FAQs for IBD teams

You can find out more about how to participate in the IBD Registry, and what the benefits are, here.

No. Our data submission process is designed to work with any system your Trust is already using, rather than making you enter the data a second time just for the Registry. We offer our WebTool to help teams participate, but this is not required in order to participate in data submission to the Registry.

You can use any IBD clinical system to collect your data. There are already a number of key clinical systems doing this, including EPIC, EMIS and Infoflex (from Civica/CIMS). These can be configured at Trust level to extract already-captured clinical data in a Registry-compatible format. This means clinical teams do not have to enter clinical information more than once. We have a list of Registry-compatible clinical systems on our website. If you are using one of these systems and want to discuss how you can use it to submit data to the IBD Registry, please contact us.

Most teams will be able to submit data to the IBD Registry using their existing data capture tool. However, changing your data capture tool could make submitting data to the Registry quicker and easier for your team. Please contact us if you would like to talk about the different options.

Whether you use Cerner, EPIC, EMIS or another system, you enter data electronically for patient care. The data fields can then be exported to the IBD Registry (see answer below). These electronic healthcare systems belong to your Trust, and we need to work with your Trust IT to be able to export the data correctly.  Once this is done, it avoids the need for entering clinical information more than once.

We are looking to find better ways of working with the companies that run these clinical systems to reduce the work required from individual Trusts to participate in the Registry. We will keep you informed on this. Contact [email protected] to receive the latest updates via our monthly newsletter.

The Registry’s WebTool now has clearer screens and faster navigation between pages. Any event or activity, such as adding a new drug, updating a problem or recording a new disease score, can be recorded from the patient’s Home page. There are also new functions on the Home page to help identify patients on high risk drugs and to support monitoring and scheduling of blood tests. However, a limitation of the WebTool is that it cannot link to your other hospital systems.

The WebTool allows you to record all IBD medications for each patient, including start and stop dates. The medication worklists built into the tool also enable you to create lists of patients who are taking particular drugs or combinations of drugs.

A new feature on each patient’s Home page now also highlights whether the patient is taking steroids or immunomodulators.

We send out quarterly reports with national and local insights on the data submitted by IBD teams. This includes a comparison of your local performance compared to a national benchmark. We have recently enhanced our reports to include visual representations, presenting the biologics KPIs as funnel plots, so you can easily compare your local clinical performance to that of other IBD teams.

We would like to hear what further analysis would be useful to hospital IBD teams. Please contact us if you have any suggestions.

The current analysis is guided by the IBD Registry’s Clinical Leadership Group, but we are always interested to hear what further analysis would be useful to hospital IBD teams. If you have any suggestions, please contact us. 

Currently, clinical reports are sent out to IBD teams on a quarterly basis. We are working hard to reduce the turnaround time from data submission to reporting as we know that receiving timely information and insights is important to you. We are working on an online clinical dashboard that will replace the current quarterly reports.

The named IBD team contacts at your hospital receive the report. Please contact us if you would like to be added to the list for your hospital.

We are building an online interactive dashboard where each team can access its current and previous reports, as well as Registry clinical help guides.

We plan to make our reporting times even faster to populate these interactive dashboards (containing primarily the same data that is in the reports, but allowing for further interrogation online). They will be specific to each IBD team, enabling deeper exploration of your own data within quick timescales. We have already built a prototype interactive dashboard and will keep you updated on our progress.

Yes. We are working closely with the BSG IBD Section on the KPI revision process. This includes ensuring that the data is easily collectable in order to calculate any new KPIs. The biological therapies KPIs were originally set out by the Royal College of Physicians Transition Steering Group in 2016, and the revision of these is included in the current review.

We have a rigorous process of checks to ensure that the calculations are correct, but there is always room for error and thus for improvement. Please contact us if you have any concerns.

Incomplete recording of patients and irregular submission of data are the commonest reasons for KPIs not accurately reflecting local perception. The most straightforward way to correct any errors is to review the data in your system. Please contact us so we can support you with this.

The IBD Registry is a founder member of IBD UK. Along with the BSG and IBD UK, the Registry is committed to avoiding duplication of effort by clinical teams in their quality improvement efforts.

 If you need any assistance with submitting data to the Registry, we would be happy to provide one-to-one advice or a training session. Please contact us to discuss. You can also watch our short video guide on how to upload your data, or download our written, step-by-step guide.

The original consent process was created almost ten years ago and meant that all data had to be processed by NHS Digital. This restricted our ability to capture data beyond England and Wales, and made it difficult to quickly change data fields, for example to incorporate new drug names. 

We have now established a new process with several improvements:

• reducing the amount of clinical time spent collecting consent
• giving patients more control of their data
• ability to capture data from Scotland and Northern Ireland
• ability to link our data to other datasets, such as IBD BioResource, enabling a wider dataset for research and QI.  

Yes. The revised (version 4) consent comprises a new form and a new Patient Information Leaflet. Both of these have been co-designed with patients and can be used online or on paper.

We can send you the revised consent materials for your patients who want to consent using a paper form. 

We will start preparing paediatric consent materials in 2023. We are working to ensure the process for adults is working smoothly first, before extending this to children.

We are no longer accepting the old version of consent, so please do not use old forms or Patient Information Leaflets.  They ideally need to be recycled to avoid being used by mistake in the future.

NHS Digital is no longer hosting our upload platform, and all data must now be submitted via our new IBD Registry Data Access Portal at AIMES.

The revised (version 4) consent process is in use now, both in online and paper form.  We are working with IBD teams to switch to new consent and start submitting data to our new platform. If your team has not switched yet, please contact us and we can support you with this.

As part of the re-design of the IBD Registry’s consent process, dataset and data submission platform, we applied to the HRA (Health Research Authority) for ethical approval for the Registry as a research database. In granting ethical approval, the HRA confirmed the validity of our consent process. This process allows patients to agree to their data (flowing to us under the revised version 4 consent) being used for research.  This means that establishing a research project can be quicker and simpler, and the data will be even more useful for research on improving treatment and care for people with IBD.

Our new e-consent tool is an online form that people with IBD can use to consent to the Registry directly. It requires an e-signature from the patient. We can send your IBD team a list of your consenting patients, plus copies (pdfs) of the signed consent forms if required. The tool can be used on mobile, desktop and tablet devices, although we have found in testing that the e-signature function is easiest on a smartphone.

Patients can also use the tool to withdraw or change their consent preferences, or change their details.

IBD teams can share the e-consent tool with patients in various ways, including clinical letters, online patient messaging systems and text messages. We can provide you with specific wording that you can use in your communications (see more below).

For IBD teams that directed patients to the COVID-19 IBD Risk Tool, the e-consent tool has been built using the same system (REDCap) and is sent out by a link in the same way.

We recognise that online consent will not be accessible for everyone. As an alternative to online consent, we have a paper form that can be downloaded from our website, or sent to your IBD team in pre-printed packs. Contact us to let us know what works best for you.

The completed paper forms (or scanned versions) will need to be returned to the IBD Registry. Any paper consent forms completed by your patients should be scanned and uploaded as a PDF document to the IBD Registry by logging onto our Data Access Portal.  You can find more information about this here. Patients can post the paper form to the postal address stated on the form if they prefer.

There is no requirement from the IBD Registry for you to keep paper copies of patients’ consent forms. We will send you a list of your patients who have given consent, along with PDF copies of the consent forms. It is entirely up to your Trust whether you print or save these PDFs for your patient records, or do nothing at all with them.

We are looking to work with all IBD teams participating in the Registry throughout 2022 to provide one-to-one support with implementing the new consent process if needed. You can also let us know if this is something you would like support with now. We have also developed a set of e-consent resources that you can start using whenever suits you (see more information above). For example, including IBD Registry consent information in a patient mailout that is already planned might save time and resources. If you would like to access these resources, please contact us.

No. The original consent information stated that the dataflow would come to the IBD Registry via NHS Digital, which is no longer the case. This means that historic consents are not allowed to ‘flow’ to the new platform. All the data from the original consents is being kept in a separate database and will still be used, just separately.

Consents collected prior to this new process are only valid for dataflow via NHS Digital, so they are not valid for data flowing to the new IBD Registry data submission platform. In order to avoid adding work for IBD teams, we have developed the new e-consent process so that consents can be collected from patients directly, rather than within clinics or by clinicians.

If a patient withdraws their consent, the Registry will ensure that their data is removed from our database within a reasonable timeframe. We will inform their NHS Trust so they can ensure they do not include this data in any future submissions. We have also created a tool that can filter your data to ensure only permissioned data flows to us. In addition to this, we will check any future data submitted by the Trust to ensure that we do not store any data from patients who have previously withdrawn.

Our system continually checks that we have a valid consent in place for the data that we hold, and that our consent record is always up to date.

Teams can access a list of consented and withdrawn patients through the IBD Registry Data Access Portal. This list is updated every morning. Two versions are available:

• a list containing patient names which we understand is useful for IBD teams
• a list with patient names removed; this should be used for our Extract Filter Tool during the data submission process.

No. The consents will not need to be recorded on your clinical system. A list of consents and withdrawals is available on our Data Access Portal and will be used as part of the submission process. We have specific about this on our website.

We regularly promote our new consent process across all our communications channels, including social media, our patient newsletter and our website. We are also working with partners such as Crohn’s & Colitis UK and the NIHR IBD BioResource to encourage people with IBD to join the IBD Registry.

However, feedback from patients suggests that people with IBD are most responsive to a message received directly from their IBD team. That’s why we have worked with IBD teams to develop resources to support Trusts in getting the message out to their patients, and these are available for all teams to use (see below). If you would like to access these resources, please get in touch.

We have lots of information for patients available on our website. Our Patient Information Leaflet is also built into our online consent tool so that information is available at the point of consent. We have produced a range of resources that clinicians can use to share information about our revised consent process with patients, including prepared text for emails and mailouts, printable handout and poster for clinics (see below).

We have worked with IBD teams to co-develop materials for supporting clinical teams. As a result, we have created: text for emails, letters, email footers, clinic websites, etc; invitation to consent letters and leaflets; display posters for clinics. Printed materials include a QR code which links directly to our website and online form

We welcome further suggestions. To access these resources please contact us.

Not yet, but this is something we hope to do. We are looking to work more closely with Crohn’s & Colitis UK to see how we can improve accessibility for everyone with IBD.

Although your patients may hear about joining the Registry and have questions, there is no deadline for Trusts to implement the new consent process.

However, the deadline for Trust compliance with the national data opt out is 31 March 2022, which means that s251 permissioned records can continue to flow after this data, but the NDOO must also be checked for compliance. Your team can decide on the best way forward – for example it may be easier to use just consented records, or if your Trust has a good NDOO checking process in place you may decide to continue submitting s251 data.

Consent takes precedence over opt out. The national data opt-out is there for patients to opt-out of their data being shared without their consent (which is permitted by the s251). However, if they have consented to the IBD Registry specifically, then their consent permission will take precedent. This means that a patient can prevent their data being shared without their explicit permission by signing the national data opt-out, but can still allow their data to be shared with specific organisations that they give their consent to.

Currently, there is no field available on these systems to mark a patient as opted-out.  It would be hard (and time-consuming) for a team to try to keep NDOO up to date manually, as these will change all the time. 

We ask that you do not try to repurpose consent fields within the WebTool (or other data capture systems) to record NDOO. This will cause a data quality issue as consent is not related to national data opt-outs. If your IG team has made any suggestions regarding recording NDOO on your system, please contact us before taking any actions.

The national data opt-out only applies to NHS Trusts in England. It allows patients to opt-out from their personal information being used for planning and research purposes without their consent. We have more information about the NDOO and how it relates to the IBD Registry here.

 Consent takes precedence over opt out.  The national data opt-out is there for patients to opt-out of their data being shared without their consent. However, if they have consented to the IBD Registry specifically, then their consent permission takes precedence. This means that a patient can prevent their data being shared without their explicit permission by signing the national data opt-out, but can still allow their data to be shared with specific organisations that they give their consent to. We have more information about how IBD teams in England can ensure compliance with the national data opt-out when submitting data to the Registry.

Currently, there is no field available on these systems to mark a patient as opted-out.  It would be hard (and time-consuming) for a team to try to keep NDOO up to date manually, as these will change all the time. 

We ask that you do not try to repurpose consent fields within the WebTool (or other data capture systems) to record NDOO. This will cause a data quality issue because of the interaction between specific Registry consent and the national data opt-out. If your IG team has made any suggestions regarding recording NDOO on your system, please contact us before taking any actions.

We have more information about how IBD teams in England can ensure compliance with the national data opt-out when submitting data to the Registry.

You will need to speak to your information governance and/or business intelligence teams. They should be able to provide you with a list of patients whose data is permissioned to flow to the Registry under section 251 (i.e. people who have not signed the NDOO). This list can then be used in our extract filter tool to ensure that you only submit permissioned records to us. We have further guidance on complying with the NDOO when submitting data.

If you have a system in place where patients who have opted out have been removed from your CSV extract files, then you don’t need an additional NDOO file. However, make sure that you untick the ‘opt-out compliancy’ box when using the extract filter tool.

A patient who has signed the NDOO may have consented separately to the IBD Registry, which would allow their data to flow to us. For this reason, we recommend continuing to input data into your clinical system, but make sure that you obtain a NDOO file to use in our extract filter tool before submitting your data. We have more information about this here.

The NDOO file that is used by the extract filter tool is just a list of NHS numbers for those patients whose data can flow by s251 permission (i.e. those patients who have not signed the NDOO). It needs to be in a very specific format, so make sure you follow our guidance.

The extract filter tool does not change any of your existing files, so you can test using it with your real files. If you save the output files make sure you label them clearly as ‘tests’ so you don’t load them onto the platform by mistake.

The upload platform (on the data access portal) is completely separate to the extract filter tool. Once you have used the tool successfully to create your upload files, you can upload them onto the system. It is important that you do not upload any test files onto the platform; only upload data that you intend to submit to the IBD Registry.

The extract filter tool will not prompt you for missing files, so please make sure you use our guidance to ensure you have included all of the required files. However, the filter tool (v1.8 onwards) will prompt you if you have the NDOO compliancy functionality switched on but have not loaded an NDOO file, or conversely, if you have loaded a NDOO file but do not have the compliancy functionality switched on.

Are you are using a tool purely to enter data to send to us? If so, we would like to work with you to find a way for you to submit data to the IBD Registry without having to duplicate data entry. We receive Registry data that has been entered directly into some clinical systems and local IBD databases, and are keen to help more teams re-use existing systems. 

We have designed the new platform to handle large amounts of data (technically up to 20GB), which should exceed the size of any file upload.

Authorised users from your IBD team. You can nominate a senior clinical approver for your team who can authorise access for other users (including clinical admin support or members of your audit team).

You can sign up to the IBD Registry Data Access Portal here.

If you have recently signed up to our new Data Access Portal, or are about to do so, we have produced a short video guide that IBD teams can use anytime to remind yourself of the data submission process, or alternatively you can download our short guide to uploading data. We also have further guidance on preparing your files to comply with the national data opt-out.

Once you are confident with the process, it should not take long. The process of extracting your files from your system is the same as before. Using the extract filter tool should take around 5 minutes once you have the files ready to import, although if you have large files with lots of patients then it may take a few minutes more. Then the upload process itself should take approximately 5 minutes.

Please note: if your Trust is in England, the process requires you to obtain a NDOO file from your information or business intelligence team, which may take them time to prepare.

We updated our data sharing agreements with Trusts in 2019 with this change in mind. This means the data flow change is already included in those agreements.  If you have an agreement that pre-dates this, we can send you an updated version to sign. If you are unsure, please contact us and we will be able to tell you which version of agreement you have in place.

Sharing consent data directly captured by the IBD Registry back to IBD teams is not specifically covered in the 2019 agreements, so we have provided you with a simple notice detailing this to pass on to your Information Governance team. If you would like us to resend this, please let us know. If there are any other paperwork requirements for your Trust, we will contact you to let you know.

Any data that has already been submitted will still be held within the Registry and usable just as before. This current database is large and will be effective in clinical quality improvement plus research (a smaller dataset) for many years to come. We will hold separate databases for the data submitted via NHS Digital and the records collected with the new data flow under the revised consent process.

Please email us and we will be happy to help you.

The e-consent tool provides an option for patients to complete the IBD-Control as many times as they want. 

These PROMS are currently collected for use by the IBD Registry (research and QI). However, we have received feedback from both patients and clinical teams that they would like the option for this information to be shared back to their IBD teams, so we are currently investigating ways to enable this for the future.

In the meantime, patients can download their answers and share them with their clinical team at their next consultation.

Yes, additional surveys can be added easily. For example, we are looking at including patient wellness self-assessment surveys used by some IBD teams, to support clinical workload by allowing easier prioritisation of patients with greatest need.

The IBD Registry and the NIHR IBD BioResource have separate consent processes. This is required as they are different organisations. However, we appreciate that IBD teams work with both, and we are working together with the NIHR IBD BioResource to find ways to reduce any overlap between us. For example, we have been able link our two datasets for specific projects that will permit the data to be used more widely and for greater benefit for people with IBD.