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 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
2021
Optimizing the Impact of Pragmatic Clinical Trials for Veteran and Military Populations: Lessons From the Pain Management Collaboratory
Ali J, Antonelli M, Bastian L, Becker W, Brandt CA, Burgess DJ, Burns A, Cohen SP, Davis AF, Dearth CL, Dziura J, Edwards R, Erdos J, Farrokhi S, Fritz J, Geda M, George SZ, Goertz C, Goodie J, Hastings SN, Heapy A, Ilfeld BM, Katsovich L, Kerns RD, Kyriakides TC, Lee A, Long CR, Luther SL, Martino S, Matheny ME, McGeary D, Midboe A, Pasquina P, Peduzzi P, Raffanello M, Rhon D, Rosen M, Esposito ER, Scarton D, Hastings SN, Seal K, Silliker N, Taylor S, Taylor SL, Tsui M, Wright FS, Zeliadt S. Optimizing the Impact of Pragmatic Clinical Trials for Veteran and Military Populations: Lessons From the Pain Management Collaboratory. Military Medicine 2021, 187: 179-185. PMID: 34791412, PMCID: PMC9389906, DOI: 10.1093/milmed/usab458.Peer-Reviewed Original ResearchMeSH KeywordsCOVID-19HumansMilitary PersonnelPain ManagementPandemicsPragmatic Clinical Trials as TopicResearch DesignVeteransConceptsPragmatic clinical trialsPain Management CollaboratoryClinical trialsMultisite pragmatic clinical trialManagement of painDual public health crisesCommon co-occurring conditionsPragmatic trial designUnmet healthcare needsMilitary Health SystemCo-occurring conditionsPublic health crisisPain managementChronic painNonpharmacological approachesOpioid misuseMultifactorial etiologyTrial designVeterans AffairsMilitary populationHealthcare needsHealth systemNational InstitutePainCOVID-19 pandemicAssessing the impact of the COVID-19 pandemic on pragmatic clinical trial participants
Coleman BC, Purcell N, Geda M, Luther SL, Peduzzi P, Kerns RD, Seal KH, Burgess DJ, Rosen MI, Sellinger J, Salsbury SA, Gelman H, Brandt CA, Edwards RR. Assessing the impact of the COVID-19 pandemic on pragmatic clinical trial participants. Contemporary Clinical Trials 2021, 111: 106619. PMID: 34775101, PMCID: PMC8585559, DOI: 10.1016/j.cct.2021.106619.Peer-Reviewed Original ResearchMeSH KeywordsCOVID-19HumansPandemicsPragmatic Clinical Trials as TopicQuarantineSocial SupportUnited StatesConceptsPain Management CollaboratoryCOVID-19 pandemicCOVID-19 infection statusClinical researchInfection statusPragmatic clinical trialsIntegrated care modelClinical trial participantsMilitary Health SystemFuture public health emergenciesClinical research teamPublic health emergencyPain managementNonpharmacological approachesPragmatic trialClinical trialsCare modelTrial participantsPain researchHealth departmentsThree-point scaleStudy participantsHealth systemHealth emergencyPeriod of quarantine