Abstract
Methods We explored mechanism behind the reminder responses in two pragmatic RCTs the TATE and STarT Back trials by utilizing the fact that data that are recovered through reminders would otherwise have been missing. The present approach considered two data scenarios: (i) with the actual dataset and (ii) with a modified dataset, where outcome responses obtained after a certain number of reminders were treated as missing. The impact of the reminder responses was assessed by comparing the estimates from MAR-based analyses between the two data scenarios.
Highlights
Missing data represent a potential source of bias in randomized clinical trials (RCTs)
We explored mechanism behind the reminder responses in two pragmatic RCTs - the TATE and STarT Back trials - by utilizing the fact that data that are recovered through reminders would otherwise have been missing
In the TATE trial, the reminder approach showed that an missing at random (MAR)-based analysis was likely to yield biased estimates of treatment effect
Summary
Missing data represent a potential source of bias in randomized clinical trials (RCTs). Results deviate, MAR-based estimates are likely to be biased, and analyses incorporating a range of plausible MNAR assumptions are advisable at least as sensitivity tests for the evaluation of treatment effect
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