Introduction: Previous orthodontic informed consent research shows low patient/parent recall and comprehension of treatment risks and limitations. The purpose of this study was to: 1) evaluate the effectiveness of a shortened oral presentation of an established informed consent method and 2) determine if customized computer-based presentations (PPTs) improve the recall and comprehension of the risks and limitations of orthodontic treatment.
Methods: Eighty parent/patient pairs were randomly assigned to one of two groups. PPTs were generated for each subject-pair including the most common “core” risk factors (pain, enamel/soft tissue destruction, root resorption, and post-treatment change), up to four patient-specific “custom” risk factors, and other “general” risks and limitations. Group A heard a presentation of the treatment plan and the key points of informed consent. Group B did not hear the verbal explanation of the key points of consent. Subjects in both groups then read the informed consent form, saw the customized PPT, and completed an interview with structured questions, two reading ability tests, and a demographic questionnaire. The interviews were recorded, transcribed, and scored using a previously developed codebook for the percentage of correct recall and comprehension responses. The informed consent issues were assigned to three domains: treatment, risk and responsibility. These groups were compared with patients/parents in the earlier Kang et al study (Group C: modified consent + 18 element PPT).
Results: Test-retest reliability for codebook-response rating was κ = 0.86 and overall subject reliabilities for interview questions for children were κ = 0.30 and parents κ = 0.42. There were no significant differences between Groups A, B, or C for any socio-demographic variables. Children in Group A scored significantly higher than Group B for risk recall. They also scored significantly higher than Group C on overall comprehension, risk recall, risk comprehension, and general risks and limitations questions. Children in Group B scored significantly higher than Group C on overall comprehension, treatment recall, and risk recall. Elements resented first in the PPT presentation were recalled and comprehended better than those presented later.
Conclusions: This study suggested little advantage to a verbal review of the informed consent form (other than for patients for the risk domain) when other means of review such as the customized PPT were included. Patients understood best those elements presented first in the informed consent PPT. The findings suggest that the most important information should be presented to patients first and any information provided beyond the first seven points should be given as supplemental take-home material.