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

Chen 2014.

Study characteristics
Methods Study design: randomised controlled trial
Study grouping: parallel group
Adequate power (evidence of power calculation): none mentioned
Allocation concealment method: none mentioned
Blinding of outcome assessors: none mentioned
Check of blinding: none mentioned
Duration of study: June 2011 to October 2012
Randomisation method: computerised/even‐odd numbers
Participants Baseline characteristics
Intervention
  • n: 34

  • Duration of symptoms (mean): 106.94 (SD 115.92) months

  • Age (mean): 50.76 (SD 12.27) years

  • Sex (% woman): 26.5%

  • Marital status currently married (%): 55.9%

  • Educational status: 12.91 (SD 1.68) years


Control
  • n: 30

  • Duration of symptoms (mean): 83.96 (SD 102.32) months

  • Age (mean): 50.70 (SD 11.55) years

  • Sex (% woman): 23.3 %

  • Marital status currently married (%): 56.7%

  • Educational status: 13.30 (SD 2.29) years


Overall
  • n: 64


Inclusion criteria: VEEG‐confirmed non‐epileptic events of interest, which were interpreted to be of psychogenic origin based on combined features of ictal semiology, psychosocial history and results from psychological screening instruments.
Exclusion criteria: main place of dwelling beyond commutable distance (patients referred from outside VA medical centres); suspected mixed disorder of PNES and epilepsy (people with prior EEG documentation of electrographic seizures or interictal epileptiform abnormalities); and Mini‐Mental Status Examination score of 25, when assessed during the EMU admission.
Pretreatment: no statistically significant differences at baseline between groups.
Interventions Intervention characteristics
Intervention
  • Description: group psychoeducation programme (3 × 1.5 hours over 3–5 months)

  • Length of treatment: 3–5 months

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

  • Comedications/other treatments while in the study: none.


Control
  • Description: TAU with 2 follow‐up appointments with neurologist

  • Length of treatment: 3–5 months

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

  • Comedications/other treatments while in the study: none

Outcomes Level of functioning (WSAS)
  • Outcome type: continuous

  • Data value: endpoint


Dropout
  • Outcome type: dichotomous

  • Data value: endpoint


Healthcare usehospital visits
  • Outcome type: dichotomous

  • Data value: endpoint

Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "patients were each independently designated a computer generated."
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 Low risk 16 withdrew in the intervention group and 9 withdrew in the control group. Withdrawal was accounted for.
Selective reporting (reporting bias) High risk The background data that are used for describing the PNES frequency were not available even though they were used in the article. The primary outcome was not sufficiently reported. No protocol available.
Other bias Low risk No other apparent sources of bias.