A Population-based Ankylosing Spondylitis [PAS] cohort

Lead Research Organisation: Swansea University
Department Name: Institute of Life Science Medical School

Abstract

Studying long term conditions can be difficult as a result of the timescale involved and the difficulty in capturing associated non-medical costs such as disability or lack of earnings due to illness. A great deal of information is already regularly collected on all people using the NHS. However, this information is held in many different NHS systems, such as with the general practitioner, their specialist, the hospital and laboratories. By linking this information, people with specific conditions can be followed through the health system. In addition, these people can also contribute directly to the data collected by completing questionnaires about the effects of their disease, such as function or pain. This information can be fed back to their usual doctor, thereby contributing to their personal care, while also improving the quality and value of the data collected. In this study we intend to apply these strategies of linking data relating to people living in Wales with ankylosing spondylitis, the second most common inflammatory arthritis. This data will be collected and analysed in a secure and anonymised manner to help address important research questions about this condition. For example, this linked information will help us to better understand the variations in this lifelong condition; help to predict early in the disease which patients will develop the most disabling disease requiring more aggressive therapy; facilitate estimates of the true cost of this condition, thereby speeding up assessments of expensive new treatments as they become available; and help to better plan the pathway of these patients through the health system. This study will facilitate genetic and biological studies, as well as trials of new medications for ankylosing spondylitis, thereby further improving understanding of this condition and attracting high quality research to the NHS. The methods used here build on existing resources in the UK and can also be applied to many other conditions in the future.

Technical Summary

Ankylosing spondylitis (AS) is the second most common form of inflammatory arthritis. However, the natural history of AS is poorly understood with considerable variability in presentation and progression. In particular, there is a paucity of research on the cost of AS which has resulted in delayed NICE approval of new effective therapies for AS. The cost-effectiveness issue is further limited by the current inability to identify patients at risk of developing aggressive disease (who would benefit most from early aggressive therapy) and inability to predict which patients will fail to respond to these therapies. Identifying and recruiting AS patients, in a prompt and cost-effective manner, for genetic validation studies and clinical trials of new therapies is becoming increasingly difficult in the current fragmented NHS system. This proposal is for a population based cohort of people with AS, utilising disease-specific data (rheumatology database, radiology imaging) and patient-centred data (quality of life, work limitations, disease activity, function) linked with existing electronic data from disparate clinical, laboratory and administrative systems held by HIRU (GP records, out-patient and in-patient data, laboratory, A&E, social services datasets etc). All patients with AS (diagnosed by a rheumatologist) living in Wales will be approached to participate in this cohort, resulting in a well characterised cohort with robust clinical data at its base. The unique link with existing datasets will allow the cohort to be followed both prospectively and retrospectively. Therefore the cohort can be used to provide data on the natural history of AS, give an objective estimate of the cost of AS at each stage of the disease, identify early risk factors for severe disease, help identify potential interventions to prevent surgery and disability, in addition to facilitating patient identification and recruitment for genetic studies and clinical trials of new interventions. This study builds on existing UK resources and enhances the NHS?s ability to attract research. The cohort can also contribute to registers and post-marketing surveillance of new therapies. The use of routine data will ensure that this study will not suffer from the ?cohort effect? as all patients nationally can be included in the linking of routine data, and the use of rheumatology and GP clinical records will ensure the cohort will not date with time as it will include all new patients every year. Therefore this cohort, which can act as a pilot for other conditions, builds on and enhances existing UK resources and infrastructure.

Publications

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Atkinson MD (2010) Protocol for a population-based ankylosing spondylitis (PAS) cohort in Wales. in BMC musculoskeletal disorders

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Brophy S (2013) Fatigue in ankylosing spondylitis: treatment should focus on pain management. in Seminars in arthritis and rheumatism

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Cooksey R (2010) Frequency and characteristics of disease flares in ankylosing spondylitis. in Rheumatology (Oxford, England)

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Husain MJ (2012) HERALD (health economics using routine anonymised linked data). in BMC medical informatics and decision making

 
Description BSR Guidelines for Ankylosing Spondylitis
Geographic Reach National 
Policy Influence Type Membership of a guideline committee
Impact Review and update of British Society for Rheumatology (BSR) national guidelines for the management of ankylosing spondylitis.
URL http://www.rheumatology.org.uk/resources/guidelines/
 
Description Pfizer Inflammation-Competitive Research Programme (I-CRP)
Amount £44,234 (GBP)
Funding ID WS2306062 
Organisation Pfizer Ltd 
Sector Private
Country United Kingdom
Start 08/2012 
End 08/2013
 
Title Health economic analysis using linked routine data 
Description Methodology for improving the validity of health economic data analysis using longitudinal routine data linked with patient completed data. Modeling Health State Utility Values in Ankylosing Spondylitis: Comparisons of Direct and Indirect Methods. 
Type Of Material Model of mechanisms or symptoms - human 
Provided To Others? No  
Impact Presented as poster at the MRC Clinical Trials Methodology Conference in October 2011. Published doi: 10.1371/journal.pone.0126105 and doi: 10.1016/j.jval.2015.02.016. 
 
Description Genetics of AS study 
Organisation University of Oxford
Department Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Diseases (NDORMS)
Country United Kingdom 
Sector Academic/University 
PI Contribution Recruited participants from our cohort.
Impact Still ongoing - will result in publications with authorship for our team.
Start Year 2011
 
Description Modelling health utility values in Ankylosing Spondylitis: Comparisons of direct and indirect methods. 
Organisation University of Sheffield
Country United Kingdom 
Sector Academic/University 
PI Contribution Contributed data from this study to a collaboration with health economists in the University of Sheffield (School of Health and Related Research). Intellectual input and drafted manuscript.
Collaborator Contribution Developed concept, analysed data and drafted manuscript.
Impact Manuscript: Wailoo A, Hernandez M, Philips C, Brophy S, Siebert S. (2015) Modelling health utility values in Ankylosing Spondylitis: Comparisons of direct and indirect methods. Value Health 2015;18:425-31
Start Year 2013
 
Description 7th Annual UK Day on Spondyloarthritis 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Keynote/Invited Speaker
Geographic Reach National
Primary Audience Health professionals
Results and Impact 70+ UK Healthcare professionals (doctors, physios and specialist nurses), researchers and patient advisory group representatives (from NASS) as part of a 2 day programme on advances in clinical and research aspects related to spondyloarthritis

Information relevant to clinical practice, including several aspects that will result in changes to clinical practice. Also has lead to discussions about further collaboration.
Year(s) Of Engagement Activity 2013
 
Description Clinical presentations 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Health professionals
Results and Impact Presentations to regional and national rheumatologists at clinical meetings

Increased participation of clinicians in research in Ankylosing Spondylitis. Development of regional clinical ankylosing spondylitis interest groups.
Year(s) Of Engagement Activity 2009,2010,2011,2012
 
Description Information day for participants and patients 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Study participants or study members
Results and Impact 95 patients and carers attended information day with talks and Q&A session.

Increased interest and recruitment in study. Increased membership numbers in local patient groups. Increased knowledge about ankylosing spondylitis
Year(s) Of Engagement Activity 2011
 
Description Media releases 
Form Of Engagement Activity A press release, press conference or response to a media enquiry/interview
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Media (as a channel to the public)
Results and Impact Regional media promotion for the study information day.

Increased interest and knowledge about the condition (Ankylosing spondylitis) and the research activities
Year(s) Of Engagement Activity 2010,2011
 
Description Participant newsletter 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Patients, carers and/or patient groups
Results and Impact Newsletter with updates of research and other AS topics of interest

Increased retention of participants in study and dissemination of information about study beyond participants. Increased knowledge about ankylosing spondylitis.
Year(s) Of Engagement Activity 2010,2011
 
Description Scottish Parliament Cross Party Group on Musculoskeletal Disorders 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Policymakers/politicians
Results and Impact Scottish Parliament Cross Party Group on Musculoskeletal disorders and arthritis - event on Ankylosing Spondylitis and cost of arthritis
Year(s) Of Engagement Activity 2014
 
Description Welsh Assembly Government information session 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? Yes
Type Of Presentation Keynote/Invited Speaker
Geographic Reach National
Primary Audience Policymakers/politicians
Results and Impact Presentation to Welsh AMs, healthcare professionals, NHS policy makers, patients and patient groups at special session on Ankylosing Spondylitis

Information from cohort was used to emphasise burden and healthcare needs of patients with AS in Wales, which would be fed into teh chronic diseases management policies.
Year(s) Of Engagement Activity 2010