Frequently Asked Questions (FAQs)
General Questions
How is the study funded?
The National Institute of Health Research (NIHR) is the primary funder of the EDGI Study.
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 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 are 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 patients 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 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 from 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. 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
Please note that our ethics do not allow sites to recruit from schools.
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. 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 then 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 leaflets/posters with your site name/logo to help patients. 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 patients should always remind patients 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 is classed as an exception study, so our central EDGI team will upload recruitment numbers to CPMS, and these numbers should then be populated into the site’s LPMS (e.g., EDGE). 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 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.
How can Primary Care get involved?
Primary Care can be added as recruiting sites or as PICs. Primary care recruiting sites will be able to take part in any of the recruiting activities listed above, same as the trusts. This can range from advertising, having clinicians mention the study to their patients and/or having a local research nurse consent/support participants signing up. Please note that Primary Care sites wishing to be recruiting sites will have to go through the full governance procedure to issue confirmation of capacity and capability in order to begin recruiting.
PIC sites will be asked to display posters and leaflets in waiting areas and to provide access to medical records for consented participants.
What are you doing about mail-out packs for GP practices?
We are currently trialling using text messages and mail-outs in a select number of GP practices. Practices interested in utilising these methods of recruitment should email our team to be kept up-to-date on the trial.
Can pharmacy care get involved?
Yes. Pharmacies are welcome to get involved as PICs or as recruiting sites. To be a recruiting site, pharmacies will have to go through governance procedures to issue confirmation of capacity and capability before launching.
Are NHS local delivery teams sending out the saliva kits or is this done centrally by the study team?
NHS teams are welcome to collect saliva kits in the clinic, although this is optional. Typically, kits are sent from the central EDGI study team. If you would like your site to collect samples for the study, please contact our team.
Will NHS sites be involved in future study recall?
No. The EDGI 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. Information on how to submit a data/sample access request is in development and will be available on the website once prepared.
Site Set-up/Steps to launch
Do you require confirmation of capacity?
For recruiting sites: Yes.
For PIC sites: No.
Do you require a delegation log to be completed for this study?
No. Sites are welcome to use one internally if helpful.
Do you require any trust CV’s/GCP’s for your files?
No.
Can you create localised versions of the participant information sheet/consent form?
The PIS and consent form are administered to patients online through the website. Sites can create a localised version of the PIS for sites to print out to give to patients, 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.
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 is likely to be done centrally, and we will only access relevant sections of our participants’ medical records that will be helpful to our research. In some cases, we might require help from specific NHS trusts or local delivery teams. If we need to access medical records through sites, then we will collaborate with each site individually to find a way to do so which is feasible and can discuss support/funding requirements if needed.
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.
