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For many interventions in health care, there is limited information on efficacy, safety and cost-effectiveness even long after they have been implemented. To decide between treatments, the randomized controlled trial (RCT) provides the strongest evidence. This creates a problem because RCTs are very expensive, logistically challenging and generally cumbersome. Observational studies are inexpensive, but create weaker evidence. The pragmatic randomized trial, enriched with routinely collected register or electronic health record (EHR) data may be a solution to this dilemma since they are much less costly than traditional RCTs but create much stronger evidence than observational studies. Pragmatic randomized trials mean that patients in routine care are randomly allocated to alternative treatments. The outcome of the treatment is then followed up in existing registers with patient data. This means that it is possible to 1) follow patients in the normal care situation - unlike the often artificial situation in the traditional RCT, 2) that the costs are low, even for large studies and 3) that a broad spectrum of outcomes, including both health and economic outcomes, can be collected. Pragmatic randomized trials using register or EHR data in principle lend themselves well to health economic evaluations. We have identified a number of such trials in the literature. Very few, however, include economic outcomes.

ObjectiveTo determine effectiveness and cost-effectiveness over a one-year time horizon of pharmacological first line treatment in primary care for patients with moderate to severe depression.DesignA multiple treatment comparison meta-analysis was employed to determine the relative efficacy in terms of remission of 10 antidepressants (citalopram, duloxetine escitalopram, fluoxetine, fluvoxamine mirtazapine, paroxetine, reboxetine, sertraline and venlafaxine). The estimated remission rates were then applied in a decision-analytic model in order to estimate costs and quality of life with different treatments at one year.Data sourcesMeta-analyses of remission rates from randomised controlled trials, and cost and quality-of-life data from published sources.ResultsThe most favourable pharmacological treatment in terms of remission was escitalopram with an 8- to 12-week probability of remission of 0.47. Despite a high acquisition cost, this clinical effectiveness translated into escitalopram being both more effective and having a lower total cost than all other comparators from a societal perspective. From a healthcare perspective, the cost per QALY of escitalopram was €3732 compared with venlafaxine.ConclusionOf the investigated antidepressants, escitalopram has the highest probability of remission and is the most effective and cost-effective pharmacological treatment in a primary care setting, when evaluated over a one year time-horizon. Small differences in remission rates may be important when assessing costs and cost-effectiveness of antidepressants.