2019
Submissions from the SPRINT Data Analysis Challenge on clinical risk prediction: a cross-sectional evaluation
Jackevicius CA, An J, Ko DT, Ross JS, Angraal S, Wallach JD, Koh M, Song J, Krumholz HM. Submissions from the SPRINT Data Analysis Challenge on clinical risk prediction: a cross-sectional evaluation. BMJ Open 2019, 9: e025936. PMID: 30904868, PMCID: PMC6475140, DOI: 10.1136/bmjopen-2018-025936.Peer-Reviewed Original ResearchConceptsRisk prediction toolsCross-sectional evaluationClinical risk predictionClinical performanceCardiovascular disease historyClinical risk scoreHigh-risk patientsLow-risk patientsClinical prediction toolRisk predictionEfficacy outcomesC-statisticDisease historyInclusion criteriaIndependent reviewersRisk scoreExternal validationPatientsPrediction toolsEfficacyOutcomesSame outcome
2017
Postapproval studies of drugs initially approved by the FDA on the basis of limited evidence: systematic review
Pease AM, Krumholz HM, Downing NS, Aminawung JA, Shah ND, Ross JS. Postapproval studies of drugs initially approved by the FDA on the basis of limited evidence: systematic review. The BMJ 2017, 357: j1680. PMID: 28468750, PMCID: PMC5421452, DOI: 10.1136/bmj.j1680.Peer-Reviewed Original ResearchConceptsSingle pivotal trialPivotal trialsPostapproval studiesSurrogate markerPrimary endpointNovel drugsClinical outcomesClinical studiesLimited evidenceSystematic reviewDouble-blind studyMedian total numberClinical evidenceSuperior efficacyBlind studyDrug AdministrationOriginal FDATrial approvalDiseaseTrialsDrugsFDAEndpointEfficacyMarkers