The Lancet
Oncology: Review: Volume 19, issue 9, PE459-PE469, September 01,
2018
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 analysis, interpretation, and reporting of these data. We
did a systematic review to assess the variability, quality, and standards of
PRO data analyses in advanced breast cancer RCTs. We searched PubMed for
English language articles published in peer-reviewed journals between Jan 1,
2001, and Oct 30, 2017. Eligible articles were those that reported PRO results
from RCTs of adult patients with advanced breast cancer receiving anti-cancer
treatments with reported sample sizes of at least 50 patients—66 RCTs met the
selection criteria.