Write a study protocol outlining proposed methods to be used in an economic evaluation within an area related to your own work. The sections listed below should be used as a guide. Your chosen methods should be justified and appropriately referenced throughout.
The word limit is 2500. You must not go over this word limit or you will only be marked to 2500.
- Introduction, background, literature review (10 marks)
This section should include an introduction to the disease area, existing interventions, the proposed new intervention, and existing evidence of effectiveness and cost-effectiveness. It should include a discussion of the expected economic impact of the proposed intervention, and thus justification for the proposed economic evaluation.
- Policy question, decision-maker, perspective (10marks)
This section should describe the policy context, policy question and decision-maker, which should determine the method of economic evaluation and the cost and outcome perspectives.
- Aims and objectives (5marks) This section should include an overarching aim, a list of clinical and economic objectives and clearly stated comparators. Aims and objectives should follow from 2 and 3, above.
- Trial design, subjects, setting (10marks)
This section should describe and justify the trial design, describe the study subjects and exclusion and inclusion criteria, and describe the study setting, including recruitment and allocation to groups.
- Sample size (5marks)
In this section, students should consider the study sample size; demonstrate understanding of the purpose and methods of such calculations, and the issues relevant to economic evaluation. If calculations are not presented, this should be justified and the implications discussed.
- Identification, measurement and valuation of outcomes (10 marks) In general, this section should describe and justify the primary clinical outcome measure, any secondary outcome measures and measures to be used in the economic evaluation.
- Identification of resources (5marks)This section should include a description and justification of the methods to be employed to identify relevant resources. It should include an initial list of resources likely to be relevant to the study.
- Measurement of resources (5marks)
This section should describe and justify proposed methods for the measurement of resources identified. These methods need to be feasible and cover all resources identified as relevant.
- Valuation of resources (10marks)
This section should describe the valuation of all resources to be measured. A variety of methods can be proposed for different resource types and each should be described and justified.
- Method of economic evaluation (10marks)
This section should describe, define and justify the method(s) of economic evaluation to be used (cost-effectiveness, cost-utility, cost-benefit analysis etc.).
- Statistical/sensitivity analysis (5marks)
This section should describe the proposed statistical approach to (i) differences in cost, (ii) differences in outcome and (iii) the sensitivity of the results to assumptions made.
- Presentation of results (10marks)
This section should explain the approach to combining costs and outcomes in order to inform decision making and should include discussion of decision rules and uncertainty. 13. Placing the results in context (5)
This section should cover such things as ethical issues, issues of affordability and implementation, and the generalizability of the results.
- Placing the results in context (5 marks) This section should cover such things as ethical issues, issues of affordability and implementation, and the generalizability of the results.
Please note: You can submit your work anytime between now and the final submission deadline