Adverse Event Monitoring and Reporting in Studies of Pediatric Psychosocial Interventions

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In this Papers Podcast, Kalee Lodewyk discusses her CAMH journal paper ‘Adverse event monitoring and reporting in studies of pediatric psychosocial interventions: a systematic review’ ( Kalee is the lead author of the paper.

There is an overview of the paper, methodology, key findings, and implications for practice.

Discussion points include:

  • The original research questions and aims of the systematic review.
  • The challenges of the review, including the lack of standardisation around adverse event terminology.
  • Insight into surprising findings from the review.
  • The implications of the review from a research perspective, and for practitioners and clinicians.

In this series, we speak to authors of papers published in one of ACAMH’s three journals. These are The Journal of Child Psychology and Psychiatry (JCPP)The Child and Adolescent Mental Health (CAMH) journal; and JCPP Advances.

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Kalee Lodewyk
Kalee Lodewyk

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.


[00:00:01.380] Mark Tebbs: Hello, welcome to the Papers Podcast series for the Association for Child and Adolescent Mental Health, or ACAMH for short. I’m Mark Tebbs, and I’m a Freelance Consultant. In this series, we speak to authors of papers published in one of ACAMH’s three journals. These are the Journal of Child Psychology and Psychiatry, commonly known as JCPP, the Child and Adolescent Mental Health, known as CAMH, and JCPP Advances. If you’re a fan of one of our Papers Podcast series, please subscribe on your preferred streaming platform, let us know how we did, with a rating or review, and do share with friends and colleagues.

I’m delighted to be interviewing Kalee Lodewyk. Kalee is a lead author of a paper entitled, “Adverse Event Monitoring and Reporting in Studies of Pediatric Psychosocial Interventions: a Systematic Review,” recently published in Child and Adolescent Mental Health. Kalee, thank you for joining me.

[00:00:57.740] Kalee Lodewyk: Thanks for having me, Mark, I’m really excited to be here today.

[00:01:00.149] Mark Tebbs: Good stuff. So, let’s start with some introduction, if you could just introduce yourself and maybe introduce the people you worked with on the paper?

[00:01:08.470] Kalee Lodewyk: Yeah, so as you said, my name’s Kalee. I recently completed a Bachelor of Science degree, Honours in Physiology, at the University of Alberta, Canada, where I wrote an Honours thesis doing in vivo neuroscience work with mice, which was definitely an interesting experience. And also, during my undergrad degree, I did a bunch of different clinical research projects, including some qualitative and then quantitative stuff, as well as some systematic reviews, one of which I’ll be talking about today. And currently I’m a Master’s of Science student in the Department of Psychiatry, at the University of Alberta, in Canada. And my co-authors on the paper are Dr. Alexa Bagnell, Dr. Darren Courtney and Dr. Amanda Newton.

[00:01:48.439] Mark Tebbs: Thank you. So, can we start with the paper, then? Could you just give us a little bit of a overview of what the paper says?

[00:01:54.540] Kalee Lodewyk: Absolutely. So, the paper focuses on adverse event reporting. And harm reporting among psychosocial intervention studies is really important, so we conducted a systematic review to investigate “Adverse Event Definition, Reporting and Measurement in Pediatric Psychosocial Intervention Studies.” And a key finding is that almost 70% of the 117 included studies didn’t monitor for adverse events. And in the studies that did report monitoring, few assessed adverse event severity or attribution.

And studies that did monitor for adverse events had many different approaches to monitoring, demonstrating a lack of standardisation in monitoring. And so our findings show that report of adverse event monitoring in current paediatric psychosocial intervention studies varies, and without this report, there may be information on risks associated with psychosocial interventions that we are unaware of.

[00:02:45.570] Mark Tebbs: Thanks for the overview. I’d like to take us back to the beginning really, so what were the original research questions that you had at the start? What were the original aims for your paper?

[00:02:55.140] Kalee Lodewyk: Our research question was, “How are adverse events defined, measured and reported in contemporary clinical studies, investigating the efficacy and effectiveness of psychosocial interventions for childhood mental disorders.” And then we ha – kind, of had a handful of aims, which I can also go over. We wanted to understand how common adverse event monitoring was among studies on psychosocial interventions for children and adolescents. And we also wanted to assess the extent of event monitoring protocols that Researchers used to understand how comprehensive their approach was, and we used guidelines from good clinical practice to assess the methods used.

[00:03:30.989] Mark Tebbs: Okay, and you just started to talk about the methodology, so were there any particular methodological challenges? Could you just give us a run-through of how you conducted the study?

[00:03:41.610] Kalee Lodewyk: So, yeah, just a brief overview of the methods for the study. So, it was a systematic review, and we had some inclusion criteria, that I’ll briefly go over. So, we were interested in including experimental and quasi-experimental studies, that were aimed at assessing psychosocial intervention efficacy and effectiveness. And studies in this review were delivered by registered healthcare provider in a healthcare setting, because we were interested in clinical studies on these interventions. Participants of the studies had to be diagnosed with a disorder of interest, and their age ranged between five and 19 years.

So, we searched for both published and unpublished studies, because we wanted to include trial registrations and trial protocols, as well as published trial results. And we searched in Medline, PsycInfo, Embase, ProQuest Dissertations and Theses Global, Google Scholar and Cochrane Library. And we looked for studies that were made available between 2011 and 2023, and studies that were written in the English language.

We then loaded the studies into Covidence, and all the studies were screened, at both the abstract and full text stage by two reviewers. And then we extracted data on the psychosocial intervention, on the clinical population characteristics, and on adverse event monitoring in reporting details.

[00:04:54.480] Mark Tebbs: Were there any particular challenges that you came across?

[00:04:57.770] Kalee Lodewyk: Yeah, so I think that one main challenge in this review was the lack of clarity around adverse event terminology in the studies. Folks tended to include a variety of different information and some studies even used the term “side effects” to refer to adverse events, which just speaks towards a lack of standardisation surrounding adverse event terminology. And I think that’s something in the future that’s important for everyone to be on the same page about.

And another methodological challenge, I guess, was that we wanted to evaluate studies that were based in clinical settings, so just to get the best understanding of harms that we could, in the clinical setting. So, we wanted to only include studies that were delivered by registered healthcare practitioners in a healthcare setting. And we had, kind of, assumed that in a lot of studies these details would be included, but actually, what we found was that a lot of studies didn’t include the setting and deliverer of the interventions. So, we actually had to contact quite a few authors, in order to clarify these details, and determine which studies were in and out of the review.

Studies that we would have excluded would be, for example, school-based studies, or studies where the intervention was delivered by a trainee, such as a Provisional Psychologist, or a Master’s student. And we contacted all these authors, and unfortunately, some didn’t end up responding, after multiple attempted contacts. So, we had to ultimately exclude these studies from the review, which was pretty unfortunate.

[00:06:17.900] Mark Tebbs: And so, what did you find? What were the, kind of, key findings? Were there any things that particularly surprised you?

[00:06:24.250] Kalee Lodewyk: Yeah, so I guess I’ll just go over the key findings first. So, I think the most important – one of the most important findings in the study, was that around 30% of studies monitored for adverse events, and of these studies only 19 included or reported an adverse event monitoring protocol. And then, for adverse event measurement, which was something that we looked at, as well, only six of the included studies assessed adverse event severity, and four assessed adverse event attribution.

So, studies also monitored and/or recorded a total of 27 different adverse events, which were mostly physical and cognitive or mental health related events. And hospitalisation was the most commonly monitored adverse event and serious adverse event. So, I guess, in conclusion, there weren’t that many studies that reported monitoring for adverse events, and, also, few studies took a comprehensive evaluation approach, including assessing for adverse event severity and attribution.

[00:07:22.330] Mark Tebbs: Did that result surprise you?

[00:07:24.259] Kalee Lodewyk: Not necessarily. Because I think that although, like, harm reporting is common practice in pharmacology trials in psychiatry, it’s not a requirement for psychotherapy trials. So, people aren’t necessarily required to include adverse event monitoring in their studies. I don’t think that this amount of studies monitoring was necessarily surprising, but I did pick out findings that I personally found interesting. So, serious adverse events were reported and monitored in only studies treating post-traumatic stress disorder and psychosis. Which was really interesting, they didn’t monitor for adverse events, only for serious adverse events.

So, another interesting finding was that adverse event monitoring was higher in frequency among certain types of studies, including eating disorder, psychosis, and PTSD. Although these studies were fewer in numbers, so fewer included studies actually were focused on treating these conditions. And, on the other hand, anxiety, OCD and depression, about a third of these studies monitored for adverse events, although they made up the majority of the included studies.

[00:08:31.740] Mark Tebbs: So, I’m just wondering what the implications are of the study?

[00:08:36.030] Kalee Lodewyk: So, the implications of this study, from a research perspective, I think the most important one being that, in the future, Researchers should aim to include comprehensive adverse event monitoring protocols when they’re thinking about designing trials. And it’s also important that they report adverse event monitoring methods in study related papers, just for transparency. So, if Researchers do aim to implement adverse event monitoring into their studies, this monitoring and reporting will allow in the future for meta-analyses, to gain a more comprehensive understanding of the harms that are related to paediatric psychosocial interventions.

So, this work is an important first step towards the development of Consensus-Based Reporting Checklist, which is something that, from a research perspective, is also important. And findings from the study could potentially contribute to the creation of such a Checklist.

[00:09:28.760] Mark Tebbs: Yeah, really, really important. And I’m wondering whether there are any messages from the study, from a Practitioner, or a, kind of, Clinician perspective?

[00:09:37.080] Kalee Lodewyk: I think when it comes to Practitioners and Clinicians, the study is important because really what we’re aiming to do is draw more attention to harms that are associated with psychosocial interventions. And it’s really important when Clinicians are making decisions with families about treatment that both the Clinician and the family are aware of both the benefits and potential harms of treatment, so that they can make informed decisions. Especially when it comes to treating children and adolescents, since they can’t necessarily make that decision for themselves, and there’s a lot of people involved, and I think it’s definitely a important decision-making process.

[00:10:14.250] Mark Tebbs: Yeah, no, I agree. The paper concludes with a “call to action,” could you explain this to us?

[00:10:21.460] Kalee Lodewyk: Yeah, so the “call to action” referred to in the paper is just kind of requesting and putting it out there that Clinicians and Researchers in the future should prioritise the inclusion of adverse event monitoring and reporting protocols in their studies, and that Clinicians consider harms when recommending treatment options to patients.

[00:10:39.600] Mark Tebbs: Yeah, thank you. So, are you planning any follow-up research? Is there anything in the pipeline that you’d be able to share with us?

[00:10:47.339] Kalee Lodewyk: So, we are working on a series of systematic reviews, with the same, kind of, aim, looking at adverse event monitoring and reporting, and measurement in different types of paediatric psychiatry interventions. So this paper was on psychosocial interventions, but we’re also looking at neuromodulation, so transcranial magnetic stimulation and vagus nerve stimulation, for example. And nutraceutical intervention, so this would include, like, omega 3 supplementation or vitamin D supplementation. And finally, we’re working on a pharmaceutical review as well.

[00:11:21.149] Mark Tebbs: Great stuff. So, we’re coming to the end of the podcast. So, I wonder whether there’s any final take home messages for our listeners?

[00:11:28.649] Kalee Lodewyk: I think I’ll just summarise it in a quick statement. So, comprehensive adverse event monitoring and reporting needs to be a priority in clinical studies of psychosocial intervention effects, so that patients and their families can make evidence-based decisions, centred around the harms and benefits of these interventions.

[00:11:45.130] Mark Tebbs: Thank you so much for your time and for a really interesting podcast. For more details on Kalee, please visit ACAMH website at, and Twitter @acamh. ACAMH is spelt A-C-A-M-H, and don’t forget to follow us on your preferred streaming platform, and let us know if you enjoy the podcast, with a rating or review, and do share with friends and colleagues.

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