الفهرس 
Subjects and methodsOnly 14 pages are availabe for public view
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Abstract
Anemia is a major and frequent consequence of chronic kidney disease (CKD) and it has been recognized as one of the non-traditional risk factors for the development of cardiovascular disease (CVD) among CKD patients. It is also associated with the increased risk of CVD mortality and morbidity. It develops early in the course of illness and affects most patients who exhibit some degree of reduced renal function. Among the disorders that affect CKD, anemia is considered the most responsive to treatment.
According to the Kidney Disease Outcome Quality Initiative (KDOQI) guidelines, anemia is defined as hemoglobin (Hb) <13.5 g/dl among males and <12.0 g/dl among females. It is a common occurrence in patients with CKD, with reported prevalence rates of 9%-64% depending mainly on CKD stage and definition of anemia.
The causes of anemia in CKD are multifactorial. Patients with CKD may develop anemia on the basis of any etiology, but most CKD patients develop anemia due to factors that specifically relate to their kidney disease. Erythropoietin deficiency is considered the most important cause of anemia in CKD.
The impact of CKD on the patient’s health related quality of life (HRQOL) has become increasingly recognized as an important outcome measure for predicting morbidity, hospitalization, and mortality among CKD patients and studying the efficacy of the medical therapy.
The aim of the present study was to estimate the prevalence of anemia, identify its predictors, modify, translate, and culturally adapt the KDQOL-SFTM version 1.3 questionnaire. Furthermore, to validate the study Arabic version, assess the HRQOL, and examine the relationship between anemia and HRQOL among pre end stage renal disease (ESRD) patients
This study was a cross sectional one. Chronic kidney disease adult patients (18 years and above) diagnosed in pre-ESRD (i.e. before dialysis or transplantation) were targeted for this study. The calculated minimum required sample size was 384 patients. Five hundred CKD patients have been included in the study. In order to undertake field testing of the study Arabic version of KDQOL-SFTM version 1.3 questionnaire, an additional 100 pre-dialysis patients were enrolled in the study. The study patients were recruited from the Outpatient Nephrology Clinic at the Main Alexandria University Hospital and a selected private clinic.
Field testing of the study Arabic version of the KDQOL-SFTM version 1.3 questionnaire was done during May, 2011. Data collection was conducted from the first of June, 2011 till the end of January, 2012 by:
1. Predesigned interview questionnaire: including sociodemographic data, history of diabetes mellitus, hypertension and CVD disease, menstrual history of the females, and symptoms of anemia.
2. Measurement of blood pressure (office BP), weight, and height.
3. Laboratory investigations: spot urine sample was taken for proteinuria detection using dipstick and aseptic venous blood withdrawn for measurement of serum creatinine to estimate glomerular filtration rate (GFR), complete blood count to determine Hb level and blood indices to detect the type of anemia, also to measure random and fasting blood sugar. All laboratory investigations were done at the Central Laboratory of the Main Alexandria University Hospital.
4. The study Arabic version of the KDQOL-SFTM version 1.3 questionnaire
The KDQOL-SFTM version 1.3 questionnaire was first modified, translated, culturally adapted, then the study Arabic version was validated before being used for assessment of HRQOL. The questionnaire was translated into Arabic by two independent translators, and then subsequently translated back into English. After translation disparities were reconciled, the final Arabic questionnaire was tested by interviewing 100 pre-dialysis CKD (stage 1-4) patients randomly selected from patients attending the Outpatient Nephrology clinic at the Main Alexandria University Hospital. Test re-test reliability was performed, with a subsample of 50 consecutive CKD patients, by two interviews 7 days apart and internal consistency estimated by Cronbach’s α. Discriminant, concept, and construct validity were assessed.
Data entry and statistical analysis were done using the software Statistical Package for Social Science (SPSS) version 16. Statistical analysis was performed in both descriptive and inferential forms.
The study revealed the following main results:
1. Prevalence of anemia was 67.8%. More than two thirds (64.9%) of the anemic patients had normocytic normochromic anemia.
2. About three quarters (71.2%) of the study sample were in stage 4 CKD while those in stage 3 constituted 28.8%.
3. Among anemic patients, the percentage of males was 55.5% and the percentage of females was 44.5%. Among the non anemic patients, the percentage of males was 45.3% and the percentage of females was 54.7%.
4. In univariate analysis; body mass index (BMI), systolic blood pressure, diastolic blood pressure, history of coronary heart disease (CHD), and eGFR were significantly correlated with Hb level.
5. Age, gender, history of coronary heart disease, BMI, systolic blood pressure, and eGFR could explain together about 17% of the variation in Hb level in univariate analysis.
6. In multivariate analysis, BMI ranked as the first factor in the rank order of the variables predicting Hb level. It could explain 5% of the variation in Hb level. Together with age, gender, systolic blood pressure, history of CHD, and eGFR; they explained 11 % of the variation in Hb level.
7. In Receiver Operating Characteristics (ROC) analysis, eGFR added 5% discrimination power for anemia detection. Moreover, eGFR produced 14% net improvement in the reclassification of patients as being anemic or not.
8. Validity and reliability of the study Arabic version of the KDQOL- SFTM version 1.3 questionnaire revealed that
a. All items of SF-36 met the criterion for internal consistency and were reproducible. Of the 10 domains of the kidney disease targeted scale, only three had Cronbach’s α <0.7: quality of social interaction (0.23), work status (0.28), and cognitive function (0.60). All domains of the kidney disease targeted scale were reproducible.
b. Discriminant validity of the study Arabic version of the KDQOL- SFTM version 1.3 questionnaire showed that the study questionnaire could discriminate between patients’ subgroups.
c. For concept validity, the correlation between all domains of the questionnaire with overall health rate was significant except for the work status, sexual function, emotional wellbeing, and role emotional. Furthermore, the correlation between the kidney disease targeted domains and the two composite summaries of SF-36 [physical composite summary (PCS) and mental composite summary (MCS)] was significant for all domains except for sexual function with MCS.
d. Construct validity indicated that the majority of the domains of the kidney disease targeted scale of the study Arabic version of the KDQOL-SFTM 1.3 were significantly inter-correlated.
e. Factor analysis of the kidney disease targeted scale indicated that this part of the questionnaire could be summarized into 10 factors that together explained 70.9% of the variance.
9. Assessment of HRQOL showed that the PCS score was lower than the MCS and the kidney disease composite summary (KDCS) scores (33.8±9.7, 43.6±7.1, and 60.2±9.03, respectively).
10. Women, widowed, below high school education, hypertensive, and those with history of CVD scored significantly lower for both PCS and KDCS. Patients aged ≥ 50 years, ex-smokers, non working, and diabetics scored significantly lower for both PCS and KDCS and significantly higher for MCS.
11. Age (F= 5.12, p=0.002), marital status (F= 6.5, p<0.001), working status (F=9.9, p<0.001), and anemic status (F= 6.6, p<0.001) have significant impacts on the three composite summary scores (PCS, MCS, and KDCS) together.
12. Anemic patients had significantly lower PCS, MCS, and KDCS scores. The Hb level was significantly correlated with the three composite summaries. Increasing Hb level by 2g/dl increased PCS, MCS, and KDCS scores by 2.72, 0.78, and 1, respectively.
Based on the results, the following items are recommended:
• Implementation of early detection programs of anemia among pre-ESRD patients for effective diagnosis and management.
• Close surveillance and, whenever needed, intensification of treatment of modifiable risk factors implicated in the progression of underlying renal disease.
• Proper management of CKD in the early stages for delaying the development of anemia with associated consequences.
• Establishing registries in Nephrology clinics for pre-ESRD patients.
• Use of EPO prior to dialysis to improve anemia management and delay its consequences as CVD, hospitalization, and even mortality.
• The need for providing EPO treatment prior to dialysis, enthuses multidisciplinary work for increasing the supply of the drugs with affordable prices that can be easily reached to all categories of the patients.
• Critical consideration of HRQOL when managing the overall condition is of utmost importance in measuring the treatment effectiveness and evaluating the clinical condition.
• Routine use of HRQOL assessments in the care of patients with CKD as this represents an important opportunity for the clinicians to better incorporate the values and concerns of the patient into their care.
• Training of the health professionals responsible for the care provided to these patients for the application of the HRQOL assessment tools, which may be valuable in the overall assistance of these patients, even in the earlier stages of disease, and allow timely health care interventions in the course of the disease.
• The HRQOL questionnaire applied in this study is advised for use in the assessment of HRQOL.
• Further research is needed in the following areas:
Estimation of the prevalence of anemia among all stages of CKD patients to exclude the effect of selective referral of patients with advanced stage of CKD for management.
Additional longitudinal studies are required to better understand the causes of anemia and also assess its prognostic effect.
Prospective studies are required to determine the effect of early management of anemia with EPO on the CKD course.
Additional longitudinal studies are required to define the changes in HRQOL during the course of CKD and explore interventions to improve it among those patients. Also, for systematic documentation of the changes in HRQOL domains that occur with the use of EPO treatment among CKD patients
Qualitative research is required to provide more insight into the factors that impact the HRQOL among Arab patients notably CKD patients.