Study design and area
An Institutional-based cross-sectional study was conducted at Fenote Selam hospital from February 2012 to April 2012. The hospital consists of an operating room, one intensive care unit (ICUs) with 12 beds, 6 wards with 130 beds and an outpatient department. The study population was all DM patients who visit Fenote Selam Hospital, diabetes clinic during data collection time. Diabetic patients who have got anemia correction treatment like iron and transfusion therapy in the last three months of data collection were excluded from the study.
Ethiopia is a country located in the Horn of Africa. It is bordered by Eritrea to the north, Djibouti and Somalia to the east, Sudan and South Sudan to the west, and Kenya to the south. With over 91,000,000 inhabitants, Ethiopia is the most populous landlocked country in the world and the second-most populated nation on the African continent. It occupies a total area of 1,100,000 square kilometers (420,000 sq mi), and its capital and largest city is Addis Ababa.
Finote Selam is a town and separate woreda in western Ethiopia. Located in the Mirab Gojjam Zone of the Amhara Region, this town has a longitude and latitude of 10°42’N 37°16’E/10.7°N 37.267°E Coordinates: 10°42’N 37°16’E/10.7°N 37.267°E with an elevation of 1917 meters above sea level. In 1964, a hospital for lepers had been built in Finote Selam by the private fund “Swedish Aid to Leprous Children in Ethiopia”. The hospital is one of the zonal (large) hospital found in the Amhara region.
Source population
The source population was all DM patients attending Fenote selam Hospital and the study population was all DM patients who visit Fenote Selam Hospital, diabetes clinic during data collection time. Out of which The DM patients who visit Fenote selam Hospital, diabetes clinic and become were our study participant.
Sample size and sampling techniques
A total of 384 study participants were determined by single population proportion sample size calculation formula with study population size less than 10,000 (9). Systematic random sampling was used to select study participants. Every other study participants were selected after a random starting study participant who was selected by lottery method.
Sample collection and examination
Socio demographic data were collected by using a structured questionnaire first prepared in English language and translated in to a local language Amharic and again translated to English. Two (2) ml venous blood was collected by vacutainer test tube coated EDTA anticoagulant for haemoglobin determination. The collected whole blood was mixed properly and analyzed for hemoglobin determination using CELL DYNE 1800 hematology analyzer. Five (5) ml venous blood was collected by vacutainer test tube without any anticoagulant for creatinine and Blood Urea Nitrogen determination. The whole blood without anticoagulant was allowed to clot for 15 to 30 minutes and was then centrifuged at 3000 rpm for 5 min and serum was separated. The separated serum was used to determine Creatinine and Blood Urea Nitrogen (BUN) using Humastar 80 chemistry analyzer.
Data analysis
All the data were manually checked for its clarity and completeness and then coded and entered into Epi-info and transported to SPSS version 16.0 soft ware package for analysis. For controlling errors frequency checks was done. The data was analyzed for its descriptive statistics and bivariate logistic regression to determine the effect of various factors on the outcome variable and multivariate logistic regression to control confounding effect. The result was presented in the form of tables, figures and text using frequencies and summary statistics such as mean, standard deviation and percentage to describe the study population in relation to relevant variables. P-value less than 0.05 was taken as statistical significant.The degree of association between independent and dependent variables was assessed using odds ratio with 95% confidence interval of Bivariate and Multivariate logistic regression.
Quality assurance
Quality assurance checks were performed daily according to the laboratory’s protocol. Commercial control materials was properly warmed and mixed according to the manufacturer’s recommendations. Internal quality control was conducted: after daily start up procedures are completed, when reagent lot changed, and when there is a reason to suspect an error in the data or results. Results was recorded, dated and initialed on the appropriate forms. Lot numbers, reagents, and expiration date are recorded where applicable.
Ethical consideration
The study was reviewed and approved by the ethical committee of the School of Biomedical and Laboratory Sciences. Permission to conduct the study was also obtained from the Fenote selam hospital. Informed consent was obtained after each study participants was informed about the objective of the study and then any participant who is not willing to participate in the study was not forced to participate. They were also informed that all data obtained from them would be kept confidential by using codes instead of any personal identifiers and is meant only for the purpose of the study. Physicians were informed about Anemic and renal damaged patients for proper management.