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Improving study conduct and data quality in clinical trials of chronic pain treatments: IMMPACT recommendations.

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.

J Pain. 2019 Dec 13. pii: S1526-5900(19)30880-6. doi: 10.1016/j.jpain.2019.12.003. [Epub ahead of print] Review.


Early phase and adaptive design clinical trials in rheumatoid arthritis: a systematic review of early phase trials.

Pickles T, Christensen R, Tam LS, Simon LS, Choy EH.

Rheumatol Adv Pract. 2018 Oct 17;2(2):rky045. doi: 10.1093/rap/rky045. eCollection 2018.


Identifying Possible Outcome Domains from Existing Outcome Measures to Inform an OMERACT Core Domain Set for Safety in Rheumatology Trials.

Klokker L, Berthelsen DB, Woodworth T, Andersen KM, Furst DE, Devoe D, Williamson PR, Suarez-Almazor ME, Strand V, Leong AL, Goel N, Boers M, Brooks PM, March L, Sloan VS, Tugwell P, Simon LS, Christensen R.

J Rheumatol. 2019 Sep;46(9):1173-1178. doi: 10.3899/jrheum.190196. Epub 2019 May 1.


Pain Measurement in Rheumatic and Musculoskeletal Diseases: Where To Go from Here? Report from a Special Interest Group at OMERACT 2018.

Chiarotto A, Kaiser U, Choy E, Christensen R, Conaghan PG, Cowern M, Gill M, de Wit M, Gargon E, Horgan B, Kirkham JJ, Simon LS, Singh JA, Tugwell P, Turk DC, Mease PJ.

J Rheumatol. 2019 Oct;46(10):1355-1359. doi: 10.3899/jrheum.181099. Epub 2019 Apr 1.


Patient Perspectives on DMARD Safety Concerns in Rheumatology Trials: Results from Inflammatory Arthritis Patient Focus Groups and OMERACT Attendees Discussion.

Andersen KM, Kelly A, Lyddiatt A, Bingham CO 3rd, Bykerk VP, Batterman A, Westreich J, Jones MK, Cross M, Brooks PM, March L, Shea B, Tugwell P, Simon LS, Christensen R, Bartlett SJ.

J Rheumatol. 2019 Sep;46(9):1168-1172. doi: 10.3899/jrheum.181185. Epub 2019 Feb 15.


OMERACT Filter 2.1: Elaboration of the Conceptual Framework for Outcome Measurement in Health Intervention Studies.

Boers M, Beaton DE, Shea BJ, Maxwell LJ, Bartlett SJ, Bingham CO 3rd, Conaghan PG, D'Agostino MA, de Wit MP, Gossec L, March L, Simon LS, Singh JA, Strand V, Wells GA, Tugwell P.

J Rheumatol. 2019 Aug;46(8):1021-1027. doi: 10.3899/jrheum.181096. Epub 2019 Feb 15.


Adaptive Trial Designs in Rheumatology: Report from the OMERACT Special Interest Group.

Pickles T, Alten R, Boers M, Bykerk V, Christensen J, Christensen R, van Hoogstraten H, Simon LS, Tam LS, Choy EH.

J Rheumatol. 2019 Oct;46(10):1406-1408. doi: 10.3899/jrheum.181054. Epub 2019 Feb 15.


Core Domain Set Selection According to OMERACT Filter 2.1: The OMERACT Methodology.

Maxwell LJ, Beaton DE, Shea BJ, Wells GA, Boers M, Grosskleg S, Bingham CO 3rd, Conaghan PG, D'Agostino MA, de Wit M, Gossec L, March L, Simon LS, Singh JA, Strand V, Tugwell P.

J Rheumatol. 2019 Aug;46(8):1014-1020. doi: 10.3899/jrheum.181097. Epub 2019 Feb 15.


Toward a Core Outcome Measurement Set for Polymyalgia Rheumatica: Report from the OMERACT 2018 Special Interest Group.

Owen CE, Yates M, Twohig H, Muller S, Neill LM, Harrison E, Shea B, Simon LS, Hill CL, Mackie SL.

J Rheumatol. 2019 Oct;46(10):1360-1364. doi: 10.3899/jrheum.181050. Epub 2019 Feb 1.


Instrument Selection Using the OMERACT Filter 2.1: The OMERACT Methodology.

Beaton DE, Maxwell LJ, Shea BJ, Wells GA, Boers M, Grosskleg S, Bingham CO 3rd, Conaghan PG, D'Agostino MA, de Wit MP, Gossec L, March LM, Simon LS, Singh JA, Strand V, Tugwell P.

J Rheumatol. 2019 Aug;46(8):1028-1035. doi: 10.3899/jrheum.181218. Epub 2019 Feb 1.


Improving Benefit-harm Assessment of Therapies from the Patient Perspective: OMERACT Premeeting Toward Consensus on Core Sets for Randomized Controlled Trials.

Andersen KM, Cheah JTL, March L, Bartlett SJ, Beaton D, Bingham CO 3rd, Brooks PM, Christensen R, Conaghan PG, D'Agostino MA, de Wit M, Dueck AC, Goodman SM, Grosskleg S, Hill CL, Howell M, Mackie SL, Richards B, Shea B, Singh JA, Strand V, Tugwell P, Wells GA, Simon LS.

J Rheumatol. 2019 Aug;46(8):1053-1058. doi: 10.3899/jrheum.181123. Epub 2019 Jan 15.


Toward a Core Domain Set for Glucocorticoid Impact in Inflammatory Rheumatic Diseases: The OMERACT 2018 Glucocorticoid Impact Working Group.

Cheah JTL, Black RJ, Robson JC, Navarro-Millán IY, Young SR, Richards P, Beard S, Simon LS, Goodman SM, Mackie SL, Hill CL.

J Rheumatol. 2019 Sep;46(9):1179-1182. doi: 10.3899/jrheum.181082. Epub 2019 Jan 15.


Proposed study designs for approval based on a surrogate endpoint and a post-marketing confirmatory study under FDA's accelerated approval regulations for disease modifying osteoarthritis drugs.

Kraus VB, Simon LS, Katz JN, Neogi T, Hunter D, Guermazi A, Karsdal MA.

Osteoarthritis Cartilage. 2019 Apr;27(4):571-579. doi: 10.1016/j.joca.2018.11.002. Epub 2018 Nov 19. Review.


Boxed in by your inbox: Implications of daily e-mail demands for managers' leadership behaviors.

Rosen CC, Simon LS, Gajendran RS, Johnson RE, Lee HW, Lin SJ.

J Appl Psychol. 2019 Jan;104(1):19-33. doi: 10.1037/apl0000343. Epub 2018 Sep 17.


Development and Validation of a Novel Evidence-Based Lupus Multivariable Outcome Score for Clinical Trials.

Abrahamowicz M, Esdaile JM, Ramsey-Goldman R, Simon LS, Strand V, Lipsky PE.

Arthritis Rheumatol. 2018 Sep;70(9):1450-1458. doi: 10.1002/art.40522. Epub 2018 Aug 3.


A Phase I study of the pharmacokinetics, safety and tolerability of a novel tocopheryl phosphate mixture/oxymorphone transdermal patch system.

Gavin PD, Simon LS, Schlagheck T, Smith AJ, Krishnarajah J.

Pain Manag. 2017 Nov;7(6):499-512. doi: 10.2217/pmt-2017-0032. Epub 2017 Aug 17.


Engaging Stakeholders and Promoting Uptake of OMERACT Core Outcome Instrument Sets.

Tunis SR, Maxwell LJ, Graham ID, Shea BJ, Beaton DE, Bingham CO 3rd, Brooks P, Conaghan PG, D'Agostino MA, de Wit MP, Gossec L, March LM, Simon LS, Singh JA, Strand V, Wells GA, Tugwell P.

J Rheumatol. 2017 Oct;44(10):1551-1559. doi: 10.3899/jrheum.161273. Epub 2017 Aug 1.


The OMERACT Core Domain Set for Outcome Measures for Clinical Trials in Polymyalgia Rheumatica.

Mackie SL, Twohig H, Neill LM, Harrison E, Shea B, Black RJ, Kermani TA, Merkel PA, Mallen CD, Buttgereit F, Mukhtyar C, Simon LS, Hill CL; OMERACT PMR Working Group.

J Rheumatol. 2017 Oct;44(10):1515-1521. doi: 10.3899/jrheum.161109. Epub 2017 Aug 1.


Pharmacokinetics, safety and tolerability of a novel tocopheryl phosphate mixture/oxycodone transdermal patch system: a Phase I study.

Gavin PD, Simon LS, Schlagheck T, Smith AJ, Shakib S.

Pain Manag. 2017 Jul;7(4):243-253. doi: 10.2217/pmt-2016-0068. Epub 2017 Apr 19.


A Patient-reported Outcome Measure for Effect of Glucocorticoid Therapy in Adults with Inflammatory Diseases Is Needed: Report from the OMERACT 2016 Special Interest Group.

Black RJ, Robson JC, Goodman SM, Hoon E, Lai LYH, Simon LS, Harrison E, Neill L, Richards P, Nelsen LM, Nebesky JM, Mackie SL, Hill CL.

J Rheumatol. 2017 Nov;44(11):1754-1758. doi: 10.3899/jrheum.161083. Epub 2017 Apr 1.


Perceptual attributes for the comparison of head-related transfer functions.

Simon LS, Zacharov N, Katz BF.

J Acoust Soc Am. 2016 Nov;140(5):3623.


Developing an OMERACT Core Outcome Set for Assessing Safety Components in Rheumatology Trials: The OMERACT Safety Working Group.

Klokker L, Tugwell P, Furst DE, Devoe D, Williamson P, Terwee CB, Suarez-Almazor ME, Strand V, Woodworth T, Leong AL, Goel N, Boers M, Brooks PM, Simon LS, Christensen R.

J Rheumatol. 2017 Dec;44(12):1916-1919. doi: 10.3899/jrheum.161105. Epub 2016 Oct 15.


Successful Stepwise Development of Patient Research Partnership: 14 Years' Experience of Actions and Consequences in Outcome Measures in Rheumatology (OMERACT).

de Wit M, Kirwan JR, Tugwell P, Beaton D, Boers M, Brooks P, Collins S, Conaghan PG, D'Agostino MA, Hofstetter C, Hughes R, Leong A, Lyddiatt A, March L, May J, Montie P, Richards P, Simon LS, Singh JA, Strand V, Voshaar M, Bingham CO 3rd, Gossec L.

Patient. 2017 Apr;10(2):141-152. doi: 10.1007/s40271-016-0198-4.


A critical review of clinical trials in systemic lupus erythematosus.

Mahieu MA, Strand V, Simon LS, Lipsky PE, Ramsey-Goldman R.

Lupus. 2016 Sep;25(10):1122-40. doi: 10.1177/0961203316652492. Review.


Patient phenotyping in clinical trials of chronic pain treatments: IMMPACT recommendations.

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 AS, Scavone JM, Scholz J, Simon LS, Smith SM, Tobias J, Tockarshewsky T, Veasley C, Versavel M, Wasan AD, Wen W, Yarnitsky D.

Pain. 2016 Sep;157(9):1851-71. doi: 10.1097/j.pain.0000000000000602. Review.


Assessment of physical function and participation in chronic pain clinical trials: IMMPACT/OMERACT recommendations.

Taylor AM, Phillips K, Patel KV, Turk DC, Dworkin RH, Beaton D, Clauw DJ, Gignac MA, 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.

Pain. 2016 Sep;157(9):1836-50. doi: 10.1097/j.pain.0000000000000577. Review.


Ms. A.M. Taylor, et al reply.

Taylor AM, Taylor JO, Singh JA, Conaghan PG, Choy EH, Tugwell PS, Kaiser U, Strand V, Simon LS, Mease PJ.

J Rheumatol. 2016 Apr;43(4):826. doi: 10.3899/jrheum.151456. No abstract available.


To branch out or stay focused? Affective shifts differentially predict organizational citizenship behavior and task performance.

Yang LQ, Simon LS, Wang L, Zheng X.

J Appl Psychol. 2016 Jun;101(6):831-45. doi: 10.1037/apl0000088. Epub 2016 Feb 15.


Development of a Provisional Core Domain Set for Polymyalgia Rheumatica: Report from the OMERACT 12 Polymyalgia Rheumatica Working Group.

Helliwell T, Brouwer E, Pease CT, Hughes R, Hill CL, Neill LM, Halls S, Simon LS, Mallen CD, Boers M, Kirwan JR, Mackie SL.

J Rheumatol. 2016 Jan;43(1):182-6. doi: 10.3899/jrheum.141179. Epub 2015 Nov 15. Review.


Current State of Reporting Pain Outcomes in Cochrane Reviews of Chronic Musculoskeletal Pain Conditions and Considerations for an OMERACT Research Agenda.

Maxwell LJ, Wells GA, Simon LS, Conaghan PG, Grosskleg S, Scrivens K, Beaton DE, Bingham CO 3rd, Busse JW, Christensen R, Goel N, Jüni P, Kaiser U, Lyddiatt A, Mease PJ, Ostelo RW, Phillips K, Sapunar D, Singh JA, Strand V, Taylor AM, Terwee CB, Tugwell P.

J Rheumatol. 2015 Oct;42(10):1934-1942. doi: 10.3899/jrheum.141423. Epub 2015 Sep 15.


Harmonizing Pain Outcome Measures: Results of the Pre-OMERACT Meeting on Partnerships for Consensus on Patient-important Pain Outcome Domains Between the Cochrane Musculoskeletal Group and OMERACT.

Phillips K, Taylor A, Mease PJ, Simon LS, Conaghan PG, Choy EH, Singh JA, Strand V, Gossec L, Kaiser U, de Wit M, Ostelo R, Maxwell L, Tugwell PS.

J Rheumatol. 2015 Oct;42(10):1943-1946. doi: 10.3899/jrheum.141386. Epub 2015 Aug 1.


Is Chronic Pain a Disease in Its Own Right? Discussions from a Pre-OMERACT 2014 Workshop on Chronic Pain.

Taylor AM, Phillips K, Taylor JO, Singh JA, Conaghan PG, Choy EH, Tugwell PS, Kaiser U, Strand V, Simon LS, Mease PJ.

J Rheumatol. 2015 Oct;42(10):1947-1953. doi: 10.3899/jrheum.141328. Epub 2015 Jul 1.


Understanding cycles of abuse: A multimotive approach.

Simon LS, Hurst C, Kelley K, Judge TA.

J Appl Psychol. 2015 Nov;100(6):1798-810. doi: 10.1037/apl0000031. Epub 2015 May 25.


OARSI Clinical Trials Recommendations: Design and conduct of clinical trials for hand osteoarthritis.

Kloppenburg M, Maheu E, Kraus VB, Cicuttini F, Doherty M, Dreiser RL, Henrotin Y, Jiang GL, Mandl L, Martel-Pelletier J, Nelson AE, Neogi T, Pelletier JP, Punzi L, Ramonda R, Simon LS, Wang S; OARSI Hand Clinical Trial Recommendations Work Group.

Osteoarthritis Cartilage. 2015 May;23(5):772-86. doi: 10.1016/j.joca.2015.03.007. Review.


OARSI Clinical Trials Recommendations: Design and conduct of clinical trials for hip osteoarthritis.

Lane NE, Hochberg MC, Nevitt MC, Simon LS, Nelson AE, Doherty M, Henrotin Y, Flechsenhar K.

Osteoarthritis Cartilage. 2015 May;23(5):761-71. doi: 10.1016/j.joca.2015.03.006. Review. Erratum in: Osteoarthritis Cartilage. 2015 Oct;23(10):1821. Herontin, Yves [Corrected to Henrotin, Yves].


Dialogue on Developing Consensus on Measurement and Presentation of Patient-important Outcomes, Using Pain Outcomes as an Exemplar, in Systematic Reviews: A Preconference Meeting at OMERACT 12.

Tugwell PS, Maxwell LJ, Beaton DE, Busse JW, Christensen R, Conaghan PG, Simon LS, Terwee C, Tovey D, Wells GA, Williamson P.

J Rheumatol. 2015 Oct;42(10):1931-1933. doi: 10.3899/jrheum.141430. Epub 2015 Feb 1.


Imaging as an Outcome Measure in Gout Studies: Report from the OMERACT Gout Working Group.

Grainger R, Dalbeth N, Keen H, Durcan L, Lawrence Edwards N, Perez-Ruiz F, Diaz-Torne C, Singh JA, Khanna D, Simon LS, Taylor WJ.

J Rheumatol. 2015 Dec;42(12):2460-4. doi: 10.3899/jrheum.141164. Epub 2015 Feb 1. Review.


Development of a bedside pain assessment kit for the classification of patients with osteoarthritis.

Osgood E, Trudeau JJ, Eaton TA, Jensen MP, Gammaitoni A, Simon LS, Katz N.

Rheumatol Int. 2015 Jun;35(6):1005-13. doi: 10.1007/s00296-014-3191-z. Epub 2014 Dec 16.


Double-blind, randomized, controlled, crossover trial of pregabalin for neurogenic claudication.

Markman JD, Frazer ME, Rast SA, McDermott MP, Gewandter JS, Chowdhry AK, Czerniecka K, Pilcher WH, Simon LS, Dworkin RH.

Neurology. 2015 Jan 20;84(3):265-72. doi: 10.1212/WNL.0000000000001168. Epub 2014 Dec 10.


The regulatory perspective.

Simon LS.

J Peripher Nerv Syst. 2014 Oct;19 Suppl 2:S15-6. doi: 10.1111/jns.12081_1. No abstract available.


Meta-analysis of assay sensitivity and study features in clinical trials of pharmacologic treatments for osteoarthritis pain.

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.

Arthritis Rheumatol. 2014 Dec;66(12):3327-36. doi: 10.1002/art.38869.


Trial evidence and approval of therapeutic agents.

Green AM, Simon LS.

JAMA. 2014 May;311(20):2128-9. doi: 10.1001/jama.2014.3401. No abstract available.


Updating the OMERACT filter: implications for imaging and soluble biomarkers.

D'Agostino MA, Boers M, Kirwan J, van der Heijde D, Østergaard M, Schett G, Landewé RB, Maksymowych WP, Naredo E, Dougados M, Iagnocco A, Bingham CO 3rd, Brooks PM, Beaton DE, Gandjbakhch F, Gossec L, Guillemin F, Hewlett SE, Kloppenburg M, March L, Mease PJ, Moller I, Simon LS, Singh JA, Strand V, Wakefield RJ, Wells GA, Tugwell P, Conaghan PG.

J Rheumatol. 2014 May;41(5):1016-24. doi: 10.3899/jrheum.131313. Epub 2014 Mar 1.


Developing core outcome measurement sets for clinical trials: OMERACT filter 2.0.

Boers M, Kirwan JR, Wells G, Beaton D, Gossec L, d'Agostino MA, Conaghan PG, Bingham CO 3rd, Brooks P, Landewé R, March L, Simon LS, Singh JA, Strand V, Tugwell P.

J Clin Epidemiol. 2014 Jul;67(7):745-53. doi: 10.1016/j.jclinepi.2013.11.013. Epub 2014 Feb 28.


Polymyalgia Rheumatica (PMR) Special Interest Group at OMERACT 11: outcomes of importance for patients with PMR.

Mackie SL, Arat S, da Silva J, Duarte C, Halliday S, Hughes R, Morris M, Pease CT, Sherman JW, Simon LS, Walsh M, Westhovens R, Zakout S, Kirwan JR.

J Rheumatol. 2014 Apr;41(4):819-23. doi: 10.3899/jrheum.131254. Epub 2014 Feb 1. Review.


Application of the OMERACT filter to measures of core outcome domains in recent clinical studies of acute gout.

Taylor WJ, Redden D, Dalbeth N, Schumacher HR, Edwards NL, Simon LS, John MR, Essex MN, Watson DJ, Evans R, Rome K, Singh JA.

J Rheumatol. 2014 Mar;41(3):574-80. doi: 10.3899/jrheum.131245. Epub 2014 Jan 15.


OMERACT 11: international consensus conference on outcome measures in rheumatology.

Simon LS, Strand V, Bingham CO 3rd, Singh JA.

J Rheumatol. 2014 Jan;41(1):145-9. doi: 10.3899/jrheum.130937. No abstract available.


Advice from professional societies: appropriate use of NSAIDs.

Meara AS, Simon LS.

Pain Med. 2013 Dec;14 Suppl 1:S3-10. doi: 10.1111/pme.12282. Review.


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