Lensen Sarah, Armstrong Sarah, Vaughan Emily, Caughey Lucy, Peate Michelle, Farquhar Cynthia, Pacey Allan, Balen Adam H, Wainwright Elaine
S Lensen, Obstetrics and Gynaecology, University of Melbourne, Melbourne, 3052, Australia.
S Armstrong, Department of Oncology and Metabolism, The University of Sheffield, Sheffield, United Kingdom of Great Britain and Northern Ireland.
Reprod Fertil. 2023 May 1;4(2). doi: 10.1530/RAF-22-0136.
Background IVF add-ons are techniques, medicines or procedures used in addition to standard IVF with the aim of improving the chance of success. The United Kingdom's IVF regulator, ( the Human Fertilisation Embryology Authority (HFEA) developed a traffic light system to categorise add-ons as either green, amber, or red, based on results of randomised controlled trials. Method Qualitative interviews were undertaken to explore understanding and views of the HFEA traffic light system among IVF clinicians, embryologists and IVF patients across Australia and the United Kingdom. Results A total of 73 interviews were conducted. Overall, participants were supportive of the intention of the traffic light system, however many limitations were raised. It was widely recognized that a simple traffic light system necessarily omits information which may be important to understanding the evidence base. In particular, the red category was used in scenarios that patients viewed as having different implications for their decision-making, including 'no evidence' and 'evidence of harm'. Patients were surprised at the absence of any green add-ons and questioned the value of a traffic light system in this context. Many participants considered the website a helpful starting point, but desired more detail, including the contributing studies, results specific to patient demographics (e.g., <35 years and >35 years), and inclusion of more options (e.g. acupuncture). Overall, participants believed the website to be reliable and trustworthy, particularly due to the Government affiliation, and despite some concerns regarding transparency and an overly cautious regulator. Conclusion Participants identified many limitations with the current application of the traffic light system. These could be considered in any future updates to the HFEA website and for others developing similar decision support tools.
背景 体外受精附加技术是指在标准体外受精基础上使用的技术、药物或程序，旨在提高成功几率。英国的体外受精监管机构，即人类受精与胚胎学管理局（HFEA），根据随机对照试验结果，开发了一种交通信号灯系统，将附加技术分为绿色、琥珀色或红色。方法 进行了定性访谈，以探讨澳大利亚和英国的体外受精临床医生、胚胎学家和体外受精患者对HFEA交通信号灯系统的理解和看法。结果 共进行了73次访谈。总体而言，参与者支持交通信号灯系统的意图，但也提出了许多局限性。人们普遍认识到，简单的交通信号灯系统必然会遗漏一些对于理解证据基础可能很重要的信息。特别是，红色类别被用于患者认为对其决策有不同影响的情况，包括“无证据”和“有害证据”。患者对没有任何绿色附加技术感到惊讶，并质疑在此背景下交通信号灯系统的价值。许多参与者认为该网站是一个有用的起点，但希望获得更多细节，包括相关研究、针对患者人口统计学特征（如<35岁和>35岁）的具体结果，以及纳入更多选项（如针灸）。总体而言，参与者认为该网站可靠且值得信赖，特别是由于其与政府的关联，尽管对透明度和监管机构过于谨慎存在一些担忧。结论 参与者指出了交通信号灯系统当前应用中的许多局限性。这些局限性可在HFEA网站未来的任何更新中以及其他开发类似决策支持工具时予以考虑。
