Drane 2016.
Study characteristics | ||
Methods |
Study design: randomised controlled trial Study grouping: parallel group Adequate power (evidence of power calculation): not adequate in power. Power analysis suggested a sample of ≥ 23 participants per group in order to detect a statistically significant difference in event frequency at 8 weeks. While we were unable to achieve this enrolment goal, our findings nevertheless achieved statistical significance. Allocation concealment method: none mentioned Blinding of outcome assessors: none mentioned Check of blinding: none mentioned Duration of study: July 2011 to May 2012 Randomisation method: simple randomisation (preset randomisation chart that was based on computer generation of random numbers). |
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Participants |
Baseline characteristics Intervention
Control
Overall
Inclusion criteria: diagnosis of PNES based on recognised criteria. Exclusion criteria: epileptiform activity during an episode and semiology characterised by: 1. a definitive motor component (e.g. shaking or writhing of the torso or limbs, convulsive or rocking movements, head shaking) or 2. a discrete episode of unresponsiveness and 3. the clinical impression that the event could not be explained by another physiological cause (e.g. syncope, sleep disturbance). Severe cognitive impairment or active homicidal or suicidal ideation. Pretreatment: age was the only baseline variable to significantly differ between groups (standard practice 45.3 (SD 11.5) years; structured inpatient feedback 37.7 (SD 10.5) years, structured ongoing feedback 34.1 (SD 9.5) years). |
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Interventions |
Intervention characteristics Intervention
Control
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Outcomes |
Mental state – depression (BDI)
Quality of life (QOLIE10‐P)
Seizure frequency (self‐made scale)
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "a preset randomisation chart that was based on computer generation of random numbers (simple randomisation)." |
Allocation concealment (selection bias) | Unclear risk | No information provided. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No information provided. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information provided. |
Incomplete outcome data (attrition bias) All outcomes | High risk | The distribution of dropouts among groups was not specified. |
Selective reporting (reporting bias) | Unclear risk | No protocol available. |
Other bias | High risk | Primary outcome was measured on a self‐made scale. |