The detailed schedule for data collection is shown in Table
1. Researchers will travel to the recruitment site of consented participants and abstract the following data from consented participants' medical notes: initials, date of birth, sex, contact information, source of notification (hospital, private site, general practitioner etc) and clinical information. Data are entered onto electronic case report forms (eCRFs) and uploaded to a secure centralised database.
Table 1
Schedule of assessments in the SESIMIC study
Initials | X | | |
Date of birth | X | | |
Sex | X | | |
Inclusion criteria | X | | |
Contact information | X | | |
Interview Characteristics
|
Method of assessment | X | X | X |
Participant or proxy | X | X | X |
Alive at scheduled time of assessment | X | X | X |
Telephone Interview for Cognitive Status (TICS) [ 63] | X | X | X |
Seizure characteristics[ 45] |
Consciousness | X | | |
Onset | X | | |
Frequency | X | X | X |
Phenomena | X | X | X |
Precipitants | X | | |
Family history | X | | |
Epilepsy-related medical history | X | | |
New medical problems | | X | X |
Modified Cumulative Illness Rating Scale [ 66] | X | X | X |
Birth History | X | | |
Medication | X | X | X |
Investigations (EEG, CT, MRI etc) | X | X | X |
Accidents/falls/injuries | | X | X |
Access to services | | X | X |
Final diagnosis | | X | |
Developmental milestones | | Xc
| Xc
|
Cognitive assessment (optional) | | X | X |
Demographic characteristics
|
Born in Australia | X | | |
Years lived in Australia | X | | |
Language other than English spoken at home | X | | |
Marital status | X | X | X |
Number of financially dependent children | X | | |
Social/financial living status | X | X | X |
Medical History
|
Psychotropic medications | X | X | X |
Brief Illness Perceptions Questionnaire [ 48] | X | X | X |
WHO Disability Assessment Schedule [ 67] | Xa
| Xa
| Xa
|
Strengths and Difficulties Questionnaire [ 50] | Xc
| Xc
| Xc
|
Alcohol consumption: Audit Alcohol Use Disorders Identification Test (AUDIT-C) [ 51] | Xa
| Xa
| Xa
|
Education and Employment
|
Highest qualification | X | X | X |
Current student | X | X | X |
Absences from education | X | X | X |
Lifetime occupation | X | X | X |
Current occupation | X | X | X |
Job content questionnaire [ 53] | Xa
| Xa
| Xa
|
Financial Situation
|
Household benefits | X | X | X |
Main source of income | X | X | X |
Insurance | X | X | X |
Economic hardship | X | X | X |
Income | X | X | X |
Transport
|
Vehicles driven and frequency | Xa
| Xa
| Xa
|
Transport to work/education | Xa
| Xa
| Xa
|
Drive for work | Xa
| Xa
| Xa
|
Childcare
|
Location | Xc
| Xc
| |
Duration | Xc
| Xc
| |
Absence from childcare | Xc
| Xc
| |
Support
|
Confiding relationship | X | X | X |
Family adaptation, partnership, growth affection, resolve questionnaire [ 55] | X | X | X |
Inventory of Family Protective Factors [ 56] | X | X | X |
Social media use | X | X | X |
Mood
|
Hospital Anxiety and Depression Scale [ 57] | Xa
| Xa
| Xa
|
General Health Questionnaire | Xc
| Xc
| Xc
|
Stigma
|
Modified HIV Stigma Scale [ 59] | X | X | X |
Disclosure of epilepsy diagnosis | X | X | X |
Sleep
|
Pittsburgh Sleep Quality Index [ 60] | X | X | X |
Health related quality of life
|
| Xa
| Xa
| Xa
|
Quality of Life in Epilepsy for Adolescents [ 61] | Xb
| Xb
| Xb
|
Longitudinal Study of Australian Children [ 62] | Xd
| Xd
| Xd
|
Baseline interview
This will be conducted through a structured face to face interview by a trained researcher at a place of the participant's or their family's convenience. Participants complete a clinical and an age-specific psychosocial assessment.
The clinical assessment for all participants, or their parent, proxy, carer or guardian includes a clinical and modified-Austin interview [
45]. This questionnaire collects information on epilepsy onset and prodromal characteristics, seizure type classification and syndromal classification, complete description of seizure: type, duration, and frequency; other ictal phenomena such as falls; and duration of post-ictal recovery, any symptom side effects if prescribed antiepileptic drugs, details of neurological investigation results (e.g.: EEG, MRI etc) and medical factors potentially associated with morbidity including comorbidity, family history and potential aetiological factors e.g. head injury, birth asphyxia.
Following completion of the clinical assessment, participants or their proxy complete either the adult/guardian or the parent/carer of a child assessment as appropriate.
The adult psychosocial interview with participants who are 18 years of age or older consists of detailed demographic, psychosocial and socioeconomic questions including: duration of residence in Australia, physical and social living situation, medical history, general wellbeing, education and employment, household financial circumstances, transport, social support, mood, stigma and sleep. At the end of the interview, all participants are given the opportunity to provide any other information about their experience or circumstances that has not been covered during the interview.
The parent or carer psychosocial interview for participants who are between 0 and 18 years of age consists of the same information as above with the addition of questions about childcare. Adolescents (between 11 and 18 years of age) and children (between 5 and 10 years of age) also complete age-specific quality of life questionnaires. At the end of the interview, all participants are given the opportunity to provide any other information about their experience or circumstances that has not been covered during the interview.
4 month interview
Participants complete a clinical and an age-specific psychosocial assessment covering the four month period since their diagnosis. The clinical assessment for all participants consists of a review of seizure frequency since last interview, clinical investigations, medications, general health, developmental milestones and an optional cognitive assessment if deemed necessary by the interviewer. The adult, parent or carer interviews are as outlined previously.
Specific questionnaires used include
The
EuroQol (EQ-5D) [
46,
47] is a measure of quality of life that provides a simple descriptive profile and a single value for health status graded on a scale from -0.59 to 1.00. Lower scores indicate poorer quality of life. A score of 0 represents no quality of life and scores less than 0 represent states perceived by the respondent to be worse than death.
The
Brief Illness Perception Questionnaire (BIPQ) [
48] is a valid and reliable measure of patients' cognitive and emotional representations of their illness across a variety of illness groups. The BIPQ assesses consequences, timeline, personal control, treatment control, identity, coherence, concern, emotional response, and causes of illness. Items are rated using a 0 (not at all) to 10 (severely affects my life) response scale.
Psychosocial disability is assessed using the
12-item World Health Organisation Disability (WHO) Assessment Schedule (WHO-DAS II) [
49]. The 12-item WHO-DAS II assesses the magnitude of disability over the previous 30 days using a five point scale from none to extreme/cannot do. Total scores range from 0-100 with higher scores indicating greater disability.
The
Strengths and Difficulties Questionnaire (SDQ) [
50] is a brief behavioural screening questionnaire for parents of 4 to 16 year olds which screens for child psychiatric disorders. In addition to assessing common emotional and behavioural difficulties, it also asks if the parent/carer/proxy thinks that the child has problems in these areas and if there is associated distress and social impairment. The SDQ consists of 5 domains with 5 items per domain with responses ranging from 0 (not true) to 2 (certainly true) with higher scores indicating more problems.
The A
lcohol Use Disorders Identification Test (AUDIT-C) [
51] uses three questions to collect information on 'at-risk' alcohol consumption. Individual question scores range from zero to four. At risk alcohol consumption is indicated by a total score of five or more for males or four or more for females.
Information on paid and unpaid work is collected using modified versions of questions 34-51 of the
Australian Bureau of Statistics 2006 Census [
52] relating to jobs and work. Participants are asked to indicate whether there has been any change in employment circumstances since their diagnosis. Specific barriers to return to work are determined using the short form of the
Job Content Questionnaire (JCQ) [
53]. This widely used measure assesses job demands, control over work and support received.
Household economic hardship is determined by a series of questions about failure to make household payments and whether there was help provided by any organisation or individual to meet these payments. An advantage of this measure is that it is sensitive to the possibility that individuals prioritise certain payments (e.g. default on power bills to pay rent). The basis for these questions is the US Census Survey of Income and Program Participation [
54].
The
Family Adaptation, Partnership, Growth, Affection, Resolve (APGAR) [
55] questionnaire is a valid and reliable 5-item instrument for assessing perceptions of adequacy of social support among adults and children. Items are rated using a three point scale from 'hardly ever' to 'almost always'. Total scores range from 0 (perceives inadequate support) to 10 (perceives adequate social support).
The
Inventory of Family Protective Factors (IFPF) [
56] is a 16-item scale which assesses stressful events the family may have experienced and how they were handled. Item scores range from 1 (not at all like my family) to 5 (almost always like my family). Total scores range from 16 to 80 with high scores indicating a perceived high degree of protection provided by the family.
The
Hospital Anxiety and Depression Scale (HADS) [
57] is used to collect information on depression and anxiety. The HADS is a self-report instrument designed for use with medically ill patients. Scores of 8 (possible range 0-21) or more on the depression or anxiety subscales are classified as 'depressed' or 'anxious', respectively. Consent has been obtained to convey scores of 8 or more directly to participants' nominated GP who will be permitted to arrange treatment or formal referral for abnormal mood symptoms according to their clinical judgement.
The
General Health Questionnaire (GHQ-12) [
58] assesses psychiatric morbidity including general level of happiness, experience of depressive and anxiety symptoms, and sleep disturbance over the last four weeks. The four-item responses range from 0 (not at all) to 1 (much more than usual) with bimodal item scoring. Total scores range from 0 to 12 with scores of 4 or more considered experiencing high psychiatric morbidity.
The
HIV Stigma Scale [
59] has been modified for use in people with epilepsy. This scale assesses 1) Personalized stigma: consequences of other people knowing they have epilepsy 2) Disclosure concerns 3) Negative self image: not as good as others, shame, guilt and 4) Public attitudes: what people think about epilepsy. The four-item responses range from 1 (strongly disagree) to 4 (strongly agree) with total scores ranging from 10 to 40 with lower scores indicating less experienced or perceived stigma.
The first seven items of the
Pittsburgh Sleep Quality Index (PSQI) [
60] are used to measure sleep quality over the previous month. Item responses range from 0 (not during the past month) to 3 (three or more times per week) with higher scores indicating more sleep disturbance.
The
Quality of Life in Epilepsy for Adolescents (QOLIE-AD-48) [
61] scale assesses the affects of epilepsy and antiepileptic medications, and daily activities for adolescents aged between 11 and 18 years of age. Items are rated on a 5 point scale from 1 (poor/much worse) to 5 (much better) with higher scores indicating better health-related quality of life.
Selected sections of questions from the
Longitudinal Study of Australian Children (LSAC) [
62] are used to assess child care, education (use, level, absence and performance) and mood.
The
Telephone Interview for Cognitive Status (TICS-M) [
63] has been validated for assessment of cognitive function for research purposes. The 13-item TICS-M test includes orientation, recent and delayed memory, attention and comprehension assessment with a maximum score of 39. As the TIICS-M can be administered via the telephone it can be used in people with visual difficulties or poor hand-eye co-ordination.
Diagnostic committee review
In all cases, information gathered from the treating clinician's notes through the diagnostic proforma and the baseline clinical interview with the participant will be reviewed by the Diagnostic Committee for a final decision as to the diagnosis. The diagnostic committee comprises a panel of Sydney epilepsy specialists. Epilepsy will be defined according to the ILAE guidelines [
64]. A clinical diagnosis will rely upon two criteria:
(a) Clear evidence of recurrent epileptic seizures, with evidence that these are unprovoked by any acute medical condition or transient brain disorder; and
(b) Documentation of diagnosis by someone with appropriate specialized training in the recognition of epilepsy. This allows for the inclusion of those who have an enduring predisposition to generate epileptic seizures yet have only had one seizure.
Each participant will be allocated to one of the following groups:
Definite epilepsy, with primary documentation that meets criteria: a) clear evidence of two or more unprovoked epileptic seizures that have occurred over interval(s) exceeding 24 hours, or b) confirmed diagnosis of epilepsy by a health care provider with appropriate specialised training in the recognition and treatment of epilepsy.
Probable epilepsy, with other sources of information indicating the likelihood that criteria (a) or (b) are met. Documentation of a diagnosis of epilepsy by a trained non-specialist health care provider without specific documentation of definite criteria above.
Possible epilepsy: requires further information from the baseline interview to confirm this and identify the seizure type classification.
Other seizure type: provoked seizure (acute symptomatic) e.g. post acute head injury, non-epileptic non-organic seizures (panic, psychogenic etc), non-epileptic organic seizures (syncope etc)
Not epilepsy