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 ResearchMeSH KeywordsAnalgesicsConsensusHumansPainPain ManagementPragmatic Clinical Trials as TopicResearch DesignConceptsPragmatic 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
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 ResearchMeSH KeywordsCOVID-19HumansMilitary PersonnelPain ManagementPandemicsPragmatic Clinical Trials as TopicResearch DesignVeteransConceptsPragmatic 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 pandemic
2020
Designing 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 investigatorsManagementStakeholder 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
2018
Testing implementation facilitation of a primary care-based collaborative care clinical program using a hybrid type III interrupted time series design: a study protocol
Midboe AM, Martino S, Krein SL, Frank JW, Painter JT, Chandler M, Schroeder A, Fenton BT, Troszak L, Erhardt T, Kerns RD, Becker WC. Testing implementation facilitation of a primary care-based collaborative care clinical program using a hybrid type III interrupted time series design: a study protocol. Implementation Science 2018, 13: 145. PMID: 30486877, PMCID: PMC6262952, DOI: 10.1186/s13012-018-0838-2.Peer-Reviewed Original ResearchMeSH KeywordsAnalgesics, OpioidCooperative BehaviorEvidence-Based PracticeHumansImplementation ScienceInservice TrainingInterrupted Time Series AnalysisPain ManagementPractice Patterns, Physicians'Primary Health CareProgram EvaluationResearch DesignUnited StatesUnited States Department of Veterans AffairsWork EngagementConceptsCollaborative care interventionVeterans Health AdministrationImplementation facilitationPrimary careCare interventionsHigh-dose opioid therapyMorphine equivalent daily doseVHA health care systemClinical programsImplementation facilitation strategyOutpatient opioid prescriptionsOpioid prescribing practicesPain management servicesCollaborative care programEquivalent daily dosePrimary care clinicsPrimary care providersRE-AIM frameworkInterrupted time seriesOpioid overdose crisisHealth care systemInterrupted time series designEligible patientsMedication taperingOpioid therapy
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
2014
Research 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
2010
Research design considerations for confirmatory chronic pain clinical trials: IMMPACT recommendations
Dworkin RH, Turk DC, Peirce-Sandner S, Baron R, Bellamy N, Burke LB, Chappell A, Chartier K, Cleeland CS, Costello A, Cowan P, Dimitrova R, Ellenberg S, Farrar JT, French JA, Gilron I, Hertz S, Jadad AR, Jay GW, Kalliomäki J, Katz NP, Kerns RD, Manning DC, McDermott MP, McGrath PJ, Narayana A, Porter L, Quessy S, Rappaport BA, Rauschkolb C, Reeve BB, Rhodes T, Sampaio C, Simpson DM, Stauffer JW, Stucki G, Tobias J, White RE, Witter J. Research design considerations for confirmatory chronic pain clinical trials: IMMPACT recommendations. Pain 2010, 149: 177-193. PMID: 20207481, DOI: 10.1016/j.pain.2010.02.018.Peer-Reviewed Original ResearchConceptsChronic pain clinical trialsPain clinical trialsClinical trialsPrimary efficacy analysisChronic pain trialsDemonstration of efficacyIMMPACT recommendationsResearch design considerationsAnalgesic effectPain trialsChronic painEfficacy analysisTypes of trialsConsensus meetingTreatment groupsNew interventionsTrue lackTrialsTrial phaseEfficacyMethodological weaknessesAssay sensitivityTreatmentSubstantial variabilityParticipant selection
2007
Interpreting the Clinical Importance of Treatment Outcomes in Chronic Pain Clinical Trials: IMMPACT Recommendations
Dworkin RH, Turk DC, Wyrwich KW, Beaton D, Cleeland CS, Farrar JT, Haythornthwaite JA, Jensen MP, Kerns RD, Ader DN, Brandenburg N, Burke LB, Cella D, Chandler J, Cowan P, Dimitrova R, Dionne R, Hertz S, Jadad AR, Katz NP, Kehlet H, Kramer LD, Manning DC, McCormick C, McDermott MP, McQuay HJ, Patel S, Porter L, Quessy S, Rappaport BA, Rauschkolb C, Revicki DA, Rothman M, Schmader KE, Stacey BR, Stauffer JW, von Stein T, White RE, Witter J, Zavisic S. Interpreting the Clinical Importance of Treatment Outcomes in Chronic Pain Clinical Trials: IMMPACT Recommendations. Journal Of Pain 2007, 9: 105-121. PMID: 18055266, DOI: 10.1016/j.jpain.2007.09.005.Peer-Reviewed Original ResearchMeSH KeywordsClinical Trials as TopicHumansPain ManagementPain MeasurementResearch DesignTreatment OutcomeConceptsChronic pain clinical trialsPain clinical trialsChronic pain treatmentClinical trialsSpecific outcome measuresClinical importanceTreatment outcomesOutcome measuresPain treatmentBrief Pain Inventory-InterferenceClinical trial outcome measuresPatient Global ImpressionChronic pain outcomesNumerical rating scaleTrial outcome measuresMultidimensional Pain InventoryPatient self-help organizationsBeck Depression InventoryIMMPACT recommendationsPain intensityPain outcomesPain InventoryChronic painPain assessmentGlobal Impression
2004
Assessing Sexual Function and Dyspareunia with the Female Sexual Function Index (FSFI) in Women with Vulvodynia
MASHEB RM, LOZANO-BLANCO C, KOHORN EI, MINKIN MJ, KERNS RD. Assessing Sexual Function and Dyspareunia with the Female Sexual Function Index (FSFI) in Women with Vulvodynia. Journal Of Sex & Marital Therapy 2004, 30: 315-324. PMID: 15672599, DOI: 10.1080/00926230490463264.Peer-Reviewed Original ResearchConceptsFemale Sexual Function IndexSexual Function IndexSexual functionFunction IndexFemale sexual arousal disorderOverall sexual functionSexual arousal disorderPatient sample dataInternal consistencySexual dysfunctionArousal disorderVulvodyniaLarge effect sizesScale scoreGreater painSexual intercourseWomenDyspareuniaEffect sizeDiscriminant validityPainDysfunction