Hypothesis
Reminders pushed from a connected pill cap to a smart-device application would improve medication adherence in people aged 65 and over with rheumatoid arthritis.
What failed
The nested subproject could not answer its research question at all. The sample size rested on over-optimistic estimates of how many older patients owned a smart device; smartcap availability and data extraction caused logistic problems; randomization and treatment allocation errors occurred despite staff training; and hardware failures left the intervention group’s data of low quality, discovered too late because data were read in batches.
Broken assumption
An adherence sub-study can be bolted onto a running trial without its own feasibility test.
Why
The authors attribute the failure to those four causes together and recommend keeping nested subprojects simple, field-testing before the study starts and monitoring data from the beginning.
From the published paper: Hartman et al. Journal of Trial and Error, 2021. ↗CC BY