BACKGROUND: Accurate capture and reporting of adverse events (AEs) in clinical trials is critical to understanding the potential harms of prospective interventions. Current AE-reporting frameworks are specifically constructed for pharmacological interventions and adaptation of these frameworks imparts the risk of excluding AEs unique to non-pharmacological interventions that have not yet been defined. As a result, clinical trials of non-pharmacological interventions seldom include a systematic method to capturing and reporting AEs, often using no method at all. These gaps make it likely that AEs in trials of non-pharmacological interventions are underreported, providing insufficient information about the safety of such interventions prior to their implementation in clinical practice. In addition, clinical trials focus primarily on participants receiving the intervention, with current AE-reporting frameworks not designed to capture potential harms to other personnel involved (i.e. family/carers, and clinical and research staff). A series of collaborative group discussions with consumers and interdisciplinary clinical trialists, and case study analyses were conducted to explore gaps in the capture and reporting of AEs specific to non-pharmacological trials, and their mitigation. MAIN BODY: Two case examples are provided. The first case example highlights that current methods are inadequate, resulting in inconsistencies in capturing AEs, influenced by the environmental context of the clinical trial. The second case example highlights the need for both systematic and simplified AE-reporting frameworks, particularly for clinical trials conducted in medically complex populations where participants may be at high risk of experiencing AEs. We recommend future trials of non-pharmacological interventions adopt a four-step framework that incorporates: (1) enhanced trial protocol development to define the participant, environmental context in which the intervention is taking place and identify other personnel involved
(2) pre-specify anticipated AEs in trial protocol
(3) selection of the most appropriate measurement system to define, report and grade AEs
and (4) develop corrective and preventative action plans. CONCLUSION: We provide recommendations for an AE-reporting framework for future trials that encompass risks unique to non-pharmacological interventions and all individuals involved. By focusing on these directions, we can streamline the process of capturing and reporting AEs and contribute to more impactful and sustainable outcomes.