Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks

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1. 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, Kalliomaki J, Katz NP, Kerns RD, Manning DC, McDermott MP, McGrath P, Narayana A, Porter L, Quessy S, Rappaport BA, Rauschkolb C, Reeve B, 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.
2. Dworkin RH, Turk DC, Peirce-Sandner S, McDermott MP, Farrar JT, Hertz S, Katz NP, Raja SN, Rappaport BA. Placebo and treatment group responses in postherpetic neuralgia vs. painful diabetic peripheral neuropathy clinical trials in the REPORT database. Pain, 2010;150:12-16.
3. Rappaport BA, Cerny I, Sanhai WR. ACTION on the prevention of chronic pain after surgery. Anesthesiology, 2010;112:509-510.
4. Dworkin RH, Peirce-Sandner S, Turk DC, McDermott MP, Gibofsky A, Simon LS, Farrar JT, Katz NP. Outcome measures in placebo-controlled trials of osteoarthritis: responsiveness to treatment effects in the REPORT database. Osteoarthritis and Cartilage, 2011;19:483-492. (Corrigendum: Osteoarthritis and Cartilage, 2011;19:919).
5. Dworkin RH, Turk DC. Accelerating the development of improved analgesic treatments: the ACTION public-private partnership. Pain Medicine, 2011;12:S109-S117.
6. Dworkin RH, Turk DC, Katz NP, Rowbotham MC, Peirce-Sandner S, Cerny I, Clingman CS, Eloff BC, Farrar JT, Kamp C, McDermott MP, Rappaport BA, Sanhai WR. Evidence-based clinical trial design for chronic pain pharmacotherapy: a blueprint for ACTION. Pain, 2011;152(suppl):S107-S115.
7. Comer SD, Zacny JP, Dworkin RH, Turk DC, Bigelow GE, Foltin RW, Jasinski DR, Sellers EM, Adams EH, Balster R, Burke LB, Cerny I, Colucci RD, Cone E, Cowan P, Farrar JT, Haddox JD, Haythornthwaite JA, Hertz S, Jay GW, Johanson CE, Junor R, Katz NP, Klein M, Kopecky EA, Leiderman DB, McDermott MP, O'Brien C, O'Connor AB, Palmer PP, Raja SN, Rappaport BA, Rauschkolb C, Rowbotham MC, Sampaio C, Setnick B, Sokolowska M, Stauffer JW, Walsh SL. Core outcome measures for opioid abuse liability laboratory assessment studies in humans: IMMPACT recommendations. Pain, 2012;153:2315-2324.
8. Dworkin RH, Turk DC, Peirce-Sandner S, Burke LB, Farrar JT, Gilron I, Jensen MP, Katz NP, Raja SN, Rappaport BA, Rowbotham MC, Backonja MM, Baron R, Bellamy N, Bhagwagar Z, Costello A, Cowan P, Fang WC, Hertz S, Jay GW, Junor R, Kerns RD, Kerwin R, Kopecky EA, Lissin D, Malamut R, Markman JD, McDermott MP, Munera C, Porter L, Rauschkolb C, Rice ASC, Sampaio C, Skljarevski V, Sommerville K, Stacey B, Steigerwald I, Tobias J, Trentacosti AM, Wasan AD, Wells GA, Williams J, Witter J, Ziegler D. Considerations for improving assay sensitivity in chronic pain clinical trials: IMMPACT recommendations. Pain, 2012;153:1148-1158.
9. Greene K, Dworkin RH, Rowbotham MC. A snapshot and scorecard for analgesic clinical trials for chronic pain: the RReACT database. Pain, 2012;153:1794-1797.
10. Smith SM, Chang RD, Pereira A, Shah N, Gilron I, Katz NP, Lin AH, McDermott MP, Rappaport BA, Rowbotham MC, Sampaio C, Turk DC, Dworkin RH. Adherence to CONSORT harms reporting recommendations in publications of recent analgesic clinical trials: an ACTTION systematic review. Pain, 2012;153:2415-2421.
11. Turk DC, O’Connor AB, Dworkin RH, Chaudhry A, Katz NP, Adams EH, Brownstein JS, Comer SD, Dart R, Dasgupta N, Denisco RA, Klein M, Leiderman DB, Lubran R, Rappaport BA, Zacny JP, Ahdieh H, Burke LB, Cowan P, Jacobs P, Malamut R, Markman J, Michna E, Palmer P, Peirce-Sandner S, Potter JS, Raja SN, Rauschkolb C, Roland CL, Webster LR, Weiss RD, Wolf K. Research design considerations for clinical studies of abuse-deterrent opioid analgesics: IMMPACT recommendations. Pain, 2012;153:1997-2008.
12. Dworkin RH, Allen R, Kopko S, Lu Y, Turk DC, Burke LB, Desjardins P, Etropolski M, Hewitt DJ, Jayawardena S, Lin AH, Malamut R, Michel D, Ottinger J, Peloso P, Pucino F, Rappaport BA, Skljarevski V, St. Peter D, Timinski S, West CR, Wilson HD. A standard database format for clinical trials of pain treatments: an ACTTION–CDISC initiative. Pain, 2013;154:11-14.
13. Dworkin RH, Turk DC, Peirce-Sandner S, He H, McDermott MP, Farrar JT, Katz NP, Lin AH, Rappaport BA, Rowbotham MC. Assay sensitivity and study characteristics in neuropathic pain trials: an ACTTION meta-analysis. Neurology, 2013;81:1-9.
14. O'Connor AB, Turk DC, Dworkin RH, Katz NP, Colucci R, Haythornthwaite JA, Klein M, O'Brien C, Posner K, Rappaport BA, Reisfield G, Adams EH, Balster RL, Bigelow GE, Burke LB, Comer SD, Cone E, Cowan P, Denisco RA, Farrar JT, Foltin RW, Haddox JD, Hertz S, Jay GW, Junor R, Kopecky EA, Leiderman DB, McDermott MP, Palmer PP, Raja SN, Rauschkolb C, Rowbotham MC, Sampaio C, Setnick B, Smith SM, Sokolowska M, Stauffer JW, Walsh SL, Zacny JP. Abuse liability measures for use in analgesic clinical trials in patients with pain: IMMPACT recommendations. Pain, 2013;154:2324-2334.
15. Smith SM, Dart RC, Katz NP, Paillard F, Adams EH, Comer SD, Degroot A, Edwards RR, Haddox JD, Jaffe JH, Jones CM, Kleber HD, Kopecky EA, Markman JD, Montoya ID, O'Brien C, Roland CL, Stanton M, Strain EC, Vorsanger G, Wasan AD, Weiss RD, Turk DC, Dworkin RH. Classification and definition of misuse, abuse, and related events in clinical trials: ACTTION systematic review and recommendations. Pain, 2013;154:2287-2296.
16. Smith SM, Wang AT, Katz NP, McDermott MP, Burke LB, Coplan P, Gilron I, Hertz SH, Lin AH, Rappaport BA, Rowbotham MC, Sampaio C, Sweeney M, Turk DC, Dworkin RH. Adverse event assessment, analysis, and reporting in recent published analgesic clinical trials: ACTTION systematic review and recommendations. Pain, 2013;154:997-1008.
17. Smith SM, Wang AT, Pereira A, Chang RD, McKeown A, Greene K, Rowbotham MC, Burke LB, Coplan P, Gilron I, Hertz SH, Katz NP, Lin AH, McDermott MP, Papadopoulos EJ, Rappaport BA, Sweeney M, Turk DC, Dworkin RH. Discrepancies between registered and published primary outcome specifications in analgesic trials: ACTTION systematic review and recommendations. Pain, 2013;154:2769-2774.
18. Dufka FL, Dworkin RH, Rowbotham MC. How transparent are migraine clinical trials? Repository of Registered Migraine Trials (RReMIT). Neurology, 2014;83:1372-1381.
19. Dworkin RH, Turk DC, Peirce-Sandner S, He H, McDermott MP, Hochberg MC, Jordan JM, Katz NP, Lin AH, Neogi T, Rappaport BA, Simon LS, Strand V. Meta-analysis of assay sensitivity and study features in clinical trials of pharmacologic treatments for osteoarthritis pain. Arthritis and Rheumatology, 2014;66:3327-3336.
20. Farrar JT, Troxel AB, Haynes K, Gilron I, Kerns RD, Katz NP, Rappaport BA, Rowbotham MC, Turk DC, Dworkin RH. The effect of variability in the 7 day baseline pain diary on the assay sensitivity of neuropathic pain randomized clinical trials: an ACTTION study. Pain, 2014;155:1622-1631.
21. Fillingim RB, Bruehl S, Dworkin RH, Dworkin SF, Loeser JD, Turk DC, Widerstrom-Noga E, Arnold L, Bennett R, Edwards RR, Freeman R, Gewandter J, Hertz S, Hochberg M, Krane E, Mantyh PW, Markman J, Neogi T, Ohrbach R, Paice JA, Porreca F, Rappaport BA, Smith SM, Smith TJ, Sullivan MD, Verne GN, Wasan AD, Wesselmann U. The ACTTION-American Pain Society Pain Taxonomy (AAPT): an evidence-based and multidimensional approach to classifying chronic pain conditions. Journal of Pain, 2014;15:241-249.
22. Fillingim R, Dworkin RH, Turk DC. The ACTTION-APS Pain Taxonomy initiative: response to Henriques et al. Journal of Pain, 2014;15:1201-1202.
23. Gewandter JS, Dworkin RH, Turk DC, McDermott MP, Baron R, Gastonguay M, 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 RL, Leong M, Petersen KL, Ravina BM, Rauschkolb C, Rice ASC, Rowbotham MC, Sampaio C, Sindrup SH, Stauffer JW, Steigerwald I, Stewart J, Tobias J, Treede RD, Wallace M, White RE. Research design considerations for proof-of-concept chronic pain clinical trials: IMMPACT recommendations. Pain, 2014;155:1683-1695.
24. Gewandter JS, McDermott MP, McKeown A, Smith SM, Pawlowski JR, Poli JP, Rothstein D, Williams MR, Bujanover S, Farrar JT, Gilron I, Katz NP, Rowbotham MC, Turk DC, Dworkin RH. Reporting of intention-to-treat analyses in recent analgesic clinical trials: ACTTION systematic review and recommendations. Pain, 2014;155:2714-2719.
25. Gewandter JS, McDermott MP, McKeown A, Smith SM, Williams MR, Hunsinger M, Farrar JT, Turk DC, Dworkin RH. Reporting of missing data and methods used to accommodate them in recent analgesic clinical trials: ACTTION systematic review and recommendations. Pain, 2014;155:1871-1877.
26. Gewandter JS, Smith SM, McKeown A, Burke LB, Hertz SH, Hunsinger M, Katz NP, Lin AH, McDermott MP, Rappaport BA, Williams MR, Turk DC, Dworkin RH. Reporting of primary analyses and multiplicity adjustment in recent analgesic clinical trials: ACTTION systematic review and recommendations. Pain, 2014;155:461-466.
27. Hunsinger M, Smith SM, McKeown A, Parkhurst M, Gross RA, Lin AH, McDermott MP, Rappaport BA, Turk DC, Dworkin RH. Disclosure of authorship contributions in analgesic clinical trials and related publications: ACTTION systematic review and recommendations. Pain, 2014;155:1059-1063.
28. Hunsinger M, Smith SM, Rothstein D, McKeown A, Parkhurst M, Hertz S, Katz NP, Lin AH, McDermott MP, Rappaport BA, Turk DC, Dworkin RH. Adverse event reporting in non-pharmacologic, non-interventional pain clinical trials: ACTTION systematic review. Pain, 2014;155:2253-2262.
29. Munch M, Dufka FL, Greene K, Smith SM, Dworkin RH, Rowbotham MC. RReACT goes global: perils and pitfalls of constructing a global open-access database of registered analgesic clinical trials and trial results. Pain, 2014;155:1313-1317.
30. Dufka FL, Munch T, Dworkin RH, Rowbotham MC. Results availability for analgesic device, complex regional pain syndrome, and post-stroke pain trials: comparing the RReADS, RReACT and RReMiT databases. Pain, 2015;156:72-80.
31. Gewandter JS, Dworkin RH, Turk DC, Farrar JT, Fillingim RB, Gilron I, Markman JD, Oaklander AL, Polydefkis MJ, Raja SN, Robinson JP, Woolf CJ, Ziegler D, Ashburn MA, Burke LB, Cowan P, George SZ, Goli V, Graff OX, Iyengar S, Jay GW, Katz J, Kehlet H, Kitt RA, Kopecky EA, Malamut R, McDermott MP, Palmer P, Rappaport BA, Rauschkolb C, Steigerwald I, Tobias J, Walco GA. Research designs considerations for chronic pain prevention clinical trials: IMMPACT recommendations. Pain, 2015;156:1184-1197.
32. Gewandter JS, McKeown A, McDermott MP, Dworkin JD, Smith SM, Gross RA, Hunsinger M, Lin AH, Rappaport BA, Rice ASC, Rowbotham MC, Williams MR, Turk DC, Dworkin RH. Data interpretation in analgesic clinical trials with statistically nonsignificant primary analyses: An ACTTION systematic review. Journal of Pain, 2015;16:3-10.
33. Gewandter JS, Smith SM, McKeown A, Edwards K, Narula A, Pawlowski JR, Rothstein D, Desjardins PJ, Dworkin SF, Gross RA, Ohrbach R, Rappaport BA, Sessle BJ, Turk DC, Dworkin RH. Reporting of adverse events and statistical details of efficacy estimates in randomized clinical trials of pain in temporomandibular disorders: Analgesic, Anesthetic, and Addiction Clinical Trial, Translations, Innovations, Opportunities and Networks systematic review. Journal of the American Dental Assocation, 2015;146:246-254.
34. McKeown A, Gewandter JS, McDermott MP, Pawlowski JR, Poli JJ, Rothstein D, Farrar JT, Gilron I, Katz NP, Lin AH, Rappaport BA, Rowbotham MC, Turk DC, Dworkin RH, Smith SM. Reporting of sample size calculations in analgesic clinical trials: ACTTION systematic review. Journal of Pain, 2015;16:199-206.
35. O’Connor AB, Turk DC, Dworkin RH. Abuse liability: study the intended patient populations. Nature Reviews Neurology, 2015;doi:10.1038/nrneurol.2014.16-c1. (Letter)
36. Singla N, Hunsinger M, Chang PD, McDermott MP, Chowdhry AK, Desjardins PJ, Turk DC, Dworkin RH. Assay sensitivity of pain intensity versus pain relief in acute pain clinical trials: ACTTION systematic review and meta-analysis. Journal of Pain, 2015;16:683-691.
37. Smith SM, Hunsinger M, McKeown A, Parkhurst M, Allen R, Kopko S, Lu Y, Wilson HD, Burke LB, Desjardins P, McDermott MP, Rappaport BA, Turk DC, Dworkin RH. Quality of pain intensity assessment reporting: ACTTION systematic review and recommendations. Journal of Pain, 2015;16:299-305.
38. Smith SM, Paillard F, McKeown A, Burke LB, Edwards RR, Katz NP, Papadopoulos EJ, Rappaport BA, Slagle A, Strain EC, Wasan AJ, Turk DC, Dworkin RH. Instruments to identify abuse potential of prescription medications in clinical trials: ACTTION systematic review. Journal of Pain, 2015;16:389-411.
39. Andrews NA, Latremoliere A, Basbaum AI, Mogil JS, Porreca F, Rice ASC, Woolf CJ, Currie GL, Dworkin RH, Eisenach JC, Evans S, Gewandter JS, Gover TD, Handwerker H, Huang W, Iyengar S, Jensen MP, Kennedy JD, Lee N, Levine J, Lidster K, Machin I, McDermott MP, McMahon SB, Price TJ, Ross SE, Scherrer G, Seal RP, Sena ES, Silva E, Stone L, Svensson CI, Turk DC, Whiteside G. Ensuring transparency and minimization of methodologic bias in preclinical pain research: PPRECISE considerations. Pain, 2016;157:901-909.
40. Bruehl S, Ohrbach R, Sharma S, Widerstrom-Noga E, Dworkin RH, Fillingim RB, Turk DC. Approaches to demonstrating the reliability and validity of core diagnostic criteria for chronic pain. Journal of Pain, 2016;17(suppl 2):T118-131.
41. Chowdhry AK, Dworkin RH, McDermott MP. Meta-analysis with missing study-level sample variance data. Statistics in Medicine, 2016;35:3021-3032.
42. 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: IMMPACT recommendations. Pain, 2016;157:288-301.
43. 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 non-pharmacologic pain treatments: ACTTION systematic review. Journal of Clinical Epidemiology, 2016;72:56-65.
44. Dworkin RH, Bruehl S, Fillingim RB, Loeser JD, Terman GW, Turk DC. Multidimensional diagnostic criteria for chronic pain: introduction to the ACTTION-American Pain Society Pain Taxonomy (AAPT). Journal of Pain, 2016;17(suppl 2):T1-T9.
45. Edwards RR, Dworkin RH, Sullivan MD, Turk DC, Wasan AD. The role of psychosocial processes in the development and maintenance of chronic pain. Journal of Pain, 2016;17(suppl 2):T70-T92.
46. Edwards RR, Dworkin RH, Turk DC, Angst MS, Dionne R, Freeman R, Hansson P, Haroutounian S, Arendt-Nielsen L, Attal N, Baron R, Brell J, Bujanover S, Burke LB, Carr D, Chappell AS, Cowan P, Etropolski M, Fillingim RB, Gewandter JS, Katz NP, Kopecky EA, Markman JD, Nomikos G, Porter L, Rappaport BA, Rice ASC, Scavone JM, Scholz J, Simon LS, Smith SM, Tobias J, Tockarshewsky T, Veasley C, Versavel M, Wasan AD, Wen W, Yarnitsky D. Patient phenotyping in clinical trials of chronic pain treatments: IMMPACT recommendations. Pain, 2016;157:1851-1871.
47. Fillingim RB, Loeser JD, Baron R, Edwards RR. Assessment of chronic pain: domains, methods, and mechanisms. Journal of Pain, 2016;17(suppl 2):T10-T20.
48. Gewandter JS, McDermott MP, McKeown A, Hoang K, Iwan K, Kralovic S, Rothstein D, Gilron I, Katz NP, Raja SN, Senn S, Smith SM, Turk DC, Dworkin RH. Reporting of cross-over clinical trials of analgesic treatments for chronic pain: Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks systematic review and recommendations. Pain, 2016;157:2544-2551.
49. Kiluk BD, Carroll KM, Duhig A, Falk DE, Kampman K, Lai S, Litten RZ, McCann DJ, Montoya ID, Preston KL, Skolnick P, Weisner C, Woody G, Chandler R, Detke MJ, Dunn K, Dworkin RH, Fertig J, Gewandter J, Moeller FG, Ramey T, Ryan M, Silverman K, Strain EC. Measures of outcome for stimulant trials: ACTTION recommendations and research agenda. Drug and Alcohol Dependence, 2016;158:1-7.
50. Maixner W, Fillingim RB, Williams DA, Smith SB, Slade GD. Chronic overlapping pain conditions: implications for diagnosis and classification. Journal of Pain, 2016;17(suppl 2):T93-107.
51. Smith SM, Amtmann A, Askew RL, Gewandter JS, Hunsinger M, Jensen MP, McDermott MP, Patel KV, Williams M, Bacci ED, Burke LB, Chambers CT, Cooper SA, Cowan P, Desjardins P, Etropolski M, Farrar JT, Gilron I, Huang I, Katz M, Kerns RD, Kopecky EA, Rappaport BA, Resnick M, Strand V, Vanhove GF, Veasley C, Versavel M, Wasan AD, Turk DC, Dworkin RH. Pain intensity rating training: results from an exploratory study of the ACTTION PROTECCT system. Pain, 2016:157:1056-1064.
52. Smith SM, Gewandter JS, Kitt RA, Markman JD, Vaughan JA, Cowan P, Kopecky EA, Malamut R, Sadosky A, Tive L, Turk DC, Dworkin RH. Participant preferences for pharmacologic chronic pain treatment trial characteristics: an ACTTION adaptive choice-based conjoint study. Journal of Pain, 2016;17:1198-1206.
53. Taylor AM, Phillips K, Patel KV, Turk DC, Dworkin RH, Beaton D, Clauw DJ, Gignac MAM, Markman JD, Williams DA, Bujanover S, Burke LB, Carr DB, Choy EH, Conaghan PG, Cowan P, Farrar JT, Freeman R, Gewandter J, Gilron I, Goli V, Gover TD, Haddox JD, Kerns RD, Kopecky EA, Lee DA, Malamut R, Mease P, Rappaport BA, Simon LS, Singh JA, Smith SM, Strand V, Tugwell P, Vanhove GF, Veasley C, Walco GA, Wasan AD, Witter J. Assessment of physical function and participation in chronic pain clinical trials: IMMPACT/OMERACT recommendations. Pain, 2016;157:1836-1850.
54. Turk DC, Fillingim RB, Ohrbach R, Patel KV. Assessment of psychosocial and functional impact of chronic pain. Journal of Pain, 2016;17(suppl 2):T21-T49.
55. Vardeh D, Mannion RJ, Woolf CJ. Toward a mechanism-based approach to pain diagnosis. Journal of Pain, 2016;17(suppl 2):T50-T69.
56. Walco GA, Krane EJ, Schmader KE, Weiner DK. Applying a lifespan developmental perspective to chronic pain: pediatrics to geriatrics. Journal of Pain, 2016;17(suppl 2):T108-T117.
57. Williams MR, McKeown A, Dexter F, Miner JR, Sessler DI, Vargo J, Turk DC, Dworkin RH. Efficacy outcome measures for procedural sedation clinical trials in adults: an ACTTION systematic review. Anesthesia & Analgesia, 2016;122:152-170.
58. Williams MR, McKeown A, Pressman Z, Hunsinger M, Lee K, Coplan P, Gilron I, Katz NP, McDermott MP, Raja SN, Rappaport BA, Rowbotham MC, Turk DC, Dworkin RH, Smith SM. Adverse event reporting in clinical trials of intravenous and invasive pain treatments: an ACTTION systematic review. Journal of Pain, 2016;17:1137-1149.
59. Dampier C, Palermo TM, Darbari DS, Hassel K, Smith W, Zempsky W. AAPT diagnostic criteria for chronic sickle cell disease pain. Journal of Pain, 2017;18:490-498.
60. Dean LE, Arnold L, Crofford L, Bennett R, Goldenberg D, Fitzcharles M, Paiva E, Staud R, Clauw D, Sarzi-Puttini P, Jones GT, Ayorinde A, Flüb E, Beasley M, Macfarlane GJ. Impact of moving from a widespread to multisite pain definition on other fibromyalgia symptoms. Arthritis Care & Research, 2017;69:1878-1886.
61. Gewandter JS, Burke L, Cavaletti G, Dworkin RH, Gibbons C, Gover TD, Herrmann DN, McArthur JC, McDermott MP, Rappaport BA, Reeve BB, Russell JW, Smith AG, Smith SM, Turk DC, Vinik AI, Freeman R. Content validity of symptom-based measures for diabetic, chemotherapy, and HIV peripheral neuropathy. Muscle & Nerve, 2017;55:366-372.
62. Gewandter JS, Freeman R, Kitt RA, Cavaletti G, Gauthier LR, McDermott MP, Mohile NA, Mohile SG, Smith AG, Tejani MA, Turk DC, Dworkin RH. Chemotherapy-induced peripheral neuropathy clinical trials: review and recommendations. Neurology, 2017;89:859-869.
63. Gewandter JS, Kitt RA, Hunsinger MR, Poku J, Lozano J, Chaudari J, Evans S, Gross RA, McDermott MP, Rowbotham MC, Turk DC, Dworkin PH. Reporting of data monitoring boards in publications of randomized clinical trials is often deficient: ACTTION systematic review and recommendations. Journal of Clinical Epidemiology, 2017;83:101-107.
64. Gewandter, JS, McDermott MP, Kitt, RA, Chaudari J, Koch JG, Evans SR, Gross RA, Markman JD, Turk DC, Dworkin RH. Interpretation of CIs in clinical trials with non-significant results: systematic review and recommendations. BMJ Open, 2017;7:e017288.doi:10.1136/bmjopen-2017-017288.
65. Kent ML, Tighe PJ, Belfer I, Brennan TJ, Bruehl S, Brummett CM, Buckenmaier CC III, Buvanendran A, Cohen RI, Desjardins P, Edwards D, Fillingim R, Gewandter J, Gordon DB, Hurley RW, Kehlet H, Loeser JD, Mackey S, McLean SA, Polomano R, Rahman S, Raja S, Rowbotham M, Suresh S, Schachtel B, Schreiber K, Schumacher M, Stacey B, Stanos S, Todd K, Turk DC, Weisman SJ, Wu C, Carr DB, Dworkin RH, Terman G. The ACTTION-APS-AAPM Pain Taxonomy (AAAPT) multidimensional approach to classifying acute pain conditions. Journal of Pain, 2017;18:479-489. (Also published in Pain Medicine, 2017;18:947-958)
66. Kiluk BD, Babuscio TA, Nich C, Carroll KM. Initial validation of a proxy indicator of functioning as a potential tool for establishing a clinically meaningful cocaine use outcome. Drug and Alcohol Dependence, 2017;179:400-407.
67. Paice JA, Mulvey M, Bennett M, Dougherty PM, Farrar JT, Mantyh PW, Miaskowski C, Schmidt B, Smith TJ. AAPT diagnostic criteria for chronic cancer pain conditions. Journal of Pain, 2017;18:233-246.
68. Rothstein D, Kitt RA, Smith SM, Abdi S, Engle MP, McDermott MP, Raja SN, Turk DC, Dworkin RH, Gewandter JS. Reporting of design features and analysis details in randomized clinical trials of procedural treatments for cancer pain: an ACTTION systematic review. Regional Anesthesia and Pain Medicine, 2017;42:392-399.
69. Smith SM, Dworkin RH, Turk DC, Baron R, Polydefkis M, Tracey I, Borsook D, Edwards RR, Harris RE, Wager TD, Arendt-Nielsen L, Burke LB, Carr DB, Chappell A, Farrar JT, Freeman R, Gilron I, Goli V, Haeussler J, Jensen T, Katz NP, Kent J, Kopecky EA, Lee DA, Maixner W, Markman JD, McArthur JC, McDermott MP, Parvathenani L, Raja SN, Rappaport BA, Rice ASC, Rowbotham MC, Tobias JK, Wasan AD, Witter J. The potential role of sensory testing, skin biopsy, and functional brain imaging as biomarkers in chronic pain clinical trials: IMMPACT considerations. Journal of Pain, 2017;18:757-777.
70. Smith SM, Jones JK, Katz NP, Roland CL, Setnik B, Trudeau JJ, Wright S, Burke LB, Comer SD, Dart RC, Dionne R, Haddox JD, Jaffe JH, Kopecky EA, Martell BA, Montoya ID, Stanton M, Wasan AD, Turk DC, Dworkin RH. Measures that identify prescription medication misuse, abuse, and related events in clinical trials: ACTTION critique and recommended considerations. Journal of Pain, 2017;18:1287-1294.
71. Ward DS, Williams MR, Turk DC, Dworkin RH, Sessler DI, Dexter F, for the SCEPTER authors. Recommendations for procedural sedation clinical trials. Anesthesia & Analgesia, 2017;125:703-704.
72. Widerstrom-Noga E, Loeser JD, Jensen TS, Finnerup NB. AAPT diagnostic criteria for central neuropathic pain. Journal of Pain, 2017:18:1417-1426.
73. Williams MR, Ward DS, Carlson D, Cravero J, Dexter F, Lightdale JR, Mason KP, Miner J, Vargo JJ, Berkenbosch JW, Clark RM, Constant I, Dionne R, Dworkin RH, Gozal D, Grayzel D, Irwin MG, Lerman J, O’Connor RE, Pandharipande P, Rappaport BA, Riker RR, Tobin JR, Turk DC, Twersky RS, Sessler DI. Evaluating patient-centered outcomes in clinical trials of procedural sedation, part 1 efficacy: Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research recommendations. Anesthesia & Analgesia, 2017;124:821-830.
74. Gewandter JS, Brell J, Cavaletti G, Dougherty PM, Evans S, Howie L, McDermott MP, O'Mara A, Smith AG, Dastros-Pitei D, Gauthier LR, Haroutounian S, Jarpe M, Katz NP, Loprinzi C, Richardson P, Lavoie-Smith EM, Wen PY, Turk DC, Dworkin RH, Freeman R. Trial designs for chemotherapy-induced peripheral neuropathy prevention: ACTTION recommendations. Neurology, 2018;91:403-413.
75. Gewandter JS, Chaudari J, Iwan KB, Kitt R, As-Sanie S, Bachmann G, Clemens Q, Lai HH, Tu F, Verne GN, Vincent K, Wesselmann U, Zhou Q, Turk DC, Dworkin RH, Smith SM. Research design characteristics of published pharmacologic randomized clinical trials for irritable bowel syndrome and chronic pelvic pain conditions: an ACTTION systematic review. Journal of Pain, 2018;19:717-726.
76. Patel KV, Allen R, Burke L, Farrar JT, Gewandter JS, Gilron I, Katz NP, Markman JD, Marshall SF, Resnick M, Rice ASC, Rowbotham MC, Smith SM, Vanhove GF, Wasan AD, Zhang S, Dworkin RH, Turk DC. Evaluation of composite responder outcomes of pain intensity and physical function in neuropathic pain clinical trials: an ACTTION individual patient data analysis. Pain, 2018;159:2245-2254.
77. Smith SM, Jensen MP, He H, Kitt R, Koch J, Pan A, Burke LB, Farrar JT, McDermott MP, Turk DC, Dworkin RH. A comparison of the assay sensitivity of average and worst pain intensity in pharmacologic trials: an ACTTION systematic review and meta-analysis, Journal of Pain, 2018;19:953-960.
78. Walco GA, Kopecky EA, Weisman SJ, Stinson J, Stevens B, Desjardins PJ, Berde CB, Krane EJ, Anand KJS, Yaster M, Dampier CD, Dworkin RH, Gilron I, Lynn AM, Maxwell LG, Raja S, Schachtel B, Turk DC. Clinical trial designs and models for analgesic medications for acute pain in neonates, infants, toddlers, children, and adolescents: ACTTION recommendations. Pain, 2018;159:193-205.
79. Ward DS, Williams MR, Berkenbosch JW, Bhatt M, Carlson D, Chappell P, Clark RM, Constant I, Conway A, Cravero J, Dahan A, Dexter F, Dionne R, Dworkin RH, Gan TJ, Gozal D, Green S, Irwin MG, Karan S, Kochman M, Lerman J, Lightdale JR, Litman RS, Mason KP, Miner J, O’Connor RE, Pandharipande P, Riker RR, Roback MG, Sessler DI, Sexton A, Tobin JR, Turk DC, Twersky RS, Urman RD, Weiss M, Wunsch H, Zhao-Wong A. Evaluating patient-centered outcomes in clinical trials of procedural sedation, part 2 safety: Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research recommendations. Anesthesia & Analgesia, 2018:127:1146-1154.
80. Williams MR, Nayshtut M, Hoefnagel A, McKeown A, Carlson DW, Cravero J, Lightdale J, Mason KP, Wilson S, Turk DC, Dworkin RH, Ward DS. Efficacy outcome measures for pediatric procedural sedation clinical trials: an ACTTION systematic review. Anesthesia & Analgesia, 2018;126:956-967.
81. Zhou Q, Wesselmann U, Walker L, Lee L, Zeltzer L, Verne GN. AAPT diagnostic criteria for chronic abdominal, pelvic, and urogenital pain: irritable bowel syndrome. Journal of Pain, 2018;19:257-263.
82. Adams M, Bicket M, Murphy J, Goli V, Wu C, Hurkey R. Opportunities and challenges for junior investigators conducting clinical trials in academia. Pain Reports, 2019;4:e639.
83. Arnold LM, Bennett RM, Crofford LJ, Dean LE, Clauw DJ, Goldenberg DL, Fitzcharles MA, Paiva ES, Staud R, Sarzi-Puttini P, Buskila D, Macfarlane GJ. AAPT diagnostic criteria for fibromyalgia. Journal of Pain, 2019;20:611-628.
84. Arnold LM, Bennett RM, Crofford LJ, Dean LE, Clauw DJ, Goldenberg DL, Fitzcharles MA, Paiva ES, Staud R, Sarzi-Puttini P, Buskila D, Macfarlane GJ. Response to Wolfe. Letter to the editor, “Fibromyalgia criteria.” Journal of Pain, 2019;20:741-742.
85. Campbell CM, Gilron I, Doshi T, Raja SN. Designing and conducting proof-of-concept chronic pain analgesic clinical trials. Pain Reports, 2019;4:e697.
86. Cohen SP, Wallace MS, Rauck RL, Stacey BR. Unique aspects of clinical trials of invasive therapies for chronic pain. Pain Reports, 2019;4:e687.
87. Comer SD, Dworkin RH, Strain EC. Medical devices to prevent opioid use disorder: innovative approaches to addressing the opioid crisis. JAMA Psychiatry, 2019;76:351-352.
88. Connolly MR, Chaudari, JY, Yang X, Ward N, Kitt RA, Herrmann RS, Krane EJ, LeBel AA, Smith SM, Walco GA, Weisman SJ, Turk DC, Dworkin RH, Gewandter JS. Design and reporting characteristics of clinical trials of select chronic and recurrent pediatric pain conditions: an Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks systematic review. Journal of Pain, 2019;20:394-404.
89. Dworkin RH, Kerns RD, McDermott MP, Turk DC, Veasley C. The ACTTION Guide to Clinical Trials of Pain Treatments: standing on the shoulders of giants. Pain Reports, 2019;4:e757.
90. 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;4:e655.
91. Field JJ, Ballas SK, Campbell CM, Crosby LE, Dampier C, Darbari DS, McClish DK, Smith WR, Zempsky WT. AAAPT diagnostic criteria for acute sickle cell pain. Journal of Pain, 2019;20:746-759.
92. Freeman R, Edwards R, Baron R, Bruehl S, Cruccu G, Dworkin RH, Haroutounian S. AAPT diagnostic criteria for peripheral neuropathic pain: focal and segmental disorders. Journal of Pain, 2019;20:369-393.
93. Gewandter JS, Eisenach JC, Gross RA, Jensen MP, Keefe FJ, Lee DA, Turk DC. Checklist for the preparation and review of pain clinical trial publications: a pain-specific supplement to CONSORT. Pain Reports, 2019;4:e621.
94. Gewandter JS, Gibbons CH, Campagnolo M, Lee J, Chaudari J, Ward N, Burke L, Cavaletti G, Herrmann DN, McArthur JC, Russell JW, Smith AG, Smith SM, Turk DC, Dworkin RH, Freeman R. Clinician-rated measures for distal symmetrical axonal polyneuropathy: ACTTION systematic review. Neurology, 2019;93:346-360.
95. Gewandter JS, McDermott MP, He H, Gao S, Cai X, Farrar JT, Katz NP, Markman JD, Senn S, Turk DC, Dworkin RH. Demonstrating heterogeneity of treatment effects among patients: an overlooked but important step toward precision medicine. Clinical Pharmacology & Therapeutics, 2019;106:204-210.
96. Gewandter JS, McDermott MP, Mbowe O, Edwards RR, Katz NP, Turk DC, Dworkin RH. Navigating trials of personalized pain treatments: we’re going to need a bigger boat. Pain, 2019;160:1235-1239.
97. Gilron I, Carr D, Desjardins P, Kehlet H. Current methods and challenges for acute pain trials. Pain Reports, 2019;4:e647.
98. Kent ML, Tighe PJ, Bruehl S, Turk DC, Dworkin RH. The ACTTION-APS-AAPM Pain Taxonomy (AAAPT) diagnostic criteria for acute pain conditions: an introduction. Journal of Pain, 2019;20:743-745.
99. Kiluk BD, Fitzmaurice GM, Strain EC, Weiss RD. What defines a clinically meaningful outcome in the treatment of substance use disorders: reductions in direct consequences of drug use or improvement in overall functioning? Addiction, 2019;114:9-15.
100. Lee DC, Schlienz NJ, Peters EN, Dworkin RH, Turk DC, Strain EC, Vandrey R. Systematic review of outcome domains and measures used in psychosocial and pharmacological treatment trials for cannabis use disorder. Drug and Alcohol Dependence, 2019;194:500-517.
101. Ohrbach R, Dworkin SF. AAPT diagnostic criteria for chronic painful temporomandibular disorders. Journal of Pain, 2019;20:1276-1292.
102. Palermo TM, Kashikar-Zuck S, Friedrichsdorf SJ, Powers SW. Unique aspects of clinical trials of chronic pain management interventions in children and adolescents. Pain Reports, 2019;4:e649.
103. Rowbotham MC, McDermott MP. Ethical considerations in the design, execution, and analysis of clinical trials of pain treatments. Pain Reports, 2019;4:e646.
104. Mbowe OB, Gewandter JS, Turk DC, Dworkin RH, McDermott MP. Are there really only two kinds of people in the world?: evaluating the distribution of change from baseline in pain clinical trials. Pain, 2020;161:195-201.
105. Xu A, Larsen B, Baller EB, Scott JC, Sharma V, Adebimpe A, Basbaum AI, Dworkin RH, Edwards RR, Woolf CJ, Eickhoff SB, Eickhoff CR, Satterthwaite TD. Convergent neural representations of experimentally-induced acute pain in healthy volunteers: a large-scale fMRI meta-analysis. Neuroscience and Biobehavioral Reviews, 2020;112:300-323.
106. Abdallah FW, Gilron I, Fillingim RB, Tighe P, Parvataneni, HK, Ghasemlou N, Sawhney M, McCartney CJL. AAAPT diagnostic criteria for acute knee arthroplasty pain. Pain Medicine, in press.
107. Cai X, Gewandter JS, He H, Turk DC, Dworkin RH, McDermott MP. Estimands and missing data in clinical trials of chronic pain treatments: advances in design and analysis. Pain, in press.
108. Gewandter JS, Dworkin RH, Turk DC, Devine EG, Hewitt D, Jensen MP, Katz NP, Kirkwood AA, Malamut R , Markman JD, Vrijens B, Burke L, Campbell JN, Carr DB, Conaghan PG, Cowan P, Doyle MK, Edwards RR, Evans SR, Farrar JT, Freeman R, Gilron I, Juge D, Kerns RD, Kopecky EA, McDermott MP, Niebler G, Patel KV, Rauck R, Rice ASC, Rowbotham M, Sessler NE, Simon LS, Singla N, Skljarevski V, Tockarshewsky T, Vanhove GF, Wasan AD, Witter J. Improving study conduct and data quality in clinical trials of chronic pain treatments: IMMPACT recommendations. Journal of Pain, in press.
109. Kleykamp BA, De Santis M, Dworkin RH, Huhn AS, Kampman KM, Montoya ID, Preston KL, Ramey T, Smith SM, Turk DC, Walsh R, Weiss RD, Strain EC. Craving and opioid use disorder: a scoping review. Drug and Alcohol Dependence, in press.
110. Kleykamp BA, Weiss RD, Strain EC. Time to reconsider the role of craving in opioid use disorder. JAMA Psychiatry, in press.
111. Loflin M, Kiluk B, Huestis MA, Aklin WM, Budney AJ, Carroll JM, D'Souza DC, Dworkin RH, Gray KM, Hasin DS, Lee DC, LeFoll B, Levin FR, Lile JA, Mason BJ, McRae-Clark AL, Montoya I, Peters EN, Ramey T, Turk DC, Vandrey R, Weiss RD, Strain EC. The state of clinical outcome assessments for cannabis use disorder clinical trials: a review and research agenda. Drug and Alcohol Dependence, in press.
112. Markman JD, Czerniecka-Foxx K, Khalsa PS, Hayek SM, Asher AL, Loeser JD, Chou R. AAPT diagnostic criteria for chronic low back pain, Journal of Pain, in press.
113. Patel K, Amtmann D, Jensen MP, Smith SM, Veasley C, Turk DC. Clinical outcome assessment in clinical trials of chronic pain treatments. Pain Reports, in press.
114. Schreiber KL, Belfer I, Miaskowski C, Schumacher M, Stacey BR, Van De Ven T. AAAPT diagnostic criteria for acute pain following breast surgery. Journal of Pain, in press.
115. Smith SM, Fava M, Jensen MP, Mbowe OB, McDermott MP, Turk DC, Dworkin RH. Size does matter, but it isn’t everything: the challenge of modest treatment effects in chronic pain clinical trials. Pain, in press.

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