2025
Effect of digital adherence technologies on treatment outcomes in people with drug-susceptible tuberculosis: four pragmatic, cluster-randomised trials
Jerene D, van Kalmthout K, Levy J, Alacapa J, Deyanova N, Dube T, Mganga A, Tasca B, Bogdanov A, Efo E, Gamazina K, Garfin A, Kochanov V, Leung A, Madden N, Maraba N, McQuaid C, Mleoh L, Onjare B, Powers R, Terleiva Y, van Rest J, Gebhard A, Fielding K, Charalambous S. Effect of digital adherence technologies on treatment outcomes in people with drug-susceptible tuberculosis: four pragmatic, cluster-randomised trials. The Lancet 2025, 405: 1155-1166. PMID: 40086457, DOI: 10.1016/s0140-6736(24)02847-2.Peer-Reviewed Original ResearchDrug-susceptible tuberculosisTreatment outcomesPoor treatment outcomesPrimary outcomeDigital adherence technologiesIntervention armCluster randomised trialIntention-to-treat populationStandard of care armTuberculosis treatment outcomesDocumented treatment failureLoss to follow-upStandard of careAdherence technologiesTreatment failureTreatment startAdult patientsFollow-upPatientsTreatment statusPatient outcomesCare armTuberculosisMedicationTrials
2024
Enhanced Tuberculosis Diagnosis With Computer-aided Chest X-ray and Urine Lipoarabinomannan in Adults With HIV Admitted to Hospital (CASTLE Study): A Cluster Randomized Trial
Burke R, Nyirenda S, Mtenga T, Twabi H, Joekes E, Walker N, Nyirenda R, Gupta-Wright A, Nliwasa M, Fielding K, MacPherson P, Corbett E. Enhanced Tuberculosis Diagnosis With Computer-aided Chest X-ray and Urine Lipoarabinomannan in Adults With HIV Admitted to Hospital (CASTLE Study): A Cluster Randomized Trial. Clinical Infectious Diseases 2024, 80: 1143-1151. PMID: 38748183, PMCID: PMC12135911, DOI: 10.1093/cid/ciae273.Peer-Reviewed Original ResearchCluster randomised trialTB treatment initiationUsual careChest X-rayPlus usual careUsual care armRandomised trialsTB diagnosisUrine lipoarabinomannanAntiretroviral therapyTreatment initiationDiagnostic armZomba Central HospitalIntention-to-treat analysisTB diagnosticsAdmitted to hospitalModified intention-to-treat analysisCare armCD4 cell countDigital chest X-rayUndiagnosed TBPost-recruitmentCause of deathSecondary outcomesPrimary outcome
2023
Impact of Visit Volume on the Effectiveness of Electronic Tools to Improve Heart Failure Care
Mukhopadhyay A, Reynolds H, King W, Phillips L, Nagler A, Szerencsy A, Saxena A, Klapheke N, Katz S, Horwitz L, Blecker S. Impact of Visit Volume on the Effectiveness of Electronic Tools to Improve Heart Failure Care. JACC Heart Failure 2023, 12: 665-674. PMID: 38043045, DOI: 10.1016/j.jchf.2023.11.002.Peer-Reviewed Original ResearchMineralocorticoid antagonistsVolume groupVisit volumeElectronic health record toolsPhysician workloadGuideline-recommended therapiesReduced ejection fractionUsual care armHeart failure carePrespecified subgroup analysisHigh-volume groupCluster-randomized trialLog-binomial modelsBusy practice settingsCare armEHR alertUsual careEjection fractionHeart failureSubgroup analysisEHR toolsNumber of visitsCardiology officePractice settingsStudy periodPay-it-forward incentives for hepatitis virus testing in men who have sex with men: a cluster randomized trial
Zhang Y, Li J, Xie Y, Wu D, Ong J, Marley G, Kamarulzaman A, Lu H, Zou F, Smith J, Tucker J, Fu G, Tang W. Pay-it-forward incentives for hepatitis virus testing in men who have sex with men: a cluster randomized trial. Nature Medicine 2023, 29: 2241-2247. PMID: 37640859, DOI: 10.1038/s41591-023-02519-w.Peer-Reviewed Original ResearchConceptsHepatitis B virusCare armHCV testingVirus testingTwo-arm cluster-randomized trialHepatitis C virus testingHepatitis virus testingCluster-randomized trialProportion of menGroup of menAdverse eventsHBV testPrimary outcomeB virusForward armFree testingHCVMenRapid testingSexTrialsArmActive community participationTestingPersonsThe Cooperative Re-Engagement Controlled Trial (CoRECT): Durable Viral Suppression Assessment
O'Shea J, Fanfair R, Williams T, Khalil G, Brady K, DeMaria A, Villanueva M, Randall L, Jenkins H, Altice F, Camp N, Lucas C, Buchelli M, Samandari T, Weidle P. The Cooperative Re-Engagement Controlled Trial (CoRECT): Durable Viral Suppression Assessment. JAIDS Journal Of Acquired Immune Deficiency Syndromes 2023, 93: 134-142. PMID: 36812382, PMCID: PMC10962216, DOI: 10.1097/qai.0000000000003178.Peer-Reviewed Original ResearchConceptsDurable viral suppressionActive public health interventionProportion of PWHPublic health interventionsViral loadCare strategiesHealth interventionsLast viral loadCopies/mLStandard of careRace/ethnicityCare armHIV careViral suppressionAntiretroviral adherenceCD4 categoryExposure categoriesCare individualsPWHCareAge categoriesInterventionTrialsBirth sexRe-EngagementImplementation strategies to address the determinants of adoption, implementation, and maintenance of a clinical decision support tool for emergency department buprenorphine initiation: a qualitative study
Simpson M, Ritger C, Hoppe J, Holland W, Morris M, Nath B, Melnick E, Tietbohl C. Implementation strategies to address the determinants of adoption, implementation, and maintenance of a clinical decision support tool for emergency department buprenorphine initiation: a qualitative study. Implementation Science Communications 2023, 4: 41. PMID: 37081581, PMCID: PMC10117277, DOI: 10.1186/s43058-023-00421-7.Peer-Reviewed Original ResearchOpioid use disorderBuprenorphine initiationClinical decision support toolEmergency departmentED cliniciansSignificant public health problemCDS interventionsIntervention EDsUsual care armPragmatic clinical trialsPublic health problemEvidence-based treatmentsCare armED initiationBuprenorphine treatmentED settingIntervention armOngoing treatmentClinical trialsClinician experienceClinician trainingUse disordersBuprenorphineHealth problemsSecondary aimPersonalised recommendations for hospitalised patients with Acute Kidney Injury using a Kidney Action Team (KAT-AKI): protocol and early data of a randomised controlled trial
Aklilu A, O’Connor K, Martin M, Yamamoto Y, Coronel-Moreno C, Shvets K, Jones C, Kadhim B, Corona-Villalobos C, Baker M, Tan J, Freeman N, Groener M, Menez S, Brown D, Culli S, Lindsley J, Orias M, Parikh C, Smith A, Sundararajan A, Wilson F. Personalised recommendations for hospitalised patients with Acute Kidney Injury using a Kidney Action Team (KAT-AKI): protocol and early data of a randomised controlled trial. BMJ Open 2023, 13: e071968. PMID: 37068906, PMCID: PMC10111926, DOI: 10.1136/bmjopen-2023-071968.Peer-Reviewed Original ResearchConceptsPrimary teamAcute Kidney Injury OutcomesAKI alert systemInvestigator-blinded trialUsual care armKey secondary outcomesClinical decision support toolIntensive care unitUS hospital systemAKI alertsAKI detectionAKI progressionCare armSecondary outcomesPrimary outcomeCare unitMedian timeMedical floorPercentage of recommendationsDiagnostic interventionsInjury outcomesRandomisationHospital systemEthics CommitteeDedicated teamColchicine and high-intensity rosuvastatin in the treatment of non-critically ill patients hospitalised with COVID-19: a randomised clinical trial
Shah T, McCarthy M, Nasir I, Archer H, Ragheb E, Kluger J, Kashyap N, Paredes C, Patel P, Lu J, Kandel P, Song C, Khan M, Huang H, Haq F, Ahmad R, Howes C, Cambi B, Lancaster G, Cleman M, Dela Cruz C, Parise H, Lansky A. Colchicine and high-intensity rosuvastatin in the treatment of non-critically ill patients hospitalised with COVID-19: a randomised clinical trial. BMJ Open 2023, 13: e067910. PMID: 36828654, PMCID: PMC9971831, DOI: 10.1136/bmjopen-2022-067910.Peer-Reviewed Original ResearchConceptsStandard of careHigh-intensity rosuvastatinElectronic medical recordsCOVID-19 diseaseMedical recordsPrimary endpointThromboembolic eventsYale New Haven Health SystemSevere COVID-19 diseaseCOVID-19Prespecified primary endpointVenous thromboembolic eventsRisk of progressionCombination of colchicineSafety monitoring boardCare armHispanics/LatinosTherapeutic anticoagulationIndex hospitalisationIll patientsMedian ageFuture trialsEffect of colchicineClinical trialsMonitoring boardCosts and cost‐effectiveness of a collaborative data‐to‐care intervention for HIV treatment and care in the United States
Shrestha R, Fanfair R, Randall L, Lucas C, Nichols L, Camp N, Brady K, Jenkins H, Altice F, DeMaria A, Villanueva M, Weidle P. Costs and cost‐effectiveness of a collaborative data‐to‐care intervention for HIV treatment and care in the United States. Journal Of The International AIDS Society 2023, 26: e26040. PMID: 36682053, PMCID: PMC9867888, DOI: 10.1002/jia2.26040.Peer-Reviewed Original ResearchConceptsCare armHIV careCare patientsIntervention armCare interventionsHealth departmentsHIV care interventionsHIV care outcomesHIV care providersHealthcare provider perspectiveHIV clinicHIV treatmentCare providersControl trialCare outcomesMicrocosting approachCare programCare servicesSurveillance dataSimilar interventionsIncremental costIntervention costsProvider perspectivesCareAverage cost
2022
Pragmatic trial of messaging to providers about treatment of acute heart failure: The PROMPT-AHF trial
Ghazi L, O'Connor K, Yamamoto Y, Fuery M, Sen S, Samsky M, Riello R, Huang J, Olufade T, McDermott J, Inzucchi S, Velazquez E, Wilson F, Desai N, Ahmad T. Pragmatic trial of messaging to providers about treatment of acute heart failure: The PROMPT-AHF trial. American Heart Journal 2022, 257: 111-119. PMID: 36493842, DOI: 10.1016/j.ahj.2022.12.002.Peer-Reviewed Original ResearchConceptsGuideline-directed medical therapyAcute heart failureHeart failurePragmatic trialElectronic health recordsSubstantial health care costsBest practice advisoryReduced ejection fractionUsual care armHealth recordsTime of dischargeEvidence-based careHealth care costsClinical decision support systemAHF patientsCare armEligible patientsHF hospitalizationInpatient initiationCardiovascular deathMedication classesEjection fractionMedical therapyPrimary outcomePractice advisoryThe impact of a community health worker intervention on uptake of antenatal care: a cluster-randomized pragmatic trial in Dar es Salaam
Regan M, Cheng C, Mboggo E, Larson E, Lema I, Magesa L, Machumi L, Ulenga N, Sando D, Mwanyika-Sando M, Barnhart D, Hong B, Mungure E, Li N, Siril H, Mujinja P, Naburi H, Kilewo C, Ekström A, Geldsetzer P, Fawzi W, Bärnighausen T, Sudfeld C, Spiegelman D. The impact of a community health worker intervention on uptake of antenatal care: a cluster-randomized pragmatic trial in Dar es Salaam. Health Policy And Planning 2022, 38: 279-288. PMID: 36377764, PMCID: PMC10019560, DOI: 10.1093/heapol/czac100.Peer-Reviewed Original ResearchConceptsMore ANC visitsCommunity health worker interventionHealth worker interventionAntenatal careANC visitsPragmatic trialHigh-quality antenatal carePragmatic cluster-randomized trialUptake of ANCDar es SalaamWorker interventionLarge-scale pragmatic trialsCluster-randomized pragmatic trialModest beneficial effectStandard of careRoutine health system dataCluster-randomized trialHealth system dataANC uptakeCare armCHW interventionPrimary outcomeIntervention armFirst trimesterPregnant womenEnrollment Lessons from a Biological Assignment Study of Marrow Transplantation versus Standard Care for Adolescents and Young Adults with Sickle Cell Disease: Considerations for Future Gene and Cellular Therapy Trials
Krishnamurti L, Neuberg D, Sullivan K, Smith S, Eapen M, Walters M. Enrollment Lessons from a Biological Assignment Study of Marrow Transplantation versus Standard Care for Adolescents and Young Adults with Sickle Cell Disease: Considerations for Future Gene and Cellular Therapy Trials. Transplantation And Cellular Therapy 2022, 29: 217-221. PMID: 36270432, PMCID: PMC10539686, DOI: 10.1016/j.jtct.2022.10.008.Peer-Reviewed Original ResearchConceptsBone marrow transplantationSickle cell diseaseMarrow transplantationNonmalignant diseasesCell diseaseAdult sickle cell diseaseMyeloablative bone marrow transplantationSingle-arm feasibility studyYoung adultsCellular therapy trialsMulticenter National InstituteRegimen-related toxicitySingle-arm studyFrequency of HLACoronavirus disease 2019 (COVID-19) pandemicAcademic medical centerDisease 2019 pandemicShort-term endpointsBMT centersBMT regimenCare armPain episodesPrimary endpointStandard careCurative therapyCommunication About Fall Risk in Community Oncology Practice: The Role of Geriatric Assessment
Jensen-Battaglia M, Lei L, Xu H, Loh K, Wells M, Tylock R, Ramsdale E, Kleckner A, Mustian K, Dunne R, Kehoe L, Bearden J, Burnette B, Whitehead M, Mohile S, Wildes T. Communication About Fall Risk in Community Oncology Practice: The Role of Geriatric Assessment. JCO Oncology Practice 2022, 18: e1630-e1640. PMID: 35984998, PMCID: PMC9835996, DOI: 10.1200/op.22.00173.Peer-Reviewed Original ResearchConceptsHistory of fallsImpaired physical performanceCommunity oncology practicesGeriatric assessmentOncology practicePractice sitesPhysical performanceAudio-recordedOdds ratioCluster Randomized Controlled TrialUsual care armGA domain impairmentSource of morbidityFall riskCare armIntervention armGA summaryOlder adultsOncologists' knowledgeLinear mixed modelsGeneralized linear mixed modelsSecondary analysisSolid tumorsTreatment intentDomain impairmentUser centered clinical decision support to implement initiation of buprenorphine for opioid use disorder in the emergency department: EMBED pragmatic cluster randomized controlled trial
Melnick ER, Nath B, Dziura JD, Casey MF, Jeffery MM, Paek H, Soares WE, Hoppe JA, Rajeevan H, Li F, Skains RM, Walter LA, Patel MD, Chari SV, Platts-Mills TF, Hess EP, D'Onofrio G. User centered clinical decision support to implement initiation of buprenorphine for opioid use disorder in the emergency department: EMBED pragmatic cluster randomized controlled trial. The BMJ 2022, 377: e069271. PMID: 35760423, PMCID: PMC9231533, DOI: 10.1136/bmj-2021-069271.Peer-Reviewed Original ResearchConceptsOpioid use disorderUsual care armEmergency departmentUse disordersCare armPragmatic clusterClinical decision supportIntervention armRoutine emergency careSecondary implementation outcomesSeverity of withdrawalTertiary care centerClinical decision support toolInitiation of buprenorphineElectronic health record tasksElectronic health record workflowsRE-AIM frameworkElectronic health record platformsHealth record platformsClinical decision support systemElectronic health recordsVisit documentationTreatment of addictionUsual careAdult patientsOverall survival from a phase II randomized study of ramucirumab plus pembrolizumab versus standard of care for advanced non–small cell lung cancer previously treated with immunotherapy: Lung-MAP nonmatched substudy S1800A.
Reckamp K, Redman M, Dragnev K, Villaruz L, Faller B, Al Baghdadi T, Hines S, Qian L, Minichiello K, Gandara D, Kelly K, Herbst R. Overall survival from a phase II randomized study of ramucirumab plus pembrolizumab versus standard of care for advanced non–small cell lung cancer previously treated with immunotherapy: Lung-MAP nonmatched substudy S1800A. Journal Of Clinical Oncology 2022, 40: 9004-9004. DOI: 10.1200/jco.2022.40.16_suppl.9004.Peer-Reviewed Original ResearchNon-small cell lung cancerAdvanced non-small cell lung cancerProgression-free survivalOverall survivalCell lung cancerProgressive diseaseLung cancerLung-MAPImmune checkpoint inhibitor therapyPlatinum-based doublet therapyRandomized phase II trialVEGF receptor inhibitionCheckpoint inhibitor therapyImproved overall survivalPD-L1 expressionPhase II trialPotential survival benefitDuration of responseLog-rank testStandard of careTumor mutational burdenMajor unmet needAnalysis of survivalMultiple tumor typesCare armElectronic Alerts to Improve Heart Failure Therapy in Outpatient Practice A Cluster Randomized Trial
Ghazi L, Yamamoto Y, Riello RJ, Coronel-Moreno C, Martin M, O'Connor KD, Simonov M, Huang J, Olufade T, McDermott J, Dhar R, Inzucchi SE, Velazquez EJ, Wilson FP, Desai NR, Ahmad T. Electronic Alerts to Improve Heart Failure Therapy in Outpatient Practice A Cluster Randomized Trial. Journal Of The American College Of Cardiology 2022, 79: 2203-2213. PMID: 35385798, DOI: 10.1016/j.jacc.2022.03.338.Peer-Reviewed Original ResearchConceptsGuideline-directed medical therapyUsual careEjection fractionHeart failureMedical therapyPrimary outcomeCluster-randomized comparative effectiveness trialSodium-glucose cotransporter 2 inhibitorsElectronic health record alertsAldosterone system inhibitorsReduced ejection fractionUsual care armCotransporter 2 inhibitorsMineralocorticoid receptor antagonistsVentricular ejection fractionComparative effectiveness trialNumber of patientsKnowledge of guidelinesLow-cost interventionCare armDays postrandomizationEligible patientsGDMT useFailure therapyPatient characteristics
2021
The influence of comorbidities on achieving an N‐terminal pro‐b‐type natriuretic peptide target: a secondary analysis of the GUIDE‐IT trial
Ezekowitz JA, Alemayehu W, Rathwell S, Grant AD, Fiuzat M, Whellan DJ, Ahmad T, Adams K, Piña IL, Cooper LS, Januzzi JL, Leifer ES, Mark D, O'Connor CM, Felker GM. The influence of comorbidities on achieving an N‐terminal pro‐b‐type natriuretic peptide target: a secondary analysis of the GUIDE‐IT trial. ESC Heart Failure 2021, 9: 77-86. PMID: 34784657, PMCID: PMC8787989, DOI: 10.1002/ehf2.13692.Peer-Reviewed Original ResearchConceptsBody mass indexLower body mass indexNT-proBNPAtrial fibrillationN-terminal pro B-type natriuretic peptide valuesMedian body mass indexHigher Body Mass IndexGUIDE-IT trialNT-proBNP targetWorse renal functionNT-proBNP levelsReduced ejection fractionCent of patientsNatriuretic peptide valuesGlomerular filtration rateHeart failure therapyInfluence of comorbiditiesSeverity of illnessEvidence-based therapiesPg/mLCare armLower eGFRRenal dysfunctionUsual careRenal functionPhase II randomized study of ramucirumab plus pembrolizumab versus standard of care for advanced non-small cell lung cancer previously treated with a checkpoint inhibitor: Toxicity update (Lung-MAP non-matched sub-study S1800A).
Reckamp K, Redman M, Dragnev K, Villaruz L, Faller B, Al Baghdadi T, Hines S, Qian L, Minichiello K, Gandara D, Herbst R, Kelly K. Phase II randomized study of ramucirumab plus pembrolizumab versus standard of care for advanced non-small cell lung cancer previously treated with a checkpoint inhibitor: Toxicity update (Lung-MAP non-matched sub-study S1800A). Journal Of Clinical Oncology 2021, 39: 9075-9075. DOI: 10.1200/jco.2021.39.15_suppl.9075.Peer-Reviewed Original ResearchVascular endothelial growth factorThromboembolic eventsAdvanced non-small cell lung cancerNon-small cell lung cancerPlatinum-based doublet therapyPD-L1 inhibitor therapyGrade 5 AEsTreatment-related AEsVEGF receptor inhibitionGrade 3 toxicityAdverse event profilePD-L1 expressionAdverse event assessmentCell lung cancerDuration of responseTumor immune microenvironmentStandard of carePhase IIEndothelial growth factorMultiple tumor typesCare armCommon AEsECOG 0Checkpoint inhibitorsDoublet therapyA case study of ascertainment bias for the primary outcome in the Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) trial
Esserman DA, Gill TM, Miller ME, Greene EJ, Dziura JD, Travison TG, Meng C, Peduzzi PN. A case study of ascertainment bias for the primary outcome in the Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) trial. Clinical Trials 2021, 18: 207-214. PMID: 33678038, PMCID: PMC8009806, DOI: 10.1177/1740774520980070.Peer-Reviewed Original ResearchConceptsPrimary outcome definitionUsual care armSerious fall injuriesMedical attentionOutcome definitionsFall injuriesElders trialCare armOvernight hospitalizationStudy powerCare managersIntervention effectsType 2 injuriesAscertainment biasAscertainment of outcomesInterim monitoring planUsual careHazard ratioPrimary outcomeIntervention armClinical trialsUnblinded observerClinical basisMulticomponent interventionAdditional fall
2020
Efficacy of Early Prophylaxis Against Catheter-Associated Thrombosis in Critically Ill Children: A Bayesian Phase 2b Randomized Clinical Trial.
Faustino EVS, Shabanova V, Raffini LJ, Kandil SB, Li S, Pinto MG, Cholette JM, Hanson SJ, Nellis ME, Silva CT, Chima R, Sharathkumar A, Thomas KA, McPartland T, Tala JA, Spinella PC. Efficacy of Early Prophylaxis Against Catheter-Associated Thrombosis in Critically Ill Children: A Bayesian Phase 2b Randomized Clinical Trial. Critical Care Medicine 2020, 49: e235-e246. PMID: 33372745, PMCID: PMC7902342, DOI: 10.1097/ccm.0000000000004784.Peer-Reviewed Original ResearchConceptsCentral venous catheter-associated deep venous thrombosisCatheter-associated deep venous thrombosisDeep venous thrombosisUsual care armCentral venous cathetersVenous thrombosisClinical trialsEnoxaparin armCare armVenous cathetersEarly prophylaxisIll childrenThrombin generationPhase 2bCatheter-associated thrombosisInternational units/mLAnti-Xa levelsCritically Ill ChildrenRandomized clinical trialsEndogenous thrombin potentialRelevant bleedingUsual careTrial armsRisk ratioThrombin potential
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