Development of a Core Outcome Set for PSC

• Research type

  Research Study

• Full title

  Development of a Core Outcome Set for Clinical Trials in Primary Sclerosing Cholangitis

• IRAS ID

  340146

• Contact name

  Palak Trivedi

• Contact email

  p.j.trivedi@bham.ac.uk

• Sponsor organisation

  University of Birmingham

• Clinicaltrials.gov Identifier

  1239, COMET Registration No: 1239

• Duration of Study in the UK

  2 years, 0 months, 1 days

• Research summary

  Primary sclerosing cholangitis (PSC) is a disease that causes inflammation and scarring of the bile ducts within the liver. There are no medicines that have been shown to slow disease progression, and liver transplantation is the only lifesaving treatment.
  Given this lack of treatment, there is an interest and an increase in developing possible treatments for PSC. However, there is no standardised list of outcomes that studies should measure when testing new drugs for PSC. This means different studies can measure different outcomes from each other, making it difficult to compare them and see which study had the best treatments. Studies may also measure outcomes which they feel is important to them as researchers, and not consider what may be important for patients.
  A solution to this, is the development of a core outcome set (COS). This is an agreed minimum set of outcomes that all studies developing treatments for PSC should report. In our study, we will develop this COS, to help make comparisons and decisions about new treatments in the future. A good COS should have input from all the different groups interested in PSC (stakeholders), especially patients, and we will do this in our study.
  There will be 3 stages in developing the COS. Firstly, stakeholder interviews involving members from the different groups. These interviews will explore the views and opinions on PSC studies and what is felt to be the most important outcomes needed. Secondly a full list of outcomes will be rated in a survey (Delphi process) to narrow the outcomes down. Finally, a consensus meeting will determine the final core set of outcomes

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  24/EM/0126

• Date of REC Opinion

  28 May 2024

• REC opinion

  Further Information Favourable Opinion