Systematic review and economic modelling of optical coherence tomography (OCT) for the diagnosis, monitoring and guiding of treatment for neovascular age-related macular degeneration

DESIGN: Systematic review and economic modelling. SEARCH STRATEGY: Databases to be searched (from 1995 onwards): MEDLINE, MEDLINE In-Process, EMBASE, CINAHL, Biosis, Science Citation Index, Cochrane Controlled Trials Register), PsycINFO, ASSIA, the Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects, MEDION, HTA database, WHO International Clinical Trials Registry, Clinical Trials and EU Clinical Trials Register. No language restrictions. REVIEW STRATEGY: Types of participants: those newly presenting with possible neovascular age-related macular degeneration or previously diagnosed with the condition and being monitored. Index test: optical coherence tomography. Comparator tests: visual acuity, colour and red-free images, fundus biomicroscopy and autofluorescence imaging. Reference standard: ophthalmologist-interpreted fluorescein angiography. Outcome measures: diagnostic accuracy, patient/clinician acceptability, interpretability of the tests, clinical efficacy and effectiveness. Types of studies: randomised controlled trials, diagnostic cross-sectional studies, and qualitative acceptability studies. The methodological quality of diagnostic studies will be assessed using QUADAS-2. The methodological quality of studies reporting effectiveness outcomes will be assessed using a checklist adapted from Verhagen and colleagues. Study selection, data extraction and quality assessment will be undertaken by two reviewers independently. If appropriate, for diagnostic studies meta-analysis models will be fitted using hierarchical summary receiver operating characteristic curves. For effectiveness outcomes, if appropriate, meta-analysis will be employed to estimate a summary effect measure (relative risk). An economic model will be developed, the main outputs of which will be NHS costs for diagnosis, total NHS costs (modelled up to the lifetime of patients), diagnostic performance, QALYs, and incremental cost per QALY. We will conduct deterministic and probabilistic analyses. Value of information analyses techniques will be considered to help inform decisions on further research. EXPECTED OUTPUT OF RESEARCH: Peer-reviewed publications; conference presentations. The results of this project may be incorporated into guidelines by the Royal College of Ophthalmologists for dissemination amongst ophthalmologists in the UK