Phenomenological Approach of Epilepsy in Patients With Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): interview with a psychologist
Intervention type(s): Other
Intervention description(s): interview with a psychologist in Bereaved families, Patients with épilepsy and relatives of patients with epilepsy Relatives (Parents / spouse/ Husband) of patients with epilepsy
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The identification of bereaved families will be based on the French sentinel network
        "Réseau Sentinelle Mortalité Epilepsie". This network was initially established by the
        French League Against Epilepsy under the leadership of bereaved families in 2010 and
        supported by the French Foundation for Epilepsy Research . 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.
        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 and relatives of patients will be recruited from tertiary
        epilepsy units, private neurologists or general practitioners and thanks from patients
        associations.
      
Keywords: SUDEP; Epilepsy; Qualitative research; Risks associated with epilepsy; Epilepsy-related deaths