Computer-based patient education. Its potential in general and plastic surgery. Bram J. Keulers

Transcription

1 Computer-based patient education Its potential in general and plastic surgery Bram J. Keulers 2008

2 Colofon The research presented in this thesis was performed at the department of surgery, Maxima Medical Centre Veldhoven, and the departments of plastic surgery of the Isala Clinics Zwolle, Radboud University Nijmegen Medical Centre, and Canisius Wilhelmina Hospital Nijmegen, The Netherlands. All rights reserved. No part of this thesis and included CD (with CTS program) may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photography, recording or any storage and retrieval system, without prior permission in writing from the author. B.J. Keulers, Nijmegen, 2008 ISBN: Cover and lay-out Trix Keulers was verantwoordelijk voor de omslag, illustraties en bijgevoegde CD. De layout werd verzorgd door Jochem Verschure. Published by BJ Keulers Printed by Paro Printing, Geldrop, The Netherlands

3 Computer-based patient education Its potential in general and plastic surgery Een wetenschappelijke proeve op het gebied van de Medische Wetenschappen Proefschrift Ter verkrijging van de graad van doctor aan de Radboud Universiteit Nijmegen op gezag van de rector magnificus prof. mr. S.C.J.J. Kortmann, volgens besluit van het College van Decanen in het openbaar te verdedigen op maandag 17 november 2008 om 13:30 uur precies Door Bram Jacques Keulers Geboren op 24 oktober 1976 te Wijchen 3

4 Promotores Prof. dr. P.H.M. Spauwen Prof. dr. G.J. van der Wilt Co-promotor Dr. M.R.M. Scheltinga (MMC, Veldhoven) Manuscriptcommissie Prof. dr. C.J.H.M. van Laarhoven, Voorzitter: Prof. dr. P.F. de Vries Robbé Prof. dr. S.G. Oei (MMC, Veldhoven) Paranimfen Drs. MG Buimer Drs. TM Potijk 4

5 Contents 7 Chapter 1 General introduction and outline. 15 Chapter 2 Can face-to-face patient education be replaced by computer-based patient education? European Journal of Plastic Surgery 2003, Vol 26; pp Chapter 3 Evidence-based development of interactive patient education programs: A guide for achieving optimal computer-based patient education. European Journal of Plastic Surgery 2006, Vol 29; pp Chapter 4 Surgeons underestimate patient s desire for pre-operative information. World Journal of Surgery 2008,Vol 32: pp Chapter 5 Can face-to-face patient education be replaced by computer-based patient education? A randomised trial. Patient Education and Counselling 2007, Vol 67; pp Chapter 6 Surgical informed consent. Past, Present and Future. Are we helping patients make better decisions? Submitted 87 Chapter 7 Summary and conclusions. Samenvatting en conclusies. 93 Chapter 8 Personal view and future directions. Submitted 99 Dankwoord 103 List of publications 107 Curriculum Vitae 5

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7 Chapter 1 General introduction and outline 7

8 Patient education in general: Patient education is considered by many an integral portion of the doctor s profession.1, 2 An important drive for educating patients may lie in the finding that effective education tools improve healthcare outcomes. For instance, proper education is found to reduce medication needs and duration of treatment and hospital stays. Risk behaviour,3-6 risk factors7-9 and morbidity and mortality are also positively influenced by a regimen of tailored education.10, 11 Computerbased patient education programs are found to improve knowledge, self-efficacy, behavioural outcomes and clinical outcomes.12 A recent review also identifies positive effects of patient education on chronic conditions as well as treatment and screening and clinical outcomes, satisfaction and quality of life, compared to normal (doctor-based) education Moreover, it is again confirmed that proper education can reduce symptoms (pain, disability, fatigue and depression) and can improve quality of decision making whereas decisional conflict is lowered. Importantly, adverse events are absent.17 Most trials are performed in an hospital environment, but patient education in primary care is also effective.18, 19 Providing instructions on health also improves adherence to medical rules and reduces the number of unnecessary visits and missed appointments. A simplified informed consent and lessened number of malpractice claims are also associated with effective education.20, 21 The patient s perspective: A patient has a passive dependent role in a traditional doctor-patient relationship. This immense difference in attitude creates an educational and social gap and hinders a productive exchange of information.22 Already in 1956 Szasz idealized mutual participation between equal participants, but this approach is not common practice and patients are still discontent. A third of the patients feels their doctor does not give enough attention.23 Patients are found to wish more information about their condition,22, 24 and they want to know as much as possible.2, 25, 26 Moreover, 42% of patients think that they are not informed adequately about their condition or treatment. Interestingly, these discontent feelings have not changed over the last 20 years.25 One study included in the present thesis explored what patients wished to know prior to surgical treatment and what their doctors thought they wished to know. The results indicate that the hypothesized gap between these two opinions indeed exists. When doctors are able to improve the quality of information for patient education, it may be expected that both awareness of treatment goals as well as compliance with treatment objectives will increase, resulting in higher patient satisfaction.27 The doctor s perspective: Doctors increasingly realize that patient education is an important part of their work, but it may well be that they rely on rather ineffective educational techniques. This might explain their pessimistic sentiments towards the efficacy of education on patients behaviour and why only one quarter of the doctors regularly gives advice in health-threatening behaviour. This poor confidence in educational tools confounded by lack of time are important reasons for not providing satisfactory education.28 As a consequence, their costumers actively search for information on the internet (53%).29 Conversely, a more active patient s role can frighten doctors and may result in protective behaviour. Patients do not want to challenge a doctor. As a consequence, doctors need to use this knowledge in their favour, and help patients in finding the correct information that is needed. Doctors do not need to feel threatened by their patients behavior.30 8

9 How does patient education work: An adequate doctor-patient communication is pivotal in influencing health care. Wellinformed patients will become more active partners in managing their own health,31 and they will be more independent and responsible.1 If quality of information improves, awareness and compliance for treatment goals will do likewise,1, 2, 25, 32 thus resulting in a higher satisfaction.2, 25 1 What is the role of emotions? Emotions can overshadow medical treatment and indeed fear, confusion, loss of control and self-image are often observed among patients.33 Interestingly, these emotions are attenuated if the patient receives correct and objective information before treatment;25, the self-regulation theory identifies a better coping strategy.34 The difference between expectations and reality are thought smaller resulting in a better insight and improved mental preparation.35 An alternative explanation of the soothing effect of proper information is provided by the perceived control theory.35 By stabilizing the patient s expectancy one has more power to engage in own treatment decisions. As a consequence, one may experiences more positive aspects following one s own decisions.35, 36 In other words, the patient feels that he contributed to his own treatment. Taking control of his own situation reduces stress and results in a higher physical and psychological well-being.25, 35 Disadvantages of patient education: Patient education is time-consuming and a repetitive task for a health care provider.2 Always recounting the same story can be boring.37 Boredom combined with an educational and social gap and time restraints are important reasons for refraining from the provision of satisfactory information. Moreover, a doctor may also forget to refer to specific topics; incompleteness results in inconsistent information.35 If quality of information improves, patients become more active conversational partners leading to an even longer consultation time. What s the current problem, and how to contribute to its solution? Although doctors are potentially willing to provide proper patient education, they just don t do well. If they want to improve on educational issues, they have to take major steps in exploring alternative ways of exchanging health information with their customers. This thesis explores the potential use of computer-based patient education in general and plastic surgical practice. Questions raised in this thesis: What information do patients wish to receive prior to surgical treatment? What do surgeons think their patients want to know prior to surgical treatment? What are advantages and potentials of computer-based patient education in general and plastic surgery? How to build an effective patient education program with elementary means and a small budget? Can a computer-based education program replace doctor-based patient education in surgical consultations? Are patients equally satisfied with computer-based education compared to doctor-based education? What is known about the surgical informed consent process in relation to patient education, and how can computerized techniques contribute to the consent process? 9

10 Outline The studies reported in this thesis discuss several aspects of computer-based patient education in general and plastic surgery. Chapter 2 contains a review that discusses general advantages and potentials of computerbased patient education. Medical, psychological and informatics data bases were studied aimed at identifying papers showing concepts with scientifical merit that could be incorporated in effective patient education programs. This body of evidence was used for building our own education program. A review of these data is presented in Chapter 3. Chapter 4 reports on the discrepancy between surgeons and their patients in terms of informational needs. Chapter 5 provides an answer to a research question that is pivotal to this thesis: Can a computer program replace a doctor in patient education? The program that is discussed in chapter 5 is used to perform this randomised and stratified trial. In Chapter 6 several aspects of the surgical informed consent are discussed as this process is considered relevant for patient education. In Chapter 7 summary and conclusions are provided, and the included CD is presented. Chapter 8 discusses future possibilities and my personal view. 10

11 Literature: 1] Ulrich, J. Conceptual framework for interactive education in practice and clinic setting. Journal of human hypertension 1990; 4 (1): ] Randale C. Computer-based patient education: observations on effective communication in the clinical setting. The journal of biocommunication 1996; 23(1): ] Haynes RB, Taylor DW, Sacket DL. Compliance in health care. John Hopkins University Press, Baltimore, ] Rosen MA, Logsdon DN, Demak MM. Prevention and health promotion in primary care: baseline results on physicians from the INSURE Project on Lifecycle Preventive Health Services. Prev Med 1984; Sep;13(5): ] Mullen PD, Green LW, Persinger GS. Clinical trials of patient education for chronic conditions: a comparative meta-analysis of intervention types. Prev Med 1985; 14: ] Pederson LL. Compliance with physician advice to quit smoking. An analysis of the literature. Prev Med 1982; 11: ] Holme I, Hjerman I, Helgeland A, Leren P. The Oslo study: diet and antismoking advice. Additional results from a 5-year primary prevention trial in middle-aged men. Prev Med 1985; 14: ] Levine DM, Green LW, Deeds SG, Chwalow J, Russel RP, Finlay J. Healt education for hypertensive patients. JAMA 1979; 241: ] Stamler J, Farinaro E, Mojonnier LM, Hall Y, Moss D, Stamler R. Prevention and control of hypertension by nutritional-hygienic means. Long term experience of the Chicago coronary prevention evaluation program. JAMA 1980; 243: ] Kaplan Nm, Stamler J. Prevention of coronary heart disease. Practical management of risk factors. Saunders. Philidelphia ] Morisky DE, Levine DM, Green LW, Shapiro S, Russel RP, Smith CR. Five-year blood pressure control and mortality following health education for hypertensive patients. Am J Public Health 1983; 73: ] Murray E, Burns J, See TS, Lai R, Nazareth I. Interactive health communication applications for people with chronic disease. Cochrane Database Syst Rev 2005; 19(4): CD ] Foster G, Taylor SJ, Eldridge SE, Ramsay J, Griffiths CJ. Self-management education programmes by lay leaders for people with chronic conditions. Cochrane Database Syst Rev 2007; 17 (4): CD ] O Connor AM, Stacey D, Entwistle V, Llewellyn-Thomas H, Rovner D, Holmes-Rovner M, Tait V, Tetroe J, Fiset V, Barry M, Jones J. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev 2003; (2): CD ] Bussey-Smith KL, Rossen RD. A systematic review of randomized control trials evaluating the effectiveness if interactive computerized asthma patient education programs. Ann Allergy Asthma Immunol 2007; 98(6): ] Wofford JL, Smith ED, Miller DP. The multimedia computer for office-based patient education: a systematic review. Patient Educ Couns 2005; 59(2): ] O Connor AM, Bennet C, Stacey D, Barry MJ, Col NF, Eden KB, Entwistle V, Fiset V, Holmes-Rovner M, Khangura S, Llewellyn-Thomas H, Rovner DR. Med Decis Making 2007; 27(5): ] Protheroe J, Bower P, Chew-Graham C, Peters TJ, Fahey T. Effectiveness of a computerized decision aid in primary care on decision making and quality of life in menorrhagia: results of the MENTIP randomized controlled trial. Med Decis Making 2007; 27 (5): ] Hill W, Weinert C, Cudney S. Influence of a computer intervention on the psychological status of chronically ill rural women: preliminary results. Nurs Res 2006; 55(1): ] Fried RA, Iverson DC, Nagle JP. The clinician s health promotion handbook. Mercy Medical Center. Denver. CO ] Kessler TM, Nachbur BH, Kessler W. Patients perception of preoperative information by interactive computer program-exemplified by cholecystectomy. Patient Educ Couns 2005; 59(2): ] Brody Ds. The patient s role in clinical decision-making. Annals of Internal medicine 1980; 93:

12 23] Szasz TS, Hollender MH. A contribution to the philosophy of medicine: the basic models of the doctor-patient relationship. Arch Intern Med 1956; 97: ] Molenaar S, Sprangers M, Oort F, Rutgers E, Luiten E, Mulder J, van Meeteren M, de Haes H. Exploring the black box of a decision aid: what information do patients select from an interactive Cd-Rom on treatment options in breast cancer. Patient Educ Couns 2007; 65(1): ] Broome, AK. Health psychology: processes and applications, HD 5: improving patients understanding, recall, satisfaction and compliance. 1989, Chapman and Hall, London, N.Y. 26] Eddy EM. Preparation for ambulatory surgery: a patient education program. Journal of post anaesthesia nurses 1991; 6 (1): ] Greenfield S, Kaplan S, Ware JE. Expanding patients involvement in care: effects on patients outcomes. Annals of Internal Medicine 1985; 102: ] Orleans CT, George LK, Houpt JL, Brodie KH. Health promotion in primary care: a survey of U.S. family practitioners. Prev Med 1985; 14: ] Sim NZ, Kitteringham L, Spitz L, Pierro A, Kiely E, Drake D, Curry J. Information on the World Wide Web: how usefull is it for parents. J Pediatr Surg 2007; 42(2): ] Stevenson FA, Kerr C, Murray E, Nazareth I. Information from the internet and the doctor-patient relationship: the patient perspective: a qualitative study.bmc Fam Pract 2007; 16;8;47. 31] Krishna, S. Clinical trials of interactive computerized patient education: implications for family practice. The journal of family practise 1997; 45(1): ] Liedholm, H. The development of an interactive education program for heart failure patients: the Kodak photo cd portfolio concept. patient education and counselling 1996; 29: ] B. Breemhaar. Voorlichting aan operatiepatiënten: knelpunten.. Medisch Contact 1992; 47(22): ] Clark, CR. Creating information messages for reducing patient distress during health care procedures. Patient education and counselling 1997; 30: ] Breemhaar, B. Effects of education and support for surgical patients: the role of perceived control. Patient education and counselling 1991; 18: , 36] B. Breemhaar. Voorlichting aan operatiepatiënten: Slot: maatregelen ter verbetering. Medisch Contact 1992; 22): ] Add patient education to other uses for CD-ROMs!, Dental economics 1997; august:

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15 Chapter 2 Can face-to-face patient education be replaced by computer-based patient education? B.J. Keulers, P.H.M. Spauwen European Journal of Plastic Surgery 2003, 26(6);

16 Abstract In plastic surgery patient education is important but time consuming. It can be performed face to face or computer-based. In order to examine the merits of computer-based patient education a research of the literature was performed. The results of this search show that computer-based education is of great potential benefit. Especially in retaining information, informed consent and time management in the medical practise. 16

17 Introduction: In 1998 Van Den Borne defined patient education: a systematic learning experience in which a combination of methods is generally used, such as the provision of information and advice and behaviour modification techniques, which influence the way the patient experiences his illness and/or his knowledge and health behaviour, aimed at improving or maintaining health or learning to cope with a condition, usually a chronic one. Patient education may also involve influencing emotions and attitudes and is often aimed at altering behaviour. Patient education is therefore more than merely the provision of information to the patient.3 Patient education is one of the most time consuming and repetitive aspects in the provision of health care services, not only in plastic surgery. It is also one of the most important tasks of the physician.32 Up to 25% of office time in general practice is spent on patient information, instruction and counselling.29 In 1984 Waitzkin found that doctors tend to underestimate patients desire for information.41 Other studies have shown that patients desire more information about health care and information concerning their conditions, treatment and prognosis.5-8, 11, 24, 33 When the quality of information a patient receives improves awareness and knowledge of treatment goals, and compliance with treatment objectives improve, and patients take a more active role in medical decision-making14, 18, 40, 43. Well-informed patients are more likely to become active partners in the management of their own health.4, 14 This ultimately creates a higher level of patient satisfaction and an improved outlook on life.41, 43 Patient education is an effective therapeutic tool. It has been shown to improve health outcomes, measured in terms of reduced medication needs, reduced duration of treatment and hospital stays, improvement in risk reducing behaviour,19, 26, 27, 30 and reduction of risk factors (for example high blood pressure and cholesterol levels).17, 20, 27, 36 Eventually it reduces morbidity and mortality.17, 20, 25, 27, 36 Vickery et all 40 found that self-care educational interventions can decrease (with 17-35%) the number of medical visits and minor illness, and decrease medical care cost. Lack of time and compensation for educating patients about preventive health practices have been found by Skinner to deter breadth of individual information.34 Patient surveys have identified considerable dissatisfaction with doctors lack of attention to patient education.15 Also doctors themselves often voice doubt about their success in patient education. They are pessimistic about their ability to change patients lifestyle, and lack confidence in their own treatment strategies.39, 42 It is proven that they over utilize ineffective education strategies, and under utilize potentially more effective behavioural or psychological treatments.29 Patient education is very important. Patients tend to ask more information. A physician is compelled to give adequate information before a patient can give informed consent. This is almost an impossible task in a society were there is little time and money for each individual patient. In this article an alternative for face-to-face patient education is discussed. The alternative is the use of a computer. A systematical literature search was done, to find clues that computer education can be a good alternative for face-to-face patient education. The following question was tried to answer: can a computer replace a physician in patient education? 2 Methods: The following databases were searched: Medline Silverplatter 1966-(05)2002, Cochrane database, PsychInfo 1967-(05)2002, uptodate (online 10.1). When necessary learning books on the subject where searched. Search terms were: (computer OR computer-based) AND (patient) AND (education). 17

18 Terms like computer-assisted, multimedia, interactive and program were also used. Potentially relevant articles were identified for retrieval if the title or abstract indicated that the mean subject of the article was computer aided patient education. Other inclusion criteria were: English, German or Dutch language, programs used in the curative sector. Describing articles, reviews and clinical trials were included. From these articles full text versions were obtained and screened for relevance. Randomised controlled trials have the most robust design. When limiting this literature search to randomised controlled trials and reviews only, a lot of experience and relevant information would be missed. The following outcomes were identified for assessment: advantages and disadvantages of computer-based patient education, and differences with face-to-face patient education. The objective of this study was to make a summary of the most relevant and frequently stated advantages and disadvantages of computer-based patient education, The outcomes are used to give an answer to the question: can a computer replace a physician in patient education? Results: The search resulted in about 720 articles. After evaluation of title and abstract 77 articles met the selection criteria. The articles were used to describe and summarize the most relevant aspects for answering the research question. In cases of overlap articles were cancelled. The advantages and disadvantages of patient education are discussed. Retaining information: People retain about 20% of what they hear, 40% of what they read, and up to 80% of what they receive through interactive multimedia programs.28 The reason for this is that interactive programs allow people to fill in their information matrixes according to individual learning styles, and at their own pace.28 The combination of video, audio and (inter)active participation stimulates multiple senses (sensory vividness). Sensory vividness and information enhancement (giving information in multiple modalities) appear to be two reasons why health promotion materials that present information trough multiple modalities (e.g. computers, videotapes) are more effective than materials that rely solely on a single channel (e.g. brochures).15, 23, 37 In 1996, Lo et all22 evaluated a computer-aided learning program (CAL) on diabetes.16 patients received education by a diabetes educator and 20 patients received CAL lessons in diabetes care. In both groups knowledge improved significantly, but CAL was more likely to motivate people to control their glucose level. This resulted in significant lower glucose levels. Active learning: Most health education is extremely passive. Videotapes are essentially passive learning media. Murphy stated: You ll never know if a patient has listened to it and what they retain.28 An education program stimulates active learning (the patient has to attribute to his own education) because the user has to choose his own education strategy (individualize knowledge). The patient has to direct his own progress through the program, access multiple modes of information (e.g. video demonstrations, stories), and has to interact with the program (e.g. 18

19 answering questions, completing missions).37 Murphy suggested that it is possible to track patients performance as an indicator of their true understanding of the subject matter.28 For example by checking their answers to questions. Individualize information: Patient education researchers and practitioners have long recognised the value of tailoring the presentation of material to the individual in face to face encounters.38 Modern computer systems are capable to be such well-trained health educators with the ability to tailor the presentation of material to an individual s needs.34 This is one of the strengths of face-to-face patient education. Patients can follow multiple pathways to get the information they need. This accommodates individual variations in learning strategies. It also helps to maintain a high level of patient involvement, as they are literally directing their own progress through the program.28 They can do this at their own speed, and repeat the information as often as needed in their own homes. The capacity to elicit and report back information about factors that influence patients health behaviours give the newest computer programs one of the strengths of face-to-face patient counselling.35 For example the program can elicit data from the patients electronic record,31 or it can use an electronic questionnaire that the patient filled in before starting the program. 2 Consistence of information: Most patients information is standard, not difficult, and without variation. In a lot of these cases, patient education is strictly verbal. As a result, it s possible for the educator to bypass important points, depending on the time of day, stress level and simple boredom of explaining the same thing over and over. In a computer program the information remains thorough and enthusiastic, no matter what time of day or how many times the same message is repeated. Each time a presentation is made, it maintains the illusion of the first time, a task that is difficult for an educator to maintain. There is no boredom factor, no speeding up or slowing down, no skipping over key points. The information given is consistent.1, 13, 38 Every patient gets the same information, and all doctors provide the same information. Communication level: Even the person-to-person interaction of a professional consultation may be fraught with problems of communication due to differences between the interactants status, knowledge, and attitudes toward health and behaviour.32, 37 Operating a computer can be difficult and a computer can t give personal reflections. However, interactive programs are currently being developed that are easy to use (e.g. touch screen monitors) and suitable for people of all ages and levels of education.1, 2, 10 In some studies patients seemed more willing to confide in computers than in human interviewers, possibly because the computers were perceived as non-judgemental or evoked less embarrassment on sensitive subjects.19 In 2001 Gustafson et all,16 conducted a randomised controlled trial (N= 246) on younger women with breast cancer. They found that computer-based patient support system can significantly make women more competent at seeking information, more comfortable participating in care, and increase confidence in doctors. 19

20 In patient education situations, patients can proceed at their own pace, in private, with several options to repeat and review information without being concerned that they are taking too much of a health care provider s time.18 This frees the health care provider to spend more time exploring or reinforce aspects of the learning that are most particular to the patient and to his or her pertinent situation.1 Informed consent: When patients understand the treatment proposed, they take ownership of their problems and they become more involved in the decision making process. An interactive program can ask a patient questions concerning the information presented in the program. It can also register which information the patient has seen and for how long. This information can be generated in a permanent record for inclusion in the patients chart. This is the gold standard for issues of informed consent.28 When used for the documentation of informed consent, interactive patient education programs exceed most local standards of care for informed consent as long as appropriate physician and nurse counselling is an integral part of the overall plan. This method of instruction allows for future verification of what they were told, as well as documentation of their response to interactive questions designed to quantify their understanding.28 In a review conducted by Lewis in ten authors of obtained articles reported that computer-based learning programs were popular and effective in delivering information and that patients were generally able to use them without difficulty. The same review noted that low socio-economic backgrounds, low literacy skills, level of computer experience, age, and gender did not influence significantly outcome variables in computer-based education research. Patients visual deficits were reported to be a problem for some participants of computer-based education. Time and costs: By using the computer to present information to patients in a standard, reproducible format, staff involvement may be reduced, thereby increasing efficiency and reducing costs in the delivery of health care services.32 The up-front costs to design and develop high quality programs, and for purchasing hardware can be high.1 Computer systems and software are still relatively expensive compared to the other media, although less expensive than professional consultations.37 If a program is developed it can easily and with low costs be updated with the latest information (text, audio, pictures and video). Once a format has been designed it can be used for different kinds of information. Discussion: The results are mainly positive in favour of computer-based patient education. Not a lot of disadvantages are discussed. A possible bias can be introduced, because research on computerbased patient education is mainly done by people who believe in the new media. A lot of the articles used to write this literature study are not controlled randomised trials. Therefore the results will resemble the opinions of the writers and possibly not the objective reality. There were no plastic surgery specific articles. A lot of research has been done about the effectiveness of computer education. It has proven to be a valuable education tool. Still nobody has tried to replace face-to-face education by a computer. 20

21 Consoli phrases the leading opinion among patient education researchers: Obviously, the computer is not designed to substitute the health professional but to provide a mediation, enriching the relation between the patient and the health professional.9 The opinion among physicians might be less positive. Theoretically face-to-face education is still the best way to individualize information. However, on a routine basis, patients are more likely to receive only a small amount of educational information from their physicians, and perhaps a brochure to take home.38 In face-to-face education the physician is able to respond to non-verbal signs of a patient. This is one of the big advantages of face-to-face education. This is important when discussing complex or emotional problems. However a lot of problems in daily practice are routine and not complex or emotional. A computer can use most of the education principles a physician can use. A computer will never forget information, it s consistent, stimulates multiple senses, individualises and can be highly interactive. A computer has all the time to answer questions and is never in a bad temper. Some patients, mainly the older ones, might be reluctant to use a computer, because they are afraid and don t now how to use a computer. Education programs on a computer must be developed in a manner that even a computerfobic patient is able to use it. The program has to be very simple and easy to control, for instance by using a touch-screen. These advantages and the ones described in this article are convincing evidence for the power of computer education. 2 Conclusion: Recent literature suggests that computer education can be a valuable asset in patient education. Randomised studies to confirm the suggestion that computers can do as good as physicians are not yet available. The evidence that a computer can replace a physician in some part of the patient education is valuable. It might improve patient education and make modern medicine more efficient. A computer can help to inform patients about there disease, and operation, and therapy, and it can also be a valuable tool in the registration of informed consent. Based on this literature study we started a prospective randomised trial in a plastic surgery setting to test the hypothesis that a computer can educate as well as a doctor can. In a large plastic surgery clinic (Isala Klinieken, Zwolle) we will educate patients about the Carpal Tunnel-Syndrome using a computer or a doctor and compare the results in a knowledge test. Acknowledgements: We thank Dr. P. Houpt, head of the department of plastic surgery in the Isala Klinieken, for his contributions in starting a randomised trial about computer education. This would not be possible without a grant from the Isala Klinieken. 21

22 Literature: 1] Adsit KI (1996). Multimedia in nursing and patient education, Orthop Nurs 15(4): ] Barry MJ, Fowler FJ, Mulley AG, Henderson J, Wennberg JE (1995). Patients reactions to a program designed to facilitate patient participation in treatment decisions for benign prostate hyperplasia. Med care 33: ] Borne van de HW (1998). The patient from receiver of information to informed decision-maker. Patient Educ Couns 34: ] Breemhaar B (1991). Effects of education and support for surgical patients: the role of perceived control. Patient Educ Couns 18: ] Breemhaar B (1992). Voorlichting aan operatiepatiënten: knelpunten, Med Contact 47: ] Brody DS, Miller SM (1989). Patient perception of involvement in medical care: relationship to illness attitude and outcomes. J Gen Intern Med 4(6): ] Brody DS (1980). The patient s role in the clinical decision-making. Ann Intern Med 93: ] Cassileth BR, Zupkis RV (1980). Information and participation preferences among cancer patients. Ann Intern Med 92: ] Consoli SM (1996). Interactive electronic teaching (ISIS): has the future started? J Hum Hypertens 10 (1): ] Day JL (1997). Learning diabetes -a multi-media learning package for patients, carers and professionals to improve chronic disease management. Med Inform 22 (1): ] Ende JL, Kazis A (1989). Measuring patients desire for autonomy: decision making and information seeking preferences among medical patients. J Gen Med 4: ] Gagliano M (1988). A literature review of the efficacy of video in patient education. J Med Educ 63: ] Giloth B.E (1993). Managing hospital-based patient education. chapter16: Using technology to enhance patient education effectiveness. American Hospital Publishing Inc., USA. 14] Greenfield S, Kaplan S, Ware JE (1985). Expanding patient involvement in care: effects on patient outcomes. Ann Intern Med 102: ] Grueninger UJ, Goldstein MG (1990). A Conceptual framework for interactive education in practice and clinic setting. J Hum Hypertens 4 (1): ] Gustafson DH, Hawkins R, Pingree S, et all (2001). Effect of computer support on younger women with breast cancer. J Gen Intern Med 16(7): ] Holme I, Hjerman I. The Oslo study: (1985) diet and antismoking advice, additional results from a 5-year primary prevention trial in middle-aged men. Prev Med 14: ] Kahn G (1993). Computer-based patient education: a progress report. MD comput 10, ] Krishna, S (1997). Clinical trials of interactive computerized patient education: implications for family practice. Fam Pract 45 (1): ] Levine DM, Green LW (1979). Health education for hypertensive patients. JAMA 241: ] Lewis D (1999). Computer-based approaches to patient education: a review of the literature. JAMIA 6: ] Lo R, Lo B, Wells E, Chard M, Hathaway J (1996). The development and evaluation of a computer-aided diabetes education program. Aust J Adv Nurs 13(4): ] Marshall WR, Rothenberger LA, Bunnell SL (1984). The efficacy of personalized audiovisual patienteducation materials. Fam Pract 19: ] McIntosh J (1974). Processes of communication, information seeking and control associated with cancer: a selective review of the literature. Sci Med 8: ] Morisky DE, Levine DM (1983). Five-year blood pressure control and mortality following health education for hypertensive patients. Am J Public Health 73:

23 26] Mullen PD, Green LW (1985). Clinical trials of patient education for chronic conditions: a comparative meta-analysis of intervention types. Prev Med 14: ] Mullen, PD (1992). A meta-analysis of controlled trials of cardiac patient education. Patient Educ Couns 19: ] Murphy KR (1998). Computer-based patient education. Comput Otolaryngol 31 (2). 29] Orleans CT, George LK, Houpt JL, Brodie KH (1985). Health promotion in primary care a survey of US family practitioners. Prev Med 14: ] Pederson LL (1982). Compliance with physician advice to quit smoking, an analysis of literature. Prev Med 11: ] Richards B (1998). The current and future role of the Internet in patient education. Int J Med Inf 50: ] Sechrest RC, Henry DJ (1996). Computer-based patient education: observations on effective communication in the clinical setting. J Biocommun 23 (1): ] Seeman M, Evans J (1962). Alienation and learning in a hospital setting. Sociol Rev 27: ] Skinner C (1993). The potential of computers in patient education. Patient Educ Couns 22: ] Skinner CS, Siegfried JC, Kegler MC, Strecher VJ (1993). The potential of computers in patient education. Patient Educ Couns 22(1): ] Stamler J, Farinaro E (1980). Prevention and control of hypertension by nutrional-hygienic means, long term experience of the Chicago coronary prevention evaluation program. JAMA 234: ] Street jr RL, Gold WR, Maning T (1997). Health promotion and interactive technology: theoretical applications and future directions, chapter 1: A conceptual foundation. Makwah: Lawrence Erlbaum associates. 38] Street jr RL, Gold WR, Maning T (1997). Health promotion and interactive technology: theoretical applications and future directions, chapter 8: Patient-specific interfaces to health and decision-making information. Makwah: Lawrence Erlbaum associates. 39] Valente CM, Sobal J (1986). Health promotion: physicians beliefs, attitudes, and practices. Am J Prev Med 2: ] Vickery DM, Kalmer H, Lowry D, Constantine M, Wright E, Loren W (1983). Effect of a self-care education program on medical visits. JAMA 250: ] Waitzkin H (1984). Doctor-patient communication: clinical implications of social scientific research. JAMA 252: ] Wechsler H, Levine S (1983). The physicians role in health promotion a survey of primary care practitioners. New Engl J Med 308: ] Wetstone SI, Sheehan TJ, Votow RG, Peterson MG, Rothfield N (1985). Evaluation of a computer based education lesson for patients with rheumatoid arthritis. J Rheumatol 12:

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25 Chapter 3 Evidence-based development of interactive patient education programs: A guide for achieving optimal computer-based patient education Bram J. Keulers, Miel J. Keulers, Marc RM Scheltinga, Paul HM Spauwen European Journal of Plastic Surgery 2006, Vol 29;pp

26 Abstract In daily plastic surgery practise patient education is of great importance. Computer-based patient education can be a helpful tool, as we described in this journal in In this paper we describe key elements of building effective computer-based patient education programs, based on the existing literature. We hope that plastic surgeons will use this paper as a guide in developing an education program for their own practise. 26

27 Introduction In 2003 we published a paper in this journal which overviewed the pro s and cons of computer-based patient education.25 Computer-based patient education (CBPE) programs may effectively enhance delivery of health care.25, 36, 47, 49 This form of teaching is theoretically associated with several advantages: inherently effective and efficient, fast, patient-focused and inexpensive.25 Indeed it has been postulated that people retain 10 percent of what they see, 20 percent of what they hear, half of what they see and hear, and 80 percent of what they see, hear and do.3 Although a CBPE program may seem worthwhile, its development is usually based on the doctors assumption of what a patient needs to know.7, 59 Moreover, the sort of media that are used for transferring information may influence the program s effectiveness. In medical literature, there is a profound paucity of data dealing with the how s of developing effective CBPE programs. However, other scientific fields such as psychology and informatics may have explored the computer as a teaching medium more extensively. Our objective was to overview the principles that may influence the effectiveness of computerbased education for adults by searching and reviewing medical, psychological, and informatics literature. Our goal is to provide a guide for health care professionals in the quest for developing and delivering effective CBPE programs. 3 Methods Search strategy Medline, Pubmed central, CINAHL, ERIC, PsycINFO, Cochrane library, and the ACM digital library were systematically searched, between 1970 and June 2004, using key words including patient education, health education, education OR information, computer, program, software, interactive OR multimedia OR multi-media. After initial reviewing we expanded the search using additional terms: computer-based, computer-assisted, student education, needs assessment, user centred design, adaptive, tailoring, learning theory, instructional design, evaluation, user interface, design, development, universal design, accessibility, usability, functionally limited, guidelines, and iterative design. Furthermore, Google was searched to retrieve relevant websites and guidelines. Special attention was paid to articles with high level evidence such as clinical trials, furthermore descriptive articles, guidelines and websites were evaluated for relevancy. Reference lists of pertinent articles were also checked for relevant articles. Study selection Articles discussing a CPBE program were excluded if its method of developing was ill defined, or if the program was intended for children or mentally ill patients. Furthermore, only English or Dutch articles were included in the present study. Papers were screened for study type, relevance for this article and the organization publishing the guidelines. After initial reviewing we subdivided the topic in four main themes, namely: the role of the patient, educational content, the use of interactive technology, and the software design. After reviewing the literature and exclusion we retrieved 101 articles, 23 guidelines, and 12 relevant websites. The most relevant and solid papers, a total of 62, were used for describing these four main themes. 27

28 Results The patient s role The patient s conceptions of illness are as valid as the doctors concepts of disease.6 Effective patient education must therefore be patient-centred in order to adapt to individual differences in characteristics and needs. A patient-centred approach is defined as an adaptation of the approaches of health care to different patients, their perspectives, experiences, and beliefs.26, 53 Populations as targets for CPBE programs are very diverse in characteristics, needs and limitations. These factors may determine contents and level of education, learning strategy, media to use, program design, input-devices to use (e.g. keyboard, mouse, or touch screen), and location of education delivery. Psychological research has also discovered that all humans possess an individual learning style.55 Therefore, no unique system design exists that is able to satisfy the needs of all patients. Barnum (2002) encourages program developers to gather information from the intended population prior to program development.2 This information is particularly useful if the intended population is diverse in its characteristics, functional limitations, or cultural aspects.11, 26 There is a variety of quantitative (surveys, questionnaires, and rating scales) and qualitative approaches (examining existing literature and educational material, interviews, focusing groups, and observing practice) to conduct such a needs assessment.14 A computer-based patient education program has the potential of adapting information to individual patients (tailoring).4 Bental (1999) concludes that computer-based tailoring offers the potential to improve current methods of patient education. Jones et al. (1999) developed such programs and found that patients preferred personalised information. Contents, its order and way of presentation is ideally automatically adjusted to the individual.10, 24 There are different strategies to personalize information. An electronic questionnaire including data from the patient s own medical record such as age, gender, diagnosis, or treatment may be completed prior to starting a program. The use of artificial intelligence to automatically produce text and content that adapts to the patient is a more complex method of tailoring.9 Educational content Applying a systematic approach to design and development of interactive educational material may result in more acceptable programs for the intended population.15, 51, 52, 61 Therefore, it is necessary for educators to utilize educational models based on learning theory, health models, and instructional design theory while delivering patient education.8, 61 Posel (1998) urged health care providers to adopt theories of instructional design into patient education to enhance patient outcomes.43 Instructional design models have the ambition to provide a link between learning theories and the practice of building educational software.14, 18, 19 These models yield a means for sound decision making to determine the who, what, when, where, why, and how of education. They are characterized by an orderly process used to identify what the population under study wants to know, what the learning goals of the CBPE program are, which learning strategies are used to satisfy the learning goals, and how an evaluation is performed once a population has actually reached those goals. The ultimate aim of an instructional design model is effective and efficient learning in its many forms.14 Patient education programs that are most likely to succeed use strategic planning models and meaningful evaluation with a learning theory basis.41, 61 28

29 Learning theory can be helpful to understand the underlying learning process. Both Wyatt (1999) and Briseno et al. (2002) discuss the use of learning theory within interactive education, and provide assumptions to choose the proper learning strategies for specific learning goals (Table 1).8, 52, 61 Size and diversity of the intended group of patients must determine the character of the learning strategy. Table 1. Practical implication of learning theory into patient education software.43, 52 Instructional strategy Assist learner in assessing individual needs and preferred learning style Encourage learners to identify their own risks to determine the motivation of learning Create a content that is relevant to the patient s needs based on their perceptions and interest Reinforce and reward learned behaviours and provide contact points Establish patient s baseline knowledge and build on baseline from familiar to unfamiliar information Establish patient s contracts developed by the patient Establish a phased educational plan Practical implications Assess patient s ability to learn, and readiness to learn Offer learning options Provide menu options Use these risks for concrete situations in learning and arrive at own conclusions Provide concrete examples and rationale for risks Reinforce responsibilities of the patient Decision support systems, intelligent support systems to identify the patient s needs Establish dissonance within patients through role-modelling behaviour, e.g. via video Use positive and negative reinforcement when trying to change behaviour Reinforce baseline knowledge Simple to complex topics with frequent reinforcement by: key point, mini-quizzes, and integrated multimedia instruction Include objectives, time line, and rewards based on what the patient feels he/she needs to know Develop modules that build on each other Organize objects with content, recall, and feedback follow before directly progressing to more difficult objectives Embed case scenarios of health promotion and risk behaviours 3 29

30 Interactive technology Interactivity allows users to participate in their own learning process.29, 51 An interactive interface appears to have a significant positive effect on learning from multimedia.54 Interactivity enhances interest, satisfaction, and active information processing, which contributes to the effectiveness of educational materials. As opposed to a single component (a brochure or a videotape), interactive media are comprised of individual modular units that all utilize a diverse array of databases (text, graphics, picture, sound, video, or animation).54 These systems allow for a more vivid presentation and may accentuate important information. Sensory vividness and information enhancement both contribute to the effectiveness of interactive technology.5, 54 Rather than making a single presentation in a predetermined linear sequence, interactive computing enables users to access different parts of the program at different moments and to move with relative ease from one domain to another.12 The selection of which media to use in a specific situation can be difficult. Research from the fields of psychology and computer science have revealed strengths and weaknesses of the different media, in table 2 we have summarized some tips and tricks for building effective educational software. Computers make it easy to combine different media types into a cohesive multimedia presentation. Alone, each of these types are effective but when combined, they can dramatically improve the effectiveness of a presentation.44 Mayer and colleagues have studied ways of implementing different media into a cohesive multimedia presentation for learning.31, 32 From their cognitive model of multimedia learning, many research-based principles have been derived on optimal use of multimedia (Table 3). The correct use of interactive components stimulates the effectiveness of an CBPE program undoubtedly. Table 2. Tips and tricks for building educational software. Text46, 57 Graphics and Pictures20, 21, 25, 27, 34, 39, 48 Use structural elements (previews, logical order, highlighting and summaries) Pictures must be an essential element for comprehension of the subject Focus on key points, rather than overwhelm in detail As simple as possible. Only add complexity where absolutely required Use large pictures Use them in a culturally sensitive ways (e.g. the right colours) Use pictographs (drawing representing instruction) Don t use photos which can cause anxiety (e.g. of a bloody surgical procedure) 30

31 Table 2 (continued). Tips and tricks for building educational software. Audio56 Video17, 25, 40, 49 Animation1, 36, 49 Use high quality audio Use audio as an interjection of the visual rather than continuously parallel with the visual Use slow speeds for transmitting verbal information Make audio levels adjustable for hearing impaired patients Use audio for feedback to patients (e.g. a click when a button is pressed) Don t use video that can enhance anxiety (e.g. surgical procedure) Make use of the role-modelling effect (thereby decreasing anxiety, pain, and sympathetic arousel while increasing knowledge, cooperation and coping ability), e.g. patient interviews Make use of narratives explaining their instructional roles for more meaningful learning Showing continuity in transition (change between two or more states) Indicating dimensionality in transition (e.g. animated arrows indicating movement) Illustrating change over time Showing more than one piece of information in the same location (e.g. button change when mouse rolls over) Avoid special effects (e.g. spinning logo s, or cycling advertisements) Make use of narratives explaining their instructional roles for more meaningful learning Enriching a graphical representation (e.g. animated icons) 3 31

32 Table 3. Multimedia learning theory principles.31, 32 Multiple representation principle Redundancy effect Split-attention principle Modality principle Temporal contiguity principle Spatial contiguity principle It is better to present an explanation in words combined with pictures than solely in words. By combining pictures and text, learners are able to build two different mental representations, a verbal model and a visual model, and build connections between them Processing of identical information in both visual and auditory form impose an unnecessary load on working memory and should therefore be avoided. The idea of redundancy is to allow the learner two modes of learning instead of one. With narration in addition to onscreen text, the learner can choose either mode Learning is more effective if materials do not require the learner to divide their attention between sources of information which refer to each other and occupy the same channel in working memory. For example, animation and on-screen text both use the visual system of the working memory and combining them can overload the visual processing system which lowers learning effectiveness Learning is more effective when the verbal information is presented to the learner auditory as speech rather than visually as on-screen text both for concurrent and sequential presentations. Because audio narration is processed in the auditory working memory and animation in the visual working memory, both can be hold in the working memory simultaneously. Now the learner can build referential connections between them When giving a multimedia explanation, present corresponding words and pictures contiguously rather than separately. Learners better understand an explanation when corresponding words and pictures are presented simultaneously Deals with placing corresponding text and images close to each other on the page. Proper proximity of text to a graphic element reduces confusion, thereby reducing cognitive load. Learning is more effective if on-screen text is close to or physically integrated with the additional graphics 32

33 Table 3 (continued). Multimedia learning theory principles.31, 32 Individual differences principle Coherence principle The foregoing principles are more important for low-knowledge than high-knowledge learners, and for high-spatial rather than low-spatial learners. For example, students who lack prior knowledge tended to show stronger multimedia effects and contiguity effects than students who possessed high levels of prior knowledge Deals with the implementation of extraneous material in multimedia presentations. When giving a multimedia explanation, use few rather than many extraneous words and pictures. Learning is more effective from a coherent summary which highlights the relevant words and pictures than from a longer version of the summary 3 Software design The nature of multimedia permits an enormous variety of design possibilities. Good design can maximize the advantages of multimedia while poor design can make learning less effective.44, 53 Design protocols exist that can improve the consistency of the software. Consistency allows users to concentrate on the information portrayed and require less time to figure out how the software works.33, 35, 38, 62 Just like for the educational content, the graphic and interface design has to adapt to needs, preferences and characteristic of the target population.53 Making the program accessible for the broadest possible audience Universal design and accessibility principles focus on making software accessible for everyone, including those with functional limitations or people without prior computer experience.15, 30 It is probably not possible to design products that are accessible for everyone. However, considerations of the functional needs of all users, including those with functional limitations, can lead to more accessible program and content design. For certain kind of limitations, accessibility aids, like screen enlargement utilities (for visual impaired patients), screen-reader utilities, and voice input systems (for certain physical handicaps), can assist the user. Due to ageing of the population, patient education for elderly patients will become more important.60 Elderly have more difficulty in using computers because they more often have functional limitations or less prior computer experience. Demiris, Finkelstein, and Speedie (2001) state that accessibility of educational software is even more important for this group.13 They developed design considerations for educational systems for elderly patients. Cultural aspects may in part determine accessibility, since elements of the software may have different meanings in different cultures, e.g. colour. As the colour red means danger in many cultures, it means joy in China. Research indicated that culture does influence software acceptance.16 Cultural differences also influence acceptance, anxiety and attitudes toward computer use.60 Russo and Boor (1993) and Horton (1993) have provided suggestions for designing for international users.20, 46 33

34 Making the program usable for the intended group of patients Only by observing how users interact with the interface and become familiar with it, designers can understand the real issues affecting usability, for example is it easy for a patient to find the information he or she wants (simplicity of navigation and searching).37 Usability is a quality attribute that assesses how easy a computer program can be used. Usability is defined by the International Organization of Standardization (ISO) as:22 the extent to which a product can be used by specified users to achieve specified goals in a specified context of use with effectiveness, efficiency and satisfaction in a specified context of use. Usability is not just the appearance of the user interface; it also relates to how the system interacts with the user (is it user friendly for everyone or not?). Usability has five quality components: learn ability, efficiency, user retention over time, error rate, and satisfaction.22, 37 The basis of usability lies in how responsive software is to needs and preferences of users, a feature that can best be determined by the people who actually will use the software. User involvement and feedback is really needed throughout the design process, since different types of usability problems may be identified and corrected at various points. This ultimately will lead to an iterative development process, in which program proto-types are repeatedly tested with users, and redesigned according to what is learned, until the resulting program is satisfying. As a designer you have to sit next to your patients while they use your program, ask them what problems they account and how they would like to alter the program. International standards can help developers to implement usability principles into their software development process.22, 35, 57, 58 Making sure that graphics and layout are used properly Graphic design is the process of designing attractive messages for on screen visualisation.42 However, a computer lacks the breadth of interaction that a human educator can provide.41, 45 Through tone of voice, facial expression, and other body language, a human teacher provides important extra information, both cognitive and affective, that a computer cannot express.41 Good graphic design should attempt to focus attention on important information, to attract and maintain interest, to promote integration of new information with things learned before, and help to find and organize information easily by facilitating to navigate through the provided information. When using graphics they should provide the patient with new information or clarify the texts, don t use graphics for fun. Graphic design principles and guidelines exist to develop the most effective multimedia learning experience in the most efficient manner (table 4).33, 38, 50, 62 34

35 Table 4. Graphic design principles.30, 38 Graphic design principle Simplicity Consistency Clarity Balance Harmony & unity Practical implications Try to keep your message as simple as possible Use only the amount of graphics and text that is absolutely necessary An overabundance of colours or fonts can distract rather than assist learning Keep the layout of pages consistent. Inconsistency increases cognitive load Strive for consistency in style of presentation, placement of items, use of colour, use of access structures (e.g. headings), use of text fonts, graphic style, terminology (e.g. menus, prompts), names of commands, and interaction behaviour for similar tasks Pare the message down to the absolute essentials and consider rules for improving clarity Keep the instruction at a language level compatible with the intended learners, use informal language, avoid jargon, keep sentences short, use enumeration marks whenever possible, use the active voice, avoid negative statements if possible, use personal pronouns, and use familiar examples Keep the screen balanced. Balance is not only affected by the size of objects, but also by their value (e.g. lightness or darkness) Asymmetrical layouts have greater vitality and are visually more interesting, but the design is more difficult compared to symmetrical layouts Design pages that utilize consistency and repetition Use similar fonts and colours, use pictures that match the topic, and use graphics which are similar in tone, ensure that all items presented on a screen belong together 3 35

36 Comment The objective of this study was to overview elements that could aid in developing more effective computer-based patient education programs. Systematic implementation of these elements into the development process of computer-based patient education programs could theoretically lead to more effective and efficient computer-based patient education. Since an evidence-based method for building a CBPE program is lacking, it seems obvious that there is room for improvement. Until recently, educational programs and multimedia were almost entirely based on the opinions of experts rather than on the results of empirical evidence. Let alone in the field of medicine, within the fields of Informatics and Psychology, few large trials exist on patient education. The importance of research based principles is recognized by major software companies, such as Microsoft. Development of guidelines by such companies shows that there is an increasing commercial attention for this empirical evidence.33 Patient education has to make a change from maximal to optimal education. If one aims at optimizing education, one must strive for providing understandable and accessible education that adapts to individual needs, preferences, and characteristics. In this situation the patient decides which information is important for his or her own situation. The program has to yield all basic information, possibly supplemented with more detailed information, that may satisfy specific patient s informational needs. It is of pivotal importance to include patients in the development process of a CBPE program. Patients are not only important in defining the informational needs, but they play an important role in evaluating program prototypes and finalizing the program. Frequent evaluation of prototypes (iterative development process) by two to three patients per evaluation is preferred above one final evaluation with a larger group of patients. By frequent evaluation, early adaptations can be evaluated in next cycles for effectiveness. This iterative approach may facilitate development of a program that is suitable for different kinds of people. Educational and software design principles should be applied on a regular base in CBPE programs. So far, this is not a standard principle. Therefore the effects of this measures are not adequately evaluated in modern literature. Most articles that evaluated the effect of a patient education program do not provide information on how their program was developed, possibly because the field of computer-based patient education is still young, and primarily bound to medical literature. Kinzie et al. (2002) belongs to one of the few groups that promoted a systematic development process.26 We claim that more computer-based patient education programs have to be developed using a systematic approach using known principles as reviewed in this paper. While technological possibilities within patient education are increasing, a systematic development approach will become more important to make effective use of these possibilities. Although existing computer-based patient education programs have already proven to be as effective as traditional educational materials and education by doctors, the use of a systematic development approach could be the next step to improve the effectiveness and efficiency of computer-based patient education. This could lead to better health care for both patients and doctors. In a randomised trial we compared face-to-face education with computer-based education in a plastic surgery clinic. 36

37 References 1] Baek Y, Layne B. Color, graphics and animation in a computer-assisted learning tutorial lesson. Journal of Computer-Based Instruction 1988;15: ] Barnum, C. Usability testing and research. (1st ed.). (Vol. 1) New York, NY: Allyn & Bacon. 3] Begley S. Teaching minds to fly with discs and mice. Newsweek May ] Bental DS, Cawsey A, Jones R. Patient information systems that tailor to the individual. Patient education and counselling 1999;36(2): ] Biocca F. Virtual reality technology: A tutorial. Journal of Communication 1992;42(4): ] Borne van den HW. The patient from receiver of information to informed decision-maker. Patient education and counselling 1998;34: ] Breemhaar B. Effects of education and support for surgical patients: the role of perceived control. Patient education and counselling 1991;18: ] Briseno G, Drumm J, Jones T, Ko JM, Lee K, Skaggs R, Travor K. Factors for Creating a Successful Learner-centered educational program on-line curriculum. ( 9] Buchanan BG, Moore JD, Forsythe DE, Carenini G, Ohlsson S, Banks G. An intelligent interactive system for delivering individualized information to patients. Artificial intelligence in medicine 7 (1995) ] Cawsey AJ, Jones RB, Pearson J. The evaluation of a personalized health information system for patients with cancer. User Modeling and User Adapted Interaction 2000;10(1): ] Coulter A. Evidence-based patient information is important, so there needs to be a national strategy to ensure it [editorial]. BMJ 1998;317(7153): ] Dede C, Fontana L. Transforming health education via new media. In L. Harris (Ed.), Health and the new media: Technology transforming personal and public 1995: Mahwah, NJ: Lawrence Erlbaum Associates. 13] Demiris G, Finkelstein SM, Speedie SM. Considerations for the design of a web-based clinical monitoring and educational system for elderly patients. Journal of the American Medical Informatics Association 2001;8(5): ] Doolittle PE. Instructional design for web-based instruction. Virginia Polytechnic Institute and State University ] EIA-EIF, Resource guide for accessible design of consumer electronics. EIA-EIF Committee on product accessibility 1996: ( 16] Evers V, Day D. The Role of Culture in Interface Acceptance, Human-computer interaction (Interact): IFIP TC 13 international conference: proceedings: 14th-18th July 1997, Sydney, Australia. London: Chapman & Hall. 17] Gagliano ME. A literature review of the efficacy of video in patient education. J Med Educ. 1988;63(10): ] Gagné RM, Dick W. Instructional psychology. Annual Review of Psychology 1983;34: ] Gros B. Instructional Design and the Authoring of Multimedia and Hypermedia Systems: Does a Marriage make Sense? Educational Technology 1997;(37)1: ] Horton W. The almost universal language: graphics for international documents. Technical communication 1993;40(4): ( 21] Houts PS, Witmer JT, Egeth HE, Loscalzo MJ, Zabora JR. Using pictographs to enhance recall of spoken medical instructions II. Patient education and counselling 2001;43: ] IOS, ISO : Guidance on Usability. (Switzerland: International Organization for Standardization) ( 23] Jimison HB, Sher PP, Appleyard R, Le vernois Y. The use of multimedia in the informed consent process. Journal of the American Medical Informatics Association 1998;5(3):

38 24] Jones R, Pearson J, McGregor S, Cawsey J, Barrett A, Craig N, Atkinson JM, Harper Gilmour W, McEwen J. Randomised trial of personalised computer based information for cancer patients. BMJ 1999;319: ] Keulers BJ, Spauwen PHM. Can face-to-face patient education be replaced by computer-based patient education? European Journal of Plastic Surgery 2003;26(6): ] Kinzie MB, Cohn WF, Julian MF, Knaus WA. A user-centered model for web-site design: needs assessment, user interface design, and rapid prototyping. Journal of the American Medical Informatics Association 2002;9: ] Levie WH, Lentz R.Effects of text illustrations: a review of research, Educational communications and technology journal 1982;30(4): ] Lewis, D. Computer-based approaches to patient education: a review of literature. Journal of the American Medical Informatics Association 1999;6: ] Lovell NH, Celler BG. Information technology in primary healthcare. Int J Med Inf. 1999;55(1): ] Mace RL, Hardie GJ, Place JP. Accessible Environment: Toward Universal Design. In W.E. Preiser, J.C. Vischer, E.T. White (Eds.), Design Intervention: Toward a More Humane Architecture pages, New York: Van Nostrand Reinhold. 31] Mayer RE. Multimedia learning. Cambridge, UK: Cambridge University Press ] Mayer RE, Sims VK. For whom is a picture worth a thousand words? Extensions of a dual-coding theory of multimedia learning. Journal of Educational Psychology 1994;86: ] Microsoft. Official guidelines for user interface developers and designers ( 34] Misanchuk, E., Schwier, R. & Boling, E. Visual design for instructional multimedia. ( 35] NCI, Researched based web design & usability guidelines provided by the national cancer institute(nci). ( 36] Nielsen J. Guidelines for multimedia on the web ( 37] Nielsen, J. Usability engineering. AP professional, Boston ] Orr KL, Golas C, Yao K. Storyboard development for interactive multimedia training ( 39] Paivio A, Csapo K. Picture superiority in free recall: Imagery or dual coding? Cognitive Psychology 1973;5: ] Park OK. Visual displays and contextual presentations in computer-based instruction. Educational Technology Research and Development 1998;46: ] Pellone G. Educational software design: A literature review. Australian Journal of Educational Technology 1995:11(1): ] Philips R. The developers handbook to interactive multimedia: a practical guide for educational applications. London: Kogan Page ] Posel N. Preoperative teaching in the preadmission clinic. Journal of Nursing Staff Development 1998;14(1): ] Ramsey TD. The effects of multimedia inferface design on original learning and retention. The Faculty of the Virginia Polytechnic Institute and State University ] Rieber LP. Animation in computer-based instruction. Educational Technology Research and Development 1990;38: ] Russo P, Boor S. How fluent is your interface? Designing for international users. Proceedings of the SIGCHI conference on Human factors in computing systems 1993: ( 47] Sechrest RC, Henry DJ. Computer-based patient education: Observations on effective communication in the clinical setting. JBC 1996;23(1):

39 48] Sewell Jr. EH, Moore RL. Cartoon embellishments in informative presentations. Educational Communication and Technology Journal 1980;28: ] Schneiderman B. Designing the User Interface: Strategies for Effective Human-Computer Interaction, 3th edition. Addison-Wesley ISBN: ] Schwier R, Misanchuk E. Interactive multimedia instruction. Englewood Cliffs, NJ 1993: Educational Technology Publications, Inc. 51] Sims R. Interactivity: A forgotten art? Computers in Human Behavior 1997;13(2): ] Sims R. Futures for computer-based training: Developing the learner-computer interface. Australian Journal of Educational Technology 1988;4(2): ] Smith RS. Interface design for educational multimedia part I ( 54] Street jr. RL, Gold WR, Maning T. Health promotion and interactive technology: theoretical applications and future directions, HD8: Patient-specific interfaces to health and decision-making information Makwah: Lawrence Erlbaum associates. 55] Talavera N, Alvarez E, Mondelo P, Terres F. Capturing requirements for e-learning systems design. Published in proceedings of international conference on computer-aided ergonomics and safety. Maui, Hawai, USA July 29 August 1, ] Thompson AD, Simonson MR, Hargrave CP. Educational Technology: A Review of the Research. Washington DC: ACET ] Usability network, the. ( 58] Useit, Usable information technology website. (Nielsen, J., 59] Waitzkin H. Doctor-patient communication. Clinical implications of social scientific research. JAMA 1984;252(17): ] Weil MM, Rosen LD. The psychological impact of technology from a global perspective: A study of technological sophistication and technophobia in university students from twenty-three countries. Computers in Human Behaviour 1996;11(1): ] Wyatt T. Instructional technology and patient education: assimilating theory into practice. The International Journal of Health Education 1999;2(3): ] Yale web style guide, 2nd edition. ( 3 39

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41 Chapter 4 Surgeons underestimate patients desire for pre-operative information BJ Keulers, MRM Scheltinga, S Houterman, GJ Van Der Wilt, PHM Spauwen World Journal of Surgery 2008, Jun:32(6):

42 Abstract Background: Provision of adequate patient information may contribute to a satisfying surgical treatment. The patient s view on successful transfer of information concerning operative characteristics may not be in concert with the surgeons. The aim of this study was to determine opinions of both surgeons and patients on issues of surgical information. Methods: A group of surgeons (n=24) and surgical patients (n=125) responded to a questionnaire including 80 topics involving domains of information on disease, physical examination, preoperative period, anaesthesia, operation, postoperative period, self care, and general hospital issues. Both groups were asked for their opinion on what they considered important and useful preoperative information for patients. Questions were scored using a visual analogue scale. The reliability of the questionnaire was calculated using Cronbach s alpha. Differences in opinions between surgeons and patients were analyzed using Student s t-tests. Results: The Cronbach s alpha of the questionnaire was high (0.91) indicating its high reliability. Patients scored significantly higher (p < 0.001) in most domains including preoperative period, anaesthesia, operation, postoperative period, self care, and general hospital information. Female patients demonstrated a significantly higher need for information than males. These findings were independent of patient s age or complexity of operation. In contrast, surgeons thought that their patients desired more extensive information on cause, effect and prognosis of the disease itself (p < 0.001). Conclusions: Surgeons generally underestimate their patient s desire for receiving extensive information prior to a surgical procedure of any complexity. Surgeons should develop strategies to bridge this informational mismatch. 42

43 Background: Medical specialists are highly committed to patient education and consider this an integral part of their profession.1 These activities are time consuming as doctors are thought to spend up to 25% of their office time providing information, instructing and counselling. One may question whether these educational endeavours influence clinical management and patient outcome. However, successful exchange of medical information between a physician and a patient apparently contributes to improved outcome measured in terms of reduced treatment time and hospital stay.2-5 Diminished medical needs, better physical and psychological well being,6 improved risk behaviour,2, 5, 7 reduced risk factors8-10 and less morbidity and mortality have also been reported to be associated with optimal transfer of information.1, 3, 8-11 Well-informed patients are found to adopt a more active role in medical decision making and become more compliant with treatment objectives as their awareness and knowledge of treatment goals improve.1, 6, Eventually, higher levels of patient satisfaction are created that may even lead to lowered incidence of malpractice claims.18 Hence, effective transfer of medical information is crucial in successful health care provision. These issues may be less clear when it comes to the surgical territory. A gap may be present between what surgical patients want to know of their condition or treatment, and what their surgeons think they should know as health care providers tend to underestimate patients desire for information.12-16, However, there is little information on the quality and quantity of this informational gap. The purpose of this study was to identify the relative importance of various areas of information observed from two different angles, the surgical patient s perspective and their surgeon s perspective. We hypothesized that a substantial difference exists between what surgical patients considered important with respect to their condition and treatment as compared to the opinion of their surgeons. 4 Methods: The study was conducted in the Máxima Medical Centre (MMC), a teaching hospital serving approximately inhabitants in the Eindhoven and Veldhoven region (The Netherlands) between December 2005 and May Initially, a literature study was conducted aimed at identifying domains that have been found relevant to surgical patients to be informed on before an operative procedure. The search strategy used standard sources (PubMed, literature lists of retrieved papers) and predefined key words (patient education, computer-based, informed consent, decision making). Only studies that were published in the English language were selected. Topics that were considered important by the authors on subjective grounds were organised into 8 domains including disease, examination, preoperative period, anaesthesia, operation, postoperative period, self care, and general hospital information. For each domain questions were composed resulting in an 80-item questionnaire. The answers to each of these 80 questions were quantified using a 100 mm visual analogue scale (VAS). Each patient or surgeon was asked to put a mark along this 100 mm scale ranging from totally irrelevant to be informed on this item (minimal score=0) via neutral (score=50) towards very relevant to be informed on this item (maximal score=100). 43

44 Characteristics including age, gender and operative procedure were also tabulated. A first draft of this questionnaire was tested in random groups of patients (13) and educational experts (psychologist (2), patient educator (1), doctors (5)) aimed at improving its readability. It was also tested for face and content validity by the same educational experts. A revised second version of the questionnaire was used for the present study. Patients who were scheduled by their surgeon for a general surgical procedure were informed of the nature of the questionnaire and asked for their consent, after they already gave consent on their surgery. All patients were asked by personnel of the operative planning bureau to fill out the questionnaire and return it by mail. This was done on the day they visited the surgeon for consultation. They were allowed to anonymously address the questionnaire if they desired to do so. All staff surgeons and residents of the department of general surgery of the MMC were also asked to fill out the same questionnaire. The surgeons were asked for their opinion on what they thought patients generally desired to know on specifics of the operative procedure. Operations were classified from very easy (class 1) to complex (class 6) as proposed by a nationally accepted and utilized standard surgical complexity list. Statistical analysis: VAS scores ranged from and were registered in an Excel database. Results were analyzed using a Student s t-test. Predefined subgroup analyses stratified for age (< 50 years versus > 50 years) and complexity of operation (class 1-2 versus 3-6) were performed. Reliability of the questionnaire was measured using Cronbach s alpha (0=totally unreliable, 1=maximally reliable, a Cronbach Alpha over 0.7 is acceptable). Cronbach s alpha increase when the correlations between the items of the questionnaire increase. Cronbach s alpha can take values between negative infinity and 1. The higher the Cronbach s alpha the better the internal consistency of the questionnaire. Data were expressed as mean ± SD. A p-value < 0.05 was considered statistically significant. Results: The 80-item questionnaire was offered to 201 patients and 29 surgeons. Response rates were 62% (125/201) and 83% (24/29), respectively. The mean patients age was 54±15 yr, and mean surgeons age was 41±11 yr. Fifty four percent of the patients were female. Simple (class 1-2) operations were performed in 68% of the cases, whereas 32% was class 3-6 procedures. These figures were based on 72 patients, as the remaining 53 chose to complete the questionnaire anonymously. However, these numbers represent the surgical mix of our current surgical practise. In table 1 VAS-scores of patients and surgeons are displayed with respect to the 8 domains of items (disease, examination, preoperative period, anaesthesia, operation, postoperative period, self care, and general hospital information). Overall, the mean information relevance score among patients was 75 (±2), while this score was 63 (±2) among surgeons (p<0.01). In the patients group, female patients scored significantly higher on the information relevance score when compared to male patients (Figure 1). In contrast, age (age <50 years vs age 50 years) and complexity of operation (class 1-2 vs 3-6) did not differ in the patients group. The overall Cronbach s alpha for this questionnaire was 0.91 (varying from 0.82 for domain preoperative period to 0.93 for domain examination). All domains are briefly discussed below. 44

45 1. Information on disease (symptomatology, prognosis, etc): The results show (table 2) that surgeons thought that their patients desired more extensive information on cause, effect and prognosis of the disease. The need for information on symptomatology associated with the disorder was judged important by both groups equally. Anatomical considerations related to the disorder were deemed less important by both patients and their surgeons. 2. Information on preoperative examination/work-up: Patients generally tended to judge information on specifics related to preoperative workup more important compared to their surgeons (p = 0.08 ns; table 1). Methods of examination scored significantly higher in the patient group (74±24.7 versus 66±16.6; p = 0.04) (table3). 3. Preoperative period: There was a significant difference in scores on receiving details on the preoperative period in favour of the patients (72±15.1versus 60±11.2; p < 0.001) (table 1). Issues on home preparation, preoperative restrictions, lockers for clothes /jewelleries, attire during hospital stay, hospital policy and facilities, and last meal/drink were judged significantly more important by patients compared to surgeons (table 4). 4. Anaesthesia: Receiving details on anaesthesia was deemed more important by patients (81±15.0) compared to what their surgeons thought (67±15.3, p < 0.001; table 1) (table5). 5. Operation: There was a significantly higher overall mean score in patients (79±13.9versus 71±11.5; p < 0.007, table 1) concerning information on operation. Questions on specifics of procedure, operation time, location of operation room, waiting list, contact with family immediately postoperatively, and complication rate scored significantly higher in the patients group (table 6) Postoperative period: Patients demonstrated significantly higher overall mean scores compared to the surgeons on items related to the postoperative period (76±15.6 versus 58±14.0; p < 0.001; table 1). Mean scores on questions concerning complaints, sensations, diet, personal hygiene, physical handicaps, home wound care, outpatient control and permission to drive a vehicle were judged significantly more important by the patient group compared to surgeons (table 7). 7. Self care: All answers to questions in this domain indicated that patients considered these items more important than surgeons (80±12.5 versus 61±16.7; p < 0.001) (table 1 and 8) 8. General hospital information: Answers to questions concerning the domain general (hospital) information indicated that the patients group deemed these items more important compared to the surgeons, with exception a question on internet pages for patient support groups (table 9). 45

46 Table 1: Desire for information on various domains judged by patients and surgeons Domain Patients* (N = 125) Surgeons* (N = 24) Mean difference (SD) p-value 1. Disease 78 (17.0) 81 (7.8) -3.5 (2.2) Examination 75 (22.6) 69 (12.9) 5.9 (3.3) Pre-operative period 72 (15.1) 60 (11.2) 11.7 (3.2) < Anaesthesia 81 (15.0) 67 (15.3) 13.8 (3.4) < Operation 79 (13.9) 71 (11.5) 8.3 (3.0) Post-operative period 76 (15.6) 58 (14.0) 18.1 (3.4) < Self care 80 (12.5) 61 (16.7) 18.5 (3.0) < General information 71 (17.0) 52 (16.1) 19.7 (3.9) < * Values are VAS-scores, range with (SD) Figure 1: Desire for information on various domains judged by males and females male female VAS score (mm) Disease (p = 0.78) Examination (p = 0.07) Pre-operative period (p < 0.001) Anaesthesia (p = 0.05) Operation (p = 0.03) Post-operative period (p = 0.02) Self care (p = 0.04) General information (p = 0.19) Domain 46

47 Discussion The present study confirms the supposition that surgical patients, even in a semi-rural environment, are interested in all domains of the hospital admission process. In the current study striking differences in opinions were observed in the domains of postoperative period and self care, as patients judged these issues approximately 25% more important compared to their surgeons. On the other hand, our surgeons are convinced that their patients are predominantly focused on aspects belonging to domains of disease, examination and operation. The results of this study show that surgeons underestimated their patients need for extensive and adequate provision of preoperative information. Surgeons routinely fail to meet their clients hunger for information and apparently misperceive the process of information that is transferred.6, One study concluded that doctors underestimate their patient s desire for information in 65% of their encounters.18 Surgical patients were also found to have a selective informational desire as they appeared more interested in specifics of the operation and recovery (43.3% each) than about operative risks (33.3%) in an interviewed group of 60 patients.21 Another study including patients receiving hip surgery demonstrated that they were eager to know almost all aspects of their operation in contrast to what their doctors thought.22 Different patient characteristics determine this desire for preoperative information. Gender apparently plays a role as females visit doctors more often, require more emotional support, ask more questions and are engaged in more verbal behaviour with health care providers compared to men.18, 23 This higher need for information associated with female gender is anticipated by their doctors as females usually receive more doctor time and more levels of explanations.18 The present study confirms this gender difference as female surgical patients scored significantly higher than male patients in all domains except for issues related to the domains disease, examination and general information (all scored higher by females, but not significantly). Informational needs were not related to the patient s age. One would assume that complex surgery a priori requires more explanation, and patients scheduled to undergo class 3-6 operations would demand more information compared to patients undergoing simple class 1-2 surgery, because the topic is more complex and complications more severe. However, our results do not confirm this assumption. In contrast, patients that were scheduled to undergo a class 1-2 operation scored higher in the self-care domain compared to the class 3-6 patients. This apparent contradiction may be explained by the fact that class 1-2 patients are quickly discharged (most of the time on the day of operation) and immediately have to rely on themselves to cope with daily demands. Interpretation of these results must be performed with caution, however, as our patients were allowed to answer questions regarding the operative procedure anonymously, and only 58% of the patients (n=72) reported their operation procedure on the questionnaire. We have no indications that patients who are scheduled for more complex operations have greater informational needs as compared to patients who are scheduled for more simple operative procedures. Current care providers intend to use the most effective ways to adequately deliver sets of required information that patients can reproduce at any time. Unfortunately, patients appear to remember only few items of all the information that is transferred by their doctors. Their level of knowledge quickly deteriorates from the initial consultation on despite supportive measures including information booklets. It may even be argued that patients are insufficiently informed to properly consent to a standard informed consent procedure.24, 25 Improving patient information using alternative strategies may have an impact on these issues and may also have legal consequences. 4 47

48 How can results of the current study be transferred to daily surgical practice? Time restraints as well as lack of skills in basic communication are common in a surgical practice and contribute to suboptimal transfer of information. It is clear from this and other studies that major improvements have to be made in patient education. Interactive computer programs may contribute to solving these problems. One study evaluating the efficacy of a video film on inguinal hernia repair demonstrated improved patient understanding, higher satisfaction, and reduced doctors time.24 Moreover, interactive computer programs appear capable of drastically improving knowledge retention from 20% to 80% and may thus be a great improvement for informed consent procedures.26 A computer program does have the time to discuss all important domains to any extent a patient chooses without ever forgetting important information.27 A computer program has a potential of aiding in educating patients on specific issues related to the scheduled operative procedure and buys time for surgeons to answer specific questions. A recent trial comparing patient education by a doctor or a computer program concluded that doctors indeed can be replaced by a computer program.28 Patients learned more by using the computer program and were also equally satisfied with either education they received. Modern surgical practice can be improved by using interactive computer programs in patient education. One may question whether the design of the present study is optimal. For instance, conclusions were drawn on the basis of comparisons of VAS scores. A recent study concluded that an alternative verbal rating score (VRS) may perform better compared to a VAS system.29 Irrespective of the design, the present study demonstrates that improvements in patient education in general are needed and probably attainable. Future research on the efficacy of computer techniques as an alternative for patient education is warranted. 48

49 References: 1] Grueninger, U.J., M.G. Goldstein, and F.D. Duffy, A conceptual framework for interactive patient education in practice and clinic settings. J Hum Hypertens, Suppl 1: p ] Pederson, L.L., Compliance with physician advice to quit smoking: a review of the literature. Prev Med, (1): p ] Mullen, P.D., D.A. Mains, and R. Velez, A meta-analysis of controlled trials of cardiac patient education. Patient Educ Couns, (2): p ] Krishna, S (1997). Clinical trials of interactive computerized patient education: implications for family practice. Fam Pract 45 (1): ] Mullen, P.D., L.W. Green, and G.S. Persinger, Clinical trials of patient education for chronic conditions: a comparative meta-analysis of intervention types. Prev Med, (6): p ] Breemhaar, B. and H.W. Van den Borne, effects of education and support for surgical patients: the role of perceived control. Patient Educ Couns, : p ] Rosen, M.A. and D.N. Logsdon, The insure project on preventive health services. Stat Bull Metrop Insur Co, (1): p ] Holme, I., et al., The Oslo Study: diet and antismoking advice. Additional results from a 5-year primary preventive trial in middle-aged men. Prev Med, (3): p ] Levine, D.M., et al., Health education for hypertensive patients. JAMA, (16): p ] Stamler, J., et al., Prevention and control of hypertension by nutritional-hygienic means. Long-term experience of the Chicago Coronary Prevention Evaluation Program. JAMA, (18): p ] Morisky, D.E., et al., Five-year blood pressure control and mortality following health education for hypertensive patients. Am J Public Health, (2): p ] Brody, D.S., et al., Patient perception of involvement in medical care: relationship to illness attitudes and outcomes. J Gen Intern Med, (6): p ] Brody, D.S., The patient s role in clinical decision-making. Ann Intern Med, (5): p ] Cassileth, B.R., et al., Information and participation preferences among cancer patients. Ann Intern Med, (6): p ] Ende, J., et al., Measuring patients desire for autonomy: decision making and information-seeking preferences among medical patients. J Gen Intern Med, (1): p ] McIntosh, J., Processes of communication, information seeking and control associated with cancer: A selective review of the literature. Soc Sci Med, (4): p ] Temple, W.J., et al., Conservation surgery for breast cancer as the preferred choice: a prospective analysis. J Clin Oncol, (21): p ] Waitzkin, H., Doctor-patient communication. Clinical implications of social scientific research. JAMA, (17): p ] Breemhaar B (1992). Voorlichting aan operatiepatiënten: knelpunten, Med Contact 47: ] Seeman M, Evans J (1962). Alienation and learning in a hospital setting. Sociol Rev 27: ] Hoermann S, Doering S, Richter R, Walter MH, Schussler G. Patients need for information before surgery. Psychother Psychosom Med Psychol Feb;51(2): ] Doust JA, Morgan TN, Weller BJ, Yuill BJ. Patient desire for information before a total hip-replacement operation. Med J Aust Aug 21;151(4):201, ] Tabenkin H, Goodwin MA, Zyzanski SJ, Stange KC, Medalie JH. Gender differences in time spent during direct observation of doctor-patient encounters. J Womens Health (Larchmt) Apr;13(3): ] Kriwanek S, Armbruster C, Beckerhinn P, Blauensteier W, Gschwantler M. Patients assesment and recall of surgical information after laparoscopic cholecystectomy. Dig Surg. 1998; 15(6): ] Turner P, Williams C. Informed consent: patients listen and read, but what information do they retain? N Z Med J Oct 25;115(1164):U

50 26] Begley S. Teaching minds to fly with discs and mice. Newsweek 1994;May 31. p ] Keulers BJ, Spauwen PHM.Can face-to-face patient education be replaced by computer-based patient education? European Journal of Plastic Surgery 2003, vol 26, nr 6 november, ] Keulers BJ, Welters CFM, Spauwen PHM, Houpt P. Can face-to-face education be replaced by computerbased patient education? A randomised trial. Patient Educ Couns 2007, vol 67, ] Loos MJ, Houterman S, Scheltinga MR, Roumen RM. Evaluating postherniorrhaphy groin pain: Visual Analogue or Verbal Rating Scale? Hernia 2007, nov 15 [Epub ahead of print]. 50

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53 Chapter 5 Can face-to-face patient education be replaced by computer-based patient education? A randomised trial Keulers BJ, Welters CFM, Spauwen PHM, Houpt P. Patient Education and Counselling 2007, 67; Presented at the Annual Meeting of the Dutch Plastic Surgeons Society (NVPC) in Noordwijk, The Netherlands (August 2005). 53

54 Abstract: Objective: Computer-based patient education is an effective (therapeutic) tool. More and more studies prove that it can be an effective additive for face-to-face education, but it s still unclear if it is possible to educate patients by only using a computer. Our objective was to compare knowledge levels and satisfaction scores after computer-based patient education versus doctor-based patient education. Methods: We started a randomised and stratified trial in a large plastic surgery clinic in the Netherlands. 113 Patients with carpal tunnel syndrome (CTS), scheduled for operation were included. One group received CTS education by a doctor using a checklist (group A). The other group received the same CTS education by especially designed interactive computer program (group B). After two weeks, knowledge levels and satisfaction scores were tested by using a questionnaire. Results: 113 patients were included, 96 patients finished the questionnaire. With respect to knowledge levels the doctor group (A) scored 20.2 points (max 40 points), and the computer group (B) scored 23.5 points. After correction the difference was 2.8 points (p=0.001). The total satisfaction score in group A was 7.6 and in group B 7.5; a difference of (p=0.585). Conclusions: The results suggest that educating patients can result in a higher knowledge levels by using a computer than by using a doctor. Satisfaction seems equal after both methods of education. Practice implications: Knowing that you can educate patients without seeing a doctor or nurse seems promising. Patient can be educated by computer-based education programs leaving more time in a consultation for asking questions and discussing treatment options. The discussion will be at a more equal level of knowledge. Possibly it can save time and money resulting in a more efficient patient care, without dissatisfying our patients. 54

55 Introduction: It has been postulated that people retain 10 per cent of what they see, 20 per cent of what they hear, half of what they see and hear, and 80 per cent of what they see, hear and do.1 Therefore, computer-based patient education (CBPE) may effectively enhance delivery of health care.2, 3, 4, 5 In theory this form of teaching is associated with several advantages: inherently effective and efficient, fast, patient-focused and inexpensive (because recurrent cost can be low).3 Patient education is a time-consuming and repetitive aspect in the provision of health care services. It is also one of the most important tasks of the physician.2 Up to 25% of office time in general practice is spent on patient information, instruction and counselling.6 In 1984 Waitzkin found, that doctors tend to underestimate patients desire for information.7 Other studies have confirmed that patients desire more information about health care and more information concerning their conditions, treatment and prognosis.8-14 When the quality of information a patient receives improves, awareness and knowledge of treatment goals, and compliance with treatment objectives improve, resulting in a more active role in medical decisionmaking Well-informed patients are more likely to become active partners in the management of their own health.15, 19 This ultimately creates a higher level of patient satisfaction and an improved outlook on life.18 In line with this, patient surveys have identified considerable dissatisfaction with doctors lack of attention to patient education.20 Doctors themselves too often voice doubt about their success in patient education. They are pessimistic about their ability to change patients lifestyle, and lack confidence in their own treatment strategies.21, 22 Physicians tend to over-utilize ineffective education strategies, and under-utilize potentially more effective behavioural or psychological treatments.6 Improvement of patient education therefore may have significant effect on the well-being of patients and doctors. In this study we present a new concept for educating patients. We suggest that a computer is able to educate patients about their disease or operation without the intervention of a doctor. In our randomised trial one group was educated on carpal tunnel syndrome (CTS) by a doctor and one group only by using a computer. Knowledge levels and satisfaction scores were compared to test if a computer can educate as well as a doctor. Methods: 5 Hypothesis: The following hypothesis was studied: knowledge levels after patient education by means of an interactive computer program are lower than after education given in a standard doctorpatient contact (face-to-face). Secondary hypothesis: Patient satisfaction is lower after education by an interactive computer-based program than after standard doctor-based education. Design: The study is a prospective randomised and stratified controlled trial, with approval of the medical Ethics Committee of the Isala Clinics. All patients with a carpal tunnel syndrome (CTS), attending the clinic, who met the inclusion criteria, were included in the study by one of the authors (CFMW), in the period from November 2002 until December After having been informed, the consent was documented and patient answered questions about: earlier CTS operations or education on this topic, frequency of computer use, age, sex, and education level. 55

56 The included patients were stratified for computer use (more or less than once a month) and previous education on CTS (yes or no). Stratification was used because the two groups would be relatively small (50-60), thus preventing the occurrence of a difference between the two groups in relevant characteristics (previous education and computer experience) even when an adequate randomisation is used. Following stratification, patients were randomised for group A (education by a doctor) or B (education by an interactive education program), using the method described by Steve Simon.1, 23 A randomisation office was used. A pre-test post-test design was not used to prevent a so called history effect, and because a solid randomisation procedure would prevent differences in pre intervention patient characteristics (knowledge retention and satisfaction) between both groups.24 In both groups, patients received the same information, but by different means (computer versus doctor). All patients in group A received their education by the same doctor, who personalised the information but also used a checklist to ensure a standard procedure. The checklist ensured that the physician gave the same information as the computer program. Just one doctor was assigned to this project to guarantee a standard procedure, as more doctors could cause more mixed results. In consensus with all plastic surgeons a doctor with good educational skills was asked. By using this concept we assured an optimal verbal education and not an average verbal education (which would have resulted in a larger difference in knowledge retention between the two groups). Patients in group B received a short instruction about the education program. The education program was displayed on a laptop with a touch screen. Collected data, blinded for randomisation, were sent once a week to an independent interviewer. Two weeks after the education the patients in both groups were interviewed by telephone using a standard questionnaire. The interviewer was blinded with respect to the kind of education the patients received. Both groups had to answer the same questions. The results were collected in a computer excel database and sent back to the primary researcher who prepared them for statistical analysis. After collection of all data, they were blinded for statistical analysis. Setting: The study was conducted in a large training hospital in the middle of the Netherlands, in a plastic surgery office with 5 plastic surgeons and 3 residents. Participants: We included all patients with idiopathic CTS. Known causes for CTS (arthritis, trauma, etc.) were a reason for exclusion. All patients had to have a good understanding of the Dutch language and had to be adequately receptive (no mental or severe physical handicaps). Main outcome measures: The outcomes measured were level of knowledge and satisfaction of education. Every question was a statement about the education received. Each question in the questionnaire generated one point for a good answer and zero points for a wrong answer. This resulted in an overall score for the questionnaire for each patient. Satisfaction was tested using scores from 1-10, 10 being best and 1 being very bad. 56

57 Content of education: The content of the education was based on Dutch law (Wet op de Geneeskundige Behandelingsovereenkomst: WGBO (Medical Treatment Contracts Act)) and on a patient survey. A literature search of educational publications was done, which resulted in 96 topics in 14 categories: disease, diagnosis, preoperative, operation, anaesthesia, post-operative, self-care, emergencies, medication, hospital, information, patient s rights, costs, accessibility of the hospital. We asked 23 patients and 10 doctors their thoughts on which topics were essential for patient education about CTS. These topics were included in the basic patient education. Computer program: We first designed the program as a flow chart on paper [figure 1]. This was based on a previous literature study. Text, animations and pictures were collected and were put in a logical order. To save time and expenses, we used pictures and animations from known sites after getting permission from their owners. A programmer built the education program using this model with the software program Macromedia Director 7. The programmer was a student in software designing and therefore we were able to build the program with limited expenses (6.000 euro). It took about 5 months to build and test the program. Figure 1: Flow chart of an education program. Standard information is information every patient has to read in a fixed order. The remainder of the program is optional and can be read in random order. quit instruction Standard information education information on CTS optional menu 5 instruction movies quiz additional information The education program consisted of two parts. The first part contained relevant information on CTS as discussed before [figure 2]. Every patient had to read all the program pages in a set order, because linear learning is better for education programs.25 The second part was an optional part for patients with additional questions. It consisted of optional information, a quiz, and movie clips of a patient who previously underwent a CTS release [figure 3 and 4]. 57

58 Figure 2, example of information on the CTS operation, illustrated with an animation. Figure 3, example of patient movie, in which a patient explains the nerve conduction test used in CTS. 58

59 Figure 4, example of optional menu after the basic information. Our program was kept as simple as possible. A touch screen was used with simple buttons.26 We only used instructional animations and pictures with essential information. All information was additionally read by a computer voice for participants with reading problems. It was possible for patients to test their knowledge in a quiz. Patients could also view videos in which a patient explained her own experiences. It was not possible to individualise the information. The information was written for the procedure that was used in this specific hospital. A pilot study was done to test the education program. At random 20 patients were asked to test the program. Afterwards they were asked questions about the programs content, layout, function and usability. The answers were used to improve the program. To limit bias, patients were allowed to use the program for maximal 30 minutes in the outpatient clinic on a laptop with a touch screen in a for all patients the same empty consultation office. The program was only used on this stand alone laptop. They were able to read the information more than ones. A secretary gave instruction how to use the program, and was able to help with software problems, but could not answer medical questions. The patients were not able to ask their surgeon any questions, until after they had their questionnaire filled out. 5 Face-to-face education: The patients in group A where educated by a plastic surgeon. We chose a surgeon with good communication skills. All patients where educated by the same surgeon with the use of a checklist to control that no topics could be forgotten. The consultations where in normal consultation time (approximately 15 minutes). If necessary pictures where drawn to explain the procedure and patients where able to ask questions. By using a sound randomisation procedure, educating patients in the same environment and using a checklist we wanted to control bias as much as possible. 59

60 Intervention: questionnaire design: The questionnaire covered all aspects of the CTS education and in the same sequence as presented during the education session. We used multiple-choice questions with three (correct, not correct, do not know) answer possibilities. A good answer was scored with one point, a false answer or don t know was scored with zero points. One of which was always open for patients who did not find their answer to the question in the proposed options. Open questions were not used for their tendency to bias. 27 For validation, patients were asked to interpret and answer the questions. This was also done by an education expert, a Dutch language teacher and a professor in medical informatics, to check all questions for face and content validity, as described by Zielhuis.28 Some questions were revised, as suggested, other questions were left out the final questionnaire. This resulted in 40 questions on 5 general topics (disease, investigations, treatment, complications, and posttreatment). A final question was added to measure satisfaction. As the questionnaire was done by telephone, patients were asked to score their satisfaction of the received education on a scale from one to ten, ten being supreme and one being very bad. Statistical analysis: We performed a power analysis before starting the inclusion of patients. For a power of 0.80 and a difference in score of 3 points we needed 126 patients, including 20% drop out. For analysis purposes groups were blinded, a database was created in SPSS and a t-test for two in dependable groups was used. Results are presented in Mean with standard deviation. There also was a correction for age, gender, frequency of computer use, and education level. This was done by means of linear regression techniques, to correct for possible confounding patient characteristics not symmetrically distributed in the two groups by randomisation (because of the smaller sample size). For the asymmetric distribution in the satisfaction scores a Mann- Whitney-U test was used. Results: 113 patients were randomised (group A 59 (doctor education), and group B 54 (computer education)). In group A: 10 patients and in group B: 7 patients refused further participation after inclusion or could not be reached two weeks after the education for answering the questionnaire. This resulted in a total of 96 (85%) retrieved complete questionnaires. The average age in group A was 52.8 years (sd 11.9), and in group B: 50 years (sd 12.2). Most patients were female (group A 79.6%, group B 83%). The education level of the patients was comparable in both groups, with a small tendency towards a higher education in group A. The frequency of computer use was equal in the two groups [table 1]. 60

61 Table 1: Patient characteristics. Group A Group B Age: mean ± standard deviation 52.8 ± ± 12.2 Female in % Education level in % per group A: no education F: university, masters degree A: 0.0 B: 8.5 C: 34.0 D: 36.2 E: 19.1 F: 2.1 A: 0.0 B: 8.5 C: 42.6 D: 34.0 E: 10.6 F: 4.3 Frequency of computer use in % A: never B: few times a year C: few times a month D: few times a week E: daily A: 31.9 B: 17.0 C: 4.3 D: 21.3 E: 25.5 A: 36.2 B: 8.5 C: 8.5 D: 27.7 E: 19.1 The total mean knowledge score in group A was 20.2 (n=49), in group B: 23.5 (n=47). The difference between the two groups after statistical analysis was 3.3 points (95% confidence interval , p<0.001). After correction for age, gender, frequency of computer use, by means of linear regression techniques, the difference was 2.8 points (95% confidence interval , p=0.001) [table2]. Table 2: Results of knowledge and satisfaction scores, also after correction for the described variables. Results are in mean ± standard deviation. (mwu = Mann-Withney-U) 5 Group A Group B Difference After correction Knowledge score 20.2 ± ± (p<0.001) Satisfaction score 7.6 ± ± (p=0.38) 2.8 (p=0.001) (p=0.407) (p=0.585, mwu-test) 61

62 The total satisfaction score in group A was 7.6 and in group B 7.5. A difference of After correction there was no significant difference. Because of an unequal distribution of variables a non-parametric analysis (Mann-Whitney-U test) was used, resulting in a non-significant difference in satisfaction between both groups (p=0.585) [table 2]. In the computer group, 3 patients noted the computer education as inadequate, one scored 5 points and one 3.5 points. One patient didn t fill out this question because she was not able to use the computer correctly. In the doctor group just one patient scored under 6 points, namely 4 points, because the education was too fast and incomplete. The overall experience was positive towards both ways of education. Discussion and conclusion: Discussion: We hypothesised the knowledge scores would be less after computer-based education. To our surprise, knowledge scores after computer-based patient education were significantly higher in this study, also after correction for age, gender, frequency of computer use, previous CTS operation, previous CTS education, and education level (p=0.001). A difference in score of 2.8 on a scale of 40 points is not a large difference, but it stresses that a computer can at least educate as well as a doctor can. Patients seemed satisfied after both kinds of education, but the satisfaction measurements were not validated in this study. The score is only used as an indication for satisfaction. Satisfaction seemed not to differ between the two kinds of patient education (p=0.585). In 2004 Wofford et all. presented a review about interactive computer-based patient education.29 This is the first review on (multimedia) interactive computer-based patient education. They selected 26 papers on computer-based patient education, of which 12 discussed the concept of knowledge retention. 4 papers compared information booklets with computer-based education; all trials showed better knowledge retention after computer-based education Rostom compared computer-based education with an audio-booklet decision aide. In this paper the computer scored higher in knowledge retention.34 Four randomised trials tested knowledge retention after face-to-face patient education compared to face-to-face education plus computerbased education. Both education strategies showed higher knowledge retention rates, but this was higher in the group with the computer-based education A paper by Green et all. was not mentioned in this review, but showed the same results after educating women on genetic testing for breast cancer susceptibility.38 As illustrated by Wofford, patient education is being investigated extensively. All these trials compare person-based education with person-based education extended with some kind of information carrier (computer program, video, and brochure), a good example is the randomised trial by Strömberg et all, recently published in Patient education and counseling.39 We don t think it s difficult to understand why a lot of trials and reviews show that standard patient education is worse than standard patient education amplified with computer-based patient education in knowledge gain and satisfaction, because the patients get extra information and attention.40 The concept of leaving the doctor-based (standard) education out, by comparing the doctor with only a computer program, is fairly new, and has only been described once by Madoff et all.41 They randomised 42 psychiatric patients for education on their medication. 50% of them received personal education and 50% computer-based education. There was no difference in knowledge and compliance. But as they used a small group and as psychiatric patients are a complex subgroup, this could explain that they found no difference in knowledge retention. 62

63 By using the same doctor with good communication skills for all patients and by using a checklist, we ensured that the face-to-face received education was better (more consistent and complete) than normally received by most CTS patients. If knowledge levels would be measured after conventional education, one can assume that the difference between face-to-face education and computer education will be bigger, in favour of the computer. Using a non-validated method for measuring satisfaction is a weakness. Therefore it can only be used as an indication but not as an absolute value. This strategy was chosen because it would be impossible to use a VAS-score in a telephone interview. Though, it shows a trend that will be investigated more extensively in a new trial. Conclusion: The results from this randomised study confirm the results from previous studies, that a computer-based education program can be an excellent tool to retain knowledge about disease and treatment. Moreover, this is the first study that shows it might be possible to educate patients only by a computer-based education programme, still keeping patients satisfied. In a new randomised trial this concept will be studied in medical conditions more complex than CTS. Although this specific study relates to carpal tunnel syndrome, the principles can be extended to numerous areas of medicine and so can be of potential interest to both clinicians and educators. Practice implications: Knowing that you can educate patients without seeing a doctor or nurse seems promising. Patient can be educated by computer-based education programs leaving more time in a consultation for asking questions and discussing treatment options. The discussion will be at a more equal level of knowledge. Possibly it can save time and money resulting in a more efficient patient care, without dissatisfying our patients. Computer-based patient education programs could become a useful medical tool, resulting in better standardised patient education, facilitating daily medical practice and informed consent procedures. 5 63

64 References: 1] Begley S. Teaching minds to fly with discs and mice. Newsweek 1994; May 31 2] Sechrest RC, Henry DJ. Computer-based patient education: Observations on effective communication in the clinical setting. J Biocommun 1996;23:8-12 3] Keulers BJ, Spauwen PHM. Can face-to-face patient education be replaced by computer-based patient education? Eur J Plast Surg 2003;26: ] Nielsen J. Guidelines for multimedia on the web. ( ] Schneiderman B. Designing the User Interface: Strategies for Effective Human-Computer Interaction, 3th edition. Addison-Wesley, ] Orleans CT, George LK, Houpt JL, Brodie KH. Health promotion in primary care a survey of US family practitioners. Prev Med 1985; 14: ] Waitzkin H. Doctor-patient communication: clinical implications of social scientific research. J Amer Med Assoc 1984; 252: ] Breemhaar B. Voorlichting aan operatiepatiënten: knelpunten, Med Contact 1992; 47: ] Brody DS, Miller SM. Patient perception of involvement in medical care: relationship to illness attitude and outcomes. J Gen Intern Med 1989; 4: ] Brody DS. The patient s role in the clinical decision-making. Ann Intern Med 1980; 93: ] Cassileth BR, Zupkis RV. Information and participation preferences among cancer patients. Ann Intern Med 1980; 92: ] Ende JL, Kazis A. Measuring patients desire for autonomy: decision making and information seeking preferences among medical patients. J Gen Med 1989; 4: ] McIntosh J. Processes of communication, information seeking and control associated with cancer: a selective review of the literature. Sci Med 1974; 8: ] Seeman M, Evans J. Alienation and learning in a hospital setting. Sociol Rev 1962;27: ] Greenfield S, Kaplan S, Ware JE. Expanding patient involvement in care: effects on patient outcomes. Ann Intern Med 1985; 102: ] Kahn G. Computer-based patient education: a progress report. MD comput 1993; 10: ] Vickery DM, Kalmer H, Lowry D, Constantine M, Wright E, Loren W. Effect of a self-care education program on medical visits. J Amer Med Assoc 1983; 250: ] Wetstone SI, Sheehan TJ, Votow RG, Peterson MG, Rothfield N. Evaluation of a computer based education lesson for patients with rheumatoid arthritis. J Rheumatol 1985; 12: ] Breemhaar B. Effects of education and support for surgical patients: the role of perceived control. Patient Educ Couns 1991; 18: ] Grueninger UJ, Goldstein MG. A Conceptual framework for interactive education in practice and clinic setting. J Hum Hypertens 1990; 4: ] Valente CM, Sobal J. Health promotion: physicians beliefs, attitudes, and practices. Am J Prev Med 1986; 2: ] Wechsler H, Levine S. The physicians role in health promotion a survey of primary care practitioners. New Engl J Med 1983; 308: ] Steve Simon. A simple approach for randomisation, Brit Med J 1999; 17 24] Molenaar S, Sprangers M, Rutgers E, Luiten E, Mulder J, Bossuyt P, et all. Decision support for patients with early stage breast cancer: effect of an interactive breast cancer Cd-Rom on treatment decision, satisfaction and quality of life. J Clin Oncol. 2001; ] Roberts C. Understanding controlled trials: Randomisation methods in controlled trials. Brit Med J 1998; 317: ] Giloth BE. Managing hospital-based patient education, chapter 16: Using technology to enhance patient education effectiveness. American Hospital Publishing, Inc ] Stewart M. Development of the diabetes knowledge (DKN) scales: forms DKNA, DKNB, and DKNC. Diabetes care 1984; 7:

65 28] Zielhuis GA. Handleiding medisch-wetenschappelijk onderzoek. Wetenschappelijke uitgeverij Bunge, ] James L. Wofford, Edward D. Smith, David P. Miller. The multimedia computer for office-based patient education: a systematic review. Patient Educ Couns 2005; 59: ] Neafsey PJ, Strickler Z, Shellman J, Chartier V. An interactive technology approach to educate older adults about drug interactions arising from over-the-counter self-medication practices. Nurs 2002; 19: ] Bulmer PJ, James M, Ellis-Jones J, Smith D, Timoney AG, Donovan J. A randomized trial comparing the effectiveness and preference of a touch-screen computer system with a leaflet for providing women with information on urinary symptoms suggestive of detrusor instability. BJU Int 2001; 88: ] Jones RB, Atkinson JM, Coia DA, Paterson L, Morton AR, McKenna K, et all. Randomised trial of personalised computer based information for patients with schizophrenia. Brit Med J 2001; 322: ] Street Jr RL, Voigt B, Geyer Jr C, Manning T, Swanson GP. Increasing patient involvement in choosing treatment for early breast cancer. Cancer 1995; 76: ] Rostom A, O Connor A, Tugwell P, Wells G. A randomized trial of a computerized versus an audiobooklet decision aid for women considering post-menopausal hormone replacement therapy. Patient Educ Couns 2002; 46: ] Jones R, Pearson J, McGregor S, Cawsey AJ, Barrett A, Craig N, et all. Randomised trial of personalised computer based information for cancer patients. Brit Med J 1999; 319: ] Shaw MJ, Beebe TJ, Tomshine PA, Adlis SA, Cass OW. A randomized, controlled trial of interactive, multimedia software for patient colonoscopy education. J Clin Gastroenterol 2001; 32: ] Consoli SM, Ben Said M, Jean J, Menard J, Plouin PF, Chatellier G. Benefits of a computer-assisted education program for hypertensive patients compared with standard education tools. Patient Educ Couns 1995; 26: ] Green MJ, Peterson SK, Wagner Baker M, Harper GR, Friedman LC, Rubinstein WS, et all. Effect of a computer-based decision aid on knowledge, perceptions, and intentions about genetic testing for breast cancer susceptibility: a randomised controlled trial. J Amer Med Assoc 2004; 292: ] Strömberg A, Dahlström, Fridlund B. Computer-based education for patients with chronic heart failure. A randomised, controlled, multicentre trial of the effects on knowledge, compliance and quality of life. Patient Educ Couns 2006; 64: ] Beranova E, Sykes C. A systematic review of computer-based softwares for educating patients with coronary heart disease. Patient Educ Couns 2006 in press: doi: /j.pec ] Madoff SA, Pristach CA, Smith CM, Pristach EA. Computerized medication instruction for psychiatric inpatients admitted for acute care. MD Comput 1996; 13:

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67 Chapter 6 Surgical informed consent. Past, Present and Future. Are we helping patients make better decisions? B.J. Keulers*, W.K.G. Leclercq*, M.R.M. Scheltinga, P.H.M. Spauwen, G.J. van der Wilt Submitted * Both authors contributed equally to this paper. 67

68 Abstract: Background: An informed consent (IC) procedure is a stepwise process built on elements of competence, information and consent. Current consent procedures in surgery are probably outdated and may require major adjustments. A literature search may provide opportunities for enhancing quality of the IC process. Methods: Relevant English literature obtained from Pubmed, Picarta, PsycINFO, and Google between was systematically reviewed. Results: The body of literature is slim and of moderate quality. The IC procedure is an underestimated part of surgery and neither surgeons nor patients sufficiently realise its importance. Surgeons are not specifically trained and lack competence in coaching a legally correct IC process. Computerised programmes can support the IC process in important ways, but are rarely used for this purpose. Conclusions: An optimally informed patient will have more realistic expectations about a surgical procedure and associated risks. Improved patient satisfaction will lead to less legal claims. The use of an interactive computer-based program may provide a successful way to improve IC procedures. 68

69 Introduction In general, informed consent (IC) is a legal term that is supported by jurisdiction and international laws and is described as voluntary authorization, by a patient or research subject, with full comprehension of the risks involved, for diagnostic or investigative procedures, and for medical and surgical treatment. 1 A set of basic elements of IC can be identified: preconditions, information and consent. Preconditions for proper IC include the patient s competence and voluntariness. The information provided must be adequate and comprehensible. The consent of a patient authorises the procedure that is to be performed. The system of giving consent by a patient for an invasive procedure or operation (Surgical IC, or SIC) has been common practice since many years. Providing appropriate preoperative information to a surgical patient is dictated by law and may prevent litigation. In spite of major developments in information technology (IT), procedural aspects of the SIC have not altered over the last decades in most hospitals. Surgeons prepare their patients very randomly, and quality will probably differ extensively. With (or without) written information, patients are supposed to give SIC. Patient education and patient-oriented care are important topics nowadays. Nevertheless the literature on the quality of the SIC process is scarce. Goal of the present overview is to analyse the elements of the SIC process. Our hypothesis is that initial concepts of SIC are outdated and have resulted in a daily practice of low quality informed consent care. Methods The search for only English publications or abstracts was limited to the period (with exception of the legal cases). Two surgical trainees (W.L. and B. K.) independently searched for relevant literature in Pubmed, Picarta, PsycINFO and Google using the following keywords/ Mesh-terms: Informed consent, surgical procedures, operative, patient education, mental competency, and history. The Cochrane search filter for randomised controlled trials was also used: (Clinical trial[pt] OR randomized[tiab] OR placebo[tiab] OR clinical trials[mh] OR randomly[tiab] OR trial[ti]) NOT (animals[mh] NOT (animals[mh] AND humans[mh])). In addition, all selected articles were scanned for relevant references or the related articles -mode (Pubmed). Only articles focussing directly on our study questions were selected for further analysis. Results Between January 1993 and December 2008, 2740 articles were identified using the Mesh surgical procedures and informed consent. Adding patient education resulted in 302 articles. The addition of the Mesh mental competency narrowed this number down to 180 articles; history provided another 58 articles. Most of these articles were not related to the present study questions, as operative procedures were tested which required an IC. Only a limited number of articles focused on the IC itself as a study target. Eventually, 172 articles were selected directly or through references or a related article search. Of this body of literature, 76 articles were deemed of sufficient quality and were directly focussing on our study questions. Only those articles were included in the present study. Meta-analysis of these articles was not possible because the studies differed in study design, tests used and outcome measurement. 6 69

70 History of Surgical Informed Consent In medieval times, doctors asked for a hold harmless document aimed at releasing them from any future responsibility towards patient or family in the event anything adverse happened following therapy. This pro corpore mortuoto can be found in Italian, French and Middle East archives as early as the 14th century and is considered an early precursor of IC, although its purpose was to protect the doctor and not the patient.2-4 The initial concept of current IC legislation has developed in later centuries from case-related litigation into a standard practice (figure 1). Some bizarre landmark cases may be identified and are worth mentioning in the present overview. In the 18th century, a patient sued his doctor for refracturing his leg and experimenting with a novel external fixating mechanism without informing or obtaining approval. This 1767 Slater vs. Baker and Stapleton trial was the first example of a kind of IC case.5, 6 The concept of IC was used in a 1845 novel by Edgar Allen Poe (figure 2) as a patient was asked for permission in an experimental therapy just before his death.7, 8 Figure 1: The history of informed consent. A timetable. Landmarks in the history of the informed consent process 1905 More vs. Williams 1767 Slater vs. Baker and Stapleton preconditions information consent 1914 Schoendorff vs. Society of New York Hospital 1957 Bolam vs. Friern Hospital Management Committee 1947 The Nuremberg code 1972 Canterbury vs. Spence 1980 Truman vs. Thomas 1992 Roger vs. Whittaker 1964 The Decleration of Helsinki Year 70

71 Figure 2: American Review: a Whig Journal (December 1845); publication of Edgar Allen Poe s The fact in the case of M. Valdemar. Retrieved from: The fundamentals of today s practice of SIC gained more structure at the beginning of 20 th century, especially after the development of anaesthesia and more invasive surgery (figure 1). In Mohr vs. Williams in 1905, a woman agreed to an operation on her right ear.9 However, during the operation the surgeon judged her left ear in the need of a repair. He was subsequently sued and convicted because he had not proceeded according to the preoperative agreement. The judge called this agreement a contract that authorizes the physician to operate only to the extent of the consent given.10 In Schoendorff vs. Society of New York Hospital in 1914, Justice Benjamin Cardozo (figure 3) became famous for his judgement in the following case. A woman had consented to an abdominal examination under anaesthesia but not to operation.11 However, the surgeon removed a tumour that eventually let the patient to file a law suit. Cardozo s opinion expressed what has become one of the most basic elements in the concept of IC development: every human being of adult years and sound mind has a right to determine what shall be done with his own body, and a surgeon who performs an operation without the patient s consent commits an assault for which he is liable in damages A patient should be viewed as a person who has the right of bodily self-determination.6,

72 Figure 3: Cardozo, Benjamin Nathan. Online Photograph. Encyclopædia Britannica Online. After the Second World War, there was a strong public reaction to cruelties committed by Nazi concentration camp doctors performing horrible tests on patients without prior information or approval. A code was written as a direct result of the Nuremberg trials (U.S.A. vs. Karl Brandt et al.). This Nuremberg Code was an important step in the development of the IC process in trials (figure 4). It consisted of 10 preconditions any human research study had to fulfil. Interestingly, the first governmental instruction for IC in trials is of German origin and already written in Later on in 1964, The World Health Organisation set the Declaration of Helsinki with 22 preconditions for human research. The 1957 case Salgo vs. Leland Stanford, Jr. University Board of Trustees introduced the term informed consent, and this term was accepted in Natanson vs. Kline in Figure 4: Nuremberg Trial: the twenty-three defendants in dock during the doctors trial. Retrieved from 72

73 A synchronous development occurred in the domain of information. A 1957 UK case Bolam vs. Friern Hospital Management Committee focused on what risks should be discussed with a surgical patient.20 This doctor-centred view resulted in a reasonable standard: any surgeon should tell what other surgeons also tell their patients, a principle known as the Bolam-principle.21 However, the 1972 Canterbury vs. Spence case determined that all risks and alternatives of a procedure have to be explained.22 This trial clearly demonstrated a shift from the doctors point of view towards the patients view as the standard of care in IC: the reasonable patient standard Subsequently, the Australian High court overruled the Bolam-principle in the 1992 Roger vs. Whittaker case of a woman losing sight in her good eye after being operated on her diseased eye.20 Although the risk was a mere 1:14 000, the court ruled that the surgeon should have informed the woman as she had apparently asked for this information. On the other hand, the doctor had considered this low risk not relevant.27, 28 Since the 1980 Truman vs. Thomas case, information provided in an IC process must also include risks of not acting or postponing.29 In this case, a Pap-smear was refused by a woman without knowing the associated risks i.e. not detecting cancer in time for curative treatment.6 Dutch legislators as well as governments from various other Western countries have realized that legislation at that time was out of date. Based on cases such as mentioned above, several adjustments have led to the 1995 Dutch Medical Treatment Contract Act in which all elements of IC are present including preconditions, information and consent. Present of Surgical Informed Consent Current elements of IC Based on historical cases and legislation, IC is supported by three corner stones, preconditions, information and consent (figure 5). Preconditions include competence and voluntariness. A patient is a person who has a right of self determination. But a patient must be able to decide about his own body and must be able to decide freely without being influenced by others. The second corner stone is information. According to the 1995 WHO declaration on the promotion of patients rights, patients have the right to be fully informed about their health status, including the medical facts about their condition; about the proposed medical procedures, together with the potential risks and benefits of each procedure; about alternatives to the proposed procedures, including the effect of non-treatment, and about the diagnosis, prognosis and progress of treatment.30 All this information must be disclosed by the surgeon to enable the patient his right of self determination. A well defined care plan incorporating the surgeon s advice should be discussed, and it must be verified that the patient indeed understands this information. The third corner stone is related to consent: registration of the patients decision and (written) consent

74 Figure 5: The elements of informed consent. Preconditions: Competence Voluntariness Informational elements: Disclosure of information Recommendation of a care plan Understanding of this information by the patient Consent Elements: Decision by patient Authorization by the patient to proceed An IC procedure usually takes place during a preoperative consult and may be directed by a consultant, a resident or a specialised nurse. The information associated with a surgical procedure can be exchanged verbally, in writing, or by video or by computer technology. In this respect, large differences in procedures exist between countries. The US demands a patient signature whereas a note in the patient chart is sufficient in the UK. In the Netherlands, doctors are not obliged to obtain written informed consent.34 Preconditions There is limited evidence on preconditions of IC. The patient s competence is only checked in a general sense and deemed appropriate if communication with a patient is normal.35 A legally appointed surrogate decision maker or another representative in accordance with the law is allowed to decide for the patient if the latter is incompetent.36 However, a normal intelligence per se does not necessarily mean that a patient is competent. Recently Appelbaum reviewed the literature on patient competence.37 A group of patients with known cognitive disease as well as patients with cancer demonstrated variable outcomes on competence tests. Moreover, low scores were also found in people of older age and limited education. The number of patients not having sufficient capacity for an IC was higher than expected. Surprisingly, the doctor s ability to differentiate between competent and incompetent was not better than throwing a dice.38 One study focused on training a specialized staff but this approach only enhanced interest in the IC procedure itself.39 Junior staff can be effectively educated to improve their skills in the IC process using feedback training strategies. Their level of knowledge increased, but skills in obtaining IC did not change.40, 41 Another option is to educate specialised nurses working with an expanded role activity that may legally fulfil the role of a doctor in an IC procedure. These nurses require training and supervision for questions beyond their competence. However, no studies were found on the quality of the IC procedure by these professionals.42 On the other hand, even patients who are objectively deemed competent may be ignorant and routinely do not know what their rights are resulting in wrong beliefs.43, 44 When patients were interviewed some 40% thought the IC paper confirmed their wishes.45 Interestingly, they usually did not feel the need for more information and their actual knowledge of the benefits and risks involved remained poor In contrast, when asked what information they would like to have, patients frequently demand more information than they actually received.51 74

75 Several misconceptions also exist with respect to voluntariness. One study revealed that 46% of the patients thought that the major goal of an IC was to protect the hospital from litigation. Moreover, 68% thought the IC process gave the doctor control of what happened.52 Information elements Literature on patient education is extensive and is usually focused on informing patients in a general sense. However, studies on information in relation to the IC procedure are scarce. Results consistently demonstrate that neither doctors nor patients are well prepared for all elements of the IC process Residents are frequently in charge of the IC procedure but do not know what to tell a patient and do not perform well in tests on IC and medical law In contrast, they are more capable in informing the patient on benefits of the procedure compared to giving information about risks or alternatives.62 Moreover, they performed this task more often than consultants as well as, surprisingly, nursing staff. Interestingly, 21% of the patients reported that they had received most information from sources outside the hospital.63 The way information is presented greatly influences what a patient remembers. Oral information is retained very poorly, and patients tend to forget crucial parts of information such as alternative treatment options.64 This will lead to false negative feelings, particularly in patients with a below average IQ, age over 60, a tendency to somatisation or a poor perceived control.65 A recent study revealed that great difference existed between points of view of surgeons and patients regarding relevance of information and what should be told or not.66 Another study demonstrated that patients were not interested in the form that was used, and two-thirds did not carefully read it.67 Studies on the patient s comprehension of information are rare. Analyses of tapes of IC indicate that various elements of the surgical procedure were discussed in 71% of the cases. However, an assessment of the patients actually understanding of these elements was only performed in a mere 1.5%.68 Consent elements. Studies focusing on the consent element as a third corner stone of SIC clearly indicate that consent forms are not composed very well.69, 70 Readability is poor, and only a minority is written on a 12-year-old reading level, which is generally accepted best practice More than half of all IC forms is filled out incorrectly.74, 75 One retrospective study found that the paper work could not be retrieved in 7.7 % of the procedures.76 Future of Surgical Informed Consent Neither surgeons nor patients are doing well when it comes to virtually any aspect of the IC process. Improving education of various stakeholders participating in IC may prove beneficial. Preconditions A number of validated tests of patients competence is available and may improve the preconditions of the IC. A recent study demonstrated that outcome of one test was almost as consistent as an expert opinion.77 Examples of such validated tests are the Mini-Mental State Examination and the MacArthur Competence Assessment Tool. These two test panels require about 8-20 minutes for one patient using a pc-based interface. Other tests including the Decision Evaluation Scales (DES) or the MacCaT-T are developed for specific purposes and are not generally used.78,

76 Information elements The use of computer-based information leaflets may offer an effective way of educating patient for the SIC process.80 In one study, patients and their relatives read these leaflets on average 5 times.81 In general, the more information is provided the more information the patient remembers (Table 1). Most studies do not consider the total IC process but only its information element. The information element of an IC performs better in interactive settings not only for operative procedures but also for other surgical interventions The amount of information provided during a preoperative consultation in the outpatient clinic can be overwhelming. If transfer of information is adjusted to the patient s own speed and wishes in an interactive setting, he tends to comprehend more and have a better recapitulation.113 Problems in language and level of literacy can also be resolved.114 Validated tests have been developed to check if the patient actually understands the information.115, 116 Better informed patients have more realistic expectations, a higher satisfaction and demonstrate more treatment cooperation.117 Training doctors to enhance their SIC skills is an option. However, providing such high quality information will take an enormous effort by the doctor next to a tremendous amount of time. Therefore improving medical education in this aspect will not be a final solution. 76

77 Table 1: Overview randomized controlled trials focused on informed consent. Author Journal Year of publication Specialism Country N= Studygroups Outcome in favor of studygroup(s) Armstrong Br J Plast Surg 1997 Plast Surg UK 269 oral vs oral and written information oral and written Deyo Med Care 2000 Neuro/Ort USA 393 oral and written information vs pc based video pc based video Chan Arch Otolaryngol Head Neck Surg 2002 Ent/Gen surg Canada 125 oral vs oral and written information with figures oral and written with figures Mason BJOG 2003 Gyn UK 31 oral vs oral and written information Rossi Arthroscopy 2005 Ort USA 150 oral vs oral and video information oral and video oral and video Danino Plast Reconstr Surg 2006 Plast Surg France 60 oral vs oral and video information oral and video Mosely Keulers Br J Ophthalmol Patient Educ Couns 2006 Oph USA 90 oral vs oral and dia or video information 2007 Plast Surg Netherlands 113 oral and written vs pc based information oral and dia or video pc based 6 Masood BJU Int 2007 Uro UK 45 oral vs oral and written information oral only N = Number of patients Ort = Orthopedics Gyn = Gynaecology Plast Surg = Plastic Surgery Ent = Ear Nose Throat Oph = Ophtalmology Neuro = Neurosurgery Gen Surg = General Surgery Uro = Urology 77

78 Consent elements Computers are particularly useful for the consent part of the IC. In one study a computer program was used for patient education and the data seen by the patient were recorded for use in case of litigation.118 In another study, computer technology was explored as the one and only way of IC.119 Even the consent form was replaced by a recorded patient authorisation via a signature on a touch screen. In a third study the IC form was completed through a computer-based interface providing an overview of all essential parts that were signed and stored electronically.120 This sort of IC form was preferred by 96% of the patients.121 However, this approach deals with the consent part of the procedure but it does not check whether a patient is competent or if he understands the information. Basically, it is only a digitalised IC form. Recording the IC process is of growing importance in medico-legal cases. Computer-based interactive IC programs have the advantage of recording every single step.122 One study discussed the possibility of computer-automated technology. This article gives several examples of programs used for the IC process, and the authors suggest that is a very good way to obtain IC. However, there is no evidence that it actually works better or if legal claims are prevented.123 Discussion The available literature demonstrates substantial weaknesses and omissions in everyday practice of the SIC process. Preconditions are neglected, information is incomplete, and the consent itself is not an accurate reflection of the patient s authorization. The number of studies focusing on IC is generally low, particularly in general surgery. The quality of the IC process can only improve if all its elements are critically re-evaluated. Why do surgeons perform suboptimal when it comes to IC? Consent apparently is not a popular part in the doctor-patient relation, and presumably both parties are guilty. In the media surgeons are blamed for making mistakes, and people are encouraged to sue for every fault their surgeons make leading to an increase in medico legal claims.124 However, it should be realised that most legal cases are not because of failures in treatment but due to failed communication.125, 126 Discrepancies between expected and achieved results (55%) next to faulty information (30%) are main reasons for patients to claim. In contrast to what one would expect, most complaints are generated after elective minor operations (70%).127 An IC form is inadequate if it only deals with the IC form itself while omitting the incorporation of the information process or the quality of the total process. Several cases based on faulty forms resulted in successful claims: no documented alternative, no risks documented, or no IC form at all.128 Hence, a non-standardized way of informing a patient about the risks of complications inherently results in a vulnerable position of the surgeon.129 Both surgeons and their patients must appreciate that an improved and standardized IC process leads to more realistic expectations. More realistic patients are more satisfied, have a higher commitment with their treatment and demonstrate less tendency towards legal claims.130 Both groups obviously have a lot to gain from optimalized IC forms. Several steps are mandatory for an improved SIC process. Optimalizing SIC can possibly be done by strengthening medical en specialist education. In today s practice however, consultation time is already scarce. A computer may aid the doctor in helping his patient to receive a high quality SIC. It must be appreciated that computer programs do not undermine the doctor-patient relationship but are of potential surplus value. On the other hand, emergencies and rare conditions or treatments are ideally approached using a non computerised SIC. 78

79 Each separate corner stone of IC may be improved using computer technology. As all preconditions require standard inclusion into the SIC process131, patient competence and characteristics can be checked, preferably using a simple questionnaire as can voluntariness and decision-making skills. Consistent information that is presented in an understandable format132 can also be communicated by computers. Using this approach, doctors buy time that can be used for discussing specific procedural details, personal questions or emotions. The consent stage of the IC includes a formal (written) consent by the patient. Registration and storage of the SIC using computer technology completes a successful IC procedure If we continue to use existing SIC techniques as we have done for decades, improvements in the quality of the IC process will become extremely time consuming and demanding for surgeons. The SIC should therefore ideally be performed using an integrated interactive computer program.133 As most surgeons prefer to spend their time on surgery itself, they must consider introducing computer technology as an aid for SIC in daily surgical practice. Acknowledgements: We Thank Professor H.D.C. Roscam Abbing, Emeritus professor of Department of Law, Economics and Governance, University Medical Centre Utrecht (Utrecht, The Netherlands) for her valuable contributions to this paper. 6 79

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82 56] Schouten B, Hoogstraten J, Eijkman M. Dutch dental patients on informed consent: knowledge, attitudes, self-efficacy and behaviour. Patient Educ Couns 2002; 46(1): ] Skene L, Smallwood R. Informed consent: lessons from Australia. BMJ 2002; 324(7328): ] Soin B, Smellie WA, Thomson HJ. Informed consent: a case for more education of the surgical team. Ann R Coll Surg Engl 1993; 75(1): ] Angelos P, Darosa DA, Bentram D, Sherman H. Residents seeking informed consent: Are they adequately knowledgeable? Curr Surg 2002; 59(1): ] McGaughey I. Informed consent and knee arthroscopies: an evaluation of patient understanding and satisfaction. Knee 2004; 11(3): ] Pleat JM, Dunkin CS, Davies CE, Ripley RM, Tyler MP. Prospective survey of factors affecting risk discussion during consent in a surgical specialty. Br J Surg 2004; 91(10): ] Angelos P, Darosa DA, Bentram D, Sherman H. Residents seeking informed consent: Are they adequately knowledgeable? Curr Surg 2002; 59(1): ] Lavelle-Jones C, Byrne DJ, Rice P, Cuschieri A. Factors affecting quality of informed consent. BMJ 1993; 306(6882): ] Keating NL, Weeks JC, Borbas C, Guadagnoli E. Treatment of early stage breast cancer: do surgeons and patients agree regarding whether treatment alternatives were discussed? Breast Cancer Res Treat 2003; 79(2): ] Lavelle-Jones C, Byrne DJ, Rice P, Cuschieri A. Factors affecting quality of informed consent. BMJ 1993; 306(6882): ] Keulers BJ, Scheltinga MR, Houterman S, Van Der Wilt GJ, Spauwen PH. Surgeons Underestimate Their Patients Desire for Preoperative Information. World J Surg ] Lavelle-Jones C, Byrne DJ, Rice P, Cuschieri A. Factors affecting quality of informed consent. BMJ 1993; 306(6882): ] Braddock CH, III, Edwards KA, Hasenberg NM, Laidley TL, Levinson W. Informed decision making in outpatient practice: time to get back to basics. JAMA 1999; 282(24): ] Bottrell MM, Alpert H, Fischbach RL, Emanuel LL. Hospital informed consent for procedure forms: facilitating quality patient-physician interaction. Arch Surg 2000; 135(1): ] Hopper KD, TenHave TR, Tully DA, Hall TE. The readability of currently used surgical/procedure consent forms in the United States. Surgery 1998; 123(5): ] Bottrell MM, Alpert H, Fischbach RL, Emanuel LL. Hospital informed consent for procedure forms: facilitating quality patient-physician interaction. Arch Surg 2000; 135(1): ] Hopper KD, TenHave TR, Tully DA, Hall TE. The readability of currently used surgical/procedure consent forms in the United States. Surgery 1998; 123(5): ] Paasche-Orlow MK, Taylor HA, Brancati FL. Readability standards for informed-consent forms as compared with actual readability. N Engl J Med 2003; 348(8): ] Edwards AG, Weale AR, Morgan JD. Informed consent in renal transplantation. Postgrad Med J 2005; 81(953): ] Issa MM, Setzer E, Charaf C, Webb AL, Derico R, Kimberl IJ et al. Informed versus uninformed consent for prostate surgery: the value of electronic consents. J Urol 2006; 176(2): ] Issa MM, Setzer E, Charaf C, Webb AL, Derico R, Kimberl IJ et al. Informed versus uninformed consent for prostate surgery: the value of electronic consents. J Urol 2006; 176(2): ] Appelbaum PS. Clinical practice. Assessment of patients competence to consent to treatment. N Engl J Med 2007; 357(18): ] Appelbaum PS. Clinical practice. Assessment of patients competence to consent to treatment. N Engl J Med 2007; 357(18): ] Stalmeier PF, Roosmalen MS, Verhoef LC, Hoekstra-Weebers JE, Oosterwijk JC, Moog U et al. The decision evaluation scales. Patient Educ Couns 2005; 57(3): ] Edwards MH. Satisfying patients needs for surgical information. Br J Surg 1990; 77(4):

83 81] Edwards AG, Weale AR, Morgan JD. Informed consent in renal transplantation. Postgrad Med J 2005; 81(953): ] Armstrong AP, Cole AA, Page RE. Informed consent: are we doing enough? Br J Plast Surg 1997; 50(8): ] Ashraff S, Malawa G, Dolan T, Khanduja V. Prospective randomised controlled trial on the role of patient information leaflets in obtaining informed consent. ANZ J Surg 2006; 76(3): ] Askew G, Pearson KW, Cryer D. Informed consent: can we educate patients? J R Coll Surg Edinb 1990; 35(5): ] Brown TF, Massoud E, Bance M. Informed consent in otologic surgery: prospective study of risk recall by patients and impact of written summaries of risk. J Otolaryngol 2003; 32(6): ] Chan Y, Irish JC, Wood SJ, Rotstein LE, Brown DH, Gullane PJ et al. Patient education and informed consent in head and neck surgery. Arch Otolaryngol Head Neck Surg 2002; 128(11): ] Danino AM, Lile A, Moutel G, Herve C, Malka G. Visual documentation of oral consent: a new method of informed consent before major gigantomastia reduction for an illiterate population. Plast Reconstr Surg 2006; 117(4): ] Dawes PJ, O Keefe L, Adcock S. Informed consent: using a structured interview changes patients attitudes towards informed consent. J Laryngol Otol 1993; 107(9): ] Deyo RA, Cherkin DC, Weinstein J, Howe J, Ciol M, Mulley AG, Jr. Involving patients in clinical decisions: impact of an interactive video program on use of back surgery. Med Care 2000; 38(9): ] Hermann M. [3-dimensional computer animation--a new medium for supporting patient education before surgery. Acceptance and assessment of patients based on a prospective randomized study--picture versus text]. Chirurg 2002; 73(5): ] Keulers BJ, Welters CF, Spauwen PH, Houpt P. Can face-to-face patient education be replaced by computer-based patient education? A randomised trial. Patient Educ Couns 2007; 67(1-2): ] Langdon IJ, Hardin R, Learmonth ID. Informed consent for total hip arthroplasty: does a written information sheet improve recall by patients? Ann R Coll Surg Engl 2002; 84(6): ] Layton S, Korsen J. Informed consent in oral and maxillofacial surgery: a study of the value of written warnings. Br J Oral Maxillofac Surg 1994; 32(1): ] Makdessian AS, Ellis DA, Irish JC. Informed consent in facial plastic surgery: effectiveness of a simple educational intervention. Arch Facial Plast Surg 2004; 6(1): ] Mason V, McEwan A, Walker D, Barrett S, James D. The use of video information in obtaining consent for female sterilisation: a randomised study. BJOG 2003; 110(12): ] Masood J, Hafeez A, Wiseman O, Hill JT. Informed consent: are we deluding ourselves? A randomized controlled study. BJU Int 2007; 99(1): ] Moseley TH, Wiggins MN, O Sullivan P. Effects of presentation method on the understanding of informed consent. Br J Ophthalmol 2006; 90(8): ] O Neill P, Humphris GM, Field EA. The use of an information leaflet for patients undergoing wisdom tooth removal. Br J Oral Maxillofac Surg 1996; 34(4): ] Pesudovs K, Luscombe CK, Coster DJ. Recall from informed consent counselling for cataract surgery. J Law Med 2006; 13(4): ] Rossi MJ, Guttmann D, MacLennan MJ, Lubowitz JH. Video informed consent improves knee arthroscopy patient comprehension. Arthroscopy 2005; 21(6): ] Shurnas PS, Coughlin MJ. Recall of the risks of forefoot surgery after informed consent. Foot Ankle Int 2003; 24(12): ] Stanley BM, Walters DJ, Maddern GJ. Informed consent: how much information is enough? Aust N Z J Surg 1998; 68(11): ] Wadey V, Frank C. The effectiveness of patient verbalization on informed consent. Can J Surg 1997; 40(2): ] Edwards MH. Satisfying patients needs for surgical information. Br J Surg 1990; 77(4):

84 105] Agre P, Kurtz RC, Krauss BJ. A randomized trial using videotape to present consent information for colonoscopy. Gastrointest Endosc 1994; 40(3): ] Deyo RA, Cherkin DC, Weinstein J, Howe J, Ciol M, Mulley AG, Jr. Involving patients in clinical decisions: impact of an interactive video program on use of back surgery. Med Care 2000; 38(9): ] Hermann M. [3-dimensional computer animation--a new medium for supporting patient education before surgery. Acceptance and assessment of patients based on a prospective randomized study--picture versus text]. Chirurg 2002; 73(5): ] Hopper KD, Zajdel M, Hulse SF, Yoanidis NR, TenHave TR, Labuski MR et al. Interactive method of informing patients of the risks of intravenous contrast media. Radiology 1994; 192(1): ] Kessler TM, Nachbur BH, Kessler W. Patients perception of preoperative information by interactive computer program-exemplified by cholecystectomy. Patient Educ Couns 2005; 59(2): ] Keulers BJ, keulers MJ, Scheltinga MR, Spauwen PH. Evidence-based development of interactive patient education programs: a guide for achieving optimal computer-based patient education. Eur J Plast Surg 2006; 29: ] Keulers BJ, Welters CF, Spauwen PH, Houpt P. Can face-to-face patient education be replaced by computer-based patient education? A randomised trial. Patient Educ Couns 2007; 67(1-2): ] Wofford JL, Smith ED, Miller DP. The multimedia computer for office-based patient education: a systematic review. Patient Educ Couns 2005; 59(2): ] Keulers BJ, Welters CF, Spauwen PH, Houpt P. Can face-to-face patient education be replaced by computer-based patient education? A randomised trial. Patient Educ Couns 2007; 67(1-2): ] Wofford JL, Smith ED, Miller DP. The multimedia computer for office-based patient education: a systematic review. Patient Educ Couns 2005; 59(2): ] Appelbaum PS. Clinical practice. Assessment of patients competence to consent to treatment. N Engl J Med 2007; 357(18): ] Stalmeier PF, Roosmalen MS, Verhoef LC, Hoekstra-Weebers JE, Oosterwijk JC, Moog U et al. The decision evaluation scales. Patient Educ Couns 2005; 57(3): ] Kessler TM, Nachbur BH, Kessler W. Patients perception of preoperative information by interactive computer program-exemplified by cholecystectomy. Patient Educ Couns 2005; 59(2): ] Klima S, Hein W, Hube A, Hube R. [Multimedia preoperative patient information.]. Chirurg 2005; 76(4): ] Jimison HB, Sher PP, Appleyard R, LeVernois Y. The use of multimedia in the informed consent process. J Am Med Inform Assoc 1998; 5(3): ] Issa MM, Setzer E, Charaf C, Webb AL, Derico R, Kimberl IJ et al. Informed versus uninformed consent for prostate surgery: the value of electronic consents. J Urol 2006; 176(2): ] Issa MM, Setzer E, Charaf C, Webb AL, Derico R, Kimberl IJ et al. Informed versus uninformed consent for prostate surgery: the value of electronic consents. J Urol 2006; 176(2): ] Shamsian N, Southern SJ, Wilkinson S, Scott DJ, Brodlie K. What is the medicolegal implication of a Web-based three-dimensional interactive virtual reality plastic surgery package? Plast Reconstr Surg 2005; 116(6): ] Baum N. Informed consent--more than a form. J Med Pract Manage 2006; 22(3): ] Shamsian N, Southern SJ, Wilkinson S, Scott DJ, Brodlie K. What is the medicolegal implication of a Web-based three-dimensional interactive virtual reality plastic surgery package? Plast Reconstr Surg 2005; 116(6): ] Armstrong AP, Cole AA, Page RE. Informed consent: are we doing enough? Br J Plast Surg 1997; 50(8): ] Shamsian N, Southern SJ, Wilkinson S, Scott DJ, Brodlie K. What is the medicolegal implication of a Web-based three-dimensional interactive virtual reality plastic surgery package? Plast Reconstr Surg 2005; 116(6):

85 127] Krause HR, Bremerich A, Rustemeyer J. Reasons for patients discontent and litigation. J Craniomaxillofac Surg 2001; 29(3): ] Baum N. Informed consent--more than a form. J Med Pract Manage 2006; 22(3): ] Pleat JM, Dunkin CS, Davies CE, Ripley RM, Tyler MP. Prospective survey of factors affecting risk discussion during consent in a surgical specialty. Br J Surg 2004; 91(10): ] Baum N. Informed consent--more than a form. J Med Pract Manage 2006; 22(3): ] World Health Organization Staff. Promotion of the Rights of Patients in Europe:Proceedings of a WHO Consultation ] World Health Organization Staff. Promotion of the Rights of Patients in Europe:Proceedings of a WHO Consultation ] Dimond B. Legal aspects of consent 22: nurses position when obtaining consent. Br J Nurs 2002; 11(4):

86 86

87 Chapter 7 Summary and conclusions 87

88 The scientific base for this thesis is presented in chapter 2 in the form of a review of the literature on the subject of computer-based patient education. Using computer technology for patient education may harbour several advantages for patients and doctors. An interactive education programs results in an active way of learning, better retention of more consistent information, a low level of literacy for easy understanding and it can be customized for every patient. Moreover, time and costs are saved. The question if a doctor can be replaced by an interactive education program is not answered yet but it may well be possible. Any success of using this novel instrument is highly dependent on appropriate design of the software. What is good software design anyway? Building an effective interactive computer program is difficult. Before doing so we needed to know the level of evidence that existed on this subject matter. Medical as well as psychological and informatics literature was systematically investigated. Chapter 3 summarises how an effective computer-based patient education program can be build based on evidence gathered from these fields of science. We also found that not only learning strategies are important but also program layout in the broadest sense of the word. The basis of this thesis was thus formed by studying advantages of computer-based patient education and increasing knowledge on strategies of designing effective educational software. However, what are the requirements of our patients when it comes to reception of information? We needed to get a sense on what patients generally want to know about their disease or treatment. Chapter 4 describes a (prospective) questionnaire study testing what patients wanted to know prior to an operative procedure. The questionnaire proved highly reliable with a mean Cronbach s Alpha of 0.91 (max, 1.0). Patients scored significantly higher (p<0.001) in most domains including hunger for information on preoperative period, anaesthesia, operation, postoperative period, self care, and general hospital information. In contrast, surgeons thought that their patients desired more extensive information on cause, effect and prognosis of the disease itself (p < 0.001). In addition, females demonstrated a significantly higher need for information than males. Findings were independent of patient s age or complexity of operation. Patients scheduled for a minor operation wanted significantly more information on the topic of self-care than patients scheduled for a major operation. We concluded that patients in general exhibit a high requirement for information concerning their condition and treatment, and this informational hunger is considerably underestimated by their surgeons. Knowledge obtained from these studies was used to develop a computer-based patient education program on the carpal tunnel syndrome (CTS). The program was build by the writer of this thesis and an informatics student using a small budget. The CD with the actual program is included for the readers. The program we designed was used in a randomised trial that is presented in chapter 5. Two groups of patients (n=113) were compared, one group was educated by the designed CTS computer program while the other group was educated by a plastic surgeon verbally using the same information. The knowledge score was significantly higher in the computer educated group (23,5 versus 20,2, p<0.001), using a 40-point questionnaire. Satisfaction did not differ between the two groups. It is therefore possible to educate patients by a computer without the requirement of a doctor. 88

89 Some educational tasks, in former days belonging to the realm of the doctor, can clearly be performed by a simple computer program. But what about the informed consent (IC) procedure? A literature search on the present IC procedure indicates that the current surgical IC in daily practise is incomplete. A proper and complete IC procedure should include 3 stages, preconditions (voluntariness and competence), information, and consent. Most aspects of today s medical practise on IC have to be improved. Theoretically, computer programs can play an important role in the modernization of the IC procedure, and are able to replace a doctor s part in this procedure. In chapter six we discuss what is known on these issues and the possible role of computer-based patient education. My personal opinion and believes are discussed in the part future directions. In summary, the present thesis discusses the advantages of computer-based patient education. Tools for designing an effective education program and its applicability are presented. The array of informational domains that patients need to know before they agree to a specific (operative) treatment is investigated. Steps that can be used to improve the informed consent procedure are presented. Hopefully this thesis will inspire other doctors to develop computer-based patient education programs in other medical and surgical fields as patient care will improve using these approaches. 7 89

90 Nederlandse samenvatting De wetenschappelijke basis voor dit proefschrift wordt in hoofdstuk 2 gepresenteerd als een literatuurstudie over computergestuurde patiëntenvoorlichting. Computertechnologie, gebruikt voor patiëntenvoorlichting, kan zowel voordelen voor de arts als voor de patiënt opleveren. Een interactief voorlichtingsprogramma stimuleert een actieve leerhouding, informatie wordt beter onthouden en is meer consistent. Een programma kan gemakkelijk aangepast worden aan bijvoorbeeld het taalniveau van de patiënt of andere patiëntkarakteristieken. Mogelijk zorgt het ook voor tijd- en kostenbesparing. Het was nog niet mogelijk om een antwoord te vinden op de vraag of een computerprogramma de voorlichting door een arts kan vervangen. Het succes van een dergelijk programma is sterk afhankelijk van een goed programmaontwerp. Wat is eigenlijk een goed programmaontwerp? Het bouwen van een effectief voorlichtingsprogramma is moeilijk. Voordat men hieraan begint moet duidelijk zijn welke toepassingen geschikt en werkzaam zijn. Om dit na te gaan is de literatuur betreffende dit onderwerp onderzocht binnen de wetenschapsgebieden geneeskunde, psychologie en informatica. Hoofdstuk 3 beschrijft de resultaten van deze literatuurstudie. Hieruit blijkt dat niet alleen leerstrategieën belangrijk zijn maar ook de lay-out in zijn breedste zin. De basis van dit proefschrift bestond dus uit het nagaan van eventuele voordelen van computergestuurde patiëntenvoorlichting en het bestuderen van de wetenschappelijke basis betreffende het ontwerpen van dergelijke programma s. Wat van groot belang was, was het verkrijgen van duidelijkheid over datgene wat patiënten eigenlijk willen weten voordat ze geopereerd worden. In hoofdstuk 4 wordt een prospectieve vragenlijststudie beschreven die nagaat wat patiënten voorafgaand aan een operatie willen weten. De gebruikte vragenlijst bleek erg betrouwbaar te zijn (Cronbach s Alpha van 0,91 (maximaal 1,0)). Patiënten scoorden significant hoger (p<0,001) op de meeste domeinen, onder andere op vragen over de preoperatieve periode, anesthesie, operatie, postoperatieve periode, zelfzorg en algemene ziekenhuisinformatie. Dit werd vergeleken met wat de chirurg dacht dat een patiënt wil weten. De chirurg scoorde hoger op het gebied oorzaak, ziekte en prognose (p<0,001). Ook bleek dat vrouwen meer informatie willen dan mannen. Dit was onafhankelijk van de leeftijd en complexiteit van de operatie. Opvallend was dat mensen die een kleine operatie moesten ondergaan meer wilden weten over de zelfzorg dan mensen die gepland stonden voor een grote operatie. We concluderen dat in het algemeen patiënten veel informatie willen over een operatie die ze moeten ondergaan en dat deze wens naar informatie sterk wordt onderschat door hun chirurg. Met de kennis die opgedaan werd in de vorige studies werd een voorlichtingsprogramma gemaakt over het carpale-tunnelsyndroom (CTS). De CD met dit programma is toegevoegd aan dit boekje. Dit programma is gebruikt in de gerandomiseerde studie die in hoofdstuk 5 wordt besproken. Twee groepen patiënten (n=113) werden onderling vergeleken. Een groep werd enkel voorgelicht door het computerprogramma en de andere groep ontving dezelfde informatie van een arts. De kennisscore (40-punts-vragenlijst) in de computergroep was hoger dan de groep voorgelicht door de arts (23,5 versus 20,2; p<0,001). De tevredenheid over de voorlichting was gelijk in beide groepen. Uit dit onderzoek blijkt dat het dus mogelijk is om een arts te vervangen door een computer, daar waar het de patiëntenvoorlichting betreft. 90

91 Enkele voorlichtingstaken, die altijd toebedeeld waren aan de arts, kunnen goed vervangen worden door een computerprogramma. Maar welke invloed zal dit hebben op het informedconsent-proces? Een literatuurstudie laat duidelijk zien dat de huidige informed-consentprocedure incompleet is. Een adequaat informed-consent moet de volgende drie elementen bevatten: ten eerste moet het de precondities van vrijwilligheid en competentie bevatten, ten tweede moet de voorlichting correct en compleet zijn en als laatste moet een patiënt zijn weloverwogen goedkeuring geven aan de arts. Het huidige informed-consent voldoet meestal niet aan deze basale voorwaarden. In theorie zouden computers een belangrijke taak kunnen vervullen in dit proces en waarschijnlijk de taak van een arts kunnen overnemen. De mogelijkheden worden in hoofdstuk 6 besproken. Tevens wordt mijn persoonlijke mening toegelicht in het volgende deel, namelijk de future directions. Samenvattend beschrijft dit proefschrift de mogelijkheden en voordelen van computergestuurde patiëntenvoorlichting. Het geeft aan hoe een effectief voorlichtingsprogramma gebouwd kan worden en welke onderwerpen het zou moeten bevatten. Ook beschrijft het de toepassing van dit medium ter verbetering van de informed-consent-procedure. Ik hoop met dit proefschrift andere artsen te stimuleren om meer gebruik te maken van dit fantastische medium binnen hun voorlichting aan patiënten. Zij zullen samen met hun patiënten de voordelen gaan ervaren. 7 91

92 92

93 Chapter 8 Personal view and future directions Submitted 93

94 Minimizing the doctor s role in informed consent? BJ Keulers My superiors decided that it was about time to start writing a thesis on possibly the most dreadful and boring subject in medicine, informed consent (IC). No invention of a glamorous new operation, no vivid description of a sexy novelty in plastic surgery, not even a detailed description of patients undergoing a successful minimally invasive surgical treatment. On the contrary, talking with patients about their scheduled operations and interviewing their relatives was my next decade s most important pastime. My feeble protests were neither heard nor granted, so I was stuck. Oh, how wrong was I! Writing a thesis on IC appeared illuminating! I previously thought that a proper informed consent would only be possible with the aid of and orchestrated by a doctor (being me). However, most research conceived in modern times does not seem to support this notion at all. My opinion radically changed, and I am now convinced that a doctor s role in the IC procedure should and can be minimized. This is what I learned over the last couple of years. An optimal IC procedure consists of three steps. Firstly, I have to know if my patient is competent and if he is able to make a voluntary decision. Secondly, I have to educate my patient correctly, and last (but not least) I have to get the consent itself. But the funny thing is that doctors are not at all capable in determining whether a patient is able to make a competent decision. This part of an IC procedure is compared to throwing dice.1 Here is another misconception. Although we spend over 25% of our office time providing information, we apparently still underestimate our patient s desire for information.2, 3, 4 Moreover, information is mostly provided in an incomplete and inadequate way undermining any positive attitude.5 Then, how should it be done? Computers have already entered the medical arena and have also been spotted for patient education. I hypothesized that doctor-based patient education would be better than computer-based. Are emotions and nonverbal communication not pivotal in our highly esteemed patient contacts? On the other hand, computer programs do not forget, are never wrong, and may stimulate multiple senses.6 A computer driven educational process can result in higher retention of information, up to 80% compared to 20% after verbal education.7 My randomized controlled trial showed that computer-based patient education indeed results in a higher knowledge level and equal satisfaction scores compared to doctor-based education.8 Can computers do even more for IC? The informational part of the procedure apparently is not the problem. What about testing my patient s competence? Computer programs will definitely be able to test cerebral qualities of a patient using a validated questionnaire. The computer will then declare my patient mentally competent and capable of comprehending the information that is presented. Validated questionnaires are already available and can also be used in various other parts of the IC procedure. Results from questionnaires and education can be summarized in a standardized IC rapport that is added to a patient s chart and digitally stored. 94

95 How to implement these steps in daily practice? After visiting the doctor and receiving a diagnosis and treatment plan, patients should be allowed to study the computer program in their own time and private space. Results can be electronically sent to their doctor who checks its validity. During the next visit, doctors verify if information corresponds with their patients believes. If needed, specific questions can be answered. Both patient and doctor sign the rapport (electronically if you will). The ultimate proof of an adequate and legal IC procedure. Think about the practical implications! We don t have to repeat the same information over and over again. Patients have more time for posing specific questions or for discussing emotions concerning disease or treatment. It is questionable if doctor s time is saved during these consultations, but communication failures and wrong believes afterwards will be minimized.9 An optimalized patient education will likely attenuate the rising number of medico legal claims.10 Implementing this novel way of IC is challenging but advantages for both parties are obvious. 95 8

96 References: 1] Appelbaum PS. Clinical practice. Assessment of patients competence to consent to treatment. N Engl J Med 2007; 357: ] Grueninger, U.J., M.G. Goldstein, and F.D. Duffy, A conceptual framework for interactive patient education in practice and clinic settings. J Hum Hypertens, Suppl 1: p ] Keulers BJ, Scheltinga MR, Houterman S, Van Der Wilt GJ, Spauwen PH. Surgeons Underestimate Their Patients Desire for Preoperative Information. World J Surg ] Waitzkin, H., Doctor-patient communication. Clinical implications of social scientific research. JAMA, (17): p ] Orleans CT, George LK, Houpt JL, Brodie KH (1985). Health promotion in primary care a survey of US family practitioners. Prev Med 14: ] Keulers BJ, Spauwen PHM. Can face-to-face patient education be replaced by computer-based patient education? Eur J Plast Surg 2003;26: ] Begley S. Teaching minds to fly with discs and mice. Newsweek 1994;May 31 8] Keulers BJ, Welters CF, Spauwen PH, Houpt P. Can face-to-face patient education be replaced by computer-based patient education? A randomised trial. Patient Educ Couns 2007; 67: ] Krause HR, Bremerich A, Rustemeyer J. Reasons for patients discontent and litigation. J Craniomaxillofac Surg 2001; 29: ] Shamsian N, Southern SJ, Wilkinson S, Scott DJ, Brodlie K. What is the medicolegal implication of a Web-based three-dimensional interactive virtual reality plastic surgery package? Plast Reconstr Surg 2005; 116:

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99 Dankwoord 99

100 Prof. dr. P.H.M. Spauwen (promotor) Beste professor, als eerstejaarsstudent kwam ik al op uw afdeling om mee te kijken. Later kwam ik terug voor mijn wetenschappelijke stage, waarbij u mij in contact heeft gebracht met Ivar van Heijningen. Met hem heb ik de eerste plannen voor een onderzoek gesmeed. Hierna ben ik nog keuze-coassistent geweest. Dit alles heeft geleid tot een opleidingsplek voor de plastische chirurgie op uw afdeling. Hier ben ik u erg dankbaar voor. U heeft altijd tijd gemaakt om mee te denken en mij te voorzien van adviezen, ondanks het feit dat mijn onderzoek op een geheel nieuw vlak ligt. U was een van de weinigen die meteen al de potenties zag en daaraan zijn steun wilde verlenen. Veel dank hiervoor. Prof. dr. G.J. Van Der Wilt (promotor) Beste Gert Jan, je bent pas in een latere fase bij dit onderzoek betrokken geraakt. In het eerste gesprek gaf je aan dat je geïnteresseerd bent in middelen die de medische zorg efficiënter kunnen maken. Ook jij zag de mogelijkheden van mijn onderzoek. Ik hoop dat we met dit onderzoek een stukje bijdragen aan een betere zorg. Bedankt voor je hulp en steun. Marc Scheltinga (co-promotor) Beste Marc, ik vind je een fantastische kerel. Als plaatsvervangend opleider hebben we bijna dagelijks contact gehad, wat geresulteerd heeft in een goede vriendschap. Je hebt mij op een perfecte manier geholpen bij het schrijven van mijn artikelen, niet alleen voor dit proefschrift. Door jouw betrokkenheid zijn ze een niveau hoger getild. Ik hoop dat we nog lang contact houden. Zonder jou was het een hele zware dobber geworden. De manuscriptcommissie Ik wil Prof. dr. C.J.H.M. van Laarhoven, Prof. dr. P.F. de Vries Robbé en Prof. dr. S.G. Oei. bedanken voor het kritisch beoordelen van het manuscript. Ivar van Heijningen Beste Ivar, bedankt voor jouw steun tijdens mijn wetenschappelijke stage. Tijdens deze stage is de basis gelegd voor dit proefschrift. Tevens heb je me laten zien hoe leuk de plastische chirurgie werkelijk is. Ik heb erg genoten van onze gesprekken en het kijken van films met een Big Mac op schoot. Peter Houpt Bedankt voor je hulp tijdens de studie in Zwolle en dat dit onderzoek onder jouw hoede mocht plaatsvinden. Carlo Welters Beste Carlo, als coassistent heb ik je leren kennen. Je was erg gemotiveerd om het werk van Ivar over te nemen en hebt zo alle patiënten geïncludeerd in Zwolle. Ook hierna ben je actief betrokken geweest bij het artikel. Je hebt een goed schrijverstalent en ik hoop dan ook dat we nog vaker samen wat op papier zullen zetten. 100

101 Miel en Saar Keulers Ik ben van mening dat dit proefschrift op een bepaalde manier uniek is. Als broer en zus hebben jullie allebei fantastisch meegewerkt. Allebei hebben jullie je wetenschappelijke stage gewijd aan mijn promotieonderzoek. Dit hebben jullie ieder op je eigen bijzondere manier gedaan. Zonder jullie was het me nooit gelukt! Mijn ouders Een vader die huisarts is en altijd een zeer uitgesproken mening heeft over zijn vak en een moeder die computerprogrammeur is geweest. Waar zou ik toch de motivatie vandaan gehaald hebben? Door onze gezamenlijke debatten heeft mijn visie zich kunnen ontwikkelen en ben ik tot dit resultaat gekomen. Zoals jullie weten houdt het hier niet mee op. Ik wil jullie bedanken voor het altijd aanwezig zijn op alle gebieden die voor mij belangrijk waren. Ik zou me geen betere ouders kunnen wensen. Thijs, Sjoerd en Niels Jullie zorgden altijd voor de nodige afleiding en ontspanning. Onze culturele bezoeken aan Europese steden waren altijd een heerlijke onderbreking. Ik hoop dat we nog jaren zo doorgaan. Frank Huntjens Als oom heb je me fantastisch geholpen met het taalkundig deel van mijn artikelen. Dit ondanks het feit dat je betere dingen te doen hebt op dat prachtige eiland Mauritius. Lang leve de . Wouter Leclercq Wout, bedankt voor je hulp, zo net voor de eindstreep. En succes met het vervolg van dit onderzoek. Tjits Potijk Fijn dat je paranimf wilde zijn zonder enige twijfel. Nu is er weer tijd om wat meer opiniestukken te gaan schrijven in de late uurtjes op je dakterras in Leiden. Mijn Vriendin Lieve Hanna, we hebben 4,5 jaar noodgedwongen gescheiden van elkaar moeten wonen: Jij moest voor je opleiding in Nijmegen blijven, terwijl ik in Veldhoven in opleiding was. In deze periode heb ik veel tijd besteed aan mijn onderzoek, maar de weekenden met jou waren veel leuker. Nu wonen we eindelijk samen in ons heerlijke huis. Ik hoop dat we nog lang samenblijven en een fijn gezin gaan starten. Mijn onderzoek wordt nu afgesloten maar rustig zal het nooit worden, ik hou heel veel van je! 101

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103 List of publications 103

104 Keulers BJ, Scheltinga MRM, Van Der Wilt GJ, Houterman S, Spauwen PHM. Surgeons underestimate their patients desire for preoperative information. World J Surg, 2008 Jun;32(6): Keulers BJ, Welters CFM, Spauwen PHM, Houpt P. Can face-to-face patient education be replaced by computer-based patient education? A randomised trial. Patient Education and Counseling 2007: 67; Scheltinga MRM, Wijburg E, Keulers BJ, De Kroon K. Conventional versus invaginated stripping of the great saphenous vein: a randomized double-blind controlled clinical trial. World J Surg, : Keulers BJ, Keulers MJ, Scheltinga RHM, Spauwen PHM. Evidence-based development of interactive patient education programs: A guide for achieving optimal computer-based patient education. European Journal of Plastic Surgery 2006; 29: Keuler BJ, Roumen R, Keulers MJ, Vandermeeren L, Bekke JPH. Bilateral groin pain from a rotten molar. Lancet: 2005 vol 365 (366:94). Keulers BJ, Keulers MJ. Medicine forgets dentistry. Lancet: 2005 vol 366 (366:94). De Jongh GJ, Keulers BJ, Spauwen PHM, Blokx WAM, Gerritsen MJP. A skin tumor as a marker for a hereditary cancer syndrome: Muir-Torre syndrome. European Journal of Plastic Surgery 2005; 28: Keulers BJ, Spauwen PHM. Can face-to-face patient education be replaced by computer-based patient education? European Journal of Plastic Surgery 2003; 26: Keyser LCM, Schreuder BHW. Boons HW, Keulers BJ, Buma P, Huiskes R, Veth RPH. Bone grafting of cryosurgically treated bone defects: experiments on goats. Clinical Orthopeadics and related research 2002, 396: Keulers BJ, Spauwen PHM. Een interactief computerprogramma als patiëntenvoorlichter: de toekomst? Operationeel, 2007, 2e jaargang, nr 1. Keulers BJ, Roumen R, Keulers MJ, Vandermeeren L, Bekke JPH. Bilaterale liespijn na een rotte kies. Operationeel, 2006, 1e jaargang, nr

105 Keulers BJ, Buimer MG, Croiset van Uchelen F, Gerlag P, Pasmans HLM. Tertiare hyperparathyreoïdie als gevolg van terminale nierinsufficiëntie. Medisch Journaal, 2005, jaargang 34, nr 3. Buimer MG, Keulers BJ, Van Oudheusden CF, Renier WO. Een zeldzame complicatie van een ventriculoperitoneale shunt: een case report. Tijdschrift voor Neurologie en Neurochirurgie, 2004, volume 105, nr 1. Keulers BJ, Buimer MG, Van Oudheusden CF, Renier WO. Appendicitis als een zeldzame complicatie van een ventriculoperitoneale shunt. Medisch Journaal, 2004, jaargang 33, nr 2. Rashaan MI, Keulers BJ, Scheltinga MRM, Pasmans HLM. Traumatische diafragmaruptuur. Medisch Journaal, 2004, jaargang 33, nr 1. Hagenouw R, Keulers BJ. Toekomstvisies, dialoog tussen twee voorzitters. Medisch Contact, 2001, nr

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107 Curriculum Vitae 107