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Table 2 Epilepsy-specific PRO instruments

From: Patient Reported Outcome (PRO) assessment in epilepsy: a review of epilepsy-specific PROs according to the Food and Drug Administration (FDA) regulatory requirements

Abbreviated name Full name Overview Scoring: total score & sub-scales Number of items Recall period Response options Published details of instrument development and psychometric properties
ABNAS Aldenkamp-Baker Neuroassessment Schedule An instrument to measure patient perceived cognitive side effects of AED treatment. Total score and 6 subscale scores: 24 No recall period Four point scale ranging from ‘no problem’ to ‘a serious problem’ [2428]
1. Fatigue
2. Slowing
3. Memory
4. Concentration
5. Language
6. Motor coordination
  Attack Symptom Measure An instrument to measure ictal symptoms that would typically be associated with panic disorder. Total score and five sub-scales: 26 During their attacks Two options indicating the absence or presence of the symptom [29]
1. Autonomic arousal symptoms
2. Chest and abdomen symptoms
3. Mental state symptoms
4. General symptoms
5. Cognitive symptoms
BPSE Bonner Psychsoziale Skalen fur Epilepsie A self-report questionnaire designed to evaluate the patient’s areas of illness-related psychosocial problems and cognitive-behavioural variables. 20 subscales in six areas: 87 No recall period in example items reviewed Analogue ratings of between 0 to 6. Scales include Never to Always or Not at all to Extremely and primarily focus on frequency of cognitions or behaviour [30]
1. Impairment to daily life
a. Physically
b. Activity/capability
c. Relations and family
d. Emotional/mood
e. Independence
f. Problem-solving/coping
2. Environmental experiences
a. Positive
b .Negative
c. Present emotions/moods
3. Attitude to illness/seizures
a. Helplessess
b. External attribution
c. Internal attribution
4. Relatives’ reaction to seizures
a. Calming down/relief
b. Punishment
c. Distraction
5. Activities
a. Home/family
b. Social
c. Cultural
6. Influences on seizure occurrence
a. Personal/others
b. Situational
EFA concerns index Epilepsy Foundation of America concerns index A HRQL measure for patients with epilepsy, covering concerns relating to affective enjoyment, general autonomy, seizure recurrence, family burden and lack of understanding. Ratings are summed to produce a Concerns Index Score. 20 Past 4 weeks Five point scales ranging from ‘not at all concerned’ to ‘extremely concerned’ or ‘none of the time’ to ‘all of the time’ [3133]
EPSES Epilepsy Psycho-Social Effects Scale An instrument to determine the social effects of epilepsy and measure psychosocial functioning. Total weighted score and 14 subscale scores: 42 No recall period Five point scale ranging from ‘almost always or always’ to ‘never’ [34]
1. Attitude towards accepting attacks
2. Fear of having seizures
3. Fear of stigma in employment
4. Lack of confidence about the future
5. Lack of confidence about travelling
6. Adverse reaction on social life
7. Adverse reaction on leisure pursuits
8. Change in outlook on life/self
9. Difficulty communicating with the family
10. Problems with taking medication
11. Distrust of the medical profession
12. Depression or emotional reactions
13. Feeling of increased social isolation
14. Lethargy/lack of energy
- EPI-QOL A HRQL assessment instrument for adults with epilepsy. Total score and six subscale scores: 46 Past two weeks and now Five point scale ranging from ‘very frequently’ to ‘not at all’. [35]
1. Physical functioning
2. Emotional wellbeing
3. Cognitive functioning
4. Social functioning
5. Seizure worry
6. Medication effects
ESES Epilepsy Self-Efficacy Scale An instrument to measure self-efficacy in regards to epilepsy management. Total score. 33 No recall period Ten point scale ranging from ‘I cannot do at all’ to ‘Sure I can do’ [36, 37]
ESI-55 Epilepsy Surgery Inventory 55 An instrument to measure HRQL in epilepsy surgery patients. Weighted total score, three composite scores (Physical, mental and cognitive role) and eleven subscale scores: 55 Various today/last week/last year/4 weeks Various response formats. (‘strongly agree’ to strongly disagree’, ‘often’ to ‘not at all’, yes/no) [38, 39]
1. Emotional wellbeing
2. Role limitations due to emotional problems
3. Energy/fatigue
4. Social function
5. Pain
6. Physical function
7. Role limitations due to physical problems
8. Health perceptions
9. Cognitive function
10. Role limitations due to memory problems
11.Overall quality of life
ICI Ictal Consciousness Inventory A quantitative assessment of the level of awareness and content of ictal consciousness. Two sub-scale scores: 20 During a single seizure Three point scale: ‘no’; ‘yes, a bit (yes, vaguely)’; ‘yes, much (yes, clearly)’. [40]
1. Level of consciousness (ICI-L)
2. Content of consciousness (ICI-C)
IES Impact of Epilepsy Scale Developed to assess the impact of epilepsy and antiepileptic drug therapy on an individual’s relationship with friends and family, social life, employment, health, self-esteem, plans for the future, and standard of living. Total impact score. 8 No recall period. Four point scale ranging from ‘not at all’ to ‘a lot’ [41, 42]
LAEP Liverpool Adverse Events Profile An instrument to measure total side effects burden of a medical regimen. It was developed to evaluate the most common negative side effects reported by patients taking AEDs. The AEP evaluates the interiactal state. It's widely used alone and is also part of the Liverpool Battery. Total score. 19 Past 4 weeks Four point scale ranging from ‘never a problem’ to ‘always or often a problem’ [4349]
Space to rate up to 3 additional AEs.
LSSS Liverpool Seizure Severity Scale 2.0 (2001) A scale designed to quantify patient’s own perceptions of seizure severity. Weighted most severe ictal effects score. 12 Past 4 weeks Various scales referring to the content of each question ranging from 4 to 6 options. For example ‘I always feel sleepy’ to ‘I never feel sleepy’ [17, 44, 5053]
NDDI-E Neurological Disorders Depression Inventory for Epilepsy An instrument to detect depression in epilepsy patients. Total score. 6 Past two weeks Four point frequency scale ranging from ‘always or often’ to ‘never’. [54]
NEWQOL Quality of Life in Newly Diagnosed Epilepsy An instrument to measure aspects of quality of life postulated as being important for patients recently diagnosed with epilepsy. Eight subscale scores and single item scores: 93 Varies from 'How you are now' to 'In the last year' Various response formats including 4 and 5 point scales ranging from ‘no problem’ to ‘a serious problem’ or ‘severely restricted’ to ‘not restricted at all’ [25]
1. anxiety
2. depression
3. social activities,
4. symptoms,
5. locus of control/mastery,
6. neuropsychological problems (subscales of fatigue, memory, concentration, motor skills, reading),
7. social stigma*, worry
8. work limitations.
Several single-item measures:
•general health
•number of seizures
•social limitations
•social support
•health transition
•general limitations
  Perceived Limitations Scale A measure of the constraints that patients with epilepsy might experience including the sense of vulnerability to the physical consequences of seizures. Total score. 5 No recall period Four point scale ranging from ‘strongly agree’ to ‘strongly disagree’ [55]
  Perceived Stigma Scale A measure of the extent to which people with epilepsy feel they are victims to prejudice, including the extent to which individuals are treated differently and inability to change the views of others. Total score. 6 No recall period Four point scale ranging from ‘strongly agree’ to ‘strongly disagree’ [55]
PESOS Performance, subjective evaluation and socio-demographic data A test-battery for assessing the severity of epilepsy, epilepsy related quality of life, restrictions in daily life and psychosocial problems. Separate scores for each instrument in the battery: 69 Various recall periods Various response options [56]
1. Restrictions in daily life^
2. Epilepsy related fear$
3. Stigma
4. Emotional adaptation
5. Problems at work
6. Problems at school
7. Problems with parents
PNS Portland Neurotoxicity Scale An instrument to measure commonly experienced adverse events associated with AEDs. Total score and two subscale scores: 15 Past few weeks Nine options ranging from ‘no problem’ to ‘severe problem’ [57]
1. Cognitive toxicity
2. Somatomotor toxicity
QOLIE-10 Quality of life in epilepsy 10 A brief measure of overall quality of life for patients with epilepsy. Total score and three subscale scores: 10 Past 4 weeks Various 5 point scales including ‘not at all‘to ‘a great deal’ and ‘not at all fearful’ to ‘extremely fearful’ [58, 59]
1. Epilepsy effects
2. Mental health
3. Role functioning
Alternatively scores are calculated for the 7 domains of the QOLIE-31, although for the QOLIE-10, 5 of the 7 subscales are scored from single items.
QOLIE-31 Quality of life in epilepsy 31 Overall quality of life for patients with epilepsy. Total weighted score and seven subscale scores: 31 Past 4 weeks Various response formats including five and six point scales ranging from ‘very fearful’ to ‘not fearful at all’ or all the time’ to ‘none of the time’ [44, 5963]
1. Seizure worry
2. Overall quality of life
3. Emotional well-being
4. Energy/fatigue
5. Cognitive functioning
6. Medication effects
7. Social functioning
QOLIE-89 Quality of life in epilepsy 89 Overall quality of life for patients with epilepsy Total weighted score and 17 subscale scores: 89 Past 4 weeks Various response formats including yes/no or 5 point scales ranging from ‘excellent’ to ‘poor’ or ‘all the time’ to ‘none of the time’ [44, 6067]
1. Seizure worry
2. medication effects
3. health perceptions
4. health discouragement
5. work/driving/social function
6. language
7. attention/concentration
8. memory
9. overall QOL
10. emotional wellbeing
11. role limitations: emotional
12. role limitations: physical
13. social isolation,
14. social support
15. energy/fatigue
16. physical functioning
17. pain.
SEALS Side Effect and Life Satisfaction Inventory A self-report questionnaire designed to measure satisfaction with AED therapy. Total score and five subscale scores: 38 Past week Four point scale ranging from ‘never’ to ‘many times’. [6871]
1. Cognition
2. Dysphoria
3. Tiredness
4. Temper
5. Worry
SHE Subjective Handicap of Epilepsy Measures patient’s subjective handicap of epilepsy based on the WHO concept of handicap. It is recommended for use in studying the long-term consequences of medical, psychosocial and surgical interventions in epilepsy. Six subscale scores: 32 Past 6 months, except for the change scale which is the last year Various 5 point scales. For example, ‘Much better’ to ‘Much worse’ or ‘Very often’ to ‘never’. [72]
1. Work and activities Some responses are optional based upon the patient’s situation.
2. Social and personal
3. Physical
4. Self-perception
5. Life satisfaction
6. Change
SIDAED Assessing side effects of AED treatment An instrument to assess the duration and severity of adverse events that are possibly AED related. Total score. 46 No recall period Four point severity scale ranging from ‘no problem’ to ‘serious problem’ and a three point duration scale ranging from ‘since a few weeks’ to ‘half a year or longer’. [7377]
Adverse events can also be grouped in 10 categories
1. General CNS
2. Behaviour (increased irritability)
3. Depressive symptoms
4. Cognitive function
5. Motor problems and coordination
6. Visual complaints
7. Headache
8. Cosmetic and dermatological complaints
9. Gastrointestinal complaints
10. Sexuality and menses
SSQ Seizure Severity Questionnaire An instrument designed to assess seizure severity as a treatment response. The measure asks about events before, during and after a seizure and covers bother, severity and frequency of seizures. Three subscale scores: 22 Past 4 weeks Various response formats. Format is primarily seven point scales referring to frequency, ranging from ‘never’ to ‘always’, bother, ranging from ‘no bother at all’ to ‘very bothersome’ and severity ‘very mild’ to ‘very severe’, There are also yes/no responses. [78]
1. Seizure severity
2. Overall assessment
3. Change after alteration of treatment
WPSI Washington Psychosocial Seizure Inventory Provides absolute and relative estimates of psychosocial functioning. Eight subscale scores: 132 No recall period Yes/no responses reflecting self-perceived feelings and actions. [7981]
1 .Family background
2. emotional adjustment
3. interpersonal adjustment
4. financial status
5. adjustment to seizures
6. medicine
7. medicinal management
8. overall psychosocial functioning
  1. * Stigma of epilepsy scale has been used as a stand-alone PRO instrument to measure epilepsy patient’s perception of stigma. It comprises 3 items forming a total score [8184].
  2. ^ Restrictions in daily life has been used as a stand-alone PRO instrument to measure social, physical and psychological dimensions that are generally stressed as central aspects of HRQL. It comprises 11 items representing three sub-scales: independent living and mobility, physical and emotional health, partnership, family and friends [56].
  3. $ Epilepsy Related Fears has been used as a stand-alone PRO instrument to measure fears regarding aspects of physical and social consequences. Comprising 11 items representing two sub-scales: Physical Consequences, Social Consequences [56].
  4. AED: anti-epileptic drug.