Information for Surgical Trainees

The Sunflower study – funded by the NIHR HTA – is the UK’s largest RCT investigating the management of patients with gallstone disease. It aims to compare the clinical and cost-effectiveness of expectant management and MRCP prior to laparoscopic cholecystectomy and will recruit over 13,500 patients from more than 50 UK hospitals. The contributions of trainees are therefore vital, and we are very much looking forward to working with you!

If you are a trainee interested in taking part, please write to natalie.blencowe@bristol.ac.uk (Clinical Lecturer at the University of Bristol) or jane.collingwood@bristol.ac.uk (Senior Administrator at the University of Bristol).

We look forward to meeting you and working with you on this exciting and ambitious study. Please follow the study's twitter: @SunflowerStudy and join our Facebook group 'The Sunflower Study'.

 

Infographic showing the main features of the study

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Trainee benefits of being involved in the Sunflower study

Sub studies: We plan to design and deliver a variety of sub-studies. Some of these will be instigated by the Sunflower study team and others by trainees. If you would like to put forward an idea, we would very much like to hear from you! Please email natalie.blencowe@bristol.ac.uk or jane.collingwood@bristol.ac.uk

Research logbook: We have worked hard to ensure that all of your efforts are recognised: screening and identifying eligible patients, recruitment consultations, collecting baseline or follow up data, and co-ordinating trainees’ efforts on a local or regional level. Much like an operative logbook, we will be able to provide you with a breakdown of your activities at regular intervals, to demonstrate your contributions for the purposes of ARCPs, interviews, portfolios etc.

CCT requirements: Participating in the Sunflower study will provide you with the opportunity to complete various CCT requirements, including: i) GCP training, ii) leadership role, iii) recruitment of patients to a national study, iv) research methods training. We will also provide you with training in how to best recruit patients into an RCT, see FAQs below.

 

NIHR Associate Principal Investigator (PI) Scheme

We fully endorse this exciting new scheme run by the NIHR. We will be looking for associate PIs in every recruiting centre.

The scheme helps junior doctors to be PIs of the future. It aims to engage, recognise and promote junior doctor engagement in NIHR portfolio research. It was developed by the West Midlands Research Collaborative, Birmingham Surgical Trials Consortium, Birmingham Clinical Trials Unit and the West Midlands NIHR Clinical Research Network.

The Associate PI scheme has been endorsed by the NIHR Clinical Research Network’s (CRN) Cancer, Surgery and Oral & Dental Specialty Cluster and the Royal College of Surgeons (England).

There will normally be one Associate PI per site, per study, at any given time. A commitment of at least 6 months will be required for gaining Associate PI status, after which the NIHR CRN will issue a certificate to confirm Associate PI status.

Please email jane.collingwood@bristol.ac.uk if you would like to be considered for this prestigious role. If you have any queries about the scheme, you can also contact associatePIscheme_surgery@nihr.ac.uk

For further details, see: https://www.nihr.ac.uk/documents/associate-principal-investigator-pi-scheme/11694?diaryentryid=53625

 

Trainee frequently asked questions

Q. What information shall I send to  natalie.blencowe@bristol.ac.uk or jane.collingwood@bristol.ac.uk?

A. We would be grateful if you could provide us with the following information so that we can keep track of where everyone is and who is doing what:

Finish date in your current hospital, if known

Hospital at next rotation (including start and finish date, if known)

An nhs.net email address if you have one

An Introduction to Good Clinical Practice (GCP) in Secondary Care certificate, less than 3 years old

 

 

 

 

Q. How do I complete Good Clinical Practice (GCP) training?

A. The relevant GCP course is called 'Introduction to Good Clinical Practice (GCP) eLearning' and can be completed here: https://learn.nihr.ac.uk/enrol/index.php?id=370

if you do not have an NIHR account already, you will need to register before starting your training.

The course takes approximately 2-3 hours, and it can be completed in several sittings as progress can be saved. Should you wish to complete training in person, a full day face-to-face training workshop is available, if preferred. You can find courses near you on the "CRN Local Learning" tab of the CRN website: https://learn.nihr.ac.uk

Once you have completed the training, please forward your certificate to jane.collingwood@bristol.ac.uk or sunflower-study@bristol.ac.uk

Please also encourage your colleagues to undertake this training.

 

Q. What training is available for recruiting patients into Randomised Controlled Trials?

A. There is a new online resource which aims to help with the practical aspects of recruiting patients into Randomise Controlled Trials, called 'Granule' https://learn.nihr.ac.uk/course/view.php?id=385

In addition, the Sunflower study has an inbuilt intervention, which aims to optimise recruitment. A ‘tip sheet’ is available from jane.collingwood@bristol.ac.uk, with further tailored advice available throughout the duration of the study. Further details of the intervention here: http://www.bristol.ac.uk/population-health-sciences/research/groups/social-sciences-health/quintet/

 

Q. What support is available for Sunflower Associate PIs?

A. You can email jane.collingwood@bristol.ac.uk at any time, or contact associatePIscheme_surgery@nihr.ac.ukor the study’s mailbox at sunflower-study@bristol.ac.uk

We also have a dedicated WhatsApp group, run by Natalie Blencowe, please email natalie.blencowe@bristol.ac.ukor Jane to join the group.

 

Q. What do I need to do in order to enter patient data to the Sunflower Trial Management System?

A. It is important to register on the Trial Management System as soon as possible, before undertaking any study specific tasks. If you need instructions for doing so, please see ‘Training videos’ on the homepage.

 

Q. How do I ensure my contributions to the study will be documented?

A. When entering data on the Trial Management System, please ensure to add your own GMC number to the bottom of the forms.

 

Q. What should I do when I move hospitals?

A. Please let us know when you rotate to a new hospital and we can put you in touch with Sunflower trainees at your new site, if it is open to recruitment.

 

Q. Does my local surgical research collaborative know about the Sunflower study?

A. Yes, Jane Collingwood is in touch with leads at all 15 UK surgical research collaboratives. Please email jane.collingwood@bristol.ac.uk for details of your collaborative.

 

Q. Will there be any opportunities to contribute to publications during the course of the study? 

A. Yes, we plan to design and deliver a variety of sub-studies. Some of these will be instigated by the Sunflower study team and others by trainees. If you would like to put forward an idea, we would very much like to hear from you! Please email natalie.blencowe@bristol.ac.uk or jane.collingwood@bristol.ac.uk 

 

Trainee roles and responsibilities in the Sunflower study

Regional lead

        Manage day to day queries from local leads and collaborators within their geographic region

        Disseminate information about the study to participating centres in their geographic region

        Help to recruit local leads and collaborators

        Present the study at regional educational and research meetings

        Liaise with the central Sunflower team to update on progress and problems

If their hospital is participating in the study:

        Identify and recruit patients

        Contribute to completion of case report forms and follow up data

        Work within the local research team (consultants, trainees, nurses)

 

Local lead

        Act as an official Associate PI, within the scheme endorsed by the NIHR (see separate documentation)

        Work with the consultant PI to lead the project in a single institution

        Recruit and manage local collaborators

        Present the study at local departmental meetings

        Identify and recruit patients

        Contribute to completion of case report forms and follow up data

        Work within the local research team (consultants, trainees, nurses)

 

Local collaborator

        Identify and recruit patients

        Contribute to completion of case report forms and follow up data

        Work within the local research team (consultants, trainees, nurses)

 

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Map of participating sites - as of 22/11/2019

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Recruitment Flow Diagram

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