2017
Ability to Reach Low-Income Smokers Enrolled in a Randomised Controlled Trial Varies with Time of Month
Hawk K, Shi R, Weiss J, Makuch R, Toll B, Bernstein SL. Ability to Reach Low-Income Smokers Enrolled in a Randomised Controlled Trial Varies with Time of Month. The Journal Of Smoking Cessation 2017, 13: 227-232. PMID: 31452822, PMCID: PMC6709708, DOI: 10.1017/jsc.2017.23.Peer-Reviewed Original ResearchLow-income smokersWeek 4Week 1Time of monthTobacco dependence treatmentOne-month followControlled TrialsAcademic EDEmergency departmentDependence treatmentWeek 2SmokersLow-income populationsWeek 3Study participantsMonthsFollowPhone callsLow-income individualsSuccessful contactTrialsFuture studiesParticipantsCellphone serviceUrban communities
2006
Detecting Rare Adverse Events in Postmarketing Studies: Sample Size Considerations
Wu Y, Makuch R. Detecting Rare Adverse Events in Postmarketing Studies: Sample Size Considerations. Therapeutic Innovation & Regulatory Science 2006, 40: 89-98. DOI: 10.1177/009286150604000111.Peer-Reviewed Original Research
2003
Systematic review of NSAID-induced adverse reactions in patients with rheumatoid arthritis in Japan
Tomita T, Ochi T, Sugano K, Uemura S, Makuch R. Systematic review of NSAID-induced adverse reactions in patients with rheumatoid arthritis in Japan. Modern Rheumatology 2003, 13: 143-152. DOI: 10.1007/s10165-002-0214-5.Peer-Reviewed Original ResearchNonsteroidal antiinflammatory drugsProportion of patientsAdverse reactionsSystematic reviewGastrointestinal adverse reactionsRheumatoid arthritis patientsFixed-effects modelRA patientsArthritis patientsRheumatoid arthritisMost withdrawalsClinical trialsAntiinflammatory drugsPatientsTrialsDrugsRiskTotalEvent analysisArthritisReviewIncidenceProportionAdministrationEndpoint103 Multicenter randomized placebo-controlled trial of non-selective beta-blockers in the prevention of the complications of portal hypertension: final results and identification of a predictive factor
Groszmann R, Garcia-Tsao G, Makuch R, Bosch J, Escorsel A, Garcia-Pagan J, Grace N, Matloff D, Burroughs A, Patch D. 103 Multicenter randomized placebo-controlled trial of non-selective beta-blockers in the prevention of the complications of portal hypertension: final results and identification of a predictive factor. Hepatology 2003, 38: 206. DOI: 10.1016/s0270-9139(03)80146-5.Peer-Reviewed Original Research
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
1997
Antecedents of Cerebral Palsy in a Multicenter Trial of Indomethacin for Intraventricular Hemorrhage-Reply
Allan W, Vohr B, Makuch R, Katz K, Ment L. Antecedents of Cerebral Palsy in a Multicenter Trial of Indomethacin for Intraventricular Hemorrhage-Reply. JAMA Pediatrics 1997, 151: 1270-1270. DOI: 10.1001/archpedi.1997.02170490095024.Peer-Reviewed Original Research
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 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
1995
Antenatal steroids, delivery mode, and intraventricular hemorrhage in preterm infants
Ment L, Oh W, Ehrenkranz R, Philip A, Duncan C, Makuch R. Antenatal steroids, delivery mode, and intraventricular hemorrhage in preterm infants. American Journal Of Obstetrics And Gynecology 1995, 172: 795-800. PMID: 7892866, DOI: 10.1016/0002-9378(95)90001-2.Peer-Reviewed Original ResearchConceptsEarly intraventricular hemorrhageAntenatal steroidsIntraventricular hemorrhageCesarean sectionPreterm infantsAntenatal steroid treatmentCesarean section deliveryHours of lifeMore vaginal deliveriesDelivery modePostnatal indomethacinSection deliveryWeight infantsSteroid treatmentVaginal deliveryHemorrhageInfantsSteroidsIndependent roleHoursDeliveryMulticenterIndomethacinTrialsEchoencephalography
1990
Ten-year survival of patients with small-cell lung cancer treated with combination chemotherapy with or without irradiation.
Johnson B, Grayson J, Makuch R, Linnoila R, Anderson M, Cohen M, Glatstein E, Minna J, Ihde D. Ten-year survival of patients with small-cell lung cancer treated with combination chemotherapy with or without irradiation. Journal Of Clinical Oncology 1990, 8: 396-401. PMID: 2155310, DOI: 10.1200/jco.1990.8.3.396.Peer-Reviewed Original ResearchConceptsSmall cell lung cancerLung cancerLung cancer 2Initiation of chemotherapyTen-year survivalCell lung cancerTherapeutic clinical trialsCranial irradiationCombination chemotherapyOriginal malignancySecond cancersClinical trialsHigh riskPatientsCancer 2CancerChemotherapyMalignancyMore yearsCauseYearsChestDiagnosisTrialsA 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 roleAntigenemiaPlacebo
1989
Issues in planning and interpreting active control equivalence studies
Makuch R, Johnson M. Issues in planning and interpreting active control equivalence studies. Journal Of Clinical Epidemiology 1989, 42: 503-511. PMID: 2661729, DOI: 10.1016/0895-4356(89)90146-7.Peer-Reviewed Original ResearchConceptsActive control equivalence studiesEquivalence studyActive-control equivalence trialsPrevention of strokeNew drugsActive control drugActive control treatmentAlternative study designsCurrent therapiesPlaceboControl drugTherapeutic equivalenceEquivalence trialNew treatmentsMethodologic issuesDrug efficacyStudy designTreatment controlDrugsEfficacyEquivalence designTrialsTreatmentStudy validation
1988
A prospective randomized trial of HLA‐matched versus mismatched single‐donor platelet transfusions in cancer patients
Messerschmidt G, Makuch R, Appelbaum F, Ungerleider R, Abrams R, O'Donnell J, Holohan T, Fontana J, Wright D, Anagnou N, Shan T, Chesbro B, Deisseroth A. A prospective randomized trial of HLA‐matched versus mismatched single‐donor platelet transfusions in cancer patients. Cancer 1988, 62: 795-801. PMID: 3293762, DOI: 10.1002/1097-0142(19880815)62:4<795::aid-cncr2820620426>3.0.co;2-7.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAmbulatory CareAntibody FormationBlood DonorsBlood PlateletsBlood TransfusionChildChild, PreschoolClinical Trials as TopicFemaleHemorrhageHistocompatibility TestingHumansInfantMaleMiddle AgedNeoplasmsPlatelet TransfusionProspective StudiesRandom AllocationThrombocytopeniaTransfusion ReactionConceptsSingle-donor platelet transfusionsPlatelet transfusionsCancer patientsFebrile patientsPosttransfusion incrementsThrombocytopenic cancer patientsTransfusion of HLASevere bleeding episodesMulti-institution trialNonfebrile patientsIntensive chemotherapyBleeding episodesAntiplatelet antibodiesAntibody titersSignificant thrombocytopeniaHistocompatability antigensTransfusionPatientsMismatched groupHLAThrombocytopeniaPlateletsEpisodesSeparate episodesTrials
1982
Sample size requirements for comparing time-to-failure among k treatment groups
Makuch R, Simon R. Sample size requirements for comparing time-to-failure among k treatment groups. Journal Of Clinical Epidemiology 1982, 35: 861-867. PMID: 7142364, DOI: 10.1016/0021-9681(82)90051-0.Peer-Reviewed Original Research
1981
Adjuvant Immunotherapy or Chemotherapy for Malignant Melanoma: Preliminary Report of the National Cancer Institute Randomized Clinical Trial
Fisher R, Terry W, Hodes R, Rosenberg S, Makuch R, Gordon H, Fisher S. Adjuvant Immunotherapy or Chemotherapy for Malignant Melanoma: Preliminary Report of the National Cancer Institute Randomized Clinical Trial. Surgical Clinics Of North America 1981, 61: 1267-1277. PMID: 7031934, DOI: 10.1016/s0039-6109(16)42582-x.Peer-Reviewed Original ResearchConceptsBacille Calmette-GuerinDisease-free intervalAdjuvant immunotherapyClinical trialsMalignant melanomaStage I malignant melanomaStage II melanomaSurvival of patientsNational Cancer InstituteOverall survivalPostsurgical patientsMethyl-CCNUCalmette-GuerinCancer InstituteMelanoma cellsMelanomaFurther treatmentPreliminary reportImmunotherapyChemotherapyPatientsTrialsSurvivalSignificant improvement