Gaëlle Romain, PhD, MSc
BiostatisticianCards
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VAMOS Lab
789 Howard Avenue
New Haven, CT 06519
United States
About
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Titles
Biostatistician
Biography
I am a PhD Biostatistician for the Vascular Medicine Outcomes research program at Yale University School of Medicine. My primary research interest is the study of health outcomes and associated risk factors in cardiovascular disease patient populations. My current research covers the development and application of statistical methods to study mortality and amputation outcomes in patients with peripheral artery disease and critical limb ischemia. In addition, my work examines the relationship between risk factors and patient reported outcomes using national cardiovascular registry databases. My research includes use of descriptive and predictive methodologies and modeling such as time-to-event survival models, linear or logistic regression, and machine learning methods such as random forest predictive models. My background in health outcomes research includes previous work studying mortality or disease recurrence in patients with cancer. I have extensive experience in survival analysis methods to study outcomes, which often involves adjustment for competing risk. I co-led biostatistics analysis and data quality in registry work and tailored competing risk models in cancer and stroke populations at the University of Dijon, France. I am the lead statistician on the VAMOS research lab which Drs. Smolderen and Mena both direct. I have an established track record of analyzing complex vascular outcomes data, specializing in analyzing competing risks, Bayesian statistics, and mixed modeling.
I am currently the lead statistician on the SCOPE-CLI registry, and the 1R21AT012430-01 “Pain Management Strategies, Associated Psychological Variables, and Outcomes in Critical Limb Ischemia” under the HEAL initiative (PIs Mena-Hurtado and Smolderen) and lead statistician for the 1R01HL163640-01A1 “Multi-isotope Hybrid PET/CT Imaging of Peripheral Artery Disease in Diabetes” (PIs Sinusas, Liu, and Smolderen) project, wherein validation methods of peripheral ischemia within current PAD registry work are being executed. The proposed multi-isotope imaging of lower extremity flow and nerve activity developed and applied in this project in conjunction with imaging of calcifications of the arteries will characterize the pathophysiology of nerve dysfunction in PAD and this information may lead to a paradigm change in the evaluation and long-term management of patients with DM and PAD.
Departments & Organizations
- All Institutions
- Internal Medicine
- VAMOS Lab
Education & Training
- PhD
- University of Burgundy, Environmental Health Sciences (2019)
- MSc
- University of Nantes, Clinical Pharmacology and Epidemiological Modeling (2014)
- Biostatistician
- National Institute of Environmental Health Sciences
- Biostatistician/Statistical programmer
- Atlanstat, Contract Research Organizations Research and Clinical Trial
- BSc (Hon)
- Nantes University, Biostatistics and Bioinformatics (2013)
- Biostatistician/Data Manager
- University Hospital of Nantes
- BSc
- University Institute of Technology , Statistics and Computer for Health (2012)
- AA
- Jean Macé Highscool, Bio-analysis and control (2011)
Research
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Overview
Public Health Interests
ORCID
0000-0003-4294-5507
Research at a Glance
Yale Co-Authors
Publications Timeline
Kim Germaine Emiel Smolderen, PhD, MSc
Carlos Mena-Hurtado, MD, FACC, FSCAI, FAHA
Santiago Callegari, MD
Lindsey Scierka, MD, MPH
Aseem Vashist, MD
Christiany Tapia
Publications
2026
Evolving dynamic needs for patient-reported outcomes assessment in individuals with an abdominal aortic aneurysm (AAA): A systematic review.
Smolderen K, Tapia C, Dennis B, Callegari S, Dahl M, Lindholt J, Van Herzeele I, Romain G, Mena-Hurtado C. Evolving dynamic needs for patient-reported outcomes assessment in individuals with an abdominal aortic aneurysm (AAA): A systematic review. Vascular Medicine 2026, 1358863x261417234. PMID: 41854119, DOI: 10.1177/1358863x261417234.Peer-Reviewed Original ResearchConceptsPatient-reported outcomesMental health assessmentAbdominal aortic aneurysmHealth assessmentPatient-centered dimensionsPatient-centered carePatient-reported outcome assessmentsHealth status instrumentsPatient-centered experiencePatient-reported outcome evaluationPatient-reported outcome studyMeasures of social connectionEmotional Well-BeingBiopsychosocial profilePhysical symptomsOutcome assessmentSystematic reviewResponse burdenDisease burdenTreatment satisfactionAbdominal aortic aneurysm (AAAClinical complexityAdaptive testingWell-beingSingle itemsHigh Community Distress is Linked to Increased Long-Term Mortality and Stroke but not Short-Term Readmission Risk in Patients Undergoing Carotid Endarterectomy
Pajarillo C, Romain G, Cleman J, Scierka L, Grubman S, Schenck C, Kluger J, Smolderen K, Mena-Hurtado C. High Community Distress is Linked to Increased Long-Term Mortality and Stroke but not Short-Term Readmission Risk in Patients Undergoing Carotid Endarterectomy. JVS-Vascular Insights 2026, 100411. DOI: 10.1016/j.jvsvi.2026.100411.Peer-Reviewed Original ResearchConceptsDistressed Communities IndexLow distress groupDistress groupReadmission riskCommunity distressLong-term mortalityCumulative incidenceCox proportional hazards regression modelsProportional hazards regression modelsRisk of mortalityHazards regression modelsSocioeconomic disparitiesMedicare claimsShort-term readmissionFine-Gray modelTargeted interventionsSocioeconomic distressMortality outcomesMortality riskStroke riskDistressZip-codeReadmissionRegression modelsFine-GrayRole of Depression and Anxiety in Peripheral Artery Disease: Correlates, Outcomes, and Considerations for Treatment
Callegari S, Mubarak E, Romain G, Golledge J, Mena-Hurtado C, Smolderen K. Role of Depression and Anxiety in Peripheral Artery Disease: Correlates, Outcomes, and Considerations for Treatment. Arteriosclerosis Thrombosis And Vascular Biology 2026, 46: e322135. PMID: 41711026, PMCID: PMC13007888, DOI: 10.1161/atvbaha.125.322135.Peer-Reviewed Original ResearchCitationsAltmetricMeSH Keywords and ConceptsConceptsPeripheral arterial diseaseArtery diseasePeripheral artery disease managementAssociated with high mortalityCardiovascular disease managementMetabolic risk factorsAnxiety assessmentAnxietyLong-term outcomesProgression of peripheral arterial diseaseDepressionExercise therapyHealth statusMajor amputationBehavioral mechanismsTreatment outcomesTeam-basedSurgical approachBiopsychosocial circumstancesTreatment planningDisease managementHigh riskRisk factorsVessel patencyWorse diseasePremature Peripheral Arterial Disease Is Associated With Worse Outcomes After Endovascular Peripheral Vascular Intervention
Rokosh R, Sperling L, Quyyumi A, Rajani R, Duwayri Y, Garcia-Toca M, Mena-Hurtado C, Smolderen K, Romain G, Alabi O. Premature Peripheral Arterial Disease Is Associated With Worse Outcomes After Endovascular Peripheral Vascular Intervention. Journal Of Vascular Surgery 2026, 83: e7-e8. DOI: 10.1016/j.jvs.2025.10.078.Peer-Reviewed Original ResearchBiopsychosocial predictors of long-term major amputation following peripheral vascular intervention in chronic limb-threatening ischemia using a machine learning algorithm approach
Joodi G, Romain G, Cleman J, Rendon I, Tabet R, Scierka L, Rahman M, Vashist A, Mubarak E, Tapia C, Smolderen K, Mena-Hurtado C. Biopsychosocial predictors of long-term major amputation following peripheral vascular intervention in chronic limb-threatening ischemia using a machine learning algorithm approach. JVS-Vascular Insights 2026, 4: 100348. DOI: 10.1016/j.jvsvi.2025.100348.Peer-Reviewed Original ResearchConceptsChronic limb-threatening ischemiaAmputation riskPeripheral vascular interventionsBiopsychosocial factorsBiopsychosocial predictorsMajor amputationLimb-threatening ischemiaRisk factorsDelivery of individualized careHigh riskCardiovascular risk factorsBelow-the-kneeIndividualized careLimb outcomesClinical risk factorsFunctional statusVascular interventionsMultidisciplinary involvementBehavioral factorsAmputationQuality InitiativeFemale sexPre-procedural variablesPatient characteristicsOutcome data
2025
Advancing Management of Patients With Lower Extremity Peripheral Artery Disease: A Focused Review and Our Institution’s Approach to Postendovascular Intervention Care
Tabet R, Rendon I, Joodi G, Filho J, Romain G, Tapia C, Smolderen K, Mena-Hurtado C. Advancing Management of Patients With Lower Extremity Peripheral Artery Disease: A Focused Review and Our Institution’s Approach to Postendovascular Intervention Care. The American Journal Of Cardiology 2025, 261: 50-58. PMID: 41455511, DOI: 10.1016/j.amjcard.2025.11.022.Peer-Reviewed Original ResearchMeSH Keywords and ConceptsConceptsPeripheral arterial diseaseLower extremity peripheral arterial diseaseHigh risk of amputationRisk of amputationCare of patientsChronic limb-threatening ischemiaHigh riskManagement of patientsPostintervention phaseInterventional careStandard careLimb-threatening ischemiaBest-practice approachAtherosclerotic cardiovascular diseaseRisk of cardiovascular eventsArtery diseaseLimb lossComprehensive road mapCareCardiovascular diseasePhysiciansInterventionAdvanced managementCardiovascular eventsClinical presentations rangeImaging practices following peripheral vascular intervention in chronic limb-threatening ischemia and association with amputation outcomes
Smolderen K, Rahman M, Romain G, Scierka L, Cleman J, Knight D, Vashist A, Mena-Hurtado C. Imaging practices following peripheral vascular intervention in chronic limb-threatening ischemia and association with amputation outcomes. Vascular Medicine 2025, 31: 35-46. PMID: 41395888, DOI: 10.1177/1358863x251379799.Peer-Reviewed Original ResearchAltmetricConceptsChronic limb-threatening ischemiaMedian odds ratioIntraclass correlation coefficientPeripheral vascular interventionsAmputation outcomesLimb-threatening ischemiaAmputation rateResults:Access to careImaging practicesHigher amputation rateImaging testsMajor amputationHigher RatesOdds ratioMethods:Significant site variablesVascular interventionsAmputationSymptom statusFollow-up imaging protocolsVascular Quality Initiative dataPropensity-matched cohortInterventionCorrelation coefficientPeriprocedural outcomes of embolic protection device use in carotid artery stenting
Callegari S, Romain G, Balasquide Odeh O, Tapia C, Pinto D, Rahman M, Vashist A, Smolderen K, Mena-Hurtado C. Periprocedural outcomes of embolic protection device use in carotid artery stenting. Journal Of Vascular Surgery 2025, 83: 738-746.e3. PMID: 41077289, DOI: 10.1016/j.jvs.2025.10.004.Peer-Reviewed Original ResearchConceptsCarotid artery stentingEmbolic protection devicesIn-Hospital MortalityNational quality improvement effortsPeriprocedural outcomesAssociated with higher oddsCumulative incidenceQuality improvement effortsArtery stentingCox proportional hazards regressionAssociated with higher in-hospitalAssociated with lower mortalityEPD groupHigher in-hospitalVascular Quality Initiative registryRisk of deathCarotid artery stenosisHigher oddsManagement of carotid artery stenosisMortality outcomesImprovement effortsTranscarotid artery revascularizationPropensity score matchingHazards regressionDevice useApplying a Random Forest Approach in Predicting Health Status in Patients with Carotid Artery Stenosis 30 Days Post Stenting
Qureshi O, Mena‐Hurtado C, Romain G, Cleman J, Callegari S, Smolderen K. Applying a Random Forest Approach in Predicting Health Status in Patients with Carotid Artery Stenosis 30 Days Post Stenting. Stroke Vascular And Interventional Neurology 2025, 5: e001938. PMID: 41608717, PMCID: PMC12697605, DOI: 10.1161/svin.125.001938.Peer-Reviewed Original ResearchCitationsAltmetricConceptsHealth statusMultivariate linear regression modelComponent summaryStroke Scale scoreLinear regression modelsScale scoreHealth status outcomesMental component summaryPhysical component summaryHealth status scoresShort Form SurveyHealth status benefitsRegression modelsDecision-making discussionsHigh riskHistory of strokeNational Institutes of Health Stroke Scale scoreNational InstituteCarotid artery stentingProtection of patientsVisual analogue scaleHealth outcomesStatus outcomesNon-Hispanic/LatinoObstructive pulmonary diseaseAssociation between depressive symptoms and health status outcomes in patients with symptomatic peripheral artery disease
Jacque F, Mubarak E, Romain G, Poghni P, Cleman J, Mares A, Callegari S, Scierka L, Mena-Hurtado C, Smolderen K. Association between depressive symptoms and health status outcomes in patients with symptomatic peripheral artery disease. Journal Of Psychosomatic Research 2025, 196: 112339. PMID: 40753799, PMCID: PMC12455933, DOI: 10.1016/j.jpsychores.2025.112339.Peer-Reviewed Original ResearchMeSH Keywords and ConceptsConceptsPeripheral Artery QuestionnaireHealth status outcomesPeripheral artery questionnaire scoresPeripheral arterial diseaseDepressive symptomsHealth statusStatus outcomesIntegration of depression managementPeripheral artery disease careDepression severityBaseline health statusPatient Health QuestionnaireBaseline depressive symptomsSevere depressive symptomsArtery diseaseAssociated with adverse clinical outcomesSymptomatic peripheral arterial diseaseAdverse clinical outcomesDepression managementSpecialty careHealth QuestionnairePropensity-matched cohortPHQ-8Summary scoreClinical outcomes
Academic Achievements & Community Involvement
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Activities
activity Cross-Validation Of Amputation Outcomes Data Elements For The Vascular Quality Initiative's Medicare Linked Registry
03/04/2023 - 03/06/2023Oral PresentationAmerican College of CardiologyDetailsNew Orleans, LA, United StatesAbstract/SynopsisBackground The Vascular Quality Initiative (VQI)’s linked Medicare registry (VISION), derived CPT-based algorithms for their amputation outcomes in peripheral vascular intervention (PVI), supra-inguinal bypass (SUPRA) or infra-inguinal bypass (INFRA) modules. We examined the validity of the amputation algorithm against medical chart abstraction. Methods In VISION, major amputation was defined by CPT codes 27590, 27591, 27592, 27880, 27881, and 27882 in the PVI, SUPRA, and INFRA modules for procedures performed between 2010 and 2017 in patients ≥18 years. We compared the number of amputations at 1, 3, and 5 years following the index revascularization procedure in these modules against Yale New Haven Hospital (YNHH) and Dartmouth Hitchcock Medical Center (DHMC) YNHH-DHMC chart abstraction as the gold standard. Concordance was examined using Spearman's rank correlation (ρ) and Cohen's kappa (κ) statistic. Results Medical records of 1,189 PVI, 247 INFRA and 93 SUPRA procedures were reviewed. Concordance for the number of amputations was moderate to strong (ρ.63-.75, p<.001), as well as in major amputation (κ.56-.73, p<.001) between VISION and YNHH-DHMC chart abstraction (Table). Conclusion Concordance between the number of major amputations between VISION and YNHH-DHMC chart abstraction was relatively high, but not perfect. Further augmentation of the CPT-based algorithm may be required to improve the quality of major amputation data in VISION.
activity Development of a 30-Day Health Status Prediction Model for High-Risk Transfemoral Carotid Artery Stenting Using a Simple Machine Learning Algorithm
11/05/2022 - 11/07/2022Oral PresentationAmerican Heart Association Scientific SessionsDetailsChicago, IL, United StatesAbstract/SynopsisIntroduction: Individualized prediction models for transfemoral carotid artery stenting (TF-CAS) health status outcomes have not been developed. We applied a machine learning algorithm to identify the most robust pre-procedural predictors of 30-day TF-CAS health status, and validated models across different health status measures to maximize generalizability. Methods: The 390-center SAPPHIRE registry enrolled high-risk patients undergoing TF-CAS from 2006-2014, containing two cohorts with pre-procedural and 30-day health status assessments: Cohort 1 (n=4,667) had EQ-5D-3L (Index and Visual Analog Scale [VAS]); Cohort 2 (n=3,594) had SF-36 (Mental [MCS] and Physical [PCS] Component Summary scores). A random forest algorithm ranked the importance of 50 pre-procedural variables (pre-procedural health status, modified Rankin and NIH stroke scores, demographics, comorbidities, and disease characteristics) for 30-day health status in each cohort. Selection thresholds were based on visual inspection of the importance plots to evaluate the information gain value of each variable considered. Overlapping variables across health status measures were retained to develop a multivariable linear regression model to predict 30-day health status in each cohort. Results: Importance plot (Figure) inspection yielded 23 variables, each of which had importance values >15% for ≥2 of the 4 health status measures. From these, 7 overlapping variables were ultimately retained in the linear regression analyses that predicted ~40% of the variance (R2=.39-.45) for 30-day TF-CAS health status, including pre-procedural health status, age, heart failure, history of stroke, Rankin stroke score, renal disease, and pulmonary disease. Conclusions: Seven easily assessed pre-procedural variables robustly predicted TF-CAS health status. This model can inform the risk-benefit analysis underlying the TF-CAS medical decision-making process for patients and clinicians.
activity Comparing performances of three cure models including a new model with time-to-cure as a parameter
07/14/2019 - 07/18/2019Oral Presentation40th Annual Conference of the International Society for Clinical BiostatisticsDetailsLeuven, Flanders, BelgiumCollaborators- Gaëlle Romain, PhD, MSc
- Olayide Boussari
- Marc Colonna
- Valerie Jooste
Abstract/SynopsisContext: In the field of population-based cancer epidemiology, net survival (Sn) is modelled through the excess hazard (EH). For many cancer sites, a proportion of patients will not die from the studied cancer, representing the cured proportion (P). Cure models have been developed to describe Sn accounting for statistical cure: the asymptotic value of Sn is P [1]. Boussari et al. have developed a new cure model that allows a direct estimation of the time-to-cure by including the Time-to-Null-Excess-Hazard (TNEH) as a covariate-dependent parameter to be estimated [2]. In this model, P is the value of Sn when time elapsed since diagnosis equals TNEH. Objective: To compare the performances of the TNEH cure model, with that of a non-mixture flexible cure model and of a mixture cure model through a simulation study and applications to real datasets. Methods: Time-of-death was generated as the minimum of time-of-death due to other cause and due to cancer. This latter was consecutively simulated using mixture and TNEH cure models. Three different scenarios were considered according to the evolution of EH with time since diagnosis. Each scenario mimicked Sn from real situations: poor, medium, and good prognosis cancers. For each of the six situations, we generated 1,000 samples. We estimated P and Sn 3, 5 and 10 years after diagnosis through the three models with age-group as a covariate. Indicators of performances (bias, root-mean-square-error and coverage-rate) were studied by age group. Sn was estimated on three sets of corresponding real data (pancreatic, colon and testicular cancers) which originated from the French cancer registries database (FRANCIM). Results: The performances of the three models were correct in the situations in which EH reached zero. Unlike the other two, TNEH model performed poorly for the situations in which although EH became low, it did not reach zero. From real data, Sn curves from the three models were identical for testicular cancer. Sn estimated with TNEH differed from the others for colon and pancreatic cancers. Conclusions: The TNEH cure model can be used to estimate Sn if EH reaches zero. On this condition the model allows estimating the time-to-cure.
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- August 14, 2024
Peripheral Artery Disease Treatment: Changing the Status Quo
- April 01, 2024
Yale Faculty Present Groundbreaking Clinical Research at the 2024 American College of Cardiology Scientific Sessions
- February 15, 2023
Discoveries & Impact (February 2023)
- February 01, 2023
2023 American College of Cardiology late-breaking clinical trials and abstracts from Yale
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VAMOS Lab
789 Howard Avenue
New Haven, CT 06519
United States