The traffic light system is shown below. More information can be found on the HFEA website.
A green symbol is given for an add-on where there is more than one good quality RCT which shows that the procedure is effective at improving live birth rates and is shown to be safe for patients to use. These treatment add-ons may be routinely used in fertility treatments therefore will not be included in this review list. Currently no add-ons are given a green rating by the HFEA.
An amber symbol for an add-on where there is conflicting evidence to show that an add-on can improve live birth rates, or that the add-on is safe for patients to use. This means that the evidence is not conclusive and further research is required, and the add-on should not be recommended for routine use.
A red symbol for an add-on where there is no evidence to show that it can improve live birth rates. A red symbol is given for an add-on where there is evidence to show that the add-on is unsafe.
In healthcare, knowledge comes from different sources. These include:
- knowledge derived from research, sometimes called evidence
- knowledge derived from audit and routinely collected data, sometimes called statistics
- knowledge derived from the experience of patients/service users and professional
The approach to evidence should aim to ensure information:
- is balanced and reduces bias
- acknowledges uncertainty
- is produced using an explicit evidence-based process
- uses consistent language
- is impartial
Randomised controlled trials (RCTs) use research methods aimed at reducing bias and that’s why they are considered the only objective way to assess whether an add-on works. However, RCTs are difficult to carry out and require a large amount of time and money and may be difficult to recruit to depending upon what is being studied.
RCT’s aren’t the only way of collecting meaningful information. For example large datasets may provide insights in to the effectiveness of add-ons but there is some discussion regarding the relative benefits of each of these approaches.
In the absence of good RCTs as evidence, an increasing proportion of the sector is relying on their own experiences and analysis of live birth rates and patient outcomes within their own clinics, to determine the suitability and effectiveness of treatments for patients. It may be appropriate to consider alternative evidence in these circumstances.
Factors to consider when evaluating add-on treatments
- care should be taken when considering add-on treatments
- risks and benefits should be carefully evaluated with your Consultant
- the level of evidence is an important consideration when considering your options
- live-birth rate may not be the only outcome important to you in terms of your treatment