2025
Skin Elasticity: A Potential Surrogate Marker for Facial Allograft Skin Fibrosis—A Case Series
Stögner V, Boroumand S, Vafa A, Huelsboemer L, Kauke‐Navarro M, Formica R, Leffell D, Haykal S, Pomahac B. Skin Elasticity: A Potential Surrogate Marker for Facial Allograft Skin Fibrosis—A Case Series. Clinical Transplantation 2025, 39: e70175. PMID: 40460163, DOI: 10.1111/ctr.70175.Peer-Reviewed Original ResearchConceptsPost-transplant yearVascularized Composite AllotransplantationRecipient/donor ageImmunosuppressive regimensSurrogate markerSmoking statusVascularized composite allotransplantation recipientsPotential surrogate markersBilateral upper armsFace transplant recipientsSkin elasticity measurementsAllograft fibrosisChronic rejectionGraft lossTransplant recipientsBilateral cheeksCase seriesDermal fibrosisSkin changesFacial allograftDegenerative skin changesGraft changesFacial skinNet elasticityRejection burdenIndustry promotion of oncology drugs with accelerated approval that failed confirmatory trials.
Mooghali M, Ramachandran R, Mohammad A, Mitchell A. Industry promotion of oncology drugs with accelerated approval that failed confirmatory trials. Journal Of Clinical Oncology 2025, 43: 11029-11029. DOI: 10.1200/jco.2025.43.16_suppl.11029.Peer-Reviewed Original ResearchClinical benefitAccelerated approvalOncology drugsConfirmatory studiesConfirmatory trialsResults of confirmatory studiesFDA-accelerated approvalInfluence treatment recommendationsAccelerated approval drugsCross-sectional studyBelantamab mafodotinMedian durationMedian timeSurrogate markerPostapproval studiesVincristine sulfateTreatment recommendationsDrugs@FDA databaseIndustry paymentsFDA recommendationsU.S. FDADrugOncologyNegative resultsFDAFrom Chronic Opioids for Pain to Microgram Buprenorphine: Key Factors in an Increasingly Recommended Transition.
Hickey T, Hitt J. From Chronic Opioids for Pain to Microgram Buprenorphine: Key Factors in an Increasingly Recommended Transition. Pain Physician Journal 2025, 28: 59-67. PMID: 39903018.Peer-Reviewed Original ResearchConceptsOpioid therapyBuprenorphine exposureTotal dose of opioidsVeterans Health AdministrationChronic opioid therapyDoses of opioidsChronic pain managementOutpatient opioid prescriptionsReducing opioid useFull-agonist opioidsPrescription of buprenorphineTransition to buprenorphineAssociated with lower oddsVeterans Affairs Corporate Data WarehouseBaseline opioidChronic opioidsOpioid doseAgonist opioidsOpioid exposureHealth AdministrationOpioid prescriptionsOpioid useSurrogate markerLarge-scale observational studiesBuprenorphine initiation
2024
Premarket Pivotal Trial End Points and Postmarketing Requirements for FDA Breakthrough Therapies
Mooghali M, Wallach J, Ross J, Ramachandran R. Premarket Pivotal Trial End Points and Postmarketing Requirements for FDA Breakthrough Therapies. JAMA Network Open 2024, 7: e2430486. PMID: 39190303, PMCID: PMC11350476, DOI: 10.1001/jamanetworkopen.2024.30486.Peer-Reviewed Original ResearchConceptsFood and Drug Administration tableFood and Drug AdministrationSurrogate end pointsSurrogate markerPostmarketing studiesEnd pointsTraditional approvalCross-sectional studyClinical benefitAccelerated approvalTherapy designClinically significant end pointsReview of therapeuticsPrimary end pointUS Food and Drug AdministrationTrial end pointsSignificant end pointsPostmarketing requirementsPreliminary clinical evidenceApproval pathwayPivotal trialsClinical evidenceBreakthrough therapiesDrug AdministrationTherapyIncreased Spironolactone Dosing in Acute Heart Failure Alters Potassium Homeostasis but Does not Enhance Decongestion
Natov P, Ivey-Miranda J, Cox Z, Rao V, Butler J, Konstam M, Kiernan M, Kapur N, Testani J. Increased Spironolactone Dosing in Acute Heart Failure Alters Potassium Homeostasis but Does not Enhance Decongestion. Journal Of Cardiac Failure 2024, 30: 1522-1526. PMID: 38986838, DOI: 10.1016/j.cardfail.2024.06.008.Peer-Reviewed Original ResearchBaseline serum potassiumAcute heart failureSerum potassiumSpironolactone treatmentTreatment armsHeart failureBaseline serum potassium levelsNatriuretic peptide levelsTreated with spironolactoneSerum potassium levelsSpironolactone-treated patientsNet fluid lossRenal potassium handlingPost Hoc AnalysisEnhance decongestionSpironolactone dosePotassium wastingUrine outputClinical congestionTreatment startPotassium handlingPotassium replacementPotassium supplementationPharmacodynamic effectsSurrogate markerEffect of Filtered Blood Return on Outcomes of Pulmonary Aspiration Thrombectomy
Bitar R, Bozal S, Sisti A, Mojibian H, Marino A, Cornman-Homonoff J. Effect of Filtered Blood Return on Outcomes of Pulmonary Aspiration Thrombectomy. Journal Of Vascular And Interventional Radiology 2024, 35: 1447-1456. PMID: 38950819, DOI: 10.1016/j.jvir.2024.06.026.Peer-Reviewed Original ResearchPulmonary artery pressureAspiration thrombectomyPulmonary embolismArterial pressureDuration of intensive care unitSeverity of adverse eventsLength of hospital stayHigh-risk PEProcedure-related complicationsAdverse event ratesIntensive care unitMarker of procedural successFluoroscopy timeTransfusion requirementsBlood lossNo significant differenceTransfusion needsHospital stayPost-procedureProcedural successAdverse eventsSurrogate markerLaboratory valuesProcedural outcomesProcedural detailsTranscriptional Profiling Underscores the Role of Preprocurement Allograft Metabolism and Innate Immune Status on Outcomes in Human Liver Transplantation
Kim J, Zimmermann M, Mathison A, Lomberk G, Urrutia R, Hong J. Transcriptional Profiling Underscores the Role of Preprocurement Allograft Metabolism and Innate Immune Status on Outcomes in Human Liver Transplantation. Annals Of Surgery Open 2024, 5: e444-e444. PMID: 38911661, PMCID: PMC11191965, DOI: 10.1097/as9.0000000000000444.Peer-Reviewed Original ResearchOrthotopic liver transplantationIschemia-reperfusion injuryCold ischemiaLiver transplantationPrimary orthotopic liver transplantationGraft ischemia-reperfusion injuryClinical orthotopic liver transplantationEffects of ischemia-reperfusion injuryLiver graft ischemia-reperfusion injuryHuman orthotopic liver transplantationTherapeutic targetLiver allograft biopsiesHuman liver transplantationInflammatory response genesIAF groupAllograft injuryDecreased metabolic activityAllograft dysfunctionAllograft functionAllograft biopsiesGene expressionSurrogate markerFatty acid-metabolizing activitiesMetabolic activityHistological evaluationAssociations Between Surrogate Markers and Clinical Outcomes for Nononcologic Chronic Disease Treatments
Wallach J, Yoon S, Doernberg H, Glick L, Ciani O, Taylor R, Mooghali M, Ramachandran R, Ross J. Associations Between Surrogate Markers and Clinical Outcomes for Nononcologic Chronic Disease Treatments. JAMA 2024, 331: 1646-1654. PMID: 38648042, PMCID: PMC11036312, DOI: 10.1001/jama.2024.4175.Peer-Reviewed Original ResearchConceptsMeta-analysesChronic diseasesFood and Drug AdministrationMeta-regression analysisMeta-analyses of observational studiesSurrogate markerClinical outcomesClinical trialsMeta-analysisEvidence of associationPublished meta-analysesStrength of associationMeta-analyses of clinical trialsChronic disease treatmentFood and Drug Administration tableResults of meta-regression analysisOutcome pairsFood and Drug Administration approvalMain OutcomesData extractionSystematic reviewStatistically significant resultsObservational studyPooled analysisDrug AdministrationSocioeconomic Disparities in Research Participation: Bias in Plastic Surgery Residency Match
Lin L, Huttinger A, Butler P, Gosman A, Janis J. Socioeconomic Disparities in Research Participation: Bias in Plastic Surgery Residency Match. Plastic & Reconstructive Surgery Global Open 2024, 12: e5565. PMID: 38313590, PMCID: PMC10836880, DOI: 10.1097/gox.0000000000005565.Peer-Reviewed Original ResearchSocioeconomic disparitiesInvestigate socioeconomic disparitiesNortheastern medical schoolCross-sectional surveyPercentage of respondentsChi-square testFinancial hardshipMedical schoolsResidency programsNonacademic settingsSocioeconomic biasSurgery residency programsDisparitiesParticipantsPlastic surgeonsResearch participantsSummary tablesPlastic surgery residency programsCareer progressionResidency matchAdvanced degreesIntegrated plastic surgery residency programsResidency applicantsRespondentsSurrogate marker
2023
Methodological rigour in preclinical urology: a systematic review reporting research quality over a 14‐year period
Park S, Lee B, Park S, Kim E, Pizzol D, Trott M, Barnett Y, Koyanagi A, Jacob L, Soysal P, Veronese N, Ippoliti S, Ghayda R, Thirumavalavan N, Hijaz A, Sheyn D, Pope R, Conroy B, Jaeger I, Shubham G, Nevo A, Ilie P, Lee S, Yon D, Han H, Hong S, Shin J, Ponsky L, Smith L. Methodological rigour in preclinical urology: a systematic review reporting research quality over a 14‐year period. BJU International 2023, 133: 387-399. PMID: 37667439, DOI: 10.1111/bju.16171.Peer-Reviewed Original ResearchConceptsStudy design elementsMethodological rigorReporting of In Vivo Experiments guidelinesUrological studiesQuality of methodological rigourInclusion/exclusion criteriaRisk of biasCitation densityPreclinical studiesSurrogate markerAnimal modelsInclusion criteriaSample size estimationStatistical analysisUrological researchNational InstituteBeta cell function in the early stages of type 1 diabetes: still a long way ahead of us
Galderisi A. Beta cell function in the early stages of type 1 diabetes: still a long way ahead of us. Pediatric Endocrinology Diabetes And Metabolism 2023, 29: 1-3. PMID: 37218722, PMCID: PMC10226454, DOI: 10.5114/pedm.2023.126360.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsConceptsBeta-cell functionType 1 diabetesIslet autoimmunityCell functionFunctional beta-cell massDisease-modifier drugsUnderlying autoimmune processPre-symptomatic phaseBeta-cell massSymptomatic diabetesAutoimmune processClinical onsetSurrogate markerDiabetes progressionC-peptideInsulin secretionModifier drugsEarly changesDiabetesMetabolic changesDysglycaemiaAutoimmunityT1DOnsetModifier treatment
2022
Borderzone infarction and recurrent stroke in intracranial atherosclerosis
Kvernland A, Torres J, Raz E, Nossek E, de Havenon A, Gebregziabher M, Khatri P, Prabhakaran S, Liebeskind D, Yaghi S. Borderzone infarction and recurrent stroke in intracranial atherosclerosis. Journal Of Stroke And Cerebrovascular Diseases 2022, 32: 106897. PMID: 36402094, DOI: 10.1016/j.jstrokecerebrovasdis.2022.106897.Peer-Reviewed Original ResearchConceptsRecurrent cerebrovascular eventsIntracranial stenosisBorderzone infarctsInfarct patternsIschemic strokeBorderzone infarctionRetrospective single-center studyAcute ischemic strokeRecurrent ischemic strokeSingle-center studySymptomatic intracranial stenosisHigh-risk cohortBinary logistic regression analysisDistal blood flowAlternative treatment strategiesLogistic regression analysisLogistic regression modelsCerebrovascular eventsRecurrent strokeIntracranial atherosclerosisPrimary outcomeCenter studyMean ageSurrogate markerTreatment strategiesCorrelative Assessment of p53 Immunostaining Patterns and TP53 Mutation Status by Next-Generation Sequencing in High-Grade Endometrial Carcinomas
Matsumoto N, Manrai P, Rottmann D, Wu X, Assem H, Hui P, Buza N. Correlative Assessment of p53 Immunostaining Patterns and TP53 Mutation Status by Next-Generation Sequencing in High-Grade Endometrial Carcinomas. International Journal Of Gynecological Pathology 2022, 42: 567-575. PMID: 36730675, DOI: 10.1097/pgp.0000000000000930.Peer-Reviewed Original ResearchConceptsHigh-grade endometrial carcinomasEndometrial carcinomaEndometrioid endometrial carcinomaTP53 mutation statusP53 immunohistochemistrySerous componentIHC staining patternNext-generation sequencing resultsNuclear overexpressionGrade 3 endometrioid endometrial carcinomaMutation statusTP53 mutationsCytoplasmic stainingStaining patternSerous endometrial carcinomaAberrant p53 expressionMixed endometrial carcinomasClinical prognosisSurrogate markerAberrant p53 proteinTherapeutic decisionsIHC patternsTP53 alterationsTumor histotypesP53 expressionEvidence of accelerated epigenetic aging of breast tissues in patients with breast cancer is driven by CpGs associated with polycomb-related genes
Rozenblit M, Hofstatter E, Liu Z, O’Meara T, Storniolo AM, Dalela D, Singh V, Pusztai L, Levine M. Evidence of accelerated epigenetic aging of breast tissues in patients with breast cancer is driven by CpGs associated with polycomb-related genes. Clinical Epigenetics 2022, 14: 30. PMID: 35209953, PMCID: PMC8876160, DOI: 10.1186/s13148-022-01249-z.Peer-Reviewed Original ResearchConceptsNormal breast tissueBreast cancerEpigenetic age accelerationBreast tissuePeripheral bloodAge accelerationStrong risk factorBreast cancer riskTissue/blood samplesGood surrogate markerBreast cancer diagnosisHealthy controlsRisk factorsSurrogate markerCancer riskBlood samplesTumor tissueCancerCancer diagnosisNew scoreTissueUnaffected individualsBloodEpigenetic aging signaturesEpigenetic aging
2021
Effects of plant-based versus marine-based omega-3 fatty acids and sucrose on brain and liver fatty acids in a mouse model of chemotherapy
Ormiston K, Gaudier-Diaz MM, TinKai T, Fitzgerald J, Cole RM, Andridge R, Lustberg M, DeVries AC, Orchard T. Effects of plant-based versus marine-based omega-3 fatty acids and sucrose on brain and liver fatty acids in a mouse model of chemotherapy. Nutritional Neuroscience 2021, 25: 2650-2658. PMID: 34772330, PMCID: PMC9095756, DOI: 10.1080/1028415x.2021.1998296.Peer-Reviewed Original ResearchConceptsAlpha-linolenic acidDietary alpha-linolenic acidBrain PUFAsMouse modelDocosahexaenoic acidEicosapentaenoic acidLiver PUFABrain nOmega-3 fatty acidsChemotherapy-treated miceHigh ALA dietLow ALA intakeBrain fatty acidsUseful surrogate markerFatty acidsLiver docosahexaenoic acidToxic side effectsLiver fatty acidALA intakeNeurotrophic markersALA dietDHA dietSurrogate markerLower brainSide effectsRegional Differences in Lymphomagenesis Identified through Quantification of AICDA-Mediated Subclonal Evolution in Follicular Lymphoma: Do Pesticides Play a Role?
Alpert A, Torres N, Snyder E, Rock P, Adlowitz D, Peterson D, Cupertino P, Casulo C, Burack R. Regional Differences in Lymphomagenesis Identified through Quantification of AICDA-Mediated Subclonal Evolution in Follicular Lymphoma: Do Pesticides Play a Role? Blood 2021, 138: 3505. DOI: 10.1182/blood-2021-146972.Peer-Reviewed Original ResearchActivation-induced cytidine deaminaseNon-Hodgkin's lymphomaFollicular lymphomaSubclonal evolutionSpecimens of patientsHigh groupLow groupProportion of womenLymphoma specimensTumor specimensSurrogate markerLymphomaZip codesLymphomagenesisInduce lymphomasEnvironmental risk factorsPatientsRisk factorsIGHVSomatic hypermutationBCL2Aberrant mutationsMedianWilcoxon testEpidemiological studiesPredicting 90-Day Outcome After Thrombectomy: Baseline-Adjusted 24-Hour NIHSS Is More Powerful Than NIHSS Score Change
Mistry EA, Yeatts S, de Havenon A, Mehta T, Arora N, La Rosa F, Starosciak AK, Siegler JE, Mistry AM, Yaghi S, Khatri P. Predicting 90-Day Outcome After Thrombectomy: Baseline-Adjusted 24-Hour NIHSS Is More Powerful Than NIHSS Score Change. Stroke 2021, 52: 2547-2553. PMID: 34000830, PMCID: PMC11261999, DOI: 10.1161/strokeaha.120.032487.Peer-Reviewed Original ResearchConceptsNIHSS scoreLong-term functional outcomeNIHSS score changeComprehensive stroke centerHealth Stroke ScaleProspective observational studyEarly time pointsStroke centersStroke ScaleEndovascular therapyMRS outcomesMRS scoreRankin ScaleStroke patientsFunctional outcomeSurrogate markerClinical studiesNIHSSMultivariable modelingObservational studyOutcome measuresPatientsPercent changeScore changeLogistic regressionTumor DNA Mutations From Intraparenchymal Brain Metastases Are Detectable in CSF
Cheok SK, Narayan A, Arnal-Estape A, Gettinger S, Goldberg SB, Kluger HM, Nguyen D, Patel A, Chiang V. Tumor DNA Mutations From Intraparenchymal Brain Metastases Are Detectable in CSF. JCO Precision Oncology 2021, 5: 163-172. PMID: 34250381, PMCID: PMC8232069, DOI: 10.1200/po.20.00292.Peer-Reviewed Original ResearchConceptsIntraparenchymal brain metastasesBrain metastasesCell-free DNAExtracranial tumorsBrain metastasis tissuesProgressive brain metastasesThird of patientsNormal pressure hydrocephalusTumor DNA mutationsPrimary cancer typeAnalysis of CSFSamples of CSFLeptomeningeal diseaseEffective surrogate markerBrain biopsyPressure hydrocephalusLumbar punctureSurrogate markerCancer-associated genesMetastasis tissuesPatientsMetastasisDiscordant responsesRenal cellsGenomic profiling
2020
ECOG-ACRIN 2399: analysis of patient related outcomes after Chemoradiation for locally advanced head and neck Cancer
Cmelak A, Dietrich MS, Li S, Ridner S, Forastiere A, Burtness BA, Cella D, Murphy BA. ECOG-ACRIN 2399: analysis of patient related outcomes after Chemoradiation for locally advanced head and neck Cancer. Cancers Of The Head & Neck 2020, 5: 12. PMID: 33353553, PMCID: PMC7756946, DOI: 10.1186/s41199-020-00059-1.Peer-Reviewed Original ResearchQuality of lifeFunctional communication measuresMajority of patientsVoice Handicap IndexFACT-HNSwallow assessmentEffects of chemoradiationLarge therapeutic trialsPatient related outcomesSevere dysphagiaAdvanced headOverall survivalBarium swallowTherapeutic trialsNeck cancerSwallow functionSurrogate markerDisability AssessmentLarynx cancerFunctional assessmentPatientsHandicap IndexVocal functionRelated outcomesMarked decreaseThe association between anti-Müllerian hormone and vitamin 25(OH)D serum levels and polycystic ovarian syndrome in adolescent females
Simpson S, Seifer DB, Shabanova V, Lynn AY, Howe C, Rowe E, Caprio S, Vash-Margita A. The association between anti-Müllerian hormone and vitamin 25(OH)D serum levels and polycystic ovarian syndrome in adolescent females. Reproductive Biology And Endocrinology 2020, 18: 118. PMID: 33218348, PMCID: PMC7679991, DOI: 10.1186/s12958-020-00676-y.Peer-Reviewed Original ResearchConceptsPolycystic ovarian syndromeRotterdam diagnostic criteriaNon-PCOS groupMedian AMHOvarian syndromePCOS groupDiagnostic criteriaAnti-Müllerian hormone levelsAdolescent femalesRetrospective chart reviewTraditional clinical markersAnti-Müllerian hormoneCross-sectional studyWilcoxon rank sum testSignificant unadjusted differencesRank sum testD deficiencyChart reviewClinical featuresEndocrinology clinicSerum levelsAdjusted analysisUnadjusted comparisonsInsurance typeSurrogate marker
This site is protected by hCaptcha and its Privacy Policy and Terms of Service apply