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• W2301645905 endingPage "e010194" @default.
• W2301645905 startingPage "e010194" @default.
• W2301645905 abstract "To find evidence, either corroborating or refuting, for many persisting beliefs regarding the feasibility of carrying out surgical randomised controlled trials with a placebo arm, with emphasis on the challenges related to recruitment, funding, anaesthesia or blinding.Systematic review.The analysis involved studies published between 1959 and 2014 that were identified during an earlier systematic review of benefits and harms of placebo-controlled surgical trials published in 2014.63 trials were included in the review. The main problem reported in many trials was a very slow recruitment rate, mainly due to the difficulty in finding eligible patients. Existing placebo trials were funded equally often from commercial and non-commercial sources. General anaesthesia or sedation was used in 41% of studies. Among the reviewed trials, 81% were double-blinded, and 19% were single-blinded. Across the reviewed trials, 96% (range 50-100%) of randomised patients completed the study. The withdrawal rate during the study was similar in the surgical and in the placebo groups.This review demonstrated that placebo-controlled surgical trials are feasible, at least for procedures with a lower level of invasiveness, but also that recruitment is difficult. Many of the presumed challenges to undertaking such trials, for example, funding, anaesthesia or blinding of patients and assessors, were not reported as obstacles to completion in any of the reviewed trials." @default.
• W2301645905 created "2016-06-24" @default.
• W2301645905 creator A5043205782 @default.
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• W2301645905 creator A5087469402 @default.
• W2301645905 date "2016-03-01" @default.
• W2301645905 modified "2023-10-14" @default.
• W2301645905 title "Feasibility of surgical randomised controlled trials with a placebo arm: a systematic review" @default.
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• W2301645905 doi "https://doi.org/10.1136/bmjopen-2015-010194" @default.
• W2301645905 hasPubMedCentralId "https://www.ncbi.nlm.nih.gov/pmc/articles/4800115" @default.
• W2301645905 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/27008687" @default.
• W2301645905 hasPublicationYear "2016" @default.
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