Background
In parallel with economy development, life standards improvement, lifestyle/diet changes and urbanization, non-communicable diseases like diabetes mellitus (DM) are the most important public health problems worldwide [
1].
The prevalence of DM is increasing in the developed and developing countries. WHO reported that the number of diabetic patients in the world has increased from 110 million in 1994 to 240 million in 2010 and it is estimated to raise at 300 million in 2025 [
2].
In Iran, the prevalence of DM is relatively high and has been estimated by various studies 12.4% in individuals aged 15–75 [
2], 12.6% in aged group 40–64 [
3], and 24.5% in the people aged 40–80 years old [
4].
As with any other chronic disease, DM is associated with many personal, familial, social and financial issues and even higher mortality rate. Problems such as increased blood glucose, dietary and exercise limitation repeatedly demand for insulin injection, musculoskeletal complications, physical disabilities, sexual dysfunction and vascular disorders are some examples which negatively affect the lives of patients with DM [
5].
Moreover, job loss, frequent hospitalization, higher demand for medical and patient care, indirect costs related to early death, reduced social and familial interactions, and worsening in lifestyle are some of the major problems which affect the familial, social and economic status of these patients [
6].
In Iran, National Program for Prevention and Control of Diabetes has been introduced in the health system in 2004. Several levels of health care have been designed including the primary level in which health workers (the behvarz) in the health house and health technician in the urban health post perform the population evaluation and screening for DM. At the secondary level such as rural and urban health centers, general practitioners and laboratory technicians serve as the diabetes team members in this regard [
7].
In the Diabetes clinic as a secondary level, several services are provided as follow: diagnosis, treatment and patients’ care, patients’ referral to the diabetes center, follow up feedback and appropriate action, assessing for complications according to clinical guidelines, and collecting as well as recording the patient information in the medical records [
7].
Health-related quality of life (HRQoL) is one of the most widely measured treatment outcomes to self-assess the effects of the management of chronic disease on health, and monitors the physical, psychological and social aspects of personal health. It is influenced by individual expectations, beliefs, perceptions and experiences [
8].
Numerous studies indicated that QoL for patients with DM is lower than that of the healthy individuals, and the factors involved in this regard are not precisely determined. It is noteworthy that some variables such as the type of DM, use of insulin, age, DM related complications, social status, psychological factors, ethnicity, educational level, knowledge about the disease, type of assistance which they received from others may interfere in the QoL for these patients [
9].
So far several tools have been devised to assess the QoL including SF-36 tool [
10] and EQ-5D created by Brook in 1991 [
11]. The EQ-5D is one of the most feasible tools to assess individuals’ QoL, and evaluates their physical, mental and social performance [
12]. It has been validated and used in many studies to determine QoL in chronic diseases such as diabetes, chronic lung diseases, stroke and chronic mental illnesses [
13‐
17]. Currently three versions of EQ-5D are available including EQ-5D-3 L, EQ-5D-5 L and EQ-5D-y. The 5-level EQ-5D version (EQ-5D-5 L) was introduced by the
EuroQol Group in 2009 to improve its sensitivity and reduce ceiling effects in comparison to EQ-5D-3 L [
18].
EQ-5D-5 L is a short and clear questionnaire which could be easily completed in a short period of time by the patients, thereby substituted with the general quality of life questionnaire in epidemiological studies and clinical evaluation for diabetic patients.
The DM complications can be responsible for the most of morbidity and mortality associated with the disease. Therefore, assessing the patients’ QoL at regular intervals is a necessity for DM as a chronic disease. This evaluation, as a powerful tool, is critical in predicting patients’ status for disease management and long-term health care. Regular evaluation for QoL as a routine clinical practice could potentially improve necessary communication among the health care providers and their patients, thereby identify the complications and help them for long care resulting in improving their health status [
19].
Evaluating the quality of life and its related factors can be helpful to improve the diabetic patients QoL. Due to the specific geographical and cultural characteristics of this region, QoL of the patients in this particular area and the factors affecting it may vary with other patients. Thereby using a short, brief and valid questionnaire which can be completed in a short time is beneficial for assessing patients’ QoL.
Therefore, the present study conducted to assess the QoL for patients with diabetes type 2 and its relationship with the demographic and clinical characteristics of these patients who referred to the Diabetes clinic in Birjand in 2017.
Discussion
In the present study which aimed to assess the QoL in type 2 diabetic patients using the EQ-5D-5 L questionnaire, the mean score for QoL and VAS scale were 0.89 ± 0.13 and 65.22 ± 9.32, respectively. In Javanbakht study, the mean score of QoL was 0.7 (in the interval of 0.69–0.71) and VAS score was 56.8 (in the interval of 56.15–57.5) [
20]. Similar studies using EQ-5D in Japan, Norway, and Korea reported a QoL score of 0.84, 0.85 and 0.91, respectively [
13,
21,
22]. Considering the fact that EQ-5Dvalue sets for each country could be different, QoL is affected by various socio-economic factors and indicators such as age, DM history and complications. This notion should be considered and assessing the results should be interpreted cautiously when comparing the QoL scores. In this context, one of the challenging issues in the developing countries like Iran is that many patients usually are not aware from their illness until the onset of the complications [
20,
23].
Our finding showed that most patients did not suffer from any problem or reported mild problems in some dimensions. It was also evident that moderate and severe issues were more common in the dimensions like anxiety/depression, pain/discomfort, and mobility. In this area, numerous studies reported that pain and depression as the major complaints by the patients [
20,
22,
24]. In a study by Solli in 2010, pain and depression were considered as the major complaints for the diabetic patients [
22]. Javanbakht et al., in 2012 also reported that challenges for DM patients were mostly common in the pain and depression dimensions [
20]. Pain and mobility were the most predominant complaints of diabetic patients reported by Sakamaki et al., [
21]. In parallel with different studies conducted in this field, our study also confirmed that the majority of patients were complaining from moderate to severe problems in depression, pain and mobility dimensions.
In the present study, mean scores for QoL and VAS scale were significantly higher in men, urban residents and employed patients. This could be due to the higher level of activities and the opportunity for having a better socio-economic status for the populations living in the urban areas, working people and men when compared with the unemployed patients, rural residents and women, especially in the developing countries such as Iran. In addition, since women in comparison to men showed a higher tendency for expressing health-related problems, it seems that they have a lower QoL score, which is similar and consistent with the findings of previous studies [
13,
21,
25,
26].
After entering and analyzing the variables related to the regression model, it is evident that the gender variable showed a significant relationship with all dimensions of QoL, with the exception of the usual activities, so that women in the mentioned dimensions had lower QoL than men. Also, the highest correlation was found among place of residence and sex with self-care dimension. In Javanbakht study [
20], individuals living in bigger cities had lower QoL than those in small cities in the self-care dimension.
Our finding also suggested that the mean score for QoL in the older age groups was lower from younger groups. Indeed, most of the complaints and problems were reported by patients who belonged to people older than 50 years. Moreover their complaints were about usual activities and mobility which were consistent with other reported studies [
13,
20,
25]. Conversely, in studies such as O’Reilly et al., [
27] the QoL scores increased with age, which could be due to different economic and social conditions in different societies.
Our study showed that patients with higher level of education possess a better QoL score. It should be noted that no significant difference was found in the QoL score for men with different levels of education; however, it was significantly higher in the illiterate and undergraduate women when compared to the postgraduate women. VAS score was significantly associated with higher education level for men, this information was also in line with other studies which shown positive effects on improving the QoL for DM patients. It could be due to better understanding of the disease and the proper and timely pursuit for better disease control and treatment [
22,
25]. In illiterate women due to lack of enough knowledge on the disease and its health consequences, it exerted a lower impact on their QoL.
In terms of the treatment type and the mean scores for the QoL and the VAS scale, our finding suggest that patients treated with insulin had significantly lower mean scores for QoL compared with individuals who received oral treatment. It was even more evident in the self-care dimension which insulin user patients reported more problems in comparison to the oral drug users. In this regard and considering the fact that insulin is used as the last resort when the oral therapy is ineffective in patients with type 2 diabetes, longer periods of diabetes are expected in insulin-dependent patients resulting in a direct negative impact on the patients’ QoL [
4,
13]. This result is consistent with Redekop et al., study suggesting that insulin-dependent diabetes patients had lower QoL in Germany [
28]. Conversely, in studies such as Bradley et.al [
29], none of the treatments showed significant associations with EQ-VAS health status.
The results of our study showed that patients with a history of hospitalization had significantly lower QoL and VAS scores. They also reported more problems in terms of mobility and their usual activities. Due to weakness of the immune system, diabetic patients are more vulnerable to various types of infections, and on the other hand, the chance of acute and chronic complications is high due to the illness’ nature and the lack of proper control for DM [
30]. The history of hospitalization may be indicative of inappropriate control for the disease and its complications which could justify a lower quality of life in this group of patients. Numerous studies in this regard suggested that diabetic patients with a hospitalization history have been associated with lower QoL [
21,
22].
In the present study, a history of longer than 10 years of DM and the presence of chronic complications including neuropathy and nephropathy were significantly associated with a decreased level of QoL and VAS scale. More significant problems were observed in patients with nephropathy in terms of mobility and pain, and individuals with neuropathy in terms of mobility, pain and routine activities. Similar studies have shown the lower QoL scores in patients with history of hospitalization, history of over 10 years with DM and the presence of chronic complications [
20,
22,
25,
27,
31], which was in line with our findings.
Although in our study, patients with HbA1c level below 7 had a higher score of the QoL than those with the level greater than 7, it was only statistically significant in men. Considering the direct correlation among DM complications and the proper control for blood glucose level [
30] and the fact that HbA1c level is indicative of DM status in the last 3 months, patients with lower HbA1c level are expected to have a better QoL with lower complications.
In this study, we have encountered several limitations as follow:
We have selected the participants from one diabetic clinic which were not included all diabetic patients in the city, therefore the results cannot be representative for all the diabetic patients in the city, which is one of the limitations of the study.
We collected the patients’ information from their profile and medical records which were previously gathered and recorded. These data include the diabetes treatment, laboratory values, presence of complications, type of complication (nephropathy, retinopathy and neuropathy), hospitalization history due to diabetes and history of IHD.
Although diabetes complications were related to individuals’ HRQoL, we did not assess all diabetic complications which influence the HRQoL. Furthermore, since this is a cross-sectional study, the observed associations are not necessarily causal. The absence of a locally appropriate set of values in our country was other limitation.
We did not also follow the PROMs guidelines for translation; this could be the other limitation for the present study.
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