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Methods for analytical validation of novel digital clinical measures: A simulation study.
Simon Turner1, Chen Chen2, Rolando Acosta3
1Digital Medicine Society (DiMe), Boston, Massachusetts, United States of America.
Plos One
|May 13, 2026
Summary
Analytical validation of sensor-based digital health technologies (sDHTs) is complex without direct reference measures. This study found Pearson Correlation Coefficient (PCC) and confirmatory factor analysis (CFA) offer complementary insights for rigorous validation.
Area of Science:
- Digital Health
- Biostatistics
- Health Informatics
Background:
- Sensor-based digital health technologies (sDHTs) generate novel digital measures.
- Analytical validation is essential but challenging when direct reference measures are unavailable.
- Simulation studies can address validation complexities.
Purpose of the Study:
- To compare analytical validation methods for sDHTs.
- To evaluate Pearson Correlation Coefficient (PCC) and confirmatory factor analysis (CFA) for assessing relationships between sDHTs and reference measures.
- To determine if multiple reference measures enhance target measure representation.
Main Methods:
- Simulated data for a latent physical ability trait.
- Used sDHT step count as a target measure and clinical outcome assessments (COAs) for self-reported physical activity as reference measures.
- Employed PCC, two-factor CFA, and multiple linear regression models.
Main Results:
- PCC is stable, easy to compute, and robust, especially with small sample sizes.
- CFA is less biased than PCC across all scenarios.
- Combined PCC and CFA increase confidence in measure comparisons.
- Multiple COA reference measures with frequent data collection improve target measure representation.
Conclusions:
- Both PCC and CFA are valuable for analytical validation of sDHTs, offering complementary strengths.
- Integrating multiple reference measures enhances the assessment of sDHT analytical validity.
- Findings guide investigators in selecting appropriate validation methods for novel digital measures.
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