2022
Association of exposure to ambient particulate matter with maternal thyroid function in early pregnancy.
Zhang X, Huels A, Makuch R, Zhou A, Zheng T, Xia W, Gaskins A, Makuch J, Zhu Z, Zhu C, Qian Z, Xu S, Li Y. Association of exposure to ambient particulate matter with maternal thyroid function in early pregnancy. Environmental Research 2022, 214: 113942. PMID: 35870505, DOI: 10.1016/j.envres.2022.113942.Peer-Reviewed Original ResearchRegional Brain Volume Abnormalities and Long-term Cognitive Outcome in Preterm Infants
Peterson B, Vohr B, Staib L, Cannistraci C, Dolberg A, Schneider K, Katz K, Westerveld M, Sparrow S, Anderson A, Duncan C, Makuch R, Gore J, Ment L. Regional Brain Volume Abnormalities and Long-term Cognitive Outcome in Preterm Infants. 2022, 215-223. DOI: 10.4324/9780203822937-21.Peer-Reviewed Original ResearchRegional brain volumesLong-term cognitive outcomesBrain volumePreterm infantsRegional brain volume abnormalitiesMagnetic resonance imaging (MRI) scansCognitive outcomesTerm control childrenPerinatal risk factorsResonance imaging scansBrain volume abnormalitiesPreterm cohortRisk factorsImaging scansPreterm childrenHigh prevalenceVolume abnormalitiesBehavioral disturbancesControl childrenTerm controlsAbnormalitiesInfantsChildrenOutcomesCognitive measures
2020
Emergency Use Authorization for Remdesivir and Its Potential Implications
Ochoa Chaar CI, Makuch R. Emergency Use Authorization for Remdesivir and Its Potential Implications. Therapeutic Innovation & Regulatory Science 2020, 55: 270-271. PMID: 32880853, PMCID: PMC7471551, DOI: 10.1007/s43441-020-00212-5.Peer-Reviewed Original Research
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 communitiesStatistical Issues in Drug Research and Development
Makuch R, Pledger G, Hall D, Herson J, Hsu J. Statistical Issues in Drug Research and Development. 2017, 225-262. DOI: 10.1201/9780203738610-5.Peer-Reviewed Original Research
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 subjectsSelection of the treatment effect for sample size determination in a superiority clinical trial using a hybrid classical and Bayesian procedure
Ciarleglio MM, Arendt CD, Makuch RW, Peduzzi PN. Selection of the treatment effect for sample size determination in a superiority clinical trial using a hybrid classical and Bayesian procedure. Contemporary Clinical Trials 2015, 41: 160-171. PMID: 25583273, DOI: 10.1016/j.cct.2015.01.002.Peer-Reviewed Original Research
2014
Comparison of Drug Approvals in Europe Versus the United States
Makuch RW, Shi R. Comparison of Drug Approvals in Europe Versus the United States. Therapeutic Innovation & Regulatory Science 2014, 48: 362-366. PMID: 30235531, DOI: 10.1177/2168479013517103.Peer-Reviewed Original Research
2012
How Do Perceptions About Cessation Outcomes Moderate the Effectiveness of a Gain-Framed Smoking Cessation Telephone Counseling Intervention?
Latimer-Cheung AE, Fucito LM, Carlin-Menter S, Rodriguez J, Raymond L, Salovey P, Makuch R, Cummings KM, Toll BA. How Do Perceptions About Cessation Outcomes Moderate the Effectiveness of a Gain-Framed Smoking Cessation Telephone Counseling Intervention? Journal Of Health Communication 2012, 17: 1081-1098. PMID: 22765277, PMCID: PMC3644974, DOI: 10.1080/10810730.2012.665420.Peer-Reviewed Original ResearchConceptsState quitlineSmoking cessation counselingTelephone counseling interventionSmoking cessation messagesCessation counselingOutcome expectanciesSmoking statusSmoking cessationCessation messagesQuit statusHealth messagesSecondary analysisSmokers' beliefsCare messagesQuitlineIndividual perceptionsCounseling conditionCounseling interventionPreventionMenPositive outcome expectanciesInterventionOutcomesExpectancyIndividual differences
2010
Preterm birth results in alterations in neural connectivity at age 16 years
Mullen KM, Vohr BR, Katz KH, Schneider KC, Lacadie C, Hampson M, Makuch RW, Reiss AL, Constable RT, Ment LR. Preterm birth results in alterations in neural connectivity at age 16 years. NeuroImage 2010, 54: 2563-2570. PMID: 21073965, PMCID: PMC3020252, DOI: 10.1016/j.neuroimage.2010.11.019.Peer-Reviewed Original ResearchConceptsDiffusion tensor imagingAge 16 yearsPT subjectsBrain injuryLow birth weight preterm childrenTerm controlsUncinate fasciculusBilateral external capsuleFA valuesWeight preterm childrenNeonatal brain injuryLower fractional anisotropy valuesYears of ageBilateral uncinate fasciculusFractional anisotropy valuesRight uncinate fasciculusRight arcuate fasciculusWhite matter disorganizationAlternative neural pathwaysPreterm birthExternal capsuleInferior frontal gyrusPreterm childrenCorpus callosumHigh riskNicotine dependence as a moderator of a quitline-based message framing intervention
Fucito LM, Latimer AE, Carlin-Menter S, Salovey P, Cummings KM, Makuch RW, Toll BA. Nicotine dependence as a moderator of a quitline-based message framing intervention. Drug And Alcohol Dependence 2010, 114: 229-232. PMID: 21036492, PMCID: PMC3044773, DOI: 10.1016/j.drugalcdep.2010.09.012.Peer-Reviewed Original ResearchConceptsMessage framing interventionsNicotine dependence scoresGain-framed messagesNicotine dependenceDependence scoresMore cigarettesPoint prevalence smoking abstinenceNew York State Smokers' QuitlineSmoking cessation treatmentHigh nicotine dependenceState Smokers' QuitlineBaseline total scoreHigher nicotine dependence scoresNicotine dependence levelHigher dependence scoresNicotine medicationsNicotine patchCessation treatmentDependent smokersSmoking abstinenceSmokersSmoking outcomesTotal scoreFraming interventionQuitlineSample 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 ResearchLow-dose naltrexone augmentation of nicotine replacement for smoking cessation with reduced weight gain: A randomized trial
Toll BA, White M, Wu R, Meandzija B, Jatlow P, Makuch R, O’Malley S. Low-dose naltrexone augmentation of nicotine replacement for smoking cessation with reduced weight gain: A randomized trial. Drug And Alcohol Dependence 2010, 111: 200-206. PMID: 20542391, PMCID: PMC3771701, DOI: 10.1016/j.drugalcdep.2010.04.015.Peer-Reviewed Original ResearchConceptsWeight gainSmoking cessationPoint prevalence smoking abstinence ratePre-specified primary outcomesLow-dose naltrexoneOpen-label therapySmoking abstinence ratesPoint prevalence abstinenceReduced weight gainNaltrexone augmentationPlacebo groupNicotine replacementPrimary outcomeQuit dateAbstinence ratesLabel therapyNicotine patchBehavioral counselingNaltrexoneAbstinent participantsSmokersWeight concernsWeeksCessationLower ratesS1918 A Hemodynamic Response to Treatment With Non-Selective Beta-Blockers Protects Against Worsening of Thrombocytopenia in Cirrhosis
Qamar A, Grace N, Groszmann R, Garcia-Tsao G, Bosch J, Burroughs A, Iskandar H, Maurer R, Planas R, Escorsell A, Garcia-Pagan J, Patch D, Matloff D, Makuch R, From P. S1918 A Hemodynamic Response to Treatment With Non-Selective Beta-Blockers Protects Against Worsening of Thrombocytopenia in Cirrhosis. Gastroenterology 2010, 138: s-817. DOI: 10.1016/s0016-5085(10)63764-x.Peer-Reviewed Original ResearchFunctional connectivity to a right hemisphere language center in prematurely born adolescents
Myers EH, Hampson M, Vohr B, Lacadie C, Frost SJ, Pugh KR, Katz KH, Schneider KC, Makuch RW, Constable RT, Ment LR. Functional connectivity to a right hemisphere language center in prematurely born adolescents. NeuroImage 2010, 51: 1445-1452. PMID: 20347043, PMCID: PMC2872040, DOI: 10.1016/j.neuroimage.2010.03.049.Peer-Reviewed Original ResearchConceptsFunctional connectivityWord Reading EfficiencyVerbal Comprehension IndexWechsler Intelligence ScaleRight supramarginal gyrusPeabody Picture VocabularyGreater cognitive deficitsPPVT-R scoresPhonological processingComprehension IndexLanguage tasksChildren-IIIIntelligence ScaleReading efficiencyLanguage deficitsPicture VocabularyWISC-IIISupramarginal gyrusCognitive outcomesNeurobiological basisHemisphere regionsCognitive deficitsWernicke's areaNeural activityLanguage processing
2009
GABAA‐benzodiazepine receptor availability in smokers and nonsmokers: Relationship to subsyndromal anxiety and depression
Esterlis I, Cosgrove KP, Batis JC, Bois F, Kloczynski TA, Stiklus SM, Perry E, Tamagnan GD, Seibyl JP, Makuch R, Krishnan‐Sarin S, O'Malley S, Staley JK. GABAA‐benzodiazepine receptor availability in smokers and nonsmokers: Relationship to subsyndromal anxiety and depression. Synapse 2009, 63: 1089-1099. PMID: 19642218, PMCID: PMC2778224, DOI: 10.1002/syn.20688.Peer-Reviewed Original ResearchConceptsSpielberger State-Trait Anxiety IndexState-Trait Anxiety IndexDepressive symptomsSubsyndromal anxietyAnxiety symptomsPain toleranceReceptor availabilityAbstinent tobacco smokersSex-matched nonsmokersSingle photon emissionPain symptomsHealthy ageSmoking statusTobacco smokersSubsyndromal depressionAbstinent smokersVulnerable smokersCold pressor taskNonsmokersGamma-aminobutyricEpidemiology ScaleSmokersAcute abstinenceBrain areasSymptomsAlterations in neural connectivity in preterm children at school age
Gozzo Y, Vohr B, Lacadie C, Hampson M, Katz KH, Maller-Kesselman J, Schneider KC, Peterson BS, Rajeevan N, Makuch RW, Constable RT, Ment LR. Alterations in neural connectivity in preterm children at school age. NeuroImage 2009, 48: 458-463. PMID: 19560547, PMCID: PMC2775072, DOI: 10.1016/j.neuroimage.2009.06.046.Peer-Reviewed Original ResearchConceptsFunctional magnetic resonance imagingLanguage tasksWernicke's areaLanguage processingPeabody Individual Achievement TestRight inferior frontal gyrusPT childrenAuditory language functionsAuditory language taskCortical language regionsSchool ageInferior frontal gyrusReading comprehension testWechsler Intelligence ScalePeabody Picture VocabularyInferior parietal lobulePT subjectsSchool-aged childrenChildren-IIIComprehension testFrontal gyrusIntelligence ScalePicture VocabularyWISC-IIILanguage regionsIncidence, Prevalence, and Clinical Significance of Abnormal Hematologic Indices in Compensated Cirrhosis
Qamar AA, Grace ND, Groszmann RJ, Garcia–Tsao G, Bosch J, Burroughs AK, Ripoll C, Maurer R, Planas R, Escorsell A, Garcia–Pagan J, Patch D, Matloff DS, Makuch R, Rendon G, Group P. Incidence, Prevalence, and Clinical Significance of Abnormal Hematologic Indices in Compensated Cirrhosis. Clinical Gastroenterology And Hepatology 2009, 7: 689-695. PMID: 19281860, PMCID: PMC4545534, DOI: 10.1016/j.cgh.2009.02.021.Peer-Reviewed Original ResearchConceptsHepatic venous pressure gradientHematologic indicesCompensated cirrhosisBaseline hepatic venous pressure gradientWhite blood cell countChild-Pugh scorePredictors of deathPrimary end pointVenous pressure gradientDevelopment of varicesKaplan-Meier analysisBlood cell countCombination of leukopeniaBaseline thrombocytopeniaVariceal bleedingClinical decompensationEsophageal varicesPrognostic significanceTransplant surgeryClinical significanceLeukopeniaThrombocytopeniaCirrhosisCell countVarices
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
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