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Reporting of harms in randomized controlled trials of psychological interventions for mental and behavioral disorders: A review of current practice
Swedish Council on Health Technology Assessment; Karolinska Institutet.
Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Social Sciences, Department of Psychology.
Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Social Sciences, Department of Psychology.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, National Center for Disaster Psychiatry. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Neuroscience, Psychiatry, Ulleråker, University Hospital.ORCID iD: 0000-0002-1317-2093
2014 (English)In: Contemporary Clinical Trials, ISSN 1551-7144, E-ISSN 1559-2030, Vol. 38, no 1, 1-8 p.Article, review/survey (Refereed) Published
Abstract [en]

Background

Data suggest that certain psychological interventions can induce harm in a significant number of patients. While the need for adequate reporting of harms in clinical trials has repeatedly been emphasized, it is uncertain whether such information routinely is collected and reported in trials within this research field.

Method

We used the two major databases in clinical psychology and medicine (PsycINFO and PubMed) to identify original publications from 2010 reporting randomized controlled trials of psychological interventions for patients with mental and behavioral disorders. Two reviewers searched the full-text reports for information about monitoring of adverse events, side effects, and deterioration.

Results

Totally 132 eligible trials were identified. Only 28 trials (21%) included information that indicated any monitoring of harms on patient level. Four (3%) of these trials provided a description of adverse events as well as the methods used for collecting these data. Five of the trials (4%) reported adverse events but gave incomplete information about the method. An additional four reports (3%) briefly stated that no adverse events occurred, whereas 15 trials (11%) only provided information on deterioration or indicated monitoring of deterioration. The probability of including harm-related information was related to the journal impact factor.

Conclusion

Important information about harms is not reported systematically within this research field, suggesting that the risk of reporting bias is nontrivial in conclusions about the risk-benefit ratio of psychological treatments. Guidelines on how to define, detect, and report harms related to psychological interventions could facilitate better reporting.

Place, publisher, year, edition, pages
2014. Vol. 38, no 1, 1-8 p.
Keyword [en]
Adverse Effects, Behavioral Disciplines and Activities, Psychotherapy, Systematic Review, Randomized Controlled Trials
Keyword [sv]
Bieffekter, Sidoeffekter, Skadliga effekter, Psykoterapi, Psykologisk behandling, Översikt, RCT
National Category
Psychology
Research subject
Clinical Psychology
Identifiers
URN: urn:nbn:se:uu:diva-219714DOI: 10.1016/j.cct.2014.02.005ISI: 000337203900001OAI: oai:DiVA.org:uu-219714DiVA: diva2:702978
Funder
Science for Life Laboratory - a national resource center for high-throughput molecular bioscience
Available from: 2014-03-05 Created: 2014-03-05 Last updated: 2017-12-05Bibliographically approved

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Alaie, ImanParling, ThomasArnberg, Filip K

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