The association between clinician-based common terminology criteria for adverse events (CTCAE) and patient-reported outcomes (PRO): a systematic review

TM Atkinson, SJ Ryan, AV Bennett, AM Stover… - Supportive Care in …, 2016 - Springer
Abstract Purpose Symptomatic adverse events (AEs) are monitored by clinicians as part of
all US-based clinical trials in cancer via the US National Cancer Institute's Common …

Patient-reported outcomes in cancer clinical trials: measuring symptomatic adverse events with the National Cancer Institute's Patient-Reported Outcomes Version of …

PG Kluetz, DT Chingos, EM Basch… - American Society of …, 2016 - ascopubs.org
Systematic capture of the patient perspective can inform the development of new cancer
therapies. Patient-reported outcomes (PROs) are commonly included in cancer clinical trials; …

Focusing on core patient-reported outcomes in cancer clinical trials: symptomatic adverse events, physical function, and disease-related symptoms

PG Kluetz, A Slagle, EJ Papadopoulos… - Clinical Cancer …, 2016 - AACR
Cancer clinical trials have relied on overall survival and measures of tumor growth or
reduction to assess the efficacy of a drug. However, benefits are often accompanied by …

Chemotherapy-induced peripheral neuropathy: Current status and progress

JR Brewer, G Morrison, ME Dolan, GF Fleming - Gynecologic oncology, 2016 - Elsevier
As there are increasing numbers of cancer survivors, more attention is being paid to the long
term unwanted effects patients may experience as a result of their treatment and the impact …

Patient-reported outcomes in the evaluation of toxicity of anticancer treatments

M Di Maio, E Basch, J Bryce, F Perrone - Nature reviews Clinical …, 2016 - nature.com
Symptomatic toxicities associated with anticancer treatments, such as nausea and vomiting,
are frequently underreported by clinicians, even when data are prospectively collected …

Comparison of patient-and practitioner-reported toxic effects associated with chemoradiotherapy for head and neck cancer

AD Falchook, R Green, ME Knowles… - … –Head & Neck …, 2016 - jamanetwork.com
Importance Agreement between patient-and practitioner-reported toxic effects during
chemoradiotherapy for head and neck cancer is unknown. Objective To compare patient …

[HTML][HTML] Mode equivalence and acceptability of tablet computer-, interactive voice response system-, and paper-based administration of the US National Cancer …

AV Bennett, AC Dueck, SA Mitchell… - Health and quality of life …, 2016 - Springer
Background PRO-CTCAE is a library of items that measure cancer treatment-related
symptomatic adverse events (NCI Contracts: HHSN261201000043C and HHSN …

Methods for implementing and reporting patient-reported outcome (PRO) measures of symptomatic adverse events in cancer clinical trials

E Basch, LJ Rogak, AC Dueck - Clinical therapeutics, 2016 - Elsevier
Purpose There is increasing interest to use patient-reported outcome (PRO) measures to
evaluate symptomatic adverse events (AEs) in cancer treatment trials. However, there are …

Under-reporting of harm in clinical trials

B Seruga, AJ Templeton, FEV Badillo, A Ocana… - The Lancet …, 2016 - thelancet.com
Appropriate safety evaluations of anticancer drugs are crucial to assess their benefit–risk
ratio. Substantial evidence shows that clinicians under-report harm in clinical trials, and at …

Self-evaluation of adjuvant chemotherapy-related adverse effects by patients with breast cancer

F Montemurro, G Mittica, C Cagnazzo, V Longo… - JAMA …, 2016 - jamanetwork.com
Importance Patient perspective on chemotherapy-related adverse effects is being
increasingly acknowledged both in experimental clinical trials and in clinical practice …