ChatGPT 是提高骨科研究同意书可读性的有效工具

Bissem Gill, John Bonamer, Henry A. Kuechly, Rajul Gupta, Scottie Emmert, Sarah Kurkowski, Kim Hasselfeld, Brian M. Grawe
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摘要

背景/目的:知情同意是医学研究的一项基本道德要求,可确保参与者全面了解参与研究的相关风险和益处。临床研究人员必须确保切实有效地传达参与研究的意义,但传统研究同意书的复杂性和篇幅可能会妨碍理解,并对研究人员和参与者之间的有效沟通造成障碍。因此,美国医学会建议所有面向患者的医疗信息都应达到六年级的阅读水平。大语言模型 ChatGPT-3.5 能否在提高可读性的同时保留充分知情同意所需的信息?方法:将 19 份经 IRB 批准的骨科手术研究同意书输入 ChatGPT,并说明要使同意书 "具有六年级水平的可读性"。使用常用的可读性指标对 ChatGPT 后的同意书进行评估。此外,一位独立执业 15 年的骨科医生对表格的准确性和必要知情同意要素的保留情况进行了评估。结果:在每项可读性指标上,ChatGPT 前和 ChatGPT 后的中位数差异都具有统计学意义(所有指标的 p 均小于 0.001),而且所有指标都认为 ChatGPT 后的同意书更具可读性。自动可读指数和 Raygor 年级水平这两项语言指标表明,ChatGPT 后的同意书可以达到美国医学会建议的 6 年级阅读水平。19 份 ChatGPT 后同意书中有 12 份至少有一处错误。结论:ChatGPT 可以大大提高骨科临床研究同意书的可读性,但这些经过编辑的同意书并非没有错误,也无法达到美国医学会建议的六年级阅读水平。因此,ChatGPT 应作为人类研究人员写作和编辑过程的补充工具。
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ChatGPT is a promising tool to increase readability of orthopedic research consents
Background/Purpose: Informed consent is a fundamental ethical requirement in medical research, ensuring that participants have a comprehensive understanding of the risks and benefits associated with their participation. Clinical researchers must ensure effective and efficient communication of the implications of participation, but the complexity and length of traditional research consent forms can impede comprehension and create barriers to effective communication between researchers and participants. For this reason, the American Medical Association recommends a 6th grade reading level for all patient-facing medical information. Can the large language model, ChatGPT-3.5, improve readability while simultaneously preserving information necessary for adequate informed consent?. Methods: Nineteen IRB approved Orthopedic surgery research consent forms were entered into ChatGPT with instructions to make the form “readable at a 6th-grade level.” Post ChatGPT consent forms were assessed using commonly used readability metrics. Additionally, a single Orthopedic surgeon who has practiced independently for 15 years assessed the forms for accuracy and retention of imperative informed consent elements. Results: The median differences between pre-ChatGPT and post-ChatGPT were statistically significant for every readability metric (all p < 0.001) and all favored the post-ChatGPT consent as being more readable. Two language metrics, Automated Readability Index and Raygor Grade Level, indicated the post-ChatGPT consent forms could meet the AMA's recommended 6th-grade reading level. Twelve of 19 post-ChatGPT consents had at least one error. Conclusion: ChatGPT can significantly improve the readability of Orthopedic clinical research consent forms, but these edited consents are not without mistakes and cannot reach the AMA's recommended 6th grade reading level. Therefore, ChatGPT should be used as a tool to supplement the writing and editing process of human researchers.
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