Individualised screening for diabetic retinopathy: the ISDR study—rationale, design and methodology for a randomised controlled trial comparing annual and individualised risk-based variable-interval screening
Individualised screening for diabetic retinopathy: the ISDR study—rationale, design and methodology for a randomised controlled trial comparing annual and individualised risk-based variable-interval screening
Introduction: currently, all people with diabetes (PWD) aged 12 years and over in the UK are invited for screening for diabetic retinopathy (DR) annually. Resources are not increasing despite a 5% increase in the numbers of PWD nationwide each year. We describe the rationale, design and methodology for a randomised controlled trial (RCT) evaluating the safety, acceptability and cost-effectiveness of personalised variable-interval risk-based screening for DR. This is the first randomised trial of personalised screening for DR and the largest ophthalmic RCT in the UK.
Methods and analysis: PWD attending seven screening clinics in the Liverpool Diabetic Eye Screening Programme were recruited into a single site RCT with a 1:1 allocation to individualised risk-based variable-interval or annual screening intervals. A risk calculation engine developed for the trial estimates the probability that an individual will develop referable disease (screen positive DR) within the next 6, 12 or 24 months using demographic, retinopathy and systemic risk factor data from primary care and screening programme records. Dynamic, secure, real-time data connections have been developed. The primary outcome is attendance for follow-up screening. We will test for equivalence in attendance rates between the two arms. Secondary outcomes are rates and severity of DR, visual outcomes, cost-effectiveness and health-related quality of life. The required sample size was 4460 PWD. Recruitment is complete, and the trial is in follow-up.
Ethics and dissemination: ethical approval was obtained from National Research Ethics Service Committee North West – Preston, reference 14/NW/0034. Results will be presented at international meetings and published in peer-reviewed journals. This pragmatic RCT will inform screening policy in the UK and elsewhere.
Trial registration number: ISRCTN87561257; Pre-results.
diabetic retinopathy, general diabetes, health economics, health policy, medical ophthalmology, medical retina
Broadbent, Deborah M.
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Sampson, Christopher J.
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Wang, Amu
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Howard, Lola
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Williams, Abigail E.
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Howlin, Susan U.
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Appelbe, Duncan
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Moitt, Tracy
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Cheyne, Christopher P.
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Rahni, Mehrdad Mobayen
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Kelly, John
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Collins, John
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García-Fiñana, Marta
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Stratton, Irene M.
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James, Marilyn
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Harding, Simon P.
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June 2019
Broadbent, Deborah M.
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Sampson, Christopher J.
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Wang, Amu
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Howard, Lola
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Williams, Abigail E.
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Howlin, Susan U.
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Appelbe, Duncan
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Moitt, Tracy
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Cheyne, Christopher P.
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Rahni, Mehrdad Mobayen
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Kelly, John
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Collins, John
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García-Fiñana, Marta
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Stratton, Irene M.
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James, Marilyn
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Harding, Simon P.
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Broadbent, Deborah M., Sampson, Christopher J., Wang, Amu, Howard, Lola, Williams, Abigail E., Howlin, Susan U., Appelbe, Duncan, Moitt, Tracy, Cheyne, Christopher P., Rahni, Mehrdad Mobayen, Kelly, John, Collins, John, García-Fiñana, Marta, Stratton, Irene M., James, Marilyn and Harding, Simon P.
(2019)
Individualised screening for diabetic retinopathy: the ISDR study—rationale, design and methodology for a randomised controlled trial comparing annual and individualised risk-based variable-interval screening.
BMJ Open, 9 (6), [e025788].
(doi:10.1136/bmjopen-2018-025788).
Abstract
Introduction: currently, all people with diabetes (PWD) aged 12 years and over in the UK are invited for screening for diabetic retinopathy (DR) annually. Resources are not increasing despite a 5% increase in the numbers of PWD nationwide each year. We describe the rationale, design and methodology for a randomised controlled trial (RCT) evaluating the safety, acceptability and cost-effectiveness of personalised variable-interval risk-based screening for DR. This is the first randomised trial of personalised screening for DR and the largest ophthalmic RCT in the UK.
Methods and analysis: PWD attending seven screening clinics in the Liverpool Diabetic Eye Screening Programme were recruited into a single site RCT with a 1:1 allocation to individualised risk-based variable-interval or annual screening intervals. A risk calculation engine developed for the trial estimates the probability that an individual will develop referable disease (screen positive DR) within the next 6, 12 or 24 months using demographic, retinopathy and systemic risk factor data from primary care and screening programme records. Dynamic, secure, real-time data connections have been developed. The primary outcome is attendance for follow-up screening. We will test for equivalence in attendance rates between the two arms. Secondary outcomes are rates and severity of DR, visual outcomes, cost-effectiveness and health-related quality of life. The required sample size was 4460 PWD. Recruitment is complete, and the trial is in follow-up.
Ethics and dissemination: ethical approval was obtained from National Research Ethics Service Committee North West – Preston, reference 14/NW/0034. Results will be presented at international meetings and published in peer-reviewed journals. This pragmatic RCT will inform screening policy in the UK and elsewhere.
Trial registration number: ISRCTN87561257; Pre-results.
Text
e025788.full
- Version of Record
More information
Accepted/In Press date: 25 March 2019
e-pub ahead of print date: 17 June 2019
Published date: June 2019
Additional Information:
Funding Information: the Individualised Screening for Diabetic Retinopathy (ISDR) RCT is part of a larger programme of applied research funded by a £2.1 million grant from the National Institute for Health Research (NIHR) Programme Grants for Applied Research programme – reference RG-PG-1210–12016. SH is the chief investigator for the seven workstream programmes, and DMB is the principal investigator for the RCT. The RCT is supported by the Clinical Trials Research Centre in Liverpool, which provides information systems support, developed electronic case report files and manage the data. There are three trial oversight committees: a trial management group, a trial steering committee and the independent data and safety monitoring committee. The composition and membership of the committees was approved by NIHR. The study protocol,34 patient information sheets and consent forms have received ethical approval from the National Research Ethics Service Committee North West – Preston (reference: 14/NW/0034). Recruitment to the trial was supported by research staff from Clinical Research Network North West Coast, Liverpool Diabetic Eye Screening Programme (LDESP) staff and trained student volunteers.
Funding Information: this paper presents independent research funded by the National Institute for Health Research (NIHR) under the Programme Grants for Applied Research programme (RP-PG-1210-12016).
Keywords:
diabetic retinopathy, general diabetes, health economics, health policy, medical ophthalmology, medical retina
Identifiers
Local EPrints ID: 487104
URI: http://eprints.soton.ac.uk/id/eprint/487104
ISSN: 2044-6055
PURE UUID: 3bc9f936-65d6-4224-876e-f31f028e28ba
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Date deposited: 13 Feb 2024 17:33
Last modified: 18 Mar 2024 04:01
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Contributors
Author:
Deborah M. Broadbent
Author:
Christopher J. Sampson
Author:
Amu Wang
Author:
Lola Howard
Author:
Abigail E. Williams
Author:
Susan U. Howlin
Author:
Duncan Appelbe
Author:
Tracy Moitt
Author:
Christopher P. Cheyne
Author:
Mehrdad Mobayen Rahni
Author:
John Kelly
Author:
John Collins
Author:
Marta García-Fiñana
Author:
Irene M. Stratton
Author:
Marilyn James
Author:
Simon P. Harding
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