2025
Learn-As-you-GO (LAGO) trials: optimizing treatments and preventing trial failure through ongoing learning
Bing A, Spiegelman D, Nevo D, Lok J. Learn-As-you-GO (LAGO) trials: optimizing treatments and preventing trial failure through ongoing learning. Biometrics 2025, 81: ujaf061. PMID: 40407021, PMCID: PMC12099308, DOI: 10.1093/biomtc/ujaf061.Peer-Reviewed Original ResearchConceptsIntervention packageBinary outcomesIntervention effectsConditional mean modelsOptimal intervention packagesOverall intervention effectContinuous outcomesComplex intervention packagesConfidence bandsInterval estimationImplementation trialLarge-scale intervention trialsMean modelIntervention trialsHypothesis testingInterventionStandard statistical methodsOutcomesTrialsConfidenceTheory
2020
Mortality under early access to antiretroviral therapy vs. Eswatini’s national standard of care: the MaxART clustered randomized stepped‐wedge trial
Chao A, Spiegelman D, Khan S, Walsh F, Mazibuko S, Pasipamire M, Chai B, Reis R, Mlambo K, Delva W, Khumalo G, Zwane M, Fleming Y, Mafara E, Hettema A, Lejeune C, Bärnighausen T, Okello V. Mortality under early access to antiretroviral therapy vs. Eswatini’s national standard of care: the MaxART clustered randomized stepped‐wedge trial. HIV Medicine 2020, 21: 429-440. PMID: 32458567, DOI: 10.1111/hiv.12876.Peer-Reviewed Original ResearchConceptsAntiretroviral therapyMortality rateDisease-related mortality rateCox proportional hazards modelCause mortality ratesStepped-wedge trialProportional hazards modelStepped-wedge designQuality of lifeEvidence of harmClinic transitionSecondary outcomesSOC participantsHealth clinicsLong-term consequencesImplementation trialHazards modelHIVStudy participantsMortalityHealth systemDecrease infectionEarly accessClinicTherapy
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