ISDR WS F phase II version 1

  • Research type

    Research Study

  • Full title

    Introducing personalised risk-based intervals in screening for diabetic retinopathy: development, implementation, and assessment of safety, cost-effectiveness and patient experience. Workstream F (qualitative) phase II

  • IRAS ID

    187979

  • Contact name

    Mark Gabbay

  • Contact email

    mbg@liverpool.ac.uk

  • Sponsor organisation

    The University of Liverpool

  • Clinicaltrials.gov Identifier

    11/NW/0183, 13/NW/0287

  • Duration of Study in the UK

    0 years, 8 months, 28 days

  • Research summary

    Diabetic retinopathy (DR) is the commonest cause of visual loss in adults of working age. The NHS currently provides annual eye screening for all people with diabetes (PWD) over the age of 12, so that sight threatening diabetic retinopathy (STDR) can be diagnosed and timely treatment can be given. Evidence to support annual screening is limited. Previous research by us and others has shown that some PWD have lower risks of developing STDR compared to others. This suggests that an individual risk based screening interval may be more cost effective than current annual screening, and low risk PWD might be screened less often than once per year, while higher risk groups might benefit from screening more often. The aim of our five year research programme is to develop and evaluate an individualised risk based screening protocol for DR based on outcomes of importance to patients. We believe that the interval can be lengthened for the majority of PWD. However the safety and acceptability of this approach has not been tested. This application is for ethical approval for the second phase of our qualitative workstream of our programme of research (workstream F) in which we will conduct interviews with a sample of patients who have participated in the RCT workstream of the programme. The aims of this phase of the work are to:
    - further explore the issues surrounding the acceptability of shifting to individualised and extended screening intervals that were highlighted in phase I interviews with patients and health professionals;
    - explore the patient experience of having individual risk assessed and being allocated to an individualised screening interval;
    - explore the degree to which some of the anticipated indirect impacts of shifting to individualised screening intervals are realised, for example, perceptions of risk, anxiety or diabetes management.

  • REC name

    North West - Preston Research Ethics Committee

  • REC reference

    16/NW/0061

  • Date of REC Opinion

    8 Mar 2016

  • REC opinion

    Favourable Opinion