Department of Orthopaedics, ACS Medical College and Hospital, Dr MGR Educational and Research Institute, Chennai, Tamil Nadu, 600077, India.
Department of Biotechnology, School of Engineering and Technology, Sharda University, Greater Noida, Uttar Pradesh, 201310, India.
Eur J Med Res. 2024 Aug 17;29(1):422. doi: 10.1186/s40001-024-02019-8.
Regarding medico-legal malpractice suits, lawyers and insurers focus on informed consent documentation. Unfortunately, there is no standard protocol for obtaining informed consent for platelet-rich plasma (PRP) injections. The objective of the present study was to create a pre-designed, evidence-based informed consent form specifically for PRP injections. The current evidence on the medico-legal implications of PRP injections was accessed, as well as informed consent in general and specifically informed consent in PRP injections. Additionally, we interviewed orthopaedic surgeons and patients who had undergone PRP injections in the past year using a semi-structured approach. A legally valid and evidence-based informed consent form for PRP injections ensures rights, encouraging open communication and transparency between the patient and surgeon. Moreover, if a lawsuit arose, informed consent would be a critical document in surgeons' defence and would withstand scrutiny from lawyers and the judiciary. An evidence-based informed consent form for PRP injections was elaborated and reviewed by a legal expert to ensure adherence to legal proprieties. The final form of the informed consent for PRP injection was administered for one year and validated at our institution.
关于医疗法律纠纷诉讼，律师和保险公司关注的是知情同意书的文件。然而，目前并没有获得富血小板血浆（PRP）注射治疗知情同意的标准方案。本研究旨在创建一个预先设计的、基于循证的 PRP 注射治疗知情同意书。本研究查阅了 PRP 注射治疗的医学法律方面的相关证据，以及一般的知情同意书和 PRP 注射治疗的具体知情同意书。此外，我们还采用半结构化方法，采访了过去一年接受过 PRP 注射治疗的骨科医生和患者。一个合法有效的、基于循证的 PRP 注射治疗知情同意书可以保障患者的权利，促进医患之间的开放沟通和透明化。此外，如果发生诉讼，知情同意书将是医生辩护的关键文件，并且能够经受律师和司法机构的审查。我们还请法律专家对 PRP 注射治疗的知情同意书进行了详细的阐述和审查，以确保符合法律规定。PRP 注射治疗的最终知情同意书在我们机构使用了一年，并进行了验证。
