الفهرس 
INTRODUCTION AND AIM OF THE WORKOnly 14 pages are availabe for public view
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Abstract
Diabetic retinopathy (DR) is a common complication of diabetes which is caused by structural changes in the retina due to leaking of tiny and delicate retinal blood vessels. In addition, diabetic patients may suffer from diabetic macular edema (DME) that is caused by the breakdown of the retinal blood barrier resulting in leakage of plasma and water from small vessels. Despite the availability of effective treatment for DR and DME, they are considered as leading causes of visual loss.
The general objective of the study was to apply second order factorial structure model for quality of life and treatment satisfaction among patients with diabetic retinopathy.
Specific objectives were:
1. To calculate the diabetic retinopathy out-of-pocket expenditures from patient perspective.
2. To determine the predictors of diabetic retinopathy quality of life and treatment satisfaction through using the most parsimonious model.
3. To assess the relationship between diabetic retinopathy quality of life, treatment satisfaction and out of pocket ocular expenditure through second order confirmatory factor analytic model.
The study was conducted among diabetic retinopathy patients attending the Retina Unit in Alexandria Ophthalmology Hospital, using a cross sectional study design. A total of 250 diabetic retinopathy patients were enrolled in the study.
Stratified sampling method as stratification was to be done according to DR stage, and then a sample from each stratum was selected using simple random sampling technique based on sample proportionate to size method.
Data was collected using pre-designed structured interview-based questionnaire including:
4. Patients’ demographic, socio-economic and clinical characteristics such as age, education, residence, income, disease duration, type and number of medications and the presence of comorbidities.
a- Fundus clinical examination and dilated fundus photography and the severity categorized as no DR, mild non- proliferative DR, moderate non-proliferative DR, severe non-proliferative DR and proliferative DR.
b- The American Academy of Ophthalmology classification as no DME, CiDME, NCiDME.
5. DR staging and DME severity was collected from the patient’s medical records after assessment by vitreoretinal consultant using:
a- Retinopathy quality of life questionnaire that consists of 21 items which is rated on 7-point Likert scale ranging from (-3) ’very much better’ to (+3) ’worse’.
b- Retinopathy treatment satisfaction questionnaire that consists of 13 items which is rated on 7-point Likert scale ranging from (7) ’very satisfied’ to (1) ’very dissatisfied’.
c- Out-of-pocket payment will be calculated through number of items:
• Medical expenditure (treatment cost, test charges, hospital fees).
• Non-medical expenditure (transportation cost, expenses related to patient’s family housing near the place of service receiving).
The study revealed the following main results:
• The prevalence of mild diabetic retinopathy was 15.1%, moderate diabetic retinopathy was 18.6%, severe non-proliferative diabetic retinopathy was 33.8% and proliferative diabetic retinopathy was 32.5% among diabetic patients. The prevalence of diabetic macular edema was 44.1% and the prevalence of sever visual impairment was 21.2% among diabetic patients.
• The prevalence of cardiac disease was 79.7% and hypertension was 61% among diabetic patients. The percentage of patients with DM period >10 years was 74.4% and the percentage of patients who had one comorbidity was 41.6% while patients who had two comorbidities was 25.5%
• About 76.6% of the studied population had FBS level>126.
• The percentage of insulin dependent diabetic patients was 68.4%.
• The total out of pocket payment by patients with DR was 1724234 LE over one year. The Average OOP payment per patient was 10913 LE over year, health insurance payment per patient was15655.6LE and expense of the state payment was16224.9LE.
• There was significant difference between different age categories regarding RetDQoL while Ret.TS did not. There was no significant difference between males and females regarding RetDQoL and Ret.TS.
• There was significant difference among different occupations and Ret.TS while RetDQoL did not.
• There was significant difference between different marital statuses regarding RetDQoL while Ret.TS did not; also there is significant difference between different educational levels regarding RetDQoL while Ret.TS did not.
• RetDQoL:
- The Log.AWI score differs significantly according to stage of retinopathy (F = 4.6, P=0.004).
- The Log.AWI score differs significantly according to the presence of CiDME and NCiDME compared to free patients (F = 9.6, P= 0.00).
- The Log.AWI score differs significantly according to the presence of sever visual impairment and patients with no light perception compared to patients with mild and moderate visual impairment (F = 12.4, P= 0.000).
• Ret.TS:
- The Ret.TS score differs significantly according to stage of retinopathy (F = 5.7, P=0.001).
- The Ret.TS score differs significantly according to the presence of CiDME and NCiDME compared to free patients (F = 7.17, P= 0.00).
- The Ret.TS score differs significantly according to the presence of sever visual impairment and legally blind patients compared to patients with mild and moderate visual impairment (F = 3.2, P= 0.008).
- The Ret.TS score differs significantly between different treatment regimens for diabetic retinopathy (F = 7.14, P= 0.000).
• The first path for the predictors of RetDQoL revealed that the level of visual impairment, OOP and number of comorbidities were significant predictors for Log.AWI score.
• Diabetic retinopathy stage and diabetic macular edema significantly affect Log.AWI score through their effect on the level of visual impairment (indirect relationship).
• The AWI score for RetDQoL ranged from 0 which is the lowest negative weighted impact to -9 which is the highest negative weighted impact of diabetic retinopathy. The questionnaire showed good composite reliability (0.88), average variance extracted (0.71) and content validity.
• Ret.TS score ranged from 1 which is the lowest level of satisfaction to 7 which is the highest satisfaction level with the treatment. The questionnaire showed good composite reliability (negative subscale=0.82, positive subscale=0.89), average variance extracted (negative subscale=0.64, positive subscale=0.73) and discriminant validity.
• The third estimated second order hypothetical model revealed that RetDQoL was significant predictor for the Ret.TS, OOP negatively correlated to RetDQoL. The model showed good fit and higher level of parsimoniously.
• The fourth estimated second order hypothetical model revealed that, Ret.TS was significant predictor for RetDQoL, OOP payment negatively affected RetDQoL. The model showed good fit but lower level of parsimoniously.
• SEM analysis revealed that level of visual impairment had a large direct significant negative causal effect on the Log.AWI (-0.42), OOP payment had significant small negative direct causal effect on Log.AWI (-0.17). Number of comorbidities had a significant small negative direct effect on Log.AWI (-0.15). The level of visual impairment significantly mediated the relationship between Log.AWI and diabetic retinopathy stage and the combined DME (-0.09, 0.083). RetDQoL had a large positive causal direct (0.97) effect on Ret.TS through second order factorial model.
6.2. Conclusions:
• The level of visual impairment, diabetic retinopathy stage, diabetic macular edema, OOP and the number of comorbidities were significant predictors the RetDQoL.
• SEM results revealed that the level of visual impairment was the most important factor in the causal pathway of RetDQoL; it had a large direct significant negative effect on the patient’s quality of life. Also, both OOP and number of comorbidities have significant small direct causal effect on RetDQoL.
• The second order factor model showed factorial validity and reliability, so it is the most proper factorial structure to present the relationship between RetDQoL, Ret.TS and OOP.
• The relationship between RetDQoL and Ret.TS could be investigated under a bidirectional approach.
• RetDQoL and Ret.TS questionnaires have a good validity and reliability so can be used as a simple inexpensive tool for detecting diabetic retinopathy patient’s quality of life and treatment satisfaction.
6.3. Recommendation:
1. Recommendations to Ministry of Health and Population:
a. Raising awareness of public about the importance of diabetic retinopathy and health consequences related to poor control of diabetes through conducting health campaigns and provision of a diabetic educator in each primary health care center.
b. To develop training programs for diabetic retinopathy management that focus on the preventive aspect and screening for diabetic retinopathy and diabetic macular edema rather symptomatic treatment only.
c. Conducting a periodic clinical audit to assure adherence of health care providers to clinical practice guidelines.
d. Establish a registration system for cases for their follow up and prognoses using a disease register recall system.
2. Recommendations to diabetic retinopathy patients:
Raising the patients’ self-awareness regarding diabetic retinopathy and diabetic macular edema through using different sources of information which include mass media and internet.
3. Recommendations to medical care providers:
Launch a screening program for diabetic retinopathy and diabetic macular edema using OCT and clinical examination while using the translated tool to assess the disease from patient perspective.
4. Recommendations to researchers:
Further studies are needed to assess external clinical validation of the translated tools, and further research is needed to determine whether early detection and treatment of diabetic retinopathy and diabetic macular edema on more frequent basis will improve RetDQoL and Ret.TS.
The impact of controls as moderator for the relationship between diabetic retinopathy stage and Ret DQoL should be assessed in future studies.