Start/end date
Start date: December 2020
End date: April 2022
Background
More women with multiple sclerosis (MS) are considering pregnancy and breastfeeding nowadays, since increasing evidence has shown positive impact on the disease course during pregnancy and breastfeeding. However, the reproductive decision remains complex due to the unpredictable nature of the disease and the range of disease modifying drug (DMD) safety profiles in pregnancy and breastfeeding. Our research area is very important yet neglected; we are looking at the challenges women with MS face when taking reproductive decisions, and trying to find solutions for them, together with the health care providers, when taking these fertility decisions and managing their medications in the best possible way.
Aims
Helping women with MS take a shared informed decision regarding their MS treatment choice considering their family plans, we should answer these important questions:
- What is the effect of switching DMD on disease course in people with stable relapsing, remitting MS (RRMS)?
- What are the sources of knowledge people with MS have about reproduction and medication management in MS?
- How well are they informed about risks of medication during pregnancy and breastfeeding?
- What are their concerns and needs when taking the decision whether to start a family or not?
And finally, can a digital decision aid that considers family planning in the DMD choice help people with MS to decide on their reproduction and treatment?
Methods
We have already completed a systematic literature review regarding the outcome of DMD switching strategy on relapse rates (findings below). We have now applied for UCL ethical approval to start our next study. Our research will involve one-to-one virtual interviews with people with MS and with health care providers. We will explore patients’ knowledge, concerns, and needs when making reproduction decisions and how that might affect their treatment plans. We will also conduct think aloud sessions with them while they use an online decision aid tool, that we propose to amend to include reproduction planning in the medication decision process, informed by their thoughts and ideas.
Findings
The systematic review showed that the effect of switching disease modifying drugs in stable relapsing remitting multiple sclerosis planning for pregnancy generally reflects medications headline efficacy and is most risky in case of de-escalation. More studies with larger sample sizes on switching different medications are needed. And there is a clear need for a comparison between the effect of pregnancy, breastfeeding and other DMDs on disease activity. Our work was published as an e-poster in Acrtims/Ectims 8th joint conference in September 2020.
Our team
Lubna Almouzain, PhD Student at PCPC, UCL, UK. Lecturer at clinical pharmacy department, KSU, SA.
Fiona Hamilton, Associate Professor at the Department of Primary Care & Population Health, University College of London, London, UK.
Fiona Stevenson, Professor of Medical Sociology, Head of Primary Care and Population Health Department.
Declan Chard, Principal Clinical Research Associate, Neuroinflammation, UCL Queen Square Institute of Neurology, Faculty of Brain Sciences.
Collaborator
The MS Trust Organization will help in recruiting participants using their social media accounts and amend their online tool according to our study findings.
Funder
King Saud University (KSU), Saudi Arabia.
Ethics and data protection
This study has been approved by the UCL Research Ethics Committee: Project ID number: 18923/001 and registered under, reference No Z6364106/2020/09/28 health research in line with UCL’s Data Protection Policy.
For local privacy notice
Important links for participation in the trial
Patient Public Involvement opportunity: You can find more information about
.If you are interested in being part of this trial please complete this online registration form.
Details of our privacy policy can be found here.
Contact details
Registration for health care providers (MS consultant, MS specialist nurse, Pharmacist, GP) please email Lubna.almouzain.19@ucl.ac.uk.