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 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 armTuberculosisMedicationTrialsSex Differences in Response to a 12-Week Resistance Training Exercise Intervention After Cardiac Surgery: A Proof-of-Concept Intervention Trial
Safdar B, Jarman A, Madsen T, DeLamielleure L, Zhou B, Axtell R, Geirsson A, Mangi A. Sex Differences in Response to a 12-Week Resistance Training Exercise Intervention After Cardiac Surgery: A Proof-of-Concept Intervention Trial. Clinical Therapeutics 2025, 47: 299-306. PMID: 39904658, DOI: 10.1016/j.clinthera.2025.01.002.Peer-Reviewed Original ResearchConceptsResistance training programExercise interventionResistance training exercise interventionResistance-based exercise programsTraining programFunctional capacityMeasurement of hand grip strengthTraditional cardiac rehabilitationResistance-based exerciseHand grip strengthTrends of improvementAcute cardiac eventsExercise programCardiac rehabilitationAerobic exerciseCardiac surgeryIntervention armCardiopulmonary rehabilitationFeasibility trialGrip strengthExercise parametersIntervention trialsControl armSecondary outcomesMeasured pre-Efficacy of a Clinical Decision Support Tool to Promote Guideline-Concordant Evaluations in Patients With High-Risk Microscopic Hematuria: A Cluster Randomized Quality Improvement Project.
Matulewicz R, Tsuruo S, King W, Nagler A, Feuer Z, Szerencsy A, Makarov D, Wong C, Dapkins I, Horwitz L, Blecker S. Efficacy of a Clinical Decision Support Tool to Promote Guideline-Concordant Evaluations in Patients With High-Risk Microscopic Hematuria: A Cluster Randomized Quality Improvement Project. Journal Of Urology 2025, 101097ju0000000000004436. PMID: 39854625, DOI: 10.1097/ju.0000000000004436.Peer-Reviewed Original ResearchClinical decision supportQuality improvement projectIntervention armImprovement projectImplementation of clinical decision supportClinical decision support alertsMultisite academic medical centerClinical decision support toolPrimary outcomeElectronic health recordsBarriers to evaluationAcademic medical centerHigh riskCDS alertsCDS toolsUsual careHealth recordsHealth systemPatient completionGuideline-concordantAmbulatory sitesImaging ordersCompletion of imagingControl armPromotion evaluation
2024
Impact of a multicomponent strategy including decentralized molecular testing for tuberculosis on mortality: planned analysis of a cluster-randomized trial in Uganda
Katamba A, Mochizuki T, Nalugwa T, Nantale M, Oyuku D, Nabwire S, Babirye D, Musinguzi J, Nakawesa A, Nekesa I, Turyahabwe S, Joloba M, Dowdy D, Moore D, Davis J, Shete P, Adams K, Reza T, Fielding K, Cattamanchi A. Impact of a multicomponent strategy including decentralized molecular testing for tuberculosis on mortality: planned analysis of a cluster-randomized trial in Uganda. EClinicalMedicine 2024, 78: 102953. PMID: 39659443, PMCID: PMC11629260, DOI: 10.1016/j.eclinm.2024.102953.Peer-Reviewed Original ResearchCommunity health centersCluster randomized trialHealth centersPragmatic cluster randomized trialMulticomponent strategiesSix-month mortality riskSecondary outcomesPan African Clinical Trials RegistryCluster-level analysisPatient-level covariatesAll-cause mortalityClinical Trials RegistryIntervention armSub-group analysisTB careMortality risk analysisRoutine careVital statusTrial armsMagnitude of effectPresumptive TBRate ratiosProximal outcomesTrial participantsUS National InstitutesBaseline predictors associated with successful weight loss among breast cancer survivors in the Lifestyle, Exercise, and Nutrition (LEAN) study
Hoobler R, Puklin L, Harrigan M, Cartmel B, Li F, Sanft T, Ferrucci L, Irwin M, Playdon M. Baseline predictors associated with successful weight loss among breast cancer survivors in the Lifestyle, Exercise, and Nutrition (LEAN) study. Journal Of Cancer Survivorship 2024, 1-9. PMID: 39528779, DOI: 10.1007/s11764-024-01702-3.Peer-Reviewed Original ResearchBreast cancer survivorsClinically meaningful weight lossCancer survivorsWeight loss interventionCancer SurvivorsBreast cancer survivorsWeight loss successConclusionBreast cancer survivorsPrevention of weight gainAssociated with lower oddsHistory of weight gainHealthy body weightMultivariate logistic regressionCancer treatmentSuccessful weight lossBreast cancer treatmentIntervention armLower oddsResultsBaseline dataDesign of programsWeight lossLogistic regressionC-statisticWeight gainSurvivorsInterventionBarriers to and facilitators of improving physical activity and nutrition behaviors during chemotherapy for breast cancer: a sequential mixed methods study
Puklin L, Irwin M, Sanft T, Ferrucci L, Harrigan M, McGowan C, Cartmel B, Zupa M, Winer E, Deyling M, Ligibel J, Basen-Engquist K, Spiegelman D, Sharifi M. Barriers to and facilitators of improving physical activity and nutrition behaviors during chemotherapy for breast cancer: a sequential mixed methods study. Supportive Care In Cancer 2024, 32: 590. PMID: 39141176, DOI: 10.1007/s00520-024-08789-5.Peer-Reviewed Original ResearchConceptsPhysical activityLifestyle interventionSelf-reported PA questionnaireSelf-reported diet qualityBreast cancerHealthy Eating Index-2015Stage I-III breast cancerBenefits of PASequential mixed methods studyI-III breast cancerChemotherapy-related symptomsMixed methods studyThematic content analysisBehavioral goalsSense of controlBody mass indexPA questionnaireSemi-structured interviewsMean body mass indexTranscribed verbatimIntervention armTailored educationDiet qualityNutritional behaviorMental benefitsImproving lifestyle behaviors during chemotherapy for breast cancer: The Lifestyle, Exercise, and Nutrition Early After Diagnosis (LEANer) Trial
Puklin L, Ferrucci L, Harrigan M, McGowan C, Zupa M, Cartmel B, Li F, Ligibel J, Spiegelman D, Sharifi M, Sanft T, Irwin M. Improving lifestyle behaviors during chemotherapy for breast cancer: The Lifestyle, Exercise, and Nutrition Early After Diagnosis (LEANer) Trial. Cancer 2024, 130: 2440-2452. PMID: 38470431, PMCID: PMC11214600, DOI: 10.1002/cncr.35280.Peer-Reviewed Original ResearchPhysical activityDiet qualityHEI-2015Strength trainingLifestyle behaviorsHealthy Eating Index (HEI)-2015Breast cancerAssociated with baseline fatigueImprove physical activityImprove lifestyle behaviorsHigher HEI-2015Associated with higher oddsExercise interventionUsual careIntervention armIntervention groupBaseline fatigueLifestyle interventionYearlong interventionLower fatigueHigher oddsSecondary analysisLogistic regressionNewly diagnosed patientsStudy arms
2023
Pediatric HIV Disclosure Intervention Improves Immunologic Outcome at 48 Weeks: The Sankofa Trial Experience
Shabanova V, Emuren L, Gan G, Antwi S, Renner L, Amissah K, Kusah J, Lartey M, Reynolds N, Paintsil E. Pediatric HIV Disclosure Intervention Improves Immunologic Outcome at 48 Weeks: The Sankofa Trial Experience. JAIDS Journal Of Acquired Immune Deficiency Syndromes 2023, 94: 371-380. PMID: 37643414, PMCID: PMC10617661, DOI: 10.1097/qai.0000000000003292.Peer-Reviewed Original ResearchConceptsHIV disclosure interventionsVirologic outcomesCD4 percentWeek 48HIV statusIntervention groupHIV disclosureDisclosure interventionDetectable viral loadWorld Health OrganizationAntiretroviral therapyImmunologic outcomesClinical outcomesIntervention armViral loadControl armClinical trialsTrial experienceSecondary analysisDisclosure statusHealth OrganizationCategorical variablesWeeksLinear mixed modelsBaselineEffectiveness of a group-based Diabetes Prevention Education Program (DiPEP) in a population with pre-diabetes: a cluster randomised controlled trial in Nepal
Shakya P, Shrestha A, Bajracharya M, Shrestha A, Kulseng B, Karmacharya B, Shrestha S, Das S, Shrestha I, Barun K, Shrestha N, Skovlund E, Sen A. Effectiveness of a group-based Diabetes Prevention Education Program (DiPEP) in a population with pre-diabetes: a cluster randomised controlled trial in Nepal. BMJ Nutrition Prevention & Health 2023, 6: 253-263. PMID: 38264365, PMCID: PMC10800278, DOI: 10.1136/bmjnph-2023-000702.Peer-Reviewed Original ResearchDiabetes prevention education programControl armIntervention armEducational sessionsMean differencePrevention education programPostintervention assessmentsLifestyle intervention programLifestyle intervention studyTRIAL REGISTRATION NUMBERTwo-arm clusterSecondary outcomesDiabetes preventionMiddle-income countriesPrimary outcomeTreat analysisWaist circumferenceMonths interventionPhysical activityRegistration numberGrain intakeIntervention studiesBaseline measuresSignificant weight reductionIntervention programsRandomized Trial Evaluating a Self-Guided Lifestyle Intervention Delivered via Evidence-Based Materials versus a Waitlist Group on Changes in Body Weight, Diet Quality, Physical Activity, and Quality of Life among Breast Cancer Survivors
Puklin L, Harrigan M, Cartmel B, Sanft T, Gottlieb L, Zhou B, Ferrucci L, Li F, Spiegelman D, Sharifi M, Irwin M. Randomized Trial Evaluating a Self-Guided Lifestyle Intervention Delivered via Evidence-Based Materials versus a Waitlist Group on Changes in Body Weight, Diet Quality, Physical Activity, and Quality of Life among Breast Cancer Survivors. Cancers 2023, 15: 4719. PMID: 37835412, PMCID: PMC10571774, DOI: 10.3390/cancers15194719.Peer-Reviewed Original ResearchBreast cancer survivorsCancer survivorsLifestyle interventionPhysical activityQuality of lifeBody weightWaitlist groupDiet qualitySelf-reported body weightWeight lossFavorable weight changeHealthy weight lossBody mass indexHealthy body weightGreater weight lossEvidence-based materialsDiverse healthcare settingsIntervention armMass indexClinical practicePositive behavior changeHealthcare settingsSurvivorsWeight changeInterventionEffect of Exercise on Chemotherapy-Induced Peripheral Neuropathy Among Patients Treated for Ovarian Cancer
Cao A, Cartmel B, Li F, Gottlieb L, Harrigan M, Ligibel J, Gogoi R, Schwartz P, Esserman D, Irwin M, Ferrucci L. Effect of Exercise on Chemotherapy-Induced Peripheral Neuropathy Among Patients Treated for Ovarian Cancer. JAMA Network Open 2023, 6: e2326463. PMID: 37526937, PMCID: PMC10394582, DOI: 10.1001/jamanetworkopen.2023.26463.Peer-Reviewed Original ResearchConceptsChemotherapy-induced peripheral neuropathyAerobic exercise interventionAttention control armExercise intervention armExercise interventionOvarian cancerControl armIntervention armSecondary analysisCIPN symptomsPeripheral neuropathyLifestyle StudyTreatment of CIPNModerate-intensity aerobic exerciseStandard oncology careEffects of exerciseSevere adverse effectsBetween-group differencesAmerican Cancer SocietyQuality of lifeAttention controlCIPN severityPrimary outcomeOncology careAerobic exerciseImplementation 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 aimRandomized trial evaluating an mHealth intervention for the early community-based detection and follow-up of cutaneous leishmaniasis in rural Colombia
Castillo M, Alexander N, Rubiano L, Rojas C, Navarro A, Rincon D, Bernal L, Lerma Y, Saravia N, Aronoff-Spencer E. Randomized trial evaluating an mHealth intervention for the early community-based detection and follow-up of cutaneous leishmaniasis in rural Colombia. PLOS Neglected Tropical Diseases 2023, 17: e0011180. PMID: 36972285, PMCID: PMC10079216, DOI: 10.1371/journal.pntd.0011180.Peer-Reviewed Original ResearchConceptsEffectiveness of treatmentIntervention armWeek 26Therapeutic responseCutaneous leishmaniasisHealth systemSerious adverse eventsEnd of treatmentStart of treatmentCutaneous leishmaniasis treatmentProportion of participantsMobile health strategiesPublic health systemCommunity-based detectionTreatment of CLPrimary endpointAdverse eventsMore patientsClinical managementControl armImproved careMedical attentionNational guidelinesParallel armsHealth strategiesImplementation of an educational intervention to improve medical student cost awareness: a prospective cohort study
Tait S, Oshima S, Leeras H, Gunn A, Sarver M, Gunes F, Greenup R. Implementation of an educational intervention to improve medical student cost awareness: a prospective cohort study. BMC Medical Education 2023, 23: 73. PMID: 36717888, PMCID: PMC9885673, DOI: 10.1186/s12909-023-04038-1.Peer-Reviewed Original ResearchConceptsProspective cohort studyPost-intervention surveysCost-conscious careCohort studyHigh-value careIntervention armMedical students' knowledgeEducational interventionNon-intervention armPre-intervention responsesCost awarenessFinancial hardshipSelf-reported preparednessMajority of participantsStudents' knowledgePatient costsTreatment decisionsHealthcare costsCare practicesLatter cohortCosts 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
Effectiveness of a community-based education and peer support led by women’s self-help groups in improving the control of hypertension in urban slums of Kerala, India: a cluster randomised controlled pragmatic trial
Suseela R, Ambika R, Mohandas S, Menon J, Numpelil M, Vasudevan B, Ved R, Danaei G, Spiegelman D. Effectiveness of a community-based education and peer support led by women’s self-help groups in improving the control of hypertension in urban slums of Kerala, India: a cluster randomised controlled pragmatic trial. BMJ Global Health 2022, 7: e010296. PMID: 36384950, PMCID: PMC9670931, DOI: 10.1136/bmjgh-2022-010296.Peer-Reviewed Original ResearchConceptsMean systolic BPSystolic BPControl armIntervention armPragmatic trialUrban slumsTarget blood pressure goalsMajor public health problemBlood pressure goalsSelf-help group membersControl of hypertensionStandard of carePublic health problemPrimary healthcare systemSelf-help groupsCommunity-based educationPeer support programAntihypertensive medicationsUncontrolled hypertensionUsual careHypertension managementPrimary outcomeHypertensionHealthy behaviorsHealth problemsThe 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 womenContent and Effectiveness of Web-Based Treatments for Online Behavioral Addictions: Systematic Review
Park J, King D, Wilkinson-Meyers L, Rodda S. Content and Effectiveness of Web-Based Treatments for Online Behavioral Addictions: Systematic Review. JMIR Mental Health 2022, 9: e36662. PMID: 36083612, PMCID: PMC9508667, DOI: 10.2196/36662.Peer-Reviewed Original ResearchPre-post studyWeb-based treatmentChange techniquesRandomized controlled trialsIntervention armEffective Public Health Practice Project Quality Assessment ToolAssessment of study qualityControlled trialsBehaviour change techniquesHealth care accessFollow-up evaluationDatabase search of MEDLINEQuality assessment toolMental health symptomsIn-person treatmentCochrane Central Register of Controlled TrialsSearch of MEDLINECentral Register of Controlled TrialsRegister of Controlled TrialsIntervention contentCare accessWeb of ScienceScreen timeCochrane Central RegisterSocial supportEffect of patient-delivered household contact tracing and prevention for tuberculosis: A household cluster-randomised trial in Malawi
Kaswaswa K, MacPherson P, Kumwenda M, Mpunga J, Thindwa D, Nliwasa M, Mwapasa M, Odland J, Tomoka T, Chipungu G, Mukaka M, Corbett E. Effect of patient-delivered household contact tracing and prevention for tuberculosis: A household cluster-randomised trial in Malawi. PLOS ONE 2022, 17: e0269219. PMID: 36074775, PMCID: PMC9455850, DOI: 10.1371/journal.pone.0269219.Peer-Reviewed Original ResearchConceptsTB preventive therapyStandard of careHousehold contactsNational guidelinesTB participantsEligible TB patientsMonths of randomisationCluster-randomised trialTRIAL REGISTRATION NUMBERHousehold contact tracingAge 5 yearsLow-resource settingsTB diseaseTB patientsPreventive therapySecondary outcomesTB screeningPrimary outcomeSymptom screeningIntervention armTB diagnosisSymptom screenMAIN OUTCOMEHigh riskTriage toolUser 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 patients
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