Home-Monitoring Vision Tests to Detect Active Neovascular Age-Related Macular Degeneration

This diagnostic test accuracy study investigates the ability of at-home vision-monitoring tests to detect reactivation of neovascular age-related macular degeneration.

.8 1 eFigure 2 Receiver operating characteristic curves and AUROCs (95% CIs) for summary test scores for all index tests; sensitivity analysis 2 (reference standard derived from independent grading of OCTs).

Objective A -CARF Right Eye
Objective A -CARF left Eye  No benefit in taking part 9 (2%)

(0%)
Too much of a commitment 54 (11%) eTable 2: Primary analysis of the diagnostic accuracy of baseline information ("no test") and of the summary scores for homemonitoring tests to identify the reference standard of lesion activity in study eyes.Each model was fitted, where possible, with a random intercept and random slope on calendar quarter since baseline visit at the participant level, and a random intercept at the eye level.
(a) Numbers of visits, eyes and participants contributing to the models and odds ratios for predictors in the models.worse for the given test. 2 VA is on a self-reported scale where 1 = worst and 6 = best eTable 3: Model Results for sensitivity analysis 1 of the diagnostic accuracy of baseline information ("no test") and of the summary scores for home-monitoring tests to identify the reference standard of lesion activity in study eyes used home-monitoring data for only the 4 weeks preceding the hospital monitoring visit.Each model was fitted, where possible, with a random intercept and random slope on calendar quarter since baseline visit at the participant level, and a random intercept at the eye level.

Numbers in models
(a) Numbers of visits, eyes and participants contributing to the models and odds ratios for predictors in the models.

Numbers in models
No eTable 4 Model Results for sensitivity analysis 2 of the diagnostic accuracy of baseline information ("no test") and of the summary scores for home-monitoring tests to identify the reference standard of lesion activity in study eyes identified by reading center grading, using all available home-monitoring data; models for right and left eyes fitted separately.Each model was fitted, where possible, with a random intercept and random slope on calendar quarter since baseline visit at the participant level.
(a) Model results for the primary outcome of lesion activity in right study eyes for all home monitoring test models and for a no-test model.

Numbers in models
No 1 Average scores below/above the threshold are means unless otherwise specified.KSJ mean summary scores are expressed the proportion who reported worse for the given test. 2 VA is on a self-reported scale where 1 = worst and 6 = best eTable 5 Model results for the alternative reference standard: a change from inactive to active lesion status.Each model was fitted, where possible, with a random intercept and random slope on calendar quarter since baseline visit at the participant level, and a random intercept at the eye level.

eTable 1 :
Reasons for being unwilling in principle to participate.

78913a
background, including the intended use and clinical role of the index test 6Whether data collection was planned before the index test and reference standard were performed (prospective study) or after (retrospective study) On what basis potentially eligible participants were identified (such as symptoms, results from previous tests, inclusion in registry) 7 (participants) Where and when potentially eligible participants were identified (setting, location and dates) 7 (patient identification) Whether participants formed a consecutive, random or convenience series 8 Test methods 10a Index test, in sufficient detail to allow replication 8-9 10b Reference standard, in sufficient detail to allow replication 9 11 Rationale for choosing the reference standard (if alternatives exist) Not applicable 12a Definition of and rationale for test positivity cut-offs or result categories of the index test, distinguishing pre-specified from exploratory 11 (AUROCs -cut-offs not available) 12b Definition of and rationale for test positivity cut-offs or result categories of the reference standard, distinguishing pre-specified from exploratory 9 Whether clinical information and reference standard results were available to the performers/readers of the index test Reference standard identified after tests had been done 13b Whether clinical information and index test results were available to the assessors of the reference standard Analysis 14 Methods for estimating or comparing measures of diagnostic accuracy Not applicable 15 How indeterminate index test or reference standard results were handled 9 16 How missing data on the index test and reference standard were handled 10 17 Any analyses of variability in diagnostic accuracy, distinguishing pre-specified from exploratory AUROCs presented.

24
Estimates of diagnostic accuracy and their precision (such as 95% confidence intervals) Figure4(AUROCs) and Supplementary Table2c

25
Any adverse events from performing the index test or the reference standard 13 DISCUSSION 26 Study limitations, including sources of potential bias, statistical uncertainty, and generalisability 15 27 Implications for practice, including the intended use and clinical role of the index test 16

Overall (within site) 502 (100%) Other
reasons include: 1 Poor memory, 1 Poor mobility, 1 Does not want internet, 4 Does not feel capable, 2 Lives alone, 1 Initially agreed, but changed mind, 2 Too complicated; 1 Not eligible, 1 Discharged from follow-up, 1 Did not attend training, 1 Poor mobile signal at home, 1 Patient died.

Below threshold Above threshold n Average 1 (95%, CI) n Average 1 (95%, CI)
Average test scores above and below thresholds defined by Youden's index.Average scores below/above the threshold are means unless otherwise specified.KSJ mean summary scores are expressed the proportion who reported worse for the given test. 2 VA is on a self-reported scale where 1 = worst and 6 = best Model performance for predicting management decisions of lesion activity at thresholds defined by Youden's index for summary test scores for all index tests; sensitivity analysis 2.
AUROC -area under the ROC curve; PPV -positive predictive value; NPV -negative predictive value Model performance for predicting management decisions for thresholds defined by Youden's index for summary test scores for index tests (except for the mVT, for which no model achieved convergence) Average test scores above and below thresholds defined by Youden's index for the models predicting management decisions tests (except for the mVT, for which no model achieved convergence)

Table 1 21a
Distribution of severity of disease in those with the target condition

Table 1 21b
Distribution of alternative diagnoses in those without the target condition Not applicable 22 Time interval and any clinical interventions between index test and reference standard Variable; addresses by sensitivity analysis 1 Test results 23 Cross tabulation of the index test results (or their distribution) by the results of the reference standard