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Table 1 Outcome measures and data collection

From: Self-Management education for adults with poorly controlled epILEpsy (SMILE (UK)): a randomised controlled trial protocol

Outcome variables

Measures

No. items

T0

T1

T2

Primary outcome

     

Quality of life

QOLIE-31-P [29]

39

RW*

SR**

RW

Secondary outcomes

     

Seizure frequency

Two scales [30, 31]

2

RW

SR

RW

Seizure recency

Patient reported date of last seizure

1

RW

SR

RW

Impact of epilepsy

Impact of epilepsy scale [32]

9

RW

SR

RW

Medication adherence

Epilepsy Self Management Scale [33]

10

RW

 

RW

Medication adverse effects

QOLIE-31-P [29]

2

RW

 

RW

Psychological distress

Hospital Anxiety and Depression scale [34, 35]

14

RW

 

RW

Perceived stigma

Stigma of Epilepsy Scale [36]

3

RW

 

RW

Mastery/control of epilepsy

Epilepsy-specific scale [37]

6

RW

 

RW

Health economics

Client Service Receipt Inventory [38] and EQ-5D [39]

13

RW

 

RW

  1. *RW = research worker collected data (in a face to face interview with a participant).
  2. **SR = self reported data (questionnaires completed by the participant and posted to the research team).