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Poster display session

3862 - Generating patient reported outcome norms for an EU cancer population using real world data (FACT-G)

Date

10 Sep 2017

Session

Poster display session

Topics

Cancers in Adolescents and Young Adults (AYA);  Bioethical Principles and GCP

Presenters

Alex Rider

Citation

Annals of Oncology (2017) 28 (suppl_5): v511-v520. 10.1093/annonc/mdx385

Authors

A. Rider1, S. Simpson2, B. Bennett2, K. Byrne1, P. Hallworth1, T. Desai2, K. Cocks2

Author affiliations

  • 1 Adelphi Real World, Adelphi Group, Sk10 5JB - Bollington/GB
  • 2 Patient-centered Outcomes, Adelphi Values Ltd., SK10 5JB - Bollington/GB
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Resources

Abstract 3862

Background

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.

Methods

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).

Results

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:

1467P

SWBEWBFWBPWBFACT-G
EU mean score17.413.312.318.561.5
US mean score22.118.718.921.380.9
Population difference4.7*5.4*6.6*2.819.4*
*

Indicates MID exceeded.

Conclusions

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

Funding

None

Disclosure

A. Rider, S. Simpson, B. Bennett, K. Byrne, P. Hallworth, T. Desai, K. Cocks: Employee of Adelphi Group.

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