2023
Characterization of US Food and Drug Administration Class I Recalls from 2018 to 2022 for Moderate- and High-Risk Medical Devices: A Cross-Sectional Study
Mooghali M, Ross J, Kadakia K, Dhruva S. Characterization of US Food and Drug Administration Class I Recalls from 2018 to 2022 for Moderate- and High-Risk Medical Devices: A Cross-Sectional Study. Medical Devices Evidence And Research 2023, 16: 111-122. PMID: 37229515, PMCID: PMC10204764, DOI: 10.2147/mder.s412802.Peer-Reviewed Original ResearchCross-sectional studyClass I medical deviceClass IHigh-risk medical devicesSerious adverse eventsSafety concernsAdverse eventsMedian numberUS FoodRecalled deviceTherapeutic useDevice recallsHigh-risk devicesDevice useSerious safety concernsMedical device recallsMultiple recallsLife-sustaining devicesDevice assessment
2022
Vibration of effect in more than 16 000 pooled analyses of individual participant data from 12 randomised controlled trials comparing canagliflozin and placebo for type 2 diabetes mellitus: multiverse analysis
Gouraud H, Wallach J, Boussageon R, Ross J, Naudet F. Vibration of effect in more than 16 000 pooled analyses of individual participant data from 12 randomised controlled trials comparing canagliflozin and placebo for type 2 diabetes mellitus: multiverse analysis. BMJ Medicine 2022, 1: e000154. PMID: 36936564, PMCID: PMC9978683, DOI: 10.1136/bmjmed-2022-000154.Peer-Reviewed Original ResearchMajor adverse cardiovascular eventsType 2 diabetes mellitusIndividual participant dataAdverse cardiovascular eventsSerious adverse eventsPooled analysisCanagliflozin treatmentFirst centileCardiovascular eventsHazard ratioAdverse eventsDiabetes mellitusParticipant dataEffect estimatesFavour of placeboSerum glycated hemoglobinIndividual patient dataVibration of effectsWeek 12Glycated hemoglobinPlaceboCentileCanagliflozinPatient dataTrials
2019
Adverse Effects of Pharmacologic Treatments of Major Depression in Older Adults
Sobieraj DM, Martinez BK, Hernandez AV, Coleman CI, Ross JS, Berg KM, Steffens DC, Baker WL. Adverse Effects of Pharmacologic Treatments of Major Depression in Older Adults. Journal Of The American Geriatrics Society 2019, 67: 1571-1581. PMID: 31140587, DOI: 10.1111/jgs.15966.Peer-Reviewed Original ResearchConceptsSerotonin-norepinephrine reuptake inhibitorsSelective serotonin reuptake inhibitorsMajor depressive disorderOverall adverse eventsAdverse eventsYears of ageStudy withdrawalAcute phaseReuptake inhibitorsObservational studyAdverse effectsChoice of antidepressantSerious adverse eventsAcute treatment phaseNorepinephrine reuptake inhibitorsSerotonin reuptake inhibitorsSpecific adverse eventsComparative long-term studiesNonpharmacologic therapiesContinuation treatmentPatients 65Pharmacologic treatmentQTc prolongationMore fallsOutpatient setting