2025
Evaluating the impact of stratification on the power and cross-arm balance of randomized phase 2 clinical trials
Moseley A, LeBlanc M, Freidlin B, Shallis R, Zeidan A, Sallman D, Erba H, Little R, Othus M. Evaluating the impact of stratification on the power and cross-arm balance of randomized phase 2 clinical trials. Clinical Trials 2025, 22: 361-366. PMID: 39815460, PMCID: PMC12143638, DOI: 10.1177/17407745241304065.Peer-Reviewed Original ResearchStratified analysisSample sizeRandomization ratioRandomization methodType 1 errorStratified block randomizationRandomized clinical trialsUnstratified analysisBlock randomizationStratification factorsClinical trialsStratification subgroupsTrialsPhase 2 trialDecreased powerSubgroupsRandomized phase 2 clinical trialFactorsRandomizationRandomized phase 2 trial
2024
Classification system of human ovarian follicle morphology: recommendations of the National Institute of Child Health and Human Development - sponsored ovarian nomenclature workshop
Yano Maher J, Zelinski M, Oktay K, Duncan F, Segars J, Lujan M, Lou H, Yun B, Hanfling S, Schwartz L, Laronda M, Halvorson L, O'Neill K, Gomez-Lobo V. Classification system of human ovarian follicle morphology: recommendations of the National Institute of Child Health and Human Development - sponsored ovarian nomenclature workshop. Fertility And Sterility 2024, 123: 761-778. PMID: 39549739, PMCID: PMC12045743, DOI: 10.1016/j.fertnstert.2024.11.016.Peer-Reviewed Original ResearchPreantral folliclesAntral folliclesWorking subgroupEunice Kennedy Shriver National Institute of Child HealthNormal antral folliclesAntral follicle stageNational Institute of Child HealthInstitute of Child HealthPre-ovulatory folliclesPreantral stageAbnormal oocytesFollicle stageGranulosa cellsCorpora luteaFolliclesFollicle typesHuman fertilitySubgroupsFollicle densityAssessed changesCliniciansChild healthNICHDGranulosaOvarianNeurostructural subgroup in 4291 individuals with schizophrenia identified using the subtype and stage inference algorithm
Jiang Y, Luo C, Wang J, Palaniyappan L, Chang X, Xiang S, Zhang J, Duan M, Huang H, Gaser C, Nemoto K, Miura K, Hashimoto R, Westlye L, Richard G, Fernandez-Cabello S, Parker N, Andreassen O, Kircher T, Nenadić I, Stein F, Thomas-Odenthal F, Teutenberg L, Usemann P, Dannlowski U, Hahn T, Grotegerd D, Meinert S, Lencer R, Tang Y, Zhang T, Li C, Yue W, Zhang Y, Yu X, Zhou E, Lin C, Tsai S, Rodrigue A, Glahn D, Pearlson G, Blangero J, Karuk A, Pomarol-Clotet E, Salvador R, Fuentes-Claramonte P, Garcia-León M, Spalletta G, Piras F, Vecchio D, Banaj N, Cheng J, Liu Z, Yang J, Gonul A, Uslu O, Burhanoglu B, Uyar Demir A, Rootes-Murdy K, Calhoun V, Sim K, Green M, Quidé Y, Chung Y, Kim W, Sponheim S, Demro C, Ramsay I, Iasevoli F, de Bartolomeis A, Barone A, Ciccarelli M, Brunetti A, Cocozza S, Pontillo G, Tranfa M, Park M, Kirschner M, Georgiadis F, Kaiser S, Van Rheenen T, Rossell S, Hughes M, Woods W, Carruthers S, Sumner P, Ringin E, Spaniel F, Skoch A, Tomecek D, Homan P, Homan S, Omlor W, Cecere G, Nguyen D, Preda A, Thomopoulos S, Jahanshad N, Cui L, Yao D, Thompson P, Turner J, van Erp T, Cheng W, Feng J. Neurostructural subgroup in 4291 individuals with schizophrenia identified using the subtype and stage inference algorithm. Nature Communications 2024, 15: 5996. PMID: 39013848, PMCID: PMC11252381, DOI: 10.1038/s41467-024-50267-3.Peer-Reviewed Original ResearchConceptsGray matter changesDisorder constructsEnlarged striatumPsychiatric conditionsMental disordersSubcortical regionsSchizophreniaBiological foundationsMatter changesBrain imagingStriatumDisordersBiological factorsIndividualsSubtypesHealthy subjectsCross-sectional brain imagingHippocampusTemporal trajectoriesInternational cohortSubgroup 2Subgroup 1SubgroupsReporting of Demographics & Subgroup Analyses in Premarketing Studies of FDA Approved High-Risk Cardiovascular Devices, 2014–2022
Swanson M, Uyeki C, Yoder S, Dhruva S, Miller J, Ross J. Reporting of Demographics & Subgroup Analyses in Premarketing Studies of FDA Approved High-Risk Cardiovascular Devices, 2014–2022. Medical Devices Evidence And Research 2024, 17: 165-172. PMID: 38707869, PMCID: PMC11067925, DOI: 10.2147/mder.s457152.Peer-Reviewed Original ResearchFood and Drug AdministrationHigh-risk cardiovascular devicesSubgroup analysisPremarketing studiesUS Food and Drug AdministrationResults of subgroup analysisParticipation of older adultsStudy participantsClinical trialsSocioeconomic positionTrial populationDrug AdministrationStudy populationConduction of subgroup analysisDemographic dataOlder adultsReporting of demographicsSubgroupsPatients' socioeconomic position.PatientsTrialsEndotracheal Tube Size Adjustments Within Seven Days of Neonatal Intubation.
Peebles P, Jensen E, Herrick H, Wildenhain P, Rumpel J, Moussa A, Singh N, Abou Mehrem A, Quek B, Wagner M, Pouppirt N, Glass K, Tingay D, Hodgson K, O'Shea J, Sawyer T, Brei B, Jung P, Unrau J, Kim J, Barry J, DeMeo S, Johnston L, Nishisaki A, Foglia E. Endotracheal Tube Size Adjustments Within Seven Days of Neonatal Intubation. 2024, 153 PMID: 38469643, PMCID: PMC10979295, DOI: 10.1542/peds.2023-062925.Peer-Reviewed Original ResearchNeonatal Resuscitation ProgramSevere oxygen desaturationEndotracheal tubeOxygen desaturationETT sizeWeight subgroupsNeonatal Resuscitation Program recommendationsRetrospective multicenter cohort studyAssociated with fewer adverse eventsMulticenter cohort studyFewer adverse eventsEndotracheal tube sizeAssociated with lower oddsNeonatal endotracheal tubeNeonatal intubationAdverse eventsResuscitation ProgramCohort studyAdverse outcomesAirway RegistryTracheal intubationInfantsLower oddsIntubationSubgroupsReal-World Evidence of Omnipod® 5 Automated Insulin Delivery System Use in 69,902 People with Type 1 Diabetes
Forlenza G, DeSalvo D, Aleppo G, Wilmot E, Berget C, Huyett L, Hadjiyianni I, Méndez J, Conroy L, Ly T, Sherr J. Real-World Evidence of Omnipod® 5 Automated Insulin Delivery System Use in 69,902 People with Type 1 Diabetes. Diabetes Technology & Therapeutics 2024, 26: 514-525. PMID: 38375861, DOI: 10.1089/dia.2023.0578.Peer-Reviewed Original ResearchGlucose targetsType 1 diabetesSubgroup analysisGlycemic outcomesReal-world evidenceMultiple daily injectionsYounger age groupsBaseline characteristicsDaily injectionsRetrospective analysisClinical trialsMedian percentageAge groupsResults:</i></b>OmnipodDelivery systemOutcomesInsulin delivery systemsT1DSubgroupsDiverse sample
2023
Pembrolizumab versus methotrexate, docetaxel, or cetuximab in recurrent or metastatic head and neck squamous cell carcinoma (KEYNOTE-040): Subgroup analysis by pattern of disease recurrence
Harrington K, Cohen E, Soulières D, Dinis J, Licitra L, Ahn M, Soria A, Machiels J, Mach N, Mehra R, Burtness B, Swaby R, Lin J, Ge J, Lerman N, Tourneau C. Pembrolizumab versus methotrexate, docetaxel, or cetuximab in recurrent or metastatic head and neck squamous cell carcinoma (KEYNOTE-040): Subgroup analysis by pattern of disease recurrence. Oral Oncology 2023, 147: 106587. PMID: 37925894, DOI: 10.1016/j.oraloncology.2023.106587.Peer-Reviewed Original ResearchConceptsSubgroup analysisRecurrence patternsNeck squamous cell carcinomaDisease recurrence patternsPlatinum-containing treatmentSquamous cell carcinomaLonger OSProlonged OSAdvanced diseaseData cutoffDefinitive therapyMetastatic headDurable responsesHazard ratioDisease recurrenceMetastatic HNSCCTreatment armsCell carcinomaM diseaseInvestigator's choicePatientsPembrolizumabRecurrentOnly subgroupSubgroupsWhen to expect scalp hair regrowth during treatment of severe alopecia areata with baricitinib: insights from trajectories analyses of patients enrolled in two phase III trials
King B, Shapiro J, Ohyama M, Egeberg A, Piraccini B, Craiglow B, Sinclair R, Chen Y, Wu W, Ding Y, Somani N, Dutronc Y. When to expect scalp hair regrowth during treatment of severe alopecia areata with baricitinib: insights from trajectories analyses of patients enrolled in two phase III trials. British Journal Of Dermatology 2023, 189: 666-673. PMID: 37708254, DOI: 10.1093/bjd/ljad253.Peer-Reviewed Original ResearchSevere alopecia areataBaricitinib-treated patientsPhase III trialsAlopecia areataResponder subgroupBaricitinib 4Hair regrowthIII trialsGrowth mixture modellingTreatment expectationsLate respondersEarly respondersBaseline disease characteristicsTreatment of adultsSALT scoreWeek 52Baseline characteristicsClinical outcomesDisease characteristicsTreatment allocationHair lossPatientsResponse subgroupsRespondersSubgroupsPolysubstance addiction patterns among 7,989 individuals with cocaine use disorder
Stiltner B, Pietrzak R, Tylee D, Nunez Y, Adhikari K, Kranzler H, Gelernter J, Polimanti R. Polysubstance addiction patterns among 7,989 individuals with cocaine use disorder. IScience 2023, 26: 107336. PMID: 37554454, PMCID: PMC10405253, DOI: 10.1016/j.isci.2023.107336.Peer-Reviewed Original ResearchCocaine use disorderUse disordersAddiction patternsMixed bipolar episodesLatent class analysisDSM-5 diagnosisPosttraumatic stress disorderAntisocial personality disorderPsA severityMedication useHigher PSAPSA subgroupsHigher oddsBipolar episodesStress disorderPersonality disorderDisordersSubgroupsAgeSexClass analysisParticipantsComorbiditiesDiseaseDiagnosisA continent-wide effort and solidarity at curbing COVID-19 pandemic: the Africa task force for novel coronavirus (AFTCOR) infection prevention and control technical working group’s experience
Paintsil E, Alimi Y, Abdulaziz M, Ogbuagu O, Ogunsola F, Kessy S, Horsney E, Lee C, Brundney K, Okwor T, Kabwe P, Waheed A, Vondran A, Bigirimana R, Ilesanmi O, Nsubuga D, Raji T, Mankoula W, Ihekweazu C, Nkengasong J. A continent-wide effort and solidarity at curbing COVID-19 pandemic: the Africa task force for novel coronavirus (AFTCOR) infection prevention and control technical working group’s experience. BMC Public Health 2023, 23: 893. PMID: 37189137, PMCID: PMC10184057, DOI: 10.1186/s12889-023-15706-8.Peer-Reviewed Original ResearchConceptsInfection preventionCDC websiteNovel coronavirus disease (COVID-19) outbreakService delivery pointsCoronavirus disease (COVID-19) outbreakTask ForceIPC trainingResearch subgroupsIPC programIPC measuresHealth personnelDisease controlWorking GroupImplementation researchOutbreaks of diseaseSubgroupsPreventionCOVID-19COVID-19 pandemicTechnical Working GroupAfrica CentrePerson trainingTraining subgroupFocal personsDisease outbreaksIncreasing Use of Cannabis for Medical Purposes Among U.S. Residents, 2013–2020
Rhee T, Rosenheck R. Increasing Use of Cannabis for Medical Purposes Among U.S. Residents, 2013–2020. American Journal Of Preventive Medicine 2023, 65: 528-533. PMID: 36918131, PMCID: PMC10440227, DOI: 10.1016/j.amepre.2023.03.005.Peer-Reviewed Original ResearchConceptsMedical cannabis useAverage annual percentage changeAnnual percentage changeUse of cannabisCannabis useClinical subgroupsPercentage changeMultivariable-adjusted modelsCorrelates of cannabisSimilar significant increaseMedical cannabisDrug useDistrict of ColumbiaCannabisMedical purposesNationwide increaseSignificant increaseNational surveyDichotomous questionsU.S. residentsSubgroupsTemporal trendsA quantitative assessment of the frequency and magnitude of heterogeneous treatment effects in studies of the health effects of social policies
Cintron D, Gottlieb L, Hagan E, Tan M, Vlahov D, Glymour M, Matthay E. A quantitative assessment of the frequency and magnitude of heterogeneous treatment effects in studies of the health effects of social policies. SSM - Population Health 2023, 22: 101352. PMID: 36873266, PMCID: PMC9975308, DOI: 10.1016/j.ssmph.2023.101352.Peer-Reviewed Original ResearchComparing a Computerized Digit Symbol Test to a Pen-and-Paper Classic
Pratt D, Luther L, Kinney K, Osborne K, Corlett P, Powers A, Woods S, Gold J, Schiffman J, Ellman L, Strauss G, Walker E, Zinbarg R, Waltz J, Silverstein S, Mittal V. Comparing a Computerized Digit Symbol Test to a Pen-and-Paper Classic. Schizophrenia Bulletin Open 2023, 4: sgad027. PMID: 37868160, PMCID: PMC10590153, DOI: 10.1093/schizbullopen/sgad027.Peer-Reviewed Original ResearchClinical high riskCHR individualsFinger-tapping taskMotor ability measuresDigit symbol testCHR stateHealthy controlsHigh riskClinical InterviewPersistent subgroupSymbol testPersistent groupImpairmentPaper versionMotor abilitiesTask performance differencesComputerized versionSimilar degreeEffect sizeMeasures impairmentPsychosisCoding TestRemote assessmentSubgroupsDigit-symbol task
2022
Tivozanib in Patients with Advanced Renal Cell Carcinoma Previously Treated With Axitinib: Subgroup Analysis from TIVO-3
Meza L, McDermott D, Escudier B, Hutson T, Porta C, Verzoni E, Atkins M, Kasturi V, Pal S, Rini B. Tivozanib in Patients with Advanced Renal Cell Carcinoma Previously Treated With Axitinib: Subgroup Analysis from TIVO-3. The Oncologist 2022, 28: e167-e170. PMID: 36576430, PMCID: PMC10020797, DOI: 10.1093/oncolo/oyac255.Peer-Reviewed Original ResearchConceptsMetastatic renal cell carcinomaProgression-free survivalRenal cell carcinomaTIVO-3Cell carcinomaResponse rateEvaluate PFSAdvanced renal cell carcinomaTreated with axitinibTreatment of patientsClinical efficacyIdentified patientsSubgroup analysisTivozanibAxitinibPatientsCarcinomaSorafenibTreatmentMonthsSubgroupsTrialsTherapySurvivalDrugDelphi study to explore a new diagnosis for “ineffective” long-term opioid therapy for chronic pain
Edmond S, Snow J, Pomeranz J, Van Cleve R, Black A, Compton P, Becker W. Delphi study to explore a new diagnosis for “ineffective” long-term opioid therapy for chronic pain. Pain 2022, 164: 870-876. PMID: 36448976, DOI: 10.1097/j.pain.0000000000002783.Peer-Reviewed Original ResearchConceptsLong-term opioid therapyNew diagnostic entityDiagnostic criteriaPotential diagnostic criteriaDiagnostic entityOpioid therapyChronic painOpioid use disorderCertain patientsNew diagnosisUse disordersDelphi studyPainDisorder criteriaSubgroup of expertsRound 2PatientsTherapyThree-quartersRefining criteriaDelphi panelistsExpert panelistsSubgroupsLikert-type scaleRapid qualitative analysisLife course traumas and cardiovascular disease—the mediating role of accelerated aging
Cao X, Zhang J, Ma C, Li X, Kuo C, Levine ME, Hu G, Allore H, Chen X, Wu X, Liu Z. Life course traumas and cardiovascular disease—the mediating role of accelerated aging. Annals Of The New York Academy Of Sciences 2022, 1515: 208-218. PMID: 35725988, PMCID: PMC10145586, DOI: 10.1111/nyas.14843.Peer-Reviewed Original ResearchRecurrent Loss of Heterozygosity in Pancreatic Neuroendocrine Tumors
Parilla M, Chapel D, Hechtman J, Wanjari P, Jabbour T, Sharma A, Ritterhouse L, Segal J, Vanderbilt C, Klimstra D, Setia N, Tang L. Recurrent Loss of Heterozygosity in Pancreatic Neuroendocrine Tumors. The American Journal Of Surgical Pathology 2022, 46: 823-831. PMID: 35125451, PMCID: PMC9106831, DOI: 10.1097/pas.0000000000001860.Peer-Reviewed Original ResearchConceptsPancreatic neuroendocrine tumorsNeuroendocrine tumorsChromosomal copy number alterationsLoss of chromosome 11Loss of chromosome 1Recurrent loss of heterozygosityLoss of heterozygosityCopy number alterationsDisease-specific mortalityPrognostic markerChromosome aneuploidyTumor typesNext-generation sequencingChromosomal subgroupsAggressive subgroupTumorRecurrent lossChromosome 1Chromosome 11Third groupSubgroupsMortalityStatistical analysisMultivariate statistical analysisAneuploidy
2021
Is Isolated Diastolic Hypertension an Important Phenotype?
Romero CA, Tabares AH, Orias M. Is Isolated Diastolic Hypertension an Important Phenotype? Current Cardiology Reports 2021, 23: 177. PMID: 34657205, PMCID: PMC8753786, DOI: 10.1007/s11886-021-01609-w.Peer-Reviewed Original ResearchConceptsNarrow pulse pressureDiastolic hypertensionCardiovascular riskPulse pressureLong-term cardiovascular riskRecent FindingsRecent guidelinesHypertension subgroupIDH definitionsIDH prevalenceHypertensive patientsYounger patientsRisk stratificationEpidemiological characteristicsTherapeutic decisionsPharmacological interventionsHypertension phenotypesCutoff levelHypertensionImportant subgroupPatientsPathophysiologyRiskSubgroupsIDHLong termObesity Prevalence and Risks Among Chinese Adults: Findings From the China PEACE Million Persons Project, 2014–2018
Mu L, Liu J, Zhou G, Wu C, Chen B, Lu Y, Lu J, Yan X, Zhu Z, Nasir K, Spatz ES, Krumholz HM, Zheng X. Obesity Prevalence and Risks Among Chinese Adults: Findings From the China PEACE Million Persons Project, 2014–2018. Circulation Cardiovascular Quality And Outcomes 2021, 14: e007292-e007292. PMID: 34107739, PMCID: PMC8204767, DOI: 10.1161/circoutcomes.120.007292.Peer-Reviewed Original ResearchConceptsAbdominal obesitySocio-demographic subgroupsSocio-demographic associationsOverall obesityHigh riskMillion Persons ProjectEpidemic of obesityAge-standardized ratesCommunity-dwelling adultsAssociation of ageMultivariable mixed modelsObesity prevalenceOlder womenLower riskObesityOlder menChinese adultsPrevalenceWomenRiskMenPersons ProjectSubgroupsAssociationAdultsDevelopment and Validation of the Brazilian Portuguese Version of the Reported and Intended Behaviour Scale (RIBS-BP)
Ribeiro W, Gronholm P, de Paula C, Hoffmann M, Vistorte A, Zugman C, Pan P, de Jesus Mari J, Rohde L, Miguel E, Bressan R, Salum G, Evans-Lacko S. Development and Validation of the Brazilian Portuguese Version of the Reported and Intended Behaviour Scale (RIBS-BP). Stigma And Health 2021, 6: 163-172. DOI: 10.1037/sah0000224.Peer-Reviewed Original ResearchIntended Behaviour ScaleBrazilian Portuguese versionStigma-related behaviorsSocioeconomic statusCommunity-based cohortPrevious contactPortuguese versionInternal consistencyHigher socioeconomic statusMental health professionalsSubgroups of genderGood internal consistencyCaregiver educationHealth professionalsMental illnessBehavior ScaleMultiple causesUnidimensional latent factorCFA fit indicesFace validitySubgroupsConfirmatory factor analysisValid measureQuestionnaire translationBehavior items
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