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 yearReportingIf you personalize it, will they use it?: Self-reported and observed use of a tailored, internet-based pain self-management program
Reuman L, Solar C, MacLean RR, Halat AM, Rajeevan H, Williams DA, Heapy AA, Bair MJ, Krein SL, Kerns RD, Higgins DM. If you personalize it, will they use it?: Self-reported and observed use of a tailored, internet-based pain self-management program. Translational Behavioral Medicine 2022, 12: 693-701. PMID: 35192703, PMCID: PMC9154266, DOI: 10.1093/tbm/ibab165.Peer-Reviewed Original ResearchEngaging 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
Justice 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 investigatorsManagement
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
A Randomized Pilot Trial of a Novel Behavioral Intervention for Chronic Pain Tailored to Individuals with HIV
Merlin JS, Westfall AO, Long D, Davies S, Saag M, Demonte W, Young S, Kerns RD, Bair MJ, Kertesz S, Turan JM, Kilgore M, Clay OJ, Starrels J, Pekmezi D, Johnson MO. A Randomized Pilot Trial of a Novel Behavioral Intervention for Chronic Pain Tailored to Individuals with HIV. AIDS And Behavior 2018, 22: 2733-2742. PMID: 29340913, PMCID: PMC6047927, DOI: 10.1007/s10461-018-2028-2.Peer-Reviewed Original ResearchConceptsChronic painPilot trialBrief Pain Inventory (BPI) total scorePain self-management interventionMedian session attendanceUsual care comparisonRandomized pilot trialSelf-management interventionsNovel behavioral interventionModerate painPain severityPreliminary efficacyIntervention groupSession attendanceCare comparisonsEligibility criteriaControl groupPainInterference ScaleBehavioral interventionsTrialsHIVPreliminary evidenceFull-scale trialEfficacy
2017
Cost-effectiveness of a chronic pain intervention for people living with HIV (PLWH)
Merlin JS, Westfall AO, Johnson MO, Kerns RD, Bair MJ, Kertesz S, Turan JM, Clay OJ, Starrels JL, Kilgore M. Cost-effectiveness of a chronic pain intervention for people living with HIV (PLWH). Journal Of Medical Economics 2017, 21: 122-126. PMID: 28880698, PMCID: PMC6028014, DOI: 10.1080/13696998.2017.1377719.Peer-Reviewed Original ResearchConceptsIncremental cost-effectiveness ratioCost/QALYChronic painPilot trialPreliminary efficacyPain self-management interventionChronic pain interventionsModerate chronic painHIV clinical settingsSelf-management interventionsCost-effectiveness ratioStandard gamble methodCostly comorbiditiesSTOMP interventionUsual carePain interventionsMean ageInclusion criteriaClinic perspectivePainClinical settingPilot studyTrialsPLWHHIV
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
2014
Using Multiple Daily Pain Ratings to Improve Reliability and Assay Sensitivity: How Many Is Enough?
Heapy A, Dziura J, Buta E, Goulet J, Kulas JF, Kerns RD. Using Multiple Daily Pain Ratings to Improve Reliability and Assay Sensitivity: How Many Is Enough? Journal Of Pain 2014, 15: 1360-1365. PMID: 25283469, DOI: 10.1016/j.jpain.2014.09.012.Peer-Reviewed Original ResearchConceptsPain intensity ratingsPain treatment trialsPain ratingsTreatment trialsIntensity ratingsDaily pain ratingsMedical Center patientsIMMPACT recommendationsBaseline measurement periodCenter patientsPain assessmentBland-Altman analysisClinical trialsSecondary data analysisDaily callsDaily ratingsTrialsMeaningful differencesAssay sensitivityMeasure reliabilityAdequate reliabilitySpecific recommendationsPatientsSmall subsetBaselineResearch designs for proof-of-concept chronic pain clinical trials: IMMPACT recommendations
Gewandter JS, Dworkin RH, Turk DC, McDermott MP, Baron R, Gastonguay MR, Gilron I, Katz NP, Mehta C, Raja SN, Senn S, Taylor C, Cowan P, Desjardins P, Dimitrova R, Dionne R, Farrar JT, Hewitt DJ, Iyengar S, Jay GW, Kalso E, Kerns RD, Leff R, Leong M, Petersen KL, Ravina BM, Rauschkolb C, Rice ASC, Rowbotham MC, Sampaio C, Sindrup S, Stauffer JW, Steigerwald I, Stewart J, Tobias J, Treede RD, Wallace M, White RE. Research designs for proof-of-concept chronic pain clinical trials: IMMPACT recommendations. Pain 2014, 155: 1683-1695. PMID: 24865794, PMCID: PMC4500524, DOI: 10.1016/j.pain.2014.05.025.Peer-Reviewed Original ResearchConceptsClinical trialsPain treatmentConfirmatory trialsPOC trialsChronic pain clinical trialsEfficacious pain treatmentsPain clinical trialsSingle-dose studyChronic pain treatmentConcept clinical trialPharmacokinetic-pharmacodynamic relationshipsSequential parallel comparison designIMMPACT recommendationsActive comparatorPatient populationConsensus meetingIneffective treatmentRapid onsetTrial designNovel treatmentsCrossover designTrial durationTrialsEnriched designStudy power