Trends in the use of adult-specific preference-weighted health-related quality of life instruments in clinical trials over the past 50 years: a protocol for a meta-research study using deep learning-based natural language processing and large language models

Background Health technology assessment bodies increasingly emphasise the importance of preference-weighted health-related quality of life (HRQoL) evidence. However, such measures are often absent in clinical trial publications.

It is not yet clear how frequently clinical trials have incorporated these measures over the past five decades, how the use of preference-weighted HRQoL instruments has evolved over time, and how trends differ across disease areas, countries and global regions. This study aims to (1) assess changes over time in the proportions of clinical trials using each preference-weighted HRQoL instrument in adults, and (2) model secular trends in the adoption of these instruments across disease areas, countries and regions.

The study will provide a comprehensive, systematic assessment of the use of preference-weighted HRQoL instruments in clinical trials since 1976 and develop a scalable approach for large-scale evidence synthesis. Methods We will identify clinical trials involving humans published in English since 1976 through systematic searches of MEDLINE, Embase, Cochrane Library and Web of Science.