2022
Interventions Targeted to Address Social Determinants of Health in Ischemic Heart Disease: A Sex- and Gender-Oriented Scoping Review
Raparelli V, Wright CX, Corica B, Sharma G, Lindley K, Brackett A, Pilote L, Wood MJ, Dreyer RP. Interventions Targeted to Address Social Determinants of Health in Ischemic Heart Disease: A Sex- and Gender-Oriented Scoping Review. Canadian Journal Of Cardiology 2022, 38: 1881-1892. PMID: 35809812, DOI: 10.1016/j.cjca.2022.06.025.Peer-Reviewed Original ResearchConceptsIschemic heart diseaseHealth care systemHeart diseaseCare systemPatient education interventionsMajor health problemSex-stratified analysesSocial supportSDOH interventionsIHD patientsMale patientsSDOH domainsMinority patientsCare implementationHealth literacyPatientsHealth problemsRCTsSocial determinantsReporting of findingsInterventionSuch interventionsSDOHScoping ReviewSocioeconomic determinants
2021
Registration, publication, and outcome reporting among pivotal clinical trials that supported FDA approval of high-risk cardiovascular devices before and after FDAAA
Swanson MJ, Johnston JL, Ross JS. Registration, publication, and outcome reporting among pivotal clinical trials that supported FDA approval of high-risk cardiovascular devices before and after FDAAA. Trials 2021, 22: 817. PMID: 34789308, PMCID: PMC8597303, DOI: 10.1186/s13063-021-05790-9.Peer-Reviewed Original ResearchConceptsHigh-risk cardiovascular devicesPrimary efficacy outcomeFDA Amendments ActPivotal clinical trialsClinical trialsEfficacy outcomesFDA approvalTrial interpretationPivotal clinical studiesPrimary clinical evidenceFDA summariesPivotal trialsClinical evidenceResultsBetween 2005Clinical studiesHigh-risk medical devicesOutcome reportingUS FoodDrug AdministrationTrialsReporting of findingsInterpretation of findingsPeer-reviewed literatureOutcomesCardiovascular devices
2017
Association 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
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