A simplified decision model was developed on the basis of published evidence in order to simulate the natural history of disease and patient management under the two scenarios (citicoline versus placebo). The time horizon of the analysis was 3 months. The authors stated that the study was carried out from the perspective of the Spanish National Health System.
A systematic review of the literature was undertaken to identify meta-analyses of placebo-controlled, double-blind, randomised clinical trials (RCTs) of citicoline versus placebo. The databases searched and inclusion criteria were described. No restrictions on the study country or language were applied. Two meta-analyses were identified. The first pooled study included 4 RCTs that enrolled 1,672 patients (pooled analysis), while the second included 8 RCTs that enrolled 2,063 patients (Cochrane study). In the current study, only 1,372 patients were included in the pooled analysis and 1,048 in the Cochrane study, given some specific inclusion and exclusion criteria. The key clinical estimate was the probability of recovery after acute ischaemic stroke with citicoline or placebo.
Monetary benefit and utility valuations:
Measure of benefit:
The model outputs used in the analysis were the probability of death or disability and the probability of recovery. Each of them was derived from the two studies identified in the review. No discounting was applied.
The health service costs included in the analysis were intensive care unit stay, hospital ward stay, consultations (cardiology, nephrology and endocrinology), physiotherapy, rehabilitation services (physiotherapy and speech therapy) and medications (citicoline at different dosages). The resource use data were derived from a panel of experts from four acute-care teaching hospitals in Spain. The unit costs were derived from the participating hospitals, consultation with experts and bibliographic sources. An annual increment of 3% was applied to take into account the inflation rate for data taken from old studies. The costs were in euros (EUR). The price year was not reported.
Analysis of uncertainty:
A deterministic sensitivity analysis was undertaken to assess the robustness of the model results, using published confidence intervals (CIs) for clinical estimates and ranges of values for economic inputs. Different scenarios were also considered on the basis of data from the expert panel in relation to the use of health care services for the management of patients with (not recovered) and without (recovered) functional disability.