Abstract：
OBJECTIVE: The aim of the present study was to evaluate the quality and readability of content contained within clear aligner therapy (CAT) informed consent forms.
METHODS: CAT informed consent forms were identified via an online search. The presence of details related to CAT-related processes, risks, benefits and alternatives in each form was recorded. A 4-point Likert type scale was used to determine the quality of content (QOC). The readability of content was evaluated with the Simple Measure of Gobbledegook (SMOG) and Flesch Reading Ease Score (FRES).
RESULTS: A total of 42 forms satisfied selection criteria. Nineteen (45.2%) were authored by companies who provided aligners to patients via clinicians. The QOC regarding CAT-related treatment processes [median 2.0; IQR 0, 2] and benefits [median 2.0; IQR 1, 2] was adequate. The QOC scores regarding treatment alternatives, consequences of no treatment and relapse were poor. There was no difference (P=0.59) in the median (IQR) QOC of the informed consent forms provided by direct-to-consumer (DTC) aligner providers [10 (8.25, 16.25)] and non-DTC aligner providers [12 (10, 14)]. The median (IQR) SMOG score was 12.1 (10.9, 12.7) and FRES was 39.0 (36.0, 44.25).
CONCLUSIONS: The QOC of the evaluated forms was incomplete and poor. The content was difficult to read and failed to reach recommended readability standards. Consent is unlikely to be valid if it is based solely on the content of the forms. Clinicians need to be aware of the limitations of informed consent forms for CAT particularly in relation to alternatives, prognosis, risks, and the need for long-term maintenance of results.
METHODS: CAT informed consent forms were identified via an online search. The presence of details related to CAT-related processes, risks, benefits and alternatives in each form was recorded. A 4-point Likert type scale was used to determine the quality of content (QOC). The readability of content was evaluated with the Simple Measure of Gobbledegook (SMOG) and Flesch Reading Ease Score (FRES).
RESULTS: A total of 42 forms satisfied selection criteria. Nineteen (45.2%) were authored by companies who provided aligners to patients via clinicians. The QOC regarding CAT-related treatment processes [median 2.0; IQR 0, 2] and benefits [median 2.0; IQR 1, 2] was adequate. The QOC scores regarding treatment alternatives, consequences of no treatment and relapse were poor. There was no difference (P=0.59) in the median (IQR) QOC of the informed consent forms provided by direct-to-consumer (DTC) aligner providers [10 (8.25, 16.25)] and non-DTC aligner providers [12 (10, 14)]. The median (IQR) SMOG score was 12.1 (10.9, 12.7) and FRES was 39.0 (36.0, 44.25).
CONCLUSIONS: The QOC of the evaluated forms was incomplete and poor. The content was difficult to read and failed to reach recommended readability standards. Consent is unlikely to be valid if it is based solely on the content of the forms. Clinicians need to be aware of the limitations of informed consent forms for CAT particularly in relation to alternatives, prognosis, risks, and the need for long-term maintenance of results.
摘要：
目的：本研究的目的是评估明确的对准治疗（CAT）知情同意书中包含的内容的质量和可读性。
方法：通过在线搜索确定了CAT知情同意书。与CAT相关流程相关的详细信息的存在，风险,记录每种形式的益处和替代方案。使用4点Likert型量表来确定内容质量（QOC）。使用Gobbledegook的简单测量（SMOG）和Flesch阅读轻松评分（FRES）评估内容的可读性。
结果：共有42个表格符合选择标准。十九（45.2％）是由通过临床医生向患者提供矫正器的公司撰写的。关于CAT相关治疗过程的QOC[中位数2.0；IQR0，2]和益处[中位数2.0；IQR1，2]是足够的。关于治疗替代方案的QOC评分，没有治疗和复发的后果很差。直接面向消费者(DTC)对准器提供者[10(8.25,16.25)]和非DTC对准器提供者[12(10,14)]提供的知情同意书的中位数(IQR)QOC没有差异(P=0.59)。中位数（IQR）SMOG评分为12.1（10.9，12.7），FRES为39.0（36.0，44.25）。
结论：评估表格的QOC不完整且较差。内容难以阅读，未能达到推荐的可读性标准。如果仅基于表格的内容，同意不太可能有效。临床医生需要意识到CAT知情同意书的局限性，特别是在替代品方面，预后,风险,以及需要长期维护的结果。
方法：通过在线搜索确定了CAT知情同意书。与CAT相关流程相关的详细信息的存在，风险,记录每种形式的益处和替代方案。使用4点Likert型量表来确定内容质量（QOC）。使用Gobbledegook的简单测量（SMOG）和Flesch阅读轻松评分（FRES）评估内容的可读性。
结果：共有42个表格符合选择标准。十九（45.2％）是由通过临床医生向患者提供矫正器的公司撰写的。关于CAT相关治疗过程的QOC[中位数2.0；IQR0，2]和益处[中位数2.0；IQR1，2]是足够的。关于治疗替代方案的QOC评分，没有治疗和复发的后果很差。直接面向消费者(DTC)对准器提供者[10(8.25,16.25)]和非DTC对准器提供者[12(10,14)]提供的知情同意书的中位数(IQR)QOC没有差异(P=0.59)。中位数（IQR）SMOG评分为12.1（10.9，12.7），FRES为39.0（36.0，44.25）。
结论：评估表格的QOC不完整且较差。内容难以阅读，未能达到推荐的可读性标准。如果仅基于表格的内容，同意不太可能有效。临床医生需要意识到CAT知情同意书的局限性，特别是在替代品方面，预后,风险,以及需要长期维护的结果。
