Use of Patient-Reported Outcomes in Randomized, Double-Blind, Placebo-Controlled Clinical Trials
Dinan MA, Compton KL, Dhillon JK, Hammill BG, DeWitt EM, Weinfurt KP, Schulman KA. Use of Patient-Reported Outcomes in Randomized, Double-Blind, Placebo-Controlled Clinical Trials. Medical Care 2011, 49: 415-419. PMID: 21368680, PMCID: PMC3682647, DOI: 10.1097/mlr.0b013e3182064aa2.Peer-Reviewed Original ResearchMeSH KeywordsData Interpretation, StatisticalDouble-Blind MethodHumansOutcome Assessment, Health CarePlacebosQuality Indicators, Health CareQuality of LifeRandomized Controlled Trials as TopicResearch SubjectsConceptsPatient-reported outcomesClinical trialsPRO instrumentsDisease-specific patient-reported outcomesDisease-specific PRO instrumentsMore PROsUse of PROsPrimary trial outcomeCurrent clinical trialsStudy inclusion criteriaUse of patientMultivariable analysisLarge trialsMajor therapeutic areasInclusion criteriaPRO measurementRelevant outcomesTrial outcomesLogistic regressionClinical researchStudy outcomesPRO outcomesTrialsTherapeutic areasStatistical significance