The importance of patient-reported outcomes in clinical trials and strategies for future optimization

R Mercieca-Bebber, MT King, MJ Calvert… - Patient related …, 2018 - Taylor & Francis
Patient-reported outcomes (PROs) can be included in clinical trials as primary or secondary
endpoints and are increasingly recognized by regulators, clinicians, and patients as …

SPIRIT-PRO Extension explanation and elaboration: guidelines for inclusion of patient-reported outcomes in protocols of clinical trials

M Calvert, M King, R Mercieca-Bebber, O Aiyegbusi… - BMJ open, 2021 - bmjopen.bmj.com
Patient-reported outcomes (PROs) are used in clinical trials to provide valuable evidence on
the impact of disease and treatment on patients' symptoms, function and quality of life. High …

Guidelines for inclusion of patient-reported outcomes in clinical trial protocols: the SPIRIT-PRO extension

M Calvert, D Kyte, R Mercieca-Bebber, A Slade… - Jama, 2018 - jamanetwork.com
Importance Patient-reported outcome (PRO) data from clinical trials can provide valuable
evidence to inform shared decision making, labeling claims, clinical guidelines, and health …

Ethical considerations for the inclusion of patient-reported outcomes in clinical research: the PRO ethics guidelines

SC Rivera, OL Aiyegbusi, J Ives, H Draper… - Jama, 2022 - jamanetwork.com
Importance Patient-reported outcomes (PROs) can inform health care decisions, regulatory
decisions, and health care policy. They also can be used for audit/benchmarking and …

A review of patient-reported outcomes used for regulatory approval of oncology medicinal products in the European Union between 2017 and 2020

MM Teixeira, FC Borges, PS Ferreira, J Rocha… - Frontiers in …, 2022 - frontiersin.org
Introduction Cancer and corresponding available treatments are associated with substantial
symptoms and functional limitations. In this context, collection of patient-reported outcomes …

Strategies to improve patient-reported outcome completion rates in longitudinal studies

LK Nielsen, M King, S Möller, M Jarden… - Quality of Life …, 2020 - Springer
Purpose The quality of patient-reported outcome (PRO) data can be compromised by non-
response (NR) to scheduled questionnaires, particularly if reasons for NR are related to …

Clinical research nurses' expectations and realities of their role: A qualitative evidence synthesis

O Hernon, R Dalton, M Dowling - Journal of Clinical Nursing, 2020 - Wiley Online Library
Aims To synthesise the available body of qualitative studies relating to clinical research
nurses' experiences of their role. Methods A systematic search of the literature in five …

User experiences on implementation of patient reported outcome measures (PROMs) in a haematological outpatient clinic

S Thestrup Hansen, M Kjerholt… - Journal of patient …, 2020 - Springer
Background PROMs can help healthcare professionals gain an improved understanding of
patients' physical burdens, functional levels, and (health-related) quality of life throughout …

Electronic patient reporting of adverse events and quality of life: a prospective feasibility study in general oncology

F Kennedy, K Absolom, B Clayton, Z Rogers… - JCO Oncology …, 2021 - ascopubs.org
PURPOSE: Adverse event (AE) reporting is essential in clinical trials. Clinician interpretation
can result in under-reporting; therefore, the value of patient self-reporting has been …

Using patient-reported outcomes in dose-finding oncology trials: Surveys of Key Stakeholders and the National Cancer Research Institute Consumer Forum

J Lai-Kwon, AM Vanderbeek, A Minchom… - The …, 2022 - academic.oup.com
Background Patient-reported adverse events may be a useful adjunct for assessing a drug's
tolerability in dose-finding oncology trials (DFOT). We conducted surveys of international …