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 …
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
Abstract Background Patient-reported outcomes (PROs) are commonly collected in clinical
trials and should provide impactful evidence on the effect of interventions on patient …
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 …
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 …
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
Abstract Background Patient-reported outcomes (PROs) are captured within cancer trials to
help future patients and their clinicians make more informed treatment decisions. However …
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 …
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
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 …
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
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 …
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
Importance Approximately 50% of all patients with cancer have an indication for
radiotherapy, and approximately 50% of radiotherapy is delivered with palliative intent, with …
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 …
(FDA) has redoubled its efforts to review patient-reported outcome (PRO) data in cancer …