Posted by Michael Wonder on 31 Aug 2018
Statistical analysis of patient-reported outcome data in randomised controlled trials of locally advanced and metastatic breast cancer: a systematic review
1 September 2018 - Although patient-reported outcomes, such as health-related quality of life, are important endpoints in randomised controlled trials, 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 patient reported outcomes data analyses in advanced breast cancer randomised controlled trials (RCTs). We searched PubMed for English language articles published in peer-reviewed journals between 1 January 2001 and 30 October 2017. Eligible articles were those that reported patient reported outcomes 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.
Only eight (12%) RCTs reported a specific PRO research hypothesis.
