Using Noninferiority Tests to Evaluate Telemedicine and E-Health Services: Systematic Review

BACKGROUND: An increasing number of studies within the field of telemedicine and e-health are designed as noninferiority studies, aiming to show that the telemedicine/e-health solution is not inferior to the traditional way of treating patients. OBJECTIVE: The objective is to review and sum up the status of noninferiority studies within this field, describing advantages and pitfalls of this approach. METHODS: PubMed was searched according to defined criteria, and 16 relevant articles were identified from the period 2008-June 2011. RESULTS: Most of the studies were related to the fields of psychiatry and emergency medicine, and most were published in journals relating to these fields or in general scientific or general medicine journals. All the studies claimed to be noninferiority studies, but 7 out of 16 tested for statistical differences as a proxy of noninferiority. CONCLUSIONS: The methodological quality of the studies varied. We discuss optimal procedures for future noninferiority studies within the field of telemedicine and e-health and situations in which this approach is most appropriate.