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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 May 1. pii: jrheum.190196. doi: 10.3899/jrheum.190196. [Epub ahead of print]


Timely renal transplantation for scleroderma end-stage kidney disease patients can improve outcomes and quality of life.

Woodworth TG, Furst DE.

Ann Transl Med. 2019 Feb;7(3):60. doi: 10.21037/atm.2018.12.64. No abstract available.


Identifying Provisional Generic Contextual Factor Domains for Clinical Trials in Rheumatology: Results from an OMERACT Initiative.

Nielsen SM, Tugwell P, de Wit MPT, Boers M, Beaton DE, Woodworth TG, Escorpizo R, Shea B, Toupin-April K, Guillemin F, Strand V, Singh JA, Kloppenburg M, Furst DE, Wells GA, Smolen JS, Veselý R, Boonen A, Storgaard H, Voshaar M, March L, Christensen R; Contextual Factors Working Group.

J Rheumatol. 2019 Jan 15. pii: jrheum.181081. doi: 10.3899/jrheum.181081. [Epub ahead of print]


Overall and cause-specific mortality in the Sentinel system: A power analysis.

Swain RS, Taylor LG, Woodworth TS, Fuller CC, Petrone AB, Menzin TJ, Haug NR, Toh S, Mosholder AD.

Pharmacoepidemiol Drug Saf. 2018 Dec;27(12):1416-1421. doi: 10.1002/pds.4692. Epub 2018 Nov 13.


Incidence of Heart Failure and Cardiomyopathy Following Initiation of Medications for Attention-Deficit/Hyperactivity Disorder: A Descriptive Study.

Mosholder AD, Taylor L, Mannheim G, Ortendahl L, Woodworth TS, Toh S.

J Clin Psychopharmacol. 2018 Oct;38(5):505-508. doi: 10.1097/JCP.0000000000000939.


Assessing the impact of the new ICD-10-CM coding system on pharmacoepidemiologic studies-An application to the known association between angiotensin-converting enzyme inhibitors and angioedema.

Panozzo CA, Welch EC, Woodworth TS, Huang TY, Her QL, Gagne JJ, Sun JW, Rogers C, Menzin TJ, Ehrmann M, Freitas KE, Haug NR, Toh S.

Pharmacoepidemiol Drug Saf. 2018 Aug;27(8):829-838. doi: 10.1002/pds.4550. Epub 2018 Jun 26.


Early impact of the ICD-10-CM transition on selected health outcomes in 13 electronic health care databases in the United States.

Panozzo CA, Woodworth TS, Welch EC, Huang TY, Her QL, Haynes K, Rogers C, Menzin TJ, Ehrmann M, Freitas KE, Haug NR, Toh S.

Pharmacoepidemiol Drug Saf. 2018 Aug;27(8):839-847. doi: 10.1002/pds.4563. Epub 2018 Jun 26.


Obesity Impacts Swelling of Ankle and Foot Joints in Early Rheumatoid Arthritis Patients.

Ranganath VK, Duffy EL, Garg VK, Woodworth T, Taylor M, Paulus HE, Altman RD, Elashoff DA.

J Clin Rheumatol. 2019 Apr;25(3):e8-e11. doi: 10.1097/RHU.0000000000000799.


Evaluation of the US Food and Drug Administration sentinel analysis tools in confirming previously observed drug-outcome associations: The case of clindamycin and Clostridium difficile infection.

Carnahan RM, Kuntz JL, Wang SV, Fuller C, Gagne JJ, Leonard CE, Hennessy S, Meyer T, Archdeacon P, Chen CY, Panozzo CA, Toh S, Katcoff H, Woodworth T, Iyer A, Axtman S, Chrischilles EA.

Pharmacoepidemiol Drug Saf. 2018 Jul;27(7):731-739. doi: 10.1002/pds.4420. Epub 2018 Mar 13.


Prospective surveillance pilot of rivaroxaban safety within the US Food and Drug Administration Sentinel System.

Chrischilles EA, Gagne JJ, Fireman B, Nelson J, Toh S, Shoaibi A, Reichman ME, Wang S, Nguyen M, Zhang R, Izem R, Goulding MR, Southworth MR, Graham DJ, Fuller C, Katcoff H, Woodworth T, Rogers C, Saliga R, Lin ND, McMahill-Walraven CN, Nair VP, Haynes K, Carnahan RM.

Pharmacoepidemiol Drug Saf. 2018 Mar;27(3):263-271. doi: 10.1002/pds.4375. Epub 2018 Jan 10.


Scleroderma renal crisis and renal involvement in systemic sclerosis.

Woodworth TG, Suliman YA, Li W, Furst DE, Clements P.

Nat Rev Nephrol. 2018 Feb;14(2):137. doi: 10.1038/nrneph.2017.183. Epub 2018 Jan 2.


Content and Construct Validity, Reliability, and Responsiveness of the Rheumatoid Arthritis Flare Questionnaire: OMERACT 2016 Workshop Report.

Bartlett SJ, Barbic SP, Bykerk VP, Choy EH, Alten R, Christensen R, den Broeder A, Fautrel B, Furst DE, Guillemin F, Hewlett S, Leong AL, Lyddiatt A, March L, Montie P, Pohl C, Scholte Voshaar M, Woodworth TG, Bingham CO 3rd.

J Rheumatol. 2017 Oct;44(10):1536-1543. doi: 10.3899/jrheum.161145. Epub 2017 Aug 15.


Sentinel Modular Program for Propensity Score-Matched Cohort Analyses: Application to Glyburide, Glipizide, and Serious Hypoglycemia.

Zhou M, Wang SV, Leonard CE, Gagne JJ, Fuller C, Hampp C, Archdeacon P, Toh S, Iyer A, Woodworth TS, Cavagnaro E, Panozzo CA, Axtman S, Carnahan RM, Chrischilles EA, Hennessy S.

Epidemiology. 2017 Nov;28(6):838-846. doi: 10.1097/EDE.0000000000000709.


An OMERACT Initiative Toward Consensus to Identify and Characterize Candidate Contextual Factors: Report from the Contextual Factors Working Group.

Finger ME, Boonen A, Woodworth TG, Escorpizo R, Christensen R, Nielsen SM, Leong AL, Scholte Voshaar M, Flurey CA, Milman N, Verstappen SM, Alten R, Guillemin F, Kloppenburg M, Beaton DE, Tugwell PS, March LM, Furst DE, Pohl C.

J Rheumatol. 2017 Nov;44(11):1734-1739. doi: 10.3899/jrheum.161200. Epub 2017 May 1.


Examining the validity of the rheumatoid arthritis magnetic resonance imaging score according to the OMERACT filter-a systematic literature review.

Woodworth TG, Morgacheva O, Pimienta OL, Troum OM, Ranganath VK, Furst DE.

Rheumatology (Oxford). 2017 Jul 1;56(7):1177-1188. doi: 10.1093/rheumatology/kew445. Review.


Clinical meaning and implications of serum hemoglobin levels in patients with rheumatoid arthritis.

Padjen I, Öhler L, Studenic P, Woodworth T, Smolen J, Aletaha D.

Semin Arthritis Rheum. 2017 Oct;47(2):193-198. doi: 10.1016/j.semarthrit.2017.03.001. Epub 2017 Mar 8.


How should worsening in osteoarthritis be defined? Development and initial validation of preliminary criteria for clinical worsening in knee and hip osteoarthritis.

Mahler E, den Broeder AA, Woodworth TG, Busch V, van den Hoogen FH, Bijlsma J, van den Ende C.

Scand J Rheumatol. 2017 Sep;46(5):396-406. doi: 10.1080/03009742.2016.1235226. Epub 2017 Feb 7.


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.


Scleroderma renal crisis and renal involvement in systemic sclerosis.

Woodworth TG, Suliman YA, Li W, Furst DE, Clements P.

Nat Rev Nephrol. 2016 Nov;12(11):678-691. doi: 10.1038/nrneph.2016.124. Epub 2016 Sep 19. Review. Erratum in: Nat Rev Nephrol. 2018 Jan 02;:.


Successful Comparison of US Food and Drug Administration Sentinel Analysis Tools to Traditional Approaches in Quantifying a Known Drug-Adverse Event Association.

Gagne JJ, Han X, Hennessy S, Leonard CE, Chrischilles EA, Carnahan RM, Wang SV, Fuller C, Iyer A, Katcoff H, Woodworth TS, Archdeacon P, Meyer TE, Schneeweiss S, Toh S.

Clin Pharmacol Ther. 2016 Nov;100(5):558-564. doi: 10.1002/cpt.429. Epub 2016 Aug 22.


Early rheumatoid arthritis treated with tocilizumab, methotrexate, or their combination (U-Act-Early): a multicentre, randomised, double-blind, double-dummy, strategy trial.

Bijlsma JWJ, Welsing PMJ, Woodworth TG, Middelink LM, Pethö-Schramm A, Bernasconi C, Borm MEA, Wortel CH, Ter Borg EJ, Jahangier ZN, van der Laan WH, Bruyn GAW, Baudoin P, Wijngaarden S, Vos PAJM, Bos R, Starmans MJF, Griep EN, Griep-Wentink JRM, Allaart CF, Heurkens AHM, Teitsma XM, Tekstra J, Marijnissen ACA, Lafeber FPJ, Jacobs JWG.

Lancet. 2016 Jul 23;388(10042):343-355. doi: 10.1016/S0140-6736(16)30363-4. Epub 2016 Jun 7.


Identifying flares in rheumatoid arthritis: reliability and construct validation of the OMERACT RA Flare Core Domain Set.

Bykerk VP, Bingham CO, Choy EH, Lin D, Alten R, Christensen R, Furst DE, Hewlett S, Leong A, March L, Woodworth T, Boire G, Haraoui B, Hitchon C, Jamal S, Keystone EC, Pope J, Tin D, Thorne JC, Bartlett SJ.

RMD Open. 2016 May 26;2(1):e000225. doi: 10.1136/rmdopen-2015-000225. eCollection 2016.


Treating to target in established rheumatoid arthritis: Challenges and opportunities in an era of novel targeted therapies and biosimilars.

Woodworth TG, den Broeder AA.

Best Pract Res Clin Rheumatol. 2015 Aug-Dec;29(4-5):543-9. doi: 10.1016/j.berh.2015.10.001. Review.



den Broeder AA, Woodworth TG.

Best Pract Res Clin Rheumatol. 2015 Aug-Dec;29(4-5):525-6. doi: 10.1016/j.berh.2015.09.008. Epub 2015 Nov 28. No abstract available.


Complementary use of passive surveillance and Mini-Sentinel to better characterize hemolysis after immune globulin.

Winiecki S, Baer B, Chege W, Jankosky C, Mintz P, Baker M, Woodworth T, Nguyen M.

Transfusion. 2015 Jul;55 Suppl 2:S28-35. doi: 10.1111/trf.13116.


Feasibility and Domain Validation of Rheumatoid Arthritis (RA) Flare Core Domain Set: Report of the OMERACT 2014 RA Flare Group Plenary.

Bartlett SJ, Bykerk VP, Cooksey R, Choy EH, Alten R, Christensen R, Furst DE, Guillemin F, Halls S, Hewlett S, Leong AL, Lyddiatt A, March L, Montie P, Orbai AM, Pohl C, Voshaar MS, Woodworth TG, Bingham CO 3rd.

J Rheumatol. 2015 Nov;42(11):2185-9. doi: 10.3899/jrheum.141169. Epub 2015 Feb 15. Review.


Acute stressor exposure modifies plasma exosome-associated heat shock protein 72 (Hsp72) and microRNA (miR-142-5p and miR-203).

Beninson LA, Brown PN, Loughridge AB, Saludes JP, Maslanik T, Hills AK, Woodworth T, Craig W, Yin H, Fleshner M.

PLoS One. 2014 Sep 26;9(9):e108748. doi: 10.1371/journal.pone.0108748. eCollection 2014.


Electronic clinical laboratory test results data tables: lessons from Mini-Sentinel.

Raebel MA, Haynes K, Woodworth TS, Saylor G, Cavagnaro E, Coughlin KO, Curtis LH, Weiner MG, Archdeacon P, Brown JS.

Pharmacoepidemiol Drug Saf. 2014 Jun;23(6):609-18. doi: 10.1002/pds.3580. Epub 2014 Feb 18.


Establishing a core domain set to measure rheumatoid arthritis flares: report of the OMERACT 11 RA flare Workshop.

Bykerk VP, Lie E, Bartlett SJ, Alten R, Boonen A, Christensen R, Furst DE, Hewlett S, Leong AL, Lyddiatt A, March L, May JE, Montie P, Orbai AM, Pohl C, Scholte Voshaar M, Woodworth T, Bingham CO 3rd, Choy EH.

J Rheumatol. 2014 Apr;41(4):799-809. doi: 10.3899/jrheum.131252. Epub 2014 Mar 1. Review.


We still don't know how to taper glucocorticoids in rheumatoid arthritis, and we can do better.

Volkmann ER, Rezai S, Tarp S, Woodworth TG, Furst DE.

J Rheumatol. 2013 Oct;40(10):1646-9. doi: 10.3899/jrheum.130019. No abstract available.


Validation of OMERACT preliminary rheumatoid arthritis flare domains in the NOR-DMARD study.

Lie E, Woodworth TG, Christensen R, Kvien TK, Bykerk V, Furst DE, Bingham CO 3rd, Choy EH; OMERACT RA Flare Working Group.

Ann Rheum Dis. 2014 Oct;73(10):1781-7. doi: 10.1136/annrheumdis-2013-203496. Epub 2013 Jul 12.


Comorbidities are associated with poorer outcomes in community patients with rheumatoid arthritis.

Ranganath VK, Maranian P, Elashoff DA, Woodworth T, Khanna D, Hahn T, Sarkisian C, Kremer JM, Furst DE, Paulus HE.

Rheumatology (Oxford). 2013 Oct;52(10):1809-17. doi: 10.1093/rheumatology/ket224. Epub 2013 Jun 27.


Effects of race and language on patient-centered cancer nursing care and patient outcomes.

Radwin LE, Cabral HJ, Woodworth TS.

J Health Care Poor Underserved. 2013 May;24(2):619-32. doi: 10.1353/hpu.2013.0058.


Construct and criterion validity of several proposed DAS28-based rheumatoid arthritis flare criteria: an OMERACT cohort validation study.

van der Maas A, Lie E, Christensen R, Choy E, de Man YA, van Riel P, Woodworth T, den Broeder AA.

Ann Rheum Dis. 2013 Nov;72(11):1800-5. doi: 10.1136/annrheumdis-2012-202281. Epub 2012 Nov 23.


Identifying core domains to assess flare in rheumatoid arthritis: an OMERACT international patient and provider combined Delphi consensus.

Bartlett SJ, Hewlett S, Bingham CO 3rd, Woodworth TG, Alten R, Pohl C, Choy EH, Sanderson T, Boonen A, Bykerk V, Leong AL, Strand V, Furst DE, Christensen R; OMERACT RA Flare Working Group.

Ann Rheum Dis. 2012 Nov;71(11):1855-60. doi: 10.1136/annrheumdis-2011-201201. Epub 2012 Jul 6.


Design considerations, architecture, and use of the Mini-Sentinel distributed data system.

Curtis LH, Weiner MG, Boudreau DM, Cooper WO, Daniel GW, Nair VP, Raebel MA, Beaulieu NU, Rosofsky R, Woodworth TS, Brown JS.

Pharmacoepidemiol Drug Saf. 2012 Jan;21 Suppl 1:23-31. doi: 10.1002/pds.2336.


OMERACT 10 Sharp Symposium: important findings in examination of imaging methods for measurement of joint damage in rheumatoid arthritis.

Strand V, Kingsbury SR, Woodworth T, Landewé R, Ostergaard M, Peterfy C, van der Heijde D, D'Agostino MA, Maksymowych W, Tak PP, Wells G, Conaghan PG.

J Rheumatol. 2011 Sep;38(9):2009-13. doi: 10.3899/jrheum.110415.


Identifying preliminary domains to detect and measure rheumatoid arthritis flares: report of the OMERACT 10 RA Flare Workshop.

Bingham CO 3rd, Alten R, Bartlett SJ, Bykerk VP, Brooks PM, Choy E, Christensen R, Furst DE, Hewlett SE, Leong A, May JE, Montie P, Pohl C, Sanderson TC, Strand V, Woodworth TG; OMERACT RA Flare Definition Working Group.

J Rheumatol. 2011 Aug;38(8):1751-8. doi: 10.3899/jrheum.110401.


Developing a construct to evaluate flares in rheumatoid arthritis: a conceptual report of the OMERACT RA Flare Definition Working Group.

Alten R, Pohl C, Choy EH, Christensen R, Furst DE, Hewlett SE, Leong A, May JE, Sanderson TC, Strand V, Woodworth TG, Bingham CO 3rd; OMERACT RA Flare Definition Working Group.

J Rheumatol. 2011 Aug;38(8):1745-50. doi: 10.3899/jrheum.110400.


'I'm hurting, I want to kill myself': rheumatoid arthritis flare is more than a high joint count--an international patient perspective on flare where medical help is sought.

Hewlett S, Sanderson T, May J, Alten R, Bingham CO 3rd, Cross M, March L, Pohl C, Woodworth T, Bartlett SJ.

Rheumatology (Oxford). 2012 Jan;51(1):69-76. doi: 10.1093/rheumatology/keq455. Epub 2011 May 12.


Biochemical markers of ongoing joint damage in rheumatoid arthritis--current and future applications, limitations and opportunities.

Karsdal MA, Woodworth T, Henriksen K, Maksymowych WP, Genant H, Vergnaud P, Christiansen C, Schubert T, Qvist P, Schett G, Platt A, Bay-Jensen AC.

Arthritis Res Ther. 2011 Apr 28;13(2):215. doi: 10.1186/ar3280. Review.


Effectiveness and safety of tocilizumab, an anti-interleukin-6 receptor monoclonal antibody, in a patient with refractory GI graft-versus-host disease.

Gergis U, Arnason J, Yantiss R, Shore T, Wissa U, Feldman E, Woodworth T.

J Clin Oncol. 2010 Oct 20;28(30):e602-4. doi: 10.1200/JCO.2010.29.1682. Epub 2010 Aug 16. No abstract available.


Novel combinations of Post-Translational Modification (PTM) neo-epitopes provide tissue-specific biochemical markers--are they the cause or the consequence of the disease?

Karsdal MA, Henriksen K, Leeming DJ, Woodworth T, Vassiliadis E, Bay-Jensen AC.

Clin Biochem. 2010 Jul;43(10-11):793-804. doi: 10.1016/j.clinbiochem.2010.03.015. Epub 2010 Apr 8. Review.


Population pharmacokinetic analysis of tocilizumab in patients with rheumatoid arthritis.

Frey N, Grange S, Woodworth T.

J Clin Pharmacol. 2010 Jul;50(7):754-66. doi: 10.1177/0091270009350623. Epub 2010 Jan 23.


Assessing single joints in arthritis clinical trials.

Keen HI, Bingham CO 3rd, Bradley LA, Conaghan PG, Heald AE, Kaeley GS, Maksymowych WP, Moskowitz RW, Schumacher HR Jr, Woodworth TE, Mease PJ.

J Rheumatol. 2009 Sep;36(9):2092-6. doi: 10.3899/jrheum.090364. Review.


Developing a standardized definition for disease "flare" in rheumatoid arthritis (OMERACT 9 Special Interest Group).

Bingham CO 3rd, Pohl C, Woodworth TG, Hewlett SE, May JE, Rahman MU, Witter JP, Furst DE, Strand CV, Boers M, Alten RE.

J Rheumatol. 2009 Oct;36(10):2335-41. doi: 10.3899/jrheum.090369. Epub 2009 Aug 14.


Comparison of tocilizumab monotherapy versus methotrexate monotherapy in patients with moderate to severe rheumatoid arthritis: the AMBITION study.

Jones G, Sebba A, Gu J, Lowenstein MB, Calvo A, Gomez-Reino JJ, Siri DA, Tomsic M, Alecock E, Woodworth T, Genovese MC.

Ann Rheum Dis. 2010 Jan;69(1):88-96. doi: 10.1136/ard.2008.105197.


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