A brief measure of perceived understanding of informed consent in a clinical trial was validated
Guarino P, Lamping DL, Elbourne D, Carpenter J, Peduzzi P. A brief measure of perceived understanding of informed consent in a clinical trial was validated. Journal Of Clinical Epidemiology 2006, 59: 608-614. PMID: 16713523, DOI: 10.1016/j.jclinepi.2005.11.009.Peer-Reviewed Original ResearchConceptsInformed Consent QuestionnaireClinical trialsGulf War veterans' illnessesPsychometric evaluationRandomized clinical trialsItem reduction techniquesVeterans AffairsItem reductionTrialsMonthsPoor acceptabilityFour-item subscaleValidity sampleIllnessGood acceptabilityInternal consistencyConsentBaselineSelf-report measuresBrief measureAcceptabilityParticipantsHospitalFollowConsumer 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 ResearchConceptsGulf 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