Utility 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 deliveryPainAdapting 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 ResearchMeSH KeywordsCOVID-19Data Interpretation, StatisticalHumansPain ManagementPragmatic Clinical Trials as TopicResearch DesignConceptsPragmatic 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