Three-Dimensional Imaging for Improving Patient Education as it Relates to Sinus Disease
Andrew Victores, M.D.; Nancy Huynh, B.A.; William Yao, M.D.; EB Butler, M.D.
Senior author: Masayoshi Takashima, M.D., F.A.C.S., F.A.A.O.A.
From the Bobby R. Alford Department of Otolaryngology - Head and Neck Surgery, Baylor College of Medicine
Corresponding author: Masayoshi Takashima
This article was presented at the 2012 AAO–HNSF Annual Meeting & OTO EXPO, Washington DC, September 9-12, 2012.
To compare the efficacy of using standard two-dimensional computed tomography (CT) and magnetic resonance imaging (MRI) against three-dimensional reconstruction during the informed consent process of sinus surgery and to determine whether three-dimensional visualization technology effects patient anxiety prior to sinus surgery.
Study Design Prospective study.
Setting An urban, tertiary academic center.
Subjects and Methods
A prospective study of patients undergoing sinus surgery was conducted from 2011-2012. Patients were assigned to receive preoperative informed consent with the assistance of two-dimensional CT/MRI followed by the three-dimensional reconstruction. Questionnaires were administered and compared to assess perceived understanding, satisfaction, and anxiety during the process.
Twenty-four patients were enrolled in this study. Three-dimensional reconstruction significantly improved the perceived understanding of the relevant anatomy and the potential complications from the procedure as compared to two-dimensional CT/MRI (P < .05). Patients were also more satisfied with the informed consent process as a whole following use of three-dimensional reconstruction. Preoperative anxiety did not vary significantly before and after visualization of three-dimensional reconstruction.
Three-dimensional reconstruction technology is an effective tool to improve patient understanding and satisfaction during the informed consent process prior to sinus surgery.
sinus surgery, informed consent, three-dimensional reconstruction, patient education
Approximately 80 million U.S. adults are thought to have low “health literacy,” meaning they lack the skills to effectively navigate the health care system [Kutner 2006]. In 2004, the Agency for Healthcare Research and Quality released a report associating low health literacy with poor health outcomes [Berkman 2004]. These findings warrant the attention of medical providers, who serve a direct role in keeping patients adequately informed to make decisions about their health.
Patient education is a particularly crucial component of the informed consent process prior to surgery. Informed consent entails providing a description of the patient’s condition as well as the risks, benefits, and alternatives to the proposed treatment. This task has become more difficult in recent years as operative procedures are more complex and physicians have less time to discuss them. Nevertheless, better communication between physicians and their patients has been linked with increased patient satisfaction and decreased malpractice litigation [Levinson 2007, Mayroforou 2004, Beckman 1994, Hickson 1992, Shapiro 1989].
Current research and standards suggest that patients prefer a thorough description of surgical procedures, anatomy, and potential complications, even if such information induces anxiety [Burns 2005, Bowden 2004, Dawes 1994]. Sinus surgery patients are no exception. They prefer to be informed of even rare complications of the procedure [Taylor 2005, Bowden 2004]. Failure to provide a thorough informed consent process has been responsible for approximately one-third of malpractice suits for sinus surgery [Lydiatt and Sewell 2008, Lynn-Macrae 2004].
Verbal and written explanations have traditionally been the means by which to convey information to patients. Although many patients find this method satisfactory, few are able to comprehend, recall, or retain information provided in this process [Cassileth 1980, Kriwanek 1998]. For this reason, some clinicians incorporate visual aids into the delivery of the informed consent. Most visual aids make use of imaging modalities such as computed tomography and magnetic resonance imaging. One limitation of these tools is their presentation of the relevant anatomy and pathology in two dimensions. The task of relating two-dimensional, stagnant images to three-dimensional anatomy could be overwhelming for the patient during the preoperative visit.
Technological advancements over the last few decades have revolutionized medicine and offer a means to facilitate patient understanding. To date, no data exists as to how three-dimensional reconstruction of imaging can impact patient education during the informed consent process of sinus surgery. Our study sought to define how the perceived understanding, the satisfaction, and the anxiety of patients undergoing sinus surgery were affected by three-dimensional reconstruction of imaging.
The subjects included in the study were twenty-four patients (age > 18 years) who were planning to undergo endoscopic sinus surgery between December 2011 and June 2012. All of the patients had either computed tomography (CT) or magnetic resonance imaging (MRI) of their sinuses. Patients were excluded from the study if they had significant visual or auditory impairments, an Abbreviated Mental score of less than 7, or were undergoing emergent surgery. The author (M.T.) obtained physical and historical assessments. Demographic data was elicited from patients or retrieved from their medical records. The Institutional Review Board at Baylor College of Medicine approved this study.
To our knowledge, there is no standardized tool to specifically assess patient perceived understanding during the informed consent process. For this reason, a questionnaire was developed to evaluate perceived understanding and satisfaction of sinus surgery patients [Appendix A]. The selection of this 6-item questionnaire was achieved by balancing patient expectations described in prior studies with the anticipated time required to complete the questionnaire [Wolf 2005, Bowden 2004]. The questions evaluated key areas of patient education, particularly those that could be influenced by visual aids. The parameters of sinus anatomy, pathophysiology, operative steps, potential complications, and satisfaction were included in this questionnaire. A five point Likert scale was used with endpoints of “strongly disagree” (1) and “strongly agree” (5).
Patient anxiety was also assessed during the informed consent process with the Amsterdam Preoperative Anxiety and Information Scale (APAIS). This instrument has been validated in prior studies [Boker 2002, Moerman 1996]. The APAIS consists of 6-items designed to evaluate preoperative anxiety and information desire. For the purposes of this study, the anxiety component was primarily analyzed. Responses were rated on a five point Likert scale ranging from “not at all” (1) to “extremely” (5).
Informed Consent Process
During the preoperative clinic visit, informed consent was obtained from patients with sinus conditions requiring surgical treatment. A verbal explanation of their condition, the operation, and the risks, benefits, and alternatives to the recommended treatment were provided to patients. This information was described in the context of their two-dimensional CT or MRI of the sinuses. Patients completed both questionnaires immediately after receiving this explanation to reduce recall bias. The patients were then presented with a three-dimensional reconstruction of their CT or MRI images (Figure 1 and Figure 2). Three-dimensional images were generated using the TeraRecon Aquarius workstation (TeraRecon Inc., San Mateo, Calif.) at Plato’s CAVE (The Methodist Hospital, Houston, Texas). Patient DICOM (Digital Imaging and Communications in Medicine) studies were transferred from a PACS (Picture Archiving and Communications System) to create these images. Templates were developed to quickly and easily emphasize the anatomy of the sinuses and the surrounding structures. Basic surface anatomic landmarks were maintained throughout the three-dimensional visualization period to improve patient comprehension and orientation. No new verbal information was provided to patients while visualizing these images and the same questionnaires were completed.
The primary comparison was between patient perception of the informed consent process when aided by two-dimensional imaging alone or supplemented with three-dimensional reconstructed images. Continuous variables including patient understanding, satisfaction, and anxiety were analyzed with a t-test for paired samples. The mean, median, and standard deviation were also calculated. For categorical variables, the McNemar test was used to compare paired samples. A P-value of < .05 was considered statistically significant.
Twenty-four patients were enrolled and anonymously participated in this study. Demographic data for the study patients is included in Table 1. A nearly even distribution of men and women took part in the study with a wide range of education levels.
Patient Perceived Understanding and Satisfaction
Patient perceived understanding during the informed consent process was compared in Table 2. Understanding significantly improved for the areas related to anatomy and complications of surgery. The most improvement was seen in comprehension of the structures residing near the sinuses (2.7 ± 1.0 to 4.4 ± 0.8, P < .05). Patient understanding of the operative steps of sinus surgery improved, but this was not significant. Disease pathogenesis remained the same regardless of inclusion of the three-dimensional imaging modality. Overall comprehension was calculated as the cumulative value of each of the questions. This value was 37% higher after visualization of the reconstructed images. Only 8% of patients reported a decline for any of the questions. Satisfaction with the informed consent process also significantly improved after inclusion of three-dimensional reconstructions (3.4 ± 0.9 to 4.6 ± 0.6, P < .05). Seventy-three percent of patients reported at least some degree of higher satisfaction with the consenting process.
Patients with lower levels of formal education benefited more from three-dimensional reconstructions. These patients had lower levels of understanding of two-dimensional images and greater improvement with the three dimensional reconstructions. Overall perceived comprehension with two-dimensional images was nearly 25% lower in patients with less than college education (12.3 ± 2.8 and 16.7 ± 3.6). This difference was reduced to less than 10% after incorporation of three-dimensional reconstructions into the informed consent. The benefits gained by using three-dimensional reconstruction were not affected by patient gender or age.
Three-Dimensional Reconstruction and Anxiety
Pre-operative anxiety as assessed by the APAIS score did not vary significantly between patients prior to and after three-dimensional reconstruction (12.3 ± 6.6 and 13.1 ± 8.2, P > .05). Female patients had lower anxiety levels with two-dimensional images, but this difference was not significant. No similar trend was seen in men.
Based on our review, this is the first study of three-dimensional reconstruction for sinus surgery informed consent. The goal of the current study was to provide initial data as to whether these reconstructions enhance patient education. Our results suggest that three-dimensional reconstruction improved patient satisfaction and perceived understanding during the preoperative encounter. Anxiety did not significantly change with inclusion of this tool.
Physicians exercise a moral, legal, and professional obligation to safeguard patient autonomy in the medical decision-making process. Formal documentation of this process, especially prior to surgery, is achieved by way of an informed consent. The document itself does not serve as a replacement for the process, but rather as a record of the discussion and education that took place [Edwards 1987, Bernat 2006]. Although the surgical informed consent process is crucial, it suffers from a number of weaknesses in its current state. Patients often perceive it to be a strictly legal means of protecting physicians and hospitals [Akkad 2006, Akkad 2004, Habiba 2004]. As a result, there can be a sense of uncertainty and disempowerment that would contradict the actual intent of the informed consent. Moreover, many clinicians fail to include all of the components of the informed consent in daily practice [Issa 2006, Skene 2002, Bernat 2007]. These factors would seem to contribute to the poor understanding patients have demonstrated in a wide variety of surgical settings [Mulsow 2012, Larobina 2007, Fagerlin 2006, Kriwanek 1998].
Informed consent is typically delivered by way of verbal explanation. A number of studies have looked at ways to enhance this process. Few patients seem to benefit from using written or illustrated handouts [Henry 2008, Brown 2003]. In contrast, communication that combines auditory information with visual cues could establish a more complete environment to learn [Mayer 2002]. Our results suggest that three-dimensional images provide a promising adjunct to educating patients prior to sinus surgery. This finding is in agreement with studies on multimedia presentations for informed consent. Multimedia presentations are tools that meld auditory and visual delivery of information in a structured fashion. These presentations seem to be better than printed materials and have been shown to be a good supplement to the verbal consultation [Klima 2005, Luck 1999, Muller 1993]. Future studies should determine whether integration of three-dimensional reconstructions into multimedia presentations improves patient education.
One of the concerns of providing further verbal or visual information is the potential for excessive patient anxiety. Some research suggests that more information can increase anxiety [Goldberger 1997]. Other studies suggest that anxiety levels were unaltered by the amount of information the patient was given [Stanley 1998]. At the minimum from a legal standpoint, most states support the concept of what a “reasonable prudent patient” would want to know. Despite these concerns, three-dimensional reconstruction did not significantly increase patient anxiety during the preoperative period. No patients were compelled to cancel the surgery. Furthermore, patients were more satisfied with the overall informed consent process. Sinus surgery patients in particular may appreciate more detailed explanations of the procedure [Bowden 2004].
Education level is another factor in the way that patients process information during the informed consent. Prior studies suggest that lower education levels correlate with poor comprehension [Crepeau 2011, Cassileth 1980]. With this in mind, clinicians should consider ways to improve information delivery. Incorporating a visual component may be an effective approach [Bollschweiler 2008]. Our findings support this notion, as three-dimensional reconstruction of images particularly benefited patients with backgrounds of less formal education.
Elderly patients present a unique challenge for educational technologies in medicine. Many educational platforms make use of new technologies that have limited benefit in the aged population. In this study, age did not correlate with benefit from three-dimensional reconstruction. This suggests that older age should not preclude use of three-dimensional reconstructions for educational purposes.
There are a number of limitations to the current study. The sample size is small and only provides a preliminary investigation into the implementation of this technology. Larger, randomized controlled trials are needed. As mentioned previously, the preoperative questionnaire assessed perceived understanding, which does not determine actual knowledge of the relevant anatomy, the disease process, the operative steps, or the potential complications. This is a subjective substitute of their understanding. Patients were not blinded to the intervention and thus may have overestimated their comprehension. Another possibility is that the examiners could have introduced bias by spending more time on explanation with the three-dimensional reconstruction. This bias was limited by restricting examiners to providing no additional verbal information during the three-dimensional reconstruction presentation. The study did not assess recall and retention after the surgery.
Three-dimensional reconstruction of patient images provides a more intuitive representation of anatomy and the disease process. However, a major limitation of this tool is the technological implementation. A variety of software programs have been developed to improve this implementation process. These programs may also improve the preoperative planning of the practitioner. Tissue layers can be peeled away similar to during the actual surgery. This technology has made its way into the operative room and may soon be integrated into a surgical navigation device.
The current prospective study suggests that the perceived understanding and satisfaction of sinus surgery patients was improved with the inclusion of three-dimensional reconstruction during the preoperative visit. Based on our results, we believe it would be beneficial to provide patients with a three-dimensional reconstruction of their images during the informed consent process of sinus surgery. Further studies could define whether these findings are generalizable to the informed consent process of other surgical procedures. Improving patient understanding is the basis of the informed consent.