Estimating the value of future research to improve guidelines on thromboprophylaxis for women during pregnancy and after delivery

RESEARCH QUESTION

What is the value of undertaking a study to determine the clinical and cost-effectiveness of risk stratification tools for the prediction of venous thromboembolism (VTE) and appropriate provision of thromboprophylaxis for women in pregnancy and after delivery? BACKGROUND

Pharmacological prophylaxis to prevent VTE is currently recommended for women who are deemed to be at high risk of VTE during pregnancy or in the 6 weeks after delivery. The decision to provide prophylaxis involves weighing the benefits, harms and costs, which will vary according to the individual’s VTE risk. It is unclear whether the current risk stratification approach could be improved by further research.

AIMS AND OBJECTIVES

The aim of the research project is to determine whether further primary research is worthwhile to inform NHS practice on the use of risk stratification tools for the prediction of VTE and appropriate provision of thromboprophylaxis for women in pregnancy and in the puerperium. The specific objectives will be;

1) To estimate the expected costs, health benefits (quality-adjusted life-years) and incremental net monetary benefit of providing thromboprophylaxis using current and alternative risk stratification tools and to quantify the uncertainty around those estimates, given current evidence

2) To determine which factors are the most important drivers of uncertainty when trying to determine the optimal risk-based thromboprophylaxis strategy in this population

3) To identify one or more potential future studies to gather additional evidence that would reduce the current decision uncertainty, whilst being feasible and acceptable to patients and clinicians.

4) To evaluate the value of the potential future research studies in terms of the net health benefits to patients and the cost of the research. METHODS

A decision analytic model will be developed which will be informed by reviews of the existing literature. This model will be used to determine which factors are the most important drivers of uncertainty using expected value of perfect information analysis. Qualitative research, in the form of workshops with patients and a survey of clinicians, will then be undertaken to identify one or more potential future studies that could be conducted to gather additional evidence to reduce the current decision uncertainty.

Expected value of sample information analysis will then be used to evaluate the value of the potential future research studies in terms of the net health benefits to patients and the cost of the research TIMELINES FOR DELIVERY

The project will take place over 15 months with cost-effectiveness modelling (including rapid reviews of parameters) and expected value of perfect information analysis in months 1 to 7, qualitative work to inform potential study designs in months 8 to 10, expected value of sample information analysis in months 11 to 12 and write up and dissemination in months 13 to 15.

ANTICIPATED IMPACT AND DISSEMINATION

We anticipate that this project will inform the funding of future research studies and may also inform clinical guideline updates. We will share our findings and research recommendations with UK research funders and guideline developers. We will also disseminate professional and plain language summaries to relevant clinical, public and patient representative organisations so they are able to make an evidence-based case for further research or changes to current clinical practice.