A Study to Evaluate the Quality of Life of Patients with Diabetes Mellitus

Aim: The aim of the study was to evaluate the QOL of patients with Diabetes Mellitus. Study Design: This was a prospective, observational study. Duration of Study: The study was conducted from August 2019 to January 2021 in Yashoda Hospital, Hyderabad. Methodology: Patients of either sex with ≥1year history of diabetes willing to give the consent were included in the study. Patients of either sex with <1year history of DM, Pregnant/lactating women and patients not willing to give the consent were excluded from the study. Data on Blood glucose levels (FBS, PPBS) and HbA1C was also obtained and assessed. QOLID questionnaire was administered to the patients and assessed which consisted of a set of 34 items representing 8 domains such as Role limitation due to the physical health, Physical endurance, General health, Treatment satisfaction, Symptom botherness, Financial worries, Mental health, and Diet satisfaction). Results: A total of 200 patients were analysed in the study,108(54%) were males and 92(46%) were females. The average age of the patients was 58.5 years with majority being 51-70years Original Research Article Reddy et al.; JPRI, 33(47B): 575-585, 2021; Article no.JPRI.76023 576 (73.5%) of age. Patients with higher age and females had poor QOL compared to others. The correlation between various categorical variables with that of scores of QOL in various domains was assessed, Age of the patients influenced QOL score in various domains like RLPH (p value0.038), PE (p value-0.0183), and SB (p value-0.0002), Gender has influenced QOL score in domains like RLPH (p value-0.0008), PE (p value-0.0106), TS (p value-0.0005) and Educational Qualification has influenced QOL score in RLPH (p value-0.0008), GH (p value-<0.0001), TS (p value-<0.0001), E/MH (p value-<0.0001). Conclusion: The results concluded that overall QOL was noticeably low in Diabetic patients especially in Women and elderly thus indicating that Diabetes management is not restricted to treatment but also requires attention on QOL of patients.


INTRODUCTION
Diabetes mellitus is a metabolic disorder with an increasing global prevalence and incidence. It presents with episodes of hyperglycaemia and glucose intolerance, as a result of lack of insulin, defective insulin action, or both. There are four types or classes of diabetes mellitus like type 1 diabetes, type 2 diabetes, gestational diabetes, and other specific types based on the aetiology.
There are more than 387 million people with Diabetes Mellitus (DM) and the number is likely to reach 592 million by 2035. The prevalence of DM is 9.1% in India [1].
Life style management is the basis of management of diabetes mellitus and is recognized as being an essential part of diabetes and cardiovascular disease prevention [2].
Uncontrolled blood glucose in the long term will lead to micro vascular and macro vascular complications with increased morbidity and mortality and negatively affects the quality of life. In order to minimise the complications of Diabetes there is a requirement for comprehensive diabetes care which is a complex task that takes the entire team of healthcare professionals including the pharmacist to work together to provide multidisciplinary care for patients [3]. This can be achieved by assessing and closely monitoring the QOL in Diabetes patients. Now, this again cannot be done by interpreting their health status measures as to their measure of QOL which can be deceptive as the patients may compromise on achieving good diabetic control to safeguard their QOL if the treatment regimen doesn't go in good terms with their way of living [4]. Most health care providers focus on medically related outcomes only when assessing the efficacy of their intervention, thus for a better outcome it is important to extend the assessment of the effect on physical, emotional, social and economic wellbeing that is, the quality of life [5] 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 significant that some variables such as 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 [6]. Thus, there is a requirement of a proper tool to measure the QOL, in particular to Diabetic patients. Although there are several QOL questionnaires available, we have chosen to utilise QOLID (Quality of life instrument for Indian Diabetic Patients) since most of the existing QOL questionnaires were developed in the western countries which might differ and cannot be considered in all aspects for the Indian population. The aim of the study was to evaluate the QOL of patients with Diabetes Mellitus.

MATERIALS AND METHODS
Prior approval from Independent ethics committee was taken. All the patients were thoroughly explained about the study in native language through informed consent form.

Study Design and Data Collection
This was a prospective observational study conducted from August 2019 to January 2021 in Yashoda Hospital, Hyderabad. Patients of either sex with ≥1-year history of diabetes and who were willing to give the consent were included in the study. Patients of either sex with <1year history of DM, Pregnant/lactating women and patients who are not willing to give the consent were excluded from the study. A Patient data collection form was designed to collect the demographic and laboratory details. An informed consent form consisting of the study information was prepared in the regional language.

Data Analysis
After obtaining the consent from the patients through the informed consent form, information was gathered into Patient data collection form that contained the socio demographic details of the patient like age, sex, educational qualification, occupation, family annual income, social and family history and also data on comorbid diseases. Data on Blood glucose levels (FBS, PPBS) and HbA1C was also obtained and assessed. QOLID questionnaire consisted of a set of 34 items representing 8 domains such as Role limitation due to the physical health, Physical endurance, General health, Treatment satisfaction, Symptom botherness, Financial worries, Mental health, and Diet satisfaction). This questionnaire was administered to the patients and the QOL was assessed. A score for each domain was calculated by adding items' scores. Each individual domain score was then divided by maximum possible domain score and multiplied by 100. All individual domain scores were then added and divided by 8 (total number of domains) to obtain an overall score.

Statistical Analysis
Descriptive and inferential statistical analysis was carried out in this study. Data was represented in mean and standard deviation(SD) values and categorical variables were presented in percentage. Microsoft word and excel were used to generate graphs and tables. The differences among the variables was analysed by ANOVA. The mean FBS was 135.09±28.15 mg/dL, with majority (20.5%) of the patients having it between 131-140 mg/dL, followed by 12.5% of patients having it between 91-100 mg/dL and 161-170 mg/dL (Fig 1).  (Fig. 2). The mean HbA 1 C was 8.29±0.85% with majority (27.5%) of the patients having it between 8.6-9%, followed by 20.5% having it between 7.6-8% (Fig. 3).     72±1.14). Here, patients with 16-2 years' history of Diabetes had better score (8.6±1.14) than others. Also, patients with family history had slightly better score (8.46±1.13) than who did not have family history.
Here, Graduate patients had higher score (10.67±1.03) followed by patients who qualified Intermediate (10.19±1.01). Patients with a 16-20 years' history of Diabetes had highest score (10.6±0.55) amongst others and patients with no Family history had better score (10.11±1.09) than the ones who did have a history (9.69±1.03).
Here, again graduate patients had higher score (9.37±1.08) followed by patients who qualified Intermediate (9.22±1.13). Patients with a 1-5 years' history of Diabetes had better score (9.23±0.92) and patients with a family history had higher score (9.31±1.03) than the ones who did not have family history (9.12±1.05).
The highest score (13.5±0.71) was found to be in the age group of 31-40 years followed by 51-60 years (12.39±1.57). Even here, females had a better (12.42±1.58) score than males (12.22±1.57). Here, patients with high school qualification had higher score (12.7±0.82) followed by Graduate patients (12.61±1.53). The highest score (12.56±1.26) was seen in patients with 1-5 years' history of Diabetes and patients with no family history had better score (12.34±1.57) than patients who had a history (12.08±1.66). The highest score (8±0) was found to be in the age group of 31-40 years followed by 51-60 years (7.34±1.26). This was the only domain where males had a slightly higher score (7.22±1.43) than females (7.18±1.32). Graduate patients had higher score (7.59±1.59) followed by patients who qualified Intermediate (7.22±1.72). Patients with 16-20 years' history of Diabetes had better score (7.6±1.52) than others and patients with a family history had better score (7.23±1.59) than the ones with no family history (7.19±1.35) ( Table 3).

Emotional/Mental
In this study, patients with higher age and females had poor QOL compared to others which correlated with the findings in many such studies that evaluated the QOL of Diabetes patients. [7,8,9,10]. These results also correspond with the findings of Thiruvananthapuram study [8]. There was statistically significant correlation found in few variables such as Age in this study. Patients with longer history of Diabetes had poor QOL compared to those who had shorter history of Diabetes, which again was in line with the findings of one of few such studies that evaluated QOL of Diabetic patients [11].
In this study, we have also assessed the correlation between various categorical variables with that of scores of QOL in various domains and found that Age of the patients influenced QOL score in various domains like RLPH (p value-0.038), PE (p value-0.0183), and SB (p value-0.0002), Gender has influenced QOL score in domains like RLPH (p value-0.0008), PE (p value-0.0106), TS (p value-0.0005) and Educational Qualification has influenced QOL score in domains like RLPH (p value-0.0008), GH (p value-<0.0001), TS (p value-<0.0001), E/MH (p value-<0.0001).

CONCLUSION
The study clearly shows that overall QOL was noticeably low in Diabetic patients especially in Women and elderly thus indicating that Diabetes management is not restricted to treatment but also requires attention on QOL of patients.
Limitations: The research was performed in only a single centre and the sample size was small (200). The study was dependent on the answers given by the patients and so there is no complete assurance of the responses of patients to be correct.

DISCLAIMER
The products used for this research are commonly and predominantly use products in our area of research and country. There is absolutely no conflict of interest between the authors and producers of the products because we do not intend to use these products as an avenue for any litigation but for the advancement of knowledge. Also, the research was not funded by the producing company rather it was funded by personal efforts of the authors.

CONSENT
All the patients were thoroughly explained about the study in native language through informed consent form.

ETHICAL APPROVAL
Prior approval from Independent ethics committee was taken.