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SPIRIT-PRO Extension explanation and elaboration: guidelines for inclusion of patient-reported outcomes in protocols of clinical trials.
Calvert M, King M, Mercieca-Bebber R, Aiyegbusi O, Kyte D, Slade A, Chan AW, Basch E, Bell J, Bennett A, Bhatnagar V, Blazeby J, Bottomley A, Brown J, Brundage M, Campbell L, Cappelleri JC, Draper H, Dueck AC, Ells C, Frank L, Golub RM, Griebsch I, Haywood K, Hunn A, King-Kallimanis B, Martin L, Mitchell S, Morel T, Nelson L, Norquist J, O'Connor D, Palmer M, Patrick D, Price G, Regnault A, Retzer A, Revicki D, Scott J, Stephens R, Turner G, Valakas A, Velikova G, von Hildebrand M, Walker A, Wenzel L. Calvert M, et al. Among authors: cappelleri jc. BMJ Open. 2021 Jun 30;11(6):e045105. doi: 10.1136/bmjopen-2020-045105. BMJ Open. 2021. PMID: 34193486 Free PMC article. Review.
Informing the Tolerability of Cancer Treatments Using Patient-Reported Outcome Measures: Summary of an FDA and Critical Path Institute Workshop.
Kluetz PG, Kanapuru B, Lemery S, Johnson LL, Fiero MH, Arscott K, Barbachano Y, Basch E, Campbell M, Cappelleri JC, Cella D, Cleeland C, Coens C, Daniels S, Denlinger CS, Fairclough DL, Hillard JR, Minasian L, Mitchell SA, O'Connor D, Patel S, Rubin EH, Ryden A, Soltys K, Sridhara R, Thanarajasingam G, Velikova G, Coons SJ. Kluetz PG, et al. Among authors: cappelleri jc. Value Health. 2018 Jun;21(6):742-747. doi: 10.1016/j.jval.2017.09.009. Epub 2017 Nov 7. Value Health. 2018. PMID: 29909880 Free article.
Patient-reported outcomes: conceptual issues.
Rothman ML, Beltran P, Cappelleri JC, Lipscomb J, Teschendorf B; Mayo/FDA Patient-Reported Outcomes Consensus Meeting Group. Rothman ML, et al. Among authors: cappelleri jc. Value Health. 2007 Nov-Dec;10 Suppl 2:S66-75. doi: 10.1111/j.1524-4733.2007.00269.x. Value Health. 2007. PMID: 17995476 Free article.
Tofacitinib or adalimumab versus placebo: patient-reported outcomes from OPAL Broaden-a phase III study of active psoriatic arthritis in patients with an inadequate response to conventional synthetic disease-modifying antirheumatic drugs.
Strand V, de Vlam K, Covarrubias-Cobos JA, Mease PJ, Gladman DD, Graham D, Wang C, Cappelleri JC, Hendrikx T, Hsu MA. Strand V, et al. Among authors: cappelleri jc. RMD Open. 2019 Jan 11;5(1):e000806. doi: 10.1136/rmdopen-2018-000806. eCollection 2019. RMD Open. 2019. PMID: 30713721 Free PMC article. Clinical Trial.
Effect of tofacitinib on patient-reported outcomes in patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors in the phase III, randomised controlled trial: OPAL Beyond.
Strand V, de Vlam K, Covarrubias-Cobos JA, Mease PJ, Gladman DD, Chen L, Kudlacz E, Wu J, Cappelleri JC, Hendrikx T, Hsu MA. Strand V, et al. Among authors: cappelleri jc. RMD Open. 2019 Jan 11;5(1):e000808. doi: 10.1136/rmdopen-2018-000808. eCollection 2019. RMD Open. 2019. PMID: 30713722 Free PMC article. Clinical Trial.
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