2024
Adapting to change: experiences and recommendations from the Pain Management Collaboratory on modifying statistical analysis plans
Yu Q, George S, Kyriakides T, Rhon D, Morasco B, Dziura J, Fritz J, Geda M, Peduzzi P, Long C. Adapting to change: experiences and recommendations from the Pain Management Collaboratory on modifying statistical analysis plans. Pain Medicine 2024, 25: s49-s53. PMID: 39514871, PMCID: PMC11548855, DOI: 10.1093/pm/pnae073.Peer-Reviewed Original ResearchConceptsPragmatic clinical trialsPain Management CollaboratoryStatistical analysis planTrial protocolAnalysis planEvaluate nonpharmacological interventionsNonpharmacological interventionsTrial launchStudy designSecondary outcomesTrials RegistryPrimary outcomeStudy armsPrincipal investigatorInstitutional review boardClinical trialsTrial initiationCOVID-19-related issuesBest practicesPainSample sizeReview boardSafety monitoring boardOutcomesTrialsRecommendations for monitoring adherence and fidelity in pragmatic trials based on experience in the Pain Management Collaboratory
Dziura J, Gilstad-Hayden K, Coffman C, Long C, Yu Q, Buta E, Coggeshall S, Geda M, Peduzzi P, Kyriakides T. Recommendations for monitoring adherence and fidelity in pragmatic trials based on experience in the Pain Management Collaboratory. Pain Medicine 2024, 25: s41-s48. PMID: 39514878, PMCID: PMC11548857, DOI: 10.1093/pm/pnae080.Peer-Reviewed Original ResearchConceptsPain Management CollaboratoryPragmatic trialPragmatic Explanatory Continuum Indicator SummaryMonitor adherenceElectronic health recordsFidelity dataIntervention deliveryIntervention fidelityIndicator SummaryHealth recordsTrial interventionProtocol adherenceParticipant engagementStudy teamAdherence dataAdherenceTrial integrityInterventionParticipantsSafety monitoring boardFrequent sourcePainLevel of monitoringTrialsMonitoring board
2022
Facilitating future implementation and translation to clinical practice: The Implementation Planning Assessment Tool for clinical trials
Kowalski C, Kawentel L, Kyriakides T, Davis L, Bowersox N, Kilbourne A, Huang G, Nevedal A. Facilitating future implementation and translation to clinical practice: The Implementation Planning Assessment Tool for clinical trials. Journal Of Clinical And Translational Science 2022, 6: e131. PMID: 36590355, PMCID: PMC9794955, DOI: 10.1017/cts.2022.467.Peer-Reviewed Original ResearchClinical trialsVeterans Health Administration OfficePost-trial implementationRoutine care settingsClinical research programCooperative Studies ProgramImplementation science principlesAssessment toolCare settingsTrial completionClinical trialistsClinical practiceEffective interventionsTrial resultsInterventionImplementation scienceResearch protocolTrialsOne-fifthRigorous data collectionOverwhelming naturePatientsTrialists
2021
258 THE ASSOCIATION OF RACE AND ETHNICITY ON PRIOR COLORECTAL CANCER SCREENING TEST USE IN A LARGE CLINICAL TRIAL OF US VETERANS
Robertson D, Dominitz J, Beed A, Williams A, Boardman K, Imperiale T, Lieberman D, Provenzale D, Shaukat A, Sultan S, Kyriakides T. 258 THE ASSOCIATION OF RACE AND ETHNICITY ON PRIOR COLORECTAL CANCER SCREENING TEST USE IN A LARGE CLINICAL TRIAL OF US VETERANS. Gastroenterology 2021, 160: s-59-s-60. DOI: 10.1016/s0016-5085(21)00886-6.Peer-Reviewed Original Research
2020
An Application of the Cure Model to a Cardiovascular Clinical Trial
Sevilimedu V, Ma S, Hartigan P, Kyriakides T. An Application of the Cure Model to a Cardiovascular Clinical Trial. Statistics In Biosciences 2020, 13: 402-430. DOI: 10.1007/s12561-020-09297-w.Peer-Reviewed Original ResearchMyocardial infarctionACS eventAggressive Drug Evaluation (COURAGE) trialClinical Outcomes Utilizing RevascularizationHazard of MICardiovascular clinical trialsDrug evaluation trialsCoronary syndromeClinical trialsMedical conditionsClinical practiceSurvival analysisCure modelNovel findingsRiskTrialsCured fractionEvaluation trialsRevascularizationInfarctionSyndrome
2018
466 - Regional and Temporal Preferences for Colonoscopy or Fecal Immunochemcial Testing (FIT) for Colorectal Cancer (CRC) Screening in us Veterans who Declined to Participate in a Randomized Trial of CRC Screening
Dominitz J, Robertson D, Beed A, Ahnen D, Boardman K, Del Curto B, Guarino P, Imperiale T, Johnson G, Kyriakides T, LaCasse A, Larson M, Lieberman D, Provenzale D, Shaukat A, Sultan S, Planeta B. 466 - Regional and Temporal Preferences for Colonoscopy or Fecal Immunochemcial Testing (FIT) for Colorectal Cancer (CRC) Screening in us Veterans who Declined to Participate in a Randomized Trial of CRC Screening. Gastroenterology 2018, 154: s-109. DOI: 10.1016/s0016-5085(18)30800-x.Peer-Reviewed Original Research“But Do They Like It?” Participant Satisfaction and Gameplay Experience of a Public Health Videogame Intervention in Adolescents
Hieftje K, Pendergrass T, Montanaro E, Kyriakides T, Florsheim O, Fiellin L. “But Do They Like It?” Participant Satisfaction and Gameplay Experience of a Public Health Videogame Intervention in Adolescents. 2018, 1-7. DOI: 10.1109/segah.2018.8401349.Peer-Reviewed Original ResearchEffect of Evidence-Based Supported Employment vs Transitional Work on Achieving Steady Work Among Veterans With Posttraumatic Stress Disorder: A Randomized Clinical Trial
Davis LL, Kyriakides TC, Suris AM, Ottomanelli LA, Mueller L, Parker PE, Resnick SG, Toscano R, Scrymgeour AA, Drake RE. Effect of Evidence-Based Supported Employment vs Transitional Work on Achieving Steady Work Among Veterans With Posttraumatic Stress Disorder: A Randomized Clinical Trial. JAMA Psychiatry 2018, 75: 316-324. PMID: 29490371, PMCID: PMC5875356, DOI: 10.1001/jamapsychiatry.2017.4472.Peer-Reviewed Original ResearchConceptsPosttraumatic stress disorderClinical trialsIPS groupIndividual PlacementVeterans Affairs Medical CenterCompetitive jobsStress disorderChronic posttraumatic stress disorderVocational rehabilitation interventionsVocational rehabilitationCompetitive employmentMore participantsTreat analysisMean ageMedical CenterMAIN OUTCOMERehabilitation interventionsMultisite trialLatino ethnicityIPS participantsSupported employment interventionTransitional workTrialsVeterans
2017
Principles of Analysis
Johnson G, Kyriakides T. Principles of Analysis. 2017, 151-162. DOI: 10.1007/978-3-319-53877-8_17.Peer-Reviewed Original Research
2010
Methodological Issues in Comparative Effectiveness Research: Clinical Trials
Peduzzi P, Kyriakides T, O'Connor TZ, Guarino P, Warren SR, Huang GD. Methodological Issues in Comparative Effectiveness Research: Clinical Trials. The American Journal Of Medicine 2010, 123: e8-e15. PMID: 21184867, DOI: 10.1016/j.amjmed.2010.10.003.Peer-Reviewed Original ResearchConceptsComparative effectiveness clinical trialEffectiveness clinical trialClinical trialsVeterans Affairs Cooperative Studies ProgramCooperative Studies ProgramComparative effectiveness researchMechanism of actionUsual careDiabetes mellitusRheumatoid arthritisFuture trialsClinical equipoisePatient preferencesRisk factorsNeurologic disordersInfectious diseasesMental healthTrialsDisease areasEffectiveness researchPharmaceutical issuesType of studyValid comparisonsMellitusArthritisConnection Domain Mutations in Treatment-Experienced Patients in the OPTIMA Trial
Dau B, Ayers D, Singer J, Harrigan PR, Brown S, Kyriakides T, Cameron DW, Angus B, Holodniy M. Connection Domain Mutations in Treatment-Experienced Patients in the OPTIMA Trial. JAIDS Journal Of Acquired Immune Deficiency Syndromes 2010, 54: 160-166. PMID: 20130473, DOI: 10.1097/qai.0b013e3181cbd235.Peer-Reviewed Original ResearchConceptsTreatment-naive populationTreatment-experienced patientsCD mutationsTreatment-experienced populationsHIV viral loadConnection domainConnection domain mutationsOPTIMA trialVirologic outcomesVirologic responseARV regimenARV therapyViral loadAntiretroviral drugsAntiretroviral trialsUnivariate analysisDiminished responseFrequency of mutationsMultivariate analysisPatientsReduced susceptibilityA371VDomain mutationsResistance phenotypeTrials
2007
Evolution of Genotypic Resistance Algorithms and Their Impact on the Interpretation of Clinical Trials: An OPTIMA Trial Substudy
Desai S, Kyriakides T, Holodniy M, Al-Salman J, Griffith B, Kozal M. Evolution of Genotypic Resistance Algorithms and Their Impact on the Interpretation of Clinical Trials: An OPTIMA Trial Substudy. HIV Research & Clinical Practice 2007, 8: 293-302. PMID: 17956830, DOI: 10.1310/hct0805-293.Peer-Reviewed Original ResearchConceptsLong-term clinical trialsGenotypic resistance algorithmsClinical trialsDisease progressionHIV disease progression ratesHIV-1 pol sequencesHIV disease progressionDisease progression rateResistance algorithmsVirologic responseDrug comparisonsProgression rateVirtual phenotypeGenotypic algorithmsPol sequencesPatientsDrug resistanceResistance interpretationTrialsProgressionDrugsExpected ratesViral sequencesFirst eventSimilar time
2003
An open-label randomized clinical trial of novel therapeutic strategies for HIV-infected patients in whom antiretroviral therapy has failed: rationale and design of the OPTIMA Trial
Kyriakides TC, Babiker A, Singer J, Cameron W, Schechter MT, Holodniy M, Brown ST, Youle M, Gazzard B, Team O. An open-label randomized clinical trial of novel therapeutic strategies for HIV-infected patients in whom antiretroviral therapy has failed: rationale and design of the OPTIMA Trial. Contemporary Clinical Trials 2003, 24: 481-500. PMID: 12865041, DOI: 10.1016/s0197-2456(03)00029-1.Peer-Reviewed Original ResearchConceptsOPTIMA trialClinical trialsTherapeutic strategiesHuman immunodeficiency virus-infected individualsVirus-infected individualsDrug-free periodVeterans Affairs hospitalDifferent therapeutic strategiesYears of intakeNovel therapeutic strategiesAnti-HIV drugsAntiretroviral therapyStrategy armART drugsTrial designHIV drugsStudy durationHospitalTrialsRelative efficacyDrugsTherapyOptimum trial designYearsMulticenter