2025
What Is a Stepped-Wedge Cluster Randomized Trial?
Li F, Wang B, Heagerty P. What Is a Stepped-Wedge Cluster Randomized Trial? JAMA Internal Medicine 2025, 185 PMID: 40063042, DOI: 10.1001/jamainternmed.2024.8216.Peer-Reviewed Original ResearchGuidelines for the content of statistical analysis plans in clinical trials: protocol for an extension to cluster randomized trials
Hemming K, Thompson J, Hooper R, Ukoumunne O, Li F, Caille A, Kahan B, Leyrat C, Grayling M, Mohammed N, Thompson J, Giraudeau B, Turner E, Watson S, Goulão B, Kasza J, Forbes A, Copas A, Taljaard M. Guidelines for the content of statistical analysis plans in clinical trials: protocol for an extension to cluster randomized trials. Trials 2025, 26: 72. PMID: 40011934, PMCID: PMC11866560, DOI: 10.1186/s13063-025-08756-3.Peer-Reviewed Original ResearchPower and Sample Size Calculations for Cluster Randomized Hybrid Type 2 Effectiveness‐Implementation Studies
Owen M, Curran G, Smith J, Tedla Y, Cheng C, Spiegelman D. Power and Sample Size Calculations for Cluster Randomized Hybrid Type 2 Effectiveness‐Implementation Studies. Statistics In Medicine 2025, 44: e70015. PMID: 39930740, DOI: 10.1002/sim.70015.Peer-Reviewed Original ResearchConceptsHybrid type 2 effectiveness-implementation studySample size calculationCluster randomized trialCluster randomized designSize calculationImplementation research outcomesReduce cardiovascular diseaseIssue of multiple testingEffective outcomesImplementation outcomesCommunity interventionsControl blood pressureBinary outcomesOutcomes approachLiterature searchMultiple testingCardiovascular diseaseInterventionRandomized trialsStandard statistical methodsBlood pressureOutcomesType 2 studiesWeighting methods for truncation by death in cluster-randomized trials
Isenberg D, Harhay M, Mitra N, Li F. Weighting methods for truncation by death in cluster-randomized trials. Statistical Methods In Medical Research 2025, 34: 473-489. PMID: 39885759, DOI: 10.1177/09622802241309348.Peer-Reviewed Original ResearchConceptsSurvivor average causal effectAverage causal effectCluster randomized trialAsymptotic variance estimatorsSubgroup treatment effectsCausal effectsPrincipal stratification frameworkFinite-sampleVariance estimationDistributional assumptionsIdentification assumptionsStratification frameworkPatient-centered outcomesNon-mortality outcomesOutcome modelQuality of lifeRandomized trialsIll patient populationMeasurement time pointsTruncationEstimationLength of hospital stayAssumptionsSurvivorsPatient populationLobectomy verses Sublobar Resection in The Society of Thoracic Surgeons Database: Importance of Patient Factors and Lymph Node Evaluation
Woodard G, Grau-Sepulveda M, Onaitis M, Udelsman B, David E, Jacobs J, Kosinski A, Blasberg J, Boffa D. Lobectomy verses Sublobar Resection in The Society of Thoracic Surgeons Database: Importance of Patient Factors and Lymph Node Evaluation. The Annals Of Thoracic Surgery 2025 PMID: 39864772, DOI: 10.1016/j.athoracsur.2025.01.004.Peer-Reviewed Original ResearchNon-small cell lung cancerSublobar resectionCell lung cancerLung cancerNodal upstagingImproved survivalHealthy patientsNode-negative non-small cell lung cancerThe Society of Thoracic Surgeons databaseRandomized trialsSociety of Thoracic Surgeons databaseAssociated with improved survivalEarly-stage lung cancerFewer lymph nodesInferior to survivalSublobar resection groupLymph node resectionThoracic Surgeons databaseLymph node evaluationProspective randomized trialsKaplan-Meier analysisForced expiratory volumeCT1 N0Pathologic upstagingNodal evaluationEfficacy and safety of anesthetic agents in awake craniotomy using monitored anesthesia care protocol: a systematic review and meta-analysis
Aghajanian S, Naeimi A, Mohammadifard F, Mohammadi I, Rajai Firouzabadi S, Baradaran Bagheri A, Khorasanizadeh M, Elsamadicy A. Efficacy and safety of anesthetic agents in awake craniotomy using monitored anesthesia care protocol: a systematic review and meta-analysis. Neurosurgical Review 2025, 48: 57. PMID: 39815114, DOI: 10.1007/s10143-025-03176-y.Peer-Reviewed Original ResearchConceptsMonitored anesthesia carePostoperative neurological deficitsNeurological deficitsAwake craniotomyClinical outcomesMeta-analysisMonitored anesthesia care protocolPooled proportion of patientsRate of postoperative neurologic deficitsRisk of neurological deficitsProportion of patientsAdverse event ratesAnesthetic agentsSystematic reviewIntraoperative seizure rateSecondary adverse outcomesImpact of anesthetic agentsTumor resectionRemifentanil usePooled proportionTense brainIntraoperative seizuresAnesthetic protocolRandomized trialsAdverse outcomesAddressing selection bias in cluster randomized experiments via weighting
Papadogeorgou G, Liu B, Li F, Li F. Addressing selection bias in cluster randomized experiments via weighting. Biometrics 2025, 81: ujaf013. PMID: 40052595, DOI: 10.1093/biomtc/ujaf013.Peer-Reviewed Original ResearchConceptsCluster-randomized experimentCluster randomized trialAverage treatment effectSelection biasInverse probability weightingOverall populationTreatment effectsCo-paymentControl armRecruited populationProbability weightingRandomized experimentRandomized trialsPopulationEstimation strategyTreatment assignmentIndividualsRecruitment assumptionR packageOverallAnalysis approachInterventionRecruitment
2024
The Relationship Between Quantitative Ischemia, Early Revascularization, and Major Adverse Cardiovascular Events A Multicenter Study
Miller R, Bednarski B, Cui Y, Calsavara V, Patel K, Rozanski A, Liang J, Builoff V, Acampa W, Bateman T, Di Carli M, Dorbala S, Einstein A, Fish M, Hauser M, Kaufmann P, Miller E, Ruddy T, Sharir T, Sinusas A, Dey D, Berman D, Slomka P. The Relationship Between Quantitative Ischemia, Early Revascularization, and Major Adverse Cardiovascular Events A Multicenter Study. JACC Advances 2024, 4: 101440. PMID: 39759439, PMCID: PMC11697767, DOI: 10.1016/j.jacadv.2024.101440.Peer-Reviewed Original ResearchMyocardial perfusion imagingEarly revascularizationMyocardial infarctionPerfusion imagingAssociated with reduced riskMedian follow-upImprove patient selectionAssociated with reduced deathSeverity of ischemiaMulticenter registryMale patientsPatient selectionRetrospective analysisFollow-upRandomized trialsRegistry sitesMyocardial ischemiaRevascularizationPatientsIschemiaSurvival analysisAuthors evaluated differencesPropensity scoreRegistryDeathTreating Migraine Patients With Cardiovascular Risks
Wang K, Sico J. Treating Migraine Patients With Cardiovascular Risks. Neurology 2024, 103: e210196. PMID: 39621947, DOI: 10.1212/wnl.0000000000210196.Peer-Reviewed Original ResearchNonaspirin nonsteroidal anti-inflammatory drugsCardiovascular safety profileSafety profileCardiovascular eventsCardiovascular riskIncreased riskIncreased risk of ischemic eventsRisk of ischemic eventsNonsteroidal anti-inflammatory drugsExclusion of patientsAdverse cardiovascular eventsMyocardial infractionRisk of acute cardiovascular eventsEffective acute treatmentTreat migraine patientsRisk of myocardial infractionCOX-2 inhibitorsAnti-inflammatory drugsAcute cardiovascular eventsMigraine patientsAcute treatmentIschemic eventsManaging cardiovascular riskRandomized trialsCOX-2Arousal threshold modifies the effect of CPAP on executive function among individuals with obstructive sleep apnoea
Zinchuk A, Kushida C, Walker A, Wellman A, Azarbarzin A, Alex R, Varga A, Sands S, Yaggi H. Arousal threshold modifies the effect of CPAP on executive function among individuals with obstructive sleep apnoea. European Respiratory Journal 2024, 65: 2401183. PMID: 39572221, DOI: 10.1183/13993003.01183-2024.Peer-Reviewed Original ResearchEffect of continuous positive airway pressureContinuous positive airway pressureObstructive sleep apneaSleep apneaArousal thresholdApnea Positive Pressure Long-term Efficacy StudySham continuous positive airway pressureEffect of CPAP treatmentPositive airway pressureLong-term efficacy studiesAssociated with neurocognitive dysfunctionCPAP treatmentAirway pressureSham-controlled trialApneaRandomized trialsSecondary outcomesNeurocognitive dysfunctionNeurocognitive outcomesTotal timeEfficacy studiesNeurocognitive functionSecondary analysisArTHExecutive functionCorrection: Randomized trial of physical activity on quality of life and lung cancer biomarkers in patients with advanced stage lung cancer: a pilot study
Bade B, Gan G, Li F, Lu L, Tanoue L, Silvestri G, Irwin M. Correction: Randomized trial of physical activity on quality of life and lung cancer biomarkers in patients with advanced stage lung cancer: a pilot study. BMC Cancer 2024, 24: 1409. PMID: 39548453, PMCID: PMC11566398, DOI: 10.1186/s12885-024-13183-9.Peer-Reviewed Original ResearchArtificial Intelligence in Cardiovascular Clinical Trials
Cunningham J, Abraham W, Bhatt A, Dunn J, Felker G, Jain S, Lindsell C, Mace M, Martyn T, Shah R, Tison G, Fakhouri T, Psotka M, Krumholz H, Fiuzat M, O’Connor C, Solomon S, Collaboratory H. Artificial Intelligence in Cardiovascular Clinical Trials. Journal Of The American College Of Cardiology 2024, 84: 2051-2062. PMID: 39505413, DOI: 10.1016/j.jacc.2024.08.069.Peer-Reviewed Original ResearchConceptsArtificial intelligenceIntegrate AIPatient privacyClinical trialsRandomized clinical trialsClinical event outcomesCardiovascular clinical trialsIntelligenceInaccurate resultsRandomized trialsInterpreting imagesCardiovascular therapyMedical decision makingDecision makingGold standardValidity of trial resultsClinical trial operationsPrivacyEstimates of intra-cluster correlation coefficients from 2018 USA Medicare data to inform the design of cluster randomized trials in Alzheimer’s and related dementias
Ouyang Y, Li F, Li X, Bynum J, Mor V, Taljaard M. Estimates of intra-cluster correlation coefficients from 2018 USA Medicare data to inform the design of cluster randomized trials in Alzheimer’s and related dementias. Trials 2024, 25: 732. PMID: 39478608, PMCID: PMC11523597, DOI: 10.1186/s13063-024-08404-2.Peer-Reviewed Original ResearchConceptsIntra-cluster correlation coefficientIntra-cluster correlation coefficient estimationSample size calculationED visitsMedicare dataMedicare fee-for-service beneficiariesEmergency departmentFee-for-service beneficiariesSize calculationDiagnosis of ADRDNational Medicare dataCluster randomized trialHospital referral regionsHospital service areasHealth care systemBackgroundCluster randomized trialsPopulation-level dataRandomized trialsDesign of cluster randomized trialsEvaluate interventionsReferral regionsCare systemICC estimatesADRDCorrelation coefficientMetabolic Effects of the SGLT2 Inhibitor Dapagliflozin in Heart Failure Across the Spectrum of Ejection Fraction
Selvaraj S, Patel S, Sauer A, McGarrah R, Jones P, Kwee L, Windsor S, Ilkayeva O, Muehlbauer M, Newgard C, Borlaug B, Kitzman D, Shah S, Margulies K, Husain M, Inzucchi S, McGuire D, Lanfear D, Javaheri A, Umpierrez G, Mentz R, Sharma K, Kosiborod M, Shah S. Metabolic Effects of the SGLT2 Inhibitor Dapagliflozin in Heart Failure Across the Spectrum of Ejection Fraction. Circulation Heart Failure 2024, 17: e011980. PMID: 39421941, PMCID: PMC11634023, DOI: 10.1161/circheartfailure.124.011980.Peer-Reviewed Original ResearchMeSH KeywordsAgedBenzhydryl CompoundsBiomarkersClinical Trials, Phase IV as TopicFatty AcidsFemaleGlucosidesHeart FailureHumansMaleMetabolomicsMiddle AgedMulticenter Studies as TopicRandomized Controlled Trials as TopicSodium-Glucose Transporter 2 InhibitorsStroke VolumeTreatment OutcomeVentricular Function, LeftConceptsHeart failureBranched-chain amino acidsEnd pointsEjection fractionLeft ventricular ejection fraction spectrumMetabolite factorsMetabolic effectsSpectrum of ejection fractionSGLT2 inhibitor dapagliflozinReduced ejection fractionHF-related outcomesEjection fraction spectrumMechanisms of benefitDEFINE-HFAcid metabolismInhibitor dapagliflozinOverall cohortMetabolomic profilesLVEFMetabolic signaturesRandomized trialsDapagliflozinHF subtypesFatty acid metabolismAmino acid metabolismHLA DQA1*05 and risk of anti-TNF treatment failure and anti-drug antibody development in children with Crohn's Disease: HLA DQA1*05 and Pediatric Crohn's Disease.
Adler J, Galanko J, Ammoury R, Benkov K, Bousvaros A, Boyle B, Cabrera J, Chun K, Dorsey J, Ebach D, Firestine A, Gulati A, Herfarth H, Jester T, Kaplan J, Leibowitz I, Linville T, Margolis P, Minar P, Molle-Rios Z, Moses J, Olano K, Pashankar D, Pitch L, Saeed S, Samson C, Sandberg K, Steiner S, Strople J, Sullivan J, Wali P, Kappelman M. HLA DQA1*05 and risk of anti-TNF treatment failure and anti-drug antibody development in children with Crohn's Disease: HLA DQA1*05 and Pediatric Crohn's Disease. The American Journal Of Gastroenterology 2024 PMID: 39423015, DOI: 10.14309/ajg.0000000000003135.Peer-Reviewed Original ResearchHLA-DQA1*05Anti-drug antibodiesDQA1*05Anti-drug antibody developmentTreatment failureCrohn's diseaseAnti-TNFPositive patientsDevelopment of anti-drug antibodiesAnti-TNF treatment failureTumor necrosis factor antagonistsIndicator of treatment failureAnti-TNF monotherapyPediatric Crohn's diseaseIncreased treatment failureTrial of childrenYears of ageRandomized trial of childrenOral methotrexatePositive participantsRisk stratificationPediatric dataRandomized trialsIncreased riskPrimary outcomeRandomized study of temporary diaphragm pacing for enhanced recovery after surgery in cardiac surgery patients at risk of prolonged mechanical ventilation
Hungate J, Onders R, Diasty M, Abu-Omar Y, Arora R, Baeza C, Elgudin Y, Gray K, Markowitz A, Pelletier M, Ribeiro I, Vega P, Rushing G, Sabik J. Randomized study of temporary diaphragm pacing for enhanced recovery after surgery in cardiac surgery patients at risk of prolonged mechanical ventilation. JTCVS Open 2024, 22: 76-84. PMID: 39780786, PMCID: PMC11704535, DOI: 10.1016/j.xjon.2024.09.031.Peer-Reviewed Original ResearchProlonged mechanical ventilationStandard of care groupRisk of prolonged mechanical ventilationMechanical ventilationCardiac surgeryDiaphragmatic pacingDiaphragm pacingTreatment groupsRandomized trialsHistory of chronic obstructive pulmonary diseaseLeft ventricular ejection fractionIntra-aortic balloon pumpDecrease mechanical ventilationCardiac surgery patientsVentricular ejection fractionHigh-risk patientsMulticenter randomized trialCare groupEnhanced recoveryChronic obstructive pulmonary diseaseRelative risk reductionIntensive care unitStandard of carePredictive enrichment strategiesObstructive pulmonary diseaseEffect of endoscopic ultrasound guided celiac plexus block on the palliation of pain in chronic pancreatitis (EPOCH Trial): study protocol for a randomized multicenter sham-controlled trial {1}
Wilcox C, Bang J, Buxbaum J, Gardner T, Hawes R, Kedia P, Mardini S, Muniraj T, Navaneethan U, Oza V, Tarnasky P, Thakkar S, Waxman I, Varadarajulu S. Effect of endoscopic ultrasound guided celiac plexus block on the palliation of pain in chronic pancreatitis (EPOCH Trial): study protocol for a randomized multicenter sham-controlled trial {1}. Trials 2024, 25: 676. PMID: 39396987, PMCID: PMC11472533, DOI: 10.1186/s13063-024-08478-y.Peer-Reviewed Original ResearchMeSH KeywordsAbdominal PainAutonomic Nerve BlockCeliac PlexusEndosonographyHumansMulticenter Studies as TopicNerve BlockPain MeasurementPalliative CarePancreatitis, ChronicProspective StudiesRandomized Controlled Trials as TopicTime FactorsTreatment OutcomeUltrasonography, InterventionalUnited StatesConceptsCeliac plexus blockAbdominal painChronic pancreatitisVisual analog scalePlexus blockSham-controlled trialRandomized sham-controlled trialEndoscopic ultrasound-guided celiac plexus blockEffectiveness of endoscopic ultrasoundBrief Pain Inventory Short FormDocumented chronic pancreatitisPainful chronic pancreatitisPalliation of painTime of EUSTreatment of abdominal painPain scoresBPI-SFSteroid combinationsAnalog scaleEndoscopic ultrasoundProspective studyCeliac plexusRandomized trialsShort formPancreatitisA review of current practice in the design and analysis of extremely small stepped-wedge cluster randomized trials
Tong G, Nevins P, Ryan M, Davis-Plourde K, Ouyang Y, Macedo J, Meng C, Wang X, Caille A, Li F, Taljaard M. A review of current practice in the design and analysis of extremely small stepped-wedge cluster randomized trials. Clinical Trials 2024, 22: 45-56. PMID: 39377196, PMCID: PMC11810615, DOI: 10.1177/17407745241276137.Peer-Reviewed Original ResearchSmall-sample correctionsStepped-wedge cluster randomized trialCluster randomized trialSample size calculation methodGeneralized linear mixed modelsLongitudinal correlation structureSize calculation methodLinear mixed modelsPermutation testSample sizeBayesian approachRandomized trialsCorrelation structureMixed modelsBayesian analysisGeneralized estimating equationsPermutationMedian sample sizeIntervention conditionRandomization methodEquationsTherapeutic management in women with a diminished ovarian reserve: a systematic review and meta-analysis of randomized controlled trials
Conforti A, Carbone L, Di Girolamo R, Iorio G, Guida M, Campitiello M, Ubaldi F, Rienzi L, Vaiarelli A, Cimadomo D, Ronsini C, Longobardi S, D'Hooghe T, Esteves S, Alviggi C. Therapeutic management in women with a diminished ovarian reserve: a systematic review and meta-analysis of randomized controlled trials. Fertility And Sterility 2024, 123: 457-476. PMID: 39332623, DOI: 10.1016/j.fertnstert.2024.09.038.Peer-Reviewed Original ResearchDiminished ovarian reserveLive birth rateOvarian reserveRandomized controlled trialsClinical management of womenHigher live birth ratesAssociated with higher live birth ratesMeta-analysis of randomized controlled trialsControlled trialsInvestigate adjuvant treatmentsManagement of womenLow-dose gonadotropinsLuteal phase stimulationBirth ratePOSEIDON criteriaCorifollitropin alfaAdjuvant treatmentGonadotropin regimensGnRH antagonistClomiphene citrateLuteinizing hormoneTherapeutic managementTestosterone supplementationClinical managementRandomized trialsEffect of single blastocyst-stage versus single cleavage-stage embryo transfer on cumulative live births in women with good prognosis undergoing in vitro fertilization: Multicenter Randomized Controlled Trial
Ma X, Wang J, Shi Y, Tan J, Guan Y, Sun Y, Zhang B, Zhao J, Liu J, Cao Y, Li H, Zhang C, Chen F, Yi H, Wang Z, Xin X, Kong P, Lu Y, Huang L, Yuan Y, Liu H, Li C, Mol B, Hu Z, Zhang H, Chen Z, Liu J. Effect of single blastocyst-stage versus single cleavage-stage embryo transfer on cumulative live births in women with good prognosis undergoing in vitro fertilization: Multicenter Randomized Controlled Trial. Nature Communications 2024, 15: 7747. PMID: 39237545, PMCID: PMC11377718, DOI: 10.1038/s41467-024-52008-y.Peer-Reviewed Original ResearchConceptsLive birth rateIn vitro fertilizationCumulative live birth rateCumulative live birthBlastocyst transferBlastocyst-stageCleavage-stageEmbryo transferLive birthsHigher preterm birth rateBlastocyst-stage groupBlastocyst-stage transferCleavage-stage groupCleavage-stage transferPreterm birth rateYear of randomizationMulticenter randomized controlled trialPrognosis womenRandomized controlled trialsPregnancy outcomesCounseling patientsRandomized trialsNon-inferiorityPrimary outcomeSecondary outcomes
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