2025
Risk of Thyroid Tumors With GLP-1 Receptor Agonists: A Retrospective Cohort Study.
Morales D, Bu F, Viernes B, DuVall S, Matheny M, Simon K, Falconer T, Richter L, Ostropolets A, Lau W, Man K, Chattopadhyay S, Mathioudakis N, Minty E, Nishimura A, Sun F, Yin C, Seager S, Chai Y, Zhou J, Lu Y, Reyes C, Pistillo A, Duarte-Salles T, Blacketer C, Schuemie M, Ryan P, Krumholz H, Hripcsak G, Khera R, Suchard M. Risk of Thyroid Tumors With GLP-1 Receptor Agonists: A Retrospective Cohort Study. Diabetes Care 2025 PMID: 40465422, DOI: 10.2337/dc25-0154.Peer-Reviewed Original ResearchRisk of thyroid tumorThyroid tumorsGLP-1RADPP-4isHazard ratioThyroid malignancyCohort studyIncreased riskSodium-glucose cotransporter 2 inhibitorsElectronic health record databaseGlucagon-like peptide 1 receptor agonistsEstimate hazard ratiosRandom-effects meta-analysisGLP-1 receptor agonistsPeptide 1 receptor agonistsDipeptidyl peptidase 4 inhibitorsThyroid tumor incidenceUsers of SGLT2isHealth record databaseSecond-line treatmentType 2 diabetes mellitusNew-user cohort studyRetrospective cohort studyUsers of sulfonylureasIntention-to-treatFive-Year Survival Outcomes With Atezolizumab After Chemotherapy in Resected Stage IB-IIIA Non-Small Cell Lung Cancer (IMpower010): An Open-Label, Randomized, Phase III Trial.
Felip E, Altorki N, Zhou C, Vallières E, Csoszi T, Vynnychenko I, Goloborodko O, Rittmeyer A, Reck M, Martinez-Marti A, Kenmotsu H, Chen Y, Chella A, Sugawara S, Fu C, Ballinger M, Deng Y, Srivastava M, Bennett E, Gitlitz B, Wakelee H. Five-Year Survival Outcomes With Atezolizumab After Chemotherapy in Resected Stage IB-IIIA Non-Small Cell Lung Cancer (IMpower010): An Open-Label, Randomized, Phase III Trial. Journal Of Clinical Oncology 2025, jco2401681. PMID: 40446184, DOI: 10.1200/jco-24-01681.Peer-Reviewed Original ResearchNon-small cell lung cancerDisease-free survivalPD-L1 TCCell lung cancerOverall survivalAdjuvant chemotherapySurvival outcomesResected stage IB-IIIA non-small cell lung cancerStage IB-IIIA non-small cell lung cancerTumor cellsResected non-small cell lung cancerFollow-upLung cancerFive-year survival outcomesStratified hazard ratioPlatinum-based chemotherapyStage II-IIIAPhase III trialsReport survival outcomesIntention-to-treatStratified HROpen-labelIII trialsAtezolizumabChemotherapyEffectiveness of a group intervention to improve mental health in siblings of children with chronic disorders: a cluster randomized controlled trial
Kirchhofer S, Fredriksen T, Orm S, Botta M, Zahl E, Cogo-Moreira H, Prentice C, Vatne T, Haukeland Y, Silverman W, Fjermestad K. Effectiveness of a group intervention to improve mental health in siblings of children with chronic disorders: a cluster randomized controlled trial. Journal Of Pediatric Psychology 2025, 50: 443-453. PMID: 40146207, PMCID: PMC12206298, DOI: 10.1093/jpepsy/jsaf021.Peer-Reviewed Original ResearchConceptsSibling mental healthComplier average causal effectParents of childrenMental healthRandomized controlled trialsParent-child communicationIntention-to-treatSiblings of childrenCluster randomized controlled trialChronic disordersImprove mental healthMental health problemsEligible siblingsPrimary careIntervention groupGroup interventionPreventive interventionsHospital settingWaitlist controlPrevention programsAverage causal effectHealth problemsManual-basedSecondary outcomesControlled trialsBurden and care time for dementia caregivers in the LIVE@Home.Path trial
Berge L, Angeles R, Gedde M, Fæø S, Mannseth J, Vislapuu M, Puaschitz N, Hillestad E, Aarsland D, Achterberg W, Allore H, Ballard C, Li F, Selbæk G, Vahia I, Husebo B. Burden and care time for dementia caregivers in the LIVE@Home.Path trial. Alzheimer's & Dementia 2025, 21: e14622. PMID: 40042468, PMCID: PMC11881633, DOI: 10.1002/alz.14622.Peer-Reviewed Original ResearchConceptsRelative Stress ScaleInformal care timeCaregiver burdenLiving interventionsCare timeIntervention periodStepped wedge randomized controlled trialVolunteer supportHome-dwelling peopleStepped-wedge trialPersonal activitiesDementia caregiversRandomized controlled trialsIntention-to-treatStress ScaleMunicipal coordinatorCaregiversPersonal supportRandomized dyadsDementiaControlled trialsPrimary outcomeControl periodInterventionPositive changesEconomic Outcomes With Precision Diagnostic Testing Versus Usual Testing in Stable Chest Pain: Results From the PRECISE Randomized Trial
Chew D, Mark D, Li Y, Nanna M, Kelsey M, Daniels M, Davidson-Ray L, Baloch K, Rogers C, Patel M, Anstrom K, Curzen N, Vemulapalli S, Douglas P, Investigators O. Economic Outcomes With Precision Diagnostic Testing Versus Usual Testing in Stable Chest Pain: Results From the PRECISE Randomized Trial. Circulation Cardiovascular Quality And Outcomes 2025, 18: e011008. PMID: 39895495, PMCID: PMC11837965, DOI: 10.1161/circoutcomes.123.011008.Peer-Reviewed Original ResearchMeSH KeywordsAgedAngina, StableComputed Tomography AngiographyCoronary AngiographyCoronary Artery DiseaseCost SavingsCost-Benefit AnalysisFemaleFractional Flow Reserve, MyocardialHospital CostsHumansMaleMiddle AgedPredictive Value of TestsProspective StudiesRisk AssessmentRisk FactorsTime FactorsTreatment OutcomeUnited StatesConceptsChest painObstructive coronary artery diseaseCoronary computed tomographic angiographyStable chest painCoronary artery bypass surgeryLow-risk patientsSecondary end pointsPrimary composite of deathPrecision strategyComputed tomographic angiographyHealth care system perspectiveComposite of deathUS health care system perspectiveArtery bypass surgeryMedical costsMean cost differenceNonfatal myocardial infarctionCoronary artery diseaseIntention-to-treatPercutaneous coronary interventionUsual testsEstimated total medical costTotal medical costsClinical practice guidelinesRisk patientsTransarterial chemoembolisation combined with lenvatinib plus pembrolizumab versus dual placebo for unresectable, non-metastatic hepatocellular carcinoma (LEAP-012): a multicentre, randomised, double-blind, phase 3 study
Kudo M, Ren Z, Guo Y, Han G, Lin H, Zheng J, Ogasawara S, Kim J, Zhao H, Li C, Madoff D, Ghobrial R, Kawaoka T, Gerolami R, Ikeda M, Kumada H, El-Khoueiry A, Vogel A, Peng X, Mody K, Dutcus C, Dubrovsky L, Siegel A, Finn R, Llovet J, investigators L. Transarterial chemoembolisation combined with lenvatinib plus pembrolizumab versus dual placebo for unresectable, non-metastatic hepatocellular carcinoma (LEAP-012): a multicentre, randomised, double-blind, phase 3 study. The Lancet 2025, 405: 203-215. PMID: 39798578, DOI: 10.1016/s0140-6736(24)02575-3.Peer-Reviewed Original ResearchConceptsEastern Cooperative Oncology GroupNon-metastatic hepatocellular carcinomaProgression-free survivalTreatment-related adverse eventsPembrolizumab groupPhase 3 studyTransarterial chemoembolisationPlacebo groupHepatocellular carcinomaIntention-to-treatOverall survivalDouble-blindPerformance statusAdverse eventsFollow-upEastern Cooperative Oncology Group performance statusChild-Pugh class A diseaseMedian progression-free survivalSolid Tumors version 1.1Blinded independent central reviewA-fetoprotein levelAlbumin-bilirubin gradeResponse Evaluation CriteriaAs-treated populationMedian follow-up
2024
Randomized in error in pragmatic clinical trials
Tong G, Coronado G, Li C, Li F. Randomized in error in pragmatic clinical trials. Contemporary Clinical Trials 2024, 148: 107764. PMID: 39603383, PMCID: PMC11752791, DOI: 10.1016/j.cct.2024.107764.Peer-Reviewed Original ResearchPragmatic clinical trialsElectronic health record dataHealth record dataPatient-reported dataExclusion of participantsSelection biasPatients' medical recordsAverage treatment effectOutcomes of participantsUsual carePragmatic trialTreatment effectsIntervention effectsIntention-to-treatOutcomes frameworkPost-randomization exclusionsPotential outcomes frameworkRecord dataCovariate-adjusted estimatesMedical recordsParticipantsClinical trialsInterventionTrialsArm beingThe UPFRONT project: tailored implementation and evaluation of a patient decision aid to support shared decision-making about management of symptomatic uterine fibroids
Forcino R, Durand M, Schubbe D, Engel J, Banks E, Laughlin-Tommaso S, Foster T, Madden T, Anchan R, Politi M, Lindholm A, Gargiulo R, Seshan M, Tomaino M, Zhang J, Acquilano S, Akinfe S, Sharma A, Aarts J, Elwyn G. The UPFRONT project: tailored implementation and evaluation of a patient decision aid to support shared decision-making about management of symptomatic uterine fibroids. Implementation Science 2024, 19: 75. PMID: 39501337, PMCID: PMC11536971, DOI: 10.1186/s13012-024-01404-5.Peer-Reviewed Original ResearchConceptsPatient decision aidsDecision aidClinician trainingSymptomatic uterine fibroidsDecision aid implementationVisit audio-recordingsImplementing decision aidsDecision-making scoresDecision aid useUterine fibroidsDecision-making experiencesIntention-to-treat resultsAid useAssessment of organizational readinessClinician surveyManagement of symptomatic uterine fibroidsOPTION-5Collaboration scoresDecision-makingIntention-to-treatEvaluate implementationPatient reportsAudio-recordedOrganizational readinessImplementation strategiesRandomized Phase III SIERRA Trial of 131I-Apamistamab Before Allogeneic Hematopoietic Cell Transplantation Versus Conventional Care for Relapsed/Refractory AML
Gyurkocza B, Nath R, Seropian S, Choe H, Litzow M, Abboud C, Koshy N, Stiff P, Tomlinson B, Abhyankar S, Foran J, Hari P, Chen G, Al-Kadhimi Z, Kebriaei P, Sabloff M, Orozco J, Jamieson K, Silverman M, Van Besien K, Schuster M, Law A, Larkin K, Pandit-Taskar N, Rowley S, Munshi P, Cook R, Levy M, Lazarus H, Sandmaier B, Pagel J, Reddy V, MacDougall J, McNamara K, Spross J, Haeuber E, Vusirikala M, Nahar A, Desai A, Giralt S. Randomized Phase III SIERRA Trial of 131I-Apamistamab Before Allogeneic Hematopoietic Cell Transplantation Versus Conventional Care for Relapsed/Refractory AML. Journal Of Clinical Oncology 2024, 43: 201-213. PMID: 39298738, PMCID: PMC11709001, DOI: 10.1200/jco.23.02018.Peer-Reviewed Original ResearchEvent-free survivalIntention-to-treat populationIntention-to-treatHazard ratioRR-AMLOverall survivalOlder patientsPhase III open-label trialEvent-free survival HRTreatment-related adverse eventsAllogeneic hematopoietic cell transplantationConventional careIncomplete platelet recoveryOS hazard ratioSecondary end pointsHematopoietic cell transplantationOpen-label trialConventional care groupPretransplant regimenRefractory AMLRelapsed/refractory AMLChemotherapy initiationDismal prognosisPlatelet recoveryCell transplantationA Digital Cognitive Behavioral Therapy Program for Adults With Alcohol Use Disorder
Kiluk B, Benitez B, DeVito E, Frankforter T, LaPaglia D, O’Malley S, Nich C. A Digital Cognitive Behavioral Therapy Program for Adults With Alcohol Use Disorder. JAMA Network Open 2024, 7: e2435205. PMID: 39325452, PMCID: PMC11428014, DOI: 10.1001/jamanetworkopen.2024.35205.Peer-Reviewed Original ResearchConceptsCognitive behavioral therapyDigital cognitive behavioral therapyAlcohol use disorderAlcohol useCBT programUse disorderCognitive behavioral therapy programCurrent alcohol use disorderTreatment-seeking adultsBehavioral therapy programEvidence-based treatmentsBaseline to 6-month follow-upRates of alcohol useReducing alcohol useTreatment periodRandomized clinical trialsBehavioral therapyOutpatient substancePercentage of daysOutpatient treatmentIntention-to-treat analysisIndividual counselingStudy periodFollow-upIntention-to-treatFuture Directions in Clinical Trials and Intention-To-Treat Analysis: Fulfilling Admirable Intentions Through the Right Questions
Silverman W, Pettit J, Jaccard J. Future Directions in Clinical Trials and Intention-To-Treat Analysis: Fulfilling Admirable Intentions Through the Right Questions. Journal Of Clinical Child & Adolescent Psychology 2024, 53: 840-848. PMID: 39110873, DOI: 10.1080/15374416.2024.2384035.Peer-Reviewed Original ResearchDemonstrating service delivery models for effective initiation and retention on pre-exposure prophylaxis (PrEP) among female bar workers in Dar es Salaam, Tanzania: A double randomized intervention study protocol
Chebet J, Akyoo W, Goymann H, Harling G, Barnhart D, Mosha I, Kamori D, Gandhi M, Mbunda T, Kipeleka J, Sando D, Spiegelman D, Mpembeni R, Bärnighausen T. Demonstrating service delivery models for effective initiation and retention on pre-exposure prophylaxis (PrEP) among female bar workers in Dar es Salaam, Tanzania: A double randomized intervention study protocol. PLOS ONE 2024, 19: e0304077. PMID: 38935796, PMCID: PMC11210872, DOI: 10.1371/journal.pone.0304077.Peer-Reviewed Original ResearchConceptsFemale bar workersPre-exposure prophylaxisIntention-to-treatBar workersPrimary outcomeRisk of HIV infectionAdherence to PrEPRisk of HIV acquisitionImprove PrEP adherenceGerman Clinical Trials RegisterPublic sector clinicsService delivery modelsRandomized trial designHIV negative womenPrevent HIV infectionHIV infectionPrEP provisionClinical Trials RegisterHIV testingPrEP initiationHealth facilitiesPromote PrEPPrEP adherenceDelivery modelsReduce barriersBuprenorphine-naloxone vs. extended-release naltrexone for opioid use disorder in individuals with and without criminal legal involvement: A secondary analysis of the X:BOT randomized controlled trial
Balter D, Puglisi L, Dziura J, Fiellin D, Howell B. Buprenorphine-naloxone vs. extended-release naltrexone for opioid use disorder in individuals with and without criminal legal involvement: A secondary analysis of the X:BOT randomized controlled trial. Journal Of Substance Use And Addiction Treatment 2024, 164: 209438. PMID: 38857827, PMCID: PMC11300157, DOI: 10.1016/j.josat.2024.209438.Peer-Reviewed Original ResearchXR-NTXBuprenorphine-naloxoneOpioid use disorderCriminal legal involvementUse disorderHazard of overdoseLifetime incarcerationLegal involvementOpioid use disorder treatment outcomesPer-protocol analysisExtended-release naltrexoneMOUD effectivenessTreatment outcomesEffects of medicationHazard of relapseSecondary analysisIntention-to-treat analysisIntention-to-treatRandomized controlled trialsEffects of MOUDRelapseControlled trialsDisordersOpioidPotential effect modifiersBacille Calmette-Guérin vaccination to prevent febrile and respiratory illness in adults (BRACE): secondary outcomes of a randomised controlled phase 3 trial
Pittet L, Messina N, McDonald E, Orsini F, Barry S, Bonten M, Campbell J, Croda J, Croda M, Dalcolmo M, Gardiner K, Gwee A, Jardim B, Lacerda M, Lucas M, Lynn D, Manning L, Perrett K, Post J, Prat-Aymerich C, Richmond P, Rocha J, Rodriguez-Baño J, Warris A, Wood N, Davidson A, Curtis N, Curtis N, Davidson A, Gardiner K, Gwee A, Jamieson T, Messina N, Morawakage T, Perlen S, Perrett K, Pittet L, Sastry A, Teo J, Orsini F, Lee K, Moore C, Vidmar S, Pittet L, Ali R, Dunn R, Edler P, Gell G, Goodall C, Hall R, Krastev A, La N, McDonald E, McPhate N, Nguyen T, Ren J, Stevens L, Messina N, Alamrousi A, Bonnici R, Dang T, Germano S, Hua J, McElroy R, Razmovska M, Reddiex S, Wang X, Anderson J, Azzopardi K, Bennett-Wood V, Czajko A, Mazarakis N, McCafferty C, Oppedisano F, Ortika B, Pell C, Spry L, Toh R, Velagapudi S, Vlahos A, Wee-Hee A, Ramos P, De La Cruz K, Gamage D, Karunanayake A, Mezzetti I, Ong B, Singh R, Sooriyarachchi E, Nicholson S, Cain N, Brizuela R, Huang H, Abruzzo V, Bealing M, Bimboese P, Bowes K, Burrell E, Chan J, Cushnahan J, Elborough H, Elkington O, Fahey K, Fernandez M, Flynn C, Fowler S, Andrit M, Gladanac B, Hammond C, Ma N, Macalister S, Milojevic E, Mojeed J, Nguyen J, O'Donnell L, Olivier N, Ooi I, Reynolds S, Shen L, Sherry B, Spotswood J, Wedderburn J, Younes A, Legge D, Bell J, Cheah J, Cobbledick A, Lim K, Elia S, Addlem L, Bourke A, Brophy C, Henare N, Jenkins N, Machingaifa F, Miller S, Mitchell K, Pitkin S, Wall K, Villanueva P, Crawford N, Pittet L, Norton W, Tan N, Chengodu T, Dawson D, Gordon V, Korman T, O'Bryan J, Abruzzo V, Agius S, Bannister S, Bucholc J, Burns A, Camesella B, Carlin J, Ciaverella M, Curtis M, Firth S, Guo C, Hannan M, Hill E, Joshi S, Lieschke K, Mathers M, Odoi S, Rak A, Richards C, Steve L, Stewart C, Sudbury E, Thomson H, Watts E, Williams F, Young A, Glenn P, Kaynes A, De Floy A, Buchanan S, Sondag T, Xie I, Edmund H, Byrne B, Keeble T, Ngien B, Noonan F, Wearing-Smith M, Clarke A, Davies P, Eastwood O, Ellinghaus A, Ghieh R, Hilton Z, Jennings E, Kakkos A, Liang I, Nicol K, O'Callaghan S, Osman H, Rajaram G, Ratcliffe S, Rayner V, Salmon A, Scheppokat A, Stevens A, Street R, Toogood N, Wood N, Bahaduri T, Baulman T, Byrne J, Carter C, Corbett M, Dao A, Desylva M, Dunn A, Gardiner E, Joyce R, Kandasamy R, Munns C, Pelayo L, Sharma K, Sterling K, Uren C, Colaco C, Douglas M, Hamilton K, Bartlett A, McMullan B, Palasanthiran P, Williams P, Beardsley J, Bergant N, Lagunday R, Overton K, Post J, Al-Hindawi Y, Barney S, Byrne A, Mead L, Plit M, Lynn D, Benson S, Blake S, Botten R, Chern T, Eden G, Griffith L, James J, Lynn M, Markow A, Sacca D, Stevens N, Wesselingh S, Doran C, Barry S, Sawka A, Evans S, Goodchild L, Heath C, Krieg M, Marshall H, McMillan M, Walker M, Richmond P, Amenyogbe N, Anthony C, Arnold A, Arrowsmith B, Ben-Othman R, Clark S, Dunnill J, Eiffler N, Ewe K, Finucane C, Flynn L, Gibson C, Hartnell L, Hollams E, Hutton H, Jarvis L, Jones J, Jones J, Jones K, Kent J, Kollmann T, Lalich D, Lee W, Lim R, McAlister S, McDonald F, Meehan A, Minhaj A, Montgomery L, O'Donnell M, Ong J, Ong J, Parkin K, Perez G, Power C, Rezazadeh S, Richmond H, Rogers S, Schultz N, Shave M, Skut P, Stiglmayer L, Truelove A, Wadia U, Wallace R, Waring J, England M, Latkovic E, Manning L, Herrmann S, Lucas M, Lacerda M, Andrade P, Barbosa F, Barros D, Brasil L, Capella A, Castro R, Costa E, de Souza D, Dias M, Dias J, Ferreira K, Figueiredo P, Freitas T, Furtado A, Gama L, Godinho V, Gouy C, Hinojosa D, Jardim B, Jardim T, Junior J, Lima A, Maia B, Marins A, Mazurega K, Medeiros T, Melo R, Moraes M, Nascimento E, Neves J, Oliveira M, Oliveira T, Oliveira I, Otsuka A, Paes R, Pereira H, Pereira G, Prado C, Queiroz E, Rodrigues L, Rodrigues B, Sampaio V, Santos A, Santos D, Santos T, Santos E, Sartim A, Silva A, Silva J, Silva E, Simão M, Soares C, Sousa A, Trindade A, Val F, Vasconcelos A, Vasconcelos H, Croda J, Abreu C, Almeida K, de Andrade C, Angelo J, de Araújo Arcanjo G, Arruda B, Ayala W, Barbosa A, Batista F, de Morais Batista F, de Jesus Costa M, Croda M, da Cruz L, Diogo R, Escobar R, Fernandes I, Figueiredo L, Gonçalves L, Lahdo S, dos Santos Lencina J, de Lima G, MEIRELES B, Moreira D, Muranaka L, de Oliveira A, de Oliveira K, de Oliveira M, de Oliveira R, dos Reis Pereira A, Puga M, Ramos C, da Rosa T, dos Santos K, dos Santos C, dos Santos D, Santos K, da Silva P, da Silva P, dos Santos Silva D, da Silva P, da Rosa Soares B, Sperotto M, Tadokoro M, Tsuha D, Vieira H, Dalcolmo M, da Paixão C, Castro G, Collopy S, da Costa Silva R, da Silveira S, Da-Cruz A, de Carvalho A, de Cássia Batista R, De Freitas M, de Oliveira Ferreira A, de Souza A, Doblas P, dos Santos A, dos Santos V, dos Santos Gomes D, Fortunato A, Gomes-Silva A, Gonçalves M, Meireless P, da Costa Carvalho E, do Couto Motta F, de Mendonça L, dos Santos Pandine G, Pereira R, Maia I, da Rocha J, Romano J, dos Santos G, da Silva E, de Siqueira M, Soares Á, Bonten M, Arroyo S, Besten H, Boon A, Brakke K, Janssen A, Koopmans M, Lemmens T, Leurink T, Prat-Aymerich C, Septer-Bijleveld E, Stadhouders K, Troeman D, van der Waal M, van Opdorp M, van Sluis N, Wolters B, Kluytmans J, Romme J, van den Bijllaardt W, van Mook L, van Rijen M, Filius P, Gisolf J, Greven F, Huijbens D, Hassing R, Pon R, Preijers L, van Leusen J, Verheij H, Boersma W, Brans E, Kloeg P, Molenaar-Groot K, Nguyen N, Paternotte N, Rol A, Stooper L, Dijkstra H, Eggenhuizen E, Huijs L, Moorlag S, Netea M, Pranger E, Taks E, Oever J, Heine R, Blauwendraat K, Meek B, Erkaya I, Harbech H, Roescher N, Peeters R, Riele M, Zhou C, Calbo E, Marti C, Palomares E, Porcuna T, Barriocanal A, Barriocanal A, Casas I, Dominguez J, Esteve M, Lacoma A, Latorre I, Molina G, Molina B, Rosell A, Vidal S, Barrera L, Bustos N, Calderón I, Campos D, Carretero J, Castellano A, Compagnone R, de Arellano E, de la Serna A, del Toro Lopez M, Espindola M, Gutierrez A, Hernandez A, Jiménez V, Moreno E, Navarrete N, Paño T, Rodríguez-Baño J, Tristán E, Villegas M, Garces A, Amo E, Guerrero R, Goikoetxea J, Jorge L, Perez C, Álvarez M, Cuadra M, de las Revillas Almajano F, Garcia P, Poderos T, Rico C, Sanchez B, Valero O, Vega N, Campbell J, Barnes A, Catterick H, Cranston T, Dawe P, Fletcher E, Fouracre L, Gifford A, Gow N, Kirkwood J, Martin C, McAnew A, Mitchell M, Newman G, O'Connell A, Onysk J, Quinn L, Rhodes S, Stone S, Symons L, Tripp H, Watkins D, Whale B, Harding A, Lockhart G, Sidaway-Lee K, Campbell J, Hilton S, Manton S, Webber-Rookes D, Winder R, Moore J, Bateman F, Gibbons M, Knight B, Moss J, Statton S, Studham J, Hall L, Moyle W, Venton T. Bacille Calmette-Guérin vaccination to prevent febrile and respiratory illness in adults (BRACE): secondary outcomes of a randomised controlled phase 3 trial. EClinicalMedicine 2024, 72: 102616. PMID: 38774675, PMCID: PMC11106519, DOI: 10.1016/j.eclinm.2024.102616.Peer-Reviewed Original ResearchBacille Calmette-Guerin vaccineBacille Calmette-GuerinRandomised controlled phase 3 trialControlled phase 3 trialPhase 3 trialIntention-to-treatRespiratory illnessBCG-DenmarkControl groupHealthcare workersDecreased all-cause mortalityRisk of severe diseasePresence of co-morbidityAssociated with protectionAll-cause mortalityEpisodes of illnessRespiratory infectionsIncreased riskHealthcare centresSecondary outcomesCo-morbiditySevere diseaseOff-target effectsSevere episodesVaccineSecondary interventions following open vs endovascular revascularization for chronic limb threatening ischemia in the BEST-CLI trial
Conte M, Azene E, Doros G, Gasper W, Hamza T, Kashyap V, Guzman R, Mena-Hurtado C, Menard M, Rosenfield K, Rowe V, Strong M, Farber A. Secondary interventions following open vs endovascular revascularization for chronic limb threatening ischemia in the BEST-CLI trial. Journal Of Vascular Surgery 2024, 79: 1428-1437.e4. PMID: 38368997, DOI: 10.1016/j.jvs.2024.02.005.Peer-Reviewed Original ResearchIntention-to-treatBEST-CLIChronic limb-threatening ischemiaOpen bypassRe-interventionBEST-CLI trialCohort 1Limb-threatening ischemiaSecondary analysisCox regression modelsOpen armMultivariate Cox regression modelRegression modelsDuration of follow-upTrial cohortCohortAnalyzed dataRandomized trialsFollow-upReduced hazardEndovascular revascularizationCLTIInitial treatmentTrialsStudy endpointBrief Educational Workshops in Secondary Schools Trial (BESST): a cluster randomised controlled trial. Secondary analysis in those with elevated symptoms of depression
Lisk S, James K, Shearer J, Byford S, Stallard P, Deighton J, Saunders D, Yarrum J, Fonagy P, Weaver T, Sclare I, Day C, Evans C, Carter B, Brown J. Brief Educational Workshops in Secondary Schools Trial (BESST): a cluster randomised controlled trial. Secondary analysis in those with elevated symptoms of depression. BMJ Mental Health 2024, 27: e301192. PMID: 39209761, PMCID: PMC11367360, DOI: 10.1136/bmjment-2024-301192.Peer-Reviewed Original ResearchConceptsTreatment-as-usualCluster randomised controlled trialNational Health ServiceElevated symptoms of depressionQuality-adjusted life yearsElevated depressive symptomsSymptoms of depressionRandomised controlled trialsDepressive symptomsSchools TrialElevated symptomsEducational workshopsIntention-to-treatSecondary analysisPersonal Social Services perspectiveControlled trialsMultilevel linear regressionSocial Services perspectiveSchool-based interventionsCost-effectiveIntention-to-treat analysisOutcomes of participantsHealth servicesIncremental cost-effectiveness ratioClinically meaningful effect
2023
Bacillus Calmette-Guérin vaccination for protection against recurrent herpes labialis: a nested randomised controlled trial
Pittet L, Moore C, McDonald E, Barry S, Bonten M, Campbell J, Croda J, Dalcolmo M, Davidson A, Douglas M, Gardiner K, Gwee A, Jardim B, Lacerda M, Lucas M, Lynn D, Manning L, de Oliveira R, Perrett K, Prat-Aymerich C, Richmond P, Rocha J, Rodriguez-Baño J, Warris A, Wood N, Messina N, Curtis N, Curtis N, Davidson A, Gardiner K, Gwee A, Jamieson T, Messina N, Morawakage T, Perlen S, Perrett K, Pittet L, Sastry A, Teo J, Orsini F, Lee K, Moore C, Vidmar S, Pittet L, Ali R, Dunn R, Edler P, Gell G, Goodall C, Hall R, Krastev A, La N, McDonald E, McPhate N, Nguyen T, Ren J, Stevens L, Messina N, Alamrousi A, Bonnici R, Dang T, Germano S, Hua J, McElroy R, Razmovska M, Reddiex S, Wang X, Anderson J, Azzopardi K, Bennett-Wood V, Czajko A, Mazarakis N, McCafferty C, Oppedisano F, Ortika B, Pell C, Spry L, Toh R, Velagapudi S, Vlahos A, Wee-Hee A, Ramos P, De La Cruz K, Gamage D, Karunanayake A, Mezzetti I, Ong B, Singh R, Sooriyarachchi E, Nicholson S, Cain N, Brizuela R, Huang H, Abruzzo V, Bealing M, Bimboese P, Bowes K, Burrell E, Chan J, Cushnahan J, Elborough H, Elkington O, Fahey K, Fernandez M, Flynn C, Fowler S, Andrit M, Gladanac B, Hammond C, Ma N, Macalister S, Milojevic E, Mojeed J, Nguyen J, O'Donnell L, Olivier N, Ooi I, Reynolds S, Shen L, Sherry B, Spotswood J, Wedderburn J, Younes A, Legge D, Bell J, Cheah J, Cobbledick A, Lim K, Elia S, Addlem L, Bourke A, Brophy C, Henare N, Jenkins N, Machingaifa F, Miller S, Mitchell K, Pitkin S, Wall K, Villanueva P, Crawford N, Pittet L, Norton W, Tan N, Chengodu T, Dawson D, Gordon V, Korman T, O'Bryan J, Abruzzo V, Agius S, Bannister S, Bucholc J, Burns A, Camesella B, Carlin J, Ciaverella M, Curtis M, Firth S, Guo C, Hannan M, Hill E, Joshi S, Lieschke K, Mathers M, Odoi S, Rak A, Richards C, Steve L, Stewart C, Sudbury E, Thomson H, Watts E, Williams F, Young A, Glenn P, Kaynes A, De Floy A, Buchanan S, Sondag T, Xie I, Edmund H, Byrne B, Keeble T, Ngien B, Noonan F, Wearing-Smith M, Clarke A, Davies P, Eastwood 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T, Rodríguez-Baño J, Tristán E, Villegas M, Garces A, Amo E, Guerrero R, Goikoetxea J, Jorge L, Perez C, Álvarez M, Cuadra M, de las Revillas Almajano F, Garcia P, Poderos T, Rico C, Sanchez B, Valero O, Vega N, Campbell J, Barnes A, Catterick H, Cranston T, Dawe P, Fletcher E, Fouracre L, Gifford A, Kirkwood J, Martin C, McAnew A, Mitchell M, Newman G, O'Connell A, Onysk J, Quinn L, Rhodes S, Stone S, Symons L, Tripp H, Warris A, Watkins D, Whale B, Harding A, Lockhart G, Sidaway-Lee K, Campbell J, Hilton S, Manton S, Webber-Rookes D, Winder R, Moore J, Bateman F, Gibbons M, Knight B, Moss J, Statton S, Studham J, Hall L, Moyle W, Venton T. Bacillus Calmette-Guérin vaccination for protection against recurrent herpes labialis: a nested randomised controlled trial. EClinicalMedicine 2023, 64: 102203. PMID: 37719417, PMCID: PMC10500555, DOI: 10.1016/j.eclinm.2023.102203.Peer-Reviewed Original ResearchBacille Calmette-GuerinRecurrent herpes labialisHerpes simplex virusBCG-DenmarkHerpes labialisCold soresRandomised controlled trialsRecurrence of herpes simplex virusDose of study drugEffects of Bacille Calmette-GuerinControlled trialsAs-treated populationBacillus Calmette-Guerin vaccineRecurrent cold soresControl groupBurden of recurrenceMean survival timeIntention-to-treatNested randomised controlled trialImpact quality-of-lifeStudy drugLive attenuated vaccinesIntradermal doseOrofacial regionProportion of participants
2022
A 10+10+30 radio campaign is associated with increased infant vaccination and decreased morbidity in Jimma Zone, Ethiopia: A prospective, quasi-experimental trial
Appiah B, Gebretsadik L, Mamo A, Kmush B, Asefa Y, France C, Samman E, Alemayehu T, Abafogi M, Ahmed M, Forastiere L, Singh G, Larsen D, Morankar S. A 10+10+30 radio campaign is associated with increased infant vaccination and decreased morbidity in Jimma Zone, Ethiopia: A prospective, quasi-experimental trial. PLOS Global Public Health 2022, 2: e0001002. PMID: 36962651, PMCID: PMC10021526, DOI: 10.1371/journal.pgph.0001002.Peer-Reviewed Original ResearchIntervention districtsRadio campaignCommunity radio stationsInfant vaccination coverageIntention-to-treatPer-protocol analysisDistrict clustersCommunity health workersInfluence health behaviorsJimma ZoneInfant morbidityQuasi-experimental trialVaccination coverageControl districtsPre-intervention differencesMass media interventionsRadio dramaRadio stationsDrama seriesCo-primary outcomesRandomized controlled trialsLow-income countriesHealth workersHealth behaviorsMedia interventions
2021
Personalized Antibodies for Gastroesophageal Adenocarcinoma (PANGEA): A Phase II Study Evaluating an Individualized Treatment Strategy for Metastatic Disease
Catenacci D, Moya S, Lomnicki S, Chase L, Peterson B, Reizine N, Alpert L, Setia N, Xiao S, Hart J, Siddiqui U, Hogarth D, Eng O, Turaga K, Roggin K, Posner M, Chang P, Narula S, Rampurwala M, Ji Y, Karrison T, Liao C, Polite B, Kindler H. Personalized Antibodies for Gastroesophageal Adenocarcinoma (PANGEA): A Phase II Study Evaluating an Individualized Treatment Strategy for Metastatic Disease. Cancer Discovery 2021, 11: 308-325. PMID: 33234578, PMCID: PMC7858231, DOI: 10.1158/2159-8290.cd-20-1408.Peer-Reviewed Original ResearchConceptsMedian overall survivalGastroesophageal adenocarcinomaTreatment strategiesHistorical controlsFirst-line response ratesOne-year survival rateDisease control ratePredefined treatment strategyTemporal molecular heterogeneityProgression-free survivalAdvanced gastroesophageal adenocarcinomaPhase II studyIndividualized treatment strategiesPersonalized treatment strategiesIntention-to-treatSequencing chemotherapyMetastatic diseaseOverall survivalOptimal chemotherapyEfficacy endpointII studyPrimary endpointRandomized studyTherapeutic resistanceControl rate
2015
Effects of Placental Transfusion on Neonatal and 18 Month Outcomes in Preterm Infants: A Randomized Controlled Trial
Mercer J, Erickson-Owens D, Vohr B, Tucker R, Parker A, Oh W, Padbury J. Effects of Placental Transfusion on Neonatal and 18 Month Outcomes in Preterm Infants: A Randomized Controlled Trial. The Journal Of Pediatrics 2015, 168: 50-55.e1. PMID: 26547399, PMCID: PMC4698069, DOI: 10.1016/j.jpeds.2015.09.068.Peer-Reviewed Original ResearchConceptsLate-onset sepsisRisk of intraventricular hemorrhageIntraventricular hemorrhageMonths corrected agePreterm infantsPremature ruptureEffects of delayed cord clampingEffects of placental transfusionRate of intraventricular hemorrhageIncidence of intraventricular hemorrhageBayley Scales of Infant DevelopmentCord clamping timeICC groupMotor outcomeIntention-to-treatOnset sepsisPlacental transfusionRandomized controlled trialsSingleton fetusesDCC groupGestational ageCord clampingClamp timeBayley ScalesMonth outcomes
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