‘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

Author:

Lensen Sarah1ORCID,Armstrong Sarah2,Vaughan Emily3,Caughey Lucy1,Peate Michelle1,Farquhar Cynthia4,Pacey Allan2,Balen Adam5,Wainwright Elaine67

Affiliation:

1. Department of Obstetrics and Gynaecology, Royal Women’s Hospital, University of Melbourne, Parkville, Victoria, Australia

2. Department of Oncology and Metabolism, The University of Sheffield, The Medical School, Beech Hill Road, Sheffield

3. NIHR Academic Clinical Fellow, University of Bristol, UK, Academic Women’s Health Unit, North Bristol NHS Trust, Bristol, UK

4. M&HS Building 507, 28 Park Ave, Grafton, Auckland, New Zealand

5. Leeds Teaching Hospitals NHS Trust, Great George St, Leeds, UK

6. Epidemiology Group, School of Medicine, Medical Sciences and Nutrition, University of Aberdeen, UK

7. Department for Health, University of Bath Honorary Research Fellow, Bath Spa University, UK

Abstract

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.

Publisher

Bioscientifica

Subject

Urology,Reproductive Medicine,Obstetrics and Gynecology,Embryology

Reference20 articles.

1. Add-ons in the laboratory: hopeful, but not always helpful;Armstrong,2019

2. VALUE study: a protocol for a qualitative semi-structured interview study of IVF add-ons use by patients, clinicians and embryologists in the UK and Australia;Armstrong,2021

3. Patient-centred infertility care: a qualitative study to listen to the patient's voice;Dancet,2011

4. Is the information on endometrial scratching provided by IVF clinics' websites biased?;Galiano,2020

5. Accounting for complexity in healthcare innovation debates: professional views on the use of new IVF treatments;Geampana,2022

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