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 …

[HTML][HTML] The impact of patient-reported outcome (PRO) data from clinical trials: a systematic review and critical analysis

SC Rivera, DG Kyte, OL Aiyegbusi, AL Slade… - Health and quality of life …, 2019 - Springer
Abstract Background Patient-reported outcomes (PROs) are commonly collected in clinical
trials and should provide impactful evidence on the effect of interventions on patient …

Patient reported outcomes in orthopaedics

JJ Gagnier - Journal of Orthopaedic Research, 2017 - Wiley Online Library
Patient reported outcome measures (PROMs) are key tools when performing clinical
research and PROM data are increasingly used to inform clinical decision‐making, patient …

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 …

Management of radiation toxicity in head and neck cancers

F Siddiqui, B Movsas - Seminars in Radiation Oncology, 2017 - Elsevier
Head and neck cancers account for approximately 3% of all cancers in the United States
with 62,000 new cases diagnosed annually. The global incidence is approximately 700,000 …

Statistical analysis of patient-reported outcome data in randomised controlled trials of locally advanced and metastatic breast cancer: a systematic review

M Pe, L Dorme, C Coens, E Basch, M Calvert… - The Lancet …, 2018 - thelancet.com
Although patient-reported outcomes (PROs), such as health-related quality of life, are
important endpoints in randomised controlled trials (RCTs), there is little consensus about …

[HTML][HTML] Patient-reported outcomes and target effect sizes in pragmatic randomized trials in ClinicalTrials. gov: A cross-sectional analysis

S Vanderhout, DA Fergusson, JA Cook… - PLoS Medicine, 2022 - journals.plos.org
Background Use of patient-reported outcomes (PROs) and patient and public engagement
are critical ingredients of pragmatic trials, which are intended to be patient centered …

Use and reporting of patient-reported outcomes in trials of palliative radiotherapy: a systematic review

A Fabian, J Domschikowski, A Letsch… - JAMA network …, 2022 - jamanetwork.com
Importance Approximately 50% of all patients with cancer have an indication for
radiotherapy, and approximately 50% of radiotherapy is delivered with palliative intent, with …

US Food and Drug Administration review of statistical analysis of patient-reported outcomes in lung cancer clinical trials approved between January, 2008, and …

MH Fiero, JK Roydhouse, J Vallejo… - The Lancet …, 2019 - thelancet.com
With the advent of patient-focused drug development, the US Food and Drug Administration
(FDA) has redoubled its efforts to review patient-reported outcome (PRO) data in cancer …