compared with either third-line antidepressants or ECT (with or without psychological therapies)? What is the cost-effectiveness of rTMS compared with antidepressants or ECT? Summary of the primary elements of the decision analysis (PICO) The PICO table for the assessment is provided in Table 2. Table 2: Summary of PICO Patients Intervention Comparators Outcomes to be assessed Adults with Repetitive Antidepressant Safety treatment resistant transcranial medication* ± Side effects from rTMS, e.g. seizures, major depression magnetic psychological therapy headache, transient scalp pain, facial muscle (two or more failed stimulation or twitching courses of (rTMS) ECT ± antidepressants) ± psychological Side effects of antidepressant medication, e.g. antidepressant therapy ± sexual dysfunction, weight gain, insomnia, medication antidepressant daytime sleepiness/sedation, treatment ± medication emergent anxiety and nervousness, cognitive, psychological memory and attention difficulties therapy *Where Side effects from ECT, e.g. transient or antidepressant permanent neuropsychological deficits, medication can be a adverse reaction to anaesthetic agents and third class of neuromuscular blocking agents, alterations in antidepressant, or blood pressure, cardiovascular complications, augmented with a death, dental and oral trauma, pain and second (eg, discomfort, pulmonary complications, skin lithium, thyroid burns, stroke. hormones, pindolol, psychostimulants, Side effects from psychological therapies, e.g. atypical damage caused by use of psychotherapy antipsychotics, when other treatments would have been more sex hormones, effective, the impact of inappropriate therapist anticonvulsants/mood behaviour, and the negative effects of stabilizers, and prolonged dependency on the therapist. dopamine agonists) or Effectiveness combined Primary outcomes: meeting diagnostic criteria antidepressant for depression (remission), severity of medications depressive symptoms, quality of life, survival Secondary outcomes: suicidal ideation and attempts, symptoms of anxiety, global functioning, social and occupational functioning, treatment refusal or discontinuation, rate of hospital admission Cost-effectiveness Cost, cost per relevant health outcome (eg LYG, QALY)
compared with either third-line antidepressants or ECT (with or without psychological therapies)? What is the cost-effectiveness of rTMS compared with antidepressants or ECT? Summary of the primary elements of the decision analysis (PICO) The PICO table for the assessment is provided in Table 2. Table 2: Summary of PICO Patients Intervention Comparators Outcomes to be assessed Adults with treatment resistant major depression (two or more failed courses of antidepressants) Repetitive transcranial magnetic stimulation (rTMS) ± antidepressant medication ± psychological therapy Antidepressant medication* ± psychological therapy or ECT ± psychological therapy ± antidepressant medication *Where antidepressant medication can be a third class of antidepressant, or augmented with a second (eg, lithium, thyroid hormones, pindolol, psychostimulants, atypical antipsychotics, sex hormones, anticonvulsants/mood stabilizers, and dopamine agonists) or combined antidepressant medications Safety Side effects from rTMS, e.g. seizures, headache, transient scalp pain, facial muscle twitching Side effects of antidepressant medication, e.g. sexual dysfunction, weight gain, insomnia, daytime sleepiness/sedation, treatment emergent anxiety and nervousness, cognitive, memory and attention difficulties Side effects from ECT, e.g. transient or permanent neuropsychological deficits, adverse reaction to anaesthetic agents and neuromuscular blocking agents, alterations in blood pressure, cardiovascular complications, death, dental and oral trauma, pain and discomfort, pulmonary complications, skin burns, stroke. Side effects from psychological therapies, e.g. damage caused by use of psychotherapy when other treatments would have been more effective, the impact of inappropriate therapist behaviour, and the negative effects of prolonged dependency on the therapist. Effectiveness Primary outcomes: meeting diagnostic criteria for depression (remission), severity of depressive symptoms, quality of life, survival Secondary outcomes: suicidal ideation and attempts, symptoms of anxiety, global functioning, social and occupational functioning, treatment refusal or discontinuation, rate of hospital admission Cost-effectiveness Cost, cost per relevant health outcome (eg LYG, QALY)
1196_rTMS_AttA_FinalAssessmentReport-accessible.docx