|Year : 2018 | Volume
| Issue : 3 | Page : 343-349
Patient Self-reported quality of life assessment in Type 2 diabetes mellitus: A pilot study
HR PrasannaKumar1, MG Mahesh1, VB Menon2, KM Srinath1, KC Shashidhara1, P Ashok1
1 Department of General Medicine, JSS Hospital, JSS University, Mysore, Karnataka, India
2 Department of Clinical Pharmacy, JSS Hospital, JSS University, Mysore, Karnataka, India
|Date of Acceptance||20-Jun-2017|
|Date of Web Publication||09-Mar-2018|
Dr. H R PrasannaKumar
Department of General Medicine, JSS Hospital, JSS University, Mysore - 570 004, Karnataka
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Background: Quality of life (QoL) is an important outcome measure to assess the diabetic care and is increasingly replacing the traditional indicators of health. Aim: The aim is to evaluate the QoL in patients with type 2 diabetes mellitus (DM) using a third generation individualized QoL instrument like an audit of diabetes-dependent QoL (ADDQoL) questionnaire and to determine the predictors. Materials and Methods: Patients who met the inclusion and exclusion criteria were recruited from a tertiary care hospital by convenience sampling. Sociodemographic and other relevant details were collected from the study patients, and ADDQoL questionnaire were administered to them. Results: A total of 200 patients were included in the study among which 66% of patients had uncontrolled type 2 DM as suggested by their glycated hemoglobin (HbA1c) values. The mean QoL score was 0.07 (0.91) and diabetes-dependent QoL was −1.33 (0.58). Approximately 38% were associated with poor health-related QoL with a mean average weighted impact score of −0.51 (0.51). Most frequently affected life domain was the freedom to eat. A positive correlation was observed between QoL and gender, age, domicile, education status, occupation, family structure, duration of type 2 DM, HbA1c, insulin treatment, and the presence of comorbidities. Conclusion: The study highlights the impact of type 2 DM on QoL. Improving QoL of type 2 diabetic patients is important and knowledge of these preventable risk factors help to implement strategies to better management of type 2 DM and ultimately improve therapeutic outcome.
Keywords: India, patient-reported outcomes, quality of life, type 2 diabetes mellitus
|How to cite this article:|
PrasannaKumar H R, Mahesh M G, Menon V B, Srinath K M, Shashidhara K C, Ashok P. Patient Self-reported quality of life assessment in Type 2 diabetes mellitus: A pilot study. Niger J Clin Pract 2018;21:343-9
|How to cite this URL:|
PrasannaKumar H R, Mahesh M G, Menon V B, Srinath K M, Shashidhara K C, Ashok P. Patient Self-reported quality of life assessment in Type 2 diabetes mellitus: A pilot study. Niger J Clin Pract [serial online] 2018 [cited 2022 Nov 29];21:343-9. Available from: https://www.njcponline.com/text.asp?2018/21/3/343/226975
| Introduction|| |
Diabetes mellitus (DM) is a chronic metabolic disease which affects about 415 million adults worldwide as in 2015, and it is projected to increase to 642 million in 2040. India leads the world with largest number of diabetic patients earning the dubious distinction of being termed the “diabetes capital of the world.” According to the Diabetes Atlas More Details 2015 (Seventh Edition) published by the International Diabetes Federation, the number of people with diabetes in India, currently around 69.2 million is expected to increase to 123.5 million by 2040. The increasing prevalence may be due to population growth, aging, urbanization, and increasing obesity and physical inactivity. Lifestyle changes/interventions are the current strategies that exist to prevent or reduce the onset of DM.
DM is often associated with complications. These complications and the complexity of the treatment regimens required to achieve strict glycemic control can significantly worsen the health care burden and reduce the quality of life (QoL) of patients in terms of their physical, social, and psychological well-being., Clinical management of the disease tends to focus mainly on the patients physical health, including glycemic control and complications. However, these treatments are insufficient in managing the full burden of DM. The overall goal for the treatment of DM, according to national and international guidelines, should be to prevent acute and chronic complications while preserving the QoL of the patient. Decision-makers have thus begun to recognize QoL as the ultimate goal of all health interventions and an important and measurable outcome to determine the effectiveness of care and burden of DM., Moreover, it is important to measure QoL to ensure that the treatment for DM does not become burdensome than the disease itself.
Considering the variations in QoL based on the ethnic and cultural backgrounds, and high prevalence of diabetes in India, its crucial to determine the QoL in the Indian diabetic patients and identify the predictors as well. However, very few studies have been conducted in South India to determine the QoL of DM patients;, although, it is at the forefront of this endemic condition. Thus, the current study aims to determine the incidence and predictors of QoL among type 2 DM patients.
| Materials and Methods|| |
Study setting and design
This prospective cross-sectional observational study with a recruitment period of 6 months was carried out at a tertiary care multi-specialty hospital, India. Patients were recruited by convenience sampling. Patients aged >18 years who can complete the questionnaire either in Kannada or English (Kannada is the local language in Karnataka region and English is the administrative language of instructions at all the education institutions in India) were included in the study. Physician-identified patients with type 2 DM, whereas patients with type 1 or gestational DM were excluded from the study.
Informed consent was obtained from included patients and they were asked to complete the audit of diabetes-dependent QoL (ADDQoL) questionnaire. Details pertaining to sociodemographic information (including sex, age, marital status, level of education, employment, etc.) were collected through face-to-face interview with the patients along with their attenders. History and physical examination of the study patients were conducted. Clinical details regarding type 2 DM duration, disease-related complications, comorbidities, modality of treatment, etc., were also investigated. Collected details were entered into appropriate data collection forms.
Data assessment scale
The audit of diabetes-dependent quality of life questionnaire
Self-reported questionnaires for the measurement of QoL help to provide information from the patient's perspective. Measurement of QoL can be done using disease-specific or generic instruments. Disease-specific instruments are more preferable as they may be more responsive to the attributes of patients with the disease of interest, whereas generic instruments are more generalizable across different diseases., Among the available disease-specific instruments, ADDQoL is one of the most widely used diabetes-specific QoL instruments to measure an individual's perception of impact of diabetes on their QoL.
ADDQoL questionnaire is a third-generation individualized QoL instrument. It evaluates the general QoL as well as the diabetes-dependent QoL. ADDQoL starts with two overview items assessing the patient's present global QoL (range +3–−3) and the impact of diabetes on the QoL (range −3–+3). For both items, lower scores indicate a poorer QoL. In the subsequent items, the respondent rates the impact of diabetes (range −3–+3) and the importance of QoL (range 3–0) on 19 item domains. The 19 life domains are as follows: leisure activities, working life, local or long-distance journeys, holidays, physical health, family life, friendships and social life, close personal relationships, sex life, physical appearance, self-confidence, motivation to achieve things, people's reactions, feelings about the future, financial situation, living conditions, dependence on others, and freedom to eat and freedom to drink. The impact scores are multiplied by the importance rating to produce a weighted impact score for each domain, resulting in scores ranging from −9 to +9. The weighted impact scores for the domains are divided by the number of applicable domains to yield an average weighted impact score (ADDQoL score), where more negative scores reflect a worse QoL and a more negative impact of diabetes on the QoL. The overall reliability coefficient (Cronbach's α) of the ADDQoL is 0.96, thus indicating a good internal consistency.
Institution Ethics Committee approval was obtained before the initiation of the study. The study was carried out in accordance with the Declaration of Helsinki.
Obtained data were entered into Microsoft Excel 2010. The results obtained were statistically analyzed using Statistical Package for the Social Sciences software for Windows (version 20.0) (IBM Corp., Armonk, NY, US). Results were presented as number and percentage for categorical variables and as mean ± standard deviation (SD) or median for parametric variables. Comparison of variables was performed using independent t-test. Differences at P < 0.05 were considered statistically significant.
| Results|| |
A total of 200 patients were included in the study. [Table 1] presents the demographic details of the study patients. Among the study population, 56% of the patients were below 60 years of age, 66% were female, 95% were married and 76% lived in a nuclear family. Nearly half (48%) of the patients had completed high school education, 55% were unemployed and 54% resided in an urban area.
Clinical characteristics of the study patients are depicted in [Table 2]. Nearly two-thirds (66%) of the patients were living with type 2 DM for 5 years or less. Among these, 58% of patients were on oral hypoglycemic agents along with lifestyle modifications and only in 35% of patients, type 2 DM was under control. Moreover, 63% and 89% performed regular physical exercises and were on diet control, respectively. Approximately 88% of patients had no family history of type 2 DM. Nearly 34% of patients had type 2 DM-related complications and 60% had at least one comorbidity (s) other than type 2 DM. Almost 83% of patients came for a regular check-up.
Type 2 DM had a negative impact to QoL in 38% of patients, whereas 69.5% believed that their QoL would be better without type 2 DM. The mean ADDQoL score was calculated to be −0.50. Distribution of responses regarding ADDQoL items and corresponding weighed impact scores are shown in [Table 3]. Type 2 DM had worst impact on freedom to eat (mean ± SD impact rating: −2.04 ± 0.707) and least effect on sex life (mean ± SD impact rating: −0.28 ± 0.550). Food enjoyment (mean ± SD impact rating: 2.34 ± 0.474), freedom to eat (mean ± SD impact rating: 2.33 ± 0.665) and family relationships (mean ± SD impact rating: 2.33 ± 0.471) were rated as the most important items, whereas travel was considered the least (mean ± SD impact rating: 1.37 ± 0.822). When weighting was taken into account, freedom to eat (mean ± SD impact rating: −4.78 ± 2.345) still remained the most affected and sex life (mean ± SD impact rating: −0.66 ± 1.447) the least affected parameter.
|Table 3: Descriptive analysis of audit of diabetes dependent quality of life (Independent T-Test)|
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Comparison of average weighed impact scores with sociodemographic and clinical characteristics of the study participants are shown in [Table 4]. Statistical significant relations were observed between QoL and gender, age, domicile, education status, occupation, family structure, duration of type 2 DM, glycated hemoglobin (HbA1c), insulin treatment, and the presence of comorbidities.
| Discussion|| |
The study has shown that patients with type 2 DM have a lower QoL, using ADDQoL, which is one of the most widely used diabetes-specific scale in medical literature. Diabetes as a chronic disease is demanding in both self-care commitment and resource consumption. It is therefore imperative that ability to meet these requirements may affect one's own QoL. Thus, QoL studies are important in the context of one's personal well-being and the ability to work and earn a living. In this study, type 2 DM had a negative impact on all domains of life. Consistent with the previous studies,,, the largest negative impact in our study was observed on the freedom to eat, which shows the strong influence of dietary restrictions on QoL. Thus, interventions to improve dietary freedom may help to improve QoL among type 2 DM patients.
Several variables influence the QoL. Poor QoL has been found to be associated with older age. Deterioration in the QoL of older age group can be due to the increased frailty component. Elderly patients suffer from several chronic diseases and take multiple medications at the same time. Longer duration of type 2 DM and several disease-related complications could be another reason. These patients usually tend to have limited access to medical facilities. With age, they become less carefree and optimistic and have narrower outlook to life. Spasic et al. also reported that older age was independently associated with lower QoL scores. In terms of gender, we observed that men with type 2 DM experienced poor QoL compared to women. Similarly, the study done by Nejati showed that female QoL score is higher than male. However, several other studies have reported that men have a higher QoL than women., Social and cultural factors related to gender in different communities may have a different effect on QoL in male and female. Our analysis shows that having urban residence is associated with decreased QoL. This could be because of a larger number of urban dwellers. A similar study conducted in Nepal reported rural residence to be associated with reduced QoL. We also found a significant effect of education on QoL. Similarly, a study from Turkey found education to be positively correlated with physical health, psychological health, social relationship, environment, and the overall QoL. Another study, however, reported that more education can negatively influence QoL. Marital status of the study participants did not affect QoL. This is different from the findings of studies conducted in India and Sweden. Furthermore, two Iranian studies also reported better QoL among married diabetic patients. One would expect better psychosocial support in the married patients and thus a better QoL. In this study, we also observed poor QoL to be significantly associated with the patient's unemployment status. Lower income due to unemployment could be a possible reason for lower QoL. A similar observation was observed in study conducted by Collins et al. Similar to the study by Kumar andMajumdar we noted significantly low QoL among those living in a nuclear family. This could probably due to poor family support among diabetics living in nuclear family compared to the traditional Indian joint families.
Previous studies have found that diabetes disease control is directly associated with the development of complications and the QoL. The UK Prospective Diabetes Study found that reducing the average yearly values of HbA1c by 1% reduces the risk of microvascular complications by 37%, of peripheral vascular disease by 43%, of heart attack by 14%, and of stroke by 12%. Uncontrolled DM and poor glycemia control can result in symptoms of hyperglycemia which could have a profound effect on QoL. We found poor QoL in patients with levels of HbA1c ≥7.5%. Similarly, results of a study presented by Wikblad et al., using the Swedish QoL scale, showed that the lowest QoL was found in patients with the worst glycemic control and levels of HbA1c >8.1%. Peyrot et al., in their study also showed a significant correlation between QoL and degree of glycemic control based on HbA1c values. However, a study conducted in Durham, using SF-36, showed no connection between QoL and degree of glycemic control. Statistically significant lower QoL was found to be associated with longer duration of disease. Results from a study by Stanetic et al. also show the duration of disease to have an effect on the QoL of patients with diabetics. However, a Finish study conducted on patients with type 1 DM and a Swedish study conducted on type 2 DM patients did not find any correlation between duration of disease and QoL. We found a positive association between comorbidities and QoL, which were similar to the findings of a large scale cohort study conducted on type 2 DM patients, where the patients with symptomatic comorbidities such as microvascular complications had a substantially reduced QoL, whereas those without symptoms showed no reduction in their QoL. Another study showed that use of insulin therapy significantly lowers patient's QoL. We also obtained similar results. Physical activity is another factor which have been identified to control DM to a great extent. A meta-analysis by Cochran et al. conducted on diabetic patients confirmed that physical activity helps to improve disease control and overall QoL. Similarly, a prospective study conducted to evaluate the impact of stages of change for exercise on QoL, found exercise to be positively associated with self-perceived QoL. According to the findings of our research, 63% of the patients were physically active. This was comparatively greater than the results of another Indian survey, which identified only 46.5% of the participants to be regularly physically active. However, we could not identify any positive significance between the QoL of patients with or without lifestyle changes in terms of physical exercise or diet modification.
A collaborative and integrated medical team based approach comprising of clinical pharmacist along with the involvement of all healthcare professionals and active support of patients' with DM, can play an vital role in improving the QoL. Several studies have reported that this multidisciplinary approach with clinical pharmacist in DM care programmes, through patient education and medication counseling, improved glycaemic control, QoL and other clinical outcomes in patients with DM.
The study has a few limitations the foremost being the duration of the study. The study was conducted for a short duration of 6 months. The second limitation is the sample size. Larger sample size would have increased the power of the study. Moreover, we only included patients with type 2 DM, and this limits the generalizability of results to other disease categories. Further studies are required to overcome these limitations. However, our findings may be helpful in determining the incidence and pattern of patient self-reported QoL in type 2 DM.
| Conclusion|| |
The study results show that type 2 DM has a negative impact on patients perceived QoL, which did not differ from those reported in studies that included patients from developing countries. We found statistically significant differences in QoL depending on gender, age, domicile, education status, occupation, family structure, duration of type 2 DM, HbA1c, insulin treatment and the presence of comorbidities. The study suggests that we need to develop and implement strategies and interventions focusing on improving QoL in type 2 DM patients.
The authors would like to thank JSS University, Mysore, Karnataka, India for the constant support and encouragement.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4]