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

May 2002.

Methods Randomised controlled trial (6 months follow‐up)
Participants 242 patients from 22 epilepsy centres in Germany, Switzerland and Austria
Mean age of participants was 38 years; 43% were male
Interventions Intervention: Modular Service Package Epilepsy (MOSES), a 2‐day educational programme
Control: waiting list control
Outcomes
  • Seizure frequency at baseline and 6 months later assessed according to six categories: (0) no seizures in last 6 months (1)one to two seizures in last 6 months (2) three to five seizures in last 6 months (3) one or more seizures per month (4) one or more seizures per week (5) one or more seizures per day

  • Health‐related quality of life as measured by German SF‐36 at baseline and 6 months later

  • Self esteem as measured by Rosenberg Self Esteem Scale at baseline and 6 months later

  • Depression as measured by von Zerssen Depression Scale at baseline and 6 months later

  • Epilepsy‐specific instruments from previously published papers

    • Restrictions in Daily Life at baseline and 6 months later

    • Epilepsy‐Related Fear at baseline and 6 months later

    • Epilepsy‐Related Stigma at baseline and 6 months later

    • Mobility and Leisure at baseline and 6 months later

  • Purpose‐built instruments developed for the study

    • Epilepsy Knowledge at baseline and 6 months later

    • Coping with Epilepsy at baseline and 6 months later

    • Adaptation to Epilepsy at baseline and 6 months later

Funding Sanofi‐Synthelabo provided financial support
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No details of randomisation provided
Allocation concealment (selection bias) Unclear risk No details of allocation provided. Participants in the control group had a longer duration of epilepsy than those in the intervention group (median 18.2 vs 13.5 years)
Blinding (performance bias and detection bias) 
 All outcomes High risk Authors 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 High risk Only 63% of those randomised completed the programme
Selective reporting (reporting bias) Low risk All outcomes detailed in the methods were reported in the results
Other bias Unclear risk No details of power calculations or required sample size were reported
Overall risk of bias Unclear risk Lack of detail about randomisation and allocation (but groups relatively similar at baseline apart from duration of epilepsy); no apparent blinding and a large minority of participants dropped out of the study