Study protocol for the health economic evaluation of outpatient long-term video EEGs for people with seizure disorders alongside the ALVEEG study - a randomized controlled equivalence trial.

BACKGROUND

Epilepsy and other seizure disorders are medical conditions that impose a substantial health economic burden on society given their considerable costs of illness and use of healthcare resources. The ALVEEG trial aims to tackle resource shortages in clinical settings and optimize patient management by evaluating outpatient ambulatory long-term video electroencephalograms (ALVEEGs) as a new diagnostic pathway to diagnose and manage epilepsy and other seizure disorders. The health economic evaluation alongside this trial aims to determine the cost-effectiveness and cost-utility of ALVEEGs for affected patients presenting themselves at participating epilepsy centers in Germany.

METHODS

This study protocol comprises the rationale and methods of the health economic evaluation of ALVEEGs embedded into the ALVEEG project. We will perform cost-effectiveness and cost-utility analyses, with the outcomes being a priori defined endpoint measures of the main trial. We will consider the proportion of solved clinical queries (primary endpoint), the number of hospital stays, the in-patient length of stay, and quality-adjusted life years for the here presented health economic evaluation. Costs will be collected by the participating health insurance companies alongside the trial, with the evaluation being conducted from a statutory health insurance perspective within the German healthcare system. The reporting of the economic evaluation follows the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklist.

DISCUSSION

The health economic evaluation of ALVEEGs for patients affected by epilepsy and other seizure disorders within the German healthcare system will deliver insightful evidence on the cost-effectiveness and cost-utility of the intervention and hence guide policy and decision makers regarding a potential inclusion of ALVEEGs into the health benefit basket of the statutory health insurance scheme.

TRIAL REGISTRATION

German Clinical Trials Register (DRKS00032220), date registered: December 11, 2023.