2025
Exposure Measurement Error Correction in Longitudinal Studies With Discrete Outcomes
Yang C, Zhang N, Li J, Mehta U, Hart J, Spiegelman D, Wang M. Exposure Measurement Error Correction in Longitudinal Studies With Discrete Outcomes. Statistics In Medicine 2025, 44: e70191. PMID: 40680786, PMCID: PMC12274082, DOI: 10.1002/sim.70191.Peer-Reviewed Original ResearchConceptsNurses' Health Study IIError-prone exposureDiscrete outcomesLongitudinal studyMeasurement error correctionEnvironmental epidemiologistsHealth outcomesTime-varying functionCoverage probability improvementStudy designOccurrence of anxiety disordersStudy IIExposure measurementsEstimation procedureSimulation studyBias reductionAnxiety disordersExposure effectsHistory functionOutcomesChronic exposure effectsExposure historyNursesError correctionEpidemiologistsLearn-As-you-GO (LAGO) trials: optimizing treatments and preventing trial failure through ongoing learning
Bing A, Spiegelman D, Nevo D, Lok J. Learn-As-you-GO (LAGO) trials: optimizing treatments and preventing trial failure through ongoing learning. Biometrics 2025, 81: ujaf061. PMID: 40407021, PMCID: PMC12099308, DOI: 10.1093/biomtc/ujaf061.Peer-Reviewed Original ResearchConceptsIntervention packageBinary outcomesIntervention effectsConditional mean modelsOptimal intervention packagesOverall intervention effectContinuous outcomesComplex intervention packagesConfidence bandsInterval estimationImplementation trialLarge-scale intervention trialsMean modelIntervention trialsHypothesis testingInterventionStandard statistical methodsOutcomesTrialsConfidenceTheoryCorrecting for bias due to mismeasured exposure in mediation analysis with a survival outcome
Cheng C, Spiegelman D, Li F. Correcting for bias due to mismeasured exposure in mediation analysis with a survival outcome. Journal Of The Royal Statistical Society Series C (Applied Statistics) 2025, 74: 969-993. PMID: 40837827, PMCID: PMC12364547, DOI: 10.1093/jrsssc/qlaf010.Peer-Reviewed Original ResearchExposure-mediator interactionProtective effect of physical activityHealth Professionals Follow-up StudyEffects of physical activityReduced body mass indexExposure measurement errorRisk of cardiovascular diseaseBody mass indexPhysical activityMismeasured exposureMass indexRare outcomesFollow-up studyCardiovascular diseaseMediation analysisCox regressionOutcomesBias formulaSurvival outcomesHealthPower and Sample Size Calculations for Cluster Randomized Hybrid Type 2 Effectiveness‐Implementation Studies
Owen M, Curran G, Smith J, Tedla Y, Cheng C, Spiegelman D. Power and Sample Size Calculations for Cluster Randomized Hybrid Type 2 Effectiveness‐Implementation Studies. Statistics In Medicine 2025, 44: e70015. PMID: 39930740, DOI: 10.1002/sim.70015.Peer-Reviewed Original ResearchConceptsHybrid type 2 effectiveness-implementation studySample size calculationCluster randomized trialCluster randomized designSize calculationImplementation research outcomesReduce cardiovascular diseaseIssue of multiple testingEffective outcomesImplementation outcomesCommunity interventionsControl blood pressureBinary outcomesOutcomes approachLiterature searchMultiple testingCardiovascular diseaseInterventionRandomized trialsStandard statistical methodsBlood pressureOutcomesType 2 studies
2024
Estimation and inference for causal spillover effects in egocentric-network randomized trials in the presence of network membership misclassification
Chao A, Spiegelman D, Buchanan A, Forastiere L. Estimation and inference for causal spillover effects in egocentric-network randomized trials in the presence of network membership misclassification. Biostatistics 2024, 26: kxaf009. PMID: 40159413, PMCID: PMC11955068, DOI: 10.1093/biostatistics/kxaf009.Peer-Reviewed Original ResearchConceptsHIV Prevention Trials NetworkBehavioral changesImpact of interventionsPopulation behavior changePeer-based strategiesRandomized trialsIntervention effectsBehavioral interventionsStudy designSpillover effectsInterventionTrials NetworkInvestigate finite sample propertiesAverage spillover effectFinite sample propertiesBehavioral trainingParticipantsLeverage peer influenceMisclassificationDisseminate informationInterference settingOutcomesPeer influenceSurrogate networksSample propertiesCausal Selection of Covariates in Regression Calibration for Mismeasured Continuous Exposure
Tang W, Spiegelman D, Liao X, Wang M. Causal Selection of Covariates in Regression Calibration for Mismeasured Continuous Exposure. Epidemiology 2024, 35: 320-328. PMID: 38630507, PMCID: PMC12337126, DOI: 10.1097/ede.0000000000001706.Peer-Reviewed Original ResearchConceptsMismeasured exposureOutcome modelRegression calibrationMeasurement error modelSelection of covariatesNonparametric settingEffect modificationCovariate adjustmentFiber intakeMeasurement errorCardiovascular diseaseEffects of fiber intakeStudy datasetOutcomesCovariatesComprehensive guidanceError modelRegressionHealthEfficiency lossErrorRosnerWillettExposureAdjustment
2023
Mediation analysis in the presence of continuous exposure measurement error
Cheng C, Spiegelman D, Li F. Mediation analysis in the presence of continuous exposure measurement error. Statistics In Medicine 2023, 42: 1669-1686. PMID: 36869626, PMCID: PMC11320713, DOI: 10.1002/sim.9693.Peer-Reviewed Original ResearchConceptsBody mass indexExposure measurement errorPhysical activityMediation proportionHealth Professionals FollowCardiovascular disease incidenceProfessionals FollowMediation analysisMass indexCardiovascular diseaseLower riskStudy designEffect estimatesValidation study designContinuous exposureBiased effect estimatesTrue exposureMediatorsExposureValidation studyBinary outcomesHealth science studiesOutcomesRiskDisease incidence
2021
swdpwr: A SAS macro and an R package for power calculations in stepped wedge cluster randomized trials
Chen J, Zhou X, Li F, Spiegelman D. swdpwr: A SAS macro and an R package for power calculations in stepped wedge cluster randomized trials. Computer Methods And Programs In Biomedicine 2021, 213: 106522. PMID: 34818620, PMCID: PMC8665077, DOI: 10.1016/j.cmpb.2021.106522.Peer-Reviewed Original ResearchConceptsWedge clusterIntracluster correlation coefficientContinuous outcomesCross-sectional cohortBinary outcomesExchangeable correlation structureWedge designPublic health intervention evaluationsHealth services researchClosed cohort designPower calculationCohort designClosed cohortStudy designIntracluster correlationIntervention evaluationNeeds of investigatorsOutcomesTrialsCohortServices researchInvestigatorsPrevious studiesSWD
2020
Coaching Intensity, Adherence to Essential Birth Practices, and Health Outcomes in the BetterBirth Trial in Utter Pradesh, India
Barnhart DA, Spiegelman D, Zigler CM, Kara N, Delaney MM, Kalita T, Maji P, Hirschhorn LR, Semrau KEA. Coaching Intensity, Adherence to Essential Birth Practices, and Health Outcomes in the BetterBirth Trial in Utter Pradesh, India. Global Health Science And Practice 2020, 8: ghsp-d-19-00317. PMID: 32127359, PMCID: PMC7108945, DOI: 10.9745/ghsp-d-19-00317.Peer-Reviewed Original ResearchConceptsEssential birth practicesSafe Childbirth ChecklistPerinatal health outcomesBirth attendantsHealth outcomesBetterBirth trialWorld Health Organization Safe Childbirth ChecklistBirth practicesQuality of careSustain behavior changeCoaching-based interventionBehavior changeFrequent coachingPerinatal mortalityBirth facilityAdherenceOutcomesGreater improvementAttendantsVisitsTrialsMonthsRegression modelsAssociationUtter PradeshOptimizing the development and evaluation of complex interventions: lessons learned from the BetterBirth Program and associated trial
Barnhart DA, Semrau KEA, Zigler CM, Molina RL, Delaney MM, Hirschhorn LR, Spiegelman D. Optimizing the development and evaluation of complex interventions: lessons learned from the BetterBirth Program and associated trial. Implementation Science Communications 2020, 1: 29. PMID: 32885188, PMCID: PMC7427863, DOI: 10.1186/s43058-020-00014-8.Peer-Reviewed Original ResearchSafe Childbirth ChecklistComplex intervention developmentComplex interventionsBetterBirth ProgramWorld Health Organization Safe Childbirth ChecklistIntervention developmentIntervention packageEffective intervention componentsReal-world studyFuture complex interventionsNeonatal healthAdvanced stageIntervention componentsComplete data collectionTrialsInterventionHealth impactsImplementation intensityFull-scale trialFuture studiesOutcomesFull-scale evaluationEvaluation
2001
The association between maternal HIV‐1 infection and pregnancy outcomes in Dar es Salaam, Tanzania
Coley J, Msamanga G, Fawzi M, Kaaya S, Hertzmark E, Kapiga S, Spiegelman D, Hunter D, Fawzi W. The association between maternal HIV‐1 infection and pregnancy outcomes in Dar es Salaam, Tanzania. BJOG An International Journal Of Obstetrics & Gynaecology 2001, 108: 1125-1133. PMID: 11762650, PMCID: PMC6276363, DOI: 10.1111/j.1471-0528.2003.00269.x.Peer-Reviewed Original ResearchConceptsAdverse pregnancy outcomesPregnancy outcomesSymptomatic HIVLow birthweightPregnant womenHigh riskMaternal HIV-1 infectionMaternal HIV infectionCohort of HIVProspective cohort studyHIV-1 infectionWeeks of gestationPotential confounding factorsDar es SalaamCohort studyHIV infectionGestational ageImmature infantsFetal lossHead circumferenceHIVConfounding factorsWomenOutcomesSignificant differencesThe association between maternal HIV-1 infection and pregnancy outcomes in Dar es Salaam, Tanzania
Coley J, Msamanga G, Fawzi M, Kaaya S, Hertzmark E, Kapiga S, Spiegelman D, Hunter D, Fawzi W. The association between maternal HIV-1 infection and pregnancy outcomes in Dar es Salaam, Tanzania. BJOG An International Journal Of Obstetrics & Gynaecology 2001, 108: 1125-1133. DOI: 10.1016/s0306-5456(01)00269-8.Peer-Reviewed Original ResearchAdverse pregnancy outcomesPregnancy outcomesSymptomatic HIVLow birthweightPregnant womenHigh riskMaternal HIV-1 infectionMaternal HIV infectionCohort of HIVHIV-1 infectionWeeks of gestationPotential confounding factorsDar es SalaamConclusion HIVHIV infectionGestational ageImmature infantsFetal lossHead circumferenceHIVConfounding factorsWomenOutcomesSignificant differencesBirthweight
1997
Adverse Outcomes of Underuse of β-Blockers in Elderly Patients-Reply
Soumerai S, McLaughlin T, Spiegelman D, Hertzmark E, Thibault G, Goldman L. Adverse Outcomes of Underuse of β-Blockers in Elderly Patients-Reply. JAMA 1997, 277: 1436-1437. DOI: 10.1001/jama.1997.03540420032022.Peer-Reviewed Original ResearchCalcium channel blockersChannel blockersΒ-blockersNondihydropyridine calcium channel blockersNational evidence-based guidelinesDihydropyridine calcium channel blockerΒ-blocker useAdministrative claims databaseLipid-lowering agentsEvidence-based guidelinesEffective drug classClaims databaseAdverse outcomesDrug classesComparative efficacyBlockersCommunity settingsPatients' repliesAspirinPrevious reportsUnderuseOutcomesPatientsTrialsStatistical issues in assessing human population exposures
Weller E, Ryan L, Spiegelman D, Smith T. Statistical issues in assessing human population exposures. Chemometrics And Intelligent Laboratory Systems 1997, 37: 189-195. DOI: 10.1016/s0169-7439(97)00003-8.Peer-Reviewed Original ResearchDose-response relationshipStatistical issuesExposure-dose relationshipsMeasurement error problemsPrimary scientific interestHealth effectsStatistical aspectsStatistical methodsEnvironmental epidemiology studiesHealth outcomesEpidemiology studiesHuman population exposureExposure levelsMeasurement errorExposure assessmentError problemDirect applicationWelding fumesLoss of efficiencyExposureOutcomesPopulation exposureDose
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