British Axial Spondyloarthritis Inception Cohort (BAxSIC)
Research type
Research Study
Full title
British Axial Spondyloarthritis Inception Cohort (BAxSIC) study
IRAS ID
253502
Contact name
Stefan Siebert
Contact email
Sponsor organisation
University of Glasgow (on behalf of NHS GG&C)
Duration of Study in the UK
4 years, 11 months, 31 days
Research summary
Axial spondyloarthritis (axSpA) is a chronic inflammatory arthritis affecting predominantly the spine, and peripheral joints, eyes (uveitis), skin (psoriasis) and bowel (colitis). This condition has a major impact on patients’ lives, exacerbated by the onset in early adulthood and long delays in diagnosis.
There have been major advances in the diagnosis and treatment of axSpA, offering opportunities to significantly alter the disease course and outcomes. In order to realise and maximise these benefits, there is a need for good longitudinal data to understand the natural history of axSpA, as well as the impact of delay to diagnosis on patient outcomes.
Most of the clinical and research outcome measures used routinely in axSpA are patient-reported, allowing information to be collected directly from people with axSpA, avoiding the need for costly and time-consuming healthcare professional involvement.
The National Early Inflammatory Arthritis Audit (NEIAA) is recording diagnosis in all new patients presenting with inflammatory arthritis to rheumatologists in England and Wales as part of NHS audit. We propose to approach participants with axSpA in the NEIAA who have given additional consent to be contacted about other studies to participate in the BAxSIC observational study. All study activities will be performed remotely, without the need for any study visits or procedures, minimising participants’ burden. Consenting participants would be asked to complete questionnaires at baseline and then every 6 months. This model of virtual cohort has previously been successfully used by the investigators in people with Ankylosing Spondylitis who were recruited via GP records.
The key study objectives are to evaluate the impact of delay in diagnosis on important disease, functional and occupational outcomes. This study has been developed in partnership with NASS, the national patient advisory group for axSpA. Participants will also be asked for optional additional permission to link their study data to existing routine datasets (via NHS Digital).
Summary of Research
As indicated in the declaration of end of study notification, the study was never started. Despite numerous discussions and reassurances prior to submission of this application, there were issues with the way the initial data consent was taken by the NEIAA, which meant that patients could not be approached via this route for “other” research or external researchers outside their main team. Several attempts to find alternative solutions were unsuccessful and the study was therefore unfortunately never started.Summary of Results
As indicated in the declaration of end of study notification, the study was never started. Despite numerous discussions and reassurances prior to submission of this application, there were issues with the way the initial data consent was taken by the NEIAA, which meant that patients could not be approached via this route for “other” research or external researchers outside their main team. Several attempts to find alternative solutions were unsuccessful and the study was therefore unfortunately never started.REC name
London - Westminster Research Ethics Committee
REC reference
19/LO/0786
Date of REC Opinion
13 May 2019
REC opinion
Favourable Opinion