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
The Moderating Effect of Obesity on Cognitive–Behavioral Pain Treatment Outcomes
Sellinger JJ, Clark EA, Shulman M, Rosenberger PH, Heapy AA, Kerns RD. The Moderating Effect of Obesity on Cognitive–Behavioral Pain Treatment Outcomes. Pain Medicine 2010, 11: 1381-1390. PMID: 20735748, DOI: 10.1111/j.1526-4637.2010.00935.x.Peer-Reviewed Original ResearchConceptsBody mass indexNon-obese participantsPain treatment outcomesMass indexTreatment outcomesSF-36Roland-Morris Disability QuestionnaireChronic low back painAverage body mass indexLow back pain outcomesPain treatment interventionsVeterans SF-36Morris Disability QuestionnaireNon-obese groupAverage pain intensityBack pain outcomesLow back painNumerical rating scaleRole of BMIMeasures of disabilityBeck Depression InventoryDisability QuestionnairePain treatmentBack painPain conditionsResearch 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 ImpressionSystematic review: opioid treatment for chronic back pain: prevalence, efficacy, and association with addiction.
Martell BA, O'Connor PG, Kerns RD, Becker WC, Morales KH, Kosten TR, Fiellin DA. Systematic review: opioid treatment for chronic back pain: prevalence, efficacy, and association with addiction. Annals Of Internal Medicine 2007, 146: 116-27. PMID: 17227935, DOI: 10.7326/0003-4819-146-2-200701160-00006.Peer-Reviewed Original ResearchMeSH KeywordsAnalgesics, OpioidChronic DiseaseClinical Trials as TopicDrug PrescriptionsHumansLow Back PainPrevalenceSubstance-Related DisordersUnited StatesConceptsChronic back painSubstance use disordersEfficacy of opioidsBack painMedication-taking behaviorUse disordersOpioid treatmentOpioid medicationsStudy qualityShort-term pain reliefCurrent substance use disorderCochrane Central RegisterLifetime substance use disorderControlled Clinical TrialsLong-term efficacyPoor study qualityEnglish-language studiesTransdermal opioidsOpioid prescribingPain reliefCentral RegisterDifferent opioidsReduced painClinical trialsNonsignificant reduction
2006
Developing patient-reported outcome measures for pain clinical trials: IMMPACT recommendations
Turk DC, Dworkin RH, Burke LB, Gershon R, Rothman M, Scott J, Allen RR, Atkinson J, Chandler J, Cleeland C, Cowan P, Dimitrova R, Dionne R, Farrar JT, Haythornthwaite JA, Hertz S, Jadad AR, Jensen MP, Kellstein D, Kerns RD, Manning DC, Martin S, Max MB, McDermott MP, McGrath P, Moulin DE, Nurmikko T, Quessy S, Raja S, Rappaport BA, Rauschkolb C, Robinson JP, Royal MA, Simon L, Stauffer JW, Stucki G, Tollett J, von Stein T, Wallace MS, Wernicke J, White RE, Williams AC, Witter J, Wyrwich KW. Developing patient-reported outcome measures for pain clinical trials: IMMPACT recommendations. Pain 2006, 125: 208-215. PMID: 17069973, DOI: 10.1016/j.pain.2006.09.028.Peer-Reviewed Original Research
2005
Core outcome measures for chronic pain clinical trials: IMMPACT recommendations
Dworkin RH, Turk DC, Farrar JT, Haythornthwaite JA, Jensen MP, Katz NP, Kerns RD, Stucki G, Allen RR, Bellamy N, Carr DB, Chandler J, Cowan P, Dionne R, Galer BS, Hertz S, Jadad AR, Kramer LD, Manning DC, Martin S, McCormick CG, McDermott MP, McGrath P, Quessy S, Rappaport BA, Robbins W, Robinson JP, Rothman M, Royal MA, Simon L, Stauffer JW, Stein W, Tollett J, Wernicke J, Witter J. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain 2005, 113: 9-19. PMID: 15621359, DOI: 10.1016/j.pain.2004.09.012.Peer-Reviewed Original Research