2022
Consistency between trials presented at conferences, their subsequent publications and press releases
Rowhani-Farid A, Hong K, Grewal M, Reynolds J, Zhang A, Wallach J, Ross J. Consistency between trials presented at conferences, their subsequent publications and press releases. BMJ Evidence-Based Medicine 2022, 28: 95-102. PMID: 36357160, PMCID: PMC10086295, DOI: 10.1136/bmjebm-2022-111989.Peer-Reviewed Original ResearchConceptsClinical trialsConference abstractsTrial resultsEndpoint definitionsPrimary efficacy end pointEnd pointEfficacy end pointPrimary efficacy endpointClinical Trials RegistryMedical conferencesMultiple logistic regressionCross-sectional analysisSafety endpointEfficacy endpointPeer-reviewed journalsTrial abstractsTrials RegistryTrial characteristicsConsistency of reportingSample sizePrimary analysisSecondary analysisInternational medical conferencesLogistic regressionStudy design
2021
US Food and Drug Administration utilization of postmarketing requirements and postmarketing commitments, 2009–2018
Skydel JJ, Zhang AD, Dhruva SS, Ross JS, Wallach JD. US Food and Drug Administration utilization of postmarketing requirements and postmarketing commitments, 2009–2018. Clinical Trials 2021, 18: 488-499. PMID: 33863236, PMCID: PMC8292154, DOI: 10.1177/17407745211005044.Peer-Reviewed Original ResearchConceptsClinical studiesPostmarketing requirementsUS FoodDrug AdministrationNew therapeuticsClinical evidenceNew prospective cohort studyProspective cohort studyCross-sectional studyDrug Administration approvalCohort studyRetrospective studyUnapproved indicationsAdministration approvalClinical indicationsClinical trialsBACKGROUND/Median numberDisease populationTherapeutic safetyTherapeutic indicationsSecondary analysisNovel therapeuticsSmall molecule drugsOriginal approval
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 dataTrialsRiskScoresParticipantsPopulationPostmarket studies required by the US Food and Drug Administration for new drugs and biologics approved between 2009 and 2012: cross sectional analysis
Wallach JD, Egilman AC, Dhruva SS, McCarthy ME, Miller JE, Woloshin S, Schwartz LM, Ross JS. Postmarket studies required by the US Food and Drug Administration for new drugs and biologics approved between 2009 and 2012: cross sectional analysis. The BMJ 2018, 361: k2031. PMID: 29794072, PMCID: PMC5967364, DOI: 10.1136/bmj.k2031.Peer-Reviewed Original ResearchConceptsProspective cohort studyCohort studyClinical trialsPostmarketing requirementsTimeliness of registrationNew drugsUS FoodDrug AdministrationFDA approvalStudy designNumber of patientsSectional analysisPostmarket studiesFirst approvalRegistrySecondary analysisTrialsBiologicsDrugsComparator typeAdministrationApprovalFDAFDA's authority
2017
Association of Changing Hospital Readmission Rates With Mortality Rates After Hospital Discharge
Dharmarajan K, Wang Y, Lin Z, Normand ST, Ross JS, Horwitz LI, Desai NR, Suter LG, Drye EE, Bernheim SM, Krumholz HM. Association of Changing Hospital Readmission Rates With Mortality Rates After Hospital Discharge. JAMA 2017, 318: 270-278. PMID: 28719692, PMCID: PMC5817448, DOI: 10.1001/jama.2017.8444.Peer-Reviewed Original ResearchConceptsRisk-adjusted readmission ratesRisk-adjusted mortality ratesAcute myocardial infarctionHeart failureReadmission ratesMortality rateMyocardial infarctionMedicare feeService beneficiariesHospital readmission ratesMean hospitalHospital mortalityPostdischarge mortalityHospital dischargeHospital readmissionRetrospective studyAffordable Care ActReadmission reductionMAIN OUTCOMEPneumoniaHospitalSecondary analysisWeighted Pearson correlation coefficientMortalityCare Act
2015
Predictors and outcomes of unplanned readmission to a different hospital
Kim H, Hung WW, Paik MC, Ross JS, Zhao Z, Kim GS, Boockvar K. Predictors and outcomes of unplanned readmission to a different hospital. International Journal For Quality In Health Care 2015, 27: 513-519. PMID: 26472739, PMCID: PMC4665363, DOI: 10.1093/intqhc/mzv082.Peer-Reviewed Original ResearchConceptsDifferent-hospital readmissionsReadmission groupAcute care hospitalsDifferent hospitalsUnplanned readmissionCare hospitalSame hospitalThirty-day unplanned readmissionsPercent of patientsSame-hospital readmissionsBetter care coordinationHospital deathIndex dischargeIndex hospitalCare coordinationHospital costsReadmissionHigher oddsMAIN OUTCOMEPatientsHealth outcomesCost outcomesHospitalSecondary analysisOutcomes
2010
Laboratory Test Ordering at Physician Offices with and without On-Site Laboratories
Bishop TF, Federman AD, Ross JS. Laboratory Test Ordering at Physician Offices with and without On-Site Laboratories. Journal Of General Internal Medicine 2010, 25: 1057-1063. PMID: 20532656, PMCID: PMC2955467, DOI: 10.1007/s11606-010-1409-7.Peer-Reviewed Original ResearchConceptsProstate-specific antigenConfidence intervalsNational Ambulatory Medical Care SurveyAmbulatory Medical Care SurveyPrimary care physiciansDesignCross-sectional studyPhysician ownersGroup practiceHealth care servicesLaboratory testsCommon laboratory testsExcess healthcare spendingGroup practice physiciansCare physiciansBlood countCare SurveyPhysician's officePrimary analysisPractice characteristicsCare servicesSecondary analysisKey ResultsThereSite laboratoryVisitsAOR