Weight loss treatment in obese adults - Reply

摘要

As Dr Gadde correctly notes, we stated in our Commentary that 58 participants in the trial1 were nonadherent to the treatment protocol for various reasons. In the trial, 48 participants dropped out, of whom 41 returned for the final visit. Therefore, 7 were lost to follow-up.The authors identified an additional 10 participants who discontinued use of the blinded study drug but remained in the study as "study completers." They only counted the 48 patients as dropouts in calculating the study completion rate of 96.9%. The 96.9% therefore included the 10 participants who discontinued taking the study drug yet completed study visits to the end of the trial.We considered those 10 patients to be nonadherent to the study protocol and therefore not truly study completers; hence, 48 dropouts plus 10 who discontinued study drug is 58 nonadherent participants.Although we fully recognize that those who complete a study despite not adhering to the prescribed treatment can be called study completers under an intent-to-treat analysis, we stand by our assertion that those 10 patients should not be counted in the study completion rate because they discontinued the use of the study drug and were nonadherent to the protocol.