Socio-demographic characteristics of the respondents
In this study, data from 376 diabetic patients who were followed up between 2019 and 2023 were collected. The reported mean baseline age of the study subjects was 34.8 years, with a standard deviation of 10. Among the study subjects, half (189, 50.3%) were females, and the majority (197, 52.4%) were married. Approximately one-third (106, 28.2%) of the participants had a college education or above, followed by 103 (27.4%) (Table 2).
Table 2: Socio-demographic characteristics of the respondents with DM at follow-up at public hospitals in the central and southern regions of Ethiopia
Variables
|
Category
|
Frequency
|
Percent (%)
|
Sex
|
Male
|
187
|
49.73
|
Female
|
189
|
50.27
|
Marital status
|
Single
|
79
|
21.01
|
Married
|
197
|
52.39
|
Divorced
|
80
|
21.28
|
Widowed
|
19
|
5.05
|
Separated
|
1
|
0.27
|
Educational status
|
No formal education
|
86
|
22.87
|
Primary
|
81
|
21.54
|
Secondary
|
103
|
27.39
|
College and above
|
106
|
28.19
|
Occupation
|
Gov’t employed
|
102
|
27.13
|
Non-gov’t employed
|
74
|
19.68
|
Farmer
|
17
|
4.52
|
Student
|
29
|
7.71
|
Housewife
|
79
|
21.01
|
Other
|
75
|
19.95
|
Others: Daily labourers, homemakers, and self-employed individuals.
Baseline clinical and behavioural characteristics
The median duration of DM treatment reported by the respondents was 20.2 months, with IQRs of 18.4 and 29.3. Three-fourths (n=282; 75.2%) of the study participants were receiving insulin treatment, and approximately 73% of the respondents had good adherence to treatment. In this study, while 17.9% of the study participants reported that they had ever smoked tobacco products, nearly 12.5% of participants reported that they had ever drunk alcoholic drinks. Among the study subjects, one-fourth (96, 25.5%) of the respondents had developed retinopathy (Table 3).
Table 3: Baseline clinical and behavioural characteristics of diabetic patients on follow-up in public hospitals in the central and southern regions of Ethiopia
Variables
|
Category
|
Frequency
|
Percent (%)
|
BMI
|
Underweight
|
56
|
14.89
|
Normal
|
303
|
80.59
|
Obesity
|
17
|
4.52
|
Proteinuria
|
Positive
|
47
|
12.5
|
Negative
|
329
|
87.5
|
DM Rx
|
Insulin
|
282
|
75.2
|
Noninsulin
|
74
|
19.7
|
Mixed
|
19
|
5.1
|
HTN
|
Yes
|
153
|
40.7
|
No
|
223
|
59.3
|
Adherence
|
Good
|
274
|
73.8
|
Fair
|
72
|
19.4
|
Poor
|
25
|
6.7
|
Retinopathy
|
Yes
|
96
|
25.5
|
No
|
280
|
74.5
|
Comorbidity
|
Yes
|
40
|
10.64
|
No
|
336
|
89.36
|
DM type
|
Type I
|
117
|
29.79
|
Type II
|
249
|
70.21
|
Family History of DM
|
Yes
|
138
|
37.23
|
No
|
227
|
62.77
|
Alcohol
|
Yes
|
27
|
7.2
|
No
|
349
|
92.8
|
Smoking
|
Yes
|
67
|
17.9
|
No
|
307
|
82.1
|
Exercise
|
Yes
|
55
|
14.9
|
No
|
315
|
85.1
|
Incidence of Retinopathy
The patients were followed for a minimum of 2.8 months and a maximum of 59.3 months, with a median follow-up time of 19.3 months and an IQR of 16.6 to 26.9. Out of 376 study participants who were followed retrospectively for four years, 96 (25.5%) developed retinopathy. The incidence rate was 11.7/1000 PM (approximately twelve cases per 1000 person-months of observation), with a 95% CI of [0.0096, 0.0143] (Figure 1).
Survival probability of patients with Diabetes
The overall Kaplan-Meier survival curves at the onset of follow-up, the likelihood of surviving was high and equal to the upper bound of the survival probability, and it then began to decline. The curve steps down to a lower value at each time in the final graph. At the maximum censorship time, it ends (Figure 2).
Proportional Hazard Assumption
The proportional assumption was met in this investigation as evidenced by the predictors' estimated logs (−log (survival)) versus survival times being parallel. Nevertheless, as these are univariate analyses and do not indicate whether risks will remain proportionate in a model with numerous other factors, examining the log (−log (survival)) alone will not provide sufficient assurance of proportionality. However, they back up our proportionality claim (Figure 3). Schoenfeld residual test for the Global test was insignificant that indicating the proportional hazard assumption holds (table 4).
Table 4: Schoenfeld residual test to check proportional hazard assumptions
Variables
|
Chi-square
|
DF
|
p-value
|
Sex
|
0.2368
|
1
|
0.627
|
Adherence
|
2.3480
|
2
|
0.309
|
DM duration
|
0.4601
|
1
|
0.498
|
BMI
|
2.0119
|
1
|
0.156
|
Smoking
|
0.5432
|
1
|
0.461
|
Exercise
|
5.7536
|
3
|
0.124
|
Alcohol
|
0.0472
|
1
|
0.828
|
DM type
|
1.6116
|
1
|
0.204
|
DM Rx
|
0.2410
|
2
|
0.886
|
Family history of DM
|
9.9806
|
3
|
0.089
|
HTN
|
0.8340
|
1
|
0.361
|
Proteinuria
|
4.3536
|
3
|
0.144
|
Global
|
23.1233
|
17
|
0.145
|
Predictors of the incidence of Diabetic Retinopathy among Diabetic patients
Based on the p-value of the Bivariable Cox proportional hazard regression analysis, twelve variables with P value ≤ 0.25 were identified as potential candidate variables for the multivariable Cox proportional hazard regression model. These were sex, marital status, DM treatment, HTN, proteinuria, adherence, and DM type, Family history of DM, comorbidity, smoking, exercise, and alcohol. In Multivariable cox proportional hazard regression analysis, HTN, DM type, and proteinuria showed statistically significant associations with the incidence of Diabetic retinopathy (Table 5).
Table 5: Bivariate and Multivariable Cox proportional hazard regression analysis results for predictors affecting diabetic retinopathy in selected public hospitals of Central and South region of Ethiopia.
Variables
|
Category
|
Censored (%)
|
Event (%)
|
CHR (95%CI)
|
AHR (95%CI)
|
p-value
|
Sex
|
Male
|
145(77.5)
|
42(22.5)
|
1(reference)
|
1(reference)
|
|
Female
|
135(71.4)
|
54(28.5)
|
1.35(0.90- 2.02)
|
1.52(0.94 - 2.46)
|
0.071
|
Marital Status
|
Single
|
63(79.7)
|
16(20.3)
|
1(reference)
|
1(reference)
|
|
Married
|
157(79.7)
|
40(20.3)
|
0.97(0.54- 1.74)
|
0.93(0.48 - 1.81)
|
0.122
|
Divorced
|
49(61.2)
|
31(38.8)
|
1.81(0.98- 3.31)
|
0.97(0.49 - 1.95)
|
0.091
|
Widowed
|
11(55.0)
|
9(45.0)
|
2.24(0.95- 5.24)
|
2.19(0.82 - 5.82)
|
0.199
|
DM treatment
|
Insulin
|
250(88.6)
|
32(11.3)
|
1(reference)
|
1(reference)
|
|
Non-insulin
|
28(37.8)
|
46(62.2)
|
6.92(4.39-10.9)
|
1.45(0.78 - 2.70)
|
0.099
|
Mixed
|
2(10.5)
|
17(89.5)
|
8.60(4.74- 15.6)
|
1.79(0.76 - 4.09)
|
0.177
|
Proteinuria
|
Negative
|
10(21.3)
|
37(78.7)
|
1(reference)
|
1(reference)
|
|
Positive
|
270(82.1)
|
59(17.9)
|
5.98(3.95- 9.07)
|
2.19(1.18-4.08)*
|
0.001
|
Hypertension
|
No
|
107(69.9)
|
46(30.1)
|
1(reference)
|
1(reference)
|
|
Yes
|
173(77.6)
|
50(22.4)
|
1.69(1.13 - 2.54)
|
2.23(1.39-3.55)*
|
0.002
|
Co morbidity
|
No
|
18(45.0)
|
22(55.0)
|
1(reference)
|
1(reference)
|
|
Yes
|
262(77.9)
|
74(22.1)
|
2.21(1.37- 3.57)
|
1.16(0.66 - 2.07)
|
0.120
|
Family Hx of DM
|
No
|
45(38.7)
|
72(61.5)
|
1(reference)
|
1(reference)
|
|
Yes
|
227(91.2)
|
22(8.8)
|
8.38(5.19- 13.5)
|
1.38(0.60 - 3.17)
|
0.096
|
DM type
|
Type I
|
208(91.6)
|
19(8.4)
|
1(reference)
|
1(reference)
|
|
Type II
|
61(44.2)
|
77(55.8)
|
7.64(4.62- 12.7)
|
2.89(1.19-7.05)*
|
0.031
|
Alcohol
|
No
|
11(44.0)
|
16(56.0)
|
1(reference)
|
1(reference)
|
|
Yes
|
269(77.1)
|
80(22.9)
|
5.88(3.91- 8.84)
|
1.28(0.61 - 2.67)
|
0.067
|
Smoking
|
Yes
|
261(85.0)
|
46(15.0)
|
1(reference)
|
1(reference)
|
|
No
|
17(25.4)
|
50(74.6)
|
5.19(3.46- 7.79)
|
0.81(0.42 - 1.57)
|
0.072
|
Exercise
|
Yes
|
12(21.8)
|
43(78.2)
|
1(reference)
|
1(reference)
|
|
No
|
263(83.5)
|
52(15.5)
|
0.17(0.11- 0.25)
|
1.62(0.82 - 3.22)
|
0.110
|
*p < 0.05 CI, confidence interval; Proteinuria, Hypertension, DM type 2
Model Adequacy
The Cox-Snell residual plot is approximately linear through the origin with a slope 1 which indicated that the fitted cox model is adequate (Figure 4).