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Composite outcome measures in a pragmatic clinical trial of chronic heart failure management: A comparative
Sungwon Chang1, Patricia M Davidson2, Phillip J Newton1
1University of Technology, Sydney, Australia.
Insights
Different heart failure outcome scores weigh mortality, hospitalization, and quality of life differently. Understanding these composite outcome components is crucial for accurate interpretation in clinical trials.
Area of Science:
- Cardiology
- Clinical Trials
- Health Outcomes Research
Background:
- Composite outcomes are vital for assessing heart failure, integrating patient, clinician, and objective health measures.
- Limited research has explored the specific composition and influence of components within these composite outcomes.
Purpose of the Study:
- To compare the comparability and interpretability of three common heart failure composite outcomes: Packer's composite, Patient Journey, and the African American Heart Failure Trial (A-HeFT) scores.
- To examine the influence of individual components (mortality, hospitalization, quality of life) on the final outcome within each scoring system.
Main Methods:
- The Which heart failure intervention is most cost-effective & consumer friendly in reducing hospital care (WHICH(?)) Trial data was used to compare Packer's composite, Patient Journey, and A-HeFT scores.
- Analysis focused on the contribution of mortality, hospitalization, and quality of life to the overall outcome in each scoring system.
Main Results:
- All three composite outcomes included mortality, hospitalization, and quality of life, but their relative impact varied.
- Hospitalization most influenced Packer's composite (67.7%), quality of life most influenced Patient Journey (61.5%), and mortality most influenced A-HeFT (45.4%).
Conclusions:
- The contribution of each component to composite heart failure outcomes differs significantly across scoring systems.
- Understanding the weighting of individual components within composite outcomes is essential for accurate interpretation of clinical trial results.
Background:
A number of composite outcomes have been developed to capture the perspective of the patient, clinician and objective measures of health in assessing heart failure outcomes. To date there has been a limited examination in the composition of these outcomes.
Methods And Results:
Three commonly used scoring systems in heart failure trials: Packer's composite, Patient Journey and the African American Heart Failure Trial (A-HeFT) scores were compared in assessing outcomes from the Which heart failure intervention is most cost-effective & consumer friendly in reducing hospital care (WHICH(?)) Trial. Comparability and interpretability of these outcomes and the influence of each component to the final outcome were examined. Despite all three composite outcomes incorporating mortality, hospitalisation and quality of life (QoL), the contribution of each individual component to the final outcomes differed. The component with the most influence in deteriorating condition for the Packer's composite was hospitalisation (67.7%), while in Patient Journey it was QoL (61.5%) and for A-HeFT composite score it was mortality (45.4%).
Conclusions:
The contribution made by each component varied in subtle, but important ways. This study emphasises the importance of understanding the value system of the composite outcomes to enable meaningful interpretation of results.
