Kalee Lodewyk, Master of Science candidate, at the University of Alberta, delivers a video abstract on her CAMH journal paper ‘Review: Adverse event monitoring and reporting in studies of pediatric psychosocial interventions: a systematic review’.
Authors: Kalee Lodewyk, Alexa Bagnell, Darren B. Courtney, Amanda S. Newton
First published: 18 July 2023
Open Access paper: doi.org/10.1111/camh.12661
Over the past few years, I’ve been looking into adverse event monitoring and reporting in trials of pediatric psychiatry interventions. I completed my undergraduate degree (Bachelor of Science Honours in Physiology) at the University of Alberta, Canada in 2023. I am currently a Master of Science candidate at the University of Alberta, Canada, in the Department of Psychiatry.
Other resources
- Featured paper ‘Review: Adverse event monitoring and reporting in studies of pediatric psychosocial interventions: a systematic review’, (2023). Kalee Lodewyk, Alexa Bagnell, Darren B. Courtney, Amanda S. Newton
Transcript
Kalee Lodewyk: My name is Kalee Lodewyk, and with my research group, I’ve been looking into adverse event monitoring and reporting in paediatric psychiatry interventions. This is a video abstract for our most recent paper that was published in Child and Adolescent Mental Health. In this systematic review, we focused on adverse event monitoring and reporting in studies of psychosocial interventions for paediatric psychiatric disorders.
And I’d just like to begin with defining an ‘adverse event’. So, an adverse event is any unfavourable outcome that is not necessarily caused by the intervention. Adverse event monitoring is standard practice in trials of psychopharmacology. On the other hand, although unwanted or negative impacts can occur with psychosocial interventions, adverse event monitoring is not a requirement for psychotherapy trials. However, if an adverse event is reported, Investigators may be obligated to report it, depending on the severity of the event.
So, why should adverse events be monitored in psychotherapy trials? To expose impacts that may otherwise remain hidden and to allow for informed clinical decision-making. Our aim for this study was to assess how adverse events were defined, measured and reported in recent clinical studies investigating the efficacy and effectiveness of psychosocial interventions for childhood mental disorders. When we looked at adverse event measurement, we were specifically looking at severity and attribution.
So, I’ll just provide a brief overview of the inclusion criteria for this review. We included studies that were experimental and quasi-experimental, and studies that evaluated psychosocial intervention, efficacy and effectiveness. Studies in this review also had to be delivered by a registered healthcare provider in a healthcare setting. Participants in included studies were diagnosed with a disorder of interest and these participants were between five and 19-years-of-age.
We searched for both published and unpublished studies, since we were interested in including trial registrations and trial protocols, in addition to published study results. Our databases included: Medline, PsycINFO, Embase, ProQuest Dissertations and Theses Global, Google Scholar and Cochrane Library. We searched for studies made available between 2011 and 2023 and studies that were written in the English language.
Studies were then uploaded into Covidence and reviewed by two reviewers, including abstract and full text screening. We extracted data on the psychosocial intervention, the clinical population characteristics, as well as adverse event monitoring and reporting details, including adverse event definition, type, methods for adverse event data collection and assessment, and adverse event reporting practices.
To effectively assess adverse event practices used by the study authors, we used this checklist, which was based on good clinical practice guidelines. Here is our PRISMA flow diagram, which summarises the screening process. We ended up with 117 studies being included in this systematic review. 19 of these were completed studies with an accompanying protocol. 79 were completed studies. The remaining 19 were protocols and trial registration, without completed study results.
This table is a really brief overview of study characteristics of the included studies in this review. The most common targeted clinical condition among the included studies was anxiety and OCD, 32 studies or 27%, and second was mood disorders, 22 studies or 19%. The most common experimental treatment was cognitive behavioural therapy, which was the psychosocial intervention being evaluated by 52 out of the 117 included studies, or 44% of our included studies. Interventions were delivered in outpatient settings for around a quarter of included studies and in community-based settings for another quarter of included studies.
So, now I’ll move onto the adverse event monitoring and reporting results. I filled in certain boxes of results, like the ones on this slide here, to show key findings from this study. 33 of the included studies, or 31% of included studies, monitored for adverse events. Only 19 studies included or reported an adverse event monitoring protocol.
In this review, there were five studies that had a protocol in addition to published study results. We compared adverse event protocol plans versus what was actually conducted in the published study, and we found differences in all five of these studies. Studies were stratified based on targeted clinical condition, and we found that adverse event monitoring was more common among studies on eating disorders, psychosis and PTSD, although these categories of studies were much smaller in number than others.
Studies on anxiety, OCD and depression were most common among included studies and approximately one third of these studies monitored for adverse events. Six studies in this review measured adverse event severity using a tool. Four studies in this review measured adverse event attribution. A total of 27 different adverse events were reported and/or monitored in the studies included in this review. Adverse events were reported by the following individuals. A self-report in five studies, parent report in two studies, child and parent in one study and Clinician and child in one study. Two studies in this review reported communication with Data Safety Monitoring Boards in regards to adverse events.
The table on the right of the slide shows a list of all adverse events that were monitored and/or reported in the studies in this review. The table on this slide shows all serious adverse events that were reported and/or monitored in the studies in this review. Interestingly, only serious adverse events were monitored and/or reported in studies on PTSD and psychosis.
In conclusion, few studies reported monitoring for adverse events and even fewer studies reported a comprehensive adverse event evaluation approach, including assessing for adverse event severity and attribution. Understanding treatment benefits, but failing to understand the negative effects associated with these treatments, results in an incomplete intervention profile. A comprehensive approach to monitoring and reporting adverse events in psychosocial treatment studies is needed to understand the potential benefits and risks of psychosocial interventions, so that Clinicians and families can make informed decisions about treatment.
