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Safety, Efficacy and Cost Effectiveness of Individualised Screening for Diabetic Retinopathy: The ISDR Randomised Controlled Trial

141 Pages Posted: 15 Jul 2019

See all articles by Deborah Broadbent

Deborah Broadbent

University of Liverpool - Department of Eye and Vision Science; Royal Liverpool University Hospital - St Paul’s Eye Unit

Amu Wang

University of Liverpool - Department of Eye and Vision Science

Christopher P. Cheyne

University of Liverpool; Clinical Trials Research Centre, Liverpool

Marilyn James

University of Nottingham

James G. Lathe

University of Nottingham - School of Medicine

Irene M. Stratton

Cheltenham General Hospital

John Roberts

Mersey Diabetes Support Group

Tracy Moitt

Clinical Trials Research Centre, Liverpool

Jiten P. Vora

Royal Liverpool University Hospital

Mark Gabbay

University of Liverpool; Brownlow Health Centre

Marta García-Fiñana

University of Liverpool; Clinical Trials Research Centre, Liverpool

Simon P. Harding

University of Liverpool - Department of Eye and Vision Science; Royal Liverpool University Hospital - St Paul’s Eye Unit

More...

Abstract

Background: Varying diabetic retinopathy (DR) screening intervals, informed by personal risk-levels, empowers people with diabetes (PWD), and offers reallocation of resources to high risk groups, while addressing the increasing prevalence of diabetes. Safety data on extending intervals is minimal. We evaluated the safety, efficacy and cost effectiveness of individualised risk-based variable-interval population screening compared to usual care, with design input from PWD.

Methods: Two-arm, parallel assignment, equivalence randomised controlled trial (minimum 2 year follow-up) in PWD aged ≥12 years registered with one English screening programme. Randomisation was 1:1 to individualised screening (6, 12 or 24 months for high, medium and low risk) determined by a risk calculation engine, using local demographic, screening and clinical data, or to annual screening (control). Primary outcome was attendance (safety). A secondary safety outcome was the development of sight threatening DR (STDR). Cost effectiveness was evaluated within a 2 year time horizon from NHS and societal perspectives.

Findings: 4534 participants were randomised, 2265 to the individualised and 2269 to the control arm. Attendance rates at first follow-up were equivalent between individualised (1754/2097, 83·6%) and control (1883/2224, 84·7%) arms (difference -1·0, 95% CI -3·2 to 1·2). STDR detection rates were non-inferior: individualised 1·4%, control 1·7% (- 0·3, -1·1 to 0·5). Sensitivity analyses confirmed findings. Incremental QALYs/person were non-significant: EQ-5D-5L 0·035 (CI -0·04, 0·13), HUI3 0·009 (CI -0·09, 0·10). Incremental cost savings were £21·31 (CI 15·24, 26·79)/person for the NHS and £28·87 (CI 21·08, 35·78) including societal costs. 43·2% fewer screening appointments were required in the individualised arm.

Interpretation: Stakeholders involved in diabetes care can be reassured by this largest ophthalmic RCT in DR screening to date that extended and individualised risk-based intervals can be safely and cost effectively introduced in established screening programmes.

Trial Registration Number: ISRCTN 87561257.

Funding Statement: This study was funded by the UK National Institute for Health Research (NIHR) (Programme Grants for Applied Research, RP-PG-1210-12016).

Declaration of Interests: We declare no competing interests. Professor Mark Gabbay is part-funded by the NIHR Collaboration for Leadership in Applied Health Research and Care North West Coast.

Ethics Approval Statement: A UK NHS Research Ethics Committee approved the trial (14/NW/0034).

Suggested Citation

Broadbent, Deborah and Wang, Amu and Cheyne, Christopher P. and James, Marilyn and Lathe, James G. and Stratton, Irene M. and Roberts, John and Moitt, Tracy and Vora, Jiten P. and Gabbay, Mark and García-Fiñana, Marta and Harding, Simon P., Safety, Efficacy and Cost Effectiveness of Individualised Screening for Diabetic Retinopathy: The ISDR Randomised Controlled Trial (May 15, 2019). Available at SSRN: https://ssrn.com/abstract=3387513 or http://dx.doi.org/10.2139/ssrn.3387513

Deborah Broadbent (Contact Author)

University of Liverpool - Department of Eye and Vision Science ( email )

United Kingdom

Royal Liverpool University Hospital - St Paul’s Eye Unit ( email )

United Kingdom

Amu Wang

University of Liverpool - Department of Eye and Vision Science

United Kingdom

Christopher P. Cheyne

University of Liverpool

Chatham Street
Liverpool, L69 7ZA
United Kingdom

Clinical Trials Research Centre, Liverpool

United Kingdom

Marilyn James

University of Nottingham ( email )

University Park
Nottingham, NG8 1BB
United Kingdom

James G. Lathe

University of Nottingham - School of Medicine

Nottingham, NG7 2UH
United Kingdom

Irene M. Stratton

Cheltenham General Hospital

United Kingdom

John Roberts

Mersey Diabetes Support Group

United Kingdom

Tracy Moitt

Clinical Trials Research Centre, Liverpool

United Kingdom

Jiten P. Vora

Royal Liverpool University Hospital

United Kingdom

Mark Gabbay

University of Liverpool

Chatham Street
Liverpool, L69 7ZA
United Kingdom

Brownlow Health Centre

United Kingdom

Marta García-Fiñana

University of Liverpool

Chatham Street
Liverpool, L69 7ZA
United Kingdom

Clinical Trials Research Centre, Liverpool

United Kingdom

Simon P. Harding

University of Liverpool - Department of Eye and Vision Science

United Kingdom

Royal Liverpool University Hospital - St Paul’s Eye Unit

United Kingdom

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