2023
Using real-world data from health systems to evaluate the safety and effectiveness of a catheter to treat ischemic ventricular tachycardia
Dhruva S, Zhang S, Chen J, Noseworthy P, Doshi A, Agboola K, Herrin J, Jiang G, Yu Y, Cafri G, Farr K, Mbwana M, Ross J, Coplan P, Drozda J. Using real-world data from health systems to evaluate the safety and effectiveness of a catheter to treat ischemic ventricular tachycardia. Journal Of Interventional Cardiac Electrophysiology 2023, 66: 1817-1825. PMID: 36738387, DOI: 10.1007/s10840-023-01496-x.Peer-Reviewed Original ResearchConceptsIschemic ventricular tachycardiaVentricular tachycardiaHealth system dataVT ablationSTSF catheterComposite outcomeHealth systemRisk differencePre-specified performance goalComposite safety outcomeReal-world safetyRoutine clinical practiceDrug Administration approvalAverage risk differenceThromboembolic eventsTotal patientsHeart failureProcedural complicationsMethodsAmong patientsAdministration approvalMayo ClinicSafety outcomesEffectiveness outcomesClinical practiceCatheter
2022
Safety and Effectiveness of a Catheter With Contact Force and 6-Hole Irrigation for Ablation of Persistent Atrial Fibrillation in Routine Clinical Practice
Dhruva SS, Zhang S, Chen J, Noseworthy PA, Doshi AA, Agboola KM, Herrin J, Jiang G, Yu Y, Cafri G, Farr K, Ervin KR, Ross JS, Coplan PM, Drozda JP. Safety and Effectiveness of a Catheter With Contact Force and 6-Hole Irrigation for Ablation of Persistent Atrial Fibrillation in Routine Clinical Practice. JAMA Network Open 2022, 5: e2227134. PMID: 35976649, PMCID: PMC9386540, DOI: 10.1001/jamanetworkopen.2022.27134.Peer-Reviewed Original ResearchConceptsPersistent AF ablationRoutine clinical practiceMercy HealthAF ablationMayo ClinicSafety outcomesClinical practiceCatheter groupCohort studyCatheter ablationPersistent AFParoxysmal atrial fibrillation ablationThermocool SmartTouch catheterComposite of deathPrimary safety outcomeAtrial fibrillation ablationPersistent atrial fibrillationElectronic health record dataHealth system dataHealth record dataHealth care systemSmartTouch catheterThromboembolic eventsFibrillation ablationProcedural complications
2020
Catheter-related complications and mortality of atrial fibrillation ablation following introduction of contact force-sensing technology
Akar JG, Hummel JP, Yao X, Sangaralingham L, Dhruva S, Dong J, Ward R, Shah ND, Ross J, Noseworthy PA. Catheter-related complications and mortality of atrial fibrillation ablation following introduction of contact force-sensing technology. BMJ Surgery Interventions & Health Technologies 2020, 2: e000058. PMID: 35047796, PMCID: PMC8647613, DOI: 10.1136/bmjsit-2020-000058.Peer-Reviewed Original ResearchContact force-sensing catheterForce-sensing catheterAcute care useAtrial fibrillation ablationCatheter-related complicationsFibrillation ablationCare useAtrial fibrillationStroke/transient ischemic attackTransient ischemic attackRetrospective cohort analysisEmergency department visitsInverse probability treatment weightsOptumLabs Data WarehouseCatheter complicationsIschemic attackBaseline characteristicsComplication rateDepartment visitsAtrioesophageal fistulaEsophageal injuryCohort analysisContact force monitoringClinical practiceCatheter
2019
The Predictive Approaches to Treatment effect Heterogeneity (PATH) Statement: Explanation and Elaboration.
Kent DM, van Klaveren D, Paulus JK, D'Agostino R, Goodman S, Hayward R, Ioannidis JPA, Patrick-Lake B, Morton S, Pencina M, Raman G, Ross JS, Selker HP, Varadhan R, Vickers A, Wong JB, Steyerberg EW. The Predictive Approaches to Treatment effect Heterogeneity (PATH) Statement: Explanation and Elaboration. Annals Of Internal Medicine 2019, 172: w1-w25. PMID: 31711094, PMCID: PMC7750907, DOI: 10.7326/m18-3668.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus Statements
2018
Will research preprints improve healthcare for patients?
Krumholz HM, Ross JS, Otto CM. Will research preprints improve healthcare for patients? The BMJ 2018, 362: k3628. PMID: 30249719, DOI: 10.1136/bmj.k3628.Commentaries, Editorials and LettersSpeed of Adoption of Immune Checkpoint Inhibitors of Programmed Cell Death 1 Protein and Comparison of Patient Ages in Clinical Practice vs Pivotal Clinical Trials
O’Connor J, Fessele KL, Steiner J, Seidl-Rathkopf K, Carson KR, Nussbaum NC, Yin ES, Adelson KB, Presley CJ, Chiang AC, Ross JS, Abernethy AP, Gross CP. Speed of Adoption of Immune Checkpoint Inhibitors of Programmed Cell Death 1 Protein and Comparison of Patient Ages in Clinical Practice vs Pivotal Clinical Trials. JAMA Oncology 2018, 4: e180798-e180798. PMID: 29800974, PMCID: PMC6143052, DOI: 10.1001/jamaoncol.2018.0798.Peer-Reviewed Original ResearchMeSH KeywordsAgedAntibodies, Monoclonal, HumanizedCarcinoma, Non-Small-Cell LungCarcinoma, Renal CellClinical Trials as TopicFemaleFollow-Up StudiesHumansKidney NeoplasmsLung NeoplasmsMaleMiddle AgedNivolumabPractice Patterns, Physicians'PrognosisProgrammed Cell Death 1 ReceptorRetrospective StudiesConceptsNon-small cell lung cancerPivotal clinical trialsRenal cell carcinomaCell death 1 proteinEligible patientsImmune checkpoint inhibitorsDeath 1 proteinClinical trialsClinical practiceFDA approvalAgent treatmentCheckpoint inhibitorsAnti-PD-1 agentsFlatiron Health networkRetrospective cohort studyAge of patientsCell lung cancerClinical trial participantsCohort studyPatient ageYounger patientsMore patientsSuch patientsTrial evidenceCell carcinomaAge of Data at the Time of Publication of Contemporary Clinical Trials
Welsh J, Lu Y, Dhruva SS, Bikdeli B, Desai NR, Benchetrit L, Zimmerman CO, Mu L, Ross JS, Krumholz HM. Age of Data at the Time of Publication of Contemporary Clinical Trials. JAMA Network Open 2018, 1: e181065-e181065. PMID: 30646100, PMCID: PMC6324269, DOI: 10.1001/jamanetworkopen.2018.1065.Peer-Reviewed Original ResearchConceptsClinical trialsFinal data collectionParticipant enrollmentInternal medicineMultivariable linear regression analysisFirst participant enrollmentPrimary end pointMultivariable regression analysisContemporary clinical trialsClinical trial dataJAMA Internal MedicineRegression analysisCross-sectional analysisTime of publicationMedian timeTrial characteristicsOutcome measuresMAIN OUTCOMENew England JournalClinical practiceLinear regression analysisTrial dataEnd pointTrial resultsTrialsStatewide Inferior Vena Cava Filter Placement, Complications, and Retrievals
Charalel RA, Durack JC, Mao J, Ross JS, Meltzer AJ, Sedrakyan A. Statewide Inferior Vena Cava Filter Placement, Complications, and Retrievals. Medical Care 2018, 56: 260-265. PMID: 29356721, DOI: 10.1097/mlr.0000000000000867.Peer-Reviewed Original ResearchConceptsIVC filter placementFilter placementIVC filtersFilter retrievalIVC filter-related complicationsProphylactic IVC filter placementInferior vena cava filter placementVena cava filter placementFilter-related complicationsPulmonary embolism riskAverage patient ageDrug Administration (FDA) safety communicationRetrospective cohort studyCava filter placementKaplan-Meier analysisAge-adjusted ratesIVC filter retrievalCohort studyPatient agePE occurrencePE ratePE eventsCumulative riskPopulation-level trendsClinical practice
2017
US Food and Drug Administration Clearance of Moderate‐Risk Otolaryngologic Devices via the 510(k) Process, 1997‐2016
Rathi VK, Gadkaree SK, Ross JS, Kozin ED, Sethi RK, Naunheim MR, Puram SV, Gray ST. US Food and Drug Administration Clearance of Moderate‐Risk Otolaryngologic Devices via the 510(k) Process, 1997‐2016. Otolaryngology 2017, 157: 608-617. PMID: 28786317, DOI: 10.1177/0194599817721689.Peer-Reviewed Original ResearchConceptsPremarket evidenceClinical evidenceClinical performance dataUS FoodAvailable FDA documentsFDA documentsEvidence of safetyDrug Administration clearanceOne-quarterNonclinical evidenceClinical practiceDrug AdministrationFDA clearanceOne-thirdTwo-thirdsClearanceFDATherapeutic devicesEvidenceSafetyOtolaryngologistsMajorityOtologicPostmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010
Downing NS, Shah ND, Aminawung JA, Pease AM, Zeitoun JD, Krumholz HM, Ross JS. Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010. JAMA 2017, 317: 1854-1863. PMID: 28492899, PMCID: PMC5815036, DOI: 10.1001/jama.2017.5150.Peer-Reviewed Original ResearchConceptsNovel therapeuticsSafety eventsAccelerated approvalTherapeutic characteristicsUS FoodDrug AdministrationFDA approvalInitial regulatory approvalClinician decision makingNew safety risksMedian followCohort studyMedian timeMultivariable analysisBoxed warningDrug classesMAIN OUTCOMEClinical practicePostmarket periodPsychiatric diseasesPriority reviewTherapeutic areasOrphan statusPsychiatric therapeuticsBiologics
2014
Evolution of Breast Cancer Screening in the Medicare Population: Clinical and Economic Implications
Killelea BK, Long JB, Chagpar AB, Ma X, Wang R, Ross JS, Gross CP. Evolution of Breast Cancer Screening in the Medicare Population: Clinical and Economic Implications. Journal Of The National Cancer Institute 2014, 106: dju159. PMID: 25031307, PMCID: PMC4155428, DOI: 10.1093/jnci/dju159.Peer-Reviewed Original ResearchConceptsEnd Results-MedicareBreast cancer stageCohort of womenEarly-stage tumorsBreast cancer screeningAdjunct imagingSignificant changesCancer screeningCancer stageIncidence rateBreast cancerAdjunct procedureOlder womenMedicare populationMedicare beneficiariesClinical practiceComputer-aided detectionPoisson regressionNational feeCohortBreast ultrasoundWomenEarlier cohortsLater cohortsMedicare spending