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IBD BioResource Summer Newsletter 2023

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Summer Newsletter 2023 

Our strategy

Our motivation

In the UK, over 500,000 people live with Crohn’s disease (CD) or ulcerative colitis (UC), collectively known as inflammatory bowel disease or IBD. As people who have IBD are all too aware, these conditions can cause severe abdominal symptoms and impact both health and quality of life. The NIHR IBD BioResource is designed to speed up the clinical benefits that can derive from research advances in Crohn's and colitis so that current and future patients can benefit sooner.

  • To create a national 'platform' recruiting adults, young people and children with IBD

  • To generate detailed genetic data and outcomes data and make this available to the research community in a de-personalised format

  • To facilitate recruitment of patients for future IBD and non-IBD research projects based on patients' genetic and clinical characteristics 

Our goal is to recruit a very large panel of 50,000 patients with Crohn’s or colitis (Main cohort) as well as 1,000 newly diagnosed patients (Inception cohortand up to 5,000 paediatric onset IBD patients – all with health data and on whom we will generate detailed genetic data.

Our target

In this issue

Translational research

1

IBD BioResource

Keeping in touch

Welcome

Adult cohort

News & updates

Meet the team

Chief Investigator

Prof. Miles Parkes


Research coordination team

Hazel Davies, Laetitia Pele, Rachel Simpkins, Cathy Thorbinson


Data manager

Rasha Shawky


Paediatric team

Dr Holm Uhlig (Lead Clinician), Sarah Hearn (Research Coordinator)


Recruitment administration team

Simon Betson, Jonathan Mitchell, Francesca Muldoon


Meet the team

1

What's coming up

*NEW* Featured site

Reminders & pointers

2

3–5

6

7–8

Paediatric cohort

Main cohort

Inception cohort

17

18

Facts & figures

9–10

11–12

13–14

15

16

IBD BioResource

Welcome 

Prof Miles Parkes, Chief Investigator of the IBD BioResource

2

It’s great to see the IBD BioResource going from strength to strength. Participant recruitment is really picking up now, including among children with IBD and patients who have been recently diagnosed with Crohn’s or colitis. We fully realise what a sensitive issue this is for individuals and families, and are grateful to all for your help. In both instances the opportunity to learn new things about IBD and how we can better treat it is particularly huge, hence our emphasis on these cohorts.


Likewise it has been great to see large numbers of recruits into the ‘main’ cohort. Many centres have focused recruitment efforts on patients on biologic and advanced therapies, in part because such folk are still coming through hospitals at a time when many clinics are still ‘virtual’. Again this does have the happy property that we can learn a great deal from patients on such treatments, especially if the numbers we can study are large. Great to see sites working out for themselves what works locally for them – and well done Southport and Ormskirk whose successes and tips are given below.

 

In our monthly Monday lunchtime training sessions (see below) for research nurses and recruitment staff we have been discussing how to improve accuracy of ‘phenotyping’ – that is, capturing accurate clinical data for participants. We hope you have found these sessions educational and helpful. If there areas you would like us to focus on please do let Laetitia and the coordinator team know. It’s the very least we can do to thank you for your support.

 






Summer is upon us at last, for those of us who had been living under a pall of grey cloud and cold north winds in East Anglia until mid June. Recruitment will slow a bit over the holiday period (hopefully not too much!) but we remain grateful to all involved for your support and wish you a restful break over the holiday period.


When? Every 4 to 5 weeks on Mondays, from 1pm to 1.30pm

How? You will be sent a link

Monthly Teams meetings

3

News & updates

Monthly SIV refresher sessions

TRAINING

The IBD BioResource has just held its fifth monthly SIV refresher training session. These drop-in training sessions are a good opportunity for newer members of the team to learn about the study, or for established study team members to refresh their memory about certain aspects of the study.

These sessions usually take place on the first Tuesday of each month, from 10am until 10.45am, and cover the following topics:

(1) Informed consent process (2) Recruitment process – Main cohort

(3) Recruitment process – Inception cohort (4) REDCap demonstration

Average attendance March–July 2023: 30 attendees




  • How do you record vaping on REDCap? Vaping does not need to be recorded on REDCap

  • For Inception recruits, should biopsies be taken <1 year of diagnosis? Or <1 year of recruitment? Biopsies (and all samples/consent) are to be taken within 12 months of diagnosis

  • Regarding participant withdrawals, can data (including bloods) collected up to the date of withdrawal continue to be used? It depends on the type of withdrawal. For 'no further contact' withdrawals, we can continue to use data from the patient's existing samples for research. For 'no further use' withdrawals, we stop using the patient's information and destroy their remaining sample. However, if research using the patient's data has already taken place, this cannot be undone. See the PIS (pages 6 and 8) for more information

  • Do many patients withdraw? Approximately 1% of participants withdraw

  • Do we need to notify the coordination team when we send samples? No, this is not necessary. However, we recommend keeping a log of the samples you send, to include date of posting, study ID (K-ID), and tracking ID on the postal label. For Inception patients, you should complete a sample manifest

  • Does the H&L questionnaire (online version) ask the participant for the site code and participant ID? No, it does not

  • Can we enrol a participant if they don’t have/use email? You can, but it will be very difficult for them to participate, particularly for patients in the Inception cohort

  • If an Inception patient has already had a colonoscopy at the time of consent and they don't have another to take the biopsies within 12 months of diagnosis, does the patient remain in the study? Yes, they do


The next session is on Tuesday 5 September, 10.00–10.45am. We hope some of you can join us!

A sample of questions we've been asked so far

4

News & updates

Substantial amendment 8 approved

As mentioned in the Spring Newsletter, we are in the process of establishing the Genetic Feedback process. A key and primary focus is that we should be able to show and remind participants what they signed up for and allow them to change their mind if needed. 


For this purpose, we have drafted emails / letters which will remind patients of their original choice and give them the opportunity to either confirm or change their genetic feedback preference.


We have also drafted emails / letters to communicate with patients when sequencing analysis of their DNA has shown there are NO known alterations linked to increased risk of developing the genetic diseases listed by Genomics England, or when it has not been possible to generate reliable DNA sequencing data from their samples. Communications with patients in cases where incidental findings have been established will be dealt with by the medical profession via Clinical Genetics departments.


All of these documents were submitted as Substantial Amendment 8 under Category C on the 6th June and have been approved by the East of England – Cambridge Central Research Ethics Committee / HRA on the 19th June. We have also submitted our Patient Information Sheet and Consent form which have been translated into Welsh, as per the Welsh Language Act 1993.

The site audit is still ongoing. If you haven't yet heard from us, we will be in touch soon. A big thank you to all the sites who have already responded to our audit requests!

As a reminder, we are auditing all our sites with specific regard to delegation logs, training logs and CVs/GCPs. We are particularly aiming to confirm:


            who is still active on the study
            who is no longer working on the study
            who has recently joined the study

Site audit

Thank you for helping us to keep site details and relevant paperwork up to date!


5

News & updates

Lab closures over the August bank holiday

We are pleased to confirm that sites can continue to recruit as normal in the days leading up to the late August bank holiday (Monday 28 August). The National Biosample Centre (NBC) will be open on Saturday 26 August, which will help to get samples processed.


IMPORTANT: if you hold clinics on Friday 25 August, please ensure that your blood packs are collected by Royal Mail on the Friday so they arrive at the lab for Saturday processing. The lab will be closed on Monday 28 August.

A very warm welcome back to The Queen Elizabeth Hospital in King's Lynn, who reopened on 9 May 2023 and have been recruiting strongly ever since!


We are also hoping to have Whipps Cross Hospital (Barts Health NHS Trust) and Whittington Hospital (Whittington Health NHS Trust) on board very soon. Watch this space!

Site updates

World IBD Day and International Clinical Trials Day

We would like to thank all the sites who kindly promoted the IBD BioResource Study on World IBD Day and International Clinical Trials Day.

To celebrate World IBD Day, the IBD BioResource (Miles Parkes and Laetitia Pele) took part in an ‘Ask the expert’ webinar organised by NIHR CRN East of England, where we covered topics dealing with IBD BioResource, the microbiome, AI & getting involved in research in general.

Click to access the webinar recording.

6

What's coming up

Substantial amendment 9




  • Minor adjustments to the data collection sheet and H&L questionnaire (sex and gender questions)

  • Adjustments to the protocol allowing further flexibility in the recruitment process, clarification about tissue storage and distribution for the Paediatric IBD BioResource (PIBD)

  • Adjustments to the ICF and PIS to align them to some of the changes made by the NIHR BioResource under which we operate

  • Slight changes to the patient invite letter to further broaden the recruitment process

  • Minor adjustments to various documents pertaining to the PIBD

  • New patient-facing documents enabling the re-consenting and transfer of PIBD patients into the adult cohort

To keep our study current and improve aspects of it, we will be submitting another substantial amendment in late summer. In the main, it will cover the following:


Development of training documents

One positive outcome of the IBD BioResource monthly Teams Meetings has been the focus on specific aspects of the recruitment process, including the completion of our clinical data sheet.

As a result, the IBD BioResource team is currently developing some new training documents to help sites with phenotyping of Crohn's and colitis. These documents should help you to more easily and accurately classify the macroscopic extent of patients with ulcerative colitis, and the disease behaviour of patients with Crohn's disease.

These training documents will be circulated late summer to coincide with a data quality audit when we will be asking relevant sites to review / correct data where applicable.

Facts and figures

7

Sex at birth


48.42%


51.58%


~40,000 samples


The IBD BioResource was set up in 2016 and, thanks to our sites' hard work, our recruitment numbers now stand at 41,854 patients. Here are a few facts and figures about our recruits.*

*Based on data as of 15 June 2023


DiagnosisUnspecified (0.08%)Crohn's (49.44%)UC (46.53%)IBD - type unspecified (IBDU) (2.97%)Other (0.03%)N/A (0.95%)
Created with Highcharts 11.4.8Age groupCountAge at diagnosisUnspecified1617–2526–3536–4546–5556–65Over 650500010000
Created with Highcharts 11.4.8Global assessmentUnspecified (8.72%)Normal (32.14%)Mild (28.06%)Moderate (14.55%)Severe (3.17%)Not known (13.36%)
Indications of UC patients withsurgical colectomyUnspecified (3.82%)Acute severe colitis (45.79%)Chronic continuous colitis (24.47%)Dysplasia (2.46%)Colorectal cancer (3.31%)Not known (20.14%)

Facts and figures

8

Treatments – Main cohort only

Created with Highcharts 11.4.8CountTherapyAdvanced therapies (Crohn's)InfliximabAdalimumabGolimumabVedolizumabUstekinumabTofacitinib02000400060008000
Created with Highcharts 11.4.8CountTherapyAdvanced therapies (UC)InfliximabAdalimumabGolimumabVedolizumabUstekinumabTofacitinib02000400060008000
Created with Highcharts 11.4.8DiagnosisCountNumber of patients who have hadazathioprine and/ormercaptopurine13554807847331921914112AzathioprineMercaptopurineCDUCIBDU050001000015000
Created with Highcharts 11.4.8DiagnosisCountNumber of patients who havehad methotrexate and/orciclosporin25557155911443213MethotrexateCiclosporinCDUCIBDU0100020003000

Main cohort

Quarterly Recruitment

9

Congratulations to all our sites who made it into the top 10 recruiting sites for April–June 2023! See next page


A massive thank you to Addenbrooke's Hospital, Macclesfield District General Hospital, Salisbury Hospital and Southampton General Hospital who made it into the top 10 table for three months in a row.


A big thank you also goes out to Queen Elizabeth Hospital (King's Lynn), who only started recruiting again this May and have already made it into two top 10 tables!




Thank you!


The Main cohort comprises individuals with established Crohn's or colitis. Both clinical data (surgery, disease extent, medication, associated conditions etc.) and self-reported information (IBD and general health questions and family history) are collected, alongside blood samples for plasma, serum and DNA. The latter are undergoing genome-wide analyses. 


Created with Highcharts 11.4.8Number of patientsrecruitedMonthly main cohortrecruitment across a...363534439AprMayJun0250500

Total main cohort recruitment

April–June:

1336

Recruitment rate:

~445 patients/month

Main cohort – top 10 sites

Quarterly Recruitment

10

April

May

June

Created with Highcharts 11.4.82626222221212121202020201515141414141414051015202530Addenbrooke's HospitalBasingstoke, North Hampshire and Royal Hampshire County HospitalsBasingstoke, North Hampshire and …Salisbury HospitalSt Richard's and Worthing HospitalsSouthampton General HospitalMacclesfield District General HospitalPrince Philip HospitalQueen Elizabeth Hospital, King's LynnHarrogate District HospitalDorset County Hospital
Created with Highcharts 11.4.81919171716161515151514141313131312121212051015202530King's Mill HospitalThe Royal Victoria InfirmarySouthampton General HospitalAddenbrooke's HospitalWhiston HospitalDorset County HospitalSouthend University HospitalMacclesfield District General HospitalMacclesfield District General Hos…Queen Elizabeth Hospital, King's LynnQueen Elizabeth Hospital, King's …Salisbury Hospital
Created with Highcharts 11.4.822222020141414141313131312121111101099051015202530Royal Cornwall HospitalSalisbury HospitalAddenbrooke's HospitalSouthampton General HospitalUniversity Hospital of North Durham & Darlington Memorial HospitalUniversity Hospital of North Durha…The Royal London HospitalMacclesfield District General HospitalMacclesfield District General Hospi…Colchester General HospitalHillingdon HospitalDarent Valley Hospital

Inception cohort

Quarterly Recruitment

11

Congratulations to all our sites who made it into the top 10 recruiting sites for April–June 2023! See next page


A massive thank you to Addenbrooke's Hospital, who made it into the top 10 table three months in a row. And a special shout-out goes to Furness General Hospital & Royal Lancaster Infirmary: not only do they appear in the top 10 table three months in a row, they recruited an impressive EIGHT Inception patients in May! They have also done really well at getting biopsies where they can, which is so important to facilitating good research.


We would like to thank ALL our sites who are recruiting to the Inception cohort – you have done a fantastic job at increasing recruitment since the introduction of the new protocol!


Thank you!


The Inception cohort aims to recruit 1,000 patients who are new to their diagnosis of Crohn’s or colitis and follow them for up to 3 years through a combination of sample and clinical data collection. This includes stool, biopsy tissue and whole blood for RNA (an important molecule that functions to convert the genetic information of DNA into proteins). This cohort offers a unique resource to undertake a wide range of studies and facilitate research into the determinants of IBD susceptibility, behaviour, and treatment response. 


Created with Highcharts 11.4.8Number of patientsrecruitedMonthly Inceptionrecruitment across a...164629AprMayJun02040

Total Inception recruitment

April–June:

91

Recruitment rate:

~30 patients/month

Inception – top 10 sites

Quarterly Recruitment

12


April

May

June

Created with Highcharts 11.4.822222222221111111111012345678910Addenbrooke's HospitalKettering General HospitalHarrogate District HospitalWythenshawe HospitalFurness General Hospital & Royal Lancaster InfirmaryFurness General Hospital & Royal …University Hospital of North Durham & Darlington Memorial HospitalUniversity Hospital of North Durha…Basingstoke, North Hampshire and Royal Hampshire County HospitalsBasingstoke, North Hampshire an…Leicester General HospitalWithybush HospitalSingleton Hospital
Created with Highcharts 11.4.888665533333333222222012345678910Furness General Hospital & Royal Lancaster InfirmaryFurness General Hospital & Royal …QEQM & William Harvey HospitalsAddenbrooke's HospitalPrince Philip HospitalQueen Elizabeth Hospital, King's LynnQueen Elizabeth Hospital, King's L…Yeovil District HospitalQueen's Medical Centre CampusThe Royal London HospitalManchester Royal InfirmaryKettering General Hospital
Created with Highcharts 11.4.844332222222222221111012345678910Addenbrooke's HospitalPinderfields General HospitalSouthend University HospitalPrince Philip HospitalHarrogate District HospitalFurness General Hospital & Royal Lancaster InfirmaryFurness General Hospital & Royal …Hinchingbrooke HospitalJames Cook University HospitalKing's Mill HospitalThe Royal Victoria Infirmary

13

Featured site  

Southport & Ormskirk NHS Trust

Southport and Ormskirk NHS Trust is our featured site for this quarter's newsletter. Ormskirk joined the study on 26 September 2022, so they are a relatively new member of the IBD BioResource family. We were therefore really pleased and impressed to see them in the top three sites for overall Main cohort recruitment for Jan–Mar 2023, which is why we chose them for our very first site interview!

Created with Highcharts 11.4.8Your X TitleYour Y TitleSales ($)FranceGermanyItalySpainPoland0200400

Please tell us a bit about your team

Southport and Ormskirk NHS Trust has the benefit of a superbly efficient Gastroenterology Team consisting of dynamic and diverse clinical professionals, which includes consultants, doctors, and specialist nurses, who are dedicated to making sure the patients in their care receive excellent, evidence-based health management.


Why did you choose to join the IBD BioResource?

IBD BioResource had long been a study that Southport and Ormskirk NHS Trust had wanted to collaborate with. The COVID Pandemic had prevented us from joining the IBD BioResource Team earlier, but we had never given up hope of being accepted. Post COVID we contacted IBD BioResource and were delighted to be informed our ambitions would become a reality.


What do you enjoy most about recruiting for IBD BioResource?

IBD BioResource allows recruits to feel they are truly making a difference to the future of healthcare. They are supported in the fact that their commitment will inform and potentially alter the future of treatments for IBD. As a researcher, recruiting to IBD BioResource is a very rewarding experience, patients are usually happy to share their health journey, and their hope and aspirations for their future health care.


Some of the members of the research team at Southport & Ormskirk

From left to right: Ian Hill, Lucy Aitchison (IBD NS), Lorraine Bickerstaff, Sabina Koprowska, Zena Haslam, Nik Apostolou (PI)

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Featured site

Southport & Ormskirk NHS Trust

Created with Highcharts 11.4.8Your X TitleYour Y TitleSales ($)FranceGermanyItalySpainPoland0200400

What are your top tips for recruiting patients? How do you approach/attract potential participants?

We have excellent electronic patient record databases which we use to review the IBD clinic lists several days prior to the patient visit; the current PIL and invitation letter is sent out to those due to attend. This process permits our patients to absorb the information before they present at clinic, allowing them to make an informed decision on whether they wish to participate in research. During their consultation they are asked if they received any information and wish to have a further discussion with the Research Nurse.


What do patients most often ask you about the study? Do you have any feedback or comments from IBD participants you would like to share?

Patients are always eager to know how often they are likely to be contacted by other research teams, how many patients have already been recruited, can we give any definitive findings from the study so far, which of course we can thanks to your updates, and they think our phlebotomy skills are amazing. We can motivate recruits through the information we give about IBD BioResource, ensuring that they feel heard and valued.


Have you encountered any challenges? How did you overcome them?

We have many of our clinical team who want to support research; the regular updates and SIV refreshers provided by IBD BioResource, via Teams, helping to inform and educate, is a huge bonus for our Research Team. We can rely on these events to help increase our delegation log and thus reach a wider audience of potential recruits.


How do you ensure timely and efficient completion of recruitment, e.g. using check lists?

By sending out the IBD PIL we can be confident that the patient has some information on which we can build our conversation around the elements of consent. Once informed consent has been received, we will obtain the samples, the H&L Questionnaire and any other data.


15

  • When you email one of the coordination team with a query, please always copy

    in our generic team email address (ibd@bioresource.nihr.ac.uk). This will help to ensure

    your query is answered as quickly as possible.


  • Please send consent forms and other PID to our secure nhs.net email account

    (add-tr.ibdbioresource@nhs.net) only. This is because our other email address is not suitable for receiving sensitive data.


  • Please also ensure that you send CFs and PID from a secure email address. Unsure whether you email address is secure? You can check the list of secure domains maintained by NHS Digital: The secure email standard - NHS Digital


  • All other emails (general queries, tracking logs, CVs, sample manifests, requests for REDCap access, etc.) should be sent to our generic email address ibd@bioresource.nihr.ac.uk

EMAIL TIPS

CONSENT FORMS

  • Take a moment to check the patient's signature on page 4 of the consent form. Has the patient signed with their initials? If yes, it's worth asking them whether this is their normal signature. If it is, please add a note to the consent form to confirm this. If the patient has signed with their initials by mistake, please ask them to provide a full signature.

  • To save you time, we recommend typing the PIS version number (7) and date (29/09/2021) into your localised consent form (page 1, under TAKING PART). That way, the correct details will always be ready to go!





  • Unless you have been told to send paper copies of consent forms (e.g. if your site does not have a secure email domain), please only send us electronic copies of consent forms.

Reminders and pointers

WE WANT TO HEAR FROM YOU!

To make these newsletters as informative as possible, please tell us what you want to hear about! Send any suggestions to: laetitia.pele@bioresource.nihr.ac.uk

IBD BioResource

Translational research

16

The success of the IBD BioResource and its partners in facilitating important health research and contributing to tomorrow's treatments strongly relies on the use of the panel.

The IBD BioResource panel is open to any investigators from science or industry to undertake studies which require:

  • Data access only (DAA)

  • Data and sample access

  • Recall studies (for e.g. intervention studies, surveys and questionnaires, clinical trials)



Between April and June, we received 3 research applications while 5 previously submitted research projects received approval.

Recently approved

The long term impact of non-response to small molecules and biological therapies in IBD: a UK nation-wide analysis through the NIHR IBD BioResource

Translating NUDT15 pharmacogenetic testing into NHS practice

Managing pain in people with Crohn's Disease: study protocol for a feasibility testing of an Acceptance and Commitment Group Therapy intervention. 

Development of a blood-based early warning system for detecting biomarkers of multimorbidity in patients with inflammatory bowel disease. A proof-of-concept study.


Recall / samples

Data access

Paediatric cohort

Recruitment

17

  • The paediatric IBD (PIBD) BioResource was launched in April 2022. Its goal is to recruit 800 paediatric patients who have been diagnosed with IBD or are under investigation for possible IBD, contributing to a final 5,000 dataset of paediatric-onset participants

  • All children recruited will be asked for specific health data, and detailed genetic data will be generated on all recruits

  • The study aims to investigate how genes and environmental factors affect the immune system and to establish similarities and differences in disease between adults and children

Since PIBD launched last year...



4 open sites, with 2 more to receive the green light to open soon


Recruitment

rate

~4 patients/month


89

newly enrolled

patients


Recruiting sites


  • Oxford Children's Hospital (joined March 2022; n recruits = 66)

  • The Royal London Hospital (joined October 2022; n recruits = 12)

  • Cambridge Children's Hospital (joined October 2022; n recruits = 9)

  • Jenny Lind Children's Hospital, Norwich (joined March 2023; n recruits = 2)


  • The emphasis currently is on collecting baseline bloods that go to the Milton Keynes lab. If sites are able to collect biopsies too this is helpful, but the main push is to collect blood for DNA analysis. Please try to get bloods rather than saliva samples

  • Recruitment is currently focused on those aged up to 15 years.  Children can be recently diagnosed (within the first year – “inception” cohort), or have been diagnosed with Crohn’s, UC, IBDU, or monogenic IBD for several years (“main” cohort)

  • The tablet e-consent process is being piloted in Oxford and will be rolled out to sites once fully established

PIBD updates

Sites opening soon


  • Birmingham Children's Hospital

  • Great Ormond Street Hospital, London

  • Bristol Royal Hospital for Children

  • Southampton Children's Hospital

If you have any questions about the PIBD BioResource, please email the central paediatric IBD BioResource team at paediatricibd@ndm.ox.ac.uk

Thank you for all your efforts supporting this study, which aims to speed up the clinical benefits that can derive from research advances into paediatric Crohn's and colitis, so that current and future children with IBD can benefit sooner.

Keeping in touch

IBD BioResource

In addition to providing regular updates on our website, we are actively engaged on social and professional media platforms.

https://twitter.com/IBD_BioResource

https://www.facebook.com/IBDBioresource/

Connect with us on Facebook

Follow us on Twitter

Join our professional network

https://www.linkedin.com/in/ibd-bioresource-b011a0157/

Find out the latest about the IBD BioResource 

https://www.ibdbioresource.nihr.ac.uk/

Contact details

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Funders of IBD BioResource

We wish to thank our funders: The National Institute for Health and Care Research (NIHR), the Medical Research Council, the Wellcome Trust, Open Targets, Crohn’s & Colitis UK, the Helmsley Charitable Trust, Crohn's in Childhood Research Association (CICRA) and our Industry partners.

https://bioresource.nihr.ac.uk/

Phone (general enquiries):
0800 090 2277


   

Postal address:
IBD BioResource Box 299
University of Cambridge and Cambridge University Hospitals  
NHS Foundation Trust
Cambridge Biomedical Campus
Hills Road
Cambridge
CB2 0QQ     

Email:

Adult cohort

ibd@bioresource.nihr.ac.uk

Paediatric cohort

paediatricibd@ndm.ox.ac.uk