Tove Ragna Reksten

Handling missing values in patient-reported outcome data in the presence of intercurrent events

Doranne Thomassen, Satrajit Roychoudhury, Cecilie Delphin Amdal, Dries Reynders et autres

INTRODUCTION: As patient-reported outcomes (PROs) are increasingly used in the evaluation of medical treatments, it is important that PROs are carefully analyzed and interpreted. This may be challenging due to substantial missing values. The missingness in PROs is often closely related to …

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The role of the estimand framework in the analysis of patient-reported outcomes in single-arm trials: a case study in oncology

Doranne Thomassen, Satrajit Roychoudhury, Cecilie Delphin Amdal, Dries Reynders et autres

BACKGROUND: Patient-reported outcomes (PROs) play an increasing role in the evaluation of oncology treatments. At the same time, single-arm trials are commonly included in regulatory approval submissions. Because of the high risk of biases, results from single-arm trials require careful interpretation. This …

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Methodological Work and Use of Patient-Reported Outcomes Data in Randomised Controlled Trials (Rcts) in Cancer: Literature Reviews on Current Practices and Guidelines

Abigirl Machingura, Corneel Coens, Madeline Lee Pe, Ahu Alanya et autres

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Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials-Innovative Medicines Initiative (SISAQOL-IMI): stakeholder views, objectives, and procedures

Madeline Lee Pe, Ahu Alanya, Ragnhild Sørum Falk, Cecilie Delphin Amdal et autres

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Author Correction: Genome-wide association study identifies Sjögren’s risk loci with functional implications in immune and glandular cells

Bhuwan Khatri, Kandice L. Tessneer, Astrid Rasmussen, Farhang F. Aghakhanian et autres

The original version of this Article contained an error in Fig. 3, in which the case and control colors were swapped in panels c and f. The correct version of Fig. 3 is:

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Author Correction: Genome-wide association study identifies Sjögren’s risk loci with functional implications in immune and glandular cells

Bhuwan Khatri, Kandice L. Tessneer, Astrid Rasmussen, Farhang F. Aghakhanian et autres

In this article the funding from ‘FOREUM Foundation for Research in Rheumatology’ was omitted. The original article has been corrected.

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Genome-wide association study identifies Sjögren’s risk loci with functional implications in immune and glandular cells

Bhuwan Khatri, Kandice L. Tessneer, Astrid Rasmussen, Farhang F. Aghakhanian et autres

Sjögren's disease is a complex autoimmune disease with twelve established susceptibility loci. This genome-wide association study (GWAS) identifies ten novel genome-wide significant (GWS) regions in Sjögren's cases of European ancestry: CD247, NAB1, PTTG1-MIR146A, PRDM1-ATG5, TNFAIP3, XKR6, MAPT-CRHR1, RPTOR-CHMP6-BAIAP6, TYK2, SYNGR1. Polygenic risk …

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Exploring the opportunities for alignment of regulatory postauthorization requirements and data required for performance-based managed entry agreements

Hans‐Georg Eichler, Róisín Adams, Einar Andreassen, Peter R. Arlett et autres

Performance-based managed entry agreements (PB-MEAs) might allow patient access to new medicines, but practical hurdles make competent authorities for pricing and reimbursement (CAPR) reluctant to implement PB-MEAs. We explored if the feasibility of PB-MEAs might improve by better aligning regulatory postauthorization requirements …

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OP0047 GENOME-WIDE ASSOCIATION STUDY OF SJÖGREN'S SYNDROME IDENTIFIES TEN NEW RISK LOCI

Bhuwan Khatri, Tove Ragna Reksten, Kandice L. Tessneer, Astrid Rasmussen et autres

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Identification of a Sjögren's syndrome susceptibility locus at OAS1 that influences isoform switching, protein expression, and responsiveness to type I interferons

He Li, Tove Ragna Reksten, John A. Ice, Jennifer A. Kelly et autres

Sjo ¨gren's syndrome (SS) is a common, autoimmune exocrinopathy distinguished by keratoconjunctivitis sicca and xerostomia.Patients frequently develop serious complications including lymphoma, pulmonary dysfunction, neuropathy, vasculitis, and debilitating fatigue.Dysregulation of type I interferon (IFN) pathway is a prominent feature of SS and is …

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Sjögren syndrome genetics vary according to ancestry

Tove Ragna Reksten, Roland Jonsson

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Genetics in Sjögren Syndrome

Tove Ragna Reksten, Christopher J. Lessard, Kathy L. Moser Sivils

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