Patient-focused Target Product Profiles (TPP) for Cystic Fibrosis
Research type
Research Study
Full title
Eliciting required and desired diagnostic test characteristics to develop patient-focused target product profiles (TPPs) for diagnosing infection and exacerbations in cystic fibrosis.
IRAS ID
316276
Contact name
Kile Green
Contact email
Duration of Study in the UK
1 years, 6 months, 0 days
Research summary
Cystic Fibrosis (CF) is an inherited condition. It causes a sticky build-up of mucus in the lungs, gut and other organs. This causes problems with infections and digestion. CF affects over 10,600 people in the UK and can shorten the lifespan of those with the condition. Although advances in treatment and diagnosis have allowed many people living with CF to lead much healthier lives, there is still much more to address.
People with CF experience frequent infections which require antibiotics. Repeated infections can cause damage and scarring to the lungs, and long-term use of antibiotics can lead to antibiotic-resistant infection, which can be difficult to treat.
NIHR Newcastle In Vitro Diagnostics Co-operative (Newcastle MIC) has been working with charity groups and collaborators in this area to better understand the requirements for diagnosing infections in people with CF. The Newcastle MIC will work alongside research group and CF charities to develop ‘target product profiles’ (TPPs) for infections in CF. The TPPs will describe the requirements (accuracy, time to diagnosis, ease of use, etc.) of current and new diagnostic tests that address the issues and concerns of patients and clinical experts.
This project has three work-packages. Work-package 1 will involve focus groups and interviews with patients, representatives and clinical experts to determine the unmet needs in CF diagnostics, the required diagnostic test characteristics, and priorities of all stakeholders involved in the care of people with CF. Work-package 2 will involve a state-of-the-art systematic review of literature, clinical guidelines and academic publications to determine the current care pathway and diagnostics in use and in development. Work-package 3 will pull together all of the information we have gathered to develop a TPP through consensus amongst all stakeholders. A finalised TPP and report will be written and shared with stakeholders before results are published in a peer-reviewed journal.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
22/EE/0251
Date of REC Opinion
18 Oct 2022
REC opinion
Further Information Favourable Opinion