=Paper= {{Paper |id=Vol-2753/paper34 |storemode=property |title=Translation, Adaptation and Initial Validation of the Food Allergy Quality of Life Questionnaire – Child Form (8 – 12 Years) in Ukrainan Language |pdfUrl=https://ceur-ws.org/Vol-2753/paper22.pdf |volume=Vol-2753 |authors=Oksana Matsyura,Olena Borysiuk,Lesya Besh,Svitlana Zubchenko,Natalia Lukyanenko,Taras Gutor,Oksana Kovalska,Bertine M. J. Flokstra - de Blok |dblpUrl=https://dblp.org/rec/conf/iddm/MatsyuraBBZLGKB20 }} ==Translation, Adaptation and Initial Validation of the Food Allergy Quality of Life Questionnaire – Child Form (8 – 12 Years) in Ukrainan Language== https://ceur-ws.org/Vol-2753/paper22.pdf
Translation, Adaptation and Initial Validation of the Food
Allergy Quality of Life Questionnaire – Child Form (8 – 12 Years)
in Ukrainan Language
Oksana Matsyuraa,b, Olena Borysiuka, Lesya Besha,b, Svitlana Zubchenkoc,
Natalia Lukyanenkod, Taras Gutore, Oksana Kovalskae, Bertine M. J. Flokstra - de Blokf,g,h
a
  Department of Pediatrics №2, Danylo Halytsky Lviv National Medical University, Ukraine;
b
  Communal Nonprofit Enterprise “City Children’s Clinical Hospital of Lviv”, Allergy Department, Ukraine;
c
  Department of Clinical Immunology and Allergology, Danylo Halytsky Lviv National Medical University, Lviv,
Ukraine
d
   Department of Propaedeutic Pediatrics and Medical Genetics, Danylo Halytsky Lviv National Medical
University, Lviv, Ukraine
e
  Department of Social Medicine, Economics and Organization of Health Care, Danylo Halytsky Lviv National
Medical University, Lviv, Ukraine
f
  General Practitioners Research Institute (GPRI), Groningen, the Netherlands
g
  University of Groningen, University Medical Center Groningen, GRIAC Research Institute, Groningen, the
Netherlands
h
  University of Groningen, University Medical Center Groningen, Beatrix Children's Hospital, Department of
Pediatric Pulmonology and Pediatric Allergology, Groningen, the Netherlands


                Abstract
                Food allergy affects quality of life of children and their families. In the current context of the
                COVID-19 pandemic, when a physician has to consult a patient remotely, the introduction of
                a disease-specific health-related quality of life questionnaire has become particularly
                important for assessing the course of the disease and the effectiveness of treatment
                interventions. Our study involved 60 children aged 8 to 12 years and was conducted at the
                Communal Nonprofit Organization "City Children's Clinical Hospital of Lviv" (Ukraine).
                After the linguistic validation, both the Ukrainian FAQLQ-CF and Food Allergy Independent
                Measure (FAIM) were used for interviewing children with diagnosed food allergy during the
                visit to the allergist. The prevalence of allergies, the proportion and the correlation between
                different allergens were analyzed in the children involved in the study. Reliability of
                FAQLQ-CF was evaluated by calculating Cronbach’s alpha. A factor analysis was performed
                to assess construct validity and to reveal an underlying structure of four factors that explain a
                total of 55% percent of the variance. The significant strong positive correlation was between
                the total FAQLQ-CF and the total FAIM (r=0.81, p>0.05). Each of the FAQLQ-CF subscales
                correlated significantly with at least one of the FAIM scale questions. The internal
                consistency of the Ukrainian FAQLQ-CF was sufficient (Cronbach’s alpha 0.73). The
                Ukrainian FAQLQ-CF is acknowledged as a suitable, reliable and valid tool to be self-
                completed by food allergic children aged 8-12 years. The information obtained from this
                questionnaire can be used in clinical trials, aiming at outcome assessment.

                Key words 1
                food allergy, quality of life, validation, children.

IDDM’2020: 3rd International Conference on Informatics & Data-Driven Medicine, November 19–21, 2020, Växjö, Sweden
EMAIL: omatsyura@gmail.com (O. Matsyura); olenabora@gmail.com (O. Borysiuk); lesya.besh@gmail.com (L. Besh);
svitlana_zu@meta.ua (S. Zubchenko); lukyanenko@ukrpost.ua (N. Lukyanenko); taras_gutor@ukr.net (T. Gutor);
oksanakovalskamk@gmail.com (O. Kovalska); bertine@gpri.nl (B. M. J. Flokstra - de Blok)
ORCID: 0000-0003-2656-259X (O. Matsyura); 0000-0002-4384-230X (O. Borysiuk); 0000-0003-1897-7461 (L. Besh); 0000-0003-4471-
4884 (S. Zubchenko); 0000-0001-7814-4766 (N. Lukyanenko); 0000-0002-3754-578X (Taras Gutor); 0000-0001-5242-601X (Oksana
Kovalska); 0000-0001-5356-764X (Bertine M. J. Flokstra - de Blok)
           © 2020 Copyright for this paper by its authors.
           Use permitted under Creative Commons License Attribution 4.0 International (CC BY 4.0).
           CEUR Workshop Proceedings (CEUR-WS.org)
1. Introduction
    Urbanization, environmental pollution and modern lifestyle have led up to an increase in allergic
diseases in children around the world over the past 30 years. In particular, nowadays food allergy
remains a fairly common problem, affecting between 6-8% [1] to 10 % [2] of children living in
    industrial areas. Recent data illustrate that about 2.4% of children suffer from multiple food
allergies, and anaphylactic reactions may occure in about 3% of children [3]
    A food allergy is an immunological reaction to the protein contained in food, mediating the rapid
onset of clinical symptoms [4]. The increased predisposition of children to food allergies can be
explained by the imperfection of the barrier between the environment and internal tissues, which
include skin, mucous membranes of the respiratory tract and gastrointestinal tract, as well as
immaturity of the immune system, T-cell tolerance dysfunction [5]. The foods that are most often
associated with the development of IgE-mediated allergic reactions include: cow’s milk, hen’s egg,
peanut, tree nuts, fish, shellfish, wheat, soybeans and seeds [[6], [7]]. And while immunological
tolerance to milk and chicken egg protein often develops, nut allergy tend to last a lifetime [8].
    Unpredictability of reactions to foods, and in some cases the development of a life-threatening
condition of anaphylaxis, cause fear and anxiety in parents or people involved in the care for an
allergy child [9]. Strict avoidance of food allergens is the only effective treatment for food allergies.
Therefore, a careful control of food composition, precautions when cooking to avoid cross-contact of
the allergen with safe foods, as well as the ability in recognizing life-threatening symptoms in a child
in a timely way and to provide emergency care remain important today [4]. However, mortality from
food allergies is relatively low, patients with this disease constantly face up to the possibility of
potentially severe reactions and the need to follow a diet. This undoubtedly cannot but affect the
quality of life of both patients and their parents. Bollinger et al. [10] found that 41% of parents
indicated an increase in stress levels since the diagnosis of their child with allergies due to the risk of
an accidental allergen consumption and fear of an allergic reaction. It becomes the responsibility of
parents to explain to the child in an accessible form that certain foods must not be consumed, thereby
not causing the food disgust in general. It is also important to avoid nutritional deficiencies by
providing the necessary nutrients at the expense of the other safe for allergy products. A frequent
complaint of modern parents is also the labor intensity of the process of cooking and ready meals
choosing. In particular, they are forced to spend more time in the store, facing difficulties with
product labeling.
    Therefore, childhood food allergies currently are not only a medical but also a social problem.
According to a number of studies, the quality of life of schoolchildren with food allergies is much
lower than that of their healthy peers [[11], [12]]. There are undoubtedly age differences among
allergy children from the feeling of some discomfort due to the inability to eat certain foods consumed
by their peers to depression and negativism in adolescents, in particular, including bullying [13].
Some parents try to minimize their anxiety about their child by avoiding certain social activities, such
as attending children's organized activities, parties, and recreations. Considering the fact that the
Health-Related Quality of Life (HRQL) of allergy patients is usually worse than in the general
population, it may be the only important indicator for assessing the effectiveness of various
therapeutic interventions [[1], [14]].
    Generic or disease-specific questionnaires are commonly used to assess the patient's quality of life.
Generic questionnaires allow to compare the life quality of patients with different diseases, but more
sensitive are questionnaires designed for specific diseases (disease-specific questionnaires), as the
latter are usually based on potentially clinically important differences for a particular disease [15]. All
researchers who evaluated the impact of food allergies in children on HRQL in different countries
with the use of generic questionnaires [[12], [16]] and some non-validated disease-specific
questionnaires [17] noted a deteriorated HRQL. The amount of food allergens and the presence of
anaphylaxis in the case history correlated with the poorer quality of life of patients and their relatives
[16].
    Nowadays, the Food Allergy Quality of Life Questionnaire (FAQLQ) is most commonly used
questionnaire to measure the quality of life of children with allergies. This disease-specific
questionnaire was developed and validated in Europe as a part of the multi-center research project
(EuroPrevall). The questionnaire includes forms created for different age-groups of children (ages 8-
12 and 13-17), as well as parents of 0-12 year old children with food allergies [18]. In order to assess
the real state and consequences of the disease, the ability of children to answer questions on their own
is very important, because their vision of the problem, their feelings are often different from those felt
by adults who take care of them. Assessing the quality of life of a child with allergies, it is possible to
identify problems in a certain age group, to compare the effectiveness of different treatment
approaches to the quality of life of a young patient, to choose the best treatment regimen and further
to evaluate its effectiveness taking into account the quality of life of a child with food allergies. The
original FAQLQ-CF questionnaire was developed in the Dutch language and has an excellent internal
consistency (Cronbach’s alpha 0.94). Nowadays it has been translated and validated in several
languages, including English, French and Greek. It is extremely important to adapt the translation of
the questionnaire to the linguistic and cultural characteristics of patients living in different countries
and even in different regions of the same country.
    The aim of the study was to conduct a translation, adaptation and initial validation of Food
Allergy Quality of Life Questionnaire – Child Form (FAQLQ-CF) for children aged 8–12 years in the
Ukrainian language.

2. Methods
2.1. Participants
    The study, conducted at the Communal Nonprofit Organization "City Children's Clinical Hospital
of Lviv" (Ukraine), involved 60 children aged 8 to 12 years on condition of the informed parental
consent. Parents were provided with comprehensive information on the conditions of the study. The
diagnosis of food allergy was established by a pediatric allergist on the basis of clinical symptoms and
skin prick tests with the use of the most common allergens such as milk, eggs, fish (hake), soy, wheat,
chicken, citrus, strawberries, cocoa, and others (grapes, veal, carrot, apple). The prick-prick method
was used with nuts (peanuts, cashews, hazelnuts, walnuts) and sesame. The test was considered as
positive (the child was allergic to one or another food product) if the size of the papule was ≥ 3 mm.
Oral provocation tests and serological diagnosis were not performed.
    The exclusion criteria from study were: autoimmune diseases, episode of anaphylaxis in the
history, as well as the inability to conduct skin prick tests.
    As it is known, depending on the affected target organ, the patient may have different symptoms of
food allergy. The pathological process may involve the skin (rash, swelling of the lips and eyelids),
digestive tract (dysphagia, vomiting, constipation, diarrhea, abdominal pain, refusal to eat, rapid
satiety), respiratory organs (cough, runny nose, wheezing). A combination of allergy symptoms from
different organs is also quite common. In the most severe cases (anaphylactic shock and food-
dependent cofactor-induced anaphylaxis) systemic signs are evident [4]. Therefore, collecting a
medical history, a comprehensive assessment of complaints and general condition of the child was
conducted.
2.2. Procedure
   During the visit to the allergist, the children were asked to fill in the questionnaires. Parents or
medical staff could read the questions aloud or explain to the child if something was not clear, but it
was monitored that the child answered the questions on his own.
2.3. Questionnaires
   Two questionnaires: FAQLQ-CF and Food Allergy Independent Measure (FAIM) were used in
the study. Both mentioned questionnaires were previously translated into the Ukrainian language in
accordance to the World Health Organization guidelines and combined in one package of papers [19].
The translation included the following steps: preliminary English to Ukrainian translation, followed
by the group of experts review, a native speaker translation backward into English from Ukrainian,
pretesting and interviewing, final questionnaires approval.
    FAQLQ-СF includes 24 questions, divided into four subscales (Table 1): allergen avoidance (AA),
risk of accidental exposure (RAE), emotional impact (EI) and dietary restrictions (DR). The answers
to the questions were evaluated on a 7-point scale (0-not: 1-barely, 2-a little bit; 3- fairly; 4-quite; 5-
very; 6- extremely). The highest score rated for FAQLQ-СF is associated with the worst quality of
life. In addition, the Food Allergy Independent Measure (FAIM) measures the perceived disease-
severity. The FAIM consists of six questions [20]. Four of those questions are related to expectation
of outcome (EO) in patient with food allergy (accidental exposure, chance of severe reaction in case
of unintentional eating of something, risk to pass away when accidentally being exposed to allergen,
and hazard of not acting effectively after exposure). Other two remaining questions concern the
independent measure (IM) accordingly they reflect severity of the disease (number of products that
should be avoided and the impact of food allergy on social life). Children have to indicate their
answer on a seven-point scale which range from 0-never (0% chance) to 7-always (100% chance).
The highest score rated for FAIM is associated with the worst perceived disease-severity. The FAIM
is a reliable and successfully applied tool for the cross-sectional validation of the FAQLQ-CF.
Consequently, we compare the results of FAQLQ-СF with the six questions listed in FAIM to
determine the correlation.
Table 1
Distribution of questionnaire questions on subscales
                                              Subscales
   Allergen avoidance         Risk accidental      Emotional impact (EI)            Dietary restriction
           (AA)              exposure (RAE)                                                 (DR)
4 - read labels            11 - beware of        19 - allergic reaction          1 - always watch
6 - less easily stay for a touching foods        terrifies you                   2 - limit yourself in
meal                       13 - the ingredients 20 - eating wrong food by        some products
7 - try fewer thing        change                accident                        3 - can’t buy food you
8 - warn in advance        14 - the label warns 21 - eat food you have           like
9 - control yourself on    16 - people always not eaten                          5 - refuse treats
allowed food               forgetting about…     22 - food allergy never         12 - refuse food
10 - hesitate to eat       17 - others can eat goes away                         18 - don’t know taste
certain food                                     23 - people have no
15 - inform the people                           regard for…
around                                           24 - makes you frustrated


2.4. Ethics issue
   Ethical Committee or Institutional Animal Care and Use Committee Approval: Nonprofit
Communal Enterprise “City Children’s Clinical Hospital of Lviv”; 16. Nov. 2018 № 6.
   Written information was given to children and their parents, indicating that participation in the
study was voluntary.
2.5. Statistical analyses
   Principal component analysis (PCA) was applied to determine whether the items form one overall
scale or more than one. Since the factor structure has been determined in similar investigations, the
confirmatory factor analysis was performed. The internal consistency was evaluated by calculating
Cronbach’s alpha (α), a widely used measure of variability. An item-total correlation test was
performed to check the contribution of each item to instrument consistency as determined by the
ability to discriminate between high- and low-scoring children.
   For the statistical analysis FAQLQ-CF and FAIM scores 0 to 6 were recoded as 1 to 7. Non-
parametric tests were used for the not normally distributed dataset. Spearman's сorrelation coefficient
was calculated in order to estimate the construct validity of the FAQLQ-CF comparing it with a
FAIM.
3. Results
3.1. Description of the study group
    The study involved 29 (48.3%) boys and 31 (51.7%) girls. The mean age of patients was 10.12
years (SD 1.58 year), the median total duration of food allergy symptoms was 7.5 years (interquartile
range 6.0-10.0 years).
    One questionnaire was excluded because the descriptive characteristics of allergy prevalence were
missing, and the statistical analysis was performed with data from the questionnaires of 59 patients.
    The most common manifestations of food allergy in children aged 8-12 years were skin reactions
33 (55%) (95% СІ: 42.41-67.59). However, distinguishing the patients, who reported a combination
of allergy symptoms from different organs (multi-organ reaction for instance, skin and gastrointestinal
tract, or skin and respiratory system) into a separate group, the combined manifestations of allergy 22
(37.3%) (95% СІ: 24.95-49.63) became dominant and displaced the isolated skin lesions into a second
place 15 (25.4%). Gastrointestinal and respiratory symptoms were hence observed in 12 (20.3%),
(95% СІ: 10.06-30.61) and 10 (16.90%) (95% СІ: 7.37-26.52) children respectively.
    The products that most often caused allergic reactions in our patients according to the results of the
skin prick test (positive test ≥ 3 mm) included; chicken 23 (38.3%) (95% СІ: 26.7-51.0), soy 19
(31.7%) (95% СІ: 20.8-44.4), wheat 18 (30%) (95% СІ: 19.4-42.4). Strawberries had the lowest
specific weight among allergens 5 (8.3%) (95% СІ: 3.0-17.3).
    A significant correlation was observed between the reported allergies by the patient and the
presence of a positive skin prick test for peanuts and other nuts (walnut r = 0.606), cashews (r =
0.680), and hazelnuts (r = 0.431)) and chicken egg (r = 0.631).
3.2. Cross-sectional validation
    Comparing the correlation of all 24 questions included in FAQLQ-CF with 6 questions of FAIM, a
strong positive correlation was found between these two questionnaires (r = 0.81, p <0.05). Each of
the FAQLQ-CF subscales (AA, RAE, EI, DR) correlated significantly with at least one of the FAIM
scale questions (Table 2). The top row in the Table 2 shows Spearman's correlation between the
overall FAQLQ scale and five of six FAIM questions.
Table 2
Spearman correlation coefficients for the FAQLQ-CF with the FAIM
                                                               FAIM
            FAQLQ-CF                  Q1*    Q2*    Q3*    Q4*    Q5*    Q6*    Total
Total                                   0.47   0.54    0.6   0.58   0.05   0.49   0.81
        Allergen avoidance              0.88   0.11   0.52   0.43  -0.21   0.19   0.62
4. importance of reading food            0.7   0.09   0.28   0.39  -0.11   0.19   0.46
labels
6. Less easily staying for a meal         0.7     0.18      0.56       0.4    -0.35       0.2      0.56
with someone
7. Tasting or trying fewer things       0.64      0.17      0.42      0.34    -0.23      0.22       0.5
when you eat out
8. Must warn in advance against         0.72     -0.06      0.39      0.25    -0.09      0.04      0.45
forbidden food consumption
when you eat out
9. Must control yourself on             0.41      0.29       0.3      0.27      -0.1     0.14      0.44
allowed food when eating out
10. Hesitate to eat certain food if     0.66      0.12      0.29      0.26      -0.2     0.13      0.43
you don’t know whether it is safe
15 Inform the people around you        0.7     0.04     0.38      0.4    -0.23     0.23     0.47
about your food allergy
    Risk of accidental exposure       0.14     0.78      0.5     0.35     0.02     0.49     0.66
11. Beware of touching definite       0.17     0.57     0.42     0.26     -0.1     0.39      0.5
foods
13. Food ingredients change           0.16     0.65     0.48     0.41    -0.03     0.39     0.62
14. The label warns: “May            -0.03     0.64     0.37     0.16     0.12     0.35     0.42
contain traces of…“
16. People around you are always      0.02     0.49     0.33     0.28     0.12     0.36     0.44
forgetting about your food allergy
17. When you deal with the other      0.18     0.64     0.37     0.27   -0.001     0.47     0.54
people, they can eat food which
is allergic for you
          Emotional impact           -0.06     0.33     0.35     0.29     0.03     0.59     0.31
19. A possible allergic reaction     0.007     0.26     0.18     0.22    -0.14     0.29     0.18
terrifies you
20. Frightened of eating the         -0.07     0.39     0.31     0.16    0.002     0.49     0.29
wrong food by accident
21. You are afraid to eat food you   -0.08     0.19     0.09     0.03    -0.24     0.24     0.07
have not eaten before
22. Worried about the fact that       0.08     0.24     0.15     0.28     0.01     0.47     0.29
your food allergy never goes
away
23. Makes you disappointed if        -0.03     0.12      0.1     0.05     0.15     0.26     0.09
people have no regard for your
food allergy
24. The food allergy makes you       -0.11     0.09      0.4     0.21     0.13     0.34     0.18
frustrated
         Dietary restriction          -0.3    -0.04    -0.11     0.07      0.6    -0.14     -0.08
1. Must always watch what you        -0.12     0.06    0.003    -0.13      0.2     0.03      0.05
eat
2. Have to limit yourself in some    -0.17    -0.09    -0.19     0.04     0.48    -0.18     -0.12
products
3. Can’t buy food you like           -0.23    -0.09    -0.22    -0.14     0.36    -0.13     -0.19
5. Must refuse treats when doing     -0.15     0.08     0.07     0.16     0.37    -0.05      0.07
something with other people
12. Must refuse food when            -0.11     0.11     -0.1     0.16     0.47     0.06     0.13
someone offers it at school
18. Don`t know the taste of food     -0.16    -0.12    -0.02     0.26     0.07    -0.08     -0.03
which you can`t try
*FAIM scale questions: Q1- How big is the chance of an accidental exposure; Q2 - Chance of a severe
reaction development if you consumed something accidentally; Q3 - Chance of dying when
accidentally exposed; chance to die if consumed something accidentally; Q4 - Chance to fail in
effective help when you consumed something accidentally; Q5 - Foods number you have to avoid;
Q6 - Impact on your social life which food allergy makes.
Italics – р > 0.05. In bold type - key pairs between specific FAQLQ-CF scales and specific FAIM
questions, significant correlation (p <0.05).
    Principal component analysis of the 24 items of the FAQLQ-CF revealed 7 factors. To clarify the
relationship among factors Varimax rotation was performed and some factors were excluded
afterwards. Considering that in the original study Flokstra-de Blok et al. [15] as well as in a similar
study of Greek colleagues, 4 factors were identified, the preference was also given to a four-factor
model. The analysis of the main components indicates that these 4 factors explain a total of 55%
percent of the variance. The obtained 4 factors were similar to the original factors highlighted by
Flokstra-de Blok et al. [15] and were called F1 - allergen avoidance (AA), F2 - risk of accidental
exposure (RAE), F3 - emotional impact (EI), and F4 - dietary restrictions (DR). Questions that were
lost with the reduction of factors, have been added to the most appropriate factor by our expert group.
    When conducting a factor analysis with the 4 factors distinguishing (according to the results of the
previous subdivision with the inclusion of all questions), the third group of questions (EI scale) was
not separated into the common factor during the statistical processing of data provided in the
questionnaires. In terms of the influence on the variance in the selection of 4 factors, other issues
dominated (Table 3).
Table 3
Confirmatory factor analysis for four factors and all questions from FAQLQ-CF(Ukrainian)
QN*                  Questions **                     F 1***       F2      F3        F4          SSº
  4     Importance of reading food labels                       0.678       0.368                 AА
  6     Less easily staying for a meal with           0.393     0.570       0.525                 AА
        someone
  7     Tasting or trying fewer things when you                 0.979                             AА
        eat out
  8     Must warn in advance against forbidden                  0.504       0.541                 AА
        food consumption when you eat out
  9     Must control yourself on allowed food         0.340     0.441                             AА
        when eating out
 10     Hesitate to eat certain food if you don’t                           0.665                 AА
        know whether it is safe
 15     Inform the people around you about                      0.312       0.672                 AА
        your food allergy
 11     Beware of touching definite foods             0.642                                      RAE
 13     Food ingredients change                       0.797                                      RAE
 14     The label warns: “May contain traces          0.738                                      RAE
        of…“
 16     People around you are always forgetting       0.569                                      RAE
        about your food allergy
 17     When you deal with the other people,          0.667                                      RAE
        they can eat food which is allergic for you
 19     A possible allergic reaction terrifies you                                                ЕI
 20     Frightened of eating the wrong food by                                                    ЕI
        accident
 21     You are afraid to eat food you have not                                                   ЕI
        eaten before
 22     Worried about the fact that your food                                                     ЕI
        allergy never goes away
 23     Makes you disappointed if people have                                                     ЕI
        no regard for your food allergy
 24     The food allergy makes you frustrated                                                     ЕI
  1     Must always watch what you eat                                      -0.469                 DR
  2     Have to limit yourself in some products                                        0.398       DR
  3     Can’t buy food you like                                                        0.353       DR
  5     Must refuse treats when doing                 0.310                            0.871       DR
        something with other people
 12     Must refuse food when someone offers it                             -0.418                 DR
        at school
 18     Don`t know the taste of food which you                                         0.444       DR
        can`t try
* Question number from the original questionnaire.
**Original question formulation in the questionnaire FAQLQ-CF.
***F1 (AA), F2 (RAE), F3 (EI), F4 (DR).
ºSubscales (SS).

       Questions 1 (must always watch what you eat) and 12 (must refuse treats when doing
something with other people) from the DR subscale had demonstrated a negative relationship (loads
negatively) with the corresponding factor instead, and therefore they were removed and the factor
analysis was conducted repeatedly. As a result, a better distribution of factors was obtained, which
coincided with our previously selected subscales (Table 4). And even though the first group of
questions (AA scale) tended to be divided into two sub-factors, these questions also clearly fit into the
general factor with the questions of their scale.
    After the two questions had been excluded, factors F1, F2, F3 demonstrated strong loadings from
0.401 to 0.853 (AA, 0.823-0.401; RAE, 0.817-0.578; EI, 0.853-0.414) and minimally acceptable one
for F4 (DR, 0.511-0.304).
Table 4
Confirmatory factor analysis for four factors after the 1 and 12 question exclusion from FAQLQ-CF
(Ukrainian)
QN*                  Questions**                     F 1***      F2       F3         F4      SSº
  4    Importance of reading food labels             0.823                                       AА
  6    Less easily staying for a meal with           0.800     0.352                             AА
       someone
  7    Tasting or trying fewer things when you       0.748                                       AА
       eat out
  8    Must warn in advance against forbidden        0.737                                       AА
       food consumption when you eat out
  9    Must control yourself on allowed food         0.401     0.309                             AА
       when eating out
 10    Hesitate to eat certain food if you don’t     0.580                                       AА
       know whether it is safe
 15    Inform the people around you about            0.624                                       AА
       your food allergy
 11    Beware of touching definite foods                       0.633                            RAE
 13    Food ingredients change                                 0.817                            RAE
 14    The label warns: “May contain traces                    0.711                            RAE
       of…“
 16    People around you are always                            0.578                            RAE
       forgetting about your food allergy
 17    When you deal with the other people,                    0.630                            RAE
        they can eat food which is allergic for
        you
 19     A possible allergic reaction terrifies you                                 0.411       ЕI
 20     Frightened of eating the wrong food by                                     0.483       ЕI
        accident
 21     You are afraid to eat food you have not                                    0.369       ЕI
        eaten before
 22     Worried about the fact that your food                                      0.500       ЕI
        allergy never goes away
 23     Makes you disappointed if people have                                      0.304       ЕI
        no regard for your food allergy
 24     The food allergy makes you frustrated                                      0.511       ЕI
  2     Have to limit yourself in some products                         0.414                  DR
  3     Can’t buy food you like                     -0.335              0.458                  DR
  5     Must refuse treats when doing                                   0.853                  DR
        something with other people
 18     Don`t know the taste of food which you                          0.420                  DR
        can`t try
* Question number from the original questionnaire.
** Original question formulation in the questionnaire FAQLQ-CF .
***F1 (AA), F2 (RAE), F3 (EI), F4 (DR).
ºSubscales (SS): AA (allergen avoidance), RAE (risk of accidental exposure), EI (emotional impact), DR
(dietary restrictions).

    The obtained results of the statistical analysis allow us to state that the total Ukrainian FAQLQ-CF
have sufficient internal consistency since Cronbach α was 0.73, although the corrected item total
correlations were between 0.067-0.67. All subscale DR questions tended to correlate negatively with
the total FAQLQ-CF scale, on condition that all questions were included. Subscales AA (Allergen
avoidance) and RAE (Risk of accidental exposure) showed good consistency both within the scale
and in general (Cronbach α index was 0.86 and 0.81, respectively). For the EI (Emotional impact)
subscale, the Cronbach α index was 0.57 with fluctuations in the adjusted correlation "parameter-
total" of 0.28-0.53. One this subscale question („How disappointed are you if people have no regard
for your food allergy?”) had α below 0.3.
    However, in the factor analysis on the impact on the dispersion the domination belonged to other
groups of questions, during the EI subscale questions selection into a separate group, they revealed
good consistency. After the 1 and 12 question excretion from the factor analysis, Cronbach α for the
Dietary Restrictions (DR) subscale was 0.61 and the corrected item total correlations were 0.45-0.59
(Table 5).
Table 5
Cronbach’s alpha, corrected item-total correlation for FAQLQ-CF (Ukrainian language)
               Scale/subscale                    NoQ      Cronbach’s        Corrected item-total
                                                             alpha               correlation
FAQLQ-CF Ukrainian (total scale)                  24          0.73               0.067-0.67
Allergen avoidance (AA)                            7          0.86                0.44-0.83
Risk of accidental exposure (RAE)                  5          0.81                0.59-0.80
Emotional impact (EI)                              6          0.57                0.28-0.53
Dietary restrictions (DR)                       6 (4)*    0.56 (0.61)       0.18-0.61 (0.45-0.59)
* Number of questions
* *All questions (after the 1 and 12 question exclusion)
4. Discussion
    The prevalence of food allergies in children nowadays requires the development of effective
preventive and curative interventions. There is no doubt that in the food allergies prophylaxis an
important place is given to the exclusion of products to which hypersensitivity has been detected.
    At the same time, young patients together with their parents face a number of difficulties related to
this straightforward, at first glance, task: safe food obtainment in the retail network, a daily menu
planning, eating in organized groups (school, kindergarten), participation in cultural activities, which
foresee food consumption (school trips, children's parties), etc. All this beyond question cannot but
affect the quality of life of both the patient and his family members. Parents are often disturbed that
food allergies may be life-threatening and a source of teasing done by peers. However, children with
food allergies may perceive this problem quite differently, and therefore it is necessary to consider
first of all the assessment of the patient’s quality of life.
    In the current context of the COVID-19 pandemic, it is important to limit patient visits to
healthcare facilities to the greatest degree, since scheduled visits may increase the risk for infection.
At the same time, it is necessary to carry out the remote control over the course of the disease and the
effectiveness of the prescribed treatment. In this regard, the introduction of appropriate questionnaires
into the practice of allergists, aiming to assess the patient’s quality of life, becomes relevant. To date,
no food allergy-specific questionnaire has been validated in Ukraine.
    The original Food Allergy Quality of Life Questionnaire - Child Form was developed and
validated by B. Flokstra-de Blok et al. [15] measures the most important problems that allergy
children face with every day, and which can consequently affect their quality of life. In order to
preserve the content validity of the original questionnaire, an important task was not only to translate
it into Ukrainian, but also to carry out a cultural adaptation.
    Construct validity is the degree to which a test measures what it claims and is verified by
comparing the implemented questionnaire to the existing independent ones. Comparing the Ukrainian
version of FAQLQ-CF to FAIM, which in turn proved its ability to measure a child's perception of the
condition severity, statistical analyses revealed the strong positive significant correlation between
these two questionnaires total-total (r=0.81, p> 0.05). In the original study by Flokstra-de Blok et al.
the total FAQLQ-CF score correlated significantly with the mean FAIM (r=0.60, p <0.001). With one
question of the six individual FAIM questions (Number of foods one needs to avoid) we did not find a
significant correlation as well as Greek researchers who were validating an identical questionnaire in
Greek [21]. At the same time, the results of our study showed that each of the FAQLQ-CF subscales
significantly correlated with at least one of the six FAIM questions, and therefore we consider the
Ukrainian version of FAQLQ-CF suitable to measure the impact of food allergies on a child's quality
of life.
    The total Ukrainian FAQLQ-CF has sufficient internal consistency since Cronbach α was 0.73.
The DR (Dietary Restrictions) subscale, including two questions affecting the internal consistency of
FAQLQ-CF, proved to be problematic. Cronbach α for DR was 0.56 and corrected item total
correlations 0.18-0.61. Excluding two questions, “Must always watch what you eat” and “Must refuse
food when someone offers it at school” solved this problem to some extent, improving both the
consistency of this scale (α = 0.61) and the overall consistency of the questionnaire.
     According to the results of the statistical analysis, the subscale EI (Emotional impact) turned out
to be insipid. The average final score value was 2.17 with fluctuations from a minimum of 1.17 to a
maximum of 3.33 (e.g. the fluctuation of the final score on the AA subscale was from 0.29 to 4.29).
Therefore, low Cronbach's alpha - 0.57 with fluctuations in the adjusted correlation "parameter-total"
0.28-0.53, reflects the poor correlation of the subscale EI. And although this subscale has a clear
factorial separation, vagueness of complaints led to mediocre indicators.
    Analyzing the results of the study, some statistical inconsistency of separate questions with
existing scales can be detected. There are several reasons to explain why these questions did not work
in our patients. First, probably these are the features of sample formation. In contrast to the studies of
Flokstra-de Blok et al. and Morou et al. [[15], [21]] we did not include children with anaphylaxis for
whom dietary restrictions are essential. Patients with mild food allergies have a simpler attitude
toward a diet and usually do not refuse if someone treats them, since it does not threaten their lives.
    Another important factor is hyper-parenting, caused by parents' fear for the life of an allergic child.
The desire to protect the child from all possible risks deprives him or her of the opportunity to make
independent choices and independent decisions, which provokes indifference to the surroundings. As
an example, a child does not need to pay attention to the inscriptions on the label, because it is done
by the parents. Since the questionnaire was filled in during the visit to the doctor, children may have
felt anxiety about it, hence the child could not focus on some questions, understand their content, and
therefore chose a picture rather than gave a real answer.
    Although some questions did not work in our patients, they cannot be removed from the
questionnaire because they may be important for the patients with severe food allergies, including
anaphylaxis in the medical history.
    We did not determine the discriminatory ability of the questionnaire among the children with
different levels of life quality, in particular due to the small sample size and the absence of children
with severe food reactions.
   5. Conclusions
    In summary, according to the results of the statistical analysis, the Ukrainian Food Allergy Quality
of Life Questionnaire - Child Form is valid and reliable, able to measure the most important problems
faced by children with food allergies. Despite the fact that some questions did not work in our sample,
a possible explanation for this is the lower severity of the disease in children involved in the study,
hence some extent of careless attitude to the risk of accidental consumption and avoidance of
allergens in children with food restrictions.
    The issues covered by this questionnaire are designed to improve the quality of life of children
with food allergies and should be taken into account not only by healthcare professionals and
researchers studying food allergies, but also by food manufacturers and regulators (including clear
labeling and ingredient list of ready-made products).

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