2024
Recommendations to promote equity, diversity and inclusion in decentralized clinical trials
Aiyegbusi O, Cruz Rivera S, Kamudoni P, Anderson N, Collis P, Denniston A, Harding R, Hughes S, Khunti K, Kotecha D, Krumholz H, Liu X, McMullan C, Molony-Oates B, Monteiro J, Myles P, Rantell K, Soltys K, Verdi R, Wilson R, Calvert M. Recommendations to promote equity, diversity and inclusion in decentralized clinical trials. Nature Medicine 2024, 30: 3075-3084. PMID: 39472759, DOI: 10.1038/s41591-024-03323-w.Peer-Reviewed Original ResearchClinical trial participationDecentralized clinical trialsTrial participantsBarriers to clinical trial participationPromote equityGeneralizability of trial resultsClinical trial teamsHealth inequalitiesUnderserved groupsBarriers individualsTrial teamClinical trialsParticipantsElectronic dataTrial resultsEquitable mannerTrialsRecommendationsHealthInclusionRemote researchAssociated with several challenges
2018
Age 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 resultsTrials
2017
Systolic Blood Pressure Response in SPRINT (Systolic Blood Pressure Intervention Trial) and ACCORD (Action to Control Cardiovascular Risk in Diabetes): A Possible Explanation for Discordant Trial Results
Huang C, Dhruva SS, Coppi AC, Warner F, Li S, Lin H, Nasir K, Krumholz HM. Systolic Blood Pressure Response in SPRINT (Systolic Blood Pressure Intervention Trial) and ACCORD (Action to Control Cardiovascular Risk in Diabetes): A Possible Explanation for Discordant Trial Results. Journal Of The American Heart Association 2017, 6: e007509. PMID: 29133522, PMCID: PMC5721802, DOI: 10.1161/jaha.117.007509.Peer-Reviewed Original ResearchConceptsSystolic blood pressure responseBlood pressure responseTreatment groupsCause deathVisit variabilityDiscordant trialsBlood pressure trialStandard treatment groupPressure responseACCORD participantsPressure trialSBP responseHeart failureMean SBPPrimary outcomeSBPDiscordant resultsMean differenceSimilar interventionsTrial resultsTrialsSimilar mean differencesTreatment effectsSignificant differencesStrokeTwo Decades of Cardiovascular Trials With Primary Surrogate Endpoints: 1990–2011
Bikdeli B, Punnanithinont N, Akram Y, Lee I, Desai NR, Ross JS, Krumholz HM. Two Decades of Cardiovascular Trials With Primary Surrogate Endpoints: 1990–2011. Journal Of The American Heart Association 2017, 6: e005285. PMID: 28325713, PMCID: PMC5524035, DOI: 10.1161/jaha.116.005285.Peer-Reviewed Original ResearchConceptsClinical outcome trialsOutcome trialsEndpoint trialsPrimary endpointCardiovascular trialsClinical outcome studiesClinical outcomesSurrogate markerPatient's perspectiveSurrogate endpointsOutcome studiesNew England JournalSample cohortTrial resultsTrialsSurrogate trialsEndpointPositive resultsAmerican MedicalInterventionHigh-impact journalsCohort
2016
Publication and reporting of clinical trial results: cross sectional analysis across academic medical centers
Chen R, Desai NR, Ross JS, Zhang W, Chau KH, Wayda B, Murugiah K, Lu DY, Mittal A, Krumholz HM. Publication and reporting of clinical trial results: cross sectional analysis across academic medical centers. The BMJ 2016, 352: i637. PMID: 26888209, PMCID: PMC4768882, DOI: 10.1136/bmj.i637.Peer-Reviewed Original ResearchConceptsAcademic medical centerInterventional clinical trialsClinical trialsMedical CenterStudy completionPrimary completion dateClinical trial resultsReporting of resultsSectional analysisInterventional trialsProportion of trialsTrial resultsTrialsMonthsPhase IIManual reviewLead investigatorUnited StatesProportionRate of publicationReportingCompletionPatientsCenter
2009
Trial Publication after Registration in ClinicalTrials.Gov: A Cross-Sectional Analysis
Ross JS, Mulvey GK, Hines EM, Nissen SE, Krumholz HM. Trial Publication after Registration in ClinicalTrials.Gov: A Cross-Sectional Analysis. PLOS Medicine 2009, 6: e1000144. PMID: 19901971, PMCID: PMC2728480, DOI: 10.1371/journal.pmed.1000144.Peer-Reviewed Original ResearchConceptsOptional data elementsClinical trialsTrial publicationsInternet-based registryCompleteness of registrationCross-sectional analysisSelective publicationPrimary outcomeUS National LibraryReporting TrialsPublication statusTrial resultsPhase ITrialsData elementsSignificant differencesEditors' SummaryEnd dateSystematic protocolClinicalTrials
2005
The Impact of Clinical Trials on the Use of Hormone Replacement Therapy
Kim N, Gross C, Curtis J, Stettin G, Wogen S, Choe N, Krumholz HM. The Impact of Clinical Trials on the Use of Hormone Replacement Therapy. Journal Of General Internal Medicine 2005, 20: 1026-1031. PMID: 16307628, PMCID: PMC1490267, DOI: 10.1111/j.1525-1497.2005.0221.x.Peer-Reviewed Original ResearchMeSH KeywordsAge DistributionAgedClinical Trials as TopicFemaleHormone Replacement TherapyHumansInformation DisseminationInsurance, Pharmaceutical ServicesLongitudinal StudiesMiddle AgedPatient Acceptance of Health CarePractice Patterns, Physicians'Retrospective StudiesTreatment RefusalUnited StatesConceptsWomen's Health InitiativeHormone replacement therapyHRT useHRT discontinuationReplacement therapyHealth initiativesHormone replacement therapy useLocal practice patternsHRT prescriptionHRT usersMarked regional variationPrescription fillingTherapy useClinical behaviorClinical trialsPractice patternsSubstantial geographic variationTrial publicationsDiscontinuationHealth databasesTrial dataAge groupsRapid effectsWest South CentralTrial results