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 analysisArthritisReviewIncidenceProportionAdministrationEndpoint
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 trialsPlaceboPatientsCelecoxibTolerabilityEndpointBlood Pressure Exceeding National Guidelines Among Women After Stroke
Kernan W, Viscoli C, Brass L, Makuch R, Sarrel P, Horwitz R. Blood Pressure Exceeding National Guidelines Among Women After Stroke. Stroke 2000, 31: 415-419. PMID: 10657415, DOI: 10.1161/01.str.31.2.415.Peer-Reviewed Original ResearchConceptsHistory of hypertensionBlood pressure valuesNational guidelinesBlood pressureFirst examinationTrial of estrogenSecondary stroke preventionTransient ischemic attackBlood pressure controlTreatment of hypertensionProportion of womenIschemic attackSevere hypertensionStroke preventionSecondary preventionDiabetic patientsMean ageHypertensionPatientsPressure valuesPersonal physicianPressure controlSeparate guidelinesStrokeWomenEvaluation of Therapeutic Strategies: A New Method for Balancing Risk and Benefit
Troche C, Paltiel A, Makuch R. Evaluation of Therapeutic Strategies: A New Method for Balancing Risk and Benefit. Value In Health 2000, 3: 12-22. PMID: 16464177, DOI: 10.1046/j.1524-4733.2000.31002.x.Peer-Reviewed Original ResearchPatient preferencesDose-related efficacyPatients' subjective assessmentPatient-specific preferencesSpecific therapeutic interventionsClinical trial informationEfficacy-toxicity tradeDose prescribedSafety profileTherapeutic alternativeAcceptable efficacyDose intervalSubjective assessmentTherapeutic strategiesTherapeutic interventionsDrug efficacyDifferent patientsTrial informationDifferent drugsDose rangeEfficacyDifferent efficacyDrugsPatientsBalancing Risks
1999
Use of Meta-Analysis to Evaluate Medical Questions of Interest: An Application to Studies of Secondary Prevention of Acute Myocardial Infarction
Chen Y, Makuch R. Use of Meta-Analysis to Evaluate Medical Questions of Interest: An Application to Studies of Secondary Prevention of Acute Myocardial Infarction. Therapeutic Innovation & Regulatory Science 1999, 33: 1161-1171. DOI: 10.1177/009286159903300420.Peer-Reviewed Original ResearchAcute myocardial infarctionMyocardial infarctionImportant public health implicationsCombinability of studiesNonfatal myocardial infarctionPublic health implicationsLiterature search strategySecondary preventionMeta-AnalysisMethodologic issuesInfarctionStudy homogeneityHealth implicationsIndividual studiesProtocol developmentMedical questionsSearch strategyPatientsMedical researchStratified 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
Prospective 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 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
Psychiatric status after human fetal mesencephalic tissue transplantation in Parkinson's disease
Price L, Spencer D, Marek K, Robbins R, Leranth C, Farhi A, Naftolin F, Roth R, Bunney B, Hoffer P, Makuch R, Redmond D. Psychiatric status after human fetal mesencephalic tissue transplantation in Parkinson's disease. Biological Psychiatry 1995, 38: 498-505. PMID: 8562661, DOI: 10.1016/0006-3223(95)00129-5.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedBrain Tissue TransplantationCaudate NucleusDepressive DisorderDopamineFemaleFetal Tissue TransplantationFollow-Up StudiesHumansMaleMesencephalonMiddle AgedNeurocognitive DisordersNeuropsychological TestsPanic DisorderParkinson DiseasePostoperative ComplicationsProspective StudiesConceptsParkinson's diseasePsychiatric statusHuman fetal mesencephalic tissueAdrenal medullary graftsAdrenal medullary transplantationFetal mesencephalic tissueSystematic psychiatric assessmentPerioperative sequelaeMesencephalic tissuePsychiatric sequelaeCaudate nucleusPsychiatric assessmentNeurobiological effectsBehavioral symptomsTissue transplantationDiseasePatientsTransplantationSequelaeSuch episodesEpisodesGroup effectsStatusDeliriumDiscrete episodes
1993
Unilateral Transplantation of Human Fetal Mesencephalic Tissue Into the Caudate Nucleus of Patients With Parkinson's Disease
SPENCER D, ROBBINS R, NAFTOLIN F, MAREK K, VOLLMER T, LERANTH C, ROTH R, PRICE L, GJEDDE A, BUNNEY B, SASS K, ELSWORTH J, KIER E, MAKUCH R, HOFFER P, REDMOND D. Unilateral Transplantation of Human Fetal Mesencephalic Tissue Into the Caudate Nucleus of Patients With Parkinson's Disease. Obstetrical & Gynecological Survey 1993, 48: 413-415. DOI: 10.1097/00006254-199306000-00013.Peer-Reviewed Original Research
1992
A model-based prediction for transvaginal ultrasonographic identification of early intrauterine pregnancy
Shapiro B, Escobar M, Makuch R, Lavy G, DeCherney A. A model-based prediction for transvaginal ultrasonographic identification of early intrauterine pregnancy. American Journal Of Obstetrics And Gynecology 1992, 166: 1495-1500. PMID: 1595805, DOI: 10.1016/0002-9378(92)91625-k.Peer-Reviewed Original ResearchConceptsHuman chorionic gonadotropin titersEarly intrauterine pregnancyMHz vaginal transducerIntrauterine pregnancyGestational ageUltrasonographic identificationVaginal transducerNormal intrauterine pregnancyHuman chorionic gonadotropinLogistic regression analysisIntrauterine sacIntrauterine gestationEmbryo transfer programInfertility clinicMIU/Ultrasonographic detectionChorionic gonadotropinPregnancyTitersRegression analysisAgeUltrasonographic equipmentPatientsGestationGonadotropin
1991
A Phase II Trial of Cyclosporin A in the Treatment of Refractory Metastatic Colorectal Cancer
Murren J, Ganpule S, Sarris A, Durivage H, Davis C, Makuch R, Handschumacher R, Marsh J. A Phase II Trial of Cyclosporin A in the Treatment of Refractory Metastatic Colorectal Cancer. American Journal Of Clinical Oncology 1991, 14: 208-217. PMID: 2031507, DOI: 10.1097/00000421-199106000-00007.Peer-Reviewed Original ResearchConceptsPhase II trialCyclosporin AII trialColorectal cancerEuropean Cooperative Oncology Group performance statusRefractory metastatic colorectal cancerSignificant toxicityRefractory colorectal cancerMetastatic colorectal cancerFlu-like symptomsMeasurable diseaseStable diseaseStarting doseColorectal malignancyObjective responsePerformance statusImmunosuppressive agentsInitial doseDose reductionColon cancerPatientsHuman neoplasmsExperimental modelCancerDoseEEG coherence of prefrontal areas in normal and schizophrenic males during perceptual activation
Hoffman R, Buchsbaum M, Escobar M, Makuch R, Nuechterlein K, Guich S. EEG coherence of prefrontal areas in normal and schizophrenic males during perceptual activation. Journal Of Neuropsychiatry 1991, 3: 169-175. PMID: 1821231, DOI: 10.1176/jnp.3.2.169.Peer-Reviewed Original ResearchConceptsPrefrontal areasUnmedicated male patientsAlpha band coherenceNormal male subjectsDegraded Stimulus Continuous Performance TestMale patientsCortical areasCortical circuitsNormal controlsSchizophrenic patientsBrain areasContinuous Performance TestMale subjectsPrefrontal dysfunctionSchizophrenic malesPrefrontal cortexFormer groupMultiple studiesEEG coherencePatientsExtensive connectionsSchizophreniaAlpha powerSubjectsDysfunctionHigh‐dose cisplatin plus dacarbazine in the treatment of metastatic melanoma
Murren J, Derosa W, Durivage H, Davis C, Makuch R, Portlock C. High‐dose cisplatin plus dacarbazine in the treatment of metastatic melanoma. Cancer 1991, 67: 1514-1517. PMID: 2001539, DOI: 10.1002/1097-0142(19910315)67:6<1514::aid-cncr2820670609>3.0.co;2-q.Peer-Reviewed Original Researchmyc family DNA amplification in 107 tumors and tumor cell lines from patients with small cell lung cancer treated with different combination chemotherapy regimens.
Brennan J, O'Connor T, Makuch R, Simmons A, Russell E, Linnoila R, Phelps R, Gazdar A, Ihde D, Johnson B. myc family DNA amplification in 107 tumors and tumor cell lines from patients with small cell lung cancer treated with different combination chemotherapy regimens. Cancer Research 1991, 51: 1708-12. PMID: 1847842.Peer-Reviewed Original ResearchConceptsMyc family DNA amplificationSmall cell lung cancerCell lung cancerLung cancerTumor cell linesExtensive-stage small-cell lung cancer patientsSmall cell lung cancer patientsCell linesPatient specimensCell lung cancer patientsDNA copy numberDifferent combination chemotherapyEtoposide/cisplatinDifferent chemotherapy regimensInitiation of therapyLung cancer patientsFrequency of amplificationChemotherapy regimensUntreated patientsCombination chemotherapyCancer patientsSame patientPatientsClinical situationsDNA amplification
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 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
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 episodesTrialsStatistical Methods for the Analysis of HIV-1 Core Polypeptide Antigen Data in Clinical Studies
Makuch R, Parks W. Statistical Methods for the Analysis of HIV-1 Core Polypeptide Antigen Data in Clinical Studies. AIDS Research And Human Retroviruses 1988, 4: 305-316. PMID: 3061416, DOI: 10.1089/aid.1988.4.305.Peer-Reviewed Original ResearchConceptsPlacebo-treated patientsInitiation of therapyPlacebo-controlled studyHIV-1 antigensDemonstrated clinical efficacyHIV-1 coreAntiretroviral effectClinical efficacyAIDS patientsAntiretroviral activityClinical studiesLymphocyte culturesVirus expressionSerum dataAntigen dataPatientsSurvival analysis methodsLaboratory dataAZTGroup differencesMost laboratory dataCulture dataStatistical methodsSignificant declineSerum
1987
myc family oncogene amplification in tumor cell lines established from small cell lung cancer patients and its relationship to clinical status and course.
Johnson B, Ihde D, Makuch R, Gazdar A, Carney D, Oie H, Russell E, Nau M, Minna J. myc family oncogene amplification in tumor cell lines established from small cell lung cancer patients and its relationship to clinical status and course. Journal Of Clinical Investigation 1987, 79: 1629-1634. PMID: 3034978, PMCID: PMC424486, DOI: 10.1172/jci112999.Peer-Reviewed Original ResearchConceptsMyc family DNA amplificationPatient tumorsTumor cell linesC-myc amplificationCell linesSmall cell lung cancer patientsCell lung cancer patientsSmall cell lung cancer cell linesCell lung cancer cell linesExtensive-stage patientsLung cancer patientsLung cancer cell linesCancer cell linesRelapsed patientsStage patientsClinical statusCancer patientsChemotherapy treatmentPatientsTumorsDNA amplificationOncogene amplification