Study design and period
Institution based cross-sectional study design was conducted from 01 to 30 December 2017 to assess the delay in diagnosis of TB and associated factors for patients who were taking TB treatment at health centers in North Shoa zone, Ethiopia.
Study site and population
The study was conducted in seven districts of North Shoa Zone. North Shoa is one of the 11 Zones in the Amhara regional state. According to the central statistical agency estimate, the total population of the zone was 2,202,023. The zone has 24 administrative districts, 9 hospitals, 95 health centers and 389 health posts. TB is a major public health problem in the zone. According to the zonal health office report, there were 1973 new and 126 previously treated TB patients in 2017 alone. Health posts refer TB suspects to health centers for diagnosis of TB, whereas, hospitals and health centers provided TB diagnosis and treatment. As part of the TB prevention and control program, the health centers and hospitals should diagnose TB suspects and treat them immediately to reduce burden of TB as delayed diagnosis could lead to increased TB transmission especially in the era of MDR TB. Hence, this study was designed to assess whether there was a delay or not in the setting and share the information to take corrective actions for the problem of TB burden in the zone. Patients who took anti-TB treatment in all government health facilities in the sampled districts of North Shoa zone was the study population.
Sample size
The sample size was calculated using a single population proportion formula based on the following assumptions (N = Ž ½ P1 (P1-Q2)/W2):
Proportion of delay in seeking health care after the onset of symptoms of TB was taken 89.9% (study from Bale zone southeast Ethiopia [14]), significant level at α = 0.05, at 95% confidence interval, margin of error was 5 and 10% non-response rate, the minimum sample size calculated was 143 TB patients. But to increase the sample size for higher precision in estimate, all TB patients who were taking TB treatment in all health facilities of selected districts at the time of data collection were included in the study regardless of age and sex. Only one TB patient who was unable to respond due to serious health conditions was excluded from the study.
Sampling procedure
There were a total of 24 districts in the north Shoa zone. About 30% of the total districts (30% of 24 = 7.2 ≈ 7) were selected based on their cluster grouped using geographical proximity /remote or near to the capital of the zone/ and climate of the districts found in the zone (hot or cold areas) in order to represent the whole part of the North Shoa zone. Even though the sample size calculated was 143, all the patients who took anti-TB treatment in the government health facilities of the seven selected districts were included in the study at the time of data collection to have higher precision in estimate by increasing the sample size. Finally, a total of 162 patients under TB treatment in the seven districts were included consecutively (Fig. 1) when they came for collection of drugs.
Operational definition
Patient delay
Is defined as the period between the onset of the illness and patient first attendance of health care facility because of this illness. The patient was said delayed if he/she visited health-facility after onset of symptoms for more than 3 weeks (2 week entry point for presumptive Tb case and 1 week period to seek health care) [15].
Health system delay
Is the period between patient’s first attendance of health care facility with symptoms of TB and the diagnosis of Tuberculosis. The patient was said delayed if TB is not diagnosed and treated at the time of first visit [15].
The date of onset for the main symptoms was taken as the date of onset for the illness. For PTB patients, cough was taken as the main symptom whereas for EPTB patients, either localizing symptoms like swelling for TB lymphadenitis, chest pain for TB pleurisy or constitutional symptoms (fever, night sweats, weight loss, and loss of appetite) were taken as the onset of the illness whichever came first [15].
Data collection procedure
Data collection tool was first prepared in English and then translated to Amharic (local language). The second version of the tool was retranslated into the original one by language experts and investigators to check its consistency. The edited final version of the questionnaire was used to collect data from study subjects and from parents/guardians for children.
Trained district health office TB officers, one for each district, collected the data. Interview technique was used to collect data with structured and pre-tested questionnaire containing socio-demographic and treatment profile of TB patients. Data quality control pretest was done at Ataye health center. The health center that was not included in the study. The questionnaire was checked for consistency and completeness before conducting real data collection (see Additional file 1). Training was given for data collectors and supervisors about research objectives, data collection tools, procedures and interview techniques for 1 day. The data were collected by interviewing the study participants. However, data from children were collected using interview of the parents/guardians. The investigators, together with five supervisors supervised the data collection and checked completeness of the entire returned questionnaires daily.
Data processing and analysis
The returned data were entered into EPI info version 3.5.1 and transferred to Statistical Package for Social Science (SPSS) version 20.0 software for analysis. Descriptive and summary statistics were calculated. The patient was said delayed if he/she visited health facility for diagnosis after onset of symptoms more than 3 weeks after the onset of symptoms. Health system delay was considered if the patient was not diagnosed at the time of first-visit. Bivariate and multivariate logistic regression was used to identify associated variables. The multivariate logistic regression was adjusted using backward LR method. Variable having P- value up to 0.2 in bivariate analyses was entered into multivariate model. Variables with P-value < 0.05 in the multivariate analysis was considered as significantly associated with delay in TB diagnosis.
Ethical considerations
Ethical clearance was assured prior to data collection from the Amhara Public Health institute Ethical Review. Permission was obtained first from North Shoal Health Department, then from the administrators of all health institutions. Each study participant was informed about the purpose, methods of collection, benefits and risk of the study by the data collector. Written informed consent was obtained from each participant. Regarding children the consent was found from their parents/guardians. They were informed that they had the right to refuse or withdraw from the interview and it would not have any effect on the services they would have.