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Diagnostic test accuracy in longitudinal study settings: theoretical approaches with use cases from clinical practice
Julia Böhnke1, Antonia Zapf2, Katharina Kramer3
1Institute of Epidemiology and Social Medicine, University of Münster, Albert-Schweitzer-Campus 1, 48149 Münster, Germany.
Estimating diagnostic test accuracy (DTA) with longitudinal data requires careful consideration of analysis levels and time units. The time-level estimation yielded higher DTA, while patient-time-level estimates were around 50%.
Area of Science:
- Biostatistics
- Clinical Epidemiology
- Health Services Research
Background:
- Longitudinal patient data, with repeated diagnostic test applications, presents unique challenges for accurately estimating diagnostic test accuracy (DTA).
- Standard DTA estimation methods may not adequately account for the complexities of repeated measurements within individuals over time.
Purpose of the Study:
- To evaluate correct methods for estimating DTA in the presence of longitudinal patient data.
- To compare DTA estimates across different analysis levels (time, block, patient-time) and time units (minute, hour, day).
Main Methods:
- Employed a nonparametric approach to estimate sensitivity and specificity for tests targeting systemic inflammatory response syndrome, depression, and epilepsy.
- DTA was estimated at 'time', 'block', and 'patient-time' levels, with varying time units, for each diagnosis.
Main Results:
- DTA estimates varied significantly based on the chosen estimation level, time unit, number of observations per patient, and diagnosis-specific characteristics.
- The 'time' level generally showed the highest DTA, especially with larger time units, while the 'patient-time' level yielded approximately 50% sensitivity and specificity.
Conclusions:
- Researchers must predefine estimation levels and time units aligned with research aims, estimands, and target outcome characteristics for unbiased and clinically relevant DTA reporting.
- Reporting DTA using multiple estimation levels or time units is recommended when uncertainty exists.
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