Emerging good practices for Translatability Assessment (TA) of Patient-Reported Outcome (PRO) measures by Catherine Acquadro, Donald L. Patrick, Sonya Eremenco, Mona L. Martin, Dagmara Kuliś, Helena Correia, Katrin Conway, on behalf of the International Society for Quality of Life Research (ISOQOL) Translation and Cultural Adaptation Special Interest Group (TCA-SIG)

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Clinical validation of a body-fixed 3D accelerometer and algorithm for activity monitoring in orthopaedic patients by Matthijs Lipperts, Simon van Laarhoven, Rachel Senden, Ide Heyligers, Bernd Grimm

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Patient-reported outcomes in vaccines research: relevance for decision-making by Desmond Curran, Eliazar Sabater Cabrera, Linda Nelsen

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Developing Angelman syndrome-specific clinician-reported and caregiver-reported measures to support holistic, patient-centered drug development by Siobhan Connor-Ahmad, Jorrit Tjeertes, Michael Chladek, Louise Newton, Tara Symonds, Susanne Clinch, Brenda Vincenzi, Fiona McDougall

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The Transthyretin Amyloidosis – Quality of Life (ATTR-QOL) Questionnaire: Development of a Conceptual Model and Disease-Specific Patient-Reported Outcome Measure by O'Connor M, Hsu K, Broderick L, McCausland KL, LaGasse K, Rebello S, Carty M, Lousada I

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How to select and understand guidelines for patient-reported outcomes: a scoping review of existing guidance by Takako Kaneyasu, Eri Hoshino, Mariko Naito, Yoshimi Suzukamo, Kikuko Miyazaki, Satomi Kojima, Takuhiro Yamaguchi, Takashi Kawaguchi, Tempei Miyaji, Takako Eguchi Nakajima, Kojiro Shimozuma

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Development of the Cutaneous Dermatomyositis Investigator Global Assessment (CDM-IGA): A De Novo IGA of Cutaneous Manifestations of Dermatomyositis by Stephanie McKee, Jason Xenakis, Harriet Makin, Chris Marshall, Randall Winnette, Rohit Aggarwal, Sarah L. Knight

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Conceptual assessment of HRQOL among Japanese non‐metastatic castration‐resistant prostate cancer (nmCRPC) patients by Kazuo Nishimura, Masaki Shiota, Masatoshi Eto, Takefumi Satoh, Angela Stroupe, Caroline Seo, Alyssa Uzumcu, Dianne Athene Ledesma

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How Much Evidence Is Enough? Research Sponsor Experiences Seeking Regulatory Acceptance of Digital Health Technology-Derived Endpoints by Brian Perry, Lindsay Kehoe, Teresa Swezey, Quentin Le Masne, Jörg Goldhahn, Alicia Staley, Amy Corneli

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Key measurement concepts and appropriate clinical outcome assessments in pediatric achondroplasia clinical trials by Natalie V. J. Aldhouse, Helen Kitchen, Chloe Johnson, Chris Marshall, Hannah Pegram, Sheryl Pease, Sam Collins, Christine L. Baker, Katherine Beaverson, Chandler Crews, Jill Massey, Kathleen W. Wyrwich

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Development of a Clinical Global Impression of Change (CGI-C) and a Caregiver Global Impression of Change (CaGI-C) measure for ambulant individuals with Duchenne muscular dystrophy by Hannah Staunton, Claire Trennery, Rob Arbuckle, Maitea Guridi, Elena Zhuravleva, Pat Furlong, Ryan Fischer, Rebecca Hall

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Technical Review of Clinical Outcomes Assessments Across the Continuum of Alzheimer's Disease by Dana B. DiBenedetti, Heather Menne, Russ Paulsen, Holly B. Krasa, George Vradenburg, Meryl Comer, Leigh F. Callahan, John Winfield, Michele Potashman, Kim Heithoff, Ann Hartry, Dorothee Oberdhan, Hilary Wilson, Deborah L. Hoffman, Dan Wieberg, Ian N. Kremer, Geraldine A. Taylor, James M. Taylor, Debra Lappin, Allison D. Martin, Brett Hauber, Carla Romano

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Flexible approaches to eCOA administration in clinical trials: The site perspective by Estelle Haenel, Celeste A. Elash, Katie Garner, Megan Turner, Scottie Kern

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Assessing the Relationship of Patient Reported Outcome Measures With Functional Status in Dysferlinopathy: A Rasch Analysis Approach by Anna G. Mayhew, Meredith K. James, Ursula Moore, Helen Sutherland, Marni Jacobs, Marni Jacobs, Jia Feng, Linda Pax Lowes, Lindsay N. Alfano, Robert Muni Lofra, Laura E. Rufibach, Kristy Rose, Tina Duong, Tina Duong, Luca Bello, Irene Pedrosa-Hernández, Scott Holsten, Chikako Sakamoto, Aurélie Canal, Nieves Sánchez-Aguilera Práxedes, Simone Thiele, Catherine Siener, Bruno Vandevelde, Brittney DeWolf, Elke Maron, Heather Gordish-Dressman, Heather Gordish-Dressman, Heather Hilsden, Michela Guglieri, Jean-Yves Hogrel, Andrew M. Blamire, Pierre G. Carlier, Simone Spuler, John W. Day, Kristi J. Jones, Diana X. Bharucha-Goebel, Diana X. Bharucha-Goebel, Emmanuelle Salort-Campana, Alan Pestronk, Maggie C. Walter, Carmen Paradas, Tanya Stojkovic, Madoka Mori-Yoshimura, Elena Bravver, Jordi Díaz-Manera, Jordi Díaz-Manera, Elena Pegoraro, Jerry R. Mendell, Volker Straub

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Experience of Daily Life with Generalized Myasthenia Gravis: A Qualitative Investigation and Assessment of Instrument Content Validity by Christopher A. Hartford, Steven A. Sherman, Stella Karantzoulis, Isabelle Guillemin, Michael G. Phinney, Kimberly L. Kelly, Kayla E. Negron, Shruti M. Raja, Diana Rofail

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Development and content validation of the Pediatric Oral Medicines Acceptability Questionnaires (P-OMAQ): patient-reported and caregiver-reported outcome measures by Diane M. Turner-Bowker, Kristina An Haack, Meaghan Krohe, Andrew Yaworsky, Norma Vivas, Masami Kelly, Godhuli Chatterjee, Emily Chaston, Erin Mann, Matthew Reaney

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Patient-reported outcome measures as an outcome variable in sports medicine research by Alison R. Snyder Valier, Alison R. Snyder Valier, Kellie C. Huxel Bliven, Kenneth C. Lam, Tamara C. Valovich McLeod, Tamara C. Valovich McLeod

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International workshop: what is needed to ensure outcome measures for Rett syndrome are fit-for-purpose for clinical trials? June 7, 2023, Nashville, USA by Jenny Downs, Dominique C. Pichard, Walter E. Kaufmann, Joseph P. Horrigan, Melissa Raspa, Gillian Townend, Eric D. Marsh, Helen Leonard, Kathleen Motil, Andrew C. Dietz, Nupur Garg, Amitha Ananth, Breanne Byiers, Sarika Peters, Christopher Beatty, Frank Symons, Aleksandra Jacobs, James Youakim, Bernhard Suter, Paramola Santosh, Jeffrey L. Neul, Tim A. Benke

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Understanding patient and caregiver perspectives using a dyad approach for data collection: A systematic review of the literature by Jane Loftus, Andrew Yaworsky, Diane Turner-Bowker, Andrew Palladino, Roger Lamoureux, Emily Love, Andreas Pleil

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Development of a novel observer-reported outcome measure for the assessment of Respiratory Syncytial Virus (RSV) infection symptoms in pediatric clinical trials by Sandy Lewis, Carla DeMuro, Stan L. Block, Shelly Senders, Paul Wisman, Seth Toback, Jason W. Chien, Valerie Williams

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