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

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References

2004Better Reporting of Harms in Randomized Trials: An Extension of the CONSORT Statement1,588 cited
2012How to Define, Find and Classify Side Effects in Psychotherapy: From Unwanted Events to Adverse Treatment Reactions395 cited
2018CONSORT-SPI 2018 Explanation and Elaboration: guidance for reporting social and psychological intervention trials348 cited
2014‘Dark logic’: theorising the harmful consequences of public health interventions347 cited
2018Reporting randomised trials of social and psychological interventions: the CONSORT-SPI 2018 Extension329 cited
2014Reporting of harms in randomized controlled trials of psychological interventions for mental and behavioral disorders: A review of current practice174 cited
2014The recording of adverse events from psychological treatments in clinical trials: evidence from a review of NIHR-funded trials165 cited

Cited by

2022Identifying and Categorizing Adverse Events in Trials of Digital Mental Health Interventions: Narrative Scoping Review of Trials in the International Standard Randomized Controlled Trial Number Registry33 cited
2024Adverse Events Reporting in Digital Interventions Evaluations for Psychosis: A Systematic Literature Search and Individual Level Content Analysis of Adverse Event Reports26 cited
2023Review: Adverse event monitoring and reporting in studies of pediatric psychosocial interventions: a systematic review18 cited
2024Measurement of Adverse Events in Studies of Digital Health Interventions for Psychosis: Guidance and Recommendations Based on a Literature Search and Framework Analysis of Standard Operating Procedures15 cited

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2024Developing a process for assessing the safety of a digital mental health intervention and gaining regulatory approval: a case study and academic’s guide13 cited

2023Conducting separate reviews of benefits and harms could improve systematic reviews and meta-analyses11 cited

2024Bridging the gap from medical to psychological safety assessment: consensus study in a digital mental health context10 cited

2024Recommendations on recording harms in randomised controlled trials of behaviour change interventions10 cited

2024Recording harms in randomized controlled trials of behavior change interventions: a scoping review and map of the evidence9 cited