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Recommendations to address respondent burden associated with patient-reported outcome assessment.
Aiyegbusi OL, Cruz Rivera S, Roydhouse J, Kamudoni P, Alder Y, Anderson N, Baldwin RM, Bhatnagar V, Black J, Bottomley A, Brundage M, Cella D, Collis P, Davies EH, Denniston AK, Efficace F, Gardner A, Gnanasakthy A, Golub RM, Hughes SE, Jeyes F, Kern S, King-Kallimanis BL, Martin A, McMullan C, Mercieca-Bebber R, Monteiro J, Peipert JD, Quijano-Campos JC, Quinten C, Rantell KR, Regnault A, Sasseville M, Schougaard LMV, Sherafat-Kazemzadeh R, Snyder C, Stover AM, Verdi R, Wilson R, Calvert MJ. Aiyegbusi OL, et al. Among authors: gnanasakthy a. Nat Med. 2024 Mar;30(3):650-659. doi: 10.1038/s41591-024-02827-9. Epub 2024 Feb 29. Nat Med. 2024. PMID: 38424214 Review.
Quality of life improvements following one year of setmelanotide in children and adult patients with Bardet-Biedl syndrome: phase 3 trial results.
Forsythe E, Haws RM, Argente J, Beales P, Martos-Moreno GÁ, Dollfus H, Chirila C, Gnanasakthy A, Buckley BC, Mallya UG, Clément K, Haqq AM. Forsythe E, et al. Among authors: gnanasakthy a. Orphanet J Rare Dis. 2023 Jan 16;18(1):12. doi: 10.1186/s13023-022-02602-4. Orphanet J Rare Dis. 2023. PMID: 36647077 Free PMC article. Clinical Trial.
Ethical Considerations for the Inclusion of Patient-Reported Outcomes in Clinical Research: The PRO Ethics Guidelines.
Cruz Rivera S, Aiyegbusi OL, Ives J, Draper H, Mercieca-Bebber R, Ells C, Hunn A, Scott JA, Fernandez CV, Dickens AP, Anderson N, Bhatnagar V, Bottomley A, Campbell L, Collett C, Collis P, Craig K, Davies H, Golub R, Gosden L, Gnanasakthy A, Haf Davies E, von Hildebrand M, Lord JM, Mahendraratnam N, Miyaji T, Morel T, Monteiro J, Zwisler AO, Peipert JD, Roydhouse J, Stover AM, Wilson R, Yap C, Calvert MJ. Cruz Rivera S, et al. Among authors: gnanasakthy a. JAMA. 2022 May 17;327(19):1910-1919. doi: 10.1001/jama.2022.6421. JAMA. 2022. PMID: 35579638
Advancing patient-centric care: integrating patient reported outcomes for tolerability assessment in early phase clinical trials - insights from an expert virtual roundtable.
Yap C, Lee Aiyegbusi O, Alger E, Basch E, Bell J, Bhatnagar V, Cella D, Collis P, Dueck AC, Gilbert A, Gnanasakthy A, Greystoke A, Hansen AR, Kamudoni P, Kholmanskikh O, King-Kallimanis BL, Krumholz H, Minchom A, O'Connor D, Petrie J, Piccinin C, Rantell KR, Rauz S, Retzer A, Rizk S, Wagner L, Sasseville M, Seymour LK, Weber HA, Wilson R, Calvert M, Peipert JD. Yap C, et al. Among authors: gnanasakthy a. EClinicalMedicine. 2024 Sep 24;76:102838. doi: 10.1016/j.eclinm.2024.102838. eCollection 2024 Oct. EClinicalMedicine. 2024. PMID: 39386161 Free PMC article. Review.
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