ReviewDigital biomarkers
Clinical Validation of Novel Digital Measures: Statistical Methods for Reliability Evaluation.
Review in Digital biomarkers. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
10 citing papers in PubMed, 10 citations in OpenAlex.
- Agreement and potential for arithmetic adjustment of anterior segment measurements across IOLMaster 700, Pentacam HR, and Sirius.Scientific reports · 2026Article
- Digital assessment in myasthenia gravis: evidence, validation, and a proposed framework for autoimmune heterogeneity, remote monitoring, and clinical endpoints.Frontiers in immunology · 2026Review
- Methods for Analytical Validation of Novel Digital Clinical Measures: Implementation Feasibility Evaluation Using Real-World Datasets.Journal of medical Internet research · 2025Article
- Exploring nightly variability and clinical influences on sleep measures: insights from a digital brain health platform.Sleep medicine · 2025Article
- Adaptive Treatment of Metastatic Prostate Cancer Using Generative Artificial Intelligence.Clinical Medicine Insights. Oncology · 2025Review
- Evidentiary basis of the first regulatory qualification of a digital primary efficacy endpoint.Scientific reports · 2024Article
- An automatic measure for speech intelligibility in dysarthrias-validation across multiple languages and neurological disorders.Frontiers in digital health · 2024Article
- Interpretation of Change in Novel Digital Measures: A Statistical Review and Tutorial.Digital biomarkersReview
- Generative AI - Assisted Adaptive Cancer Therapy.Cancer control : journal of the Moffitt Cancer CenterReview
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 4 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: Assessment of reliability is one of the key components of the validation process designed to demonstrate that a novel clinical measure assessed by a digital health technology tool is fit-for-purpose in clinical research, care, and decision-making. Reliability assessment contributes to characterization of the signal-to-noise ratio and measurement error and is the first indicator of potential usefulness of the proposed clinical measure. Summary: Methodologies for reliability analyses are scattered across literature on validation of PROs, wet biomarkers, etc., yet are equally useful for digital clinical measures. We review a general modeling framework and statistical metrics typically used for reliability assessments as part of the clinical validation. We also present methods for the assessment of agreement and measurement error, alongside modified approaches for categorical measures. We illustrate the discussed techniques using physical activity data from a wearable device with an accelerometer sensor collected in clinical trial participants. Key Messages: This paper provides statisticians and data scientists, involved in development and validation of novel digital clinical measures, an overview of the statistical methodologies and analytical tools for reliability assessment.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.