Lupus & antiphospholipid syndrome

Protocol for virtual physical examination in an observational, longitudinal study evaluating virtual outcome measures in SLE

Lupus Sci MedPublished Study protocol for an observational, longitudinal study

Study context

Population
Patients with SLE with varying levels of disease activity from 4 academic lupus centres serving diverse populationsplanned
Participants
200 patients
Planned comparison
Videoconference-based telemedicine (TM) vs face-to-face (F2F) encounter for SLE disease activity measures
Primary endpoint
Agreement between TM and F2F SLE disease activity measures (Bland-Altman method)
Methodological detailsmulticentre, prespecified interim analysis, Each participant evaluated at a baseline and a follow-up visit, first via TM then F2F by the same physician, Interim analysis planned after enrolment of the first 50 participants
  • Multicentre
  • Prespecified interim analysis
  • Each participant evaluated at a baseline and a follow-up visit, first via TM then F2F by the same physician
  • Interim analysis planned after enrolment of the first 50 participants

No results yet. This paper sets out the design of a trial; its results are to come.

Original publication

Protocol for virtual physical examination in an observational, longitudinal study evaluating virtual outcome measures in SLE. Lupus Sci Med. Published 10 July 2023. doi:10.1136/lupus-2023-000952

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