Gaëlle Romain, PhD, MSc
BiostatisticianCards
Contact Info
VAMOS Lab
789 Howard Avenue
New Haven, CT 06519
United States
About
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
- 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
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
Peter Blume
Albert Sinusas, MD
Publications
2024
Lack of diversity in patients undergoing carotid artery stenting: Implications for the Distressed Community Index.
Pajarillo C, Romain G, Cleman J, Scierka L, Grubman S, Schenck C, Kluger J, Smolderen K, Mena-Hurtado C. Lack of diversity in patients undergoing carotid artery stenting: Implications for the Distressed Community Index. Vascular Medicine 2024, 1358863x241292545. PMID: 39526556, DOI: 10.1177/1358863x241292545.Peer-Reviewed Original ResearchAltmetricConceptsDistressed Communities IndexCommunity distressDistress groupCarotid artery stentingDistressed Communities Index scoreHierarchical Cox regressionCumulative incidence function curvesSocial determinantsNon-Hispanic/LatinoStroke incidenceAccess barriersFine-Gray modelArtery stentingDistressKaplan-Meier survival curvesVascular Quality Initiative databaseZip-codeFine-GrayMortality incidenceCox regressionAssociationAnalyzed patientsNo significant differenceMortalityLack of diversityPrediction of Health Status in Patients Undergoing Lower Extremity Intervention for Claudication
Peri-Okonny P, Romain G, Callegari S, Cleman J, Vashist A, Smolderen K, Mena-Hurtado C. Prediction of Health Status in Patients Undergoing Lower Extremity Intervention for Claudication. Annals Of Vascular Surgery 2024, 110: 314-322. PMID: 39395588, DOI: 10.1016/j.avsg.2024.08.016.Peer-Reviewed Original ResearchConceptsHealth statusPeripheral arterial diseaseEQ-5D VASPeripheral vascular interventionsPredictor of future health statusPredictor of health statusDrug-coated balloonLower extremity peripheral arterial diseaseHealth status outcomesFuture health statusEQ-5D-3LHistory of deep venous thrombosisImprove patient outcomesStatus outcomesPrediction of health statusChronic lung diseaseDeep venous thrombosisPlain balloon angioplastyPatient outcomesDisease managementExtremity interventionsApproach to treatmentSD ageVenous thrombosisBaseline characteristicsTCT-702 Shockwave Intravascular Lithotripsy in Calcified Common Femoral Lesions in Patients With Peripheral Arterial Disease: 30-Day Health Status Outcomes From CRUSH-PAD Trial
Rahman, Romain G, Cleman J, Aggarwal A, Smolderen K, Mena-Hurtado C. TCT-702 Shockwave Intravascular Lithotripsy in Calcified Common Femoral Lesions in Patients With Peripheral Arterial Disease: 30-Day Health Status Outcomes From CRUSH-PAD Trial. Journal Of The American College Of Cardiology 2024, 84: b276-b277. DOI: 10.1016/j.jacc.2024.09.839.Peer-Reviewed Original ResearchAssociation of health status and hospitalization risk for peripheral artery disease in the PORTRAIT registry.
Cleman J, Romain G, Scierka L, Labrosciano C, Bradley B, Fitridge R, Beltrame J, Shishehbor M, Spertus J, Mena-Hurtado C, Smolderen K. Association of health status and hospitalization risk for peripheral artery disease in the PORTRAIT registry. Vascular Medicine 2024, 1358863x241274758. PMID: 39319857, DOI: 10.1177/1358863x241274758.Peer-Reviewed Original ResearchConceptsPeripheral Artery QuestionnairePeripheral arterial diseaseED visitsHealth statusHospital admissionHealthcare utilizationPAD-specific health statusEmergency departmentCause-specific hospital admissionsAssociation of health statusPatient-reported outcome measuresPatient's risk of hospitalizationBaseline health statusAll-cause hospital admissionsCox proportional hazards modelsRisk of hospitalizationOverall summary scorePAQ scoresProportional hazards modelSummary scoreOutcome measuresHospitalization riskArtery diseaseVisitsHazards modelVariability and Factors Associated With the Use of Embolic Protection Devices in Carotid Artery Stenting
Callegari S, Romain G, Pajarillo C, Cleman J, Scierka L, Smolderen K, Mena-Hurtado C. Variability and Factors Associated With the Use of Embolic Protection Devices in Carotid Artery Stenting. Journal Of The Society For Cardiovascular Angiography & Interventions 2024, 3: 102170. DOI: 10.1016/j.jscai.2024.102170.Peer-Reviewed Original ResearchAltmetricConceptsCompeting risk analysis to estimate amputation incidence and risk in lower-extremity peripheral artery disease
Callegari S, Smolderen K, Cleman J, Mena-Hurtado C, Romain G. Competing risk analysis to estimate amputation incidence and risk in lower-extremity peripheral artery disease. Vascular Medicine 2024, 29: 496-506. PMID: 39219174, DOI: 10.1177/1358863x241268727.Peer-Reviewed Original ResearchAltmetricConceptsChronic limb-threatening ischemiaAmputation riskTime-to-event analysisPeripheral arterial diseaseLower-extremity peripheral arterial diseaseCumulative incidence functionCompeting risk analysisAmputation incidenceAmputation dataMedicare claimsLimb-threatening ischemiaVascular Quality Initiative registryMortality riskOutcomes researchPeripheral vascular interventionsArtery diseaseAmputationVascular outcomesCox regressionRiskMortalityCohortVascular interventionsTime-to-event methodsPatientsTwelve-Month Health Status Response Following Peripheral Vascular Intervention for Femoropopliteal Lesions Using Zilver PTX Databases Focusing on the Role of Preprocedural Health Status, Comorbid Risks, and Global Setting
Smolderen K, Romain G, Cleman J, Callegari S, Peri-Okonny P, Mena-Hurtado C. Twelve-Month Health Status Response Following Peripheral Vascular Intervention for Femoropopliteal Lesions Using Zilver PTX Databases Focusing on the Role of Preprocedural Health Status, Comorbid Risks, and Global Setting. Journal Of Vascular Surgery 2024 PMID: 39214426, DOI: 10.1016/j.jvs.2024.08.035.Peer-Reviewed Original ResearchConceptsMinimal clinically important differenceEQ-5D indexHealth statusPeripheral vascular interventionsPeripheral arterial diseaseEQ-5DNon-respondersValue-based careEuroQol-5D-3LClinically important differenceSecondary data analysisFemoropopliteal peripheral vascular interventionsStable health statusLogistic regression modelsArtery diseaseSymptomatic peripheral arterial diseaseStatus responseTailored resourcesVascular interventionsSingle-arm studyImportant differenceCarotid artery diseaseComorbidity riskEnrolling centersPatient characteristicsAssociation of Social Support and Health Status Outcomes in Peripheral Artery Disease
Callegari S, Romain G, Cleman J, Scierka L, Peri-Okonny P, Spertus J, Labrosciano C, Beltrame J, Abbott J, Fitridge R, Mena-Hurtado C, Smolderen K. Association of Social Support and Health Status Outcomes in Peripheral Artery Disease. Journal Of Vascular Surgery 2024 PMID: 39151740, DOI: 10.1016/j.jvs.2024.08.010.Peer-Reviewed Original ResearchAltmetricConceptsENRICHD Social Support InventoryLow social supportLow perceived social supportGeneric health statusHealth status outcomesPeripheral arterial diseaseSocial supportHealth statusBiopsychosocial variablesStatus outcomesAssociation with health status outcomesAssociated with lower health statusDisease-specific health statusBaseline perceived social supportImprove social supportLower health statusSocial Support InventoryImprove health statusPerceived social supportDisease-specificEQ-5D-3LCare of patientsQuality of lifeEQ-5D-3L indexBiopsychosocial factorsFactors associated with sustained improvement after peripheral vascular intervention in patients with claudication.
Peri-Okonny P, Romain G, Rambhujun V, Callegari S, Vashist A, Cleman J, Smolderen K, Mena-Hurtado C. Factors associated with sustained improvement after peripheral vascular intervention in patients with claudication. Vascular Medicine 2024, 1358863x241261369. PMID: 39087625, DOI: 10.1177/1358863x241261369.Peer-Reviewed Original ResearchAltmetricAddressing Psychosocial Care Needs in Women with Peripheral Artery Disease
Mubarak E, Cleman J, Romain G, Mena-Hurtado C, Smolderen K. Addressing Psychosocial Care Needs in Women with Peripheral Artery Disease. Current Cardiology Reports 2024, 26: 1085-1095. PMID: 39073508, DOI: 10.1007/s11886-024-02106-6.Peer-Reviewed Original ResearchConceptsVascular careIncreased psychosocial riskPsychosocial care needsIntegration of careMental health comorbiditiesBehavioral health careReviewPeripheral artery diseaseManagement of individualsCare integrationIllness perceptionsGender-based factorsCare needsHealthcare accessHealth behaviorsHealth comorbiditiesSubstance use disordersCare strategiesHealth carePeripheral arterial diseasePsychosocial comorbiditiesReimbursement structuresClinician educationCare paradigmUnique sexPsychosocial risks
Academic Achievements & Community Involvement
activity Cross-Validation Of Amputation Outcomes Data Elements For The Vascular Quality Initiative's Medicare Linked Registry
Oral PresentationAmerican College of CardiologyDetails03/04/2023 - 03/06/2023New 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
Oral PresentationAmerican Heart Association Scientific SessionsDetails11/05/2022 - 11/07/2022Chicago, IL, United StatesCollaboratorsAbstract/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
Oral Presentation40th Annual Conference of the International Society for Clinical BiostatisticsDetails07/14/2019 - 07/18/2019Leuven, 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.
News
News
- 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