Langenbecks Arch Surg (2009) 394:227–233 DOI 10.1007/s00423-008-0460-x
CONTROLLED PROSPECTIVE CLINICAL TRIALS
Extended preoperative patient education using a multimedia DVD—impact on patients receiving a laparoscopic cholecystectomy: a randomised controlled trial D. Wilhelm & S. Gillen & H. Wirnhier & M. Kranzfelder & A. Schneider & A. Schmidt & H. Friess & H. Feussner
Received: 8 May 2008 / Accepted: 27 October 2008 / Published online: 17 January 2009 # Springer-Verlag 2009
Abstract Purpose The informed consent is a legal requirement prior to surgery and should be based on an extensive preoperative interview. Multimedia productions can therefore be utilised as supporting tool. In a prospective randomised trial, we evaluated the impact of an extended education on patients undergoing cholecystectomy. Materials and methods For extended patient information, a professionally built DVD was used. After randomisation to either the DVD or the control group, patients were informed with or without additional presentation of the DVD. The quality of education was evaluated using a purpose-built questionnaire. Results One hundred fourteen patients were included in the DVD and 98 in the control group. Patient characteristics did not differ significantly despite a higher educational level in the DVD group. The score of correctly answered questions was higher in the DVD group (19.88 vs. 17.58 points, p< 0.001). As subgroup analysis revealed, particular patient characteristics additionally impacted on results. D. Wilhelm : S. Gillen : M. Kranzfelder : H. Friess : H. Feussner (*) Department of Surgery, Klinikum r.d.Isar, Technische Universität, Munich, Germany e-mail:
[email protected] D. Wilhelm : S. Gillen : H. Wirnhier : M. Kranzfelder : A. Schneider : H. Feussner Workgroup for Minimal Invasive Therapy and Intervention (MITI), Klinikum r.d. Isar, Technische Universität München, München, Germany A. Schmidt Institute for media informatics, Ludwig-Maximilian Universität München, München, Germany
Conclusion Patients should be informed the most extensively prior to any surgical procedure. Multimedia productions therefore offer a suitable instrument. In the presented study, we could prove the positive impact of an information DVD on patients knowledge. Nevertheless, multimedia tools cannot replace personal interaction and should only be used to support daily work. Keywords Informed consent . Surgery . Multimedia . DVD . Education
Introduction The informed consent of patients undergoing surgery is a legal requirement prior to any surgical intervention. It requires the patients’ free decision whether an intervention can be done or not. As the patient normally possesses only lay knowledge concerning specific procedures and does not have the ability to capture all potential consequences of a surgical procedure, the education dialogue is an essential issue and has to communicate all relevant information [1]. The extent of communicated information is still in discussion and depends on the type of surgery to be performed (elective plastic surgery vs. acute intervention for traumatic injury). The missing informed consent or its inadequate form and extent are one of the main points of criticism in case of medico-legal affairs and comprehends about one third of all lawsuits against doctors in Germany [2] and most likely also in other countries. Many factors seem to effect on the quality of the informed consent, such as the use of oral or written information or the implementation of illustrations [3–5]. Additionally, patient characteristics, such as age or intelligence quotient, impact on understanding medical educa-
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tions [6, 7], but have to be taken as given and not influenceable. Consequently, to raise the quality of the informed consent, one has to improve the way in which information is presented. A step-by-step education is seen to be superior and does impact significantly on the patients knowledge, but is demanding to be realised in daily practice [2, 8]. Accordingly, supporting methods for patient education, to be used as a supplement to conventional dialogue, are of highest interest. As described elsewhere, the use of visual information brought by video and computer animations probably can correspond to these needs [9–11]. Several studies tried to evaluate its impact on patients knowledge but with inconsistent results [8, 12–15]. Some of the studies investigated only small collectives, which might be a reason for unclear benefit of the extended education, but also quality and extend of the presented media might have had contributed on the results. Fortunately, computer science has made relevant steps ahead over the past years, allowing now realistic multimedia productions with high interactivity. The goal of this study was to construct a digital versatile disc (DVD) at a highest pedagogical level using all recently available technologies and to evaluate its impact on the quality of the informed consent in a large group of patients. The evaluation was realised as a prospective randomised trial.
Materials and methods Interactive DVD—cholecystectomy The DVD was designed by the Institute of Media Informatics of the University of Munich and in close cooperation with the Department of Surgery of the Technische Universität of Munich as an educational tool to inform about laparoscopic surgery for cholecystolithiasis. As laparoscopic cholecystectomy is increasingly performed in short-stay surgery with tight time schedules, the potential benefit of an educational tool should become even more evident; furthermore, this disease affects all age groups and genders, allowing investigations on a large collective. The DVD content is mainly based upon literature studies, clinical information leaflets and on direct discussions with surgeons. The DVD is sectioned into five chapters containing basic information about cholecystolithiasis and its pathophysiology (02:58 min), the potential course of the disease without treatment (complications due to cholecystolithiasis; 03:13 min), therapeutic principles, with focus on surgical treatment (laparoscopic or conventional cholecystectomy; 08:30 min), possible complications following surgery (07:45 min) and at the end, interviews with patients prior and after surgery (03:10 min).
Langenbecks Arch Surg (2009) 394:227–233
The DVD is realised in standardised PAL format (720× 576, 25 frames/s, true colour, country code 2) with a total length of 26 min. The DVD includes written text and pictured information, complex three-dimensional computer animations and video sequences. Construction of the content was realised by Macromedia Flash Pro® (Adobe Systems, USA), 3dsMax® (discreet, Autodesk, USA) and the Adobe video package (Adobe Photoshop®, Premiere Pro®, Encore®, Adobe Systems, USA). The DVD includes an audio commentary spoken by a professional commentator. The central topic of the disc is an education dialogue between a surgeon and a pretended patient personated by a professional actor. The dialogue is supported by explaining computer animations and text fields giving additional information to the user. It was emphasised to construct a medium which conforms to highest pedagogical principles by utilising all currently available technologies. The quality of the DVD and the correctness of the presented information were assessed by experienced computer scientists and media developers as well as by experienced surgeons. Evaluation of the DVD Evaluation of the DVD on patient education was based upon a multiple choice questionnaire consisting of 25 questions, which was handed out during postoperative consultation in our outpatient department 1 week after discharge from hospital. Each patient undergoing laparoscopic cholecystectomy was informed about the upcoming surgery 1 week prior to admission to hospital. In the DVD group, patient education was realised by direct conversation with the surgeon and additional presentation of the education DVD “Interactive DVD Cholecystectomy”. The control group was educated traditionally by sole conversation with the surgeon, without seeing the disc. All patients were assigned randomly to either the DVD or the control group using a specifically built randomisation list and after having given informed consent concerning participating the study. The questionnaire was mainly composed of 21 specific questions concerning the underlying disease, the operation performed and potential complications (the specific knowledge which should be gained during patient education dialogue before surgery). Four additional general questions were asked to evaluate the quality of the presented disc and to estimate patients’ satisfaction for extended education (additional use of a DVD compared to sole conversation). The questionnaire was designed and developed by a team of surgeons unaware of the content of the DVD and unaware of presented information.
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Table 1 Demographic data of the collective
Total number of patients Number of patients included Mean age Gender (m/f) Nationalitya (g/e) Educationb (+/−) a b
DVD group
Control group
Total
Test value
114 52,8 33/81 89/25 53/61
98 53,7 31/67 80/18 32/66
259 212 53,2 64/148 169/43 85/127
n.s. n.s. n.s. n.s. p=0.046
g native-born German or patients living in Germany for over 20 years, e foreign patients + high school degree, − elementary school degree
For further evaluation, demographic parameters (gender, age, etc.) of all patients were included in the database as well as the level of education (elementary vs. high school degree) and the command of language. Additionally, parameters concerning the performed operation and the educational process are recorded. The point-score resulting from correctly answered questions was calculated for both groups. As some questions allowed for more than only one correct answer, the maximum score achievable was 30 for the specific part of the questionnaire (21 questions). Four supplementary questions were interpreted separately. SPPS for Microsoft Windows, version 11.0 was used for statistical analysis using the Mann–Whitney test to test for significant differences between two or more groups and the linear regression model for multivariate analysis; a test value below 0.05 was regarded as significant. Data schedules were drawn with the help of Microsoft Excel, version 2007.
Results Two hundred fifty-nine patients who underwent laparoscopic cholecystectomy between May 2005 and May 2007 were included in the study, wherefrom 212 (81.8%) patients did fill in and return the questionnaire in time. The number of patients in the DVD group (patient who had seen the DVD) was slightly higher compared to the control the group, with 114 persons in the DVD and 98 persons in the control group. Patient characteristics of both groups did not differ in regard to age, gender and nationality, but showed a significant difference concerning the educational level (Table 1). Duration of the
information process was 25:26 min longer in the DVD group, as additional time was required for presentation of the DVD. However, during this, period no medical assistant was required. Evaluation of the questionnaire showed the following results: Supplementary questions Only 84% (178/212) of all patients remembered the doctors’ name having informed about potentially complications of the intervention. Interestingly, most of those patients who did not remember the surgeons’ name marked the name of the leading surgeon of the ward, who did not take part in the education. Moreover, another 15 patients (7.1%) of the complete collective was unaware of having signed the informed consent. As shown in Table 2, both questions did not reveal a significant difference between both groups. Ninety-six per cent of all patients in the DVD group judged the quality of the information process easy to be understood, whereas 4% of patients could not understand the bigger part of provided information. In this context, the control group showed similar results without a statistical difference. In a value ranking from 0 to 5, with 5 being the highest value demonstrating high comprehensibility, mean value was 4.58 for the DVD and 4.49 for the control group (p=0.951). Concerning the quantity of information provided by both methods of patient information, the majority of subjects was generally satisfied (DVD and control group). The mean score (ranking 0 to 5 as highest value) was 4.64 in the DVD and 4.60 in the control group. Again, there was no
Table 2 Results for supplementary questions
Remember educationing doc’ Remember having signed Comprehensibility Information content
DVD group
Control group
Total
94/114 107/114 4.58 4.64
84/98 90/98 4.49 4.6
178/212 197/212 4.54 4.62
Test value (p) 0.415 0.328 0.951 0.834
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Fig. 1 Mean score values differed for both groups (1 DVD group, 2 control group), with the DVD group scoring significantly higher (p= 0.001)
Fig. 3 Different scores for well-educated patients and patients without higher education. The analysis reveals a positive influence of education, respectively, intelligence on understanding information. p
