Adverse effects (AEs) are untoward medical events that are thought to be causally related to clinical interventions [1], [2]. These events can range from mild, such as headaches and mild nausea, to serious, such as hospitalization or even death. Identifying and monitoring adverse effects are critical for ensuring the safety of patients participating in clinical trials, and help researchers track and mitigate any harms that arise during the course of a study. Research sponsors (e.g., National

Conclusions

There is currently a knowledge gap regarding the role of adverse effects in the field of implementation science. Our work attempts to fill this gap by identifying an object of study (i.e., IAEs) as well as potential mechanisms driving patient harms. In this paper, we identify four types of patient-level adverse effects in implementation trials to clarify the mechanisms linking implementation strategies and patient harms. We propose a new definition that links implementation strategies to

Ethics approval and consent to participate

Not applicable

Projects

Currently no objects available

Currently no objects available