Review of patient-reported outcomes (PROs) and non-PROs in randomized controlled trials addressing head/neck cancers

Abstract

Background: To assess the frequency of patient-reported outcomes (PROs) and non-PROs in randomized controlled trials (RCTs) addressing head/neck cancers.

Methods: We included RCTs about interventions to treat head/neck cancers. PubMed was searched on September 16, 2022 and included studies published during three periods (2000-2002, 2010-2012, and 2020-2022). Data on types of outcomes and instruments to measure them were extracted and organized into PROs and non-PROs, and temporal trends for reporting outcomes were determined.

Results: There was a reduction in the frequency of non-PROs (40% to 22%) and an increase in PROs (5% to 19%) over 20 years. The frequency of reporting both non-PROs and PROs seemed to be stable over the same period (55% to 58%). A great variety of instruments to measure PROs and non-PROs was identified.

Conclusions: There has been a growth in the types of PROs in more recent years, and they were more frequently reported in RCTs. However, head/neck cancer trials with a combination of PROs and non-PROs were the most prevalent.

Keywords: head/neck cancer; methodological study; methods; randomized controlled trial; systematic review.