FEMME Newsletter October 2012

Page 1

Make the jump and recruit your first FEMME patient!

Congratulations to the

teams at the Royal Hallamshire Hospital, Sheffield

and Birmingham Women’s Hospital who have both recruited their

first FEMME patients!

1

2

3

4

5

6

7

Patients screened up to 30th September

St. George’s, London

Glasgow Sheffield

St. Thomas’ Devon & Exeter

Worthing Truro

Patients recruited up to 30th September

St. George’s

Glasgow

Up to September a total of 188 patients have been screened across 7 centres

Up to September a total of 20 patients had

been randomised but during October a further 5 patients have been randomised bringing the current total to 25 patients! In addition to St. George’s Hospital, London

and Glasgow Royal Infirmary/Gartnavel General, 2 patients have now been

recruited from Birmingham Women’s Hospital and 1 patient from the Royal Hallamshire Hospital, Sheffield

Centre Patients Recruited Patients Recruited - September Total

1st - St. George's Hospital, London 13 2 15

2nd - Glasgow Royal Infirmary/Gartnavel General 5 0 5

Royal Hallamshire Hospital, Sheffield 0 0 0

St. Thomas' Hospital 0 0 0

Worthing Hospital 0 0 0

The Royal Devon & Exeter Hospital 0 0 0

Royal Cornwall Hospital, Truro 0 0 0

Total 18 2 20

Patients randomised up to 30th September

Page 2

Reminders:

Please remember to return your completed screening logs to BCTU at the end of each month

Teleconferences for FEMME Research Nurses are held fortnightly in order for nurses to discuss recruitment and share best practice. The next teleconference is being held w/c 5th November—look out for your email invite and we welcome your attendance!

St. George’s Hospital, London

September

IMPORTANT NOTE

As quality of life is the primary outcome of FEMME, this information is very important. From now on please can you ensure that the quality of life sections (all pages except page 3) of the Patient Baseline Questionnaire are completed before a patient is randomised. The Menstrual Blood Loss Diary section can be completed when the patient starts their next period. Further details will be circulated...

Page 3

FEMME—A Nurse’s View

St. George’s Hospital, London is currently our top recruiting site. Kelly Faillo started as a dedicated FEMME Trial Co-ordinator in June 2012 and works with two of the FEMME Clinical Lead Investigators; Mr Issac Manyonda and Prof Anna Belli. Below, Kelly gives us an insight in to her experiences working on FEMME...

HOW HAVE PATIENTS BEEN SUCCESSFULLY SCREENED FOR THE TRIAL AT ST.

GEORGE’S?

The screening process is very important in recruiting patients. At St. George’s, we’re fortunate enough to have a dedicated FEMME team, in which both the interventional radiologist and gynaecologist have invited me to participate in weekly fibroid clinics. I typically screen patients’ notes ahead of time (electronically) in the hope of identifying potential FEMME patients. This has been very successful and therefore I am able to target these specific patients in clinic.

WHAT DO YOU THINK ARE THE CHALLENGES THAT THE FEMME TRIAL POSES IN

TERMS OF COORDINATION AT SITE(S) AND HOW HAVE YOU SUCCESSFULLY OVER-

COME THEM?

Because the FEMME trial involves both the radiology and gynaecology teams, coordination and open lines of communication are essential. Having routine meetings between the two departments is often difficult to organise, but vital in the recruitment process and execution of the trial. It is also important to streamline the trial process for the consultants involved, so that we avoid burdening them with a large time commitment outside of their normal daily practice.

WHAT HAS YOUR EXPERIENCE BEEN OF EXPLAINING THE TRIAL TO PATIENTS?

Talking with patients is the most enjoyable part of my day. Early on, I attended both a myomectomy procedure as well as a uterine artery embolization. From these experiences, I am able to accurately educate patients regarding both treatments and provide realistic expectations. I also keep an open line of communication with all of my patients, even ones who are still considering trial participation. I have found that they feel more comfortable and are more willing to participate when they have an easily accessible point of contact within the trust.

DO YOU HAVE A TAKE HOME MESSAGE/TIPS FOR OTHER PARTICIPATING FEMME

SITES? WHAT DO YOU THINK HAS BEEN CRITICAL TO YOUR RECENT RECRUITMENT?

Convincing patients to enrol in a randomised controlled trial is often challenging, especially considering the two treatment options offered within FEMME are very different. However, I believe the question we are trying to answer is an important one, and therefore this research is vital and may drastically change the future of symptomatic, uterine fibroid management. Conveying the importance of our research to patients is difficult, but if done effectively, they are able to see the benefit of helping women in similar situations for generations to come.

Page 4

FEMME—A Nurse’s View continued...

WHAT ARE THE MAIN THINGS YOU’VE LEARNT FROM WORKING ON FEMME?

Most importantly, FEMME has taught me the value of research. As a practising clinician, I know what it feels like to be bombarded with requests from researchers in the midst of an over-booked clinic list. However, in moving to the research side, I now understand the importance of research, and value its role in developing the future of medicine. That being said, I also understand how important it is to make things easy for the busy clinician, and that streamlining the recruitment process is essential for success. The best scenario for all of those involved in FEMME is to develop open lines of communication to lay the foundation of a well-rounded, multidisciplinary team.

TO RANDOMISE OR NOT TO RANDOMISE?

1. A 46 year-old woman presents to the gynaecology clinic with heavy menstrual bleeding. She was

diagnosed with uterine fibroids 10 years earlier. She did not pursue surgical treatment initially, however the heavy bleeding has increased to the point of casuing her to be anemic. She has a history of hyperthyroidism, but is otherwise healthy. She is gravida 2, para 2, and states that her family is complete, but wishes to avoid a hysterectomy. An MRI has been ordered as there is no documentation of any recent imaging. Assuming the MRI demonstrates uterine fibroids and no other alarming conditions...would you randomise this patient? Please vote:

2. A 42 year-old woman presents to the gynaecology clinic with subfertility and heavy menstrual bleeding. She was recently diagnosed with uterine fibroids on transvaginal ultrasound while undergoing an infertility work-up. This scan demonstrates a 5 centimetre fundal, intramural fibroid along with multiple other small intramural fibroids throughout the uterus. She presents to the clinic to discuss management options including myomectomy and uterine artery embolisation, as she saw a FEMME poster in clinic...would you randomise this patient?

Please vote:

YES NO UNDECIDED

YES NO UNDECIDED

Contact details Trial Co-ordinator: William McKinnon, Email: w.mckinnon@bham.ac.uk, Tel: 0121 414 8335 Data Manager: Leanne Homer, Email: l.e.homer@bham.ac.uk, Tel: 0121 414 9011 Trial Email: femme-trial@trials.bham.ac.uk Office fax: 0121 415 9136 FEMME website: www.birmingham.ac.uk/femme Facebook: www.facebook.com/femme2

Twitter: www.twitter.com/femme_trial Randomisation line: 0800 953 0274

Page 5

Site recruitment

FEMME currently has local approval at 25 sites across the UK with many more approvals imminent

The latest centres to gain approval

are Ninewells Hospital, Dundee and University Hospital of North

Staffordshire

Approved centres

Centres pending approval

Would you like to be a FEMME Champion? We are looking for Clinicians to help promote FEMME to their clinical colleagues

Please contact us for further details