Consumer involvement in consent document development: a multicenter cluster randomized trial to assess study participants' understanding
Guarino P, Elbourne D, Carpenter J, Peduzzi P. Consumer involvement in consent document development: a multicenter cluster randomized trial to assess study participants' understanding. Clinical Trials 2006, 3: 19-30. PMID: 16539087, DOI: 10.1191/1740774506cn133oa.Peer-Reviewed Original ResearchMeSH KeywordsAdultCommunity ParticipationComprehensionConsent FormsFemaleHumansLeast-Squares AnalysisMaleProgram DevelopmentResearch SubjectsSurveys and QuestionnairesConceptsGulf War veterans' illnessesStudy participantsClient Satisfaction Questionnaire-8Outcome assessment questionnaireProportion of patientsPrimary outcome measureMean treatment differenceUS medical centersConsent documentsSignificant differencesPotential study participantsSecondary outcomesAdherence ratesTrial protocolClinical trialsMulticenter clusterOutcome measuresMedical CenterStudy investigatorsAssessment QuestionnaireStudy refusalThree monthsTrial initiationClinical researchInformed consent