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 …

Patient reported outcome measures in rare diseases: a narrative review

A Slade, F Isa, D Kyte, T Pankhurst, L Kerecuk… - Orphanet journal of rare …, 2018 - Springer
Background Rare diseases can lead to a significant reduction in quality of life for patients
and their families. Ensuring the patients voice is central to clinical decision making is key to …

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 …

[HTML][HTML] Probing oral anticoagulation in patients with atrial high rate episodes: Rationale and design of the Non–vitamin K antagonist Oral anticoagulants in patients …

P Kirchhof, BF Blank, M Calvert, AJ Camm… - American heart …, 2017 - Elsevier
Background Oral anticoagulation prevents ischemic strokes in patients with atrial fibrillation
(AF). Early detection of AF and subsequent initiation of oral anticoagulation help to prevent …

Patient‐reported outcomes in the swedish national quality registers

E Nilsson, L Orwelius… - Journal of internal …, 2016 - Wiley Online Library
Patient‐reported outcomes (PRO s) are important in the healthcare system to gain
understanding of patients' views on the effects of a treatment. There is an abundance of …

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 …

Minimal clinically important difference and substantial clinical benefit values for the 12-item international hip outcome tool

RRL Martin, BR Kivlan, JJ Christoforetti, AB Wolff… - … : The Journal of …, 2019 - Elsevier
Purpose To define minimal clinically important difference (MCID) and substantial clinical
benefit (SCB) values for the 12-item International Hip Outcome Tool (iHOT-12) in patients …

[HTML][HTML] Health-related quality of life in patients with previously treated advanced urothelial carcinoma from EV-301: a phase 3 trial of enfortumab vedotin versus …

JE Rosenberg, R Mamtani, GP Sonpavde, Y Loriot… - European Urology, 2024 - Elsevier
Background and objective In comparison to chemotherapy, enfortumab vedotin (EV)
prolonged overall survival in patients with previously treated advanced urothelial carcinoma …

Systematic evaluation of the patient-reported outcome (PRO) content of clinical trial protocols

D Kyte, H Duffy, B Fletcher, A Gheorghe… - PloS one, 2014 - journals.plos.org
Background Qualitative evidence suggests patient-reported outcome (PRO) information is
frequently absent from clinical trial protocols, potentially leading to inconsistent PRO data …