Results 1 to 10 of about 2,569,145 (337)

Clinical outcome assessment in clinical trials of chronic pain treatments [PDF]

PAIN Reports, 2021
. Clinical outcome assessments (COAs) measure outcomes that are meaningful to patients in clinical trials and are critical for determining whether a treatment is effective.
Kushang V. Patel, Dagmar Amtmann, Mark P. Jensen, Shannon M. Smith, Christin Veasley, Dennis C. Turk   +5 more
doaj   +4 more sources

Clinical outcome assessment trends in clinical trials—Contrasting oncology and non‐oncology trials [PDF]

Cancer Medicine, 2023
Background Clinical outcome assessments (COAs) are key to patient‐centered evaluation of novel interventions and supportive care. COAs are particularly informative in oncology where a focus on how patients feel and function is paramount, but their ...
Yeonju Kim, Mark R. Gilbert, Terri S. Armstrong, Orieta Celiku   +3 more
doaj   +2 more sources

Review of Clinical Outcome Assessments in Pediatric Attention-Deficit/Hyperactivity Disorder

Neuropsychiatric Disease and Treatment, 2020
Jessica T Markowitz,1 Dorothee Oberdhan,2 Anna Ciesluk,1 Alissa Rams,1 Sharon B Wigal3 1Research Department, Modus Outcomes, Cambridge, MA 02142, USA; 2HEOR and Outcomes Management, Otsuka America Pharmaceutical, Inc, Rockville, MD 20850, USA ...
Markowitz JT, Oberdhan D, Ciesluk A, Rams A, Wigal SB   +4 more
doaj   +1 more source

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

JTO Clinical and Research Reports, 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 ...
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   +7 more
doaj   +1 more source

Comparability of a provisioned device versus bring your own device for completion of patient-reported outcome measures by participants with chronic obstructive pulmonary disease: qualitative interview findings

Journal of Patient-Reported Outcomes, 2022
Background There is interest in participants using their own smartphones or tablets (“bring your own device”; BYOD) to complete patient-reported outcome (PRO) measures in clinical studies.
Louise Newton, Oliver Knight-West, Sonya Eremenco, Stacie Hudgens, Mabel Crescioni, Tara Symonds, David S. Reasner, Bill Byrom, Paul O’Donohoe, Susan Vallow, the Patient-Reported Outcome (PRO) Consortium, Electronic Clinical Outcome Assessment (eCOA) Consortium   +11 more
doaj   +1 more source

Tumor-infiltrating lymphocytes provides recent survival information for early-stage HER2-low-positive breast cancer: a large cohort retrospective study

Frontiers in Oncology, 2023
PurposeIt has been reported that breast cancer (BC) with low expression of human epidermal growth factor receptor 2 (HER2) might be a distinct subtype of BC. However, the prognostic effect of low HER2 expression on BC patients remains controversial.
Teng Sun, Teng Sun, Tong Wang, Xiangjun Li, Xiangjun Li, Haibo Wang, Haibo Wang, Yan Mao, Yan Mao   +8 more
doaj   +1 more source

Comparability of a provisioned device versus bring your own device for completion of patient-reported outcome measures by participants with chronic obstructive pulmonary disease: quantitative study findings

Journal of Patient-Reported Outcomes, 2022
Highlights Historically, provisioned handheld devices [PD] have been provided to participants to enter patient-reported outcome (PRO) data during a clinical trial.
Stacie Hudgens, Louise Newton, Sonya Eremenco, Mabel Crescioni, Tara Symonds, Philip C. G. Griffiths, David S. Reasner, Bill Byrom, Paul O’Donohoe, Susan Vallow, the Patient-Reported Outcome (PRO) Consortium and Electronic Clinical Outcome Assessment (eCOA) Consortium   +10 more
doaj   +1 more source

Long-term progression of clinician-reported and gait performance outcomes in hereditary spastic paraplegias

Frontiers in Neuroscience, 2023
IntroductionHereditary spastic paraplegias (HSPs) are a heterogeneous group of neurodegenerative diseases in which little is known about the most appropriate clinical outcome assessments (COAs) to capture disease progression.
Diana Maria Cubillos Arcila, Diana Maria Cubillos Arcila, Gustavo Dariva Machado, Valéria Feijó Martins, Vanessa Bielefeldt Leotti, Vanessa Bielefeldt Leotti, Rebecca Schüle, Leonardo Alexandre Peyré-Tartaruga, Leonardo Alexandre Peyré-Tartaruga, Jonas Alex Morales Saute, Jonas Alex Morales Saute, Jonas Alex Morales Saute, Jonas Alex Morales Saute, Jonas Alex Morales Saute   +13 more
doaj   +1 more source

How Much Evidence Is Enough? Research Sponsor Experiences Seeking Regulatory Acceptance of Digital Health Technology-Derived Endpoints

Digital Biomarkers, 2023
Introduction: Digital health technologies (DHTs) provide opportunities for real-time data collection and assessment of patient function. However, use of DHT-derived endpoints in clinical trials to support medical product labelling claims is limited ...
Brian Perry, Lindsay Kehoe, Teresa Swezey, Quentin Le Masne, Jörg Goldhahn, Alicia Staley, Amy Corneli   +6 more
doaj   +1 more source

Objective Assessment of Surgical Operative Performance by Observational Clinical Human Reliability Analysis (OC-HRA):A Systematic Review [PDF]

, 2020
Background: Both morbidity and mortality data (MMD) and learning curves (LCs) do not provide information on the nature of intraoperative errors and their mechanisms when these adversely impact on patient outcome.
Cuschieri, Alfred, Tang, Benjie
core   +2 more sources