Study area and Design
The research was lead in Arada Sub-city, Yekatit 12 teachings specialized hospital Addis Ababa Ethiopia located Around Sdist kilo. A cross-sectional study design was applied from 28 February to 30 April 2020. Those patients who came to Yekatit 12 teaching hospitals for treatment of dyspepsia or gastritis and send to the laboratory to confirm H. Pylori states during the data collection period were taken as source population. The study population was selected patients with symptoms of gastritis and dyspepsia undertaking laboratory investigation for H. Pylori.
Sample size and Sample size determination Formula
n = (𝑍𝛼/2)2 ∗ (1 − 𝑝) d2
n = sample size
Level of significance=0.05 Z (α/2)2 =Z score at 95%
10% Non-response rate = 10* 358= 35.8 (Confidence interval which is 1.96) Marginal Error=5%=0.05
The minimum sample size and the prevalence (p) taken was 36.8%, from earlier study in Jasmin internal medicine and pediatrics clinic at Addis Ababa , Ethiopia which is given a large size sample compared to the other H.Paylori prevalence study (14) with a marginal error of 5, and a 95% confidence interval. Based on this estimation the sample size was 358 by adding 10% non- response rate we have to gate 394 samples. The participant selected from the gastritis patients in the hospital come to treatment in both out patient and in patient department. All the patients who have signs and symptom of gastritis and who are volunteers, will include in the sample.
To calculate sample size for associated factor, I used Epi-info version 7.2 and Sample size calculation by epi info for associated factor lower than the 385, therefor I take the previous one 385.
Data collection procedure
Participants were selected from the medical recorded books; emergency recorded books and admitted patent recorded books of Yekatit 12 teaching hospital. All patients from February 28/2020-Aprial 30/2020 come to Yekatit 12 teaching Hospital for gastritis treatments or admitted by gastritis symptom are selected. The first gastritis patient in every out-patients, admitted patients and emergency patients selected by lottery methods then, every other gastritis patient selected from the recorded books were selected. All patients who needed to send to laboratory to confirm H. pylori status was participated voluntarily in the study.
Collection of Data
Information was gathered by four BSC nurse and two Health officers were participated as a supervisor. Participants were interviewed about sociodemographic profile, environmental situations, individual habits and the complication of H.Pylori. Data were collected from patient by using a pre tasted and structured questionnaire.
Dependent: H. Pylori status
Independent: Sociodemographic factors like age, sex, education, etc. hygiene practice like hand washing, environment and personal habits like drinking alcohol, smoking etc. Complications of H. Pylori (gastric outlet obstruction, gastric cancer, peptic ulcer disease)
1) Patients with age > 18.
2) Presence of minimum 2 manifestations like upper abdominal pain, bloating , nausea, vomiting.
3) Persistent symptoms occurring at least 3 times per week in > 3 months in the year or years preceding the study.
4) Absence of nocturnal or postprandial symptoms of gastro esophageal reflux.
5) No previous abdominal surgery except for uncomplicated appendectomy, cholecystectomy.
Different other illness and age below 18 years old will excluded.
Data quality control
Stool antigen test is inexpensive and more convenient. It is a simple and accurate test using monoclonal antibodies specific for H. Pylori antigens and potentially less expensive than the urea breath test. The best of these tests are as accurate as other diagnostic methods (10). The sensitivity, specificity, positive and negative predictive values of HpSA were found to be 98%, 100%, 100%, and 96.5%, respectively (11).
The pretesting of questionnaire was made with the same type of patients who are not in the study then necessary changes have been made. For data collector and supervisor training has been given and pretest was done in Debre Berhan referral hospital.
The stool samples were tested according to the procedure. A samples were collected from each participant. A lesser quantity of the stool sample was transmitted to a vial with diluents, strongly agitated for 15 seconds and after that 2to3 drops were mixed into the round window of the test cassette. The findings were read after 15 minutes and the results are read based on the appearance. The presence of two lines, C (control) and T (test), specifies a positive test, and presence of only one line, C (control) shows a negative result.
Data were coded, The collected information entered into the Epi-data 3.1,coded and analyzed using version 20 SPSS.The presence of an association between dependent and independent variables was checked by Binary logistic regression analysis. Variables that showed below 0.25 in binary logistic regression were selected for further analysis with multiple logistic regressions and hosmer-lemenshow goodness of fit above 0.05 was considered as a fit of model. A P-value less than 0.05 were taken as statistically significant.
The studies have been approved by the Ethical committee of Dere Berhan University (Reference No: DBUMF 053-009; presented in Annexure-I) and permission was obtained from Yekatit 12 teaching referral hospital administrator (Reference No: Y12HMC-20/20; presented in Annexure-II). Moreover, informed consent has been obtained from participants who are involved in the study and all methods were performed in accordance with the relevant guidelines and regulations..
Dissemination of the results
The finding of the study will be submitted to the Debre Berhan University College of health science department of public health Yekatit 12 teaching hospital and ministry of health Addis Ababa, Ethiopia.