Cited by 135Meta-analysis and systematic reviewsStatistical Methods in Clinical TrialsPsychotherapy Techniques and Applications

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Blinding in randomised clinical trials of psychological interventions: a retrospective study of published trial reports

Juul, Sophie, Gluud, Christian, Simonsen, Sebastian, Frandsen, Frederik Weischer, Kirsch, Irving, Jakobsen, Janus Christian·2021·BMJ Evidence-Based Medicine

DOI 10.1136/bmjebm-2020-111407

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Abstract

Objectives: To study the extent of blinding in randomised clinical trials of psychological interventions and the interpretative considerations if randomised clinical trials are not blinded. Design: Retrospective study of trial reports published in six high impact factor journals within the field of psychiatry in 2017 and 2018. Setting: Trial reports published in World Psychiatry , JAMA Psychiatry , Lancet Psychiatry , American Journal of Psychiatry , British Journal of Psychiatry , or Psychotherapy and Psychosomatics . Main outcome measures: Blinding status of participants, treatment providers, outcome assessors, data managers, the data safety and monitoring committee, statisticians and conclusion makers, if trialists rejected the null hypothesis on the primary outcome measure, and if trialists discussed the potential bias risk from lack of blinding in the published trial report. Results: 63 randomised clinical trials of psychological interventions were identified. None (0%; 95% CI 0% to 5.75%) of the trials reported blinding of all possible key persons. 37 (58.7%; 95% CI 46.42% to 70.04%) trials reported blinding of outcome assessors. Two (3.2%; 95% CI 0.87% to 10.86%) trials reported blinding of participants. Two (3.2%; 95% CI 0.87% to 10.86%) trials reported blinding of data managers. Three (4.8%; 95% CI 1.63% to 13.09%) trials reported blinding of statisticians. None of the trials reported blinding of treatment providers, the data safety and monitoring committee, and conclusion makers. 45 (71.4%; 95% CI 59.30% to 81.10%) trials rejected the null hypothesis on the primary outcome(s). 13 (20.7%; 95% CI 12.48% to 32.17%) trials discussed the potential bias risk from lack of blinding in the published trial report. Conclusions: Blinding of key persons involved in randomised clinical trials of psychological interventions is rarely sufficiently documented. The possible interpretative limitations are only rarely considered. There is a need of randomised clinical trials of psychological interventions with documented blinding attempts of all possible key persons.

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Authors: Juul, S., Gluud, C., Simonsen, S., Frandsen, F. W., Kirsch, I., & Jakobsen, J. C.
Affiliations: Mental Health Services (DK)
Copenhagen University Hospital (DK)
Harvard University (US)
University of Southern Denmark (DK)
Corresponding author: Juul, Sophie
ORCID: Juul, Sophie
Gluud, Christian
Simonsen, Sebastian
Frandsen, Frederik Weischer
Kirsch, Irving
Jakobsen, Janus Christian
Venue: BMJ Evidence-Based Medicine
Publisher: BMJ
Published: 2020-09-30
Volume: 26
Issue: 3
Pages: 109-109
ISSN: 1356-5524 (ISSN-L)
2515-446X
2515-4478
DOI: 10.1136/bmjebm-2020-111407
OpenAlex: W3091014787
Semantic Scholar: d3805f0a7094ac1f67a6cd4cf28729cf664779c8
Cited by: 135
References: 113
Citations by year: 2026: 21 · 2025: 28 · 2024: 47 · 2023: 22 · 2022: 12 · 2021: 5
FWCI: 5.95
Type: journal article
Language: en
Open access: closed
Locations: BMJ Evidence-Based Medicine (publishedVersion)
PubMed (publishedVersion)
University of Southern Denmark Research Portal (University of Southern Denmark) (publishedVersion)
Topics: Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Social Sciences › Psychology › Clinical Psychology › Psychotherapy Techniques and Applications
Keywords: blinding, randomized controlled trials, psychological intervention, risk of bias, null hypothesis rejection
MeSH terms: Humans, Retrospective Studies, Randomized Controlled Trials as Topic, Research Report

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Blinding in randomised clinical trials of psychological interventions: a retrospective study of published trial reports

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