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

Area of Science:

• Rheumatology
• Digital Health
• Clinical Research Methodology

Background:

• Systemic Lupus Erythematosus (SLE) outcome measures are complex.
• Clinicians and researchers question the accuracy of virtual disease activity assessments.
• The COVID-19 pandemic accelerated the need for reliable telemedicine (TM) in SLE management.

Purpose of the Study:

• To evaluate the agreement between virtual SLE outcome measures and face-to-face (F2F) encounters.
• To establish the reliability of TM for assessing SLE disease activity.
• To provide data supporting the use of TM in clinical trials and patient care.

Main Methods:

• An observational, longitudinal study involving 200 SLE patients across four academic centers.
• Patients undergo simultaneous TM and F2F evaluations by the same physician.
• Virtual physical examination guidelines were developed; disease activity measures compared using Bland-Altman analysis.

Main Results:

• Interim analysis of the first 50 patients' data is planned.
• The study design focuses on quantifying agreement between TM and F2F assessments.
• Full results will be available after analyzing data from 200 patients.

Conclusions:

• Establishing high agreement between TM and F2F SLE measures is crucial.
• Validated TM measures can improve disease activity assessment when F2F visits are not feasible.
• This research aims to guide medical decisions and enhance reliability in clinical research outcome measures.