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 …

Maximising the impact of patient reported outcome assessment for patients and society

M Calvert, D Kyte, G Price, JM Valderas, NH Hjollund - Bmj, 2019 - bmj.com
Maximising the impact of patient reported outcome assessment for patients and society Page 1
Maximising the impact of patient reported outcome assessment for patients and society Patient …

Low ligation of inferior mesenteric artery in laparoscopic anterior resection for rectal cancer reduces genitourinary dysfunction: results from a randomized controlled …

GM Mari, J Crippa, E Cocozza, M Berselli, L Livraghi… - 2019 - journals.lww.com
Objectives: The aim of the present study was to compare the incidence of genitourinary (GU)
dysfunction after elective laparoscopic low anterior rectal resection and total mesorectal …

The evidence base of US Food and Drug Administration approvals of novel cancer therapies from 2000 to 2020

V Gloy, AM Schmitt, P Düblin, J Hirt… - … Journal of Cancer, 2023 - Wiley Online Library
Concerns have been raised that regulatory programs to accelerate approval of cancer drugs
in cancer may increase uncertainty about benefits and harms for survival and quality of life …

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 …

Rituximab in primary central nervous system lymphoma—A systematic review and metaanalysis

AM Schmitt, AK Herbrand, CP Fox… - Hematological …, 2019 - Wiley Online Library
The CD20 antibody rituximab is a standard component of treatment of nonHodgkin Bcell
lymphomas, including diffuse large Bcell lymphoma (DLBCL). Primary DLBCL of the central …

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 …

“The patient is speaking”: discovering the patient voice in ophthalmology

S Dean, JM Mathers, M Calvert, DG Kyte… - British Journal of …, 2017 - bjo.bmj.com
Eye disease can be devastating. The most feared impact is sight loss, but in a number of
ophthalmic conditions, there can be wide-ranging systemic, psychological, emotional and …