Review: Adverse event monitoring and reporting in studies of pediatric psychosocial interventions: a systematic review.

BACKGROUND: Adverse event monitoring in studies of psychotherapy is crucial to clinical decision-making, particularly for weighing of benefits and harms of treatment approaches. In this systematic review, we identified how adverse events are defined, measured, and reported in studies of psychosocial interventions for children with mental disorders. METHOD: Medline, PsycINFO, Embase, ProQuest Dissertations and Theses Global, and the Cochrane Library were searched from January 2011-January 2023, and Google Scholar from January 2011-February 2023. English language experimental and quasi-experimental studies that evaluated the efficacy or effectiveness of psychosocial interventions for childhood mental disorders were included. Information on the definition, assessment, and report of adverse events was extracted using a checklist based on Good Clinical Practice guidelines. RESULTS: In this review, 117 studies were included. Studies most commonly involved treating anxiety disorders or obsessive-compulsive disorder (32/117; 27%); 44% of the experimental interventions tested (52/117) were cognitive behavioral therapies. Adverse events were monitored in 36 studies (36/117; 31%) with a protocol used in 19 of these studies to guide monitoring (19/36; 53%). Twenty-seven different events were monitored across the studies with hospitalization the most frequently monitored (3/36; 8%). Event severity was fully assessed in 6 studies (17%) and partially assessed in 12 studies (33%). Only 4/36 studies (11%) included assessing events for cause. CONCLUSIONS: To date, adverse events have been inconsistently defined, measured and reported in psychosocial intervention studies of childhood mental health disorders. Information on adverse events is an essential knowledge component for understanding the potential impacts and risks of therapeutic interventions.

Adverse event monitoring and reporting in pediatric neuromodulatory studies: A systematic review.

Neuromodulatory interventions are relatively novel and approaches to studying harms and tolerability have varied. Using a checklist based on guidelines from Good Clinical Practice and the Harms Extension of the CONSORT (Consolidated Standards of Reporting Trials) Statement, we identified how adverse events are measured, assessed, and reported in studies evaluating neuromodulation for the treatment of mental and neurodevelopmental disorders among children and adolescents. A systematic literature review identified 56 experimental and quasi-experimental studies evaluating transcranial magnetic stimulation (TMS), transcranial alternating (tACS) or direct (tDCS) current stimulation, transcranial pulse stimulation (TPS), and vagus or trigeminal nerve stimulation (VNS or TNS). For 22 studies (39%), the types of adverse events to be monitored were identified, and for 31 studies (55%), methods for collecting adverse event data were described. Methods for assessing adverse events were less commonly described with 23 studies (41%) having details on assessing event severity, and 11 studies (20%) having details on assessing event causality. Among 31 studies with reported results, headache, skin irritation, and general pain or discomfort were the most reported across studies. Seizure, untoward medical occurrences, and intracranial bleeding, edema, or other intracranial pathology were considered serious events, but these events were not reported as occurring in any results-based papers. Taken together, the findings from this review indicate that most studies of pediatric neuromodulatory interventions did not include descriptions of adverse event monitoring and evaluation. Comprehensive event monitoring and reporting across studies can significantly augment the current knowledge base.

Ambiguity Tolerance and Prospective Specialty Choice Among Third-Year Medical Students.

INTRODUCTION: Poor tolerance of ambiguity is consequential in clinical practice, and has been linked to avoidance of family medicine, in which there is inherently more ambiguity. This study aimed to investigate the relationship between tolerance of ambiguity and prospective specialty choice of medical students in their third year of medical school. This stage of medical training is of particular importance as students develop clinical reasoning skills and encounter clinical ambiguity. METHODS: This was a cross-sectional study using an online survey. Sixty-one third-year medical students (62% response rate) from a large Canadian university completed the survey with a validated measure of ambiguity tolerance (the 29-item Tolerance of Ambiguity in Medical Students and Doctors scale) and their top three specialty choices. Specialty choices were subsequently grouped into two categories: family medicine (FM) and non-family medicine (non-FM) specialties. RESULTS: There was no significant mean difference in tolerance of ambiguity between students who reported interest in FM and students interested in non-FM specialties. Similarly, we observed no significant difference in tolerance of ambiguity between female and male students. Older students reported higher levels of ambiguity tolerance. Older students were also more likely to report FM as one of their top three specialty choices. CONCLUSION: Qualitative studies are needed to explore possible reasons for the observed results, including the effects of digital information resources and clinical decision-making tools on medical students' ambiguity tolerance. Medical educators should be aware that some students may require explicit training in how to respond to ambiguity.