PMID- 33684508
OWN - NLM
STAT- MEDLINE
DCOM- 20211015
LR  - 20211015
IS  - 1878-5921 (Electronic)
IS  - 0895-4356 (Linking)
VI  - 136
DP  - 2021 Aug
TI  - Adverse event recording failed to reflect potential harms: a review of trial 
      protocols of behavioral, lifestyle and psychological therapy interventions.
PG  - 64-76
LID - S0895-4356(21)00074-3 [pii]
LID - 10.1016/j.jclinepi.2021.03.002 [doi]
AB  - 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.
CI  - Copyright (c) 2021. Published by Elsevier Inc.
FAU - Papaioannou, Diana
AU  - Papaioannou D
AD  - Sheffield Clinical Trials Research Unit, School of Health and Related Research, 
      University of Sheffield, Sheffield, United Kingdom. Electronic address: 
      d.papaioannou@sheffield.ac.uk.
FAU - Cooper, Cindy
AU  - Cooper C
AD  - Sheffield Clinical Trials Research Unit, School of Health and Related Research, 
      University of Sheffield, Sheffield, United Kingdom.
FAU - Mooney, Cara
AU  - Mooney C
AD  - Sheffield Clinical Trials Research Unit, School of Health and Related Research, 
      University of Sheffield, Sheffield, United Kingdom.
FAU - Glover, Rachel
AU  - Glover R
AD  - Sheffield Clinical Trials Research Unit, School of Health and Related Research, 
      University of Sheffield, Sheffield, United Kingdom.
FAU - Coates, Elizabeth
AU  - Coates E
AD  - Sheffield Clinical Trials Research Unit, School of Health and Related Research, 
      University of Sheffield, Sheffield, United Kingdom.
LA  - eng
PT  - Journal Article
DEP - 20210305
PL  - United States
TA  - J Clin Epidemiol
JT  - Journal of clinical epidemiology
JID - 8801383
SB  - IM
MH  - *Behavior Therapy
MH  - *Data Accuracy
MH  - *Drug-Related Side Effects and Adverse Reactions
MH  - Humans
MH  - *Life Style
MH  - Patient Harm/*statistics & numerical data
MH  - *Psychotherapeutic Processes
MH  - Randomized Controlled Trials as Topic/*statistics & numerical data
OTO - NOTNLM
OT  - Adverse events
OT  - Behavioral interventions
OT  - Harms
OT  - Psychological therapies
OT  - Public health
OT  - Randomized controlled trials
EDAT- 2021/03/09 06:00
MHDA- 2021/10/16 06:00
CRDT- 2021/03/08 20:11
PHST- 2020/10/21 00:00 [received]
PHST- 2021/02/07 00:00 [revised]
PHST- 2021/03/01 00:00 [accepted]
PHST- 2021/03/09 06:00 [pubmed]
PHST- 2021/10/16 06:00 [medline]
PHST- 2021/03/08 20:11 [entrez]
AID - S0895-4356(21)00074-3 [pii]
AID - 10.1016/j.jclinepi.2021.03.002 [doi]
PST - ppublish
SO  - J Clin Epidemiol. 2021 Aug;136:64-76. doi: 10.1016/j.jclinepi.2021.03.002. Epub 
      2021 Mar 5.