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

Thompson 2013.

Study characteristics
Methods Study design: randomised controlled trial
Study grouping: parallel group
Adequate power (evidence of power calculation): the sample size of 19 participants was small, but the effect size of the primary outcome (follow‐up with therapist) was large for this pilot study. Based on the preliminary study where 100% followed up with a mental health professional with the intervention compared with 10% before, the sample size (nQuery Advisor 6.01, 1995–2005) would have 84% power to detect similar results (using a conservative estimate of 80% vs 10% following up with a therapist, or 90% vs 20% following up).
Allocation concealment method: no information provided
Blinding of outcome assessors: at 5‐week postdischarge, the principal investigator sent a reminder letter about the upcoming telephone interview and the QOLIE31, with instructions to complete prior to the telephone interview between weeks 6 and 8. The research assistant conducted telephone interviews with the 19 participants.
Check of blinding: no information provided
Duration of study: 6 weeks
Randomisation method: table of random numbers
Participants Baseline characteristics
Overall
  • n: 19

  • Duration of symptoms: no information provided

  • Age (mean): 33 years

  • Sex (% woman): 60%

  • Ethnicity: 85.7% white

  • Marital status: no information provided

  • Currently married: no information provided

  • Educational status: 85.7% more than associated degree


Inclusion criteria: able to provide written informed consent; diagnosis of PNES established by a neurologist using history, examination and VEEG capturing ≥ 1 of their typical events; and not have a comorbid neurological disease or confirmed medical condition causing the seizures. 
Exclusion criteria: people with legal guardians; concurrent epilepsy; history of psychiatric disorders that included psychotic features (hallucinations or delusions, or both).
Pretreatment: no information provided.
Interventions Intervention characteristics
Intervention
  • Description: brief educational intervention while the participants were still in the hospital for VEEG diagnostic testing

  • Length of treatment: 40–90 minutes depending on the participant’s needs

  • Longest follow‐up after end of treatment: 6–8 weeks postdiagnosis

  • Comedications/other treatments while in the study: no information provided


Control
  • Description: SC in which the neurologist informed the participant that the seizures were PNES and suggested seeking mental healthcare and may or may not have provided the participant with a mental health referral

  • Length of treatment: provided once

  • Longest follow‐up after end of treatment: 6–8 weeks postdiagnosis

  • Comedications/other treatments while in the study: no information provided

Outcomes  
Notes There were no data available for the primary or secondary outcomes specified for the review, as it was not possible for the author to provide these (Thompson 2018).
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "The 19 subjects were randomly assigned into either the control or treatment group by using a table of random numbers."
Allocation concealment (selection bias) Unclear risk Quote: "[The] attending neurologist identified appropriate candidates while they were in the EMU before the final diagnosis was provided."
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk The personnel were not blinded when delivering the intervention and control.
Quote: "The study was explained and informed consent was obtained by the PI [principal investigator] to subjects in the treatment group. She used a consent script (...) The study was explained and informed consent obtained by an advanced practice registered nurse to subjects in the control group."
Quote: "The principal investigator (PI), who was also the interventionist, had no contact with subjects who were randomly assigned to the control group. She did not have contact with treatment group subjects prior to meeting them for the intervention."
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Unclear whether the outcome assessor was blinded.
Quote: "At the 5‐week postdischarge time, the PI [principal investigator] sent a reminder letter about the upcoming telephone interview and the QOLIE‐31, with instructions to complete prior to the telephone interview between weeks 6 and 8. The research assistant (RA) conducted telephone interviews with the 19 subjects."
Incomplete outcome data (attrition bias)
All outcomes High risk Only data for the 19 participants were included, even if the text described 25 participants to consent to participate.
Quote: "Twenty‐five subjects consented to be in the study. We lost six subjects. One subject was not eligible because she had been diagnosed with psychosis. Two subjects were not eligible as they were also diagnosed with epilepsy. We were unable to find three subjects at the time of the second interview."
Selective reporting (reporting bias) Unclear risk No protocol available.
Other bias Low risk No apparent sources of bias.