Value of Informed Consent in Surgical Orthodontics

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 consultation 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 treatment. Preoperative orthodontic treatment is followed by surgery and consecutively by postoperative orthodontic treatment. The aim of this study was to determine 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 orthodontic 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 opera- The next most recalled items were “prevention” tion. and “poor occlusal fit.” Both items are not very spe- The mean recall percentage of the consequences cific and are likely to be remembered even without and possible complications of the operation was 42%. the consultation. This also might explain the reason However, the most important risk of sagittal split items with a more medical and specific foundation, osteotomy, a permanent change in the sensation of such as “impossible to correct with orthodontics the inferior alveolar nerve, was recalled most fre- only,” “prosthetic problems,” and “progressive pro- quently by 71% of the patients. However, this also cess,” were recalled less often. meant that although much attention was given to this The reasons not to undergo the surgery were far risk, almost 3 of 10 patients still did not recall this risk, less often recalled even when a few were present. which could have a serious effect. Some patients were confused whether an item be- longed under “consequences and possible complica- Discussion tions” or “reasons not to operate.” This was not as- tonishing, because an overlap exists between both. It No reports were found of comparable research on seems that the arbitrary classification of an item to the preoperative recall after consultation before maxillo- division “reason not to operate” or “consequences facial surgery. The investigation of recall has been and possible complications” was not understood by done in other medical specialties. most patients. Not recalling the reasons to refrain Krupp et al5 reported a recall rate of 18%. This rate from surgery demonstrates that patients tend to retain was found 2 hours after the consent interview on the day before the operation. That the operation was nearby was likely experienced as a threat. This alters Table 2. RECALL RATES OF REASONS TO CORRECT one’s emotion and cognitive processes, decreasing MANDIBULAR DEFICIENCY attention during the consent interview and decreas- Reason Recall Rate (%) ing the recall afterward. Herz et al6 reported an immediate retention rate of Poor esthetics 13/24 (54) 43.5% and a mean score of 38.4% at 6 weeks after the Prevention 11/24 (46) consent interview. This greater retention rate can be Poor occlusal fit 4/24 (17) Traumatic deep bite 4/24 (17) explained because the patients met or spoke with the Impaired masticatory function 4/24 (17) physician 3 times and also attended an additional Prosthetic problems 3/24 (13) educational conference. This intensive teaching seemed Myogenic TMD 2/24 (8) to improve recall. Not possible to correct with Godwin7 reported a retention rate of 25% 6 days orthodontics only 2/24 (8) Psychological problems 2/24 (8) postoperatively in a group of patients undergoing Damage of teeth 1/24 (4) reduction mammoplasty. The patients were informed Progressive process 1/24 (4) 3 different times by 3 different health care profession- Impaired speech 1/23 (4) als. Because the recall test was done postoperatively, Impaired closure of lips 0/24 (0) a tendency existed for cognitive dissociation, which Abbreviation: TMD, temporomandibular disorder. decreases recall. 8 Brons et al. Value of Informed Consent. J Oral Maxillofac Surg Morgan and Schwab found, in a survey of patients 2009. undergoing cataract extraction, a recall rate of 37% at 1024 VALUE OF INFORMED CONSENT

1 day postoperatively. This was after a single, rela- Furthermore, determining an adequate answer for tively short consultation, of 10 to 20 minutes, and the open-ended questions is a subjective process. This average age of the patients undergoing cataract ex- can be better used for a recall survey than multiple traction was 72 to 75 years. The explanation might be choice questions as these give the possibility of rec- that of the 10 questions asked to measure retention, ognition. only a few (3 or 4 questions) could be answered Because a relationship seems to exist between the correctly without consulting a physician. Thus, number of items discussed during the consultation instead of recalling new information, “long time and the recall percentage, it might be advisable to known” information might have been recorded. Fur- mention the number of consequences and possible thermore, age and educational level are factors that risks of the operation. In this way, patients will know influence the recall percentage. Advanced age and a whether all items have been recalled. Furthermore, it less than high school education resulted in a lower has been shown that a small amount of information is recall rate. retained for a longer period than a large amount of Priluck et al9 found in a survey of patients under- information. Summarizing the consultation and read- going eye surgery, a retention rate of 49.4% at a mean ing over the written information at the end or at a of 4 days postoperatively. In that study, an effort was follow-up consultation visit might improve patients’ made to be liberal in determining whether a question recall. was adequately answered. This might have resulted in Patients seem to have some reasons to undergo the outcome of a greater than average recall. surgery before the consultation. In general, these are 10 Turner and Williams found that patients immedi- based on their opinion. Additional information should ately after consultation recalled a small percentage of be given about the medical reasons in favor of surgical information. In particular, patients recalled the post- correction. operative recovery time frames and possible opera- Surgical correction of a maxillofacial disproportion 4 tive complications poorly. It is known that a descrip- is an elective procedure. By emphasizing this, patients tion of the diagnosis, alternative therapies, and the can be made aware that it is necessary to take the surgical techniques are recalled twice as frequently as reasons not to undergo surgery into account. 4,7 the period of rehabilitation and the surgical risks. Finally, giving information requires communication Also, patients tend to retain only what is in favor of skills. Patients’ main criticisms about physicians have 3,4,8 the decision to undergo surgery and suppress in- been the lack of time to adequately inform patients, formation that provokes anxiety and is life-threaten- talking too fast or too quietly, the use of jargon, and ing. the use of an excessively familiar manner of expres- Our study had some limitations, for instance, the sion. Furthermore, the effect of nonverbal expression question regarding the reasons patients know to un- is known to be greater than that of verbal communi- dergo treatment and the reasons not to undergo treat- cation. ment. This question implies not only the items men- Information recall of the risks and possible compli- tioned in the discussion during the consultation but cations immediately after an informed consent inter- also the possible reasons that were not discussed. view for surgical orthodontic treatment resulted in a Also, the question about the “rules of the game,” mean recall rate of 42%. It is possible that the recall which asks for the consequences and possible risks of rate increases when the preoperative orthodontic operation, was not fully understood by some patients, procedure is started and information comes “to life.” even though the phrase “the rules of the game” was Clarification is needed of other factors relevant to the mentioned several times during the consultation. All improvement of recall, as well as legal terms to define patients had the opportunity to ask for an explanation whether physicians have fulfilled their obligation of of any indistinct questions. Nevertheless, this lack of informed consent. clarity might have led to a lower recall rate. Answering a questionnaire also requires abilities other than the recall of spoken, written, and visual information. It requires abilities such as reading, writ- References ing, and comprehension. These requirements will 1. Gasparini G, Boniello R, Longobardi G, Pelo S: Orthognathic also influence the patient’s recall. surgery: An informed consent model. J Craniofac Surg 15:858, 2004 The size of the patient sample might be another 2. Humphris GM, O’Neill P, Field EA: Knowledge of wisdom flaw in our survey. In a small sample, only large tooth removal: Influence of an information leaflet and valida- differences and relationships will be noted. There- tion of a questionnaire. Br J Oral Maxillofac Surg 31:355, 1993 3. Rittersma J: Patient information and patient preparation in fore, the results of our research can only serve as an orthognathic surgery: The role of an information brochure—A indication for additional studies. medical audit study. J Craniomaxillofac Surg 6:278, 1989 BRONS ET AL 1025

4. Tuinzing DB, Greebe RB, Dorenbos J, Becking AG: Surgical 3. What reasons do you know to and not to un- Orthodontics: Classiﬁcation Diagnosis and Treatment. Maars- sen, Elsevier, 2005 dergo this operation? 5. Krupp W, Spanehl O, Laubach W, Seifert V: Informed consent Reasons to: Reasons not to: in neurosurgery: Patients’ recall of preoperative discussion. 1...... 1...... Acta Neurochir 142:233, 2000 6. Herz DA, Looman JE, Lewis SK: Informed consent: Is it a myth? 2...... 2...... Neurosurgery 30:453, 1992 3...... 3...... 7. Godwin Y: Do they listen? A review of information retained by 4...... 4...... patients following consent for reduction mammoplasty. Br J Plast Surg 53:540, 2000 8. Morgan LW, Schwab IR: Informed consent in senile cataract 4. What “rules of the game” do you know regard- extraction. Arch Ophthalmol 104:42, 1986 9. Priluck IA, Robertson DM, Buettner H: What patients recall of ing the operation itself and the expectations of the preoperative discussion after retinal detachment surgery. the recovery period after the operation? Am J Ophthalmol 5:620, 1979 1...... 10. Turner P, Williams C: Informed consent: Patients listen and read, but what information do they retain? N Z Med J 115:1164, 2...... 2002 3...... 4...... Appendix 5...... 6...... TEST OF INFORMED CONSENT 7...... 8...... 1. Was the interview today the ﬁrst time you had this consultation or have you had it more than 5. What is the next step in the treatment planning once? now you have had this consultation? a. Once ______a. You make an appointment yourself b. More than once ______b. You expect to be called to be operated on c. You consider the operation 2. Which operation(s) do you need to undergo to d. You decide not to be operated on correct the relation of your jaws? e. You have been advised not to have the oper- a. Upper jaw ______ation b. Lower jaw ______f. You don’t know c. Upper and lower jaw ______g. Other: ......