2022
TIDieR-telehealth: precision in reporting of telehealth interventions used in clinical trials - unique considerations for the Template for the Intervention Description and Replication (TIDieR) checklist
Rhon DI, Fritz JM, Kerns RD, McGeary DD, Coleman BC, Farrokhi S, Burgess DJ, Goertz CM, Taylor SL, Hoffmann T. TIDieR-telehealth: precision in reporting of telehealth interventions used in clinical trials - unique considerations for the Template for the Intervention Description and Replication (TIDieR) checklist. BMC Medical Research Methodology 2022, 22: 161. PMID: 35655144, PMCID: PMC9161193, DOI: 10.1186/s12874-022-01640-7.Peer-Reviewed Original ResearchConceptsTelehealth interventionsReplication (TIDieR) checklistIntervention DescriptionMethodsA working groupPain Management CollaboratoryFuture clinical trialsRemote care deliveryClinical trialsCare deliveryHealth interventionsHealth systemPrimary investigatorHealth eventsIntervention guidelinesRelevant interventionsComplete reportingInterventionUnique considerationsTrialsChecklist developmentReporting guideChecklistWorking GroupPast yearReporting
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 ResearchConceptsPragmatic 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 ResearchConceptsPain 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 quarantineDevelopment and Implementation of the Military Treatment Facility Engagement Committee (MTFEC) to Support Pragmatic Clinical Trials in the Military Health System
Scarton DV, Roddy WT, Taylor JA, Geda M, Brandt CA, Peduzzi P, Kerns RD, Pasquina PF. Development and Implementation of the Military Treatment Facility Engagement Committee (MTFEC) to Support Pragmatic Clinical Trials in the Military Health System. Military Medicine 2021, 186: 70-75. PMID: 33499543, PMCID: PMC7980475, DOI: 10.1093/milmed/usaa368.Peer-Reviewed Original ResearchConceptsPain Management CollaboratoryPragmatic clinical trialsMilitary treatment facilitiesHealth care systemPain managementClinical trialsDOD health care systemVA health care systemCare systemChronic pain managementService membersTraumatic brain injuryMilitary Health SystemMilitary service membersChronic painNonpharmacological approachesBrain injuryLimb lossClinical practiceHealth systemCoordinating CenterTrialsVA programsNational InstituteDepartment of Defense
2020
Strategy for addressing research-site overlap in pragmatic clinical trials: lessons learned from the NIH-DOD-VA Pain Management Collaboratory (PMC)
Geda M, George SZ, Burgess DJ, Scarton DV, Roddy WT, Gordon KS, Pasquina PF, Brandt CA, Kerns RD, Peduzzi P. Strategy for addressing research-site overlap in pragmatic clinical trials: lessons learned from the NIH-DOD-VA Pain Management Collaboratory (PMC). Trials 2020, 21: 1021. PMID: 33308289, PMCID: PMC7731473, DOI: 10.1186/s13063-020-04941-8.Peer-Reviewed Original ResearchConceptsPain Management CollaboratoryPragmatic clinical trialsVA Medical CenterMilitary treatment facilitiesClinical trialsExclusion criteriaVeterans AffairsHealth care systemPain managementNonpharmacological approachesPragmatic trialMedical CenterEligibility criteriaTrial settingsTrial integrityCare systemNational InstituteTrialsRecruitment methodsRecruitment strategiesRecruitment planRecruitment sitesNIH-DOD-VA Pain Management Collaboratory: Pragmatic Clinical Trials of Nonpharmacological Approaches for Management of Pain and Co-occurring Conditions in Veteran and Military Health Systems: Introduction
Kerns RD, Brandt CA. NIH-DOD-VA Pain Management Collaboratory: Pragmatic Clinical Trials of Nonpharmacological Approaches for Management of Pain and Co-occurring Conditions in Veteran and Military Health Systems: Introduction. Pain Medicine 2020, 21: s1-s4. PMID: 33313722, DOI: 10.1093/pm/pnaa358.Peer-Reviewed Original ResearchStakeholder Engagement in Pragmatic Clinical Trials: Emphasizing Relationships to Improve Pain Management Delivery and Outcomes
Bastian LA, Cohen SP, Katsovich L, Becker WC, Brummett BR, Burgess DJ, Crunkhorn AE, Denneson LM, Frank JW, Goertz C, Ilfeld B, Kanzler KE, Krishnaswamy A, LaChappelle K, Martino S, Mattocks K, McGeary CA, Reznik TE, Rhon DI, Salsbury SA, Seal KH, Semiatin AM, Shin MH, Simon CB, Teyhen DS, Zamora K, Kerns RD, Collaboratory T. Stakeholder Engagement in Pragmatic Clinical Trials: Emphasizing Relationships to Improve Pain Management Delivery and Outcomes. Pain Medicine 2020, 21: s13-s20. PMID: 33313726, PMCID: PMC7824996, DOI: 10.1093/pm/pnaa333.Peer-Reviewed Original ResearchConceptsPragmatic clinical trialsPain Management CollaboratoryTarget treatment populationClinical trialsManagement of painPrimary care cliniciansHealth care teamCo-occurring conditionsMilitary service membersCare cliniciansNonpharmacological approachesPragmatic trialCare teamPain researchHealth system leadersTreatment populationTrial researchersCoordinating CenterHealth OrganizationTrialsService membersPainPrincipal investigatorManagement deliveryGroupAdapting to disruption of research during the COVID-19 pandemic while testing nonpharmacological approaches to pain management
Coleman BC, Kean J, Brandt CA, Peduzzi P, Kerns RD, . Adapting to disruption of research during the COVID-19 pandemic while testing nonpharmacological approaches to pain management. Translational Behavioral Medicine 2020, 10: 827-834. PMID: 32885815, PMCID: PMC7499692, DOI: 10.1093/tbm/ibaa074.Peer-Reviewed Original ResearchMeSH KeywordsBetacoronavirusChronic PainCommunicable Disease ControlCoronavirus InfectionsCOVID-19HumansMental HealthNational Institutes of Health (U.S.)Pain ManagementPandemicsPatient SelectionPneumonia, ViralResearchSARS-CoV-2Socioeconomic FactorsUnited StatesUnited States Department of Veterans AffairsConceptsPain Management CollaboratoryPragmatic clinical trialsChronic painCOVID-19 pandemicUrgent public health challengePain management interventionsClinical care teamPatient-reported measuresPublic health challengeVeterans Health SystemCOVID-19Pain managementNonpharmacological approachesStudy protocolClinical trialsCare teamIntervention deliveryHealth departmentsHealth outcomesHealth challengesHealth systemStudy designMental healthDisruption of researchParticipant recruitment