2020
Principles of Large-scale Evidence Generation and Evaluation across a Network of Databases (LEGEND)
Schuemie MJ, Ryan PB, Pratt N, Chen R, You SC, Krumholz HM, Madigan D, Hripcsak G, Suchard MA. Principles of Large-scale Evidence Generation and Evaluation across a Network of Databases (LEGEND). Journal Of The American Medical Informatics Association 2020, 27: 1331-1337. PMID: 32909033, PMCID: PMC7481029, DOI: 10.1093/jamia/ocaa103.Peer-Reviewed Original ResearchConceptsNetwork of databasesLarge-scale Evidence GenerationObservational Health Data SciencesObservational health care databasesHealth Data SciencesHealth care dataElectronic health recordsData sciencePublication biasPatient-level informationGeneric overviewHealth recordsMethods addressAforementioned concernsHealth care databasesAnalytic codeNetworkNew paradigmSuch dataHackingEvidence generationDissemination of evidenceHypertension treatmentResidual confoundingAdministrative claims
2018
Registration, results reporting, and publication bias of clinical trials supporting FDA approval of neuropsychiatric drugs before and after FDAAA: a retrospective cohort study
Zou CX, Becker JE, Phillips AT, Garritano JM, Krumholz HM, Miller JE, Ross JS. Registration, results reporting, and publication bias of clinical trials supporting FDA approval of neuropsychiatric drugs before and after FDAAA: a retrospective cohort study. Trials 2018, 19: 581. PMID: 30352601, PMCID: PMC6199729, DOI: 10.1186/s13063-018-2957-0.Peer-Reviewed Original ResearchConceptsRetrospective cohort studyPublication biasNeuropsychiatric indicationsCohort studyClinical trialsRelative riskEfficacy trialsFDA approvalPositive trialsFisher's exact testRecent FDA approvalDrug Administration Amendments ActClinical trial publicationsTRIAL REGISTRATIONMAIN OUTCOMEProportion of trialsNeuropsychiatric drugsNew drug approvalsTrial publicationsExact testMedical interventionsTrialsDrug approvalNew drugsDrugs
2003
Overestimation of genetic risks owing to small sample sizes in cardiovascular studies
Morgan T, Coffey C, Krumholz H. Overestimation of genetic risks owing to small sample sizes in cardiovascular studies. Clinical Genetics 2003, 64: 7-17. PMID: 12791034, DOI: 10.1034/j.1399-0004.2003.00088.x.Peer-Reviewed Original ResearchConceptsACE DMyocardial infarctionRisk factorsPublication biasEnzyme deletion polymorphismStudies of angiotensinThrombotic risk factorsGenetic risk factorsPotential publication biasCardiovascular outcomesPlA2 polymorphismOdds ratioEgger's testFunnel plotSystematic reviewCardiovascular studiesRelevant outcomesOverall riskSmall sample sizeGenetic riskSample sizeDeletion polymorphismUnderpowered studiesInfarctionPLA2