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 …

International standards for the analysis of quality-of-life and patient-reported outcome endpoints in cancer randomised controlled trials: recommendations of the …

C Coens, M Pe, AC Dueck, J Sloan, E Basch… - The Lancet …, 2020 - thelancet.com
Summary Patient-reported outcomes (PROs), such as symptoms, function, and other health-
related quality-of-life aspects, are increasingly evaluated in cancer randomised controlled …

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 …

Increasing value and reducing waste in biomedical research: who's listening?

D Moher, P Glasziou, I Chalmers, M Nasser… - The Lancet, 2016 - thelancet.com
The biomedical research complex has been estimated to consume almost a quarter of a
trillion US dollars every year. Unfortunately, evidence suggests that a high proportion of this …

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 …

Analysing data from patient-reported outcome and quality of life endpoints for cancer clinical trials: a start in setting international standards

A Bottomley, M Pe, J Sloan, E Basch… - The Lancet …, 2016 - thelancet.com
Measures of health-related quality of life (HRQOL) and other patient-reported outcomes
generate important data in cancer randomised trials to assist in assessing the risks and …

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 …

Reminding peer reviewers of reporting guideline items to improve completeness in published articles: primary results of 2 randomized trials

B Speich, E Mann, CM Schönenberger… - JAMA Network …, 2023 - jamanetwork.com
Importance Numerous studies have shown that adherence to reporting guidelines is
suboptimal. Objective To evaluate whether asking peer reviewers to check if specific …

Design, implementation and reporting strategies to reduce the instance and impact of missing patient-reported outcome (PRO) data: a systematic review

R Mercieca-Bebber, MJ Palmer, M Brundage… - BMJ open, 2016 - bmjopen.bmj.com
Objectives Patient-reported outcomes (PROs) provide important information about the
impact of treatment from the patients' perspective. However, missing PRO data may …

Systematic evaluation of patient-reported outcome protocol content and reporting in cancer trials

D Kyte, A Retzer, K Ahmed, T Keeley… - JNCI: Journal of the …, 2019 - academic.oup.com
Abstract Background Patient-reported outcomes (PROs) are captured within cancer trials to
help future patients and their clinicians make more informed treatment decisions. However …