13063_2024_8166_MOESM1_ESM.docx (17.52 kB)
Additional file 1 of Patient information leaflets for placebo-controlled surgical trials: a review of current practice and recommendations for developers
journal contribution
posted on 2024-05-23, 03:41 authored by S. Cousins, M. Huttman, N. Blencowe, C. Tsang, D. Elliott, J. Blazeby, D. J. Beard, M. K. Campbell, K. GilliesSupplementary Material 1: Supplementary Table 1. Comparison of characteristics of trials included in systematic review (reference 7) and PIL analysis.
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NIHR Bristol Biomedical Research Centre Chief Scientist Office
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determine optimal approaches62 eligible rctsprovide balanced presentationspatient information leafletsrecently completed placebo‘ sham ’.recent systematic reviewpotential therapeutic benefitsinformed consent processsurgical intervention separatelygood practice guidancegeneral trial designdirected content analysis36 %) presentedpils included contentcontrolled surgical trialspils included informationplacebo surgical trialspotential benefitssurgical interventiontrials includedincluded pilscontrolled trialstrial characteristicspil contentkey contentgood practiceplacebo intervention57 %)43 %)information provisionmethods pils59 trials14 pilsplacebo interventionsplacebo differsplacebo componentwhilst 8used acrossstudy aimedpublished regulatoryprovide recommendationsnarrative summarymock ),legal requirementleast 50invasive proceduresinvasive componentsincluding surgeryimportant ethicalidentify gapshighlight areascurrent practicecore componentconclusion developerscarefully consider
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