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Keywords:

  • bariatric surgery;
  • obesity surgery

Abstract

  1. Top of page
  2. Abstract
  3. Introduction
  4. Research Methods and Procedures
  5. Results
  6. Discussion
  7. Conclusion
  8. Acknowledgments
  9. References

Objective: Severe obesity is a clear indication for appropriate, effective weight loss therapy. One option is operative intervention, e.g., gastric banding. Risks of the operation and therapeutic alternatives need to be comprehensibly presented to the patient. The literature has shown that better informed consent is obtained using information presented in a multimedia/video-based format. The current study developed and evaluated a multimedia program aimed at obtaining informed consent from obese patients before gastric banding.

Research Methods and Procedure: An interactive multimedia program was developed with information about preoperative examinations, the operation itself, hospital stay, operative risks, alternative therapies, and the pathophysiology and health risks of obesity. Two groups (Group 1, n = 20, mean age 38 years, informed consent attained with conventional document information; Group 2, n = 20, mean age 37 years, informed consent attained with additional multimedia information) were interviewed regarding comprehensibility of the information presented, personal satisfaction, and anxiety levels during the informed consent process.

Results: Group 2 showed significantly better (p < 0.05) understanding of the presented information and higher levels of satisfaction with the informed consent process. Anxiety levels did not significantly differ between the two groups.

Discussion: Because patient satisfaction with the informed consent process and understanding of the presented information significantly improved, the multimedia program clearly benefits both surgeons and patients. Personal contact from the surgeon remains essential. High volumes of information presented in multimedia format do not alleviate patient anxiety, and personal contact may be beneficial.


Introduction

  1. Top of page
  2. Abstract
  3. Introduction
  4. Research Methods and Procedures
  5. Results
  6. Discussion
  7. Conclusion
  8. Acknowledgments
  9. References

Obesity is currently one of the biggest and most urgent health problems and will likely remain so for at least the near future. The latest World Health Organization reports (1) estimate that more than 1 billion adults are overweight, and at least 300 million of these are clinically obese. Current obesity levels range from below 5% in China, Japan, and certain African nations to over 75% in urban Samoa. For the U.S., up to 65% of the population is overweight and 31% obese (2). In Europe, figures vary among central Europe, eastern Europe, and the Mediterranean region (45% to 75% overweight and 10% to 30% obese) (3). A solution to this problem has not yet been identified. Various multimodal therapeutic approaches have been discussed in the last few years and presented to patients. Because of the wide range of offered opinions and treatment options, the process of reaching a treatment decision frequently overwhelms obese patients. Conflicting information is available through newspapers, advertisements, television, radio, and increasingly through the Internet. Sorting through it is often a difficult task for patients.

There are numerous therapeutic alternatives for obese patients, many non-invasive. Therefore, in-depth preoperative counseling and education is of utmost importance. Surgical therapy is the last step of a multimodal treatment spectrum. Legal and ethical concerns demand comprehensive preparation for the elective procedure, and communication regarding risks, possible side effects, and alternatives to operative therapy is essential. According to the current concept of shared decision making, patients should be empowered to reach medical decisions together with the physician (4). Using this concept, patient and physician are equally involved in the decision-making process and attempt to reach ample concordance, despite possibly differing opinions (5, 6). Under certain conditions the patient should be free to disagree (informed dissent) (7). Multimedia instruments are powerful tools to support this concept.

Surgeons are often short on time and cannot focus on the primary questions and worries of patients. Unfortunately, surgical departments are often unable to give patients’ needs first priority. Also, patients and surgeons have differing ideas regarding which and how information should be shared (8, 9).

Complex material, e.g., the context of an operation, is better explained with multimedia instruments than with conventional documents alone. Despite this, systematic review of the literature shows that multimedia tools are rarely used to obtain informed consent. Computer-supported patient education is used primarily in the English-speaking world for a variety of topics. Very few attempts have been made to obtain video-based or computer-assisted informed consent. However, results of completed studies have been encouraging. Jimison et al. (10) and Münch et al. (11) showed that interactive, animated, and video-based elements achieve significant reductions in stress and anxiety scores. Using multimedia-formatted information before thyroid surgery, Hermann et al. (12) found that patients showed better comprehension of the procedure, decreased anxiety, and improved confidence regarding the surgery. Similarly, Doering et al. (13) showed that both stress and anxiety (measured by urine cortisol concentrations) were reduced in patients before hip replacement surgery using video-based information. Three months post-operatively, mobility scores were also improved in the multimedia group when compared with the controls. However, despite these promising results, we were unable to identify any reports in the literature of the use of a comprehensive multimedia tool for the communication of disease pathophysiology, description of the recommended procedure including risks and side effects, and discussion of pre- and post-operative therapy and alternative treatments.

We developed a multimedia program aimed at obtaining informed consent from obese patients before a gastric banding operation. Because this intervention is elective, we considered this patient group ideal for in-depth education regarding the risks, side effects, and therapeutic alternatives of obesity surgery. The current study discusses the development, establishment, and evaluation of this multimedia program. The goal of the current study was to develop and introduce a new type of patient education for obese patients before gastric banding surgery using a multimedia format and to determine whether such an instrument affects such parameters as patient anxiety, understanding, and satisfaction with the informed consent process.

Research Methods and Procedures

  1. Top of page
  2. Abstract
  3. Introduction
  4. Research Methods and Procedures
  5. Results
  6. Discussion
  7. Conclusion
  8. Acknowledgments
  9. References

Program

The multimedia program was developed in a step-wise fashion (concept, development of the program, formative evaluation, improving the program, retesting, final version, summative evaluation) over 3 years. The group responsible for the principal structure included a surgeon, a linguist, and psychotherapists, who defined the major topics and contents for the program and created the concept.

The basic concept was based on Microsoft PowerPoint 2000 (Microsoft Corp., Redmond, WA) sheets and included the main information and structure. Evidence-based information (risks of the operation), videos, and animated portions were subsequently generated and included. The professional design was created by a graphic designer, and further program development was performed by an information technology specialist using ToolBook 7.2 (Click2learn, Inc., Bellevue, WA). A professional female speaker provided the voiceover. The storybook was adapted to patients’ understanding, using uncomplicated language and avoiding technical and medical jargon. The formative evaluation of the multimedia program was done by three patients according to the paper from Fürstenberg et al. (14). The summative evaluation was done by 12 members of the medical staff of the surgical department. Once the multimedia presentation was completely developed, a touch-screen terminal was presented to the public in the hospital. The pilot phase lasted 6 weeks. Generally, visitors and patients of the surgical department and the University hospital had access to the terminal and were invited to test it. Two hundred fifty-eight users were registered, and total length of visit, visited sites, and length of the stay on each site were recorded.

Questionnaires

Two questionnaires (one for traditional information process and one for multimedia procedure) were developed to evaluate the informed consent process. After surveying existing, previously evaluated questionnaires (15, 16), the parameters of patient anxiety, understanding of the presented material, and satisfaction with the process were chosen for evaluation. A visual analogue scale (grading, 0 to 7) was used to rate understanding and satisfaction, whereas anxiety was rated using descriptions (not at all, some, a lot, very much). The questionnaires for both groups were similarly designed; however, the multimedia questionnaire was expanded regarding interactive features (videos, animation, speech, program structure, etc.).

The questionnaire for the summative evaluation was designed for medical staff. This questionnaire focused on the clarity, layout, and usability of the multimedia program and the resulting improvements in the clinical process due to its use.

Patients

We compared two groups of patients. During the development process of the multimedia program, all patients planned for gastric banding were included in the control group (n = 20). These patients received a questionnaire after conventional informed consent with a commercial standardized informed consent sheet (Perimed Compliance Verlag, Erlangen, Germany). After finishing the multimedia program, the next 20 patients were included in the study group. In addition to the conventional information, the study group also got the multimedia information program. Both groups had personal consultations with their surgeon.

Statistics

In this pilot study, the calculation of the sample size was based on the assumption that the improvement of understanding the risks of surgery would be at least 30%. Assuming α = 0.05 and β = 0.80, we needed 20 patients per group. Statistical analysis compared the frequency of the different levels of understanding the presented information using the Mantel-Haenszel Test for trend. The median values of the anxiety scores were calculated, and a non-parametric signed rank test was performed to compare the two groups. A p value < 0.05 was set as significant.

Results

  1. Top of page
  2. Abstract
  3. Introduction
  4. Research Methods and Procedures
  5. Results
  6. Discussion
  7. Conclusion
  8. Acknowledgments
  9. References

The 3-year development period yielded an interactive, multimedia presentation. The following chapters were used as a patient guideline:

  • Etiology: Why am I obese?
  • Risks of obesity: Why should I lose weight?
  • Alternatives: Which “exits” are still open?
  • Why preoperative examinations?
  • About the operation
  • Potential complications
  • The next 4 weeks
  • Checklist

Program Development

The main features of the program are chapter-wise information regarding all details of the disease, therapeutic alternatives, and the hospital stay including the operation itself (see Figure 1). The information is organized in a step-wise fashion, beginning with easier texts, many pictures, and mostly schematic images and reaching levels of more detailed explanation. Individual chapters are selectable at any time of the visit. Certain pages are mandatory for procurement of informed consent (e.g., risks of the operation or alternatives). Written informed consent is still necessary and includes a personal conversation with the attending physician. The chapters inform the patients about 1) The etiology of the disease in terms of behavior, genetics, exercise, and nutrition is explained. The patients should learn about their own risks and reasons for being overweight. 2) The risks of obesity are presented in the second chapter. Risks of serious secondary diseases are shown in a comprehensible display. This chapter avoids reducing obesity to a cosmetic problem. 3) Alternatives to the gastric banding procedure are shown (see Figure 2). Different options like medication, exercise therapy, tips for behavioral changes, recipes, and/or suggestions for combined therapy alternatives are presented. All advice is accompanied by detailed information of local contacts and specific references. 4) The preoperative examinations are described in detail. Complex examinations are shown to the patient using videos of the procedure. 5) The chapter explaining the procedure has different subdivisions, including those discussing gastric banding, other bariatric treatment options, analyses of weight loss after gastric banding, interviews with treated patients, expectations of the patient, and frequently asked questions. The discussion of the gastric banding itself has the key role in this chapter and is explained using an animated graphic from the operation and a parallel description of the procedure from the surgeon. For interested patients, there is a video from an actual operation. 6) Information regarding possible complications due to the operation or post-operative risks is given objectively, without focusing on emotional aspects. All risks are shown with occurrence frequency (as described in the literature) and a severity index. Complications are demonstrated using a risk wheel (see Figure 3). Every topic is shown on a navigation bar. By clicking on a risk, the background information appears. Finally, an interactive quiz gives the patient the opportunity to test his/her new knowledge. 7) “The next 4 weeks” chapter includes practical information about the length of hospital stay, post-operative nutrition, and aspects of wound treatment for the first 4 weeks after the operation. 8) The program is designed for long-term use. Because the time period between first contact until the post-operative period is often long with many intervening steps, the patient can keep an overview with a checklist.

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Figure 1. : Navigation menu of the multimedia program.

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Figure 2. : Excerpt of the multimedia program: alternative therapy options (medication, exercise, behavioral changes, nutrition, and combined therapy).

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Figure 3. : Excerpt of the multimedia program: risk wheel for the representation of the possible operative and post-operative risks.

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Summative Evaluation Pilot Testing

Twelve medical staff completed questionnaires (five physicians, two nurses, four secretaries, and one student assistant). All of these showed a high overall acceptance of the program (mean, 6.1 from 7 points). In particular, the design (6.5 points) and overview and usability (both 6.0 points) were judged positively. Communication of professional competence (5.75 points) and easing of workload for the staff (5.25 points) was somewhat less positively evaluated.

In a 6-week pilot phase, 258 participants tested the program on a multimedia terminal. The most frequently visited sites were “reasons for obesity,” “about the operation,” and “explanations from the surgeon.” In contrast, the longest site sessions were indexed at “information about genetic causes,” “information about satiety regulation,” and the “BMI calculator.”

Informed Consent of the Patients

We compared 40 patients from the obesity clinic for their assessments of conventional (control group) vs. multimedia informed consent (study group). The median age was not different between the control group (n = 20) with 38 years (3 men, 17 women), and 37 years in the study group (n = 20) (10 men, 10 women). There was no significant difference according to education.

The patients in the control group were markedly less satisfied with the informed consent process and also had more problems understanding the given information (Table 1). In comparison, the patients of the study group had improved ratings of both satisfaction and comprehension. There were no differences between men and women according to these parameters of informed consent in the study group. Anxiety scores stayed constant between the groups and showed no significant difference (Figure 4).

Table 1. . Frequency of patients with well- or very well-graded “understanding of information”
Understanding well or very well the information aboutPatients with conventional information (n = 20) (%)Patients with multimedia information (n = 20) (%)p (trend)
Disease44750.0058
Therapeutic alternatives331000.0003
Kind of surgical procedure40850.0003
Risks of surgical procedure53950.0009
Postoperative problems50900.0007
Long-term course40750.0009
image

Figure 4. : Comparison of anxiety scores between conventional- and multimedia-informed consent groups. * p < 0.05 (signed rank test).

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Discussion

  1. Top of page
  2. Abstract
  3. Introduction
  4. Research Methods and Procedures
  5. Results
  6. Discussion
  7. Conclusion
  8. Acknowledgments
  9. References

The developed multimedia instrument for the elicitation of informed consent from obese patients before gastric banding offers a new approach to patient education and self-determination. Due to the abundance of indiscriminate sources available on the Internet and in the media, a jungle of information develops. Patients do not know which information is reliable, consistent, and evidence-based. The system used here gives patients an opportunity to access detailed, high-quality information regarding their upcoming surgery, combined with pertinent details of their hospitalization and treating surgeon. The interactivity of the program allows the patient to determine exactly how much and the depth of information they receive, a massive advantage compared with conventional informed consent sheets or even personal conversation with a surgeon. Information about the development of the disease and alternative therapies is presented in particular detail; in the program, patients have access to accurate information regarding alternatives, self-help groups, and even comments from other patients. The gastric banding procedure can have drastic consequences for patients’ lives, with various side-effects and risks (17). It is, therefore, of utmost importance that patients are well informed of possible complications before the procedure.

The first prototype required substantial investments of both effort and money to obtain an accurate and error-free system. Subsequent presentations are now much more reasonable. Regarding medical conditions besides obesity, particularly those requiring more common therapies with fewer alternatives and clearer surgical indications, further studies are indicated to determine the utility of multimedia instruments for patient education.

In the run-up to our pilot phase, we explored the general interest in multimedia objectives and particularly multimedia instruments for informed consent. Patient feedback showed a high level of interest in our project (over 45% gave the highest score of 7; mean value, 6.1 of 7). During the entire project, we received highly positive reactions from patients and staff alike, which underscored again the importance of and the general interest in the program. However, the small group of staff interviewees was skeptical concerning the communication of professional competence and the easing of staff workload. Results of patient questionnaires were also positive, with improved understanding and satisfaction with the education process using the multimedia presentation. Patient and staff interest in the project and positive findings of the questionnaires correlate well with the findings of Klima et al. (18), who reported similar results in nearly 300 patients before orthopaedic interventions. Evrard et al. (19) used a multimedia DVD for patients before oncological interventions. Seventy-one percent of their patients considered that viewing the DVD had been positive and encouraging. Similar findings regarding patient satisfaction and better comprehension were reported by Müller et al. (20), Luck et al. (15), and Rossi et al. (21), who all used more rudimentary systems (simple text-based computer or videotape-based information).

The lack of change in anxiety scores indicates the limits of the multimedia approach. Patient anxiety was not reduced with use of the program; however, subgroups demonstrated a shift from more somatic/autonomous anxiety to a more cognitive anxiety. Also, a huge reduction of anxiety was not expected because the level of information given in the program regarding surgical procedure, risks, etc., was in much more detail than that given to the control group. As described earlier, anxiety can be produced by education regarding risks and complications during the informed consent process (19). In any case, previous studies have demonstrated decreased anxiety scores measured by urine cortisol concentrations (13) or questionnaires (11). Thus, our results may not be representative regarding anxiety reduction through multimedia-based information. One limitation of the current study was, perhaps, the highly elective nature of the operation, which requires a long period of consideration. Prolonged reflection about the upcoming operation may raise anxiety levels. Also, the current study used small patient collectives.

For many patients, it was the first time they used a multimedia program. Thus, they needed assistance using the multimedia navigation. There might be bias introduced by the examiners through the higher attention given the users in the multimedia group than in the written informed consent group. Additionally, it might be that the investigators motivated patients from the multimedia group more intensively answering the questionnaires than in the conventional group.

Compared with most general surgical patient collectives, our patients were quite young (mean age, 37.5 years). Generally patients in this age group respond better to new, interactive media tools. Thus, the advantages for more routine interventions and older patient groups remain to be seen. In an earlier study, Jimison et al. (10) developed a multimedia information program focusing on the needs of patients with potential cognitive impairment. The patients in this study group felt that the prototype system was useful, and the use of it was less stressful and information more understandable than with conventional methods. Therefore, there is benefit even for older patients. In any case, these results indicate that further investigation of multimedia use for informed consent is warranted.

Multimedia is a sufficient tool to educate patients about general risks, alternatives, and surgical routines during pre- and post-operative procedures. Multimedia can only be an additional tool for the informed consent process because personal counseling is the most suitable method to address patients’ sorrows, doubts, and the questions that a multimedia program is not capable of answering. Thus, the personal consultation will always remain of high relevance for both patients and surgeons. Both the one-on-one-counseling and the group counseling support the possibility to interact directly with the patient. The group members might support each other through similar experiences in frustrating weight reductions or the social stigmatization. On the other hand, patients using a multimedia program do not have to overcome their inhibitions to ask questions or repeatedly recall information.

In Germany, there is no single law regulating informed consent; rather, regulation is the result of legal practice. Thus, the legal situation for doctors often remains uncertain; the gap between optimal patient-orientated informed consent and legal-orientated informed consent is large. Doctors are alienated by this uncertainty and focus on avoiding mistakes with legal consequences during the informed consent process. The results of prevailing case law define that the patient has to consent and that this consent has to be voluntary. The patient has to be informed about the intervention. The operation is unlawful if the patient has not given his consent, even if the intervention has been carried out error-free and lege artis. A multimedia program in this situation is a means to merge the various needs of patients and physicians. The multimedia program easily fulfills legal conditions by using the formulations of established informed consent sheets. An added benefit of the multimedia format is that this information can be displayed in various interesting ways. Thus, information is given not only for legal protection but to educate thoroughly patients regarding the risks and benefits of the intervention.

In the introduction here, the divergence between patients’ and surgeons’ expectations and desires was mentioned. This multimedia tool can reduce the communication gap between doctor and patient by giving the patients the chance to educate themselves about the upcoming operation. Patients can spend time with the subject and prepare themselves for consultation with the surgeon. As the literature suggests (22), informed consent should be developed in a dialogue between patient and physician, where the patient has enough time and information to orient him/herself about the topic. These conditions are fulfilled in a context using combined multimedia and personal informed consent. Thus, the multimedia tool enables concordance of the needs of patient and physician. This is important because ideal conditions as defined by Klima et al. (18) are not realistically attainable under current clinical practice due to time restrictions of (German) doctors.

Conclusion

  1. Top of page
  2. Abstract
  3. Introduction
  4. Research Methods and Procedures
  5. Results
  6. Discussion
  7. Conclusion
  8. Acknowledgments
  9. References

Overall, the current study shows that the multimedia instrument is a useful and valuable tool for both surgeons and patients. However, the structure of the program and its use in the medical context continue to have room for improvement, and the indications for program use can be broadened. Multimedia is a useful tool to educate patients in sufficient detail about their upcoming surgery and therapeutic alternatives. Particularly because the gastric banding procedure is an elective yet high-risk procedure, every effort should be made to educate the patient thoroughly regarding the above and preparation and perioperative routines. At the same time, personal consultation between surgeon and patient will always remain an indispensable part of the preoperative process.

Acknowledgments

  1. Top of page
  2. Abstract
  3. Introduction
  4. Research Methods and Procedures
  5. Results
  6. Discussion
  7. Conclusion
  8. Acknowledgments
  9. References

The authors thank Pavlos Steurer for irreplaceable effort in technical support and Marlies Janson for high level of commitment during the obese consultation hours.

References

  1. Top of page
  2. Abstract
  3. Introduction
  4. Research Methods and Procedures
  5. Results
  6. Discussion
  7. Conclusion
  8. Acknowledgments
  9. References
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