Deficiencies in health-related quality of life assessment and reporting: a systematic review of oncology randomized phase III trials published between 2012 and 2016

Abstract

Background

Quality of life (QoL) is a relevant endpoint and a topic of growing interest by both scientific community and regulatory authorities. Our aim was to review QoL prevalence as an endpoint in cancer phase III trials published in major journals and to evaluate QoL reporting deficiencies in terms of underreporting and delay of publication.

Methods

All issues published between 2012 and 2016 by 11 major journals were hand-searched for primary publications of phase III trials in adult patients with solid tumors. Information about endpoints was derived from paper and study protocol, when available. Secondary QoL publications were searched in PubMed.

Results

446 publications were eligible. In 210 (47.1%), QoL was not included among endpoints. QoL was not an endpoint in 40.1% of trials in the advanced/metastatic setting, 39.7% of profit trials and 53.6% of non-profit trials. Out of 231 primary publications of trials with QoL as secondary or exploratory endpoint, QoL results were available in 143 (61.9%). QoL results were absent in 37.6% of publications in the advanced/metastatic setting, in 37.1% of profit trials and 39.3% of non-profit trials. Proportion of trials not including QoL as endpoint or with missing QoL results was relevant in all tumour types and for all treatment types. Overall, 70 secondary QoL publications were found: for trials without QoL results in the primary publication, probability of secondary publication was 12.5%, 30.9% and 40.3% at 1, 2 and 3 years respectively. Proportion of trials not reporting QoL results was similar in trials with positive results (36.5%) and with negative results (39.4%), but the probability of secondary publication was higher in positive trials.

Conclusions

QoL is not included among endpoints in a relevant proportion of recently published phase III trials in solid tumors. In addition, QoL results are subject to significant underreporting and delay in publication.