In an international surgery trial, a key decision which must be made at the trial development stage is whether or not a health economic evaluation will be undertaken for all collaborating countries. In making this decision, the following points should be considered:
Should all the countries have their own economic evaluation?
- It may be feasible for each country to have their own economic evaluation or instead, it may be preferable to have a series of economic evaluations grouped by countries with similar health systems or another option is one main economic evaluation covering all countries.
Is it feasible to collect economic data in all trial countries?
- This may determine the decision of which countries an economic evaluation will be undertaken in.
Country-Specific Guidelines on Economic Evaluation
Countries have different guidelines on what is expected when undertaking an economic evaluation alongside a trial. This can impact study design.
An awareness of country-specific guidelines is necessary to ensure that the relevant costs and outcomes are being collected which will help to inform decision makers. However, some countries have no explicit economic evaluation guidelines.
If countries in a multinational trial require different types of outcomes as per guidelines, this can potentially impact on and increase the patient burden as completion of multiple CRFs may be required.
Some outcomes may have country-specific preference weights on how the outcome should be valued (e.g. EQ-5D and Quality Adjusted Life Years[QALYs]).
Therefore, it must be decided whether the outcome is valued according to the patient’s country or should the outcome be consistently valued from one country’s value set?
Some countries have no preference weights for outcomes, how these should be valued must be decided.