Participant Informed Consent in Cluster Randomized Trials Review 英文参考文献.docVIP

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Participant Informed Consent in Cluster Randomized Trials Review 英文参考文献.doc

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Participant Informed Consent in Cluster Randomized Trials Review 英文参考文献

ParticipantInformedConsentinClusterRandomized Trials:Review BrunoGiraudeau1,2,3,4*,Agne`sCaille1,2,3,4,Ame′lieLeGouge2,4,PhilippeRavaud1,5,6 1INSERM,U738, Paris, France, 2INSERM, CIC 202, Tours, France, 3Universite′ Franc?ois Rabelais, Tours, France, 4CHRU deTours, Tours, France,5AssistancePublique– Ho?pitauxdeParis,Ho?pitalHo?telDieu,Centred’Epide′miologieClinique,Paris,France,6Universite′ ParisDescartesSorbonneParisCite′,Paris,France Abstract Background:TheNurembergcodedefinesthegeneralethicalframeworkofmedicalresearchwithparticipantconsentasits cornerstone. In cluster randomized trials (CRT), obtaining participant informed consent raises logistic and methodologic concerns.First,withrandomizationoflargeclusterssuchasgeographicalareas,obtainingindividualinformedconsentmay be impossible. Second, participants in randomized clusters cannot avoid certain interventions, which implies that participant informed consent refers only to data collection, not administration of an intervention. Third, complete participantinformationmaybeasourceofselectionbias,whichthenraisesmethodologicalconcerns.Weassessedwhether participantinformedconsentwasrequiredinsuchtrials,whichtypeofconsentwasrequired,andwhetherthetrialwasat riskofselectionbiasbecauseoftheverynatureofparticipantinformation. Methods and Findings: We systematically reviewed all reports of CRT published in MEDLINE in 2008 and surveyed correspondingauthorsregardingthenatureoftheinformedconsentandtheprocessofparticipantinclusion.Weidentified 173reportsandobtainedananswerfrom113authors(65.3%).Intotal,23.7%ofthereportslackedinformationonethics committeeapprovalorparticipantconsent,53.1%ofauthorsdeclaredthatparticipantconsentwasfordatacollectiononly and 58.5% that the group allocation was not specified for participants. The process of recruitment (chronology of participantrecruitmentwithregardtoclusterrandomization)wasrarelyreported,andweestimatedthatonly56.6%ofthe trialswerefreeofpotentialselectionbias. Conclusions:Fo