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Published on: October 12, 2012
Assessing outcome measures of oral anticoagulation management in children
Sophie Jones1, Fiona Newall, Elizabeth Manias
1Department of Paediatrics, The University of Melbourne, The Royal Children's Hospital, Flemington Road, Parkville, Victoria, Australia. sophie.jones@rch.org.au
Insights
Managing oral anticoagulation therapy in children requires better outcome measures. Including quality of life in pediatric oral anticoagulant studies can improve research on management interventions.
Area of Science:
- Pediatric Hematology
- Pharmacology
- Clinical Trial Design
Background:
- Oral anticoagulation therapy in children presents unique management challenges.
- Current pediatric studies primarily measure therapeutic range achievement and adverse events.
- Limitations exist in multi-center trials due to small pediatric populations.
Purpose of the Study:
- To review current outcome reporting in pediatric oral anticoagulation management.
- To propose the inclusion of quality of life as a key outcome measure.
- To enhance the methodological rigor of research in this field.
Main Methods:
- Literature review of existing outcome reporting in pediatric oral anticoagulation studies.
- Analysis of the limitations of current outcome measures.
- Identification of quality of life as a potential complementary outcome.
Main Results:
- Existing outcome measures in pediatric anticoagulation research are limited.
- Small patient numbers and trial difficulties hinder robust interventional studies.
- Quality of life (QoL) is underutilized as an outcome measure.
Conclusions:
- Current outcome reporting in pediatric oral anticoagulation is insufficient.
- Incorporating quality of life measures can significantly strengthen research methodology.
- Enhanced outcome measures are crucial for evaluating management interventions in pediatric anticoagulation.
Abstract:
The complexities of managing oral anticoagulation therapy in children have been well described and various management strategies have been designed to optimise clinical outcomes within this challenging population. To date, outcome measurements used within paediatric studies investigating oral anticoagulant management have focused upon achieving therapeutic range and examining the incidence of medication-related adverse events. Whilst the reporting of such data is a priority, the relatively small number of children participating in clinical studies of oral anticoagulant management and the difficulties associated with conducting multi-centre interventional trials in such populations limit the ability of researchers to measure the significance of interventions made. This review examines current methods of reporting outcomes for paediatric oral anticoagulation management and identifies how the inclusion of quality of life as an outcome measure may strengthen the methodology of research aimed at measuring the impact of management interventions within the field of paediatric oral anticoagulant therapy.
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