2024
Information Disclosure, Medical Device Regulation, and Device Safety: The Case of Cook Celect IVC Filters.
Kadakia K, Bikdeli B, Gupta A, Dhruva S, Ross J, Krumholz H. Information Disclosure, Medical Device Regulation, and Device Safety: The Case of Cook Celect IVC Filters. Annals Of Internal Medicine 2024 PMID: 39556835, DOI: 10.7326/annals-24-00089.Peer-Reviewed Original ResearchMedical device regulationDetect adverse eventsDevice regulationInferior vena cavaPatient safetyFood and Drug AdministrationDevice safetyOutcome definitionsStudy protocolPatient deathClinical study protocolAdverse eventsProfessional societiesCourt documentsClinical practiceRegulatory reformCliniciansInferior vena cava perforationDevice labelingPrevention of pulmonary embolismPublished literaturePublic recordsInaccurate informationCelect IVC filtersMedical devices
2022
Effectiveness of a clinical decision support system for hypertension management in primary care: study protocol for a pragmatic cluster-randomized controlled trial
Song J, Wang X, Wang B, Gao Y, Liu J, Zhang H, Li X, Li J, Wang JG, Cai J, Herrin J, Armitage J, Krumholz HM, Zheng X. Effectiveness of a clinical decision support system for hypertension management in primary care: study protocol for a pragmatic cluster-randomized controlled trial. Trials 2022, 23: 412. PMID: 35578345, PMCID: PMC9109449, DOI: 10.1186/s13063-022-06374-x.Peer-Reviewed Original ResearchConceptsHypertension managementPrimary carePrimary outcomeDual antihypertensive therapyHypertension Treatment TrialBlood pressure managementGuideline-based treatmentPrimary care sitesCluster-randomized trialUnit of randomizationGuideline-based decision support systemClinical decision support systemAntihypertensive regimensAntihypertensive treatmentUsual careGuideline adherenceBlood pressureMiddle-income countriesTreatment trialsManagement visitsStudy protocolCare sitesPatientsTrialsPressure managementStudy 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
2020
Non-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 interpretationOutcomesMarkersIntervention
2014
Protocol for the China PEACE (Patient-centered Evaluative Assessment of Cardiac Events) retrospective study of coronary catheterisation and percutaneous coronary intervention
Li J, Dharmarajan K, Li X, Lin Z, Normand SL, Krumholz HM, Jiang L, Group F. Protocol for the China PEACE (Patient-centered Evaluative Assessment of Cardiac Events) retrospective study of coronary catheterisation and percutaneous coronary intervention. BMJ Open 2014, 4: e004595. PMID: 24607563, PMCID: PMC3948460, DOI: 10.1136/bmjopen-2013-004595.Peer-Reviewed Original ResearchConceptsPercutaneous coronary interventionCoronary catheterisationCoronary interventionPatient characteristicsRetrospective studyCardiovascular diseaseComplications of treatmentCost of hospitalisationMedical record abstractionPatterns of careDiagnostic testing patternsTwo-stage clusterHospital outcomesRecord abstractionChinese healthcare systemStudy protocolCase ascertainmentImproved careCatheterisationProcedural treatmentsHospitalCentral Ethics CommitteeChinese hospitalsPatientsChina National Center
2006
A Taxonomy for Disease Management
Krumholz HM, Currie PM, Riegel B, Phillips CO, Peterson ED, Smith R, Yancy CW, Faxon DP. A Taxonomy for Disease Management. Circulation 2006, 114: 1432-1445. PMID: 16952985, DOI: 10.1161/circulationaha.106.177322.Peer-Reviewed Original ResearchMeSH KeywordsCardiologyCase ManagementClinical ProtocolsComorbidityDelivery of Health CareDepressionDiabetes MellitusDisease ManagementHeart FailureInterdisciplinary CommunicationMedicareModels, TheoreticalOutcome and Process Assessment, Health CarePatient Care ManagementPatient Care TeamPatient Education as TopicPatient SelectionRisk FactorsSocieties, MedicalTerminology as TopicConceptsDisease management programsDisease management interventionsHeart failureDisease managementHealthcare providersTerms heart failureLevel of comorbidityMedical resource utilizationHome-based programPatient-centered measuresSystematic MEDLINE searchDuration of exposureHealthcare delivery systemSecondary outcomesClinical outcomesPatient populationPostacute careCaregiver burdenMedication managementStudy protocolChronic carePatient outcomesPatient educationWriting groupManagement interventions