Articlehybrid2021

Adverse event recording failed to reflect potential harms: a review of trial protocols of behavioral, lifestyle and psychological therapy interventions

Diana E. Papaioannou · Cindy L. Cooper · Cara Mooney · Rachel Glover · Elizabeth J. Coates

60 citations0/0 files storedJournal of Clinical Epidemiology

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Meta-analysis and systematic reviews Pharmacovigilance and Adverse Drug Reactions Statistical Methods in Clinical Trials

Abstract

OBJECTIVE: To explore how potential harms are assessed in trials of behavioral, lifestyle and psychological therapy interventions. STUDY DESIGN AND SETTING: This study was a review of protocols from the National Institute of Health Research Health Technology Assessment and Public Health Research programmes. Protocols were included if the study was a randomized controlled trial and the intervention intended to change lifestyle or behavior to improve health or improve psychological outcomes. RESULTS: 95 of 151 protocols planned to record adverse events (AEs). Definitions of AEs were often not given and varied widely. Serious AEs were mostly defined using standards originally devised for pharmacological trials. Twenty-two protocols listed expected AEs. Few protocols described assessment of causation between AEs and intervention. Examples of useful AE recording practice were identified. CONCLUSION: Monitoring and recording AEs in behavioral intervention trials was variable and frequently based on reporting guidelines for pharmacological trials. This may mean potential harms are being missed. Future trials should consider: 1) Potential harms posed by the intervention 2) How to define serious AEs 3) What are expected AEs. Further research to achieve consensus on AE recording is required, including identification of core adverse outcomes in clinical areas or caused by interventions.

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References

2004Better Reporting of Harms in Randomized Trials: An Extension of the CONSORT Statement 2012How to Define, Find and Classify Side Effects in Psychotherapy: From Unwanted Events to Adverse Treatment Reactions 2018CONSORT-SPI 2018 Explanation and Elaboration: guidance for reporting social and psychological intervention trials 2014‘Dark logic’: theorising the harmful consequences of public health interventions 2018Reporting randomised trials of social and psychological interventions: the CONSORT-SPI 2018 Extension 2014Reporting of harms in randomized controlled trials of psychological interventions for mental and behavioral disorders: A review of current practice 2014The recording of adverse events from psychological treatments in clinical trials: evidence from a review of NIHR-funded trials

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