Journal of Patient-Reported Outcomes

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Patient-reported outcomes in breast cancer FDA drug labels and review documents
Journal of Patient-Reported Outcomes - - 2021
Kyungwan Hong, Kayleigh R. Majercak, Ester Villalonga-Olives, Eleanor M. Perfetto
Patient-reported outcomes (PROs) can provide valuable information about drug benefit-risk tradeoffs from the patient perspective and are particularly important to patients with breast cancer due to its symptoms and adverse events from breast cancer treatments. The United States Food and Drug Administration (U.S. FDA) has acknowledged PROs as important approval endpoints used in clinical trials of ...... hiện toàn bộ
Listening to the elephant in the room: response-shift effects in clinical trials research
Journal of Patient-Reported Outcomes - Tập 6 - Trang 1-14 - 2022
Carolyn E. Schwartz, I.-Chan Huang, Gudrun Rohde, Richard L. Skolasky
While a substantial body of work postulates that adaptation (response-shift effects) may serve to hide intervention benefits, much of the research was conducted in observational studies, not randomized-controlled trials. This scoping review identified all clinical trials that addressed response shift phenomena, and characterized how response-shift effects impacted trial findings. A scoping review ...... hiện toàn bộ
Qualitative research with patients and caregivers of patients with PIK3CA related overgrowth spectrum: content validity of clinical outcome assessments
Journal of Patient-Reported Outcomes - Tập 6 - Trang 1-11 - 2022
Kimberly Raymond, Susan Vallow, Cory Saucier, Kristi Jackson, Michelle K. White, Andrew Lovley, Denise D’Alessio
PIK3CA-Related Overgrowth Spectrum (PROS) are rare syndromes caused by a mutation in the PIK3CA gene, including fibroadipose hyperplasia or overgrowth; congenital lipomatous overgrowth, vascular malformations, epidermal nevi, scoliosis/skeletal and spinal (CLOVES); megalencephaly-capillary malformation (MCAP or M-CM); fibro-adipose vascular anomaly (FAVA); Klippel-Trenaunay syndrome (KT; also know...... hiện toàn bộ
Development of consensus-based considerations for use of adult proxy reporting: an ISOQOL task force initiative
Journal of Patient-Reported Outcomes - Tập 7 - Trang 1-16 - 2023
Brittany Lapin, Matthew L. Cohen, Nadia Corsini, Alyssa Lanzi, Sarah C. Smith, Antonia V. Bennett, Nancy Mayo, Rebecca Mercieca-Bebber, Sandra A. Mitchell, Claudia Rutherford, Jessica Roydhouse
Many large-scale population-based surveys, research studies, and clinical care allow for inclusion of proxy reporting as a strategy to collect outcomes when patients are unavailable or unable to provide reliable self-report. Prior work identified an absence of methodological guidelines regarding proxy reporting in adult populations, including who can serve as a proxy, and considerations for data c...... hiện toàn bộ
Psychometric properties of a custom Patient-Reported Outcomes Measurement Information System (PROMIS) physical function short form and worst stiffness numeric rating scale in tenosynovial giant cell tumors
Journal of Patient-Reported Outcomes - Tập 4 - Trang 1-14 - 2020
Rebecca M. Speck, Xin Ye, Nicholas M. Bernthal, Heather L. Gelhorn
The purpose of this study was to evaluate the psychometric properties of the PROMIS-Physical Function (PF) and Worst Stiffness Numeric Rating Scale (NRS) among patients with tenosynovial giant cell tumors (TGCT). Measurement properties of the customized lower extremity (LE) and upper extremity (UE) PROMIS-PF scales and Worst Stiffness NRS were assessed using data from the Phase 3 ENLIVEN trial (n ...... hiện toàn bộ
Validation of the French version of the Functional, Communicative and Critical Health Literacy scale (FCCHL)
Journal of Patient-Reported Outcomes - Tập 2 - Trang 1-6 - 2018
Youssoufa M. Ousseine, Alexandra Rouquette, Anne-Déborah Bouhnik, Laurent Rigal, Virginie Ringa, Allan ‘Ben’ Smith, Julien Mancini
Health literacy is a key asset, defined as the capacity to acquire, understand and use information in ways which promote and maintain good health. To assess the reliability and validity of the French translation of the Functional, Communicative and Critical Health Literacy (FCCHL) scale. A cross-sectional survey using an online questionnaire was proposed to all members of Seintinelles association....... hiện toàn bộ
A prospective study to validate the functional assessment of cancer therapy (FACT) for epidermal growth factor receptor inhibitor (EGFRI)-induced dermatologic toxicities FACT-EGFRI 18 questionnaire: SWOG S1013
Journal of Patient-Reported Outcomes - Tập 4 Số 1 - 2020
Siu-Fun Wong, Joseph M. Unger, James L. Wade, Lynne I. Wagner, Mario E. Lacouture, Keisha C. Humphries, Anna Moseley, Kathryn B. Arnold, M Velasco, Justin D. Floyd, Benjamin Esparaz, Afsaneh Barzi, Heinz Josef Lenz, Marianna Koczywas, Shaker R. Dakhil, Gary V. Burton, Michael Fisch, Norah Lynn Henry, Dawn L. Hershman, Carol M. Moinpour
Abstract Background Papulopustular rash is a common class effect of epidermal growth factor receptor inhibitors (EGFRI) that can affect patients’ health-related quality of life and cause disruptions to treatment. SWOG S1013 (NCT01416688) is a multi-center study designed to validate the Functional As...... hiện toàn bộ
The Severity of Chronic Cough Diary (SCCD): development and content validation of a novel patient-reported outcome instrument for evaluating the symptom experience of chronic cough
Journal of Patient-Reported Outcomes - Tập 7 - Trang 1-12 - 2023
Margarita de la Orden Abad, Claudia Haberland, Hayley Karn, Anne Skalicky, Asha Hareendran
Refractory chronic cough (RCC), a cough lasting longer than 8 weeks with an unexplained underlying etiology and unresponsive to conventional treatment, can have substantial effects on patients’ quality of life. For assessment of the efficacy of antitussive medication in clinical trials in RCC, patient-reported outcome (PRO) instruments should be fit for purpose with appropriate content validity. H...... hiện toàn bộ
Use of the patient-reported outcomes measurement information system (PROMIS®) to assess late-onset Pompe disease severity
Journal of Patient-Reported Outcomes - Tập 4 - Trang 1-11 - 2020
Melodi Harfouche, Priya S. Kishnani, Eva Krusinska, Jamie Gault, Sheela Sitaraman, Amanda Sowinski, Irina Katz, Stephanie Austin, Margi Goldstein, Andrew E. Mulberg
Patient-Reported Outcomes provide an opportunity for patients to establish dialogue with pharmaceutical or biotechnology companies about their health conditions without interpretation by a clinician or anyone else. However, Patient-Reported Outcomes that can be widely applicable for use in patient-focused drug development or clinical trial designs are not yet validated for all diseases. The aim of...... hiện toàn bộ
Content validation and psychometric evaluation of the Angioedema Quality of Life Questionnaire for hereditary angioedema
Journal of Patient-Reported Outcomes -
Magdalena Vanya, Maureen Watt, Saeid Shahraz, Charlotte E Kosmas, Stephanie Rhoten, Sara Costa-Cabral, Joan Mendívil, Giovanna Devercelli, Karsten Weller
Abstract Background There is considerable burden of illness in hereditary angioedema (HAE). However, instruments to assess health-related quality of life (HRQoL) in HAE are limited. The Angioedema Quality of Life Questionnaire (AE-QoL) was developed to measure HRQoL in patients with recurrent angioe...... hiện toàn bộ
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