Kayser 2017.
Study characteristics | ||
Methods |
Study design: open‐label, parallel, randomised Total duration of study: 4 to 6 weeks Number of study centres and locations: 1, University Hospital, Bonn, Germany. Study setting: no information Withdrawals: 5 patients discontinued the study for different reasons: 3 because of MST device defect, 1 because of cognitive adverse effect during ECT, and 1 because of worsening of preexisting coronary heart disease during ECT Dates of study: February to June 2011 |
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Participants |
Number: 10 for MST (8 MDD, 2 BPII); 10 for ECT (9 MDD, 1 BPI) Mean age (SD), age range: 45 (14) for MST; 55 (12) for ECT; no information on range Gender: 3 females for MST; 4 females for ECT Course of disease: no information Severity of condition: HAMD‐28 26.1 (4) for MST; 28.4 (4) for ECT Diagnostic criteria
Inclusion criteria
Exclusion criteria
Co‐morbid conditions: no information |
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Interventions |
MST (coil placement, frequency, dose, number of sessions)
ECT (electrode placement, pulse width, dose, number of sessions)
Concomitant medications: psychotropic medication was stable for a minimum of 4 weeks before MST/ECT treatments and remained unchanged during the study Concomitant psychosocial interventions: no information Excluded medications: no information |
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Outcomes |
Primary and secondary outcomes specified and collected
Time points reported
Outcome data reported in a usable way: yes |
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Notes | Funded in part by MagVenture A/S | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Protocol described the study as a case‐control trial. However, paper claims "the patients were randomized to ECT or MST using a randomized block design, with a block size of 5 patients" |
Allocation concealment (selection bias) | Unclear risk | No information |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Described as open‐label |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Described as open‐label |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Attrition rates were similar (3 for MST vs 2 for ECT), however, for different reasons (MST device defect vs adverse effects). As‐treated analysis was done |
Selective reporting (reporting bias) | High risk | Protocol specified recovery time as the only outcome. However, study reported HAMD and seizure features |
Other bias | High risk | The study is funded in part by a manufacturer of MST devices |