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Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols: The SPIRIT-PRO Extension.
Calvert M, Kyte D, Mercieca-Bebber R, Slade A, Chan AW, King MT; the SPIRIT-PRO Group; Hunn A, Bottomley A, Regnault A, Chan AW, Ells C, O'Connor D, Revicki D, Patrick D, Altman D, Basch E, Velikova G, Price G, Draper H, Blazeby J, Scott J, Coast J, Norquist J, Brown J, Haywood K, Johnson LL, Campbell L, Frank L, von Hildebrand M, Brundage M, Palmer M, Kluetz P, Stephens R, Golub RM, Mitchell S, Groves T. Calvert M, et al. Among authors: norquist j. JAMA. 2018 Feb 6;319(5):483-494. doi: 10.1001/jama.2017.21903. JAMA. 2018. PMID: 29411037 Free article.
International Society for Quality of Life Research commentary on the draft European Medicines Agency reflection paper on the use of patient-reported outcome (PRO) measures in oncology studies.
Kyte D, Reeve BB, Efficace F, Haywood K, Mercieca-Bebber R, King MT, Norquist JM, Lenderking WR, Snyder C, Ring L, Velikova G, Calvert M. Kyte D, et al. Qual Life Res. 2016 Feb;25(2):359-362. doi: 10.1007/s11136-015-1099-z. Epub 2015 Aug 15. Qual Life Res. 2016. PMID: 26275979 Free article.
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: norquist j. BMJ Open. 2021 Jun 30;11(6):e045105. doi: 10.1136/bmjopen-2020-045105. BMJ Open. 2021. PMID: 34193486 Free PMC article. Review.
Methods for interpreting change over time in patient-reported outcome measures.
Wyrwich KW, Norquist JM, Lenderking WR, Acaster S; Industry Advisory Committee of International Society for Quality of Life Research (ISOQOL). Wyrwich KW, et al. Among authors: norquist jm. Qual Life Res. 2013 Apr;22(3):475-83. doi: 10.1007/s11136-012-0175-x. Epub 2012 Apr 17. Qual Life Res. 2013. PMID: 22528240 Review.
55 results