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Conceptualizing patient-level adverse effects in implementation trials.

Charles W Goss¹, Lindsey M Filiatreau², Lisa R Hirschhorn³

¹Institute for Informatics, Data Science, and Biostatistics, Washington University School of Medicine, St. Louis, MO, USA.

Annals of Epidemiology

|December 28, 2024

Summary

This summary is machine-generated.

This study introduces a new framework for identifying adverse effects (AEs) in implementation science trials. It proposes four types of AEs and a definition for Implementation strategy Adverse Effects (IAEs) to improve patient safety.

Keywords:

adverse effects clinical trials implementation strategies implementation trials patient safety unintended consequences

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Area of Science:

Implementation Science
Clinical Trials
Patient Safety

Background:

Patient safety in clinical trials relies on identifying and monitoring adverse effects (AEs).
Existing policies guide researchers, but adaptation for implementation science trials is unclear.
A conceptual model is developed to trace pathways from implementation strategies to AEs.

Purpose of the Study:

To propose a definition and classification of adverse effects specific to implementation science trials.
To provide recommendations for monitoring and oversight of these effects.
To enhance patient safety in implementation research.

Main Methods:

Characterized four types of adverse effects in implementation trials: proper use, misuse, disuse, and nonuse of evidence-based interventions (EBIs).
Proposed an extended definition of adverse effects, termed Implementation strategy Adverse Effects (IAEs).
Recommended collaborative efforts among stakeholders for identifying, monitoring, and reporting IAEs.

Main Results:

A conceptual model identifies four types of AEs in implementation trials.
The model clarifies mechanisms linking implementation strategies to EBI use patterns and patient harms.
A new definition for IAEs is proposed, linking implementation strategies to AEs.

Conclusions:

The proposed definition and classification of IAEs guide the conceptualization, monitoring, and oversight of potential harms in implementation trials.
This work advances the understanding of adverse effects in implementation research.
Lays groundwork for future research on other types of adverse effects, such as provider harms.