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Appendix table

What is the clinical and cost effectiveness of systemic pharmacological thrombolysis vs standard initial anticoagulation therapy in patients with confirmed PE who are haemodynamically stable and present with right ventricular dysfunction?
PICO questionPopulation: Patients with confirmed PE who are haemodynamically stable and present with right ventricular dysfunction.
Interventions: Systemic thrombolysis (for example alteplase [rt-PA]).
Comparison: Standard initial anticoagulation therapy (with LMWH or fondaparinux).
Importance to patients or the populationThe impact would be that future guidance could recommend the most appropriate initial therapy for patients with confirmed PE who are haemodynamically stable and present with right ventricular dysfunction, to reduce morbidity and improve long term outcomes.
Relevance to NICE guidanceThe results of this study would inform an update of this guideline as currently the recommendation is not to offer systemic thrombolysis to patients with PE who are haemodynamically stable. This study would provide evidence which could change the current recommendation for this particular subgroup of the population.
Relevance to the NHSThe results of this study would allow for correct and standardised treatment for this patient group.
National prioritiesVTE has been identified as an important area at a national level (House of Commons Select Committee on Health Second Report, 2005194) because of the number of deaths related to it.
Current evidence baseThere is insufficient evidence looking at the role of thrombolysis this particular patient group.
Study designRCT. Power calculations should be conducted to establish the required sample size of the trial. It is important that the study is adequately powered to detect a clinically important effect size. Follow-up should be long enough to capture the outcomes appropriately (especially for CTEPH).
Economic considerationsSystemic pharmacological thrombolysis could have a higher initial cost compared to standard treatment. The cost increase could be justified if systemic pharmacological thrombolysis is proven to be overall more effective when all the outcomes are considered. It is important to estimate the expected costs and QALYs associated with both strategies.
FeasibilityIt should be feasible to carry out the research in a realistic timescale at a reasonable cost.
EqualitiesThere no specific equality issues.
Other commentsNone.

From: Appendix J, Research Recommendations

Cover of Venous Thromboembolic Diseases
Venous Thromboembolic Diseases: The Management of Venous Thromboembolic Diseases and the Role of Thrombophilia Testing [Internet].
NICE Clinical Guidelines, No. 144.
National Clinical Guideline Centre (UK).
Copyright © 2012, National Clinical Guideline Centre.

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