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This protocol defines the requirements to demonstrate that the PRO instruments which were designed as paper-based are equivalent to the nSpire Health ePRO (electronic patient reported outcome), following the ISPOR's ePRO Good Research Practices Task Force recommendations. All validation studies of the questionnaires were conducted using the original paper versions.
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Inclusion criteria
Exclusion criteria
• Unwilling to complete the 3 electronic PRO questionnaires or participate in an interview during completion of questionnaires
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Data sourced from clinicaltrials.gov
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