2024
Natural Language Processing of Clinical Documentation to Assess Functional Status in Patients With Heart Failure
Adejumo P, Thangaraj P, Dhingra L, Aminorroaya A, Zhou X, Brandt C, Xu H, Krumholz H, Khera R. Natural Language Processing of Clinical Documentation to Assess Functional Status in Patients With Heart Failure. JAMA Network Open 2024, 7: e2443925. PMID: 39509128, PMCID: PMC11544492, DOI: 10.1001/jamanetworkopen.2024.43925.Peer-Reviewed Original ResearchConceptsFunctional status assessmentArea under the receiver operating characteristic curveClinical documentationElectronic health record dataHF symptomsOptimal care deliveryHealth record dataAssess functional statusStatus assessmentClinical trial participationProcessing of clinical documentsFunctional status groupCare deliveryOutpatient careMain OutcomesMedical notesTrial participantsNew York Heart AssociationFunctional statusQuality improvementRecord dataHeart failureClinical notesDiagnostic studiesStatus groupsRecommendations 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
2016
Participation of the elderly, women, and minorities in pivotal trials supporting 2011–2013 U.S. Food and Drug Administration approvals
Downing NS, Shah ND, Neiman JH, Aminawung JA, Krumholz HM, Ross JS. Participation of the elderly, women, and minorities in pivotal trials supporting 2011–2013 U.S. Food and Drug Administration approvals. Trials 2016, 17: 199. PMID: 27079511, PMCID: PMC4832528, DOI: 10.1186/s13063-016-1322-4.Peer-Reviewed Original ResearchMeSH KeywordsAdultAge FactorsAgedClinical Trials as TopicCross-Sectional StudiesDatabases, FactualDrug ApprovalEthnicityFemaleHealth Status DisparitiesHealthcare DisparitiesHumansMaleMiddle AgedMinority GroupsPatient SelectionSex FactorsTime FactorsUnited StatesUnited States Food and Drug AdministrationConceptsSubgroup efficacy analysesPivotal trialsEfficacy analysisNovel therapeuticsSubgroup analysisTrial participantsU.S. FoodMean proportionAvailable FDA documentsCross-sectional studyDrug Administration approvalBasis of approvalYears of ageTrial patientsElderly patientsMedian ageBlack patientsAsian patientsAdministration approvalClinical studiesFDA reviewersPatientsHispanic participantsTrialsDemographic characteristics
2006
Does Random Treatment Assignment Cause Harm to Research Participants?
Gross CP, Krumholz HM, Van Wye G, Emanuel EJ, Wendler D. Does Random Treatment Assignment Cause Harm to Research Participants? PLOS Medicine 2006, 3: e188. PMID: 16719548, PMCID: PMC1470665, DOI: 10.1371/journal.pmed.0030188.Peer-Reviewed Original ResearchConceptsClinical outcomesTreatment assignmentRCT participantsClinical trialsTrial participantsRandom treatment assignmentPrimary study outcomeMeeting eligibility criteriaImproved patient outcomesSimilar health statusSubstandard medical careBaseline characteristicsPatient groupPatient outcomesEligibility criteriaHealth outcomesHealth statusEligible manuscriptsMedical careSystematic reviewSame interventionClinical researchStudy outcomesOutcomesSignificant differences
2005
Enrolling Older Persons in Cancer Trials: The Effect of Sociodemographic, Protocol, and Recruitment Center Characteristics
Gross CP, Herrin J, Wong N, Krumholz HM. Enrolling Older Persons in Cancer Trials: The Effect of Sociodemographic, Protocol, and Recruitment Center Characteristics. Journal Of Clinical Oncology 2005, 23: 4755-4763. PMID: 16034051, DOI: 10.1200/jco.2005.14.365.Peer-Reviewed Original ResearchConceptsCancer trialsOlder personsRecruitment centerElderly enrollmentProportion of patientsEffect of patientProstate cancer trialsPatient-level variationFinal study sampleNational Cancer InstituteCross-sectional analysisEffects of sociodemographicsNonwhite patientsTrial participantsOutlier centersCancer InstitutePatientsEnrollment centerMultivariate analysisLikelihood of participantsCancer typesLogistic multilevel modelsTrialsCenter characteristicsStudy sampleEnrollment of Older Persons in Cancer Trials After the Medicare Reimbursement Policy Change
Gross CP, Wong N, Dubin JA, Mayne ST, Krumholz HM. Enrollment of Older Persons in Cancer Trials After the Medicare Reimbursement Policy Change. JAMA Internal Medicine 2005, 165: 1514-1520. PMID: 16009867, DOI: 10.1001/archinte.165.13.1514.Peer-Reviewed Original ResearchConceptsOlder patientsCancer trialsReimbursement policy changesOlder personsPatients' sociodemographic characteristicsTrial exclusion criteriaMultivariate logistic regressionProstate cancer trialsProportion of participantsNational Cancer InstituteRoutine care costsSignificant changesClinical trialsPrimary study sampleExclusion criteriaTrial participantsCancer InstitutePatientsPrimary analysisCare costsMultivariate analysisSecondary analysisSociodemographic characteristicsLogistic regressionCancer typesThe impact of socioeconomic status and race on trial participation for older women with breast cancer
Gross CP, Filardo G, Mayne ST, Krumholz HM. The impact of socioeconomic status and race on trial participation for older women with breast cancer. Cancer 2005, 103: 483-491. PMID: 15597407, DOI: 10.1002/cncr.20792.Peer-Reviewed Original ResearchMeSH KeywordsAgedAsianBlack or African AmericanBreast NeoplasmsCase-Control StudiesClinical Trials as TopicFemaleHispanic or LatinoHumansLogistic ModelsMedicaidMultivariate AnalysisNational Institutes of Health (U.S.)Odds RatioPatient SelectionPovertySEER ProgramUnemploymentUnited StatesWhite PeopleConceptsBreast cancer trialsTrial participationOlder womenBreast cancerSocioeconomic statusMedicaid insuranceTrial enrollmentCancer patientsCancer trialsMultivariable logistic regression modelBreast cancer patientsMedicaid insurance coverageAssociation of SESHigh-poverty zip codesCase-control studyPopulation-based sampleLow socioeconomic statusLogistic regression modelsImpact of SESWhite patientsBlack patientsSEER areasBlack raceElderly womenTrial participants
2004
Cancer Trial Enrollment After State-Mandated Reimbursement
Gross CP, Murthy V, Li Y, Kaluzny AD, Krumholz HM. Cancer Trial Enrollment After State-Mandated Reimbursement. Journal Of The National Cancer Institute 2004, 96: 1063-1069. PMID: 15265967, DOI: 10.1093/jnci/djh193.Peer-Reviewed Original ResearchMeSH KeywordsBreast NeoplasmsClinical Trials, Phase II as TopicClinical Trials, Phase III as TopicColorectal NeoplasmsFemaleGovernment RegulationHumansIncidenceLogistic ModelsLongitudinal StudiesLung NeoplasmsMaleMulticenter Studies as TopicNational Institutes of Health (U.S.)NeoplasmsPatient SelectionPoisson DistributionProstatic NeoplasmsReimbursement MechanismsRetrospective StudiesState GovernmentUnited StatesConceptsCancer trial enrollmentTrial enrollment ratesTrial enrollmentMultivariable analysisTrial participationOdds ratioTrial participantsCoverage policiesCancer trial participantsCooperative group trialsClinical trial enrollmentEarly phase trialsRecruitment of patientsCancer trial participationMedical care costsPhase II trial participantsCancer patientsPhase trialsCancer research studiesGroup trialsCare costsPoisson regressionCancer typesReimbursement policiesPhase IIParticipation in Cancer Clinical Trials: Race-, Sex-, and Age-Based Disparities
Murthy VH, Krumholz HM, Gross CP. Participation in Cancer Clinical Trials: Race-, Sex-, and Age-Based Disparities. JAMA 2004, 291: 2720-2726. PMID: 15187053, DOI: 10.1001/jama.291.22.2720.Peer-Reviewed Original ResearchConceptsCancer trialsCancer clinical trialsClinical trialsTrial participantsEnrollment fractionWhite patientsAge groupsCross-sectional population-based analysisProstate cancer clinical trialsCancer research participationCancer trial participantsColorectal cancer trialsPatients 75 yearsIncident cancer patientsLung cancer trialsPopulation-based analysisRelative risk ratiosAge-based disparitiesYears of ageNational Cancer InstituteLogistic regression modelsLittle recent informationTrial enrolleesYounger patientsPatient group