What is FEMME?
FEMME is an NIHR funded trial whose primary outcome is to measure the changes in the quality of life women experience after their fibroids are treated with UAE or myomectomy.
On top of this FEMME has a number of secondary outcomes. These include:
Measuring the changes in ovarian reserve associated with UAE and myomectomy
Measuring the changes in menstrual blood loss associated with each procedure
Recording the number of adverse events as well as collecting data on resource use and reintervention rates to determine the cost effectivness of UAE and myomectomy in treating fibroids
I'm reluctant to take part as I think that UAE shouldn't be used in patients who wish to retain their fertility
Although this view is strongly held by some clinicians there is a lack of reliable evidence to either support or disprove this stance. Although a number of studies have been carried out to examine the effect of UAE on fertility these have been underpowered and so are difficult to interpret.
If I join FEMME will you dictate to me how to treat my patients?
Of course not. The patients we'd like you to consider for FEMME are those whose fibroids you believe would be treated equally well with myomectomy or UAE. If you think that your patient would respond best to a certain treatment then your patient must have the treatment you think is best for them.
If my patient joins FEMME then how will you decide their treatment?
If your patient agrees to take part in FEMME then they will be randomly allocated to the myomectomy or UAE arm of the trial.
To randomise a patient please call the randomisation line on 0800 953 0274 between 9am - 5pm, Monday to Friday.You can also randomise online anytime on the FEMME randomisation website
Should the clinical needs of the patient changeafter randomisation and they need to receive a treatment other than theone they've been randomised to how would I do this?
As with all trials run in the UK it is important that patients receive the treatment that is best for them . Should the clinical needs of your patient change and you have to change their treatment then there is no need to tell us before hand. The change in treatment will be captured on the data collection forms and, as FEMME is an intention to treat trial, the patient can continue in the trial.
I'd like to take part but I'm very busy and I don't have the time to complete the paperwork
We appreciate just how busy you are with your clincial commitments and realise that these can stop you taking part in research.
In FEMME we have worked very closely with a number of clinicians to ensure that we only collect the minimum amount of information required to meet all the outcomes of the trial.
Whilst there will be some paperwork to complete we have kept this to an absolute minimum and all the information we ask for is readily available from the patient's notes.
Although on first glance it does look as if there is a lot of paperwork to complete we hope that the data collection forms are short and easy to fill in, and not all the forms are filled in at once but over a period of around six months.
Trials staff from BCTU will send out the follow up questionnaires to the participants and chase up all those forms not returned.
You can view copies of all the documentation for the FEMME trial here.
Can I speak to someone about the trial?
The FEMME trial co-ordinator, William McKinnon, will be happy to answer any questions you may have about the FEMME trial.You can contact William by email anytime or you can call him on 0121 414 8335.
Should you wish to speak to one of the clinical team directing the FEMME trial then please do contact William who will direct your query to the most appropriate person.