Stakeholder perspectives on minimum clinically important difference and noninferiority margin for hospital-free days to assess interventions

Hospital-free days (HFDs), or days alive and outside the hospital, is increasingly reported as a research outcome. This outcome is a patient-centered and pragmatic measure, but no consensus exists regarding how many HFDs represent a minimum clinically important difference (MCID), or the smallest change in an outcome that a patient considers meaningful. Similarly, there is uncertainty regarding the noninferiority margin (NIM), or maximal difference in HFDs obtained by 2 or more treatments that would lead stakeholders (patients, caregivers, and health care professionals) to view a treatment as no worse than another. We surveyed stakeholders on the MCID and NIM for HFDs to guide design of future superiority and noninferiority trials.

National Heart, Lung, and Blood Institute (NHLBI)
National Institute on Aging (NIA)