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Clear aligner therapy informed consent forms: A quality and readability evaluation.

Maurice J Meade1, Sven Jensen1, Xiangqun Ju2

  • 1Orthodontic Unit, Adelaide Dental School, University of Adelaide, South Australia, Australia.

International Orthodontics
|May 7, 2024
PubMed
Summary
This summary is machine-generated.

Clear aligner therapy (CAT) informed consent forms have poor quality and readability, failing to meet standards. This makes patient consent potentially invalid, highlighting the need for clinician awareness of form limitations.

Keywords:
Clear aligner therapyDirect-to-consumer treatmentEthicsInformed consentOrthodontic treatmentValid consent

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Area of Science:

  • Dental technology
  • Informed consent
  • Patient communication

Background:

  • Clear aligner therapy (CAT) is increasingly popular.
  • Informed consent is crucial for ethical patient care.
  • The quality of information provided in CAT consent forms is not well understood.

Purpose of the Study:

  • To evaluate the quality of content (QOC) in CAT informed consent forms.
  • To assess the readability of CAT informed consent forms.
  • To identify limitations in current CAT informed consent forms.

Main Methods:

  • Online search to identify 42 CAT informed consent forms.
  • Assessed QOC for treatment processes, risks, benefits, alternatives, and consequences.
  • Evaluated readability using Simple Measure of Gobbledegook (SMOG) and Flesch Reading Ease Score (FRES).

Main Results:

  • QOC for treatment processes and benefits was adequate, but poor for alternatives and consequences.
  • Readability scores indicated content was difficult to understand (SMOG: 12.1, FRES: 39.0).
  • No significant difference in QOC between direct-to-consumer and non-DTC aligner providers.

Conclusions:

  • CAT informed consent forms are incomplete and poorly written.
  • Content readability fails to meet recommended standards, potentially invalidating patient consent.
  • Clinicians must recognize form limitations regarding alternatives, risks, and long-term maintenance.