Study setting
Batkhela is the capital city of Malakand district and it is one of the popular business city in Khyber Pakhtunkhwa province. Malakand district is situated in Khyber Pakhtunkhwa province. The total population of the district is 720,295 (2017 census). The area is surrounded by district Dir (Lower) in the north, Swat district in the east, Mardan and Charsadda districts in the south east and south west respectively, Mohmand and Bajaur agencies are in the west [9]. The DHQ Hospital Batkhela, providing health care facilities to the local residence of Batkhela and district Malakand (Figure 1). The area has been providing humanitarian protection and shelter for a large number of refugees from different districts of Malakand division during flood and war.
Study population
Study population was all registered TB patients attending DOTS services in TB centre, DHQ Hospital Batkhela from 1st January 2011 to 31st December 2014.
Study design and data collection
A hospital based retrospective study was conducted. The data were retrieved from the TB clinic registration books. The unit registers reviewed contained basic information such as socio-demography and clinical profile of the patients, date of TB diagnosis and treatment outcome. The data was collected by trained unit healthcare personnel under supervision of principal investigator by using self-designed performa and entered in to Excel sheet.
Laboratory procedure
Diagnosis of all the registered TB patients was done in the entire hospital. According to the standard protocol the sputum was collected from the suspected patients having symptom of TB in 5ml sterile bottle, after collection of sputum the bottle were kept in 15 ml sterile bottle to avoid the leakage of the infectious samples. The samples were labeled and further process by the laboratory technician of the hospitals. The Zheil-Neelsen stain/sputum smear microscopy was performed for all the suspected PTB cases.
Standard definition
According to the standard definitions of the WHO, the following clinical case and treatment outcome operational terms were used [10].
Smear-positive pulmonary TB (SPPTB)
A patient with at least two sputum specimens which were positive for acid fast bacilli (AFB) by microscopy, or a patient with only one sputum specimen which was positive for AFB by microscopy, and chest radiographic abnormalities consistent with active pulmonary tuberculosis (PTB).
Smear-negative pulmonary tuberculosis (SNPTB)
A patient with symptoms suggestive of TB, with at least two sputum specimens which were negative for AFB by microscopy, and with chest radiographic abnormalities consistent with active PTB, or a patient with two sets of at least two sputum specimens taken at least two weeks apart, and which were negative for AFB by microscopy and radiographic abnormalities consistent with PTB and lack of clinical response to one week of broad spectrum antibiotic therapy.
Extra-pulmonary tuberculosis (EPTB)
This included TB of organs other than the lungs, such as lymph nodes, abdomen, genitourinary tract, skin, joints and bones, the meninges and others.
Treatment outcomes were categorized into: (a) cured, a patient who was initially sputum smear-positive and who finished treatment with a negative bacteriology result at the end of treatment or was sputum smear negative on two occasions at the end of treatment; (b) treatment completed, a patient who completed treatment but did not meet the criteria for cure or failure; this definition applies to sputum smear-positive and sputum smear-negative patients with pulmonary TB and to patients with EPTB; (c) died, a patient who died from any cause during treatment time; (d) failed, a patient who was initially sputum smear-positive and remained bacteriology or sputum smear-positive at month five or later during treatment; (e) defaulted, a patient whose treatment was interrupted for two consecutive months or more; (f) transferred out, a patient who was referred to another health facility for treatment from whom information on treatment outcome could not be obtained; (g) successfully treated, a patient who was cured and/or completed treatment; and (h) unsuccessful outcome: If treatment resulted in treatment failure , defaulted, or died.
Statistical analysis
The collected data were checked for completeness by principal investor. Data were entered, cleared and descriptive analyses were carried out using Statistical Package for Social Sciences (SPSS) version 20. Multivariable logistic regression model was used to analyze the association between treatment outcome and potential determinate variables at 95% confidence interval. P-value of less than 0.05 was considered as statistically significant.
Ethical consideration
The study protocol was reviewed and approved by the Advanced Studies and Research Board (ASRB) of Hazara University Mansehra, Pakistan (Reference No. HU/R&P/ASRB/2015/1995). Official permission was also sought from District Health Officer (DHO) and District Tuberculosis Officer (DTO), Malakand district. The written informed consent was obtained from the patients. To ensure confidentiality of the information collected from TB registration books, names or identification numbers of TB patients were not included in the data collection sheet.