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 monitoringDeliveryTIDieR-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 yearReportingEngaging 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 ResearchPartnering with patients in clinical trials of pain treatments: a narrative review
Holzer KJ, Veasley C, Kerns RD, Edwards RR, Gewandter JS, Langford DJ, Yaeger LH, McNicol E, Ferguson M, Turk DC, Dworkin RH, Haroutounian S. Partnering with patients in clinical trials of pain treatments: a narrative review. Pain 2022, 163: 1862-1873. PMID: 35297799, DOI: 10.1097/j.pain.0000000000002600.Peer-Reviewed Original ResearchConceptsPain treatmentClinical trialsPatient engagementNarrative reviewClinical researchPatient-centered clinical researchPain research studiesPain-related studiesMeaningful patient engagementClinical studiesPatient recruitmentPatient partnersPatientsTrialsTreatmentCurrent evaluationReviewSpecific guidance
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 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 deliveryGroupDesigning 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
2019
Considerations of trial design and conduct in behavioral interventions for the management of chronic pain in adults
Edmond SN, Turk DC, Williams DA, Kerns RD. Considerations of trial design and conduct in behavioral interventions for the management of chronic pain in adults. PAIN Reports 2019, Publish Ahead of Print: &na;. PMID: 31583335, PMCID: PMC6749925, DOI: 10.1097/pr9.0000000000000655.Peer-Reviewed Original ResearchChronic painClinical trialsQuality of lifeLarge-scale trialsLeast modest evidenceNonpharmacological approachesPharmacological trialsClinical utilityHigh-quality researchTrial designPainMedical interventionsIntervention fidelityBehavioral interventionsTrialsBehavioral approachIntervention developmentEmotional functioningAdaptive behavioural changesAppropriate outcomesBehavioral changesInterventionModest evidencePrimary objectiveResearch design considerations
2018
An evaluation of the feasibility, acceptability, and preliminary efficacy of cognitive-behavioral therapy for opioid use disorder and chronic pain
Barry DT, Beitel M, Cutter CJ, Fiellin DA, Kerns RD, Moore BA, Oberleitner L, Madden LM, Liong C, Ginn J, Schottenfeld RS. An evaluation of the feasibility, acceptability, and preliminary efficacy of cognitive-behavioral therapy for opioid use disorder and chronic pain. Drug And Alcohol Dependence 2018, 194: 460-467. PMID: 30508769, PMCID: PMC6312460, DOI: 10.1016/j.drugalcdep.2018.10.015.Peer-Reviewed Original ResearchConceptsOpioid use disorderCognitive behavioral therapyChronic painPreliminary efficacyDrug counselingUse disordersImproved pain outcomesProportion of patientsMethadone-maintained patientsNonmedical opioid useEnd of treatmentPrimary study aimPatient satisfaction ratingsManualized cognitive behavioral therapyOpioid usePain outcomesPain interferenceClinical trialsStandard drug counselingPatientsMean sessionSecondary aimStudy aimPainPilot study
2017
Taking ACTION to reduce pain: ACTION study rationale, design and protocol of a randomized trial of a proactive telephone-based coaching intervention for chronic musculoskeletal pain among African Americans
Bhimani RH, Cross LJ, Taylor BC, Meis LA, Fu SS, Allen KD, Krein SL, Do T, Kerns RD, Burgess DJ. Taking ACTION to reduce pain: ACTION study rationale, design and protocol of a randomized trial of a proactive telephone-based coaching intervention for chronic musculoskeletal pain among African Americans. BMC Musculoskeletal Disorders 2017, 18: 15. PMID: 28086853, PMCID: PMC5237146, DOI: 10.1186/s12891-016-1363-6.Peer-Reviewed Original ResearchConceptsChronic musculoskeletal painMusculoskeletal painTreatment outcomesHealth care service utilizationMorris Disability QuestionnairePain outcome measuresPain treatment outcomesTelephone counseling sessionsAfrican American patientsAfrican AmericansPrimary aimUsual careDisability QuestionnaireOpioid analgesicsPain outcomesPain treatmentPrimary outcomeChronic painPain assessmentTreat methodologyAmerican patientsClinical trialsPhysical functioningService utilizationOutcome measures
2016
Research design considerations for single-dose analgesic clinical trials in acute pain
Cooper SA, Desjardins PJ, Turk DC, Dworkin RH, Katz NP, Kehlet H, Ballantyne JC, Burke LB, Carragee E, Cowan P, Croll S, Dionne RA, Farrar JT, Gilron I, Gordon DB, Iyengar S, Jay GW, Kalso EA, Kerns RD, McDermott MP, Raja SN, Rappaport BA, Rauschkolb C, Royal MA, Segerdahl M, Stauffer JW, Todd KH, Vanhove GF, Wallace MS, West C, White RE, Wu C. Research design considerations for single-dose analgesic clinical trials in acute pain. Pain 2016, 157: 288-301. PMID: 26683233, DOI: 10.1097/j.pain.0000000000000375.Peer-Reviewed Original ResearchConceptsClinical trialsEarly phase clinical trialsAcute pain studiesAcute pain trialsPain clinical trialsAnalgesic clinical trialsPhase clinical trialsShort-duration trialsPostoperative painAcute painPain trialsPain assessmentStudy design factorsPain studiesDental impactionStudy designTrialsPainAssessment measuresResearch design considerationsPlaceboSurgeryBunionectomyDifferent settings
2015
Deficiencies in reporting of statistical methodology in recent randomized trials of nonpharmacologic pain treatments: ACTTION systematic review
Dworkin JD, McKeown A, Farrar JT, Gilron I, Hunsinger M, Kerns RD, McDermott MP, Rappaport BA, Turk DC, Dworkin RH, Gewandter JS. Deficiencies in reporting of statistical methodology in recent randomized trials of nonpharmacologic pain treatments: ACTTION systematic review. Journal Of Clinical Epidemiology 2015, 72: 56-65. PMID: 26597977, DOI: 10.1016/j.jclinepi.2015.10.019.Peer-Reviewed Original ResearchConceptsRandomized clinical trialsPain treatmentPrimary analysisSystematic reviewNonpharmacologic pain treatmentsRecent randomized trialsJournal of PainQuality of reportingHalf of studiesClinical trial publicationsPercent of studiesNoninterventional trialStatistical methodsPrimary outcomeRandomized trialsClinical trialsTrial publicationsPainTrial resultsTrialsStatistical methodologyTreatmentReviewDeficiencyReporting