Results 1 to 10 of about 2,863,004 (297)

Systematic review of guidance for the collection and use of patient-reported outcomes in real-world evidence generation to support regulation, reimbursement and health policy

Journal of Patient-Reported Outcomes, 2022
Background Real-world evidence (RWE) plays an increasingly important role within global regulatory and reimbursement processes. RWE generation can be enhanced by the collection and use of patient-reported outcomes (PROs), which can provide valuable ...
Konrad Maruszczyk, Olalekan Lee Aiyegbusi, Barbara Torlinska, Philip Collis, Thomas Keeley, Melanie J. Calvert   +5 more
doaj   +1 more source

Feasibility of a new electronic patient-reported outcome (ePRO) system for an advanced therapy clinical trial in immune-mediated inflammatory disease (PROmics): protocol for a qualitative feasibility study

BMJ Open, 2022
Introduction The use of electronic patient-reported outcome (ePRO) systems to capture PRO data in clinical trials is increasing; however, their feasibility, acceptability and utility in clinical trials of advanced therapy medicinal products (ATMPs) are ...
Ameeta Retzer, Christel McMullan, Melanie Calvert, Gary Price, Sarah E Hughes, Elin Haf Davies, Anna Rowe, Chris Frost, Roger Wilson, Philip N Newsome, Anita Walker, Gary McNamara, Rebecca Malpass, Camilla Bathurst, Rosie Harding   +14 more
doaj   +1 more source

Paving the way for patient centricity in real-world evidence (RWE): Qualitative interviews to identify considerations for wider implementation of patient-reported outcomes in RWE generation

Heliyon, 2023
Objectives: Real-world evidence (RWE) generation can be enhanced by including patient-reported outcomes (PROs). Methods for collecting and using PRO data in the real-world setting are currently underdeveloped and there is no international guidance ...
Konrad Maruszczyk, Christel McMullan, Olalekan Lee Aiyegbusi, Thomas Keeley, Roger Wilson, Philip Collis, Catherine Bottomley, Melanie J. Calvert   +7 more
doaj   +1 more source

Development and usability testing of an electronic patient-reported outcome (ePRO) solution for patients with inflammatory diseases in an Advanced Therapy Medicinal Product (ATMP) basket trial

Journal of Patient-Reported Outcomes, 2023
Background Electronic patient-reported outcome (ePRO) systems are increasingly used in clinical trials to provide evidence of efficacy and tolerability of treatment from the patient perspective.
Christel McMullan, Ameeta Retzer, Sarah E. Hughes, Olalekan Lee Aiyegbusi, Camilla Bathurst, Alan Boyd, Jamie Coleman, Elin Haf Davies, Alastair K. Denniston, Helen Dunster, Chris Frost, Rosie Harding, Amanda Hunn, Derek Kyte, Rebecca Malpass, Gary McNamara, Sandra Mitchell, Saloni Mittal, Philip N. Newsome, Gary Price, Anna Rowe, Wilma van Reil, Anita Walker, Roger Wilson, Melanie Calvert   +24 more
doaj   +1 more source

Assessing asthma symptoms in children: qualitative research supporting the development of the Pediatric Asthma Diary—Child (PAD-C) and Pediatric Asthma Diary—Observer (PAD-O)

Journal of Patient-Reported Outcomes, 2023
Background Pediatric asthma has been identified by regulators, clinicians, clinical trial sponsors, and caregivers as an area in need of novel fit-for-purpose clinical outcome assessments (COAs) developed in accordance with the U.S.
Helena Bradley, Claire Trennery, Amy M. Jones, Aoife Lydon, Frances White, Rebecca Williams-Hall, Rob Arbuckle, Erin Tomaszewski, Vivian H. Shih, John Haughney, Amanda Eisen, Tonya Winders, Stephen Joel Coons, Sonya Eremenco, the Patient-Reported Outcome Consortium’s Pediatric Asthma Working Group   +14 more
doaj   +1 more source

Patient-reported outcome (PRO) instruments used in patients undergoing adoptive cell therapy (ACT) for the treatment of cancer: a systematic review

Systematic Reviews, 2023
Introduction Adoptive cell therapy (ACT) is a rapidly evolving field. Patient-reported outcomes (PROs) allow patients to report the impact of treatment on their quality of life during and after treatment.
Sally Taylor, Kate Law, Jake Coomber-Moore, Michelle Davies, Fiona Thistlethwaite, Mel Calvert, Olalekan Aiyegbusi, Janelle Yorke   +7 more
doaj   +1 more source

Protocol for a scoping review exploring the use of patient-reported outcomes in adult social care

BMJ Open, 2021
Introduction Patient-reported outcomes (PROs) are measures of a person’s own views of their health, functioning and quality of life. They are typically assessed using validated, self-completed questionnaires known as patient-reported outcome measures ...
Grace M Turner, Christel McMullan, Melanie Calvert, Sarah E Hughes, Daniel S Lasserson, Jon Glasby, Olalekan Lee Aiyegbusi, Philip Collis, Samantha Cruz Rivera   +8 more
doaj   +1 more source

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

Current Therapeutic Research, 2021
: 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 regulatory ...
Donald M. Bushnell, MA, Thomas M. Atkinson, PhD, Kelly P. McCarrier, PhD, Astra M. Liepa, PharmD, Kendra P. DeBusk, PhD, Stephen Joel Coons, PhD   +5 more
doaj   +1 more source

Patient reported outcome measures in rare diseases: a narrative review

Orphanet Journal of Rare Diseases, 2018
Background Rare diseases can lead to a significant reduction in quality of life for patients and their families. Ensuring the patients voice is central to clinical decision making is key to delivering, evaluating and understanding the efficacy of ...
Anita Slade, Fatima Isa, Derek Kyte, Tanya Pankhurst, Larissa Kerecuk, James Ferguson, Graham Lipkin, Melanie Calvert   +7 more
doaj   +1 more source

Machine learning to predict individual patient-reported outcomes at 2-year follow-up for women undergoing cancer-related mastectomy and breast reconstruction (INSPiRED-001)

Breast, 2021
Background: Women undergoing cancer-related mastectomy and reconstruction are facing multiple treatment choices where post-surgical satisfaction with breasts is a key outcome.
André Pfob, Babak J. Mehrara, Jonas A. Nelson, Edwin G. Wilkins, Andrea L. Pusic, Chris Sidey-Gibbons   +5 more
doaj   +1 more source