92d03b14-8996-4c77-8e5a-0d2a56196235_148074_-_imen_ben

Latest published:

30 Apr 2024,

:429

benabdesselem12imen@gmail.com

Abstract

Aim

To determine the influencing factors of health-related quality-of-life
(HRQoL) perceived by North-African children/adolescents with type-1
diabetes-mellitus (T1DM) and their parents.

Methods

It was a cross sectional study conducted in Tunisia. A total of 116
patients (

; 43 children and 73 adolescents) and their parents were

included. The Arabic validated version of the Pediatric Generic Core
Quality-of-Life Inventory 4.0-Scale (PedsQL4.0) was used to evaluate
the HRQoL of children/adolescents as perceived by patients and
parents. The dependent data were the patients’ self-report and the
parents’ proxy-report of the PedsQL4.0 total scores, and the
independent data were the patients and parents characteristics.

Results

Open Peer Review

Approval Status

AWAITING PEER REVIEW

Any reports and responses or comments on the
article can be found at the end of the article.

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F1000Research 2024, 13:429 Last updated: 30 APR 2024

Corresponding author:

Imen Ben Abdesselem (

)

Author roles:

Ben Abdesselem I

: Conceptualization, Data Curation, Formal Analysis, Investigation, Methodology, Project

Administration, Resources, Software, Writing – Original Draft Preparation;

Kebeili R

: Resources, Supervision, Validation, Visualization,

Writing – Original Draft Preparation;

Derbel K

: Formal Analysis, Methodology;

Ben Said H

: Resources;

Boughamoura L

: Project

Administration, Supervision, Validation;

Bouguila J

: Conceptualization, Investigation, Methodology, Resources, Supervision, Validation;

Ben Saad H

: Data Curation, Formal Analysis, Investigation, Methodology, Resources, Software, Supervision, Validation, Visualization,

Writing – Original Draft Preparation

Competing interests:

No competing interests were disclosed.

Grant information:

The author(s) declared that no grants were involved in supporting this work.

Copyright:

et al

. This is an open access article distributed under the terms of the

Creative Commons

Attribution License

, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly

cited.

How to cite this article:

Ben Abdesselem I, Kebeili R, Derbel K

et al.

Influencing factors of health-related quality-of-life perceived by

both children/adolescents patients with type-1 diabetes mellitus and their parents: A North-African study [version 1; peer

review: awaiting peer review]

F1000Research 2024,

:429

First published:

30 Apr 2024,

:429

Patients’ PedsQL4.0 total score was influenced significantly by siblings
in the family > 2; lipodystrophy, and glycosylated hemoglobin
(HbA1C). The combination of these factors explained 34.84% of the
PedsQL4.0 total score variability. Parents’ PedsQL4.0 total score was
influenced significantly by lipodystrophy, siblings; body mass index
(BMI), hypoglycemia episodes, and HbA1C. The combination of these
factors explained 56.92% of the PedsQL4.0 total score variability.

Conclusion

T1DM patients self-reported HRQoL was influenced by siblings in the
family > 2; lipodystrophy, and HbA1C. The parents’ proxy-report
HRQoL was influenced by lipodystrophy, siblings, BMI, hypoglycemia
episodes, and HbA1C.

Keywords

Adolescent, Child, Diabetes mellitus type 1, Parents, HRQoL, North

Africa

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F1000Research 2024, 13:429 Last updated: 30 APR 2024

Abbreviations

BMI: Body mass index
HbA

C: Glycosylated hemoglobin

HRQoL: Health related quality of life
PedsQL4.0: Pediatric Generic core Quality of life Inventory 4.0 Scale
PedsQL3.0: Pediatric Generic core Quality of life Inventory 3.0 Scale
PSI: Parents stress index
SD: Standard deviation
T1DM: Type1 diabetes mellitus

Introduction

Type 1 diabetes mellitus (T1DM) is a major public health problem.

It is one of the most common chronic childhood

diseases, with approximately 208000 children/adolescents worldwide affected in 2017.

The 2010-2020 decades have

seen a significant increase in the incidence of T1DM worldwide.

This corresponds to an increase of more than 120000

new cases of T1DM per year in children/adolescents.

Between 2011 and 2021, and according to the 2022-report of the

world health organization, the number of cases of T1DM in African children/adolescents increased fivefold (

; from 4 to

20 cases per 1000 children/adolescents).

In low and middle- incomes countries, an increase of the incidence of T1DM

was also observed.

T1DM influences negatively the physical and mental health, emotional development and vital

prognosis of children/adolescents.

Traditionally, the management of T1DM has focused on achieving an optimal

glycemic control in order to prevent long-term complications.

In addition to technological advances in the treatment of

T1DM, more and more attention is being paid to the psychosocial component, and the family dynamics of the diabetic
patient.

In fact, the complexity of the daily care plan, which continues throughout life, can affect negatively health-

related quality of life (HRQoL) in children/adolescents with T1DM.

According to the Erikson's developmental

theory, the disease brings significant changes to the development of the children/adolescents, and when the latter
experience long-term treatment with painful injections, their normal mental development process is interrupted, and their
self-esteem can be affected.

Every day, these children/adolescents live with the burden of this disease.

HRQoL, which

is a concept, formed from the physical environment and a combination of social, emotional and school functions,

has become an important issue in the health field.

Generic and diabetes-specific HRQoL assessments are often advocated and have been shown to be useful in research.

For this reason, and in order to take decisions about the management of T1DM, approaches that focus on the triad

‘

child-family-disease

’

are needed.

Improving the HRQoL and the well-being of children/adolescents with T1DM is as

important as metabolic control to prevent secondary morbidity.

Consequently,

‘

modern

’

diabetes care for children/

adolescents has shifted from a purely medical approach to one that aims at optimal glycemic control and maximum
HRQoL.

Despite the large number of international scientific studies examining HRQoL of diabetic children/

adolescents,

only one Egyptian study were performed in North-Africa.

The Egyptian authors evaluated the

HRQoL of 72 children with T1DM, tested how much it could be affected by their mood and family attitudes, and
studied the relationship between these variables and the metabolic control of the patients.

They have included a control

group of 72 children apparently healthy, non-diabetic, age and sex matched and siblings of the diabetic patients were
included as a control group.

The authors have applied the Pediatric Generic core Quality of life Inventory 3.0 Scale

(PedsQL3.0), parent stress index (PSI) questionnaire and glycosylated hemoglobin (HbA

C, %).

The authors reported

significant positive fair correlations between the age, weight and body mass index (BMI) of diabetic children with the

children and parent

’

PedsQL; and

ii)

significant negative weak correlations between PSI score and children and parent

’

PedsQL (

; the higher parental stress, the lower HRQoL of the diabetic child (reported by both child and parent).

The results of the studies to examine the HRQoL of diabetic children/adolescents

can contribute to the

evolution of professional practices and lead to the improvement of the delivery of health services to children/adolescents
with T1DM in low- or middle- income countries, such as Tunisia. Therefore, the objectives of this study were to

assess

the HRQoL of Tunisian children/adolescents with T1DM as perceived by both patients (self-reported) and parents
(proxy-reported); and

ii)

determine the influencing factors of the self-reported and proxy-reported HRQoL perceived by

patients and their parents, respectively.

Methods

Study design

It was a cross-sectional study performed between January 2019 and February 2022 in the pediatric department of the
Farhat HACHED Sousse university hospital, Tunisia. The study

’

s ethical approval was obtained from the ethics

committee of the faculty of medicine of Sousse

(Reference: CEFMS 61/2021).

After obtaining their agreement, the

parents of the children/adolescents signed a consent form. In addition, adolescents over 13 years old signed the consent

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F1000Research 2024, 13:429 Last updated: 30 APR 2024

form. The children/adolescents and their parents were informed about the

study protocol and its aims, and

ii)

possibility

of withdrawal from the research project at any time. During the period between June 2020 and February 2022,
all recommended preventive measures to fight against the transmission of the severe acute respiratory syndrome
coronavirus 2 were applied (eg; physical distancing of at least one meter, wearing a fitted facemask properly and
cleaning hands frequently with alcohol-based hand rub or soap and water), During each study step, all recommended
preventive measures to fight against COVID-19 transmission were applied. The study was conducted following the
guidelines established by the STROBE statement.

In order to respect the anonymity and confidentiality of the data, a

code was assigned to each patient.

Population

The source population was the children/adolescents (and their parents) attending pediatric outpatient consultations at the
above cited hospital. The target population was the children/adolescents with T1DM who were consulted during the study
period. Only children/adolescents aged 8 to 18 years, who were accompanied by their parents, who had a medical
diagnosis of T1DM at least one year before the inclusion in the study, and who received only insulin analogues for at least
three months were included in the study. Children/adolescents who had a mental retardation, a sensor neural disorder that
interferes with normal communication; or another chronic disease, such as celiac disease, were not included in this study.
Children/adolescents who participated in another experimental survey during the study period were excluded from the
statistical analysis.

Figure 1

exposes the study flow chart.

Sample size

The sample size was appraised according to the following formula

= (

)

, where

“

”

is the standard deviation

(SD= 9.79) and

“

”

is the accuracy of estimate or how close it is to the true mean (= 76.51). Given the pioneering nature of

this study, the above

“

”

and

“

”

data were collected from a previous work including 503 adolescents with T1DM,

aiming to evaluate the HRQoL via the diabetes quality of life instrument for youth.

In the aforementioned study, the

percentage mean score of the total HRQoL for all adolescents was 76.51

9.79.

“

”

is the normal deviate for a one-tailed

alternative hypothesis at a level of significance (Z

equal to 1.28 at an error rate of 0.10%). The appraised sample size

gives a sample of 116 patients. The assumption of 25% for the non-inclusion and exclusion criteria gives a revised sample
of 154 patients (154 =116/ (1.0-0.25)).

Data collection and procedure

One investigator (

IBA

in the authors

’

list) was in charge of administering and explaining the different components of the

questionnaire to children/adolescents and their parents. On the beginning of the consultation day, the questionnaire was
given to patients and parents independently in order to improve the response rate. The questionnaire was then collected at
the end of the morning of the same day. The questionnaire included two parts and the time taken to complete it was
15 minutes.

The first part of the questionnaire, which was written in Arabic, was pretested, structured, and self-administered by the
researcher (

IBA

in the authors

’

list). It was related to personal data of both diabetic patients and their parents. For parents,

Figure 1.

Study flow chart.

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F1000Research 2024, 13:429 Last updated: 30 APR 2024

the following data were collected: accompanying tutor (

; mother; father), marital status (

; married; divorced),

schooling-level (

; illiterate or primary or secondary school; university), and socio-economic level [

; low (

; unskilled

worker, jobless); high (

; skilled worker, farmer, manager)]. For patients, the following data were collected: sex (

;

male; female), age (

; years, children (8 to 12 years), adolescents (13 to 18 years)); BMI (kg/m

), corpulence status (

;

normal weight; overweight or obese),

siblings in the family (

; number sibling > 2), schooling-level [

; low (primary or

preparatory school) and high (secondary school)], schooling-performance (

; normal; repeating or stop); family history

of diabetes mellitus (

; yes, no), onset age and seniority of T1DM (

; year), person in charge of insulin injection (

;

patient, parents), dietetic education (

; yes, no), diet (

; yes, no), hypoglycemia episodes during the last three months

before the inclusion in the study (

; number, yes, no), average glycaemia during the hypoglycemia episodes (

; g/l),

home self-monitoring (

; yes, no), home self-monitoring frequency (

; never, > 1), most recent HbA

C level (

; %),

duration of HbA

C control (

; control < 3 months, control > 6 months), lipodystrophy (

; yes, no), previous

hospitalization (

; yes, no), and etiologies of hypoglycemia (

; lipodystrophy, diet, stop insulin). Two subgroups of

patients (

; non-active; active) were formed according to regular sports activity based on the response to the following

question

: do you practice any sports activities outside of school? Some data (

; family history of T1DM, HbA

C levels

and potential previous hospitalizations) were extracted from the patients

’

medical records.

The second part of the questionnaire was reserved to the PedsQL4.0.

The latter was developed to assess the HRQoL

of children/adolescents (self-reported) as well as their parents

’

(proxy-report).

HRQoL is assessed in four domains:

physical function

(8 items)

, emotional function

(5 items),

social function

(5 items),

and school function

(5 items).

The

following three scores are determined: total score, physical health score, and psychosocial health score (covering
emotional, social and academic function).

Total scores are obtained by adding the scores and dividing them by

the total number of items completed. Patients and parents were asked to rate the

‘

problem in the past three months

’

5 Likert scales from 0 to 4 (

= never a problem;

= almost never a problem;

= sometimes a problem;

= often a

problem,

= almost always a problem). Then each item was scored backwards and linearly transformed on a scale of 0 to

100 (

= 100,

= 75,

=50,

= 25,

= 0), so that the highest score indicates better HRQoL.

The PedsQL4.0 has

appropriate forms for child self-assessments and parent proxy reports,

and has shown good internal consistency,

reliability and validity.

The validated Arabic version of the PedsQL4.0 was applied.

Permission to use the PedsQL 4.0

was obtained from the authors.

Statistical analysis

Data expression

. The Kolmogorov Smirnov test was used to analyze quantitative data

’

s distribution. All quantitative

data have a normal distribution, and therefore were expressed as means

standard deviation. Categorical data were

expressed as number (frequency).

Comparisons parents vs. patients

. Comparisons of the PedsQL4.0 scores between parents and patients were performed

by the Student-T test.

Univariate and multiple regression analysis (influencing factors)

. The dependent variable (

; PedsQL4.0 total

scores of patients and parents) was normally distributed. Student-T test were used to evaluate the associations between the
PedsQL4.0 total score and categorical data [

, parents

’

data (accompanying tutor, marital status, schooling-level, and

socio-economic-level); patients

’

data (sex, age range, siblings in the family, schooling-level, schooling-performance,

corpulence status, charge of injections, dietetic education, diet, regular physical activity, hypoglycemia, home self-
monitoring, frequency of home self-monitoring, duration of the control of HbA

C, lipodystrophy, previous hospitali-

zations, and family history of diabetes mellitus)]. The Pearson product-moment correlation coefficients (r) evaluated the
associations between the PedsQL4.0 total score and continuous data [

; age, siblings, BMI, hypoglycemia episodes,

average glycaemia during hypoglycemia episodes, HbA

C, onset age of T1DM, and seniority of T1DM]. The linearity of

the association between the PedsQL4.0 total scores and the continuous data was checked graphically by plotting each
regressor against the PedsQL4.0 total scores. Only significantly and linearly associated data were entered into the model.

Linear regression models were used to evaluate the independent data explaining the variance in PedsQL4.0 total scores.
Candidate data were put into the model with a stepwise selection method. To determine entry and removal from the
model, significant levels of 0.15 and 0.05 were used, respectively. No colinearity between predictors was detected with
variance inflation factors. The linear regression models were evaluated by the (r) and the standard error. All statistical
procedures were performed using a statistical software (StatSoft, Inc. (2014). STATISTICA (data analysis software
system), version 12.

www.statsoft.com

, RRID: SCR_014213). The significance level was set at p<0.05.

Results

Among the 154 patients assessed for eligibility, and after applying the inclusion, non-inclusion, and exclusion criteria,
116 diabetic patients aged 8 to 18 years and 116 parents were included in the study (

Figure 1

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F1000Research 2024, 13:429 Last updated: 30 APR 2024

Table 1.

Characteristics of parents and patients with type-1 diabetes mellitus (T1DM) (n=116).

PARENTS

Category

Patients

’

self-report

P-value

Parents

’

proxy-report

P-value

Home self-
monitoring

Yes

(n=61)

0.789

0.429

(n=55)

Frequency of home
self-monitoring

Never

(n=51)

0.514

0.169

≥

(n=65)

Duration of the
control of
glycosylated
hemoglobin

<3 months

(n=110)

0.787

0.366

3-6 months

(n=6)

Lipodystrophy

Yes

(n=80)

0.024

0.001

(n=36)

Previous
hospitalizations

Yes

(n=47)

0.903

0.332

(n=69)

Family history of
diabetes mellitus

Yes

(n=32)

0.617

0.253

(n=84)

Parents (n=116)

Accompanying tutor

Mother

(n=87)

0.721

0.165

Father

(n=29)

Marital status

Divorced

(n=2)

0.297

0.367

Married

(n=114)

Schooling-level

Preparatory school

(n=91)

0.5731

0.391

University

(n=25)

Socio-economic-
level

Low

(n=92)

0.243

0.252

High

(n=24)

Data were median

standard deviation.

P-value (Student T test) < 0.05: comparison between 2 categories for the same group (patients or parents).

Table 3.

Univariate analysis between the pediatric generic core quality of life inventory 4.0 total score

(patients

’

self-report; parents

’

proxy report) and quantitative data.

Patients data

Unit

Patients

’

self-

report (n=116)

Parents

’

proxy

report (n=116)

p-value

Age

Yrs

0.0331

0.724

0.0530

0.571

Siblings

Number

-0.1774

0.0567

-0.3415

0.001

Body mass index

kg/m

0.1815

0.051

0.3163

0.001

Hypoglycemia episodes

Number

-0.0610

0.515

-0.2357

0.011

Average glycaemia during hypoglycemia episodes

g/l

0.0221

0.814

-0.1071

0.252

Glycosylated haemoglobin

-0.1946

0.036

-0.2647

0.004

Onset age of diabetes mellitus

Yrs

-0.0497

0.596

-0.1180

0.207

Seniority of diabetes mellitus

Yrs

0.0966

0.302

0.1346

0.149

: correlation coefficient.

p-value < 0.05.

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F1000Research 2024, 13:429 Last updated: 30 APR 2024

variance. In parents, only five data influence the PedsQL4.0 total score: lipodystrophy, siblings, BMI, hypoglycemia
episodes, and HbA

C. Altogether, they explain 56.92% of the PedsQL4.0 total score variance.

Discussion

The main results of the present study including 116 diabetic children with T1DM (and their parents) were that the diabetic
patients self-reported HRQoL was influenced by siblings in the family >2; lipodystrophy, and HbA

C, and that the

parents

’

proxy-report HRQoL was influenced by lipodystrophy, siblings; BMI, hypoglycemia episodes, and HbA1C.

Patients living with T1DM experience various challenges, related mainly to a restrictive lifestyle, multiple daily insulin
injections, and monitoring of blood glucose levels.

The process to manage this chronic disease impacts the HRQoL of

the children/adolescents, and interferes also with the familial dynamics and the parents

’

HRQoL.

This study provides

results useful for assessing HRQoL in patients with chronic diseases living in Tunisia, and North Africa. To the best of the
authors

’

knowledge, this is the first North-African study that evaluates the influencing factors of the HRQoL of children/

adolescents with T1DM as perceived by patients and parents.

Tunisian diabetic HRQoL scores

The Arabic version of PedsQL4.0 is understandable and usable in Tunisia.

It has a high validity and reliability.

exposes the PedsQL4.0 scores among different populations of diabetic children/adolescents with TIDM.

In this study, the patients

’

total score was 68

13 (

). In the one hand, it was comparable to the one of the Iranian

population of patients aged 8 to 18 years

who has a score of 68

14 (

). In the other hand, our score was lower than

the ones reported in similar studies [

, score ranging from 76

to 88

]. In this study, while the patients

’

social

function score was high at 81

18, this of the emotional function was low at 53

20. Our results are intermediate with

those reported in literature (

). First, almost all previous studies

reported that the social function score was

the highest [

; ranging from 77

to 95

(

)]. Second, while some previous studies,

reported

that the emotional function score was the lowest [

; ranging from 60

to 76

(

)], three studies

identified that the academic function score was the lowest [

; ranging from 67

to 72

(

)].

The discrepancy between results could be explained partly by the age of included patients ranging from 2-18 years

to 8-18 years.

In addition, according to Abderrassoul et al.,

impaired emotional function may be explained by the

lack of autonomy and preoccupation with chronic complications. In order to increase the emotional function score, and to
early detect and solve problems that children/adolescents may encounter, we recommend that HRQoL assessment after
T1DM diagnosis should be a routine practice.

Table 4.

Multivariate linear regression analysis: predictors of the pediatric generic core quality of life

inventory 4.0 total score (PedsQL4.0) of patients and parents.

Independent variables

Category/unit

Standard
error of B

Cumulative
correlation coefficient

Patient self-report (n=116)

Constant

88.10

Siblings in the family >2

Yes=1, No=0

- 6.84

2.1521

0.2575

Lipodystrophy

Yes=1, No=0

- 4.29

2.6577

0.3225

Glycosylated hemoglobin (HbA

- 1.20

8.3276

0.3484

Parents proxy-report (n=116)

Constant

80.77

Lipodystrophy

Yes=1, No=0

- 6.97

2.1865

0.3419

Siblings

Number

- 3.73

4.0199

0.4641

Body mass index (BMI)

kg/m

1.03

8.5660

0.5265

Hypoglycemia episodes

Number

- 1.69

8.6265

0.5610

HbA

- 0.96

11.4378

0.5692

non-standardized regression coefficient.

PedsQL4.0 of patients =

88.10-6.84

Siblings in the family > 2-4.29

Lipodystrophy - 1.20

HbA

PedsQl4.0 of parents =

80.77-6.97

Lipodystrophy - 3.73

Siblings + 1.03

BMI -1.69

Hypoglycemia episodes - 0.96

HbA

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F1000Research 2024, 13:429 Last updated: 30 APR 2024

Table

Pediatric

generic

core

quality

life

inventory

4.0

data

(scores

and

influencing

factors)

among

different

populations

diabetic

children/adole

scents

with

type

diabetes

mellitus.

This

study

USA

Greece

USA

Iran

Greece

Kuwait

Turkey

Ethiopia

Reference

Number

116

pat

par

each

child

300

pat

308

par

pat

par

122

pat

par

each

child

390

pat

par

each

child

117

pat

128

control

group

Par

groups

112

pat.131

par

104

436

pat

389

Par

groups

149

pat

par

each

child

470

pat

par

each

child

379

pat

Age

(yrs)

8-18

5-18

2-18

11.5

8-18

5-18

2-18

8-18

11.65

Physical

health

Emotional

function

Social

function

Academic

function

Total

score

Influencing

factor

the

paients

total

score

Siblings

the

family

Lipodystrophy

HbA

Depression

Adherence.

HbA

Age

Sex

HbA

Hypoglycemia

Hyperglycemia

Onset

diabetes

Duration

diabetes

HbA

Sex

Age

HbA

Age

Sibling

Sex

Sibling

HbA

Socioeconomic

level

Therapeutic

education

Hospitalization

Mothers

’

and

fathers

’

educational

status

Fars

’

occupation,

Monitoring

blood

glucose

control

group.

HbA1c:

Glycosylated

hemoglobin.

Not

reported

Par:

parents.

Pat:

patients.

Yr:

year.

Data

were:

Minimum-maximum,

Mean,

Mean

standard

deviation.

Page 10 of 15

F1000Research 2024, 13:429 Last updated: 30 APR 2024

Patients

’

self-report vs. parents

’

proxy-report of PedsQL4.0

The PedsQL4.0 scores of diabetic patients were comparable with those of their parents. This result is inconsistent with
previous studies, which reported a significant difference between patients and their parents

’

subjective perception of

T1DM and the impact of the disease on their daily life.

The concordance between patient and parents results

observed in this study can be explained by different factors, such as the presence of communication between parents and
their children/adolescents, especially among children, who do not present generally a withdrawal and oppositional
behavior before the pubertal period.

Moreover, parents seem to have more concern about their children/adolescents

health when they reach school age, given the fact that kids haven

’

t yet developed an independent personality and weren

’

became self-sufficient around this range of age.

Influencing factors of the patients

’

and parents

’

PedsQL4.0 total scores

exposes the influencing factor of the patients

’

PedsQL4.0 scores among different populations of diabetic children/

adolescents with TIDM. It appears that the following factors are independent predictors of HRQoL as perceived by
diabetic patients: HbA

age,

sex,

siblings,

depression,

adherence to treatment,

hypoglycemia,

hyperglycemia,

onset of T1DM,

duration of T1DM,

socioeconomic level,

therapeutic

education,

hospitalization,

mothers

’

and fathers

’

educational status,

fathers

’

occupation,

monitoring blood glucose.

In the present study, among all studies data, siblings in the family, lipodystrophy and HbA1C were independent
predictors of HRQoL as perceived by diabetic patients, and lipodystrophy, siblings, BMI, hypoglycemia episodes,
and HbA

C were independent predictors of HRQoL as perceived by parents (

). The following sentences will

discuss the aforementioned factors.

An increase in the number of children in the family had a statistically significant effect on the HRQoL of children/
adolescents as well as their parents (

). A number of

“

siblings higher than 2

”

reduces the patients

’

HRQol total

score by 6.84, and one unit of sibling reduced the parents

’

HRQoL total score by 3.73 (

). Our results, which are in

line with the findings of some studies from Turkey

and Ethiopia,

could be explained by the fact that increasing number

of children in family may reduce parental support. Thus, siblings should be included in diabetes health education and
diabetic children/adolescents should be supported by all family members.

Lipodystrophy was an independent predictor of HRQoL as perceived by both patients and parents (

). It appears

that the presence of lipodystrophy reduces the patients and parents

’

HRQoL total scores by 4.29 and 6.97, respectively.

Besides, the changes of the skin and the unsightly aspect of lipodystrophy can also perturb the body image, especially
among adolescents, and thus decreases the emotional function in HRQoL. To the best of the authors

’

knowledge, no

previous study has found an association between lipodystrophy and HRQoL (

HbA

C level (%) was an independent predictor of HRQoL as perceived by both patients and parents (

). One unit of

HbA

C reduces the patients and parents

’

HRQoL total scores by 1.20 and 0.96, respectively (

). Our result is in line

with the findings of some previous studies reporting an association between lower HRQoL of patients and higher HbA

levels.

BMI (kg/m

) was an independent predictor of HRQoL as perceived by parents (

). In our study, we observed a

noteworthy and positive correlation (r = 0.526), one unit of BMI increases the parents

’

HRQoL total score by 1.03

(

). This finding aligns with two previous studies conducted in Saudi Arabia

and in Egypt.

Hypoglycemic episodes was an independent predictor of HRQoL as perceived by parents (

). Each hypoglycemic

episode decreases the parents

’

HRQoL total score by 1.69 (

). Our finding was consistent with other studies

that indicated that treatment ongoing risk of hypoglycemia (especially nocturnal hypoglycemia) negatively affect the
HRQOL of patients and their families.

In fact, hypoglycemia episodes are uncomfortable experiences and could cause

an important psychological impact on the children/adolescents. Therefore, assessment of psychosocial burden, including
fear of hypoglycemia, should be part of the management of T1DM.

Our findings suggest that motivating a child/

adolescent to achieve optimal glycaemia levels and incorporating routine clinical assessment of HRQoL as an important
component of diabetes management are necessary to determine the appropriate intervention to improve HRQoL.

Contrary to the present study, one Greece study

identified hypoglycemia as an independent predictor of HRQoL as

perceived by diabetic patients (

Additional factors, such as age,

sex,

and socioeconomic data,

need to be discussed. First, in the present

study, and similar to other studies,

Creative Commons Attribution 4.0 International license

there were no effects of age or sex on HRQoL. However, some previous studies

reported that girls have lower total HRQoL scores than boys.

In general population, during adolescence, girls

tend to have less self-esteem than boys,

and present more signs of depression,

which may constitute factors of a lower

Page 11 of 15

F1000Research 2024, 13:429 Last updated: 30 APR 2024

HRQoL. Moreover, adolescent girls with T1D are reported to be more anxious and less satisfied than boys,

and

experience hormonal changes with an increase of insulin require. In our study, there was no significant association
between socioeconomic status and patients

’

HRQoL. This is consistent with the finding of a Norwegian study.

However, some other studies reported that a low socioeconomic level was significantly associated with sub-optimal
management of T1DM, and this may negatively affect quality of life.

Strengths and limitations of this study

The main two strengths of our study were the high enrolment rate (76%) and its pioneer character. Since it is the first study
from the Great Maghreb, which assessed HRQoL and associated factors in a pediatric diabetic population.

Our study has three main limitations. The first limitation is related to the lack of a control group. The second limitation
concerns the non-evaluation of some other potential determinant of HRQoL such as family and psychological relation-
ships. The third limitation is related to the recruitment method from one center. Since all our patients were recruited from a
single pediatric hospital, our results may not be easily generalized to children/adolescents with T1DM living in other
locations in Tunisia or North Africa.

Clinical implications

In clinical practice, providing support to patients with T1DM to guide them in reducing the risk of acute and chronic
complications. Involving parents in the management of their children/adolescents

’

disease and more particularly

encouraging a constant commitment for the potential disease progression would eventually improve the HRQoL of
children/adolescents as well as their parents. Therefore, our research emphasizes the significance of adequate manage-
ment of diabetes for improved HRQoL, and conversely, the importance of good HRQoL for maintaining good diabetic
control. To improve the low emotional and school function scores identified in the study, it is advisable to regularly
evaluate the HRQoL of these children to detect any significant deterioration early on. This will facilitate the implemen-
tation of appropriate interventions that can enhance the overall management of the disease. Additionally, in families with
multiple children/adolescents, it is essential to involve the siblings in diabetes education and empower them to take
responsibility. Providing families with information on available social support resources can also be helpful.

Conclusion

The study indicated that the PedsQL4.0 scores were satisfactory overall, with higher scores on the social function
subscale, and lower scores in emotional and school functions. Furthermore, PedsQL4.0 scores for children/adolescents
patients, and their parents were comparable. HRQoL of children/adolescents was influence significantly by sibling
relationships, lipodystrophy, and HbA

C levels. Therefore, assessing the HRQoL after a diabetes diagnosis can aid in

identifying and addressing potential challenges early on for children/adolescents.

Ethical approval

The study

’

s ethical approval was obtained from the ethics committee of the faculty of medicine of Sousse, Tunisia

(Reference: CEFMS 61/2021, date: September 7, 2021).

Informed consent

Written informed consent was obtained from all parents of the children/adolescents after receiving an explanation of the
study. In addition, adolescents over 13 years old signed the consent form

Declaration

We have looked for assistance from artificial intelligence (

; language model, ChatGPT 3.5) in the language editing our

scientific paper.

Data availability

Underlying data

Zenodo

: Excel data of the 116 Tunisian participants and their parents [Data set]. Zenodo.

https://doi.org/10.5281/

zenodo.10900075

The project contains the following underlying data

- [Excel Data of the 116 participants and parents.xls] (Excel file including the numerical data of the 116 patients

and their parents).

Data are available under the terms of the

(CC-BY 4.0).

Page 12 of 15

F1000Research 2024, 13:429 Last updated: 30 APR 2024

Extended data

Zenodo: Influencing factors of health-related quality-of-life perceived by both children/adolescents patients with type-1
diabetes mellitus and their parents: A North-African study

The project contains the following underlying data:

- [

Appendix A

Copy of the PedsQl4 French questionnaire] (Applied questionnaire).

https://doi.org/10.5281/

zenodo.10900088

- [

Appendix B

: Copy of the translated PedsQl4 Arabic questionnaire] (Translated questionnaire).

https://doi.

org/10.5281/zenodo.10900100

- [

Appendix C

: Copy of the translated PedsQl4 English questionnaire] (Translated questionnaire).

https://doi.

org/10.5281/zenodo.10900109

Data are available under the terms of the

Creative Commons Attribution 4.0 International license

(CC-BY 4.0).

Reporting guidelines

Zenodo:

STROBE checklist for

‘

[Influencing factors of health-related quality-of-life perceived by both children/

adolescents patients with type-1 diabetes mellitus and their parents: A North-African study].

https://doi.org/10.5281/

zenodo.10900117

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STROBE checklist for the original study titled

“

Influencing factors of health-related quality-of-life perceived

by both children/adolescents patients with type-1 diabetes
mellitus and their parents: A North-African study

”

Zenodo.

2024.

(Last visit: April 12, 2024).