There were five objectives:
A. Estimate the accuracy of three home-monitoring tests to detect active nAMD.
B. Determine the acceptability of home-monitoring to patients and carers and adherence to home-monitoring.
C. Explore whether inequalities exist in recruitment, participants’ ability to self-test, and their adherence to weekly testing during follow-up.
D. Provide pilot data about the accuracy of home-monitoring to detect conversion to nAMD in fellow eyes of patients with unilateral nAMD.
E. Describe challenges experienced when implementing home-monitoring tests.
Design: Diagnostic test accuracy cohort study, stratified by time since starting treatment.
Setting: Six UK Hospital Eye Service (HES) Macular Clinics (Belfast, Liverpool, Moorfields, James Paget, Southampton, Gloucester).
Patients with at least one study eye being monitored by hospital follow-up.
Detection of active nAMD by an ophthalmologist at hospital follow-up.
1. KeepSight Journal (KSJ): paper-based near vision tests presented as word puzzles.
2. MyVisionTrack® (mVT®): electronic test, viewed on a tablet device.
3. MultiBit (MBT): electronic test, viewed on a tablet device.
Participants provided test scores weekly. Raw scores between hospital follow-ups were summarised as averages.
Results: 297 patients (mean age 74.9 years) took part. At least one hospital follow-up was available for 317 study eyes, including 9 second eyes that became eligible during follow-up, in 261 participants (1,549 complete visits). Median testing frequency was 3 times/month. Estimated areas under receiver operating curves (AUROCs) were <0.6 for all index tests, and only KSJ summary score was significantly associated with the lesion activity (OR=3.48, 95% confidence interval 1.09-11.13, p=0.036). Older age and worse deprivation for home address were associated with lower participation (chi-squared=50.5 and 24.3 respectively, p<0.001) but not ability or adherence to self-testing. AUROCs appeared higher for conversion of fellow eyes to nAMD (0.85 for KSJ) but were estimated with less precision. Almost half of participants called a study helpline, most often due to inability to test electronically.
Limitations: Pre-specified sample size not met; participants’ difficulties using the devices; electronic tests not always available.
No index test provided adequate test accuracy to identify lesion diagnosed as active in follow-up clinics. If used to detect conversion, patients would still need to be monitored at hospital. Associations of older age and worse deprivation with study participation highlights the potential for inequities with such interventions. Provision of reliable electronic testing was challenging.
Future studies evaluating similar technologies should consider:
(i) Independent monitoring with clear stopping rules based on test performance.
(ii) Deployment of apps on patients own devices since providing devices did not reduce inequalities in participation and complicated home-testing.
(iii) Alternative methods to summarise multiple scores over the period preceding a follow-up.
|Journal||Health Technology Assessment|
|Publication status||Accepted - 31 Jan 2023|