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45 clinical trials using digital measures as primary or secondary endpoints were analyzed in a scoping review. The qualitative analysis of trial protocols identified a frequent disconnect between regulatory guidelines and research practice regarding the justification of meaningfulness to patients. The dataset supports the need for clearer guidelines and shared examples for developing meaningful digital health measures.
The 'last updated' date appears erroneous. The dataset is a document (DOCX) containing supplementary review material, not a typical structured dataset.