Pediatrics. 2017 Jan;139(1). doi: 10.1542/peds.2016-3437.
Advances in medical care may occur when a change in practice incorporates a new treatment or methodology. In surgery, this may involve the translation of a completely novel concept into a new procedure or device or the adaptation of existing treatment approaches or technology to a new clinical application. Regardless of the specifics, innovation should have, as its primary goal, the enhancement of care leading to improved outcomes from the patient's perspective. This policy statement examines innovation as it pertains to surgical care, focusing on some of the definitions that help differentiate applied innovation or innovative therapy from research. The ethical challenges and the potential for conflict of interest for surgeons or institutions seeking to offer innovative surgical therapy are examined. The importance of engaging patients and families as "innovation partners" to ensure complete transparency of expectations from the patient's and provider's perspectives is also examined, with specific emphasis on cultural competence and mutually respectful approaches. A framework for identifying, evaluating, and safely implementing innovative surgical therapy in children is provided.
当实践中的改变纳入新的治疗方法或技术时，医疗护理就会取得进展。在外科手术中，这可能涉及将全新的概念转化为新的手术程序或设备，或者将现有的治疗方法或技术应用于新的临床用途。无论具体情况如何，创新的首要目标都应该是从患者的角度改善护理并提高治疗效果。本政策声明审视了与外科护理相关的创新，重点关注一些有助于区分应用创新或创新疗法与研究的定义。探讨了寻求提供创新手术疗法的外科医生或机构所面临的伦理挑战和利益冲突可能性。还探讨了让患者及其家属作为“创新伙伴”参与进来的重要性，以确保从患者和提供者的角度完全透明地了解期望，特别强调文化能力和相互尊重的方法。提供了一个识别、评估和安全实施儿童创新手术疗法的框架。
