Home-monitoring for neovascular age-related macular degeneration in older adults within the UK: the MONARCH diagnostic accuracy study

Hogg RE, Wickens R, O'Connor S, Gidman E, Ward E, Treanor C, Peto T, Burton B, Knox P, Lotery AJ, Sivaprasad S, Donnelly M, Rogers CA, Reeves BC
Record ID 32018012997
English
Authors' objectives: Most neovascular age-related macular degeneration treatments involve long-term follow-up of disease activity. Home monitoring would reduce the burden on patients and those they depend on for transport, and release clinic appointments for other patients. The study aimed to evaluate three home-monitoring tests for patients to use to detect active neovascular age-related macular degeneration compared with diagnosing active neovascular age-related macular degeneration by hospital follow-up. There were five objectives: Estimate the accuracy of three home-monitoring tests to detect active neovascular age-related macular degeneration. Determine the acceptability of home monitoring to patients and carers and adherence to home monitoring. Explore whether inequalities exist in recruitment, participants’ ability to self-test and their adherence to weekly testing during follow-up. Provide pilot data about the accuracy of home monitoring to detect conversion to neovascular age-related macular degeneration in fellow eyes of patients with unilateral neovascular age-related macular degeneration. Describe challenges experienced when implementing home-monitoring tests. Neovascular age-related macular degeneration (nAMD) is the leading cause of blindness in older adults. Advanced nAMD causes substantial retinal damage, loss of central vision and reduced quality of life. Several intravitreal drugs [anti-vascular endothelial growth factor (VEGF) that inhibits neovascularisation, i.e. anti-VEGF agents] are used to treat nAMD. Some eyes become fluid free after initial treatment over 3–6 months but relapse is common, and most patients require retreatment at some stage, with the disease typically becoming inactive for a period and then becoming active again. Hence, patients in the maintenance phase with inactive disease still need to be monitored regularly in hospital outpatient clinics for disease reactivation, when treatment is restarted. Monitoring places a substantial burden on hospital resources, patients and their family or carers. This burden would be substantially reduced if patients with inactive disease could self-monitor at home and attend hospital only when the disease reactivates. Estimate the accuracy of three home-monitoring tests to detect active nAMD. Determine the acceptability of home monitoring to patients and carers and barriers to adhering to regular testing. Describe inequalities in recruitment, participants’ ability to self-test and adherence to testing during follow-up. Estimate the accuracy of home monitoring to detect conversion to nAMD in fellow eyes of patients with unilateral nAMD. Describe the challenges experienced when implementing the tests. Study design Diagnostic test accuracy cohort study. Recruitment to the qualitative component began 3 months after the monitoring for neovascular age-related macular degeneration reactivation at home (MONARCH) study began recruiting. During the consent process for participation in the study, patients could consent to further contact from the qualitative research team to discuss participation in the qualitative study. Maximum variation sampling ensured a range of perspectives were captured in relation to: age (young-old 50–69 years and older-old > 70 years), gender, one or both eyes with nAMD, time since first treatment (defined as above) and adherence to home monitoring (test data from the two electronic tests were used to categorise participants into ‘regular’ testers and ‘irregular’ testers). Patients who declined to participate in MONARCH but provided consent to be contacted about the qualitative study, informal ‘carers’, supporters or significant others in the lives of patients and healthcare professionals who interacted with participants at study sites visits were also approached to gather their perspectives about the acceptability of home monitoring.
Authors' results and conclusions: Two hundred and ninety-seven 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 (1549 complete visits). Median testing frequency was three times/month. Estimated areas under receiver operating curves were < 0.6 for all index tests, and only KeepSight Journal summary score was significantly associated with the lesion activity (odds ratio = 3.48, 95% confidence interval 1.09 to 11.13, p = 0.036). Older age and worse deprivation for home address were associated with lower participation (χ2 = 50.5 and 24.3, respectively, p 
Authors' methods: Diagnostic test accuracy cohort study, stratified by time since starting treatment. Six United Kingdom Hospital Eye Service macular clinics (Belfast, Liverpool, Moorfields, James Paget, Southampton, Gloucester). Patients with at least one study eye being monitored by hospital follow-up. Pre-specified sample size not met; participants’ difficulties using the devices; electronic tests not always available. Participants recruited from six UK HES macular clinics (Belfast, Liverpool, Moorfields, James Paget, Southampton, Gloucester). Participants We invited patients to take part who had at least one study eye being monitored by HES for nAMD, were first treated > 6 and < 42 months earlier. We tried to recruit equal numbers by time since starting treatment in the first-treated study eye (6–17 months; 18–29 months; 30–41 months) to ensure test performance was estimated across this range of duration of nAMD. Patients were followed for at least 6 months. A smaller-than-planned sample size (less than half the target number of monitoring visits); nonetheless, 95% CIs for AUROCs were narrow (± 0.04) and estimates were able to rule out tests providing adequate accuracy for diagnosing active nAMD to enable patients to be monitored without hospital review. Tests were sometimes not available for technical reasons that were beyond the control of the research team. The study had no control over monitoring visits and participants are likely to have reported their subjective visual experience to their consultants, which might have influenced the reference standard. We could not define test thresholds a priori, and instead estimated AUROCs. We did not compare AUROCs for tests due to their poor accuracy. The ways in which patients were approached and screened varied across sites, generating a site effect in analyses of potential inequalities; variations may have reflected the pre-conceptions of research staff regarding the capabilities of patients to use the electronic tests.
Details
Project Status: Completed
Year Published: 2024
URL for additional information: English
English language abstract: An English language summary is available
Publication Type: Full HTA
Country: England, United Kingdom
MeSH Terms
  • Macular Degeneration
  • Monitoring, Ambulatory
  • Self Care
  • Aged
  • Aged, 80 and over
  • Mobile Applications
  • Wet Macular Degeneration
  • Visual Acuity
  • Vision Tests
Contact
Organisation Name: NIHR Health Technology Assessment programme
Contact Address: NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK
Contact Name: journals.library@nihr.ac.uk
Contact Email: journals.library@nihr.ac.uk
This is a bibliographic record of a published health technology assessment from a member of INAHTA or other HTA producer. No evaluation of the quality of this assessment has been made for the HTA database.