2023
Research objectives and general considerations for pragmatic clinical trials of pain treatments: IMMPACT statement
Hohenschurz-Schmidt D, Cherkin D, Rice A, Dworkin R, Turk D, McDermott M, Bair M, DeBar L, Edwards R, Farrar J, Kerns R, Markman J, Rowbotham M, Sherman K, Wasan A, Cowan P, Desjardins P, Ferguson M, Freeman R, Gewandter J, Gilron I, Grol-Prokopczyk H, Hertz S, Iyengar S, Kamp C, Karp B, Kleykamp B, Loeser J, Mackey S, Malamut R, McNicol E, Patel K, Sandbrink F, Schmader K, Simon L, Steiner D, Veasley C, Vollert J. Research objectives and general considerations for pragmatic clinical trials of pain treatments: IMMPACT statement. Pain 2023, 164: 1457-1472. PMID: 36943273, PMCID: PMC10281023, DOI: 10.1097/j.pain.0000000000002888.Peer-Reviewed Original ResearchConceptsPragmatic trialPain treatmentClinical careSystematic reviewAddiction Clinical Trial TranslationsNetworks (ACTTION) public-private partnershipTraditional efficacy trialsRoutine clinical careDaily clinical carePragmatic clinical trialsEvidence-based treatmentsRelated health policiesInternal validityPain assessmentClinical managementClinical trialsEfficacy trialsConsensus meetingTrial designConsensus discussionTrial objectivesSuch trialsHealth policyTrialsExpert presentations
2022
Intervention Fidelity in Pain Pragmatic Trials for Nonpharmacologic Pain Management: Nuanced Considerations for Determining PRECIS-2 Flexibility in Delivery and Adherence
Kerns R, Davis A, Fritz J, Keefe F, Peduzzi P, Rhon D, Taylor S, Vining R, Yu Q, Zeliadt S, George S. Intervention Fidelity in Pain Pragmatic Trials for Nonpharmacologic Pain Management: Nuanced Considerations for Determining PRECIS-2 Flexibility in Delivery and Adherence. Journal Of Pain 2022, 24: 568-574. PMID: 36574858, PMCID: PMC10079571, DOI: 10.1016/j.jpain.2022.12.008.Peer-Reviewed Original ResearchConceptsPragmatic clinical trialsDelivery of interventionsClinical trialsNonpharmacologic pain managementPain management strategiesRoutine clinical settingPain managementNonpharmacological treatmentsRoutine careNonpharmacological interventionsPragmatic trialIntervention core componentsProvider trainingReal-world settingClinical settingIntervention fidelityTreatment flexibilityTrialsInterventionTreatment effectsDegree of pragmatismImplementation barriersAdherenceIntervention monitoringDeliveryEngaging Veterans and Military Service Members to Optimize Pragmatic Clinical Trials of Nonpharmacological Approaches for Pain Management
Anicich A, Katsovich L, Kerns RD. Engaging Veterans and Military Service Members to Optimize Pragmatic Clinical Trials of Nonpharmacological Approaches for Pain Management. Pain Medicine 2022, 23: pnac020-. PMID: 35143672, PMCID: PMC9425849, DOI: 10.1093/pm/pnac020.Peer-Reviewed Original Research
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 quarantineJustice and equity in pragmatic clinical trials: Considerations for pain research within integrated health systems
Ali J, Davis AF, Burgess DJ, Rhon DI, Vining R, Young‐McCaughan S, Green S, Kerns RD. Justice and equity in pragmatic clinical trials: Considerations for pain research within integrated health systems. Learning Health Systems 2021, 6: e10291. PMID: 35434355, PMCID: PMC9006531, DOI: 10.1002/lrh2.10291.Peer-Reviewed Original ResearchPragmatic clinical trialsPain management researchIntegrated health systemCo-occurring conditionsHealth systemClinical trialsEvidence-based therapiesClinical Trials NetworkVeterans Health SystemMultidisciplinary working groupPain researchEquitable careStudy settingTrials NetworkHealth inequitiesHealth equityEquitable healthcareHealthcare deliveryPainTrialsWorking GroupRelevant literaturePatientsGroupTherapyDevelopment 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 DefenseThe ACTTION Guide to Clinical Trials of Pain Treatments, part II: mitigating bias, maximizing value
Dworkin RH, Kerns RD, McDermott MP, Turk DC, Veasley C. The ACTTION Guide to Clinical Trials of Pain Treatments, part II: mitigating bias, maximizing value. PAIN Reports 2021, 6: e886. PMID: 33521484, PMCID: PMC7838005, DOI: 10.1097/pr9.0000000000000886.Peer-Reviewed Original Research
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 sitesStakeholder 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 deliveryGroupNIH-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 ResearchDesigning Trials with Purpose: Pragmatic Clinical Trials of Nonpharmacological Approaches for Pain Management
Gordon KS, Peduzzi P, Kerns RD. Designing Trials with Purpose: Pragmatic Clinical Trials of Nonpharmacological Approaches for Pain Management. Pain Medicine 2020, 21: s7-s12. PMID: 33313727, PMCID: PMC7825099, DOI: 10.1093/pm/pnaa347.Peer-Reviewed Original ResearchConceptsPragmatic clinical trialsPatient-centered outcomesPain managementNonpharmacological approachesPRECIS-2 domainsClinical trialsFuture pragmatic clinical trialsImportant patient-centered outcomesPragmatic-Explanatory Continuum Indicator SummaryNonpharmacological pain managementPain care planManagement of painCommon co-occurring conditionsRoutine clinical practiceCo-occurring conditionsDesigning TrialsUsual careCare plansClinical practiceSignificant causeTrialsPainOutcomesFuture investigatorsManagementAdapting 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