Accepted for/Published in: JMIR Research Protocols
Date Submitted: Mar 9, 2023
Date Accepted: Sep 12, 2023
Methods for Clinical Validation of Digital Endpoints: A Scoping Review Protocol
ABSTRACT
Background:
Digital endpoints are clinical outcome measures captured by a certain technology or sensor, during activities of daily living. They enable traditional outcome measures to be assessed in a more precise and accurate way and to have new outcome measures that were not previously possible to assess. Their use in clinical care and research needs regulatory approval, following the demonstration of their validity. However, no guidelines specifically addressing methodologies for validating digital endpoints are available.
Objective:
The objective of this scoping review is to develop a comprehensive synthesis of the methods used in the validation of digital endpoints. This synthesis should support researchers in understanding the different possibilities at their disposal, when considering validating digital endpoints to support clinical research.
Methods:
We will search the electronic literature databases MEDLINE (via PubMed), SCOPUS, and ACM Digital Library. Search will use a range of combinations of free text words, indexed terms, search queries and search term alternatives related to digital clinical endpoints for use in clinical practice and/or clinical trials, and validation studies and methodologies. Boolean operators adapted to each database will be used. Inclusion criteria: Scientific methodologies that have been employed or proposed to validate digital endpoints related with clinically relevant outcomes, described in studies of any study design, as well as letters, guidelines, book chapters, editorials, commentaries. Additional information will be retrieved with desk research using online sources such as websites, blogs, opinion studies and other relevant sources; there will be no date and language restrictions.
Results:
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Conclusions:
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Citation
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Copyright
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