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. 2016 Feb 4;2016(2):CD006244. doi: 10.1002/14651858.CD006244.pub3

DiIorio 2011.

Methods Randomised controlled trial (6 months follow‐up)
Participants 194 people recruited through epilepsy‐based websites and forums, online clinical research matching services, and referrals from healthcare professionals in a large southeastern metropolitan area, USA
Mean age of participants was 43 years; 68% were male
Interventions Intervention: WebEase (Epilepsy Awareness, Support, and Education), an online epilepsy self management programme to assist people with taking medication, managing stress and improving sleep quality
Control: waiting list control (control group was put on a waiting list receiving usual care and then received the intervention at a later point in time)
Outcomes
  • Medication adherence measured by the Medication Adherance Scale (MAS) completed three times over 6 months

  • Sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI) completed three times over 6 months

  • Epilepsy self management measured using the Epilepsy Self Management Scale (ESMS) completed three times over 6 months

  • Self efficacy measured using the Epilepsy Self Efficacy Scale (ESES) completed three times over 6 months

  • Knowledge about epilepsy measured using the Epilepsy Knowledge Profile (EKP) completed three times over 6 months

  • Quality of life measured using the Quality of Life in Epilepsy Scale‐10 (QOLIE‐10) completed three times over 6 months

Funding Study funded by a grant from the Emory University Research Committee
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Participants were consecutively assigned to intervention and control groups (after random assignment of the first participant)
Allocation concealment (selection bias) Unclear risk Details of allocation concealment were not reported
Blinding (performance bias and detection bias) 
 All outcomes High risk Investigators do not report if any of the participants, clinicians or assessors were blinded. The subjective nature of the outcomes measured (all by self reported questionnaire) means this may have introduced bias
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk The drop out rate was 24%. However, investigators conducted a completer vs non‐completer analysis and an intention‐to‐treat analysis
Selective reporting (reporting bias) Unclear risk All outcomes detailed in the Methods were referred to in the Results, although not all values presented
Other bias Unclear risk No details of power calculations or required sample size were reported. Recruitment took place via the Internet which may have appealed to those people who are computer‐literate. There were no baseline differences reported in the comparison of study groups. There was a risk of contamination as the participants could have known each other
Overall risk of bias Unclear risk Participants were consecutively assigned to intervention and control groups (after random assignment of the first participant)