patient perception of the likelihood of a successful outcome with surgery rather than a true/false-type question design. Before consenting to a operative procedure patients must be given a balanced and unbiased understanding of the likelihood of success and have a clear understanding of
what the surgery involves, including postoperative recovery and what the likely outcome of surgery will be. Patients must also comprehend the material risks associated with a operative procedure.22 It is the personal view of the senior author that all patients considering a operative intervention must also clearly understand that any surgery carries a chance of failure, which includes the risk of being made worse by surgery. Question 1.2 dealt with acknowledgment by the patient of the possibility of failure or of being made worse by surgery (ie, that the Morton’s neuroma could recur). Patients were advised by the surgeon and by the MEM that the neuroma could recur at the resected stump of the nerve and this could be as or possibly more symptomatic than the original lesion. Only half of all patients correctly answered this question after the consultation with the surgeon. The correct response rate improved to 90% after viewing the module. We believe this significant and substantial improvement was due to the clear depiction of an incisional neuroma forming following initial resection using 3-D animation. Patients in this study reported a high level of satisfaction with the format, ease of understanding, and duration of the MEM. The study was undertaken in a facility containing 3 or 4 consulting rooms for the use of the senior author. After having consulted with the surgeon, patients were left alone in the consulting room where they had seen the surgeon to view the module and complete the questionnaires on their own. Only if they had further questions after completing this process did the surgeon return to the patient. In this setting,
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Wang et al introduction of the MEM did not negatively impact on patient flow through the clinic as patients rarely had further questions after having completed this process. In a clinic with less consulting rooms available to be used for viewing of the MEM by patients it is possible that its use could negatively impact on patient flow. Consequently our group is developing MEMs that would perform better on tablet-type devices, which could potentially be used in a greater number of clinical environments such as the waiting room. When these multimedia education modules are available online in a format that can be viewed on a tablet type device, patients will be able to access the educational content when they wish. At this point we intend to explore if repeated viewing of the content by patients further improves their comprehension of issues related to a pending surgery. A potential criticism of this study is that the questionnaires that were used have not been formally validated as an assessment tool. The question items were, however, carefully constructed and reviewed by 2 fellowship-trained foot and ankle surgeons. Patients were also able to answer “unsure” if they did not understand the question clearly. Another potential criticism is the study design that was chosen. As patients were tested twice it is possible that this methodology introduced a potential bias where patients were primed by the initial questionnaire to information that they were to receive when they viewed the MEM. Consequently the increased proportion of correct responses observed in Q2 could have been due to the priming phenomenon. We do not believe that this phenomenon is the cause for the observed difference in this study as our group has previously undertaken studies using different randomized experimental designs. These studies have demonstrated that the priming effect did not appear to be a major factor influencing patients’ responses to the knowledge questionnaires.11,24 In the current study we wished to explore the effect of the MEM when used as an adjunct to the usual verbal consent provided by a consultant foot and ankle surgeon in a busy clinical setting. We also aimed to determine patient satisfaction regarding the utility of the MEM when incorporated into the senior authors informed consent process. The true/false/unsure and VAS design of questions used in this study appeared easy for patients to use, as it was rare for a patient to seek help regarding how to complete them. A statistical analysis of the performance of the questionnaires was outside the scope of this study but the results of this pilot study have lead our group to now investigate the optimization of questionnaire design and the process of questionnaire validation. The purpose of this research was to potentially develop simple, reproducible, and useful tools to assess patient comprehension of issues central to making an informed decision regarding surgery. It is possible that the significant improvement in patient understanding that was observed after viewing the MEM was that the surgeon had performed poorly as an educator.
We contend that this was not the case as not only does the senior author has a particular interest and enthusiasm for patient education but many others have reported on the failure of the traditional verbal consent process to reliably convey to patients the information they need to make an informed decision.9,12,16,17,29 General barriers for patients not retaining information include lack of time in a busy clinic, poor communication techniques, and patient comprehension and anxiety. This study has shown that use of a multimedia tool can allow patients to process and review information at their own pace, and reinforce relevant information previously discussed by the surgeon. As the patients in this group varied from 28 to 65 years of age, it showed that the general population could use the program without difficulty. The majority of patients felt that the module provided as much or more information than the surgeon, indicating its usefulness as an adjunct to the traditional informed consent process.
Conclusion The use of an MEM as an adjunct to the usual informed consent process significantly improved patient understanding regarding Morton’s neuroma resection surgery. Patients of both sexes and all age groups felt the module was easy to understand, and provided as much or better information than the surgeon consultation alone. We contend that multimedia tools can be used effectively in the clinical setting to better prepare patients for surgery. Declaration of Conflicting Interests The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: The multimedia patient education module (MEM) examined in this study was created by Surgical Multimedia Services (SMS). SMS received a grant from MRFWB to create and study the Morton’s neuroma MEM. SMS is a private research company. Andrew Beischer is a director and shareholder of SMS but has not received nor expects to receive any financial reward for this association with SMS.
Funding The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The authors would like to acknowledge the generous financial support of this research project by the Medical Research Foundation for Women and Babies.
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