Table 8 Summary of PICO criteria to define research questions that assessment will investigate Patients Intervention Comparator Outcomes Patients with treatment- Vagus nerve stimulation Standard of care (SoC) or Effectiveness measures: resistant depression (VNS) treatment as usual Response/remission (TRD) who have failed to VNS therapy involves an SoC for these patients rates and time to achieve an adequate implanted pacemaker-like consist of alternative response (based on key response after at least pulse generator and a pharmacological measures of depression, four appropriate nerve stimulation strategies (switching, e.g., HAMD, MADRS, antidepressant trials electrode to deliver augmentation or IDS, CGI-I measures of intermittent stimulation combination), depression) to the left vagus nerve. psychotherapeutic Duration of strategies or brain response/remission stimulation therapies such as ECT. QoL / utility values Of note, VNS is to be Adaptive functioning added onto SoC; VNS Cognitive functioning provides a chronic, Suicide ideation continuous therapy alongside the SoC Mortality (all cause) provided to the patient Safety measures: as required. Complications (related to device or surgery) Adverse events Withdrawals due to adverse events Resource use: Reduced hospitalisation and other acute care (to be considered in the economic model).
Table 8 Summary of PICO criteria to define research questions that assessment will investigate Patients Intervention Comparator Outcomes Patients with treatment- resistant depression (TRD) who have failed to achieve an adequate response after at least four appropriate antidepressant trials Vagus nerve stimulation (VNS) VNS therapy involves an implanted pacemaker-like pulse generator and a nerve stimulation electrode to deliver intermittent stimulation to the left vagus nerve. Standard of care (SoC) or treatment as usual SoC for these patients consist of alternative pharmacological strategies (switching, augmentation or combination), psychotherapeutic strategies or brain stimulation therapies such as ECT. Of note, VNS is to be added onto SoC; VNS provides a chronic, continuous therapy alongside the SoC provided to the patient as required. Effectiveness measures: Response/remission rates and time to response (based on key measures of depression, e.g., HAMD, MADRS, IDS, CGI-I measures of depression) Duration of response/remission QoL / utility values Adaptive functioning Cognitive functioning Suicide ideation Mortality (all cause) Safety measures: Complications (related to device or surgery) Adverse events Withdrawals due to adverse events Resource use: Reduced hospitalisation and other acute care (to be considered in the economic model).
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