ASSIST Applicability Scoring of Surgical trials. An Investigator-reported aSsessment Tool 英文参考文献.docVIP

ASSISTApplicabilityScoringofSurgicaltrials.An Investigator-reportedaSsessmentTool IdrissTourabaly1,2,IsabelleBoutron1*,Re′myNizard2,PhilippeRavaud1 1Inserm,U738,Paris,France;AssistancePubliquedesHo?pitauxDeParis,Ho?pitalHo?telDieu,Centred’e′pide′miologieClinique,Paris,France;UniversityParisDescartes, Sorbonne Paris Cite′, Faculte′ de Me′decine, Paris, France, 2Assistance Publique des Ho?pitaux de Paris, Ho?pital Lariboisie`re, Service de Chirurgie Orthope′dique et Traumatologique,Paris,France;UniversityParisDiderot,SorbonneParisCite′,Faculte′ deMe′decine, Paris,France Abstract Context:Weaimedtodevelopanewtoolforassessinganddepictingtheapplicabilityoftheresultsofsurgicalrandomized controlledtrials(RCTs)fromthetrialinvestigators’perspective. Methods: We identified all items related to applicability by a systematic methodological review, and then a sample of surgeons used these items in a web-based survey to evaluate the applicability of their own trial results. For each applicability item, participants had to indicate on a numerical scale that was simplified as a three-item scale: 1) items essentialtoconsider,2)itemsrequiringattention,and3)itemsinconsequentialtotheapplicabilityoftheresultsoftheir own RCT to clinical practice. For the final tool, we selected only items that were rated as being essential or requiring attention for at least 25% of the trials evaluated. We propose a specific process to construct the tool and to depict applicability in a graph. We identified all investigators of published and registered ongoing RCTs assessing surgery and invitedthemtoparticipateintheweb-basedsurvey. Results:148surgeonsassessedapplicabilityfortheirowntrialandparticipatedintheprocessofitemselection.Thefinal tool contains 22 items (4 dedicated to patients, 5 to centers, 5 to surgeons and 8 to the intervention). We proposed a straightforward process of constructing the graphical tool: 1) a multidisciplinary team of investigators or other care providersparticipatinginthe