2024
Reporting 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.PatientsTrials
2020
Vibration of effects in epidemiologic studies of alcohol consumption and breast cancer risk
Chu L, Ioannidis JPA, Egilman AC, Vasiliou V, Ross JS, Wallach JD. Vibration of effects in epidemiologic studies of alcohol consumption and breast cancer risk. International Journal Of Epidemiology 2020, 49: 608-618. PMID: 31967637, PMCID: PMC7266551, DOI: 10.1093/ije/dyz271.Peer-Reviewed Original ResearchConceptsObservational studyRelative effect estimatesImpact of alcoholEffect estimatesExposure definitionAlcohol-breast cancer relationshipDifferent exposure definitionsBreast cancer riskVibration of effectsRelative risk estimatesMost observational studiesAdjustment covariatesCancer relationshipEligible studiesBreast cancerStudy populationEpidemiologic studiesCancer riskSmaller effect estimatesAlcohol consumptionRisk estimatesContrast levelsSame associationStability of findingsOne-third
2018
Accurate estimation of cardiovascular risk in a non-diabetic adult: detecting and correcting the error in the reported Framingham Risk Score for the Systolic Blood Pressure Intervention Trial population
Warner F, Dhruva SS, Ross JS, Dey P, Murugiah K, Krumholz HM. Accurate estimation of cardiovascular risk in a non-diabetic adult: detecting and correcting the error in the reported Framingham Risk Score for the Systolic Blood Pressure Intervention Trial population. BMJ Open 2018, 8: e021685. PMID: 30037874, PMCID: PMC6059296, DOI: 10.1136/bmjopen-2018-021685.Peer-Reviewed Original ResearchConceptsSystolic Blood Pressure Intervention TrialFramingham risk scoreCardiovascular riskRisk scoreStudy populationStudy participantsNon-diabetic adultsTotal study populationHigh-risk populationClinical trial dataClinical trial sitesTrial populationIntervention trialsRisk populationsNew England JournalIndependent investigatorsTrial dataSecondary analysisSPRINT trialSPRINT dataTrialsRiskScoresParticipantsPopulation
2016
Characterisation of trials where marketing purposes have been influential in study design: a descriptive study
Barbour V, Burch D, Godlee F, Heneghan C, Lehman R, Perera R, Ross JS, Schroter S. Characterisation of trials where marketing purposes have been influential in study design: a descriptive study. Trials 2016, 17: 31. PMID: 26792624, PMCID: PMC4720997, DOI: 10.1186/s13063-015-1107-1.Peer-Reviewed Original ResearchConceptsMedian numberDrug trialsGeneral medical journalsComposite primary outcome measureStudy designTerms of blindingPrimary outcome measureTrials of drugsHigh-impact general medical journalsKey trial characteristicsIndustry-funded trialsMedical journalsAdverse eventsCategories of trialsTrial characteristicsOutcome measuresStudy populationSafety outcomesBlinded researcherStudy characteristicsDescriptive studyTrial documentationTrialsSignificant differencesMarketing trials
2015
HbA1c overtesting and overtreatment among US adults with controlled type 2 diabetes, 2001-13: observational population based study
McCoy RG, Van Houten HK, Ross JS, Montori VM, Shah ND. HbA1c overtesting and overtreatment among US adults with controlled type 2 diabetes, 2001-13: observational population based study. The BMJ 2015, 351: h6138. PMID: 26646052, PMCID: PMC4673101, DOI: 10.1136/bmj.h6138.Peer-Reviewed Original ResearchConceptsType 2 diabetesGlycemic controlControlled type 2 diabetesNational administrative claims databaseExcessive testingAdministrative claims databaseGood glycemic controlStable glycemic controlStudy patientsTreatment intensificationSevere hypoglycemiaTreatment regimenStudy cohortUS patientsClaims databasePotential overtreatmentUS cohortHypoglycemic drugsInsulin treatmentPatient burdenRetrospective analysisStudy populationUS adultsDiabetes managementObservational population