Health-Related Quality of Life In Patients With Type 2 Diabetes (ADDQoL) In Poland, The Czech Republic And Slovakia-Gender Differences

Sylwia Anna Krzemińska (  sylwia.krzeminska@umed.wroc.pl ) Wroclaw Medical University: Uniwersytet Medyczny im Piastow Slaskich we Wroclawiu https://orcid.org/0000-0001-7695-0967 Ewelina Bąk University of Bielsko-Biala: Akademia Techniczno Humanistyczna w Bielsku-Bialej Andrea Polanská University Hospital Ostrava: Fakultni Nemocnice Ostrava Kateřina Hašová University Hospital Ostrava: Fakultni Nemocnice Ostrava Milan Laurinc Laurinc Ministry of Health of The Slovak Republic Zrubcová Dana University of Nitra


Introduction
Diabetes mellitus (DM) as a group of metabolic syndromes characterized by hyperglycemia due to a defect in the secretion and/or activity of insulin [1] is a major global health threat. Unfortunately, diabetes leads to serious complications which might result in disability or even death.
Diabetes is a concern for 463 million people globally and 60 million in Europe. In European countries, it affects 8.9% of the population aged between 20 and 79 years. In this population, type 2 diabetes accounts for 90% of all cases.
The prevalence of diabetes increases with age, and it is estimated that there are more cases in the group of women in the population of DM patients, which may be related to their average life expectancy. [2] Diabetes mellitus requires specialized management in terms of education, therapy and self-care. [3] Restrictions related to compliance with therapy rules based on diet, regular use of medications or insulin therapy and optimal physical activity combined with blood glucose measurements can result [4] in a negative impact of diabetes on the quality of life in patients. [5] Gender differences are an important factor in the assessment of the health-dependent quality of life because gender plays a major role in decisions concerning health, as well as in the perception of health in different countries and cultures.
[6] Poland, Czech Republic, and Slovakia are neighboring countries with similar economic status and cultural behavior patterns, which is why the authors decided to conduct this type of assessment in these countries.
In the literature, there are reports concerning gender differences in the perception of the quality of life with respect to selected population samples [6] or comorbidities: cardiovascular, [7] HIV, [8] or chronic diseases in relation to mental state, [9] but studies on gender differences in the perception of the diabetes-dependent quality of life are scarce. [10] The objective of the present study was to compare the impact of type 2 diabetes mellitus (T2DM) on the quality of life (QoL), taking into account gender differences in relation to individual domains of the Audit of Diabetes-Dependent Quality of Life (ADDQoL) and relationships between QoL, selected socio-demographic factors or clinical parameters in adult women and men with diabetes from Poland, the Czech Republic, and Slovakia.

Patients And Methods
This observational-correlational study was conducted from May 2016 to August 2019 among T2DM patients treated at specialized diabetes clinics in Poland, Slovakia, and the Czech Republic.
The study procedure followed the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) recommendations.
A total of 660 patients participated in the study, 220 from each country. The participants were enrolled for the study based on the following inclusion criteria: type 2 diabetes mellitus, age over 18 years, duration of the disease longer than 5 years, no cognitive impairment, the possibility In the male group, the overall quality of life was slightly higher in Slovak men (3.51 ± 0.94) than in Polish (3.47 ± 0.89) and Czech (3.32 ± 0.81) men.
It can be noted that the generally perceived quality of life in the study group is higher in men than in women. There are also no signi cant differences between women from Poland, the Czech Republic, and Slovakia, and between men from Poland, the Czech Republic, and Slovakia (p-value > 0.05 in both cases) ( Table 2.).
In general, my present quality of life is Weighted impact score Table 3 presents weighted impact scores by gender for each country. In the study group, weighted scores were negative for all the domains. In all three groups of women, the lowest scores were given to "freedom to eat", and they were − 4.15 ± 2.7 for Polish, − 4.17 ± 2.,53 for Czech, and − 4.06 ± 2.26 for Slovak women. Similarly, in the male group, the lowest scores were given to "freedom to eat", but in a different order: -4.32 ± 2.7 for

Ranks
In all the study groups of women, the domain on which DM had the highest impact was the patients' "freedom to eat". For Poles, the second-most affected sphere was "feelings about the future", and for Czech and Slovak women it was "freedom to drink". The third-most affected domain for Polish women was their "working life", while for Czech and Slovak women -"feelings about the future".
Also, for all the male participants, it was "freedom to eat" that was the most affected by DM. The second-most affected domain for Poles and Czechs was "feelings about the future", while for Slovaks it was "freedom to drink".
The third-most affected area for Poles and Czechs was "freedom to drink", and for Slovaks -"feelings about the future" (Table 4.).  The least affected domains of life in all of the groups of women and men were "living conditions", then "people's reaction" for Polish and Czech men and women, and Slovak men, and "leisure activities" for Slovak women (Table 4.).
The impact of diabetes on "Sex life" was almost in the middle, although it was greater in women than in men; and among the female group, it was the strongest in Czech women. (Table 4.).

AWI
In the assessment of AWI, the impact of diabetes on particular items pertaining to the domains of quality of life can be divided into: high negative impact (a score from − 9 to − 6,1), moderate negative impact (a score from − 6 to − 3,1), small negative impact (a score from − 3 to 0) and the absence of negative impact or a positive impact (a score from 0 to 3).
The average weighted impact (AWI) score in the study group was the lowest for Slovak women (-2.46 ± 1.62), then for Polish (-2.41 ± 1.71) and Czech (-2.27 ± 1.66) women. The results indicate a small negative impact of diabetes on the female part of the study group. The lowest weighted impact score was for Czech men (-2.33 ± 1.61), then for Slovak (-2.31 ± 1.67) and Polish (-2.21 ± 1.51) men, which also points to a small negative impact of diabetes on participants. It can be noted that the average weighted impact (AWI) score was higher for men than for women. However, no correlation was statistically signi cant (p > 0.05). In general, it can be concluded that diabetes has a small negative impact on all the study groups, regardless of gender (Table 5.). The linear regression model was used to verify whether the selected social and demographic factors (gender, education, residence, marital status) or clinical parameters (smoking, alcohol consumption, hypertension, and anti-hypertensive drugs), or parameters that were statistically signi cant in individual groups could affect the quality of life by lowering the AWI score. Additionally, the groups were divided into women and men, and within these groups, into subgroups with a lower (<-3.0), and with a higher (>-3.0) AWI score.
Women with AWI >-3.0 predominate in all three countries. In the female group, no statistically signi cant differences between the groups with AWI < -3.0 and > -3.0 were observed depending on the selected demographic and clinical factors (all p-values higher than 0.05) ( Table 6.).  Except for the different AWI scores in men with type 2 diabetes depending on their education, neither women nor men revealed any signi cant changes in terms of the impact of education, residence, marital status, smoking, hypertension, or taking anti-hypertensive drugs.

Discussion
Our study provides information about diabetes-related QoL and its assessment by women and men with T2DM in Poland, Slovakia, and the Czech Republic based on a study that employs the widely used DM-speci c ADDQoL scale.[16, [19][20][21] The issue of the QoL is also addressed by the International Diabetes Federation which considers the quality of life as one of the fundamental goals of diabetes care, along with metabolic control and prevention. This is because it has been proven that laboratory results which are so important for physicians, are important for patients with DM only to the extent that they affect their physical, emotional and social well-being, namely the quality of life. [22] Currently, there are few studies presenting sex differences with regard to the quality of life of DM patients, and studies that assess the quality of life of women and men with the use of the ADDQoL tool are very rare.
In our study, we focussed on identifying features that differentiated female groups from male ones in individual countries, and on examining the quality of life of DM patients with regard to sex in individual countries.
The subjective assessement of patients' quality of life is affected by clinical, as well as social and demographic factors. [22] In the analyzed group of women, the overall average quality of life was slightly higher in Czech women than in women from Slovakia and Poland.
In general, women form all three countries assessed their quality of life as good and very good. Men also rated their overall quality of life as good and very good. In the group of men, the average quality of life was slightly higher in Slovaks than in Poles and Czechs. In our study, it can however be noted that the generally perceived quality of life in the study group is higher in men than in women.
Similar results were obtained in a study by Kurowska et al. Although the study used a different research tool for assessing the level of QoL, men from the study group obtained de nitely higher scores than women in the domain of psychology, [23] which can also be interpreted in line with other studies that conclude that men have higher self-con dence in terms of their ability of self-care and management of diabetes, and they less frequently are anxious due to their illness or experience depressive disorders. Hence the good knowledge and a positive attitude that are the predictors of adherence to self-care rules and are conducive to good QoL. [24][25][26] In studies by Pufal et al., [27] and in a work by Lewko and Krajewska-Kułak,[28] as well as by Glasgow,[29] sex also differentiated participants in terms of satisfaction with the quality of life. The authors claim that women had lower scores because of their lower self-reported quality of life compared to men. They referred the results to a higher propensity of women to depressive states.
Also, the results of studies by Polish authors indicate that the quality of life is signi cantly reduced by the female gender and the symptoms of depression [30] and anxiety.
Quite the opposite results, pointing to a lower quality of life in a group of men, were obtained by D´Souza et al. [31] who concluded that women, in general, better cope with compliance with therapy rules, and therefore have better results for HbA1c levels and a lower BMI and hence their quality of life, in general, is higher. These ndings are consistent with other studies which have proven that the duration of diabetes, fasting blood glucose [32] and a positive attitude to treatment [33][34] are conducive to a better perception of the quality of life by women.
Szcześniak and Żmurowska [35] concluded in their study that gender does not constitute a factor differentiating the participants in terms of the assessment of the quality of life.
In our study, it can be noted that the quality of life received the highest scores from Polish patients, both women, and men. There are also no signi cant differences neither between women from Poland, the Czech Republic, and Slovakia, nor between men from Poland, the Czech Republic, and Slovakia.
About 50% of female (most of them from Poland) and male (most of them from the Czech Republic) participants with type 2 diabetes declared at least a good level of QoL. On the other hand, more than 80% of participants (both women and men) in each country stated that their quality of life would be better without DM. Similar results were obtained also in a study by Chudiak et al. in which participants unanimously stated that their quality of life would be much better had it not been for their diabetes. [37] In the study group, the weighted impact scores were negative for all the domains. The lowest scores in all three groups of women and in all three groups of men were obtained for "freedom to eat".
Studies by the present authors demonstrate that for both women and men, diabetes has the greatest impact on "freedom to eat" and "freedom to drink", which con rms that dietary restrictions related to the non-pharmacological control of diabetes are burdensome to them. The need for adherence to a dietary regime affects the presence of early complications of diabetes, such as hypoglycemia and hyperglycemia, the levels of HbA1C, as well as the occurrence of a variety of complications and overweight present in a large group of women and men in the study group.
Studies by the present authors con rm previous studies carried out in Poland, [16,38] as well as in other countries, such as Argentina, [39] Greece, or cross-sectional studies with the participation of patients from nine European [21] countries.
In a study by Bradley conducted with the use of ADDQoL among patients with type 1 and type 2 diabetes mellitus, the negative impact of diabetes on the quality of life in all domains was con rmed for almost all cases, despite a high level of satisfaction with treatment observed in the patients. Adherence to the diet had a dominant impact on the quality of life, and it was perceived by the participants as very restrictive. [14] The least affected domains of life in all of the groups of women and men were "living conditions", then "people's reaction" for Polish and Czech men and women, and Slovak men, and "leisure activities" for Slovak women.
Almost in the middle of the scale, there is the impact of diabetes on "sex life". Diabetes has a higher impact on this aspect of life in men (in all groups), and a slightly lower impact in women (the highest in Slovak women, then in Polish and Czech women). Sexual dysfunctions in women with diabetes are primarily impaired libido and pain during intercourse, mainly due to vaginal dryness. [40][41][42] Sexual problems in men with diabetes involve erectile dysfunction, with the problem increasing with the duration of diabetes. [43][44] This common, increasing, and embarrassing problem poses a challenge for contemporary diabetes care, as con rmed by the authors' own study, although our analyses pointed to a higher intensity of this problem in men. The results of a study by Bąk et al. [45] also con rm that diabetes has a negative impact on the quality of life of patients with diabetes in Poland, especially in terms of "freedom to eat", "freedom to drink" and "sex life" in both genders of patients with T1DM, "freedom to eat," "freedom to drink" and "feelings about the future" in both genders, and "working life" and "sex life" in men with T2DM. Also, functional capacity is a signi cant factor determining the quality of life of patients with diabetes mellitus. What is more, the quality of life is signi cantly reduced by the female gender, autonomic or peripheral neuropathy, lack of physical activity, high BMI, and symptoms of depression and anxiety. [31] The authors' own study did not reveal any statistically signi cant impact of the selected social and demographic factors on the extent to which diabetes affects women and men. However, it was noted that in the study group both women and men were characterized by a small negative impact of diabetes on the overall quality of life.

Conclusions
Type 2 diabetes mellitus negatively affects all the domains of life both in women and men, however, this impact is inconsiderable. The most affected domains are "freedom to eat" and "feelings about the future". The generally perceived quality of life in the study group is higher in men than in women, and it received the highest scores from patients from Poland, both women and men. Most of women and men in the study group assessed their quality of life as good and very good.
Strengths and limitations of the study: To the best of our knowledge, there have been no similar studies in such an internationally selected group of patients by gender. Our study reveals that type 2 diabetes has a negative impact on the health and perceived quality of life, especially in women who are prone to suffer from diabetesrelated emotional and depressive disorders.
Nonetheless, our study does not illustrate the entire issue, or all problems experienced by patients with type 2 diabetes in the analyzed countries. It seems reasonable to extend the research on the quality of life and correlate it with additional parameters such as, for example, the level of anxiety, depression or diabetes-related stress. And, perhaps, also with adherence to therapeutic recommendations or level of self-care.

Abbreviations
ADDQoL -Audit of Diabetes-Dependent Quality of Life AWI -average weighted impact BMI -Body Mass Impact

Declarations
Data and/or code availability The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.

Ethical Considerations
The study was approved by the Bioethics Committee of the Beskidy Regional Chamber of Physicians in Bielsko Biała, Poland, on February 11, 2016 (approval no. 2016/02/ 11/1), and the Bioethics Committee of the Wroclaw Medical University (no. 621/2017). All participants were informed about the content of the study and gave their informed consent to participate in it. The study protocol was prepared in accordance with the Helsinki Declaration.