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 monitoringDelivery
2021
Assessing 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 quarantine
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 deliveryGroup