2018
Comparison of treatment effect sizes from pivotal and postapproval trials of novel therapeutics approved by the FDA based on surrogate markers of disease: a meta-epidemiological study
Wallach JD, Ciani O, Pease AM, Gonsalves GS, Krumholz HM, Taylor RS, Ross JS. Comparison of treatment effect sizes from pivotal and postapproval trials of novel therapeutics approved by the FDA based on surrogate markers of disease: a meta-epidemiological study. BMC Medicine 2018, 16: 45. PMID: 29562926, PMCID: PMC5863466, DOI: 10.1186/s12916-018-1023-9.Peer-Reviewed Original ResearchConceptsPostapproval trialsPivotal trialsActual clinical effectSurrogate markerTrial endpointsLarge treatment effectsPrimary endpointNovel therapeuticsNovel drugsTreatment effectsFDA approvalPatient-relevant outcomesMeta-epidemiological studyStandardized mean differenceTreatment effect sizeClinical effectsResultsBetween 2005Odds ratioDrug trialsSame indicationDrug AdministrationEvidence of differencesMean differenceU.S. FoodDisease
2017
Systolic Blood Pressure Response in SPRINT (Systolic Blood Pressure Intervention Trial) and ACCORD (Action to Control Cardiovascular Risk in Diabetes): A Possible Explanation for Discordant Trial Results
Huang C, Dhruva SS, Coppi AC, Warner F, Li S, Lin H, Nasir K, Krumholz HM. Systolic Blood Pressure Response in SPRINT (Systolic Blood Pressure Intervention Trial) and ACCORD (Action to Control Cardiovascular Risk in Diabetes): A Possible Explanation for Discordant Trial Results. Journal Of The American Heart Association 2017, 6: e007509. PMID: 29133522, PMCID: PMC5721802, DOI: 10.1161/jaha.117.007509.Peer-Reviewed Original ResearchConceptsSystolic blood pressure responseBlood pressure responseTreatment groupsCause deathVisit variabilityDiscordant trialsBlood pressure trialStandard treatment groupPressure responseACCORD participantsPressure trialSBP responseHeart failureMean SBPPrimary outcomeSBPDiscordant resultsMean differenceSimilar interventionsTrial resultsTrialsSimilar mean differencesTreatment effectsSignificant differencesStroke
2013
Comparison of Clinical Interpretation With Visual Assessment and Quantitative Coronary Angiography in Patients Undergoing Percutaneous Coronary Intervention in Contemporary Practice
Nallamothu BK, Spertus JA, Lansky AJ, Cohen DJ, Jones PG, Kureshi F, Dehmer GJ, Drozda JP, Walsh MN, Brush JE, Koenig GC, Waites TF, Gantt DS, Kichura G, Chazal RA, O’Brien P, Valentine CM, Rumsfeld JS, Reiber JH, Elmore JG, Krumholz RA, Weaver WD, Krumholz HM. Comparison of Clinical Interpretation With Visual Assessment and Quantitative Coronary Angiography in Patients Undergoing Percutaneous Coronary Intervention in Contemporary Practice. Circulation 2013, 127: 1793-1800. PMID: 23470859, PMCID: PMC3908681, DOI: 10.1161/circulationaha.113.001952.Peer-Reviewed Original ResearchConceptsQuantitative coronary angiographyPercent diameter stenosisPercutaneous coronary interventionDiameter stenosisCoronary interventionCoronary angiographyCoronary lesionsClinical interpretationAngiographic interpretationStenosis severityHigher percent diameter stenosisMedian percent diameter stenosisElective percutaneous coronary interventionMean differenceCoronary stenosis severityIntermediate lesionsUS hospitalsStenosisLesionsAngiographyPatientsInterventionSeverityVisual assessmentSuch findings