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 boardOutcomesTrialsUtility of the PICOTS framework to assess clinical trial disruptions: monitoring the impact of COVID-19 in the Pain Management Collaboratory
Peduzzi P, Brandt C, Dearth C, Dziura J, Farrokhi S, George S, Kyriakides T, Long C, Mascha E, Patterson C, Rhon D, Kerns R. Utility of the PICOTS framework to assess clinical trial disruptions: monitoring the impact of COVID-19 in the Pain Management Collaboratory. Pain Medicine 2024, 25: s34-s40. PMID: 39514876, PMCID: PMC11548861, DOI: 10.1093/pm/pnae078.Peer-Reviewed Original ResearchConceptsPain Management CollaboratoryPICOTS frameworkIndividual-level randomizationPain management researchPragmatic clinical trialsIntervention fidelityCare deliveryStepped-wedgeSpecialty careClinical partnersCOVID-19 experienceIn-personPain managementOutcome assessmentStudy designCOVID-19Nonpharmacologic approachesImpact of COVID-19PICOTExperimental interventionLead investigatorsTrial designDesign of clinical trialsAffective deliveryPain
2023
Correlation of a commercial platform’s results with post-vaccination SARS-CoV-2 neutralizing antibody response and clinical host factors
Slotkin R, Kyriakides T, Kundu A, Stack G, Sutton R, Gupta S. Correlation of a commercial platform’s results with post-vaccination SARS-CoV-2 neutralizing antibody response and clinical host factors. PLOS ONE 2023, 18: e0289713. PMID: 37643190, PMCID: PMC10464955, DOI: 10.1371/journal.pone.0289713.Peer-Reviewed Original Research
2022
Serum Neutralizing Antibody Titers 12 Months After Coronavirus Disease 2019 Messenger RNA Vaccination: Correlation to Clinical Variables in an Adult, US Population
Zhao M, Slotkin R, Sheth AH, Pischel L, Kyriakides TC, Emu B, McNamara C, Shi Q, Delgobbo J, Xu J, Marhoffer E, Mercer-Falkoff A, Holleck J, Ardito D, Sutton RE, Gupta S. Serum Neutralizing Antibody Titers 12 Months After Coronavirus Disease 2019 Messenger RNA Vaccination: Correlation to Clinical Variables in an Adult, US Population. Clinical Infectious Diseases 2022, 76: e391-e399. PMID: 35639598, PMCID: PMC9278145, DOI: 10.1093/cid/ciac416.Peer-Reviewed Original ResearchConceptsMonth postboosterRNA vaccinationClinical variablesNeutralization responseEnd-stage renal diseaseBooster dose responsePrimary series vaccinationPrimary vaccine seriesMultiple clinical factorsSystemic steroid useDoses of vaccinePrior COVID-19Maximal inhibitory concentration valuesHalf maximal inhibitory concentration (IC50) valuesSeries vaccinationVaccine seriesVaccine regimensClinical factorsDiabetes mellitusRenal diseaseComorbid conditionsSteroid useCOVID infectionImmune responseUS populationClinical and virologic factors associated with outcomes of COVID‐19 before and after vaccination among Veterans: Retrospective analysis from six New England states
Lee M, Cosentino D, Kyriakides TC, Cavallaro T, Stack G, Gupta S. Clinical and virologic factors associated with outcomes of COVID‐19 before and after vaccination among Veterans: Retrospective analysis from six New England states. Journal Of Hospital Medicine 2022, 17: 534-538. PMID: 35661577, PMCID: PMC9348310, DOI: 10.1002/jhm.12852.Peer-Reviewed Original ResearchConceptsCOVID-19Intensive care unit admissionVeterans Administration Healthcare SystemCare unit admissionNonpsychiatric hospitalizationsVirologic factorsFull vaccinationUnit admissionICU careClinical outcomesPoor outcomeMean ageRetrospective analysisD614G mutationHealthcare systemVeteransNew England statesHospitalizationOlder cohortOutcomesViral epidemiologyVaccinationDemographic factorsG mutationAge
2021
Microbiota or placebo after antimicrobial therapy for recurrent Clostridioides difficile at home: A clinical trial with novel home-based enrollment
Drekonja DM, Shaukat A, Zhang JH, Reinink AR, Nugent S, Dominitz JA, Davis-Karim A, Gerding DN, Kyriakides TC. Microbiota or placebo after antimicrobial therapy for recurrent Clostridioides difficile at home: A clinical trial with novel home-based enrollment. Clinical Trials 2021, 18: 622-629. PMID: 34154439, DOI: 10.1177/17407745211021198.Peer-Reviewed Original ResearchConceptsClinical trialsCase identificationRecurrent infectionsIndividuals meeting inclusion criteriaVeterans Affairs Corporate Data WarehouseFrequent antimicrobial usePrevention of recurrentRecurrent Clostridioides difficileSuccessful initial treatmentFecal microbiota transplantationIncidence of recurrentVeterans Affairs systemFecal microbiota transplantNationwide clinical trialMeeting inclusion criteriaQuality of lifeCorporate Data WarehouseTransplant administrationPrimary endpointStandard therapySubstantial morbidityInitial treatmentCapsule administrationMicrobiota transplantationRandomized comparison