J Oral Maxillofac Surg 67:1021-1025, 2009 Value of Informed Consent in Surgical Orthodontics Sander Brons, DDS,* Alfred G. Becking, DMD, MD, PhD,† and D. Bram Tuinzing, DMD, PhD‡ Purpose: Informed consent forms an important part of treatment, especially in the case of elective treatment. The aim of this survey was to establish how much patients can recall of the information given during an informed consent interview before orthognathic surgery. During the consultation, attention was given to all aspects of the treatment. However, because of “insurance-related factors,” the need for treatment because of functional reasons was stressed over esthetics. The recall of information given during an informed consent interview before orthognathic surgery was measured using a questionnaire. Materials and Methods: Patients with a mandibular deficiency with a low mandibular plane angle were questioned after an informed consent interview regarding surgical orthodontic treatment. Results: Esthetics were more frequently and functional problems were less frequently recalled as the reason for operation than was expected. The risk of a change in the sensation of the lower lip by surgery was frequently recalled as a reason to refrain from the operation. The overall recall rate of the possible risks and complications of orthodontic surgery was 40%. Conclusions: No reports were found of comparable research on the preoperative recall after consul- tation before surgical orthodontic surgery. The aspects of communication that can improve recall must be clarified. A recall rate of 100% seems a utopia, although an arbitrary line is needed to determine the quality of an informed consent interview. © 2009 American Association of Oral and Maxillofacial Surgeons J Oral Maxillofac Surg 67:1021-1025, 2009 Currently, informed consent forms an important part verbally by the physician or nurse practitioner and by of medical treatment. Adequately informing a patient written or visual information (pictures or video). By confirms the patient–doctor relationship is based on Dutch law (Wet Geneeskundige Behandel Overeen- trust. Another important function of informed con- komst [WGBO]) physicians are obligated to provide sent is the fulfillment of the legal obligation of the patients with a description of the diagnosis; the rec- physician to inform the patient to the best of his ommended or proposed treatment; technical details knowledge. However, to be certain of having fulfilled of the procedure; probable risks, goals, and benefits; the legal obligation, it is necessary to qualify the and alternative modes of therapy. process of informed consent. Recently, an informed consent model for orthog- For patients to consent to a procedure, they should nathic surgery was proposed by Gasparini et al.1 In be informed by the medical staff. This can be done this model, it is recommended to divide the informed consent form into 2 parts. The first part concerns the Received from the Department of Oral and Maxillofacial Surgery/ diagnostic procedures and the therapeutic and surgi- Pathology, Academic Centre for Dentistry Amsterdam and VU Uni- cal time frames, and the second part, the possible versity Medical Center, Amsterdam, The Netherlands. problems and difficulties of the procedure. 2 *Postgraduate Student. According to Humphris et al, the informed con- †Oral and Maxillofacial Surgeon. sent interview should be supported by an information ‡Professor. leaflet. In their study on third molar removal, it ap- Address correspondence and reprint requests to Dr Tuinzing: peared that the provision of an information leaflet as Department of Oral and Maxillofacial Surgery/Pathology, Academic an adjunct to the verbal information resulted in an Centre for Dentistry Amsterdam and VU University Medical Center, increase of patient knowledge. 3 PO Box 7057, Amsterdam 1007 MB The Netherlands; e-mail: In contrast, Rittersma stresses the importance of [email protected] personal surgeon–patient communication as superior © 2009 American Association of Oral and Maxillofacial Surgeons to written information. 0278-2391/09/6705-0014$36.00/0 The correction of maxillofacial deformities by sur- doi:10.1016/j.joms.2008.12.038 gical orthodontic treatment is an elective procedure. 1021 1022 VALUE OF INFORMED CONSENT Orthodontic therapy is an integral part of the treat- ment. Preoperative orthodontic treatment is followed by surgery and consecutively by postoperative orth- odontic treatment. The aim of this study was to de- termine what patients could recall after a pretreat- ment consultation of surgical orthodontic treatment. Materials and Methods This survey was performed at the Department of Oral and Maxillofacial Surgery of the VU University Medical Centre/Academic Centre for Dentistry Am- sterdam in Amsterdam, The Netherlands. During a consultation, the patient was informed about their dentofacial deformity and the surgical procedure that would be a part of the surgical orth- odontic treatment to correct it. The reasons to decide in favor of this treatment and the reasons to refrain FIGURE 1. Mandibular deficiency with low mandibular plane angle. were balanced with each other and any possible com- Brons et al. Value of Informed Consent. J Oral Maxillofac Surg plications were mentioned. The “rules of the game” 2009. were explained verbally and illustrated by pictures and drawings. The diagnosis of most patients could be categorized in 1 of the 5 following categories: mandibular progn- immediately after the preoperative consultation of athism, mandibular prognathism with open bite, man- maxillofacial surgery. (See Appendix for an example dibular deficiency with a low mandibular plane angle, of the questionnaire.) relative mandibular deficiency, and an absolute man- The process of the informed consent interview and dibular deficiency with a high mandibular plane answering the questionnaire was standardized. The angle.4 surgeon who would perform the surgery conducted A total of 24 patients (age range 16 to 48 years, the informed consent interview. The information was mean 24) classified as having mandibular deficiency given in particular order and, at the same time, the with a low mandibular plane angle (sellar nasion– points mentioned were written down. Illustrations mandibular plane angle Ͻ35°) (Fig 1) were included were shown, and the opportunity was given to ask for in this survey. clarification during the entire conversation. Immedi- All the patients were, before the decision of ately after the consultation, the patient was requested whether to start or refrain from surgical orthodontic to answer the questionnaire. Assistance was only al- therapy, informed by 1 surgeon of the reasons for and lowed by the person who conducted the question- against undergoing correction of the deformity and naire, someone other than the surgeon. If a question about the consequences and possible complications was indistinct, the patient had the opportunity to ask of the sagittal split osteotomy (Table 1). for clarification. The questionnaire consisted of 3 multiple-choice and 2 open-ended questions in the Dutch language. Results The open-ended questions concerned the reasons for and against undergoing the treatment and about the The recall rates of the reasons to undergo correc- possible complications and consequences of the treat- tion of the maxillofacial disproportion are listed in ment. Table 2. The recall rates of the reasons to not undergo A pilot study was performed to determine the qual- correction of the maxillofacial disproportion are ity of the questionnaire. This pilot study contained 9 listed in Table 3. The recall rates of the consequences completed questionnaires. The findings from the pilot and possible complications of surgical correction of study were that the instructions on answering the the craniofacial disproportion are listed in Table 1. questionnaire were not clear. Therefore, the instruc- Poor esthetics was the most-often recalled reason tions were rewritten, and the lines for where the for undergoing the operation. This was logical, be- answers to the open-ended questions should be writ- cause a fine esthetic appearance is highly appreciated ten were numbered to highlight the concern for giv- and of high value. At least of equal importance is that ing multiple answers. The final questionnaire was esthetics is a subjective item, and an opinion about it answered from February to June 2005 by 24 patients requires no medical education or information, making BRONS ET AL 1023 Table 1. RECALL OF CONSEQUENCES AND POSSIBLE Table 3. RECALL RATES OF REASONS TO REFRAIN COMPLICATIONS OF OPERATION FROM SURGICAL INTERVENTION Sagittal Osteotomy Recall Rate (%) Reason Recall Rate (%) Numbness of lower lip/chin for months 17/24 (71) Operation under narcosis 4/24 (17) Risk of having different feeling after 1 yr 17/24 (71) Affect of changed appearance 8/24 (33) Fixation with titanium screws (permanent) 4/24 (17) Brons et al. Value of Informed Consent. J Oral Maxillofac Surg 2009. Tenderness of temporomandibular joint 3/24 (13) 5 wk of soft diet 16/24 (67) Overall percentage 42 only what is in favor of the decision to undergo Brons et al. Value of Informed Consent. J Oral Maxillofac Surg 2009. surgery and to suppress information that provokes anxiety or is life threatening. It appears that some part of all patients convinced themselves of the need to the remembrance of poor esthetics a reason to oper- correct the maxillofacial disproportion by surgery by ate invariably possible. not remembering the contraindications to the