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 |
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Participants |
Baseline characteristics Intervention
Control
Overall
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. |
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Interventions |
Intervention characteristics Intervention
Control
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Outcomes |
Level of functioning (WSAS)
Dropout
Healthcare use – hospital visits
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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. |