The main aim of this analysis was to generate population norms from an EU sample of cancer patients for the FACT-G instrument using real world data. Comparisons were made between existing norms based on a US population and the newly developed EU norms.
Data was collected through the Adelphi Real World Disease-Specific Programmes (DSPs) across breast, gastric, melanoma, non-small cell lung and prostate cancers. Cross-sectional surveys were administered to physicians and patients between January 2015 and March 2017, resulting in a total sample of 4899 patients. The US population norms outlined by Brucker et al. (Evaluation & the Health Professions. 2005;28(2):192-211) are commonly used to aid interpretation of FACT-G scores but there are no large sample norms specifically derived for the EU population. Analysis included checking internal reliability of the FACT-G sub-scales in the EU sample and comparisons between the EU and existing US population norms using minimum important differences (MIDs) of 3 points for FACT-G sub-scales and 7 points for total FACT-G score (Yost et al. Evaluation & the Health Professions. 2005;28(2):172-191).
The EU sample had similar population characteristics to the US sample with respect to age, gender and ECOG status but consisted of a wider sample of cancer types (including haematological cancers). Internal consistency was met (α > 0.7) for all sub-scales within the FACT-G for the EU population. Comparisons between the population norms indicate differences in FACT-G scores between the EU and US samples based on MIDs. Differences exceeding MIDs were noted across social well-being (SWB), emotional well-being (EWB), functional well-being (FWB) and overall FACT-G, but not for physical well-being (PWB). Further analysis was undertaken to explore differences by gender.Table:
|EU mean score||17.4||13.3||12.3||18.5||61.5|
|US mean score||22.1||18.7||18.9||21.3||80.9|
Indicates MID exceeded.
Differences highlighted between FACT-G scores for the EU and US cancer populations indicate that population norms may be region-specific or specific to cancer type. The resulting EU population norms can be used to aid interpretation of FACT-G scores across a range of cancer types.
Clinical trial identification
Legal entity responsible for the study
Adelphi Real World
A. Rider, S. Simpson, B. Bennett, K. Byrne, P. Hallworth, T. Desai, K. Cocks: Employee of Adelphi Group.