2015
Successful Tobacco Dependence Treatment in Low-Income Emergency Department Patients: A Randomized Trial
Bernstein SL, D’Onofrio G, Rosner J, O’Malley S, Makuch R, Busch S, Pantalon MV, Toll B. Successful Tobacco Dependence Treatment in Low-Income Emergency Department Patients: A Randomized Trial. Annals Of Emergency Medicine 2015, 66: 140-147. PMID: 25920384, PMCID: PMC4819432, DOI: 10.1016/j.annemergmed.2015.03.030.Peer-Reviewed Original ResearchConceptsEmergency department patientsDepartment patientsUS EDsTobacco abstinence ratesGroup of smokersTobacco dependence treatmentMultivariable logistic modelingState Smokers' QuitlineLow incomeED smokersFaxed referralsQuitline referralQuitline useSecondary endpointsEligible subjectsPrimary outcomeIntervention armMedicaid insuranceNicotine patchNicotine replacementAbstinence ratesBooster callsIntervention subjectsControl armControl subjects
2010
Sample size for post‐marketing safety studies based on historical controls
Wu Y, Makuch RW. Sample size for post‐marketing safety studies based on historical controls. Pharmacoepidemiology And Drug Safety 2010, 19: 869-875. PMID: 20572025, DOI: 10.1002/pds.1990.Peer-Reviewed Original Research
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
2000
Upper gastrointestinal tolerability of celecoxib, a COX-2 specific inhibitor, compared to naproxen and placebo.
Bensen W, Zhao S, Burke T, Zabinski R, Makuch R, Maurath C, Agrawal N, Geis G. Upper gastrointestinal tolerability of celecoxib, a COX-2 specific inhibitor, compared to naproxen and placebo. The Journal Of Rheumatology 2000, 27: 1876-83. PMID: 10955327.Peer-Reviewed Original ResearchMeSH KeywordsAbdominal PainAnti-Inflammatory Agents, Non-SteroidalArthritis, RheumatoidCelecoxibCyclooxygenase 2Cyclooxygenase 2 InhibitorsCyclooxygenase InhibitorsDigestive SystemDouble-Blind MethodDyspepsiaFemaleHumansIsoenzymesMaleMembrane ProteinsMiddle AgedNaproxenNauseaOsteoarthritisProspective StudiesProstaglandin-Endoperoxide SynthasesPyrazolesRisk FactorsSulfonamidesTime FactorsTreatment OutcomeConceptsUpper gastrointestinal tolerabilityUpper GI symptomsSevere abdominal painComposite endpointAbdominal painGastrointestinal tolerabilityGI symptomsIndependent predictorsRheumatoid arthritisRelative riskCOX-2-specific inhibitorsUpper GI tolerabilityTreatment group patientsDose-response relationshipGI tolerabilityPlacebo patientsGroup patientsCumulative incidenceParallel groupClinical trialsPlaceboPatientsCelecoxibTolerabilityEndpoint
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 ResearchConceptsStratified randomizationSmall trialsInterim analysisActive-control equivalence trialsClinical factorsLarge trialsSuperiority trialSubgroup analysisClinical trialsTreatment responsivenessTreatment outcomesMEDLINE searchTreatment groupsStratification factorsEquivalence trialPrognosisTrialsRandomizationType ITheoretical benefitsImportance of stratificationStratificationSample sizeInvestigatorsPatients
1998
Cognitive Outcome at 4½ Years of Very Low Birth Weight Infants Enrolled in the Multicenter Indomethacin Intraventricular Hemorrhage Prevention Trial
Ment L, Westerveld M, Makuch R, Vohr B, Allan W. Cognitive Outcome at 4½ Years of Very Low Birth Weight Infants Enrolled in the Multicenter Indomethacin Intraventricular Hemorrhage Prevention Trial. Pediatrics 1998, 102: 159-159. PMID: 9714645, DOI: 10.1542/peds.102.1.159.Peer-Reviewed Original Research
1996
Variations in the natural history and survival of patients with supratentorial low-grade astrocytomas.
Piepmeier J, Susan Christopher R, Spencer D, Byrne T, Kim J, Knisel J, Lacy J, Tsukerman L, Makuch R. Variations in the natural history and survival of patients with supratentorial low-grade astrocytomas. Neurosurgery 1996, 38: 872-8; discussion 878-9. PMID: 8727811, DOI: 10.1097/00006123-199605000-00002.Peer-Reviewed Original ResearchConceptsLow-grade astrocytomasGross total resectionChronic epilepsySupratentorial low-grade astrocytomasNatural historyGross total tumor resectionImmediate postoperative radiotherapyExtent of surgerySurvival of patientsTen-year survivalPopulation of patientsUse of radiotherapyRisk of recurrenceHigh-grade lesionsLength of survivalMore malignant tumorsTypes of symptomsAggressive surgeryPostoperative radiotherapyPreoperative symptomsConsecutive patientsBetter prognosisTumor recurrenceTumor resectionMalignant tumorsCan 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 ResearchConceptsClinical 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
1994
Low-dose indomethacin therapy and extension of intraventricular hemorrhage: A multicenter randomized trial
Ment L, Oh W, Ehrenkranz R, Phillip A, Vohr B, Allan W, Makuch R, Taylor K, Schneider K, Katz K, Scott D, Duncan C. Low-dose indomethacin therapy and extension of intraventricular hemorrhage: A multicenter randomized trial. The Journal Of Pediatrics 1994, 124: 951-955. PMID: 8201485, DOI: 10.1016/s0022-3476(05)83191-9.Peer-Reviewed Original ResearchConceptsLow-grade intraventricular hemorrhageIntraventricular hemorrhageAdverse eventsBirth weightLow birth weight infantsDistribution of hemorrhageGrade intraventricular hemorrhageBirth weight infantsPlacebo-controlled trialPercentage of infantsPatent ductus arteriosusGm birth weightHours of ageIndomethacin therapyWeight infantsApgar scoreParenchymal involvementSaline placeboDuctus arteriosusGestational ageIntracranial hemorrhagePostnatal hoursCascade of eventsPatent ductusCranial sonogramsLow-dose indomethacin and prevention of intraventricular hemorrhage: a multicenter randomized trial.
Ment L, Ehrenkranz R, Duncan C, Scott D, Taylor K, Katz K, Schneider K, Makuch R, Oh W, Vohr B, Philip A, Allan W. Low-dose indomethacin and prevention of intraventricular hemorrhage: a multicenter randomized trial. Pediatrics 1994, 93: 543-50. PMID: 8134206, DOI: 10.1542/peds.93.4.543.Peer-Reviewed Original ResearchConceptsLow birth weight neonatesSeverity of IVHBirth weight neonatesIntraventricular hemorrhageWeight neonatesDose indomethacinBirth weightGrade 4 intraventricular hemorrhageSerial cranial ultrasound examinationsSignificant adverse drug eventsPercent of neonatesPlacebo-controlled trialPatent ductus arteriosusCranial ultrasound examinationMajor risk factorAdverse drug eventsHours of ageFirst postnatal dayDuctal closureProphylactic indomethacinApgar scoreNeurodevelopmental handicapParenchymal involvementPlacebo groupAdverse events