Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ): Measurement Properties and Estimated Clinically Meaningful Thresholds From a Phase 3 Study

Autor: Paul Williams, MPH, Thomas Burke, PharmD, PhD, Josephine M. Norquist, MS, Christina Daskalopoulou, PhD, Rebecca M. Speck, PhD, MPH, Ayman Samkari, MD, Sonya Eremenco, MA, Stephen Joel Coons, PhD

Publikováno v: JTO Clinical and Research Reports, Vol 3, Iss 4, Pp 100298- (2022)

Introduction: The NSCLC Symptom Assessment Questionnaire (NSCLC-SAQ) was developed to assess NSCLC symptom severity in accordance with Food and Drug Administration evidentiary expectations leading to Food and Drug Administration qualification in 2018

Externí odkaz: https://doaj.org/article/8d468e1a5b034839bcd5b307bedd8363

Non–Small Cell Lung Cancer Symptom Assessment Questionnaire: Psychometric Performance and Regulatory Qualification of a Novel Patient-Reported Symptom Measure

Autor: Donald M. Bushnell, MA, Thomas M. Atkinson, PhD, Kelly P. McCarrier, PhD, Astra M. Liepa, PharmD, Kendra P. DeBusk, PhD, Stephen Joel Coons, PhD

Publikováno v: Current Therapeutic Research, Vol 95, Iss , Pp 100642- (2021)

ABSTRACT: Background: The Non–Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) was developed to incorporate the patient's perspective into evaluation of clinical benefit in advanced non–small cell lung cancer trials and meet re

Externí odkaz: https://doaj.org/article/8a6efa162794453a945beaf5008c4499

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

Autor: Madeline Pe, Ahu Alanya, Ragnhild Sorum Falk, Cecilie Delphin Amdal, Kristin Bjordal, Jane Chang, Paul Cislo, Corneel Coens, Linda Dirven, Rebecca M Speck, Kristina Fitzgerald, Jayne Galinsky, Johannes M Giesinger, Bernhard Holzner, Saskia Le Cessie, Daniel O'Connor, Kathy Oliver, Vivek Pawar, Chantal Quinten, Michael Schlichting, Jinma Ren, Satrajit Roychoudhury, Martin J B Taphoorn, Galina Velikova, Lisa M Wintner, Ingolf Griebsch, Andrew Bottomley, Cat Bui, Nnadozie Emechebe, Rajesh Kamalakar, Elektra Papadopoulos, Kavita Sail, Rohini Sen, Sean C Turner, Kim Cocks, Jaap Reijneveld, Christoph Gerlinger, Karen Keating, Yun Su, Birgit Wolf, Miaomiao Ge, Anders Ingelgaard, Barbara Peil, Maarten Voorhaar, Brendon Wong, Gracia Dekanic Arbanas, Karin Kuljanic, Duska Petranovic, Ivana Rede, Juan Arraras, Stephen Joel Coons, Sonya Eremenco, Lindsey Murray, Bryce Reeve, Corinne De Vries, Ralf Herold, Francesco Pignatti, Abigirl Machingura, Francesca Martinelli, Jammbe Musoro, Martine Piccart, Jorge Barriuso, Nathan Cherny, Ourania Dafni, Elisabeth De Vries, Bishal Gyawali, Barbara Kiesewetter, Sjoukje Oosting, Felipe Roitberg, Gerhard Rumpold, Felix Schoepf, Michael Tschuggnall, Jennifer Black, Maxime Sasseville, Katherine Soltys, Montserrat Ferrer, Olatz Garin, Gemma Vilagut, Christoph Schürmann, Stefanie Thomas, Beate Wieseler, Claire Snyder, Ariel Alonso Abad, Kris Bogaerts, Febe Brackx, Geert Molenberghs, Geert Verbeke, Cristián Frigolett Catalan, Jan Choi, Doranne Thomassen, Jan Geissler, Willi Sauerbrei, Franziska Gross, Micha Johannes Pilz, Yolanda Barbachano, Lisa Campbell, Khadija Rantell, Gregoire Desplanques, Antoine Regnault, Kate Morgan, Ananda Plate, Silene ten Seldam, Mitsumi Terada, Junki Mizusawa, Sandra Mitchell, Ashley Wilder Smith, Tove Ragna Reksten, Anja Schiel, Kenth Louis Hansen Joseph, Alicyn Campbell, Joseph Cappelleri, Patrizia de Besi, Alexander Russell-Smith, Rickard Sandin, Carla Mamolo, Michael Brundage, Dongsheng Tu, Mogens Groenvold, Morten Petersen, Charlie Cleeland, Lori Williams, Xin Shelley Wang, Jolie Ringash, Melanie Calvert, Samantha Cruz Rivera, Olalekan Lee Aiyegbusi, Els Goetghebeur, Limin Liu, Kelly Van Lancker, Florien Boele, Alexandra Gilbert, Rosemary Peacock, Ethan Basch, Madeleine King, Claudia Rutherford, Vishal Bhatnagar, Mallorie Fiero, Erica Horodniceanu, Laura Lee Johnson, Paul Kluetz, Lisa Rodriguez

Publikováno v: SISAQOL-IMI Consortium & et al. 2023, ' 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 ', Lancet Oncology, vol. 24, no. 6, pp. e270-e283 . https://doi.org/10.1016/S1470-2045(23)00157-2

Patient-reported outcomes (PROs), such as symptoms, functioning, and other health-related quality-of-life concepts are gaining a more prominent role in the benefit–risk assessment of cancer therapies. However, varying ways of analysing, presenting,

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5c9c09b5d5b8e72fb9e0a912f8763409
https://research.manchester.ac.uk/en/publications/0a737d16-9496-4acc-8a64-8e7eca001879

Asthma Daytime Symptom Diary (ADSD) and Asthma Nighttime Symptom Diary (ANSD) : measurement properties of novel patient-reported symptom measures

Autor: Adam Gater, Linda Nelsen, Cheryl D. Coon, Sonya Eremenco, Sean O’Quinn, Asif H. Khan, Laurent Eckert, Hannah Staunton, Nicola Bonner, Rebecca Hall, Jerry A. Krishnan, Stuart Stoloff, Michael Schatz, John Haughney, Stephen Joel Coons

Publikováno v: JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY-IN PRACTICE

BACKGROUND: The Asthma Daytime Symptom Diary (ADSD) and the Asthma Nighttime Symptom Diary (ANSD) were developed to meet the need for standardized patient-reported measures of asthma symptoms to assess treatment trial outcomes in adults and adolescen

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9b9d2b63442bf16c52f200f677f8542c
https://hdl.handle.net/1854/LU-8747116

Why Reinvent the Wheel? Use or Modification of Existing Clinical Outcome Assessment Tools in Medical Product Development

Autor: Sonya Eremenco, Stephen Joel Coons, Elizabeth Nicole Bush, Elektra J. Papadopoulos

Publikováno v: Value in Health. 23:151-153

Assessment of clinical benefit in treatment trials can be made through report by a clinician, a patient, or a nonclinician observer (eg, caregiver) or through a performance-based assessment. The US Food and Drug Administration (FDA) published a final

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::11ab54c0482be472169786e349a432ce
https://doi.org/10.1016/j.jval.2019.09.2745