Statistical analysis plan for a cluster stepped-wedge randomized clinical trial assessing the effects of a multicomponent telemedicine-based intervention on quality of life in adults with respiratory failure requiring mechanical ventilation (Tele-Rehab MV Trial)

OBJECTIVE: To describe the analytical objectives and procedures of the Tele-Rehab MV Trial prior to database lock. METHODS: The Tele-Rehab MV Trial is a cluster stepped-wedge randomized clinical trial comparing a telemedicine-based quality improvement program focused on disability prevention and rehabilitation strategies with usual care. The intervention is implemented during the patient's intensive care unit stay, continued through ward admission, and extends up to 2 months post-hospital discharge. The trial targets adult patients with acute hypoxemic respiratory failure requiring invasive mechanical ventilation, in whom SARS-CoV-2 infection is part of the differential diagnosis. The protocol was approved by the Research Ethics Committee of the coordinating center and by the ethics committees of each of the 20 participating intensive care units, in accordance with Brazilian regulations. The primary outcome is health-related quality of life, assessed 90 days after hospital discharge using the EuroQol 5-Dimension 3-Level (EQ-5D-3L) scale. Secondary outcomes include 30-day rehospitalization, all-cause mortality, anxiety, depression, cognitive impairment, new disabilities in instrumental activities of daily living, and return to work or study 90 days after discharge. This report outlines the primary statistical procedures to be used for evaluating results and conducting sensitivity analyses. CONCLUSION: We anticipate that this reporting approach will minimize analysis bias and enhance the interpretation of the Tele-Rehab MV Trial results.