TY - JOUR

T1 - Blinding in randomised clinical trials of psychological interventions

T2 - a retrospective study of published trial reports

AU - Juul, Sophie

AU - Gluud, Christian

AU - Simonsen, Sebastian

AU - Frandsen, Frederik Weischer

AU - Kirsch, Irving

AU - Jakobsen, Janus Christian

N1 - © Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ.

PY - 2021

Y1 - 2021

N2 - 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.

AB - 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.

U2 - 10.1136/bmjebm-2020-111407

DO - 10.1136/bmjebm-2020-111407

M3 - Journal article

C2 - 32998993

JO - Evidence-Based Medicine

JF - Evidence-Based Medicine

SN - 1356-5524

ER -