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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: 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.
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.
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.
Defining changes in physical limitation from the patient perspective: insights from the VITALITY-HFpEF randomized trial.
Butler J, Spertus JA, Bamber L, Khan MS, Roessig L, Vlajnic V, Norquist JM, Anstrom KJ, Blaustein RO, Lam CSP, Armstrong PW; VITALITY-HFpEF Study Group. Butler J, et al. Among authors: norquist jm. Eur J Heart Fail. 2022 May;24(5):843-850. doi: 10.1002/ejhf.2481. Epub 2022 Apr 3. Eur J Heart Fail. 2022. PMID: 35274420 Free PMC article. Clinical Trial.
Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ): Measurement Properties and Estimated Clinically Meaningful Thresholds From a Phase 3 Study.
Williams P, Burke T, Norquist JM, Daskalopoulou C, Speck RM, Samkari A, Eremenco S, Coons SJ. Williams P, et al. Among authors: norquist jm. JTO Clin Res Rep. 2022 Feb 17;3(4):100298. doi: 10.1016/j.jtocrr.2022.100298. eCollection 2022 Apr. JTO Clin Res Rep. 2022. PMID: 35400081 Free PMC article.
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