2024
How to Use Quasi-Experimental Methods in Cardiovascular Research: A Review of Current Practice
Carter A, Jayawardana S, Costa-Font J, Nasir K, Krumholz H, Mossialos E. How to Use Quasi-Experimental Methods in Cardiovascular Research: A Review of Current Practice. Circulation Cardiovascular Quality And Outcomes 2024, 17: e010078. PMID: 38362765, DOI: 10.1161/circoutcomes.123.010078.Peer-Reviewed Original ResearchConceptsRandomized controlled trialsDecision aidJoanna Briggs Institute checklistControlled trialsQuasi-experimental methodObservational studyInterrupted time series analysisQuasi-experimental studyDifference-in-differences analysisEstimate causal relationshipsSystematic search strategyInstrumental variable analysisQuality appraisalInstitute checklistInclusion criteriaGraphical decision aidReview of current practicesCurrent practicesRandom assignmentSearch strategyHigh-impact articlesVariability analysisTime series analysisCardiovascular researchAIDS
2020
Characteristics and Strength of Evidence of COVID-19 Studies Registered on ClinicalTrials.gov
Pundi K, Perino AC, Harrington RA, Krumholz HM, Turakhia MP. Characteristics and Strength of Evidence of COVID-19 Studies Registered on ClinicalTrials.gov. JAMA Internal Medicine 2020, 180: 1398-1400. PMID: 32730617, PMCID: PMC7385669, DOI: 10.1001/jamainternmed.2020.2904.Peer-Reviewed Original ResearchNon-inferiority trials using a surrogate marker as the primary endpoint: An increasing phenotype in cardiovascular trials
Bikdeli B, Caraballo C, Welsh J, Ross JS, Kaul S, Stone GW, Krumholz HM. Non-inferiority trials using a surrogate marker as the primary endpoint: An increasing phenotype in cardiovascular trials. Clinical Trials 2020, 17: 723-728. PMID: 32838556, PMCID: PMC8088773, DOI: 10.1177/1740774520949157.Peer-Reviewed Original ResearchConceptsNon-inferiority trialPrimary endpointClinical outcome trialsNon-inferiority marginSurrogate markerNon-inferiority designCardiovascular trialsOutcome trialsClinical outcomesDefinitive clinical outcome trialsNon-inferiority criteriaStudy protocolSurrogate outcomesBACKGROUND/Median numberSurrogate endpointsPrimary analysisCardiovascular interventionsCardiovascular medicineTrialsEndpointClinical interpretationOutcomesMarkersInterventionAn instrument for assessing the quality of informed consent documents for elective procedures: development and testing
Spatz ES, Suter LG, George E, Perez M, Curry L, Desai V, Bao H, Geary LL, Herrin J, Lin Z, Bernheim SM, Krumholz HM. An instrument for assessing the quality of informed consent documents for elective procedures: development and testing. BMJ Open 2020, 10: e033297. PMID: 32434933, PMCID: PMC7247404, DOI: 10.1136/bmjopen-2019-033297.Peer-Reviewed Original Research
2019
The China Patient-centred Evaluative Assessment of Cardiac Events (PEACE) prospective heart failure study design
Huang X, Yu Y, Li X, Masoudi FA, Spertus JA, Yan X, Krumholz HM, Jiang L, Li J. The China Patient-centred Evaluative Assessment of Cardiac Events (PEACE) prospective heart failure study design. BMJ Open 2019, 9: e025144. PMID: 30782925, PMCID: PMC6377534, DOI: 10.1136/bmjopen-2018-025144.Peer-Reviewed Original ResearchConceptsPatient-reported outcomesHeart failureChina PatientMedical historyCardiac Events Prospective Heart Failure StudyDisease-specific health statusEthics CommitteeCardiovascular risk factorsProspective cohort studyMin walk testHeart Failure StudyPatient's medical historyLocal ethics committeeQuality of careCollection of bloodHF hospitalisationHospitalisation eventsHospital outcomesCohort studyPatient demographicsTransthoracic echocardiogramWalk testHospital treatmentMedical recordsRisk factors
2018
Registration, results reporting, and publication bias of clinical trials supporting FDA approval of neuropsychiatric drugs before and after FDAAA: a retrospective cohort study
Zou CX, Becker JE, Phillips AT, Garritano JM, Krumholz HM, Miller JE, Ross JS. Registration, results reporting, and publication bias of clinical trials supporting FDA approval of neuropsychiatric drugs before and after FDAAA: a retrospective cohort study. Trials 2018, 19: 581. PMID: 30352601, PMCID: PMC6199729, DOI: 10.1186/s13063-018-2957-0.Peer-Reviewed Original ResearchConceptsRetrospective cohort studyPublication biasNeuropsychiatric indicationsCohort studyClinical trialsRelative riskEfficacy trialsFDA approvalPositive trialsFisher's exact testRecent FDA approvalDrug Administration Amendments ActClinical trial publicationsTRIAL REGISTRATIONMAIN OUTCOMEProportion of trialsNeuropsychiatric drugsNew drug approvalsTrial publicationsExact testMedical interventionsTrialsDrug approvalNew drugsDrugsAge 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 ResearchMeSH KeywordsCross-Sectional StudiesJournal Impact FactorPublishingRandomized Controlled Trials as TopicResearch DesignTime FactorsConceptsClinical 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 resultsTrialsThe China Patient-centered Evaluative Assessment of Cardiac Events (China PEACE) retrospective heart failure study design
Yu Y, Zhang H, Li X, Lu Y, Masoudi FA, Krumholz HM, Li J. The China Patient-centered Evaluative Assessment of Cardiac Events (China PEACE) retrospective heart failure study design. BMJ Open 2018, 8: e020918. PMID: 29748344, PMCID: PMC5950642, DOI: 10.1136/bmjopen-2017-020918.Peer-Reviewed Original ResearchConceptsHeart failureChina PatientEthics CommitteeRetrospective cohort studyHeart Failure StudyCardiovascular disease prevalenceEthics committee approvalQuality of careHospital outcomesCohort studyPatient characteristicsLeading causeMedical recordsCardiovascular diseaseCase ascertainmentTreatment outcomesCurrent burdenCommittee approvalData abstractionDiagnostic testingPatient recordsCentral Ethics CommitteeLocal approvalPatientsStudy designRationale, Design and Methodology of the Computerized Registry of Patients with Venous Thromboembolism (RIETE)
Bikdeli B, Jimenez D, Hawkins M, Ortíz S, Prandoni P, Brenner B, Decousus H, Masoudi FA, Trujillo-Santos J, Krumholz HM, Monreal M. Rationale, Design and Methodology of the Computerized Registry of Patients with Venous Thromboembolism (RIETE). Thrombosis And Haemostasis 2018, 118: 214-224. PMID: 29304541, PMCID: PMC5821113, DOI: 10.1160/th17-07-0511.Peer-Reviewed Original ResearchMeSH KeywordsAnticoagulantsCardiologyCause of DeathFemaleFollow-Up StudiesHemorrhageHumansInternational CooperationIschemiaPregnancyPregnancy Complications, CardiovascularProspective StudiesPuerperal DisordersPulmonary EmbolismRecurrenceRegistriesResearch DesignTreatment OutcomeVena Cava FiltersVenous ThromboembolismConceptsOutcomes of patientsVenous thromboembolismDeep vein thrombosisPulmonary embolismOngoing registryClinical trialsOutcomes of VTEPragmatic comparative effectiveness studyLong-term outcome dataUnstable pulmonary embolismPattern of presentationPatterns of carePrevalent vascular diseaseComparative effectiveness studiesHospital deathVein thrombosisVenous thrombosisPreventable causeComputerized registryVascular diseaseRIETEInclusion criteriaThrombotic conditionsOutcome dataPatients
2017
Design and rationale of the Cardiovascular Health and Text Messaging (CHAT) Study and the CHAT-Diabetes Mellitus (CHAT-DM) Study: two randomised controlled trials of text messaging to improve secondary prevention for coronary heart disease and diabetes
Huo X, Spatz ES, Ding Q, Horak P, Zheng X, Masters C, Zhang H, Irwin ML, Yan X, Guan W, Li J, Li X, Spertus JA, Masoudi FA, Krumholz HM, Jiang L. Design and rationale of the Cardiovascular Health and Text Messaging (CHAT) Study and the CHAT-Diabetes Mellitus (CHAT-DM) Study: two randomised controlled trials of text messaging to improve secondary prevention for coronary heart disease and diabetes. BMJ Open 2017, 7: e018302. PMID: 29273661, PMCID: PMC5778311, DOI: 10.1136/bmjopen-2017-018302.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAgedAged, 80 and overBlood PressureChinaCoronary DiseaseDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2ExerciseFemaleGlycated HemoglobinHumansLife StyleMaleMedication AdherenceMiddle AgedMotivationResearch DesignRisk FactorsSecondary PreventionSelf CareSingle-Blind MethodTelemedicineText MessagingYoung AdultConceptsSystolic blood pressureBody mass indexTrials of textProportion of patientsMedication adherencePhysical activitySecondary outcomesPrimary outcomeSmoking cessationCardiovascular healthMellitus StudySecondary coronary heart disease preventionCoronary heart disease preventionLow-density lipoprotein cholesterolUsual scientific forumsBlood pressure controlRisk factor managementHeart disease preventionCoronary heart diseaseMobile health interventionsInstitutional review boardUniversity Institutional Review BoardBehavioral skills modelText messagingBehavioral change techniquesProtocol for a nationwide survey of primary health care in China: the China PEACE (Patient-centered Evaluative Assessment of Cardiac Events) MPP (Million Persons Project) Primary Health Care Survey
Su M, Zhang Q, Lu J, Li X, Tian N, Wang Y, Yip W, Cheng KK, Mensah GA, Horwitz RI, Mossialos E, Krumholz HM, Jiang L. Protocol for a nationwide survey of primary health care in China: the China PEACE (Patient-centered Evaluative Assessment of Cardiac Events) MPP (Million Persons Project) Primary Health Care Survey. BMJ Open 2017, 7: e016195. PMID: 28851781, PMCID: PMC5629739, DOI: 10.1136/bmjopen-2017-016195.Peer-Reviewed Original ResearchConceptsPrimary health careMillion Persons ProjectQuality of careCardiac Events Million Persons ProjectHealth carePrimary care servicesEssential medicines programmeHealth Care SurveyChina PatientCare SurveyPatient satisfactionPHC servicesPHC workforceCardiovascular diseaseCare servicesObservational designPHC institutionsCentral Ethics CommitteeInformed consentChina National CenterEthics CommitteeCarePerson interviewsMedicine programsNationwide surveyAssociation of the FDA Amendment Act with trial registration, publication, and outcome reporting
Phillips AT, Desai NR, Krumholz HM, Zou CX, Miller JE, Ross JS. Association of the FDA Amendment Act with trial registration, publication, and outcome reporting. Trials 2017, 18: 333. PMID: 28720112, PMCID: PMC5516301, DOI: 10.1186/s13063-017-2068-3.Peer-Reviewed Original ResearchConceptsCardiovascular diseaseTRIAL REGISTRATIONFDA approvalNew drugsClinical trial registrationFDA Amendments ActDrug Administration Amendments ActAccessible trial registryClinical trial publicationsTrials RegistryResultsBetween 2005Efficacy trialsFDA reviewersTrial publicationsOutcome reportingMedical literatureReviewer interpretationsTrialsReporting of findingsDiseaseFDA documentsDrugsDiabetesFDAAAReviewers
2016
The china patient‐centered evaluative assessment of cardiac events (PEACE) prospective study of percutaneous coronary intervention: Study design
Du X, Pi Y, Dreyer RP, Li J, Li X, Downing NS, Li L, Feng F, Zhan L, Zhang H, Guan W, Xu X, Li S, Lin Z, Masoudi FA, Spertus JA, Krumholz HM, Jiang L, Group F. The china patient‐centered evaluative assessment of cardiac events (PEACE) prospective study of percutaneous coronary intervention: Study design. Catheterization And Cardiovascular Interventions 2016, 88: e212-e221. PMID: 26945565, PMCID: PMC5215582, DOI: 10.1002/ccd.26461.Peer-Reviewed Original ResearchMeSH KeywordsChinaClinical ProtocolsCoronary AngiographyHealth StatusHealthcare DisparitiesHumansMedication AdherenceMyocardial InfarctionPatient Reported Outcome MeasuresPatient-Centered CarePercutaneous Coronary InterventionPredictive Value of TestsProspective StudiesResearch DesignRisk AssessmentRisk FactorsSecondary PreventionTime FactorsTreatment OutcomeConceptsPercutaneous coronary interventionPatient-reported outcomesCardiovascular risk factor controlRisk factor controlProspective studyHealth statusMedical historyLong-term clinical outcomesLong-term patient outcomesHospital-level factorsIndependent core laboratoryNationwide prospective studyLong-term outcomesPatient's medical historyHospital outcomesCoronary interventionPatient demographicsSecondary preventionConsecutive patientsMedical chartsPCI indicationPrimary outcomeClinical outcomesClinical presentationHealthcare utilization
2015
Characteristics of Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving FDA Premarket Approval in 2010 and 2011
Rathi VK, Krumholz HM, Masoudi FA, Ross JS. Characteristics of Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving FDA Premarket Approval in 2010 and 2011. JAMA 2015, 314: 604-612. PMID: 26262798, DOI: 10.1001/jama.2015.8761.Peer-Reviewed Original ResearchConceptsPrimary effectiveness end pointEffectiveness end pointPostmarket studiesClinical studiesClinical evidencePMA pathwayPremarket studiesEnd pointAvailable FDA documentsInitial marketing approvalPremarket approval pathwayTherapeutic devicesMedian durationMedian enrollmentHigh-risk medical devicesMAIN OUTCOMEPatientsDrug AdministrationUS FoodFDA approvalMarketing approvalLonger durationFDA documentsMonthsPostmarket
2014
Hospital Cardiovascular Outcome Measures in Federal Pay-for-Reporting and Pay-for-Performance Programs
Spivack SB, Bernheim SM, Forman HP, Drye EE, Krumholz HM. Hospital Cardiovascular Outcome Measures in Federal Pay-for-Reporting and Pay-for-Performance Programs. Circulation Cardiovascular Quality And Outcomes 2014, 7: 627-633. PMID: 25205787, PMCID: PMC4415521, DOI: 10.1161/circoutcomes.114.001364.Peer-Reviewed Original ResearchReporting of Results in ClinicalTrials.gov and High-Impact Journals
Becker JE, Krumholz HM, Ben-Josef G, Ross JS. Reporting of Results in ClinicalTrials.gov and High-Impact Journals. JAMA 2014, 311: 1063-1065. PMID: 24618969, PMCID: PMC3979514, DOI: 10.1001/jama.2013.285634.Peer-Reviewed Original ResearchClinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents, 2005-2012
Downing NS, Aminawung JA, Shah ND, Krumholz HM, Ross JS. Clinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents, 2005-2012. JAMA 2014, 311: 368-377. PMID: 24449315, PMCID: PMC4144867, DOI: 10.1001/jama.2013.282034.Peer-Reviewed Original ResearchConceptsPivotal efficacy trialsNovel therapeutic agentsClinical trial evidencePivotal trialsEfficacy trialsTherapeutic agentsEnd pointTrial evidenceMedian numberAvailable FDA documentsSingle pivotal trialTrial end pointsSurrogate end pointsNumber of patientsLength of treatmentCross-sectional analysisPrimary outcomeClinical outcomesTrial completion ratesClinical benefitPlacebo comparatorSurrogate outcomesMAIN OUTCOMEDrug AdministrationUS FoodIncreasing value and reducing waste: addressing inaccessible research
Chan AW, Song F, Vickers A, Jefferson T, Dickersin K, Gøtzsche PC, Krumholz HM, Ghersi D, van der Worp HB. Increasing value and reducing waste: addressing inaccessible research. The Lancet 2014, 383: 257-266. PMID: 24411650, PMCID: PMC4533904, DOI: 10.1016/s0140-6736(13)62296-5.Peer-Reviewed Original Research
2013
Grant Applications With a Result-Based Orientation
Krumholz HM. Grant Applications With a Result-Based Orientation. Circulation Cardiovascular Quality And Outcomes 2013, 6: 507-508. PMID: 24021690, DOI: 10.1161/circoutcomes.113.000562.Peer-Reviewed Original ResearchPromoting Publication of Rigorous Qualitative Research
Krumholz HM, Bradley EH, Curry LA. Promoting Publication of Rigorous Qualitative Research. Circulation Cardiovascular Quality And Outcomes 2013, 6: 133-134. PMID: 23481529, DOI: 10.1161/circoutcomes.113.000186.Peer-Reviewed Original Research