Quality of Life Clinical Trial
Official title:
Posttraumatic Stress Disorder and Quality of Life of Avalanche Survivors From 2014 to 2018, Based on the French North Alpine Avalanche Register: Risk Factor Analysis
The aim of this study is to identify if an avalanche accident has a psychological impact on
avalanche victims.
The investigators hypothesize that being exposed to an avalanche could generate enough stress
to develop posttraumatic stress symptoms or even more, an authentic posttraumatic stress
disorder (PTSD). Additionally, the investigators think that such symptoms might lead to
physical and psychological distress in daily life. Lastly, the investigators suppose that a
serious traumatism, a complete and/or prolonged burial, the death of a family member or a
closed friend could be a potential risk factors to develop PTSD symptoms in avalanche
victims. To evaluate post traumatic stress symptoms and the quality of life of avalanche
survivors, the investigators use the Impact of Event Scale - Revised and the Short Form 12.
These two scales are included in a standardized questionnaire, which is submitted to
avalanche victims during a phone call.
It is already known that a traumatism, whatever nature or gravity, could lead to acute stress
symptoms and a posttraumatic stress disorder (PTSD) one month after (1). In the last decades,
less than ten studies showed that avalanche survivors are likely to develop PTSD, even
sixteen years after exposure (2, 3). In those studies, authors focused on natural disaster
avalanches (on habitations or roads). This study would like to evaluate psychological impact
of an avalanche accident occurring during mountain recreational activities.
The primary outcome concerns the research of PTSD symptoms using the Impact of Event Scale -
Revised (IES-R). It is a 22 items scale, which explores specifics symptoms of Post Traumatic
Stress Disorder that may have occurred during the week before the interview. It concerns 3
different possible areas of PTSD: intrusion (eight items), avoidance (eight items) and
hyperarousal symptoms (six items). Each item ranges from 0 (not at all) to 4 (extremely). The
total score of the IES-R ranges between 0 and 88. A score equal or more than 33 is highly in
favour of PTSD (91% sensitivity, 82% specificity, 90% positive predictive value and 84%
negative predictive value). However, above 33 the diagnostic of posttraumatic stress disorder
must be confirmed by a psychiatric analysis. Our results will be separated in two categories
for the analysis: 1) IES-R score higher or equal to 33; 2) IES-R score lower than 33.
The secondary outcome is the result of the Short Form 12 questionnaire (SF-12). The SF-12
consists of 12 items selected from the "Medical Outcomes Study 36-items Short-Form Health
Survey" (SF-36) to reproduce the Physical Component Summary and Mental Component Summary
scales in the general US population. The SF-12 Health Survey was developed in the United
States to provide a shorter alternative to the SF-36. The SF-12 contains a subset of 12 items
from the SF-36, including one or two items from each of the eight SF-36 scales (general
health, physical role, physical bodily, vitality, social and emotional functioning, role
emotional and mental health). SF-12 Physical and Mental Components are scored from 0 to 100.
A higher score indicates a better health state. Scores will be compared to literature data.
Study population concerns avalanche survivors in the French Northern Alps during the last
four years. Furthermore, the investigators will try to identify risk factors to develop PTSD
in these circumstances. They will try to know if survivors have changed their mountain
practice after the accident. From 2014 to 2018, there were 211 avalanche victims in the
French North Alps included in the North Alpine Avalanche Register (RENAAV), 132 victims
survived. Considering the rate of non-response, the investigators are expecting between 50 to
80 subjects to be analysed. Data will be collected in the medical records and during a phone
interview with a standardized questionnaire. A rate of 9,2 % of posttraumatic stress symptoms
is expected, corresponding to the prevalence of PTSD (1) after traumatism.
Concerning statistical analysis, quantitative data will be described in terms of mean,
standard deviation, median and extreme values. Qualitative data will be described in terms of
absolute frequency and percentage by modality. The 95% confidence intervals will be
presented. Quantitative data will be compared by a Student's parametric test, replaced by the
Wilcoxon test in case of deviation from the normality of distribution. Categorical data will
be compared by a Chi 2 test or Fischer's exact test in case of too small sample. A threshold
of significance will be retained for a value of p < 0.05. Univariate and multivariate
analyses will be performed to independently identify risk factors at a higher frequency of
PTSD.
The research team received the approval of ethical research committees since the March 19th
of 2019.
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