Juul Sophie, Gluud Christian, Simonsen Sebastian, Frandsen Frederik Weischer, Kirsch Irving, Jakobsen Janus Christian
Stolpegaard Psychotherapy Centre, Mental Health Services in the Capital Region of Denmark, Gentofte, Denmark
Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital, Copenhagen Ø, Denmark.
BMJ Evid Based Med. 2021 Jun;26(3):109. doi: 10.1136/bmjebm-2020-111407. Epub 2020 Sep 30.
To study the extent of blinding in randomised clinical trials of psychological interventions and the interpretative considerations if randomised clinical trials are not blinded.
Retrospective study of trial reports published in six high impact factor journals within the field of psychiatry in 2017 and 2018.
Trial reports published in , , , , , or .
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.
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.
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.
研究心理干预随机临床试验中的盲法实施程度，以及在随机临床试验未采用盲法时的解释性考量。
对2017年和2018年发表于精神病学领域六种高影响因子期刊上的试验报告进行回顾性研究。
发表于《 》《 》《 》《 》《 》或《 》上的试验报告。
参与者、治疗提供者、结果评估者、数据管理者、数据安全与监测委员会、统计学家以及结论决策者的盲法状态；试验者是否在主要结局指标上拒绝了原假设；试验者是否在已发表的试验报告中讨论了因缺乏盲法而导致的潜在偏倚风险。
共识别出63项心理干预随机临床试验。无一试验（0%；95%置信区间0%至5.75%）报告对所有可能的关键人员均实施了盲法。37项试验（58.7%；95%置信区间46.42%至70.04%）报告对结果评估者实施了盲法。两项试验（3.2%；95%置信区间0.87%至10.86%）报告对参与者实施了盲法。两项试验（3.2%；95%置信区间0.87%至10.86%）报告对数据管理者实施了盲法。三项试验（4.8%；95%置信区间1.63%至13.09%）报告对统计学家实施了盲法。无一试验报告对治疗提供者、数据安全与监测委员会以及结论决策者实施了盲法。45项试验（71.4%；95%置信区间59.30%至81.10%）在主要结局指标上拒绝了原假设。13项试验（20.7%；95%置信区间12.48%至32.17%）在已发表的试验报告中讨论了因缺乏盲法而导致的潜在偏倚风险。
心理干预随机临床试验中涉及的关键人员的盲法实施情况很少有充分记录。可能的解释性局限性很少被考虑。需要开展对所有可能的关键人员进行盲法尝试记录的心理干预随机临床试验。
