2025
Protocol for the economic evaluation of group interpersonal therapy for postnatal depression compared with high-quality standard care in Kenya and Lebanon (SUMMIT trial)
Jaoude G, Madeghe B, Maradian S, Posbic P, Machoka J, Ndamaiyu G, Simes E, O’Donnell C, Wallace-Hanlon S, Evans R, Fearon P, Allison E, Pilling S, Verdeli L, Cheng B, Fouad F, Ngunu C, Chammay R, Kumar M, Fonagy P, Skordis J. Protocol for the economic evaluation of group interpersonal therapy for postnatal depression compared with high-quality standard care in Kenya and Lebanon (SUMMIT trial). NIHR Open Research 2025, 5: 17. DOI: 10.3310/nihropenres.13838.1.Peer-Reviewed Original ResearchInterpersonal therapyIncremental cost-effectiveness ratioChildren's cognitive developmentCognitive developmentPostnatal depressionEconomic evaluationUniversity College London Research Ethics CommitteeStandard careEstimate incremental cost-effectiveness ratiosLong-term depressionTrial outcomesPoor developmental outcomesPrimary trial outcomeDepression outcomesSecondary trial outcomesMaternal depressionPeer-reviewed journal publicationsControlled superiority trialImprove children's cognitive developmentResearch Ethics CommitteeKenyatta National HospitalQuality of lifeCost-effectiveness ratioIntention-to-treat analysisTrial follow-upArtificial Intelligence–Guided Lung Ultrasound by Nonexperts
Baloescu C, Bailitz J, Cheema B, Agarwala R, Jankowski M, Eke O, Liu R, Nomura J, Stolz L, Gargani L, Alkan E, Wellman T, Parajuli N, Marra A, Thomas Y, Patel D, Schraft E, O’Brien J, Moore C, Gottlieb M. Artificial Intelligence–Guided Lung Ultrasound by Nonexperts. JAMA Cardiology 2025, 10: 245-253. PMID: 39813064, PMCID: PMC11904735, DOI: 10.1001/jamacardio.2024.4991.Peer-Reviewed Original ResearchThis study shows AI helps non-experts create expert-quality lung ultrasound images, which may improve healthcare diagnostics access in underserved areas.
2024
Effect of a youth-led early childhood care and education programme on children's development and learning in rural Sindh, Pakistan (LEAPS): a stepped-wedge cluster-randomised implementation trial
Yousafzai A, Siyal S, Franchett E, Dai Q, Rehmani K, Sudfeld C, Bhamani S, Hakro S, Reyes C, Fink G, Ponguta L. Effect of a youth-led early childhood care and education programme on children's development and learning in rural Sindh, Pakistan (LEAPS): a stepped-wedge cluster-randomised implementation trial. The Lancet Child & Adolescent Health 2024, 9: 25-36. PMID: 39637878, DOI: 10.1016/s2352-4642(24)00304-3.Peer-Reviewed Original ResearchChildren's school readinessEarly childhood careSchool readinessFemale youthChildhood carePopulation-based cross-sectional surveyStepped-wedge cluster randomised trialImprove children's school readinessRural SindhPromote children’s school readinessRural PakistanCluster randomised trialStepped-wedge designEarly Learning AssessmentCross-sectional surveyEnrollment of childrenMiddle-income countriesHigh-quality ECCESocio-emotional developmentIntention-to-treat analysisECCE participationEmergent numeracyEmergent literacyClinical health conditionsEligible clustersEfficacy and Safety of Pembrolizumab Added to Azacitidine Plus Venetoclax for Patients with Acute Myeloid Leukemia: Results from an Investigator-Initiated, Multi-Center, CTEP-Sponsored Randomized, Phase II Trial (BLAST AML-2)
Stempel J, Uy G, Dinner S, Gojo I, Reed D, Roy R, Byrd K, Yerrabothala S, Lai C, Doucette K, Caldwell A, Blaha O, Podoltsev N, Mendez L, Bewersdorf J, Kewan T, Wistuba I, Alatrash G, Haymaker C, Streicher H, Sharon E, Little R, Gore S, Radich J, Wood B, Zeidan A, Shallis R. Efficacy and Safety of Pembrolizumab Added to Azacitidine Plus Venetoclax for Patients with Acute Myeloid Leukemia: Results from an Investigator-Initiated, Multi-Center, CTEP-Sponsored Randomized, Phase II Trial (BLAST AML-2). Blood 2024, 144: 736. DOI: 10.1182/blood-2024-210370.Peer-Reviewed Original ResearchPhase II trialTreatment-related AEsII trialFrequent treatment-related AEsSafety run-in periodAllogeneic stem cell transplantationNo dose limiting toxicitiesRandomized phase II trialAML-2Multi-centerControl armSafety of pembrolizumabDose-limiting toxicityPD-1 inhibitionAnti-PD1 antibodyIncomplete count recoveryFLT3 wild-typeIntermediate cytogenetic riskStem cell transplantationAcute myeloid leukemiaActivated T cellsRun-in periodIntention-to-treat analysisCancer Immune MonitoringLong-term survivalA 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 ResearchBuprenorphine-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 modifiersEfficacy of Voluntary Medical Male Circumcision to Prevent HIV Infection Among Men Who Have Sex With Men : A Randomized Controlled Trial.
Gao Y, Zhan Y, Sun Y, Zheng W, Zhang W, Fu L, Guo Z, Lin Y, Li Y, Zheng L, Zhan Y, Zhu Z, Duan J, Zhang G, Huang T, Su B, Yu M, Wu G, Ouyang L, Zhao J, Wang G, Zhou Y, Qian H, Fitzpatrick T, Vermund S, Zou H. Efficacy of Voluntary Medical Male Circumcision to Prevent HIV Infection Among Men Who Have Sex With Men : A Randomized Controlled Trial. Annals Of Internal Medicine 2024, 177: 719-728. PMID: 38801778, DOI: 10.7326/m23-3317.Peer-Reviewed Original ResearchVoluntary medical male circumcisionEfficacy of VMMCPreventing incident HIV infectionsRandomized controlled trialsMedical male circumcisionIncident HIV infectionIntervention groupInsertive anal intercoursePractice insertive anal intercourseMale circumcisionAnal intercourseIncidence rate of syphilisHIV infectionRates of syphilisMale sex partnersSexually transmitted infectionsIntention-to-treat analysisPrevent HIV infectionHIV incidenceControl groupHIV riskIncidence rateHerpes simplex virus type 2HIV seroconversionSelf-reportEnhanced Tuberculosis Diagnosis With Computer-aided Chest X-ray and Urine Lipoarabinomannan in Adults With Human Immunodeficiency Virus 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 Human Immunodeficiency Virus Admitted to Hospital (CASTLE Study): A Cluster Randomized Trial. Clinical Infectious Diseases 2024, ciae273. PMID: 38748183, 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 outcomeClinical effectiveness and cost-effectiveness of a brief accessible cognitive behavioural therapy programme for stress in school-aged adolescents (BESST): a cluster randomised controlled trial in the UK
Brown J, James K, Lisk S, Shearer J, Byford S, Stallard P, Deighton J, Saunders D, Yarrum J, Fonagy P, Weaver T, Sclare I, Day C, Evans C, Carter B. Clinical effectiveness and cost-effectiveness of a brief accessible cognitive behavioural therapy programme for stress in school-aged adolescents (BESST): a cluster randomised controlled trial in the UK. The Lancet Psychiatry 2024, 11: 504-515. PMID: 38759665, DOI: 10.1016/s2215-0366(24)00101-9.Peer-Reviewed Original ResearchTreatment-as-usualCognitive behavioral therapyTreatment-as-usual groupCluster randomised controlled trialCognitive behavioral therapy workshopRandomised controlled trialsCognitive behavioural therapy programmeSymptoms of depressionBehavioural therapy programmePrimary intention-to-treat analysisSchools TrialIndex of Multiple DeprivationBehavioral therapyDepressive symptomsHealth Technology Assessment programmeSchool-aged adolescentsControlled trialsSelf-referral systemIntention-to-treat populationDiscover interventionsFull school yearMental healthDepressionTherapy programmeIntention-to-treat analysisBrief 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
FC46: The effectiveness of a multicomponent intervention on caregiver burden and informal care time in home-dwelling people with dementia and their caregivers. Results from the stepped wedge randomized controlled LIVE@Home.Path tria
Berge L, Angeles R, Allore H, Vislapuu M, Gedde M, Puaschitz N, Ballard C, Aarsland D, Selbæk G, Vahia I, Tzoulis C, Nouchi R, Husebo B. FC46: The effectiveness of a multicomponent intervention on caregiver burden and informal care time in home-dwelling people with dementia and their caregivers. Results from the stepped wedge randomized controlled LIVE@Home.Path tria. International Psychogeriatrics 2023, 35: 107-108. DOI: 10.1017/s1041610223001448.Peer-Reviewed Original ResearchRelative Stress ScaleHome-dwelling peopleIntervention periodCare timeCaregiver burdenPersonal activities of daily livingStepped-wedge randomized controlled trialMild to moderate dementiaActivities of daily livingDementia (RUDInformal caregiver burdenInformal care timeActive intervention periodMixed-effects regression modelsIntention-to-treat analysisRandomized controlled trialsInformal caregiversNursing careLiving interventionsMulticomponent interventionGlobal Impression of ChangeClinical Global Impression of ChangeModerate dementiaDaily livingHomecare servicesReport of the first seven agents in the I-SPY COVID trial: a phase 2, open label, adaptive platform randomised controlled trial
Consortium T, Files D, Aggarwal N, Albertson T, Auld S, Beitler J, Berger P, Burnham E, Calfee C, Cobb N, Crippa A, Discacciati A, Eklund M, Esserman L, Friedman E, Gandotra S, Khan K, Koff J, Kumar S, Liu K, Martin T, Matthay M, Meyer N, Obermiller T, Robinson P, Russell D, Thomas K, Wong F, Wunderink R, Wurfel M, Yen A, Youssef F, Darmanian A, Dzierba A, Garcia I, Gosek K, Madahar P, Mittel A, Muir J, Rosen A, Schicchi J, Serra A, Wahab R, Gibbs K, Landreth L, LaRose M, Parks L, Wynn A, Ittner C, Mangalmurti N, Reilly J, Harris D, Methukupally A, Patel S, Boerger L, Kazianis J, Higgins C, McKeehan J, Daniel B, Fields S, Hurst-Hopf J, Jauregui A, Swigart L, Blevins D, Nguyen C, Suarez A, Tanios M, Sarafian F, Shah U, Adelman M, Creel-Bulos C, Detelich J, Harris G, Nugent K, Spainhour C, Yang P, Haczku A, Hardy E, Harper R, Morrissey B, Sandrock C, Budinger G, Donnelly H, Singer B, Moskowitz A, Coleman M, Levitt J, Lu R, Henderson P, Asare A, Dunn I, Barragan A. Report of the first seven agents in the I-SPY COVID trial: a phase 2, open label, adaptive platform randomised controlled trial. EClinicalMedicine 2023, 58: 101889. PMID: 36883141, PMCID: PMC9981330, DOI: 10.1016/j.eclinm.2023.101889.Peer-Reviewed Original ResearchInvestigational agentsSevere COVID-19Hazard ratioModified intention-to-treat analysisEvaluating investigational agentsRegimen of dexamethasoneIntention-to-treat analysisBackbone regimensOpen-labelDornase alfaEfficacy signalsScreening of agentsScreening potential therapeuticsData monitoring committeeHigh morbidityAdaptive platform trialCOVID trialsMedical CentrePfizer Inc.Controlled trialsHospitalised patientsI-SPYPre-specified criteriaFast GrantTime-to-recovery
2022
Adjuvant Intravesical Chemohyperthermia Versus Passive Chemotherapy in Patients with Intermediate-risk Non–muscle-invasive Bladder Cancer (HIVEC-II): A Phase 2, Open-label, Randomised Controlled Trial
Tan W, Prendergast A, Ackerman C, Yogeswaran Y, Cresswell J, Mariappan P, Phull J, Hunter-Campbell P, Lazarowicz H, Mishra V, Rane A, Davies M, Warburton H, Cooke P, Mostafid H, Wilby D, Mills R, Issa R, Kelly J. Adjuvant Intravesical Chemohyperthermia Versus Passive Chemotherapy in Patients with Intermediate-risk Non–muscle-invasive Bladder Cancer (HIVEC-II): A Phase 2, Open-label, Randomised Controlled Trial. European Urology 2022, 83: 497-504. PMID: 35999119, DOI: 10.1016/j.eururo.2022.08.003.Peer-Reviewed Original ResearchConceptsIntermediate-risk non-muscle-invasive bladder cancerNon-muscle-invasive bladder cancerDisease-free survivalAdverse eventsBladder cancerMitomycin CChemotherapy instillationOpen-labelControl armAdjuvant intravesical chemotherapyProgression-free survivalPhase 2 randomised controlled trialIntention-to-treat analysisLow gradePer-protocol analysisChemohyperthermia groupIntravesical chemotherapyUrinary cytologyHeated chemotherapyOverall survivalWeekly instillationsTumor resectionPrimary endpointRandomised controlled trialsChemohyperthermia
2021
Clarifying selection bias in cluster randomized trials
Li F, Tian Z, Bobb J, Papadogeorgou G, Li F. Clarifying selection bias in cluster randomized trials. Clinical Trials 2021, 19: 33-41. PMID: 34894795, DOI: 10.1177/17407745211056875.Peer-Reviewed Original ResearchConceptsAverage treatment effectCluster randomized trialPost-randomization selection biasPrincipal strataAnalysis of cluster randomized trialsSelection biasCausal effectsCovariate adjustment methodsData generating processRecruited populationPrincipal stratification frameworkPresence of selection biasHeterogeneous treatment effectsRegression adjustment methodEstimate causal effectsRandomized trialsElectronic health recordsOverall populationEffect heterogeneityIntention-to-treat analysisSimulation studyTreatment effectsEmpirical performanceEstimandsEstimation strategy
2005
240 Delayed Cord Clamping in Very Low Birthweight Infants Reduces the Incidence of Intraventricular Hemorrhage and Late Onset Sepsis
Mercer J, Vohr V, Oh W. 240 Delayed Cord Clamping in Very Low Birthweight Infants Reduces the Incidence of Intraventricular Hemorrhage and Late Onset Sepsis. Pediatric Research 2005, 58: 395-395. DOI: 10.1203/00006450-200508000-00269.Peer-Reviewed Original ResearchLate-onset sepsisSuspected necrotizing enterocolitisVery low birth weightIntraventricular hemorrhageDelayed cord clampingBronchopulmonary dysplasiaNecrotizing enterocolitisCord clampingOnset sepsisDCC groupBirth weightVery low birth weight infantsPeak serum bilirubin levelsIncidence of bronchopulmonary dysplasiaIncidence of intraventricular hemorrhageVery low birthweight infantsLow birth weight infantsBirth weight infantsLow birthweight infantsSerum bilirubin levelsLow birth weightIntention-to-treat analysisSecondary outcome variablesIntention-to-treatOutcome variables
2003
Immediate and Delayed Cord Clamping in Infants Born Between 24 and 32 Weeks: A Pilot Randomized Controlled Trial
Mercer J, McGrath M, Hensman A, Silver H, Oh W. Immediate and Delayed Cord Clamping in Infants Born Between 24 and 32 Weeks: A Pilot Randomized Controlled Trial. Journal Of Perinatology 2003, 23: 466-472. PMID: 13679933, DOI: 10.1038/sj.jp.7210970.Peer-Reviewed Original ResearchConceptsDelayed cord clampingImmediate cord clampingCord clampingBlood pressureRandomized controlled trialsDelayed cord clamping groupIntention-to-treat analysisInitial blood pressureMean blood pressureIntention-to-treatPreterm birthGroup infantsControlled trialsPilot randomized controlled trialGlucose levelsInfantsPilot study's aimStudy aimClampWeeksTrialsPreterm
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