2005
Control Group Bias in Randomized Atypical Antipsychotic Medication Trials for Schizophrenia
Woods SW, Gueorguieva RV, Baker CB, Makuch RW. Control Group Bias in Randomized Atypical Antipsychotic Medication Trials for Schizophrenia. JAMA Psychiatry 2005, 62: 961-970. PMID: 16143728, DOI: 10.1001/archpsyc.62.9.961.Peer-Reviewed Original ResearchMeSH KeywordsAge FactorsAntipsychotic AgentsBrief Psychiatric Rating ScaleDouble-Blind MethodDrug Administration ScheduleFemaleHumansMalePlacebosPsychotic DisordersRandomized Controlled Trials as TopicResearch DesignSchizophreniaSchizophrenic PsychologySelection BiasSeverity of Illness IndexSex FactorsTreatment OutcomeConceptsBrief Psychiatric Rating ScalePlacebo-controlled trialPsychiatric Rating ScalePlacebo-controlled studyAtypical antipsychotic medicationsDose-controlled studyMedication trialsAntipsychotic medicationRating ScaleDouble-blind clinical trialNew atypical antipsychotic medicationsDose-controlled trialsTreatment completion ratesPlacebo control groupEnd point changePercentage of menDrug Administration databaseRandom effects analysisIll adultsMedication armClinical trialsNew medicationsNovel medicationsSame drugAverage age
1999
Stratified Randomization for Clinical Trials
Kernan W, Viscoli C, Makuch R, Brass L, Horwitz R. Stratified Randomization for Clinical Trials. Journal Of Clinical Epidemiology 1999, 52: 19-26. PMID: 9973070, DOI: 10.1016/s0895-4356(98)00138-3.Peer-Reviewed Original ResearchMeSH KeywordsBiasData Interpretation, StatisticalEffect Modifier, EpidemiologicGuidelines as TopicHumansPrognosisRandom AllocationRandomized Controlled Trials as TopicReproducibility of ResultsResearch DesignTreatment OutcomeConceptsStratified randomizationSmall trialsInterim analysisActive-control equivalence trialsClinical factorsLarge trialsSuperiority trialSubgroup analysisClinical trialsTreatment responsivenessTreatment outcomesMEDLINE searchTreatment groupsStratification factorsEquivalence trialPrognosisTrialsRandomizationType ITheoretical benefitsImportance of stratificationStratificationSample sizeInvestigatorsPatients
1998
Verapamil use in patients with cardiovascular disease: An overview of randomized trials
Pepine C, Faich G, Makuch R. Verapamil use in patients with cardiovascular disease: An overview of randomized trials. Clinical Cardiology 1998, 21: 633-641. PMID: 9755379, PMCID: PMC6655547, DOI: 10.1002/clc.4960210906.Peer-Reviewed Original ResearchMeSH KeywordsAngina PectorisCalcium Channel BlockersCardiovascular DiseasesFemaleHumansHypertensionMaleMEDLINEMiddle AgedMyocardial InfarctionRandomized Controlled Trials as TopicRecurrenceSurvival RateVerapamilConceptsMyocardial infarctionVerapamil useNonfatal reinfarctionCalcium antagonistsDecreased riskDrug classesCardiovascular diseaseCertain calcium antagonistsNonfatal myocardial infarctionOutcome of deathParallel-group studyStandard meta-analytic techniquesRandomized clinical trialsAcute myocardial infarctionEnglish-language articlesEvidence of harmAngina StudyHypertensive patientsOverall mortalityRandomized studyRandomized trialsTrial characteristicsClinical trialsPatient outcomesMEDLINE searchProspective individual matching: covariate balance and power in a comparative study
Makuch R, Zhang Z, Charpentier P, Inouye S. Prospective individual matching: covariate balance and power in a comparative study. Statistics In Medicine 1998, 17: 1517-1526. PMID: 9695196, DOI: 10.1002/(sici)1097-0258(19980715)17:13<1517::aid-sim859>3.0.co;2-0.Peer-Reviewed Original ResearchMeSH KeywordsAnalysis of VarianceClinical Trials, Phase II as TopicClinical Trials, Phase IV as TopicHumansMatched-Pair AnalysisRandomized Controlled Trials as TopicSelection Bias
1996
Can treatment that is helpful on average be harmful to some patients? A study of the conflicting information needs of clinical inquiry and drug regulation
Horwitz R, Singer B, Makuch R, Viscoli C. Can treatment that is helpful on average be harmful to some patients? A study of the conflicting information needs of clinical inquiry and drug regulation. Journal Of Clinical Epidemiology 1996, 49: 395-400. PMID: 8621989, DOI: 10.1016/0895-4356(95)00058-5.Peer-Reviewed Original ResearchMeSH KeywordsAdrenergic beta-AntagonistsAdultAgedDrug ApprovalFemaleHumansMaleMiddle AgedMulticenter Studies as TopicMyocardial InfarctionPropranololRandomized Controlled Trials as TopicRisk FactorsTreatment OutcomeConceptsClinical inquiryBeta-Blocker Heart Attack TrialCoronary artery surgeryHeart Attack TrialSubgroup of patientsArtery surgeryAspirin useCoronary surgeryMulticenter RCTClinical featuresAttack TrialClinical centersClinical conditionsTreatment groupsPatientsBenefit of propranololClinical decisionTrial resultsHeterogeneous groupPropranololRCTsSurgeryTreatmentTrialsOverall benefit
1990
A multicenter clinical trial of oral ribavirin in HIV-infected people with lymphadenopathy
Roberts R, Hollinger F, Parks W, Rasheed S, Laurence J, Heseltine P, Makuch R, Lubina J, Johnson K, Group R. A multicenter clinical trial of oral ribavirin in HIV-infected people with lymphadenopathy. AIDS 1990, 4: 67-72. PMID: 1690551, DOI: 10.1097/00002030-199001000-00009.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAdolescentAdultAIDS-Related ComplexDouble-Blind MethodFemaleGene Products, gagHIVHIV AntigensHIV Core Protein p24HIV InfectionsHumansMaleMiddle AgedMulticenter Studies as TopicRandomized Controlled Trials as TopicRibavirinRibonucleosidesRNA-Directed DNA PolymeraseUnited StatesViral Core ProteinsConceptsOral ribavirinPeripheral blood mononuclear cellsPlacebo-controlled trialBlood mononuclear cellsMulticenter clinical trialHIV isolationP24 antigenemiaStudy drugMulticenter trialActive treatmentDaily dosesMononuclear cellsClinical trialsMedical CenterWeek 6HIV activityAdult menRibavirinTrialsLymphadenopathyHIVInterlaboratory variationCritical roleAntigenemiaPlaceboA multicenter clinical trial of oral ribavirin in HIV-infected patients with lymphadenopathy. The Ribavirin-LAS Collaborative Group.
Roberts R, Dickinson G, Heseltine P, Leedom J, Mansell P, Rodriguez S, Johnson K, Lubina J, Makuch R. A multicenter clinical trial of oral ribavirin in HIV-infected patients with lymphadenopathy. The Ribavirin-LAS Collaborative Group. JAIDS Journal Of Acquired Immune Deficiency Syndromes 1990, 3: 884-92. PMID: 1974628.Peer-Reviewed Original ResearchMeSH KeywordsAcquired Immunodeficiency SyndromeAdministration, OralAdolescentAdultCD4 AntigensCD4-Positive T-LymphocytesDose-Response Relationship, DrugDouble-Blind MethodEvaluation Studies as TopicHumansImmunoblastic LymphadenopathyLeukocyte CountMaleMiddle AgedMulticenter Studies as TopicRandomized Controlled Trials as TopicRibavirinRibonucleosidesConceptsOral ribavirinActive treatmentBaseline CD4 cell countMajor protocol violationsCD4 cell countPlacebo-controlled trialMulticenter clinical trialSignificant differencesPlacebo patientsPlacebo groupPlacebo treatmentStudy entryTreat analysisWashout periodDaily dosesClinical trialsKaposi's sarcomaProtocol violationsMedical CenterTreatment superiorityTreatment groupsPlaceboRibavirinPatientsOverall significant difference