2024
Advancing patient-centric care: integrating patient reported outcomes for tolerability assessment in early phase clinical trials – insights from an expert virtual roundtable
Yap C, Aiyegbusi O, Alger E, Basch E, Bell J, Bhatnagar V, Cella D, Collis P, Dueck A, Gilbert A, Gnanasakthy A, Greystoke A, Hansen A, Kamudoni P, Kholmanskikh O, King-Kallimanis B, Krumholz H, Minchom A, O'Connor D, Petrie J, Piccinin C, Rantell K, Rauz S, Retzer A, Rizk S, Wagner L, Sasseville M, Seymour L, Weber H, Wilson R, Calvert M, Peipert J. Advancing patient-centric care: integrating patient reported outcomes for tolerability assessment in early phase clinical trials – insights from an expert virtual roundtable. EClinicalMedicine 2024, 76: 102838. PMID: 39386161, PMCID: PMC11462221, DOI: 10.1016/j.eclinm.2024.102838.Peer-Reviewed Original ResearchEarly phase trialsPatient-reported outcomesPhase trialsInvestigator-reported adverse eventsEarly phase clinical trialsTolerability assessmentsPhase clinical trialsIntegration of patient-reported outcomesAdverse eventsClinical trialsPatient-centred careDosing decisionsDiverse clinical areasTherapy risksLaboratory assessmentPatientsTrialsPatient advocatesClinical areasOutcomesSafety alertsPharmaceutical representativesVirtual roundtableRisk
2023
Impact of Marital Stress on 1‐Year Health Outcomes Among Young Adults With Acute Myocardial Infarction
Zhu C, Dreyer R, Li F, Spatz E, Caraballo‐Cordovez C, Mahajan S, Raparelli V, Leifheit E, Lu Y, Krumholz H, Spertus J, D'Onofrio G, Pilote L, Lichtman J. Impact of Marital Stress on 1‐Year Health Outcomes Among Young Adults With Acute Myocardial Infarction. Journal Of The American Heart Association 2023, 12: e030031. PMID: 37589125, PMCID: PMC10547344, DOI: 10.1161/jaha.123.030031.Peer-Reviewed Original ResearchConceptsAcute myocardial infarctionCardiac-specific qualityGeneric health statusMyocardial infarctionBaseline healthMarital stressHealth outcomesHealth statusWorse patient-reported outcomesMental healthYoung adultsObservational cohort studyPatient-reported outcomesSocioeconomic factorsWorse mental healthReadmission 1Cause readmissionCohort studyYounger patientsRoutine screeningDepressive symptomsGreater oddsAnginaMale participantsOutcomes
2022
Association of Initial SARS-CoV-2 Test Positivity With Patient-Reported Well-being 3 Months After a Symptomatic Illness
Wisk L, Gottlieb M, Spatz E, Yu H, Wang R, Slovis B, Saydah S, Plumb I, O’Laughlin K, Montoy J, McDonald S, Lin Z, Lin J, Koo K, Idris A, Huebinger R, Hill M, Gentile N, Chang A, Anderson J, Hota B, Venkatesh A, Weinstein R, Elmore J, Nichol G, Santangelo M, Ulrich A, Li S, Kinsman J, Krumholz H, Dorney J, Stephens K, Black K, Morse D, Morse S, Fernandes A, Sharma A, Stober T, Geyer R, Lyon V, Adams K, Willis M, Ruiz L, Park J, Malone K, Shughart H, Schaeffer K, Shughart L, Arab A, Grau D, Patel A, Watts P, Kelly M, Hunt A, Hannikainen P, Chalfin M, Cheng D, Miao J, Shutty C, Chavez S, Kane A, Marella P, Gallegos G, Martin K, L'Hommedieu M, Chandler C, Diaz Roldan K, Villegas N, Moreno R, Eguchi M, Rodriguez R, Kemball R, Chan V, Chavez C, Wong A, Hall A, Briggs-Hagen M. Association of Initial SARS-CoV-2 Test Positivity With Patient-Reported Well-being 3 Months After a Symptomatic Illness. JAMA Network Open 2022, 5: e2244486. PMID: 36454572, PMCID: PMC9716377, DOI: 10.1001/jamanetworkopen.2022.44486.Peer-Reviewed Original ResearchConceptsCOVID-19 positive groupCOVID-19-negative groupSARS-CoV-2 infectionCOVID-19 testCOVID-19 resultsSymptomatic illnessSymptomatic SARS-CoV-2 infectionNegative COVID-19 resultsSARS-CoV-2 statusSARS-CoV-2 test positivityPositive COVID-19 testSARS-CoV-2 testNegative COVID-19 testLongitudinal registry studyOutcomes Measurement Information SystemPatient-reported outcomesHealth care usePositive COVID-19 resultMultivariable regression analysisMeasurement Information SystemCOVID-19 testingNegative test resultsCohort studyRegistry studyPROMIS scoresStudy protocol for the Innovative Support for Patients with SARS-COV-2 Infections Registry (INSPIRE): A longitudinal study of the medium and long-term sequelae of SARS-CoV-2 infection
O’Laughlin K, Thompson M, Hota B, Gottlieb M, Plumb ID, Chang AM, Wisk LE, Hall AJ, Wang RC, Spatz ES, Stephens KA, Huebinger RM, McDonald SA, Venkatesh A, Gentile N, Slovis BH, Hill M, Saydah S, Idris AH, Rodriguez R, Krumholz HM, Elmore JG, Weinstein RA, Nichol G, . Study protocol for the Innovative Support for Patients with SARS-COV-2 Infections Registry (INSPIRE): A longitudinal study of the medium and long-term sequelae of SARS-CoV-2 infection. PLOS ONE 2022, 17: e0264260. PMID: 35239680, PMCID: PMC8893622, DOI: 10.1371/journal.pone.0264260.Peer-Reviewed Original ResearchConceptsSARS-CoV-2 infectionLong-term sequelaePatient-reported outcomesRelative riskAcute SARS-CoV-2 infectionSARS-CoV-2 negative participantsHealth system encountersPredictors of sequelaeHealth recordsInstitutional review board approvalLongitudinal studyDigital health recordsReview board approvalSARS-CoV-2Secure online platformClinical outcomesStudy protocolNegative participantsViral testsSimilar symptomatologyNew diagnosisBoard approvalSequelaeSelf-administered surveyInfection
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
Sex Differences in Omega‐3 and ‐6 Fatty Acids and Health Status Among Young Adults With Acute Myocardial Infarction: Results From the VIRGO Study
Lu Y, Ding Q, Xu X, Spatz ES, Dreyer RP, D'Onofrio G, Caulfield M, Nasir K, Spertus JA, Krumholz HM. Sex Differences in Omega‐3 and ‐6 Fatty Acids and Health Status Among Young Adults With Acute Myocardial Infarction: Results From the VIRGO Study. Journal Of The American Heart Association 2018, 7: e008189. PMID: 29848494, PMCID: PMC6015388, DOI: 10.1161/jaha.117.008189.Peer-Reviewed Original ResearchConceptsAcute myocardial infarctionHealth status scoresArachidonic acidVIRGO StudyStatus scoreMyocardial infarctionHealth statusPoorer health status outcomesYoung menPatient-reported health statusYoung womenOmega-3 fatty acidsSex differencesPatient-reported outcomesFatty acidsHealth status outcomesCardiovascular outcomesClinical characteristicsAdjusted analysisAMI patientsRisk factorsUS adultsStatus outcomesOmega-3Women 1
2017
Reductions in Readmission Rates Are Associated With Modest Improvements in Patient-reported Health Gains Following Hip and Knee Replacement in England
Friebel R, Dharmarajan K, Krumholz HM, Steventon A. Reductions in Readmission Rates Are Associated With Modest Improvements in Patient-reported Health Gains Following Hip and Knee Replacement in England. Medical Care 2017, 55: 834-840. PMID: 28742545, PMCID: PMC5555974, DOI: 10.1097/mlr.0000000000000779.Peer-Reviewed Original ResearchConceptsRisk-adjusted readmission ratesReadmission ratesEQ-VASHealth gainsEQ-5DKnee replacementHip replacementOxford Hip ScoreOxford Knee ScorePatient-reported healthPatient-reported outcomesVisual analog scaleKnee replacement surgeryReadmission reduction initiativesHealth care systemAdditional health gainsHip scoreKnee scoreAnalog scalePresurgical assessmentReplacement surgeryPatients' senseHospital groupModest ImprovementPatient healthPatient–Provider Communication and Health Outcomes Among Individuals With Atherosclerotic Cardiovascular Disease in the United States
Okunrintemi V, Spatz ES, Di Capua P, Salami JA, Valero-Elizondo J, Warraich H, Virani SS, Blaha MJ, Blankstein R, Butt AA, Borden WB, Dharmarajan K, Ting H, Krumholz HM, Nasir K. Patient–Provider Communication and Health Outcomes Among Individuals With Atherosclerotic Cardiovascular Disease in the United States. Circulation Cardiovascular Quality And Outcomes 2017, 10: e003635. PMID: 28373270, DOI: 10.1161/circoutcomes.117.003635.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAgedAspirinAtherosclerosisCommunicationEmergency Service, HospitalFemaleHealth Care CostsHealth Care SurveysHealth ExpendituresHealth StatusHumansHydroxymethylglutaryl-CoA Reductase InhibitorsLength of StayMaleMental HealthMiddle AgedOdds RatioPatient Reported Outcome MeasuresPatient-Centered CarePhysician-Patient RelationsPlatelet Aggregation InhibitorsQuality Indicators, Health CareRisk FactorsUnited StatesYoung AdultConceptsAtherosclerotic cardiovascular diseasePatient-provider communicationHealthcare resource utilizationPatient-reported outcomesCardiovascular diseaseHealth Plans SurveyMedical Expenditure Panel Survey cohortHigher annual healthcare expendituresRepresentative US adult populationHealthcare expendituresAtherosclerotic cardiovascular disease (ASCVD) patientsConsumer AssessmentEmergency room visitsEvidence-based therapiesAnnual healthcare expendituresCardiovascular disease patientsUS adult populationPlans SurveyMental health statusPatient-centered careOutcomes of interestASA useHospital stayRoom visitsPoor outcome
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 utilizationThe China Patient-Centred Evaluative Assessment of Cardiac Events (China PEACE)-Prospective Study of 3-Vessel Disease: rationale and design
Rao C, Bongiovanni T, Li X, Gao H, Zhang H, Li J, Zhao Y, Yuan X, Hua K, Hu S, Krumholz HM, Jiang L, Zheng Z. The China Patient-Centred Evaluative Assessment of Cardiac Events (China PEACE)-Prospective Study of 3-Vessel Disease: rationale and design. BMJ Open 2016, 6: e009743. PMID: 26880670, PMCID: PMC4762131, DOI: 10.1136/bmjopen-2015-009743.Peer-Reviewed Original ResearchConceptsComplex coronary artery diseaseCoronary artery diseaseArtery diseaseLarge cardiovascular centresCardiac eventsProspective studyCardiovascular CenterTreatment strategiesCoronary revascularisation proceduresSYNTAX score calculationThree-vessel diseaseElective coronary angiographyMedical record abstractionPatient-reported outcomesAppropriateness of treatmentQuality improvement initiativesQuality of lifeEligible patientsRevascularisation proceduresAdverse eventsGuideline adherenceHospital factorsProspective cohortSecondary preventionCoronary angiographyChina Patient-centered Evaluative Assessment of Cardiac Events Prospective Study of Acute Myocardial Infarction: Study Design
Li J, Dreyer RP, Li X, Du X, Downing NS, Li L, Zhang HB, Feng F, Guan WC, Xu X, Li SX, Lin ZQ, Masoudi FA, Spertus JA, Krumholz HM, Jiang LX, Group T. China Patient-centered Evaluative Assessment of Cardiac Events Prospective Study of Acute Myocardial Infarction: Study Design. Chinese Medical Journal 2016, 129: 72-80. PMID: 26712436, PMCID: PMC4797546, DOI: 10.4103/0366-6999.172596.Peer-Reviewed Original ResearchConceptsPatient-reported outcomesAcute myocardial infarctionChina PatientMedical historyMyocardial infarctionPatient experienceLong-term adverse eventsRisk factor controlConsecutive AMI patientsAMI studyPatient's medical historyQuality of lifeNational Coordinating CentreQuality improvement activitiesHospital outcomesCardiac eventsPatient demographicsAdverse eventsMedical chartsHealthcare utilizationAMI patientsMedication adherenceProspective studyHospitalization eventsRisk factors
2015
Racial Differences in Heart Failure Outcomes Evidence From the Tele-HF Trial (Telemonitoring to Improve Heart Failure Outcomes)
Qian F, Parzynski CS, Chaudhry SI, Hannan EL, Shaw BA, Spertus JA, Krumholz HM. Racial Differences in Heart Failure Outcomes Evidence From the Tele-HF Trial (Telemonitoring to Improve Heart Failure Outcomes). JACC Heart Failure 2015, 3: 531-538. PMID: 26160368, PMCID: PMC8635169, DOI: 10.1016/j.jchf.2015.03.005.Peer-Reviewed Original ResearchConceptsPatient-reported health statusKansas City Cardiomyopathy QuestionnaireHeart failureBlack patientsHealth statusHF hospitalizationRacial differencesBaseline KCCQ scoresClinical laboratory valuesPatient-reported outcomesSignificant racial differencesKCCQ scoresHF admissionsPatient demographicsWhite patientsLaboratory valuesPropensity score methodsPatientsHospitalizationOutcome evidenceMonthsLinear mixed modelsBaselineTrialsStatus