Sample size and appropriate powering of randomised controlled trials in IBD: A Delphi study to achieve minimum recruiting targets for UK studies

Sample size and appropriate powering of randomised controlled trials in IBD: A Delphi study to achieve minimum recruiting targets for UK studies

Why is this project being done?

A recent project has investigated every RCT in IBD in both adults and children published globally since 1996 (the year the first publication guidance in the CONSORT statement were released). We found that 20% of studies have no sample size estimate to guide how many patients should be recruited to the project. However, for the studies that did calculate power, they used variable and often highly spurious figures of the difference between groups that they expected which leads low numbers of patients included. This has left many studies underpowered and impacts the entire evidence base, as we often see when completing systematic reviews. Guidance, based on actual observed effect sizes, could support trial designers and most importantly ensure funded studies are completed to an appropriate power.

What will participation involve?

We will ask you to attend a face to face session in one of five locations across the UK for approximately 2-4 hours with 5-12 other professionals working within IBD. We will present the actual data for effect size seen over trials in a number of different settings, categorised by disease (UC or CD), current state of activity (induction or remission studies), specific agents of study and age of patients. We will then ask you, based on the actual data presented and the quality and certainty of that data, to estimate what you would think a minimum and maximum likely effect size would be for a trial in a similar setting. Once all the sessions are complete, you will be invited to participate in a second and third stage online, consistent with a Delphi approach. This will present the data from all the sessions analysed and allow a national expert consensus to be reached and this paper published.

Who can get involved?

We are looking at a range of professionals involved with the care of IBD. This can involve consultants, specialist nurses, researchers and indeed patients. We are particular keen on those who have practical experience with a range of treatments with their patients and the success rates / impact of these with their patients, as this will allow practical expert view to enhance the decision making based on the data we represent. No research experience is needed.

Can you tell me more about the face to face session?

These will take place in February and March 2020 in London, Cardiff, Glasgow and Preston. We will have a local meeting space and provide refreshments and also reimburse travel up to £60.

How else can I get involved?

If participants are keen to support this work, they can discuss with our team and potentially support the analysis and write up of the project. We also invite anyone involved in this and other Cochrane works to contact us.

If you are interested in getting involved, please contact

New 2019 IBD Standards launch

In June the new IBD Standards has been launched with the aim to improve how we care for people with Inflammatory Bowel Disease (IBD) across the UK. These have been created by IBD UK, a partnership of 17 patient and professional organisations, including BSPGHAN, the BSG, CICRA and Crohn’s & Colitis UK.

The IBD Standards say what high-quality care should look like at every point of a patient’s journey – from first symptoms, to diagnosis, treatment, and ongoing care, whatever their age and wherever they live in the UK. They also set out how an IBD service should be organised and managed to deliver this. Paediatric and adolescent care has been considered throughout.

Announced at the BSG annual conference, these 59 statements set out what good care and treatment looks like for patients with IBD, with the aim that every IBD service in the UK will work to meet these.

A new digital IBD Benchmarking Tool has been developed to help with this, so that services can assess how they are doing against the IBD Standards and plan to improve. A new UK-wide IBD Patient Survey will give people with IBD the opportunity to rate their experience of care, allowing patient experience to support the development of a service. This will provide an opportunity to push through real change, support with business cases and make the case for additional resources needed.

Through this process, healthcare professionals and patients will be able to work together to improve standards of care for everyone with IBD across the UK.

What your team needs to do to make the IBD Standards a successful reality:
• Register for the IBD Benchmarking Tool – from now!
• Promote the IBD Patient Survey in your service from 8th July
• Incorporate the IBD Standards in your overall service design and work, and making opportunities to discuss and raise awareness of the IBD Standards at meetings, events and talks
To see the full list of IBD Standards, register for the IBD Benchmarking Tool and find more information visit For any queries, and to obtain flyers to promote the IBD Patient Survey, email

Yours sincerely,

Dr Rafeeq Muhammed
Chair of BSPGHAN IBD Working Group

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