Table 6 Amendments to the study protocol post pilot phase
Pilot study findings | Amendments to study protocol |
|---|---|
Female to male ratio slightly higher than 50:50 overall | If the proportion of females to males consistently exceeds 55:45 within the overall cohort, the study team may institute a 50:50 split for females: males in line with known BE prevalence, at the discretion of the Trial Statistician. |
Cytosponge™ appointment uptake < 50% | Patients will receive a total of one reminder in the form of a letter, phone call or text message. |
Time required for practice and patient recruitment might take longer for each practice than anticipated | Practices recruited in the latter stages of the trial may adopt a 6 month follow-up period to allow timely completion of study activities with a simulation tool used to ensure parity across the datasets. |