The authors chose placebo as the comparator for the intervention. This allowed the active value of the treatment to be evaluated, but no other active treatments were compared. If these exist, it means that the study was only a partial analysis.
The use of a randomised controlled trial (RCT) to derive the clinical data was appropriate, given the strengths of its design. It was not clear that this RCT was the best available evidence; there may have been other relevant RCTs that could have contributed evidence. Some details of the RCT, such as the inclusion and exclusion criteria, randomisation procedures, and power calculations to ensure an appropriate sample size, were not reported, which makes it difficult to make an objective assessment of the validity of the data. The patient groups were reported to have been comparable at baseline, which make the comparison more robust, but no statistical analysis was reported. The authors used a disease-specific outcome for the measure of benefit, which prevents an assessment of the impact on the intervention on the patients’ quality of life and hinders cross-disease comparisons.
The costs appeared to reflect the perspective adopted. The unit costs and resource quantities were presented separately. Apart from the fact that the price year was not reported, which will make any future reflation exercises difficult, the economic analysis was carried out transparently.
Analysis and results:
The synthesis of the costs and benefits was appropriately performed. The issue of uncertainty was partially addressed using a deterministic approach, but a probabilistic approach would have strengthened the findings. The authors acknowledged the limitations of their study relating to the generalisation of the results and the disease-specific measure of benefit.
Despite the limited reporting of the effectiveness data, overall, the methodology was valid. The conclusions reached by the authors appear to be appropriate and reflect the limited scope of their analysis.