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
| Autor: | 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, Harding, Simon P, Thetford, Clare |
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| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
medicine.medical_specialty
Cost-Benefit Analysis A990 030209 endocrinology & metabolism Workload Risk Assessment law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial Quality of life law Protocol health economics Humans Medicine 030212 general & internal medicine Referral and Consultation medical retina Health policy Probability Randomized Controlled Trials as Topic Research ethics Diabetic Retinopathy Health economics business.industry general diabetes Health Policy Attendance General Medicine medical ophthalmology United Kingdom Annual Screening Ophthalmology Diabetes Mellitus Type 1 Diabetes Mellitus Type 2 Family medicine Disease Progression Quality of Life Risk assessment business |
| Zdroj: | BMJ Open BMJ OPEN |
| Popis: | IntroductionCurrently, 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 analysisPWD 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 disseminationEthical 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 numberISRCTN87561257; Pre-results. |
| Databáze: | OpenAIRE |
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