Short
Research Question
When formulating the research question it is necessary to meet three criteria:
- The question should be economically important.
- The question should be phrased in a way that takes both cost and outcome into consideration.
- The question should clearly state the viewpoint of the economic evaluation.
Finally the hypothesis of the economic evaluation should also be stated clearly.
Selection of Statistical Tests
The statistical tests which are used should match the data set they are used on. Overview of statistical tests. The chosen test should be justified for better traceabillity.
Also details of the statistical tests should be given as well as the confidence intervals of the observed variables.
Searching for Data
Economic evaluations are based on effectiveness data which can be derived from either single clinical trials or an overview of several clinical trials (meta-analysis). Clinical trials and overviews, i.e. their results, are often published in renowned journals. Search for such publications in databases.
Rating Data
In order to judge the quality for publications used in an economic evaluation it might be useful to allocate the Jadad score. If possible only rely on clinical trials which are randomized, double-blinded and controlled. This type of study design is called gold standard and ensures highest internal validity.
When using data from a sample, samplesize and power should be given.
Costs: What should be considered?
Costing involves estimating the resources used and their prices (unit costs) for example, days in hospital. All kind of clinical procedures of a patient should be reported. But not all procedures take place in a regular clinical care therefore it should be considered whether all procedures in the trial are characteristic of normal clinical practice.
Measurement
The benchmarks for a primary outcome should be declared in a detailed form. There are many possibilities to interpret these and it is advisable to give the reader a little help with this. In the case of measuring health benefits have been treasured it is necessary to give the methods used. Further it is important to mention the sources from whom valuations were obtained. For instance patients, members of the general public, health care professionals etc. If there are indirect benefits in the productivity, these should be reported separately and their denotation to the study should be discussed.
Modelling
In most cases economic data, collected in clinical trials, cannot be used as the sole base for a fully informed decision. Often this data is neither permanently available nor transferable. Often data is derived from different databases. Thereby the modelling of target size is an essential component of evaluation. In addition, modelling techniques allow evaluations beyond the measured data.
Forms of Evaluation
Please go to the information of the schedule in the long version
Handling Uncertainty
Uncertainty is a side effect if a sample is used. To figure out the influence of uncertainty on the results a sensitivity analysis should take place.
Discounting Data
Discounting monetary and non-monetary values with a time horizon longer than one year is advisable. Add discounted data with the discount rates 0%, 3%, 5%, 7% and 10%.
Study Question
The study question should be comparable and relevant, the research question should be stated as well as the point of view of the study and how costs are made up.
Selection of Alternatives
Alternatives need to be stated clearly, they should also be comperable and be described in sufficient detail. Decision trees and other decision making methods can be used to justify calculated outcome.
Transparency
Data of one economic study is closely bound to a specific setting. Decision makers need to generalize results or transform them so that it suits their point of view. Transparency of data helps alleviate this process.
Reporting cost data
What should be reported?
- Estimates of resources used and their prices (unit costs)
- costs of all clinical procedures done to a patient
- dates of both the estimates of resource quantities and prices
- adjustments to a more recent price level
Rating Data
In order to judge the quality for publications used in an economic evaluation it might be useful to allocate the Jadad score. If possible only rely on clinical trials which are randomized, double-blinded and controlled. This type of study design is called gold standard and ensures highest internal validity.
Missing Data
Missing data can be acquired by either modelling, a delphi panel or an expert opinion. Naturally information gained under such conditions is not as reliable as outcomes from a clinical trial.
Information about tests used
Statistical tests and tests used for sensitivity analysis should be explained in a basic way. This supports a better understanding of how results were obtained, as well as a better understanding of the results.
Reporting about Uncertainty
It is necessary to make a proper consideration of uncertainty if the reader should be able to decide for himself whether conclusions are meaningful and robust or not. Except for sampled data, uncertainty can be handled well by using a form of sensitivity analysis. The ranges of values tested need to be justified, based on evidence or logic.
It should be clear whether the precision of the quantitative results or the robustness of the conclusion drawn out of them is more important, as the importance of uncertainty depents on that.
Comparison
Authors ofter compare their cost effectiveness ratios with other studies using league tables. Those rankings should be handled with care. Encapsulating only comparisons with health care interventions should be made which are quite similar in setting and study design.
Report Contents
Health-economic publications and reports follow a different line of argumentation as for instance when reporting a prospective clinical trial. We suggest following structure of a sound HE publication:
Introduction / Background
Aims
Definitions
Limitations
Methods: Patient characteristics, Cost data set, clinical data etc.
Health-economic study type and study design
Economic perspective
Model used for the analyses
Scenarios investigated
Data sources and data handling (incl. synthesis)
Underlying assumptions (if any)
Results: Medical outcomes, Economic outcomes, combined health-economic outcomes (e.g. ICERs, CLYG), other outcomes
Validation(Sensitivity analyses, extreme value analysis)
Influence of discounting
Discussion
Conclusion
