EAGLE STUDY SET-UP

EAGLE STUDY SET-UP Step 1 Email the EAGLE Office Step 2 Complete Site Set-up Pathway Step 3 Identify your local EAGLE team Step 4 Secure local approvals Step 5 Confirm hospital readiness Step 6 Commence EAGLE!

EAGLE STUDY SET-UP Step 1 Email the EAGLE Office 1. Email your expression of interest in participating in the EAGLE study to eagle@contacts.bham.ac.uk. 2. The EAGLE Coordinating Office based at University of Birmingham will send you a link to the Site Set-up Pathway (this webpage!) 3. The EAGLE Coordinating Office will also put you in touch with a dedicated EAGLE Coordinator. EAGLE Coordinator: a surgeon who will support you to set-up EAGLE at your site and guide you through the delivery of EAGLE. They will teleconference with you weekly, in addition to email and WhatsApp contact. Your coordinator is the first point of contact for any queries and they will liaise between you and the EAGLE Committee.

EAGLE Site Set-up Pathway webpage EAGLE STUDY SET-UP Step 1 Email the EAGLE Office 1. Email your expression of interest in participating in the EAGLE study to eagle@contacts.bham.ac.uk. 2. The EAGLE Coordinating Office based at University of Birmingham will send you a link to the Site Set-up Pathway (this webpage!) 3. The EAGLE Coordinating Office will also put you in touch with a dedicated EAGLE Coordinator. EAGLE Coordinator: a surgeon who will support you to set-up EAGLE at your site and guide you through the delivery of EAGLE. They will teleconference with you weekly, in addition to email and WhatsApp contact. Your coordinator is the first point of contact for any queries and they will liaise between you and the EAGLE Committee. EAGLE Site Set-up Pathway webpage

Complete Site Set-up Pathway EAGLE STUDY SET-UP Step 2 Complete Site Set-up Pathway 1. Read through the Site Set-up Pathway (this webpage!) 2. Complete your details at the end of the Site Set-up Pathway webpage. 3. The EAGLE Coordinating Office will use your details to issue you with a login for the Site Registration Form. It is mandatory for site Principal Investigators to complete the Site Set-up Pathway (this webpage). It is recommended that all co-investigators also complete the Site Set-up pathway.

Complete your details at the end of the Site Set-up Pathway webpage EAGLE STUDY SET-UP Step 2 Complete Site Set-up Pathway 1. Read through the Site Set-up Pathway (this webpage!) 2. Complete your details at the end of the Site Set-up Pathway webpage. 3. The EAGLE Coordinating Office will use your details to issue you with a login for the Site Registration Form. It is mandatory for site Principal Investigators to complete the Site Set-up Pathway (this webpage). It is recommended that all co-investigators also complete the Site Set-up pathway. Complete your details at the end of the Site Set-up Pathway webpage

Identify your local EAGLE team EAGLE STUDY SET-UP Step 3 Identify your local EAGLE team 1. On the Site Registration Form complete details of the team that have agreed to lead EAGLE at your hospital. This must include: Surgeon Principal Investigator (a consultant/ attending surgeon) Surgeon Associate Principal Investigator (a registrar/ resident/ trainee) Theatre Nurse Principal Investigator (a senior member of theatre team) Anaesthetist Principal Investigator (a consultant/ attending anaesthetist) In addition there is an option to enter details for up to three additional collaborators who have agreed to support data collection at your site. 2. On the Site Registration Form complete the brief site survey (e.g. number of surgeons who perform right colectomy at your hospital). Manuscripts arising from EAGLE will be published using the same authorship model as for the 2015 ESCP Right Hemicolectomy audit. There will be a single corporate author (e.g. “EAGLE Collaborative”) with all collaborators listed as PubMed-citable co-authors. Up to seven collaborators will be listed as co-authors per site. If you think you need additional collaborators (i.e. more than seven) at your site, please contact your EAGLE Coordinator.

Identify your local EAGLE team EAGLE STUDY SET-UP Step 3 Identify your local EAGLE team 1. On the Site Registration Form complete details of the team that have agreed to lead EAGLE at your hospital. This must include: Surgeon Principal Investigator (a consultant/ attending surgeon) Surgeon Associate Principal Investigator (a registrar/ resident/ trainee) Theatre Nurse Principal Investigator (a senior member of theatre team) Anaesthetist Principal Investigator (a consultant/ attending anaesthetist) In addition there is an option to enter details for up to three additional collaborators who have agreed to support data collection at your site. 2. On the Site Registration Form complete the brief site survey (e.g. number of surgeons who perform right colectomy at your hospital). Manuscripts arising from EAGLE will be published using the same authorship model as for the 2015 ESCP Right Hemicolectomy audit. There will be a single corporate author (e.g. “EAGLE Collaborative”) with all collaborators listed as PubMed-citable co-authors. Up to seven collaborators will be listed as co-authors per site. If you think you need additional collaborators (i.e. more than seven) at your site, please contact your EAGLE Coordinator. Complete details for all EAGLE team members on the Site Registration Form

Identify your local EAGLE team EAGLE STUDY SET-UP Step 3 Identify your local EAGLE team 1. On the Site Registration Form complete details of the team that have agreed to lead EAGLE at your hospital. This must include: Surgeon Principal Investigator (a consultant/ attending surgeon) Surgeon Associate Principal Investigator (a registrar/ resident/ trainee) Theatre Nurse Principal Investigator (a senior member of theatre team) Anaesthetist Principal Investigator (a consultant/ attending anaesthetist) In addition there is an option to enter details for up to three additional collaborators who have agreed to support data collection at your site. 2. On the Site Registration Form complete the brief site survey (e.g. number of surgeons who perform right colectomy at your hospital). Select how many additional collaborators are needed at your site and enter their details on the Site Registration Form Manuscripts arising from EAGLE will be published using the same authorship model as for the 2015 ESCP Right Hemicolectomy audit. There will be a single corporate author (e.g. “EAGLE Collaborative”) with all collaborators listed as PubMed-citable co-authors. Up to seven collaborators will be listed as co-authors per site. If you think you need additional collaborators (i.e. more than seven) at your site, please contact your EAGLE Coordinator.

Identify your local EAGLE team EAGLE STUDY SET-UP Step 3 Identify your local EAGLE team 1. On the Site Registration Form complete details of the team that have agreed to lead EAGLE at your hospital. This must include: Surgeon Principal Investigator (a consultant/ attending surgeon) Surgeon Associate Principal Investigator (a registrar/ resident/ trainee) Theatre Nurse Principal Investigator (a senior member of theatre team) Anaesthetist Principal Investigator (a consultant/ attending anaesthetist) In addition there is an option to enter details for up to three additional collaborators who have agreed to support data collection at your site. 2. On the Site Registration Form complete the brief site survey (e.g. number of surgeons who perform right colectomy at your hospital). Single corporate authorship model used for the 2015 ESCP Right Hemicolectomy audit Manuscripts arising from EAGLE will be published using the same authorship model as for the 2015 ESCP Right Hemicolectomy audit. There will be a single corporate author (e.g. “EAGLE Collaborative”) with all collaborators listed as PubMed-citable co-authors. Up to seven collaborators will be listed as co-authors per site. If you think you need additional collaborators (i.e. more than seven) at your site, please contact your EAGLE Coordinator.

Secure local approvals EAGLE STUDY SET-UP Step 4 Secure local approvals 1. Identify what regulatory approvals are required at your hospital to set-up the EAGLE study. If you are unsure, please discuss with your head of department or your hospital’s research office. Your EAGLE coordinator is also available to support you through these steps. 2. Once you know what approvals are required, please enter these details on the Site Registration Form. 3. Apply for the approvals you require. 4. Once approvals are confirmed, update details on the Site Registration Form.

Secure local approvals EAGLE STUDY SET-UP Step 4 Secure local approvals 1. Identify what regulatory approvals are required at your hospital to set-up the EAGLE study. If you are unsure, please discuss with your head of department or your hospital’s research office. Your EAGLE coordinator is also available to support you through these steps. 2. Once you know what approvals are required, please enter these details on the Site Registration Form. 3. Apply for the approvals you require. 4. Once approvals are confirmed, update details on the Site Registration Form. Complete details of the approvals required at your site on the Site Registration Form

Focus on ethics & consent EAGLE STUDY SET-UP Focus on ethics & consent The approvals needed to set-up EAGLE will vary across the world according to national laws and hospital regulations. Your EAGLE Coordinator will support you through these processes, as required. In some countries EAGLE will require research ethics committee review. If you submit to a research ethics committee, you should emphasise that EAGLE is a low-risk study, evaluating an educational package delivered to clinical staff. EAGLE does not require any changes to the treatment patients receive, any additional tests/ data collection, or any additional follow-up. Many research ethics committees may agree to waive the requirement for patient consent. This is because the intervention is being delivered at the hospital-level rather than patient-level. In addition, EAGLE will not require any changes to clinical care or follow-up and the study will only collect routinely available data, which will be anonymised.

Confirm hospital readiness EAGLE STUDY SET-UP Step 5 Confirm hospital readiness 1. On the Site Registration Form confirm that all your hospital’s EAGLE team have been trained and are ready to commence data collection. 2. On the Site Registration Form confirm agreement to the EAGLE ‘conditions of participation’. It is mandatory for all EAGLE team members to be trained prior to commencing the study. Team members can either complete the Site Set-up Pathway, or alternatively training can be delivered directly by the local site Surgeon Principal Investigator. The EAGLE ‘conditions of participation’ are a small number of key regulatory conditions that all participating hospitals must agree to and these are explained in the Site Set-up Pathway (this webpage).

Confirm hospital readiness EAGLE STUDY SET-UP Step 5 Confirm hospital readiness 1. On the Site Registration Form confirm that all your hospital’s EAGLE team have been trained and are ready to commence data collection. 2. On the Site Registration Form confirm agreement to the EAGLE ‘conditions of participation’. It is mandatory for all EAGLE team members to be trained prior to commencing the study. Team members can either complete the Site Set-up Pathway, or alternatively training can be delivered directly by the local site Surgeon Principal Investigator. The EAGLE ‘conditions of participation’ are a small number of key regulatory conditions that all participating hospitals must agree to and these are explained in the Site Set-up Pathway (this webpage). Confirm completion of EAGLE team training and agreement with the EAGLE Conditions of Participation on the Site Registration Form

EAGLE STUDY SET-UP Step 6 Commence EAGLE! 1. Once your Site Registration Form is fully completed, you will receive an AMBER LIGHT, indicating that your site is ready to be randomised. 2. Once a batch of hospitals have an amber light, the EAGLE Coordinating Office will: Randomise the hospitals and inform hospitals of their randomisation. Issue logins to the REDCap case report form. 3. Your hospital’s EAGLE team will then be invited to a GREEN LIGHT teleconference with your EAGLE coordinator. This will set out the next steps for your site and give you the GREEN LIGHT to commence data collection. 4. Once you start data collection, ensure every eligible patient is captured and all data fields are completed. 5. At the appropriate time you will be sent a login to the online educational modules. Your EAGLE Coordinator will support you to ensure all surgeons who perform right colectomies have completed the online training modules.