Date

2024-11-11

Protocol

Protocol changed

Item Changed

Target number/sample size

Previous Version

30

Next Version

100 FDA suggest increasing the sample size to 150 participants, including at least 50 participants from the United States. Accordingly, we propose increasing the Sri Lankan sample size to 100 participants to fulfill this requirement. When sample calculation formula used, we only needed a very small sample. However, as a rule of thumb in Bland-Altman analysis, a common approach is to use 30-50 subjects for a preliminary study if specific estimates are not available. Therefore, we initially decided to conduct the study for 30 subjects. To align with FDA requirement, we intend to increase the total number of subjects to 100 in Sri Lankan setting. Multicenter Study Design: The FDA recommends conducting the study in diverse settings of care. To meet this criterion, we propose expanding the study beyond De Soysa Hospital to multiple centers. Therefore, we propose to include Hemas Hospital Thalawathugoda and Kothalawala Defence University (KDU) as study sites. These sites will demonstrate different standards of care including government funded, partially funded and completely patient funded institutions into the equation. I will be supervising all three sites as the principal investigator. Dr. Dilshan Fernando (who is already an investigator) will be appointed to Hemas Hospitals and Dr. Chinthaka Banagala will be appointed to KDU as the site supervisor.