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RESEARCH
Open Access
Abstract
Background: To assess quality of life and treatment satisfaction in patients with type 2 diabetes mellitus with diabetic
retinopathy (DR) using validated instruments, with comparison to patients without DR.
Methods: A prospective cross-sectional study was designed to assess the influence of retinopathy on quality of life and
treatment satisfaction in patients with type 2 diabetes mellitus who do not have any other advanced late complications
that could interfere with these outcomes. We included 148 patients with DR and 149 without DR, all without
other advanced diabetic complications. Quality of life was assessed using the Audit of Diabetes Dependent Quality of Life
(ADDQoL) questionnaire, and treatment satisfaction was assessed using the Diabetes Treatment Satisfaction Questionnaire
(DTSQ). Clinical and treatment variables related to diabetes were also collected. The degree of DR was classified according
to the International Clinical Classification System. Multivariate linear regression models were used to model the ADDQoL
and DTSQ scores according to sociodemographical and clinical characteristics, and to model the adjusted relationship of
DTSQ with ADDQoL. In DR patients, a subanalysis assessed the relationship of these scores with the degree of retinopathy,
severity of macular edema, and previous photocoagulation treatment.
Results: DR was associated with significantly lower quality of life (p < 0.001), when examining the two general quality
of life items and most of the specific domains. Concerning DTSQ, no difference was found in the total score, and only
two domains that assess the perception of glycemic control (hyper- and hypoglycemia) showed a worse score in DR
(p < 0.001 and p = 0.008, respectively). Quality of life was significantly affected by the severity of DR, and treatment
satisfaction was significantly affected by the severity of macular edema. In the multivariate analysis, a significant effect
of the interaction between diabetes duration, insulin therapy, and the presence of DR was found for both, ADDQoL
and DTSQ.
Conclusion: In the absence of other major complications, DR has a negative impact on quality of life in patients with
type 2 diabetes. Further, treatment satisfaction was not affected by the presence of DR.
Keywords: Diabetic retinopathy, Quality of life, Treatment satisfaction, Specific questionnaires, Type 2 diabetes mellitus
* Correspondence: didacmauricio@gmail.com
1
Institut de Recerca Biomdica de Lleida, University of Lleida, Lleida, Spain
5
Department of Endocrinology and Nutrition, Hospital Germans Trias Pujol,
Carretera Canyet, S/N, 08916 Badalona, Spain
Full list of author information is available at the end of the article
2014 Alcubierre et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the
Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use,
distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public
Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this
article, unless otherwise stated.
Background
Diabetic retinopathy (DR) is a diabetes-specific ophthalmic
complication that is still very common and often severe. It
is the leading cause of preventable blindness in workingage adults [1,2]. In Spain, 15.6% of patients with type 2 diabetes mellitus are affected by the disease in its different
stages, with a 4% prevalence of proliferative DR [3,4].
Improving quality of life is a primary goal when treating
diabetic patients with DR. Diabetic visual impairment
places the individual in a situation that can profoundly
affect their quality of life [5-7]. Photocoagulation, the firstline and most frequently used treatment for diabetic retinopathy, has an adverse effect on health-related quality of
life and treatment satisfaction in these patients [8].
We understand treatment satisfaction to be the confirmation of expectations for a patient, that is, the agreement
between what the patients expects from the treatment and
the results obtained [9]. Although new treatment standards
advise reconciling traditional measures of vision assessment
with the use of patient-reported outcome measures, choosing the most appropriate instrument to measure quality of
life can be difficult [10]. The primary reason for using specific measures of diabetes-related quality of life is to provide
an accurate, comprehensive, and personal assessment of
this complication, analyzing its role in the patients life and
maximizing the variability in the responses of patients with
the same pathology or in certain groups [11].
In a recent review, Fenwick et al. established that DR is
a threat to the quality of life of patients with type 1 or type
2 diabetes, especially in later stages, and illustrated the
way in which different psychometric properties of the
most frequently used scales can lead to very different outcomes [12]. However, the presence of other diabetic late
complications is the very frequent in participants included
in studies assessing quality of life in diabetic retinopathy
[13,14]. For instance, in the study by Davidov et al.,
complications like coronary heart disease, nephropathy,
peripheral vascular disease or cerebrovascular disease
have been shown to be frequent in patients with retinopathy; in that study, patients had a mean of 2.4 associated co-morbidities and only 11% of them were free of
any of this major health conditions [13]. In a very large
study, the Andhra Pradesh Eye Disease Study [15], the
authors showed the specific adverse impact in terms of
quality of life of different eye diseases i.e. cataract, corneal
diseases, retinal diseases, glaucoma and uncorrected refractive deffects. Specifically, in that study diseases of the
retina with a very similar impact on visual health, like
macular degeneration, showed an unfavourable impact
on quality of life. Therefore, the specific impact of retinopathy on quality of life in type 2 diabetes deserves
further research.
Few studies have assessed the impact of DR on the quality of life of type 2 diabetic patients. In addition, none of
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Methods
A prospective, observational, cross-sectional study was designed. Patients were identified from a unpublished prospective study on cerebral microcirculation conducted by
our research team in patients with and without retinopathy.
From a total sample of 314 patients and based on the
sample size calculation (see below), a total of a 299
were offered participation in the current study. All initially
contacted patients fulfilled the predefined inclusion criteria and accepted the participation in the study; however,
finally 2 subjects did not show up for the study visit even
after additional efforts were made to include them. It
should be noted that the study visits were scheduled
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developed by Bernstein et al. was used, which defines a sedentary person as one who spends less than 10% of his/her
daily energy expenditure performing any physical activity
that requires at least 4 METs (The Metabolic Equivalent)
(equal or greater physical activity expenditure than brisk
walking for 30 minutes) [20]. MET is the ratio of a persons
working metabolic rate relative to his/her resting metabolic rate and is equivalent to a caloric consumption of
1 kcal/kg/hour [21]. Visual acuity was measured using
the Snellen chart. For statistical analysis, Snellen acuities
were converted to equivalent values using logarithm of
the minimum angle of resolution [22].
All the questionnaires were administered individually by
personal interview by a single trained interviewer (N.A.),
after the diagnostic assessment at the Department of
Ophthalmology. The response rate was 99.3%.
Quality of life
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No retinopathy (n = 149)
Retinopathy (n = 148)
p-value
Sex (men)
78 (52.3%)
73 (49.3%)
0.685
Age (years)
57.9 (19.26)
60.5 (8.77)
0.042
13 (8.7%)
25 (16.9%)
Complete primary
79 (53.1%)
90 (60.8%)
39 (26.1%)
30 (20.3%)
Graduate or higher
18 (12.1%)
3 (2.0%)
5 (3.3%)
6 (4.0%)
Yes
31 (21.1%)
31 (21.1%)
No
65 (44.2%)
74 (50.3%)
Former smoker
51 (34.7%)
42 (28.6%)
6.0 [3,10]
11.0 [7.2,9.1]
<0.001
HbA1c (%)
7.1 [6.5,7.9]
8.1 [7.2,9.1]
<0.001
Hypertension
74 (49.7%)
94 (63.5%)
0.022
Dyslipidemia
65(43.6%)
66 (44.6%)
0.959
Antiplatelet agents
46(30.9%)
68 (45.9%)
0.011
Psychotropic drugs
35 (23.5%)
48 (32.4%)
0.112
0.80 (0.2)
0.81 (0.2)
0.830
134.4 (15.5)
144.4 (20.1)
<0.001
Education
<0.001
Ethnicity
Non caucasian
0.990
Smoking
0.483
76.5 (10.4)
77.1 (11.0)
0.634
Waist (cms)
104.1 (12.1)
107.26 (11.3)
0.010
BMI (kg/m2)
31.25 (5.1)
31.92 (5.5)
0.240
Diabetes treatment
OAD
96 (64.4%)
65 (43.9%)
OAD + insulin
13 (8.7%)
62 (41.9%)
Insulin
4 (2.7%)
18 (12.2%)
Diet
36 (24.2%)
3 (2.0%)
< = 0.2
3 (2.0%)
30 (20.4%)
0.2-0.4
11 (7.4%)
8 (5.4%)
0.4-0.6
17 (11.4%)
24 (16.3%)
0.6-0.8
44 (29.5%)
36 (24.5%)
>0.8
74 (49.7%)
49 (33.4%)
87 (58.4%)
96 (64.9%)
62 (41.6%)
52 (35.1%)
<0.001
Visual acuity
<0.001
Physical activity
0.304
Values are shown as mean SD or median interquartile range for age, diabetes duration, HbA1c, systolic blood pressure, diastolic blood pressure, waist and BMI; frequency
(%) for all other variables. HbA1c: glycated haemoglobin; BMI: body mass index; OAD: oral antidiabetic agents. The p-values correspond to the unadjusted univariate analysis
that compares the difference for each variable between patients with and without retinopathy.
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Life domains
No retinopathy*
Retinopathy*
Present QoL
0.99 (1.00)
0.39 (1.19)
Average weighted
impact score
1 [0,2]
1 [ 0,1]
Diabetes specific
QoL
0.50 (0.74)
1.08 (1.00)
0 [1,0]
1[2,0]
Leisure
0.42 (1.29)
1.06 (2.01)
0 [0,0]
0 [2,0]
0.38 (1.19)
1.05 (2.02)
0[0,0]
0 [0,0]
0.41 (1.33)
0.79 (1.78)
0 [0,0]
0 [0,0]
0.29 (1.13)
0.46 (1.56)
0 [0,0]
0 [0,0]
0.63 (1.60)
1.74 (2.54)
0 [0,0]
0 [3,0]
0.34 (1.13)
0.92 (2.18)
0 [0,0]
0 [0,0]
Friends/social
life
0.11 (0.51)
0.47 (1.44)
0 [0,0]
0 [0,0]
Personal
relationship
0.18 (1.10)
1.04 (2.31)
0 [0,0]
0 [0,0]
Sex life
0.64 (1.63)
2.05 (2.60)
0 [0,0]
1 [4,0]
0.16 (0.92)
0.47 (1.58)
0 [0,0]
0 [0,0]
Work life
Travels
Holidays
Physical ability
Family life
Physical
appearance
0.36 (1.25)
0.92 (1.99)
0 [0,0]
0 [0,0]
0.51 (1.65)
1.33 (2.33)
0 [0,0]
0 [2,0]
Society/peoples
reaction
0.10 (0.53)
0.38 (1.40)
0 [0,0]
0 [0,0]
Future
1.51 (2.59)
2.53 (3.03)
0 [2,0]
2[6,0]
0.13 (0.72)
0.56 (1.84)
0 [0,0]
0 [0,0]
0.08 (0.60)
0.25 (1.03)
0 [0,0]
0 [0,0]
0.15 (0.66)
0.96 (2.00)
0 [0,0]
0 [0,0]
3.00 (3.25)
3.85 (3.78)
2 [6,0]
2.5 [9,0]
1.48 (2.73)
1.91 (3.04)
0 [1,0]
0[2,0]
Self-confidence
Motivation
Finances
Living conditions
Dependence
Freedom to eat
Freedom to drink
p-value
<0.001
<0.001
<0.001
0.022
0.009
0.233
<0.001
0.018
0.010
<0.001
0.58 (0.74)
1.22 (1.17)
0.35 [0.78,-0.06]
0.88 [1.76,-0.38]
<0.001
*mean (standard deviation) in first line, and median [P25,P75] in second line.
The p-values correspond to the unadjusted univariate analysis that compares
the difference for each variable between patients with and
without retinopathy.
<0.001
0.065
0.006
<0.001
0.084
<0.001
0.022
0.062
<0.001
0.074
0.129
Results
The primary clinical and sociodemographic characteristics
and their comparison between the two groups are shown
in Table 1. Patients with retinopathy had a slightly higher
average age because fewer patients with DR were identified between 40 and 50 years of age. Patients with DR had
less schooling, a longer duration of diabetes, greater glycosylated hemoglobin levels, and greater frequency of arterial hypertension. As expected, patients with DR had
higher urinary albumin concentrations and higher systolic
blood pressure. Although body mass was not different,
patients with retinopathy had a higher waist circumference.
Patients with DR also received more complex treatment
which is related to the longer duration of diabetes.
The distribution of each degree of retinopathy was as follows: 40.7% with mild nonproliferative DR, 35.9% with
moderate nonproliferative DR, and 23.4% with severe
proliferative DR. Diabetic macular edema was present
in 52 patients (35.9% of those with DR). Of this percentage,
edema was clinically significant in 21.4% and not clinically
significant in 14.5%. For the DR group, a significant association between the degree of DR and the presence of clinically significant macular edema was observed (p < 0.0001). A
significant association was also observed between the
degree of DR and previous photocoagulation treatment
(p < 0.0001).
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Intercept
0.8020
0.5098
0.1168
0.0269
0.0418
0.5203
0.0008
0.001
0.6305
Retinopathy
0.0108
0.3645
0.9762
Insulin
1.6923
0.8318
0.0428
Age >65
0.2798
0.1155
0.0161
Ethnicity
1.0309
0.27292
0.0001
Waist (centimetres)
0.0116
0.0044
0.0101
Diabetes duration* DR
0.0483
0.0851
0.5705
Diabetes duration-squared * DR
0.0003
0.0039
0.9302
0.7326
0.2457
0.0031
0.0394
0.0152
0.0102
DR * insulin
1.9684
0.9583
0.0409
0.7348
0.2590
0.0049
0.0156
0.0122
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Figure 1 Relationship between ADDQoL and duration of diabetes by groups defined by the presence of diabetic retinopathy (DR) or
absence of retinopathy (nRD), and insulin treatment (Ins) or not (nIns). Panel a shows the smoothed relationship while panel b shows the
fitted trend assuming a linear relationship. a. Smoothed relationship between Audit Diabetes Dependent Quality of Life (ADDQoL) and duration
of diabetes. b. Linear relationship between ADDQoL and duration of diabetes.
No retinopathy
Retinopathy
Hyperglycemias
frequency perception
2.46 (2.23)
3.58 (2.19)
2 [0,4]
0 [2,6]
0.99 (1.63)
1.64 (2.12)
0 [0,2]
0 [0,3]
Hypoglycemias
frequency perception
Current treatment
Convenience
Flexibility
Understanding
The DTSQ median score was not different between patients with or without retinopathy (mean score: 26 vs 27,
respectively; p = 0.236) (Table 4). However, differences were
found in some of the specific questionnaire items. There
was a greater perception of having suffered hyper- and
hypoglycemic episodes in patients with DR, with a statistically significant difference (p < 0.001 and p = 0.008, respectively). These patients also expressed greater discomfort
regarding treatment and its results (p < 0.001).
Recommend to others
Continue with
Final score
p-value
<0.001
0.008
5.00 (1.48)
4.8 (1.53)
5 [5,6]
5[4,6]
4.99 (1.63)
4.41 (1.82)
6 [5,6]
5 [4,6]
3.34 (2.49)
2.91 (2.36)
4 [0,6]
3 [0,5]
4.37 (1.89)
4.45 (1.85)
5 [3,6]
5 [3,6]
3.19 (2.23)
3.00 (2.27)
3 [1,5]
3 [0.75,5]
5.81 (0.85)
5.76 (1.00)
6 [6,6]
6 [6,6]
26.73 (5.61)
25.43 (6.70)
27 [23,30]
26 [21.75,31]
0.445
<0.001
0.057
0.808
0.362
0.642
0.236
Mean (standard deviation) in first line, and median [P25,P75] in second line.
The p-values correspond to the unadjusted univariate analysis that compares
the difference for each variable between patients with and without retinopathy.
Discussion
We have shown that patients with type 2 diabetes with
DR and no other advanced late complications report a
Table 5 Multivariate linear regression for the diabetes
treatment satisfaction questionaries
Coefficients
Estimate
Standard deviation
p-value
Intercept
24.7585
1.0030
< 2e 16
Insulin
1.6874
0.9514
0.077
Diabetes duration
(years)
0.1571
0.0907
0.084
Retinopathy
1.7524
1.1792
0.138
Physical
activity > 20 minutes
2.3979
0.7176
0.001
Smoker
0.6628
0.92503
0.474
Former smoker
1.6248
0.8016
0.044
Diabetes duration
* DR
0.2587
0.1070
0.016
Tobacco use:
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Figure 2 Relationship between Diabetes Treatment Satisfaction Questionnaire status version (DTSQ-s) and duration of diabetes mellitus by
groups defined by the presence of diabetic retinopathy (DR) or absence of diabetic retinopathy (nRD), and insulin treatment (Ins) or not (nIns).
Panel a shows the smoothed relationship while panel b shows the fitted trend assuming a linear relationship. a. Smoothed relationship between
Diabetes Treatment Satisfaction Questionnaire status version and duration of diabetes in patiens with and without diabetic retinopathy. b. Linear
relationship between Diabetes Treatment Satisfaction Questionnaire status version and duration of diabetes in patiens with and without diabetic
retinopathy.
studied using a generic health questionnaire and a visionspecific functioning and quality of life questionnaire designed for people with visual disabilities. The results of the
study showed that patients with DR had lower scores on
both the Medical Outcomes study 12-Item Short Form
Health Survey and the National Eye Institute Visual Function Questionnaire [16]. This association was influenced
by both the severity and the laterality of DR. However, the
presence of other comorbidities may have had an additive
Estimate
Standard deviation
p-value
Intercept
0.3086
0.5783
0.594
0.0166
0.0111
0.137
Insulin
0.3869
0.9188
0.674
Retinopathy (DR)
0.0256
0.3506
0.942
0.0343
0.0404
0.396
0.0011
0.0017
0.528
Age >65
0.2809
0.1108
0.012
Waist
0.0109
0.0043
0.012
Insulin * DR
1.8622
0.9199
0.044
DR * Diabetes duration
0.0424
0.0818
0.604
DR * Diabetes duration-squared
0.0002
0.0038
0.947
0.6268
0.2367
0.009
0.0330
0.0146
0.025
0.6405
0.2492
0.011
0.0333
0.0150
0.028
0.0433
0.0157
0.010
Multiple R-squared: 38.49%. *stands for the existence of interactions between variables. DTSQ: diabetes treatment satisfaction questionnire; DR: diabetic retinopathy.
Page 10 of 12
Figure 3 Relationship between Audit Diabetes Dependent Quality of Life (ADDQoL) and Diabetes Treatment Satisfaction Questionnaire
(DTSQ) by groups defined by the presence of diabetic retinopathy (DR) or absence of retinopathy (nDR), and insulin treatment (Ins) or not
(nIns). Panel a shows the smoothed relationship while panel b shows the fitted trend assuming a linear relationship. a. Smoothed relationship
between Audit Diabetes Dependent Quality of Life and Diabetes Treatment Satisfaction Questionnaire. b. Linear relationship between Audit Diabetes
Dependent Quality of Life and Diabetes Treatment Satisfaction Questionnaire.
and the use of data from patients with either type 1 or type
2 diabetes does not allow for the comparison of these results with our results.
Our results also illustrate the impact of insulin therapy
on quality of life and treatment satisfaction. We could not
identify any studies specifically designed to assess the issue
of treatment satisfaction in patients with type 2 diabetes
and retinopathy. Mozaffarieh et al. observed an influence
of age on treatment satisfaction in a mixed sample of type
1 and 2 diabetic patients with retinopathy who were
treated with photocoagulation [17]. Younger patients had
lower DTSQ scores. Using the same instrument, Redekop
et al. investigated the clinical and sociodemographic
characteristics associated with treatment satisfaction in
a sample of Dutch patients with type 2 diabetes mellitus [35]. Lower levels of satisfaction were observed in
univariate analyses of patients with diabetic complications, but this association was not maintained after adjustment for age, insulin, and glycated haemoglobin
levels. In our study, treatment satisfaction was significantly affected by the patients perceived glycemic control,
the duration of the disease, the degree of physical activity
and smoking.
Regarding the limitations of this study, the study design
inherently allows us to study only associations and not
causality. Additionally, the fact that diabetes duration is a
major factor in the development of DR caused a discrete
bias in age distribution, with a lower proportion of younger patients in the retinopathy group. While other major
complications that could affect quality of life and treatment satisfaction have been ruled out, potential symptoms
of peripheral neuropathy that might influence these aspects were not assessed. However, none of the patients
had advanced neuropathy leading to serious complications
such as diabetic foot disease. The representativeness of
the study groups is partially limited and the conclusions
may not be generalized to all the population of patients
with type 2 diabetes. The results may be applicable to
patients with or without retinopathy in the absence of
other advanced late diabetic complications that is an important proportion of patients in the Spanish population
according to recent reports [36].
In conclusion, in type 2 diabetic patients, the presence of
DR is associated with poorer quality of life. Although satisfaction with the overall treatment is not different between
the two groups of patients, it is influenced by other clinical
variables. The results of this study are relevant because they
demonstrate for the first time the negative influence of DR,
regardless of the presence of other complications, on the
quality of life of type 2 diabetic patients in a study specifically designed for that purpose. Clinicians should be aware
that quality of life is one of the primary objectives of diabetes treatment. In addition, these findings should be taken
into account in clinical practice when treating patients with
DR and type 2 diabetes mellitus. Apart from the benefits in
terms of visual outcomes, early identification and treatment
of patients with DR would have a positive impact on the
different dimensions of the patients quality of life. However,
the potential impact of the early diagnosis and treatment of
DR on quality of life deserves the performance of specific
intervention studies to address this issue. We also believe
that there is a need for additional studies to conduct a linguistic and psychometric validation of new measures of
quality of life and treatment satisfaction and to develop
measurement tools that would allow the assessment of the
impact of DR treatments on the patient.
Competing interests
The authors declare that they have no competing interests.
Authors contributions
NA and DM designed the study. NA, ER, AT, MH and CJ collected the data. NA,
MM-A and DM analyzed the data. All authors contributed to the interpretation of
the data. NA drafted the manuscript. DM contributed to the writing, reviewing
and final editing of the manuscript. NA and DM take full responsibility for
the integrity of the data and the accuracy of the data analysis. All authors
critically revised and approved the final manuscript.
Acknowledgements
This study was supported by grant PS09/01035 from Instituto de Salud
Carlos III. N.A holds a predoctoral fellowship (FI11/0008) from Instituto de
Salud Carlos III, Spain.
Author details
1
Institut de Recerca Biomdica de Lleida, University of Lleida, Lleida, Spain.
2
Department of Endocrinology and Nutrition, University Hospital Arnau de
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