Presentation (CTI)

OBJECTIVES: Health-related quality of life (HRQoL) is increasingly measured in RCTs, yet analysis and reporting of HRQoL remain challenging, affecting the quality of evidence from clinical trials used in oncology decision-making. We evaluated the quality of HRQoL analysis and reporting in breast cancer RCTs and examined how this was associated with the integration of HRQoL evidence in drug appraisals by the Dutch National Health Care Institute and the National Institute for Health and Care Excellence.
METHODS: MEDLINE, Embase and Cochrane were searched for breast cancer RCTs of anti-cancer drugs reporting HRQoL as a primary or secondary outcome using validated HRQoL measures (2021-November 2025). Analysis quality was evaluated using Setting International Standards in Analysing Patient-Reported Outcomes and Quality of Life Endpoints (SISAQOL) recommendations, and reporting quality using CONSORT-PRO guidance and SISAQOL recommendations. Breast cancer drug appraisals were retrieved from both agencies’ publication databases.
RESULTS: Sixty-five publications representing 61 unique RCTs were included. The quality of both analysis and reporting was generally low. The main deficiencies concerned missing data, including poor reporting of compliance rates and inadequate handling if missing data (e.g., no or incorrect imputation). Additionally, the impact of relevant intercurrent events on the estimand was often not specified. Thresholds for clinically meaningful differences were well reported; however, thresholds often relied on outdated sources and sensitivity analyses with alternative thresholds were rarely performed. Among the 28 drug appraisals, HRQoL evidence from publications identified in this review was rarely used, mainly due to timing mismatches. Instead, HRQoL data were predominantly from confidential or regulatory sources.
CONCLUSIONS: Improving HRQoL analysis and reporting, particularly regarding handling of missing data and intercurrent events, together with earlier publication of results, may optimize the integration of HRQoL evidence in oncology decision-making. Adherence to SISAQOL and CONSORT-PRO guidance could strengthen the quality of HRQoL analysis and reporting in breast cancer RCTs.