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Recruitment Update
At EDGI UK, we are working with NHS recruitment sites across England to support the study.
So far, over 5,000 people have signed up, completed their questionnaire and sent back their saliva kit! Please help us to reach our goal of recruiting 10,000 participants by getting involved.
We are still launching new recruitment sites so please get in touch with us if you are interested. We are looking forward to working alongside you!
Please don’t hesitate to get in touch at EDGIadmin@kcl.ac.uk if you have any questions.
About the Eating Disorders Genetics Initiative Study
The Eating Disorders Genetics Initiative (EDGI UK) is a research project, funded by the National Institute for Health and Care Research (NIHR) BioResource, that aims to further investigate how genetics and the environment can contribute to eating disorders, in the hope of improving diagnosis and treatment of eating disorders for future generations.
EDGI UK aims to achieve this by recruiting 10,000 people who have experienced eating disorder(s) at any point in their lives. Through this, they will join the NIHR Mental Health BioResource, a re-contactable biobank of volunteers who have provided phenotypical as well as biological (genetic) data. The biological samples linked with clinical data provided to EDGI UK will act as a valuable resource to advance research in the important area of eating disorders and mental health.
Participant Recruitment
We are aiming to recruit individuals aged 16 years or above who have experienced any eating disorder(s). They do not need a formal diagnosis to take part; lived experience is sufficient.
Participants will be directed to the EDGI UK website (edgiuk.org) to sign up online. After participants have registered on the website, they will be able to read through the information sheet, electronically sign the consent form, and complete core psychological screening questionnaires online. This will take approximately 30 - 40 minutes. If participants are eligible, they will then receive a saliva kit in the post so that a biological sample can be collected at home and sent back to the lab via a prepaid return envelope. Once their kit has been received, participants will be full participants in EDGI UK.
EDGI UK participants will be able to view ongoing research projects and can volunteer to sign up online for studies which they are eligible for. They may also be contacted by the EDGI UK or BioResource teams about future research projects, in which they may want to participate. If at any point a member decides they do not want to be part of EDGI UK or the NIHR BioResource, they can withdraw and ask for their biological sample and/or questionnaire data to be destroyed.
NHS Involvement
Individual sites can decide on the extent of their involvement.
Recruiting Sites
Recruiting sites will be involved in the recruitment of patients to join EDGI UK. Since the study is designed to be an online resource, involvement and support of the study by NHS Trusts and clinical services can be accomplished at varying levels of involvement. Recruitment methods for EDGI UK include:
- Advertising and access to data
- Mail-outs (sending letters, emails and/or SMS)
- In-person or over-the-phone recruitment of participants
- A local research team which assists patients in reading through study information, consenting, completing the questionnaire, and perhaps also in providing a saliva sample
First Episode Rapid Early Intervention for Eating Disorders (FREED) Services
EDGI UK is also recruiting through FREED services and welcomes sites that are a part of the FREED Network.
Please note that recruitment for EDGI UK is not limited to FREED services, and trusts can use more than one method or site of recruitment. Trusts with FREED services can also recruit through other clinics.
EDGI UK Study Team Responsibilities
The EDGI UK team is available to answer any questions or concerns from NHS sites. The team can be contacted directly at EDGIadmin@kcl.ac.uk.
The EDGI UK team will provide training materials to teach local delivery teams about the study protocol and sign-up process. The EDGI UK team will also schedule phone calls or video conference calls to discuss the study and answer any remaining questions.
How to Get Involved
Sites that are interested in getting involved with EDGI UK as a recruiting site should follow the link below to register your interest and fill out information about your site.
Please contact the EDGI UK team at EDGIadmin@kcl.ac.uk to let us know when you have completed the Expression of Interest form so we can add you to our waiting list.
Once our team has the capacity to launch your site, we can begin discussions with your local R&D department regarding the feasibility of launching EDGI UK and the details of patient recruitment and on-site staff involvement.
Frequently Asked Questions (FAQs)
General FAQs
- How is the study funded?
- The National Institute for Health and Care Research (NIHR) is the primary funder of EDGI UK.
- What is the study end date?
- Our CRN portfolio eligibility and ethical approval end on 01/09/2024, so Trusts should use that end date. Trust participation can continue as long as there is interest. Note that we will likely apply to have those dates extended, and will inform participating sites of any updates.
- Is the study offering any incentives to participants?
- Due to the large scale of the study, there are no financial incentives for taking part. Participants are asked to join the study to help other people in the future. We send newsletters with updates on our research and have a resources page of helpful links. In addition, because they will be part of our database, participants may be invited to take part in other similar studies in which incentives may be offered.
- Will study aims and procedures be made clear to participants?
The EDGI UK website, information sheet, consent form, and questionnaire underwent extensive user testing and were revised and checked by the NIHR and other mental health charities to make sure they were written in a clear and accessible way.
However, we do understand that some people might still find it difficult to understand, so we have also included a video in the information sheet to explain things more clearly and in a different way. If people are still unsure, we are happy to individually clarify over the phone or by email any questions or queries they may have.
Participant Eligibility
- What are the eligibility criteria for the study?
Eligibility criteria are as follows:
- Have experienced, or have been diagnosed with an eating disorder
- Be aged 16 and above
- Live in England
Anyone who meets the above criteria is eligible to take part.
- Are there any exclusion criteria?
- No. There are no exclusion criteria (beyond individuals who do not meet the eligibility criteria or do not have capacity to consent). However, due to the nature of the study, participants will need access to the Internet and to be proficient in English.
- Do participants need an ‘official’ diagnosis to take part?
- No. Individuals are eligible regardless of diagnosis or treatment. An official diagnosis is therefore not required. For individuals without a diagnosis, the sign-up questionnaire screens for eligibility by assessing current/lifetime symptoms of these disorders to provide a “likely” diagnosis.
- Are NHS sites involved in assessing the eligibility of participants based on their responses to the screening questionnaire?
- No. Eligibility of participants will be assessed centrally by the EDGI UK Study team based on responses to the questionnaire. It’s worth noting that all participants who have received an ‘official’ diagnosis will automatically be eligible, so this is a simple way for sites to verify if someone is assuredly eligible.
- Do participants have to sign up to the study online?
Yes. We cannot offer paper copies of the consent form or the survey. However, sites are welcome to print out the information sheet if there is a local team that will be recruiting.
Individuals who are computer illiterate can receive support in completing the sign-up process from friends, family, or a local delivery team at participating NHS sites. Furthermore, NHS sites can offer individuals without access to the Internet to come on-site to sign up or recommend that they sign up at their local library.
- Is study information available in other languages?
- Unfortunately not. Many of the questionnaires that we use are only validated in English. As a result, we have written into our protocol that one of the eligibility requirements is to be able to complete the questionnaire in English.
- Can participants refuse consent to data linkage and still be involved in the trial?
- No. This is a crucial item in our consent form as the aims of the study directly relate to combined analyses of clinical, questionnaire, and genetic data.
Recruitment numbers and accruals
- For recruiting sites, is there a minimum site target?
- No. We recommend a target of two to five participants a month but sites can select their own recruitment targets.
- Are there any methods of recruitment that you recommend?
Sites are free to use a range of recruitment strategies. This may include:
- Displaying posters/leaflets
- Mail-outs (letters, emails, SMS)
- Opportunistic recruitment by the local research team
Sites are welcome to contact us if they would like to have a further discussion about recruitment strategies, brainstorm ideas or discuss what our top recruiting sites have found to be successful methods.
Please email us at EDGIadmin@kcl.ac.uk if you would like to discuss recruitment strategies further or to arrange a call to speak with us.
- How are accruals assigned?
- Accruals will be assigned based on participant completion and submission of the questionnaire and eligibility for the study. At the beginning of the questionnaire, we will ask participants if they heard about our study through an NHS site/service and they will be required to respond yes/no. If they indicate yes, they will be asked to select their practice or Trust from a dropdown list that will include all active sites (as well as an “other” option, in case).
- What would you recommend to ensure participants know which Trust/NHS site they have been referred from?
- We would recommend adding a sticker to EDGI UK leaflets/posters with your site name/logo to help participants. If you are doing social media posts or advertisements, we would also recommend including the trust’s name in the post. Local delivery teams approaching participants should always remind participants to indicate on the questionnaire that they found out about the study through the site.
- Who is responsible for uploading accrual/recruitment numbers to CPMS/LPMS?
According to the CRN, EDGI UK is classed as an exception study, so our central EDGI UK team will upload recruitment numbers to CPMS, and these numbers should then be populated into the site’s LPMS (e.g., EDGE, ODP). NHS sites should not need to do any uploads to their LPMS.
However, we are often informed that the CPMS numbers are not automatically being transferred to the LPMS. We therefore send out monthly updates with our latest recruits to all sites, so that local delivery teams can upload the latest recruitment numbers to their LPMS.
- Can sites receive updates on their recruitment numbers?
- Yes, our team sends out monthly updates of recruitment numbers to the staff member(s) of the site’s choosing.
Site Involvement
- Are there any specific requirements for sites to run the study?
- No. There are no requirements to be a site.
- Do NHS local delivery teams send out the saliva kits or is this done centrally by the study team?
Saliva kits are sent directly from the central EDGI UK team to the participant’s chosen postal address.
If the participant doesn’t want anything to be sent to their home address, they can provide the clinic’s address. Please let us know in these cases so that we are aware that if we need to resample the participant (e.g. saliva sample is contaminated), we know we will have to ask them to go back to the clinic to collect another saliva kit.
- Will NHS sites be involved in future study recall?
- No. The EDGI UK team is responsible for inviting participants/research teams to collaborate in future research. Any access to data/sample information should be requested through the Manager of the NIHR BioResource Centre Maudsley.
Site Set-up/Steps to launch
- Do you require confirmation of capacity?
- Yes
- Do you require a delegation log to be completed for this study?
- No. Sites are welcome to use one internally if helpful.
- Are there specific requirements for the PI?
- We do not have specific requirements for the PI at your site, as long as they are confident they have the capacity for the role.
- Do you require any trust CV’s/GCP training certificates for your files?
- No.
- Can you create localised versions of the participant information sheet (PIS) and consent form?
- The PIS and consent form are administered to participants online through the website. Sites can create a localised version of the PIS for sites to print out to give to participants, but please note that the consent form must be administered online. However, if sites wish for a localised version of the consent form for site records, we can get that sent to you as well.
- Can you create localised versions of the poster/leaflet?
- We order large batches of posters/leaflets to be professionally printed at a single time, and therefore can’t print localised versions. If sites have stickers with the trust/practice logo, these can be added to the pre-printed versions. Otherwise, we can send sites editable versions of the poster/leaflet which sites are welcome to print locally.
- Are you happy with electronic site files?
- Yes. Please keep electronic site files and send all site-related documents over email. If the document contains participant information, please send that to us via a password-protected document as we do not have an encrypted NHS inbox.
Costs
- Is there any funding available to sites?
- EDGI has been accepted onto the NIHR CRN Portfolio, which provides funding to the sites. However, due to the scale of the study and limitations of funding, we do not typically provide funding for research costs.
- Are there any Excess Treatment Costs (ETCs) associated with this study?
- No
Medical records
- How will you link to medical records?
- Accessing medical records will be done centrally through the Longitudinal Linkage Collaboration (LLC). The LLC is a collaborative research effort, part of the Longitudinal Health & Wellbeing National Core Study for COVID-19 research, which is run and funded by the UK Government. We will only access relevant sections of our participants’ medical records that will be helpful to our research.
- How are you planning to use medical records?
- We would combine this information with questionnaire data and DNA to provide a comprehensive overview to be used in a wide range of investigations looking into mental health disorders (e.g. risk factors, co-morbidities) and treatment outcomes.