The importance of patient-reported outcomes in clinical trials and strategies for future optimization
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 …
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
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 …
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
Importance Patient-reported outcome (PRO) data from clinical trials can provide valuable
evidence to inform shared decision making, labeling claims, clinical guidelines, and health …
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
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 …
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
Introduction Cancer and corresponding available treatments are associated with substantial
symptoms and functional limitations. In this context, collection of patient-reported outcomes …
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 …
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 …
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 …
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
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 …
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 …
tolerability in dose-finding oncology trials (DFOT). We conducted surveys of international …