Phenomenological Approach of Epilepsy in Patients With Epilepsy
Phenomenological Approach of Epilepsy in Patients With Epilepsy
Rationale : Persons with epilepsy have a greater risk of incurring accidental injury and a
 higher mortality risk than the general population.

 The main objective of the study is to understand life experience of the disease or risks
 associated with epilepsy in patients with epilepsy, relatives of patients and bereaved
 families.

 Study design: Qualitative study (study based on interviews) Population: Three groups will be
 interviewed: bereaved families, patients with epilepsy and relatives of patient. Bereaved
 family: relatives who contact the French sentinel network "Réseau Sentinelle Mortalité
 Epilepsie" (RSME) notifying an epilepsy-related death (regardless the cause of the death and
 the timeframe between death and interview). Patients with epilepsy: patients having a secure
 diagnostic of epilepsy from 15 years old to 65 years old. Relatives of patients with
 epilepsy: spouse/husband or parents invited by a patient with epilepsy to participate to the
 interview who consent to participate.

 Method: Semi structured in-depth interviews will be conducted by an experienced qualitative
 psychologist in face to face, at home, at the hospital or at any other place (depending on
 the choice of the participants). The interview topic guide will be centered on
 participants'personal experience. Interviews will be digitally recorded and will be
 transcribed by a secretary.

 The results of this study will be integrated in educational therapeutic programs regarding
 prevention of risks related to epilepsy.
Rationale: Persons with epilepsy have a greater risk of incurring accidental injury and a
 higher mortality risk than the general population.

 Study Objective : To understand life experience of the disease and risks associated with
 epilepsy in patients with epilepsy, relatives of patients with epilepsy and bereaved
 families.The results of this study will be integrated in educational therapeutic programs
 regarding risks related to epilepsy.

 Study design : Qualitative study with a phenomenological approach and semiopragmatic
 analysis. Three different groups will be interviewed: bereaved families, patients with
 epilepsy and relatives of patients with epilepsy.

 Recrutement procedures :

 The identification of bereaved families will be based on the French sentinel network "Réseau
 Sentinelle Mortalité Epilepsie" (RSME). This network was initially established by the French
 League Against Epilepsy (LFCE) under the leadership of bereaved families in 2010 and
 supported by the French Foundation for Epilepsy Research (FFRE). The primary aim of the RSME
 is to detail the causes and circumstances of epilepsy-related deaths in France. Secondary
 objectives are to evaluate the expectations and needs of bereaved families and create a
 national database for future research programs. Epilepsy-related deaths are reported by
 physicians but also by bereaved families. The interview will be proposed at this moment.
 Moreover the RSME includes a national network of bereaved families. The interview will be
 also proposed to the participants of this network.

 Patients with epilepsy will be recruited from tertiary epilepsy units, private neurologists
 or general practitioners and thanks from patients associations. Patients living in the
 Languedoc Roussillon area and referred to the epilepsy unit of the University Hospital of
 Montpellier (CHRU Montpellier) will be preferentially invited to participate to the
 interview. The interview will be also proposed to relatives of patients (parents or
 spouse/husband) who consent to participate. The study could be proposed to patients included
 in the PRERIES study (Risk Factors in Sudden Unexpected Death in Epilepsy: A matched
 case-control study, coordinated by the coordination unit of the RSME).

 Method :The characteristics of this methodology are based on COREQ criteria (consolidated
 criteria for reporting qualitative research).

 A qualitative study with phenomenological approach will be used. The aim of this approach is
 to collect participants 'life-experiences in their own real and personal situation.
 Semistructured interviews with an in-depth questioning will be conducted by a psychologist
 who received specific patient-centered interview training. The interview topic guide using
 open questions will be centered on participants' personal experience.The same topic guide
 will be used for the first group (epileptic patients) and the second group (relatives group).
 However, for the third group (bereaved families), the interview guide will be adapted,
 looking at life experience before death: focusing circumstances, particular events, behaviors
 or clinical signs which could give alarm. This interview is more difficult because of a
 frequent sense of guilt and requires an experienced qualitative interviewer.The
 phenomenological questions will be asked on a temporal prospect.The first part, concern the
 disclosure of the disease. The questions invite participants to relive this moment,
 remembering when they were told about epilepsy and what happened after that: how they felt,
 what they thought? Behaviors and how the risks of epilepsy were be told by doctors.Secondly,
 participants will be invited to describe the current disease influence on the way of life.The
 key topics guide focused on epilepsy influence on body, relation to others or to relatives,
 employment, lifestyle and personal identity.

 The saturation point will be determined when no more new information pertaining to the matter
 of research emerge.

 The interviews will be conducted in face to face at home, at the hospital or in any other
 place (depending on the choice of the participants). The different conditions in which the
 interviews will be conducted will be all clearly identified and included in each recording:
 time, place, positioning of the actors, and context (family presence, disturbing
 environment). Interviews will be digitally recorded and will be transcribed by a secretary.
 According to that comprehensive approach, categories will be not identified in advance but
 derived from the data.

 Other data collected : Sociodemographic data (gender, age, current occupation, education
 level, leasure, physical activity, driving and lifestyle) will be collected from a
 questionnaire filled in by the participants before the interviews. Clinical characteristics
 (duration of epilepsy, age at onset, syndrome and etiology, seizure type, seizures frequency)
 will be completed by the physicians in charge of the patients. For bereaved families, the
 cause of death will be recorded.

 Data analysis :

 Sample size : In qualitative studies, the sample size cannot be determined previously.
 Patients or relatives who satisfy the inclusion criteria will be invited for the study
 participation until a saturation point.

 The saturation point is determined as the point at which further collection of data does not
 result in uncovering any new information pertaining to the topic under investigation. We
 estimate that approximately 30 interviews would be sufficient to reach data saturation.

 Transcripts analysis : The analysis will be conducted using a grounded theory approach
 incorporating the pragmatism of Peirce. A semiopragmatic analysis according to CS Peirce's
 theories (semiopragmatical approach) guarantees a clearly and precise analysis and limits the
 biases or errors of interpretation. So, conceptual categories will not be identified not in
 advance but will be derived from the data by constant comparison.

 Transcripts will be analyzed by two qualitative methodologists following these
 steps:Transcribing the recordings word for word (verbatim), Floating reading then focused
 reading, Breaking the text down into units of meaning and themes, Identifing all the
 semiotic, textual and contextual elements to let the category emerge through constant
 comparison (empirical category), Characterizing the empirical categories obtained according
 to the theory of classes of Signs (semiotics) (Quality, Fact, Law), Setting the categories in
 hierarchical order according to relationships between them in which law presuppose fact who
 presuppose quality, econstructing the meaning in the form of a synthetic generalizing
 proposition to restore the meaning of studied phenomenon Verbatim extract will be presented
 to illustrate the obtained categories with a number in order to identify them anonymously.

 Descriptive analysis: Descriptive statistics on sociodemographic and clinical characteristics
 will be performed using SAS® version 9.1. (SAS Institute, Cary, NC). Intergroup differences
 will be examined using chi-squared and Mann-Whitney U analyses.

 Practical course Study procedures and visits Informed consent procedures :The participant or
 participant's parent(s) / legal representative(s) must be informed by the interviewer about
 all aspects of the study that are relevant to decide to participate in particular concerning
 the personal data collection, and must have sufficient time and opportunity to ask any
 questions. Prior to the interviews, the written Informed Consent form must be signed and
 personally dated by the participant or participant's parent(s) / legal representative(s).

 Collection of data: This interview will be conducted by a psychologist using the interview
 topic guide and a standardized form for sociodemographic data and clinical data.
Inclusion Criteria:

 -  Bereaved family: Parents or spouse/husband who contact the coordination unit of the
 RSME in order to notify an epilepsy related death and who consent for an interview
 regardless of the cause of death and timeframe between death and interview.

 -  Patients with epilepsy: Patients having a secure diagnostic of epilepsy with active
 epilepsy (treated or not) or in remission under treatment or without treatment aged
 from 15 years to 65 years old.

 -  Relatives of patients with epilepsy: Parents or spouse/husband invited by a patient
 with epilepsy to participate to the interview who consent to participate.

 Exclusion Criteria:

 -  Patients or relatives with learning difficulties

 -  Refusal of participation of the patients or relatives or legal representatives for
 patients aged under 18 years old

 -  Refusal for audio recording