‘It all depends on why it’s red’: qualitative interviews exploring patient and professional views of a traffic light system for in vitro fertilisation add-ons

In vitro fertilisation (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. We undertook qualitative interviews to explore understanding and views of the HFEA traffic light system among IVF clinicians, embryologists, and IVF patients across Australia and the United Kingdom (n = 73). Overall, participants were supportive of the intention of the traffic light system; however, many limitations were raised. It was widely recognised that a simple traffic light system necessarily omits information which may be important to understanding the evidence. In particular, the red category was used in scenarios that patients viewed as having different implications for their decision-making, including ‘no evidence’ and ‘evidesssnce 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. The limitations of the traffic light system could be considered in any future updates to the HFEA website and others developing similar decision support tools. LAY SUMMARY: In vitro fertilisation (IVF) add-ons are medical procedures or technologies that may be used in addition to standard IVF. They are usually used with the aim of increasing the chance of pregnancy and live birth. However, most add-ons have not been studied in high-quality clinical trials so it is uncertain whether they are beneficial. The UK’s IVF regulator developed a traffic light system for add-ons. They label them red, amber, or green, depending on whether there is evidence the add-on increases the chance of having a baby from IVF. We interviewed IVF patients, IVF doctors, and embryologists about the traffic light system. Overall, many people thought it was a reliable and trustworthy resource – however, many problems were identified. People generally thought the system was too simple and didn’t give enough information, it had limited detail about the number and types of studies included, and some important add-ons were missing, such as acupuncture.