Impact of verbal explanation and modified consent materials on orthodontic informed consent.

INTRODUCTION: Comprehension of informed consent information has been problematic. The purposes of this study were to evaluate the effectiveness of a shortened explanation of an established consent method and whether customized slide shows improve the understanding of the risks and limitations of orthodontic treatment. METHODS: Slide shows for each of the 80 subject-parent pairs included the most common core elements, up to 4 patient-specific custom elements, and other general elements. Group A heard a presentation of the treatment plan and the informed consent. Group B did not hear the presentation of the informed consent. All subjects read the consent form, viewed the customized slide show, and completed an interview with structured questions, 2 literacy tests, and a questionnaire. The interviews were scored for the percentages of correct recall and comprehension responses. Three informed consent domains were examined: treatment, risk, and responsibility. These groups were compared with a previous study group, group C, which received the modified consent and the standard slide show. RESULTS: No significant differences existed between groups A, B, and C for any sociodemographic variables. Children in group A scored significantly higher than did those in group B on risk recall and in group C on overall comprehension, risk recall and comprehension, and general risks and limitations questions. Children in group B scored significantly higher than did those in group C on overall comprehension, treatment recall, and risk recall. Elements presented first in the slide show scored better than those presented later. CONCLUSIONS: This study suggested little advantage of a verbal review of the consent (except for patients for risk) when other means of review such as the customized slide show were included. Regression analysis suggested that patients understood best the elements presented first in the informed consent slide show. Consequently, the most important information should be presented first to patients, and any information provided beyond the first 7 points should be given as supplemental take-home material.

Informed consent recall and comprehension in orthodontics: traditional vs improved readability and processability methods.

INTRODUCTION: Low general and health literacy in the United States means informed consent documents are not well understood by most adults. Methods to improve recall and comprehension of informed consent have not been tested in orthodontics. The purposes of this study were to evaluate (1) recall and comprehension among patients and parents by using the American Association of Orthodontists' (AAO) informed consent form and new forms incorporating improved readability and processability; (2) the association between reading ability, anxiety, and sociodemographic variables and recall and comprehension; and (3) how various domains (treatment, risk, and responsibility) of information are affected by the forms. METHODS: Three treatment groups (30 patient-parent pairs in each) received an orthodontic case presentation and either the AAO form, an improved readability form (MIC), or an improved readability and processability (pairing audio and visual cues) form (MIC + SS). Structured interviews were transcribed and coded to evaluate recall and comprehension. RESULTS: Significant relationships among patient-related variables and recall and comprehension explained little of the variance. The MIC + SS form significantly improved patient recall and parent recall and comprehension. Recall was better than comprehension, and parents performed better than patients. The MIC + SS form significantly improved patient treatment comprehension and risk recall and parent treatment recall and comprehension. Patients and parents both overestimated their understanding of the materials. CONCLUSIONS: Improving the readability of consent materials made little difference, but combining improved readability and processability benefited both patients' recall and parents' recall and comprehension compared with the AAO form.

Clinical color match of porcelain visual shade-matching systems.

BACKGROUND: Accuracy of the total color replication process has not been clinically evaluated for various porcelain visual shade-matching systems. PURPOSE: The purpose of this study was to evaluate the final color replication process of three porcelain visual shade-matching systems. Subjects' natural dentition was compared with laboratory-fabricated individualized porcelain shade tabs. MATERIALS AND METHODS: Shade matches of 10 subjects' incisors were obtained using three different porcelain visual shade-matching systems. Commercial laboratories fabricated one corresponding individualized porcelain shade tab for each incisor per visual shade-matching system selection. Color-match evaluations of the fabricated individualized porcelain shade tabs to the corresponding teeth were completed by prosthodontists' consensus and by subjects' self-evaluation using the US Public Health Service criteria. Statistical analysis was carried out on the combined evaluations with logistic regression and the Generalized Estimating Equation for repeated measures. RESULTS: The Vitapan 3D Master/Omega 900 system (Vident Inc., Brea, CA, USA) was significantly more likely than the Vita Lumin Vacuum/VMK 68 system (Vident Inc.) to obtain a clinically acceptable color match (odds ratio [OR]=6.31; 95% CI=1.24-32.07). The likelihood of obtaining a clinically acceptable color match through subjects' self-evaluation was found to be significantly higher compared with prosthodontists' consensus (OR=2.75; 95% CI=1.27-5.94). CONCLUSIONS: Within the limits of this preliminary study, significant differences in clinical acceptability were seen between the color matches of the fabricated individualized porcelain shade tabs from different systems and subjects' central incisors. Subjects' range of acceptability was much broader compared with that of the prosthodontists in assessing the color match of the fabricated porcelain shade tabs. CLINICAL SIGNIFICANCE: The use of certain porcelain visual shade-matching systems may result in a clinically acceptable color match of the final restoration more readily than the use of other systems. Color-match evaluation of final restorations should be accomplished through a consensus between prosthodontists and patients, given the difference in thresholds of acceptability.