2014
Effect of Vitamin E and Memantine on Functional Decline in Alzheimer Disease: The TEAM-AD VA Cooperative Randomized Trial
Dysken MW, Sano M, Asthana S, Vertrees JE, Pallaki M, Llorente M, Love S, Schellenberg GD, McCarten JR, Malphurs J, Prieto S, Chen P, Loreck DJ, Trapp G, Bakshi RS, Mintzer JE, Heidebrink JL, Vidal-Cardona A, Arroyo LM, Cruz AR, Zachariah S, Kowall NW, Chopra MP, Craft S, Thielke S, Turvey CL, Woodman C, Monnell KA, Gordon K, Tomaska J, Segal Y, Peduzzi PN, Guarino PD. Effect of Vitamin E and Memantine on Functional Decline in Alzheimer Disease: The TEAM-AD VA Cooperative Randomized Trial. JAMA 2014, 311: 33-44. PMID: 24381967, PMCID: PMC4109898, DOI: 10.1001/jama.2013.282834.Peer-Reviewed Original ResearchConceptsAlpha-tocopherol groupModerate Alzheimer's diseaseIU/dAlzheimer's diseaseFunctional declineTocopherol groupAlpha-tocopherolVitamin EAlzheimer's Disease Cooperative Study/ActivitiesVeterans Affairs Medical CenterInventory scoresSlow functional declineSerious adverse eventsSevere Alzheimer's diseaseMemantine groupCause mortalityPlacebo groupSecondary outcomesAdverse eventsRandomized trialsClinical progressionCombination groupCaregiver burdenClinical trialsSlow progression
2006
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