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. 2020 Jul 17;2020(7):CD005331. doi: 10.1002/14651858.CD005331.pub3

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).
Participants Baseline characteristics
Intervention
  • n: 15

  • Age (mean): 34.1 (SD 9.5) years

  • Sex (% woman): 86.67%

  • Educational status: 13.9 (SD 3.1) years


Control
  • n: 12

  • Age (mean): 45.3 (SD 11.5) years

  • Sex (% woman): 83.3%

  • Educational status: 13.3 (SD 2.5) years


Overall
  • n: 27


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).
Interventions Intervention characteristics
Intervention
  • Description: structured ongoing feedback (scripted delivery of diagnosis, inpatient psychiatric consultation, educational handout material and 4 weekly follow‐up calls)

  • Length of treatment: 5 weeks

  • Longest follow‐up after end of treatment: 3 weeks

  • Comedications/other treatments while in the study: any


Control
  • Description: standard practice. The attending physician presented the PNES diagnosis at his/her own discretion (without a script) and suggested mental health follow‐up in the community. These patients did not receive an inpatient psychiatric consultation or educational materials, and the study team did not contact them until eight weeks after discharge

  • Length of treatment: 5 weeks

  • Longest follow‐up after end of treatment: 3 weeks

  • Comedications/other treatments while in the study: any

Outcomes Mental state – depression (BDI)
  • Outcome type: continuous


Quality of life (QOLIE10‐P)
  • Outcome type: continuous


Seizure frequency (self‐made scale)
  • Outcome type: continuous

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.