Study design
An audit of the case management practices in a historical cohort was done by reviewing patient records. We included all children aged less than 15 years who were registered as cases of TB at the nine public hospitals (district and sub-district) in three districts of the province of Punjab. Children detected with TB at health facilities other than these hospitals such as maternal, child and primary health facilities, private clinics and para-statal hospitals were not included in the study. The study received ethical clearance from the National Bioethics Committee of Pakistan.
Diagnosis and treatment criteria
The diagnosis was based on the combination of history and examination suggestive of TB, history of close contact with an adult case of TB, bacteriological examination, chest X-ray, TST and histopathology of tissue samples. In addition there was a scoring chart meant to help in making diagnostic decisions. A diagnostic algorithm has been presented by NTP in the guidelines to facilitate the case management process (Figure 1). These criteria have been part of WHO guidelines [7] and NTP Pakistan policy guidelines [9] related to management of children with TB. The prescription protocols were also part of the policy guidelines. The prescription was based on body weight of the patient and the category of disease. The four treatment categories were as follow: Category-I was pulmonary TB, severe forms of new extra-pulmonary TB, new severe concomitant HIV disease and TB meningitis. Category-II was previously treated smear positive pulmonary TB, relapse, treatment after interruption and treatment failure. Category-III was new smear negative pulmonary and less severe forms of extra-pulmonary TB and Category-IV was chronic and multi-drug resistant (MDR) TB. The drugs prescribed to a child diagnosed with category I-III TB always have an intensive phase of 2 to 3 months duration and a continuation phase of 4 to 6 months duration. The anti-TB drug dosage depends on body weight and category of patient. Category I, is 2 months of Isoniazid (H) plus Rifampicin (R) plus Pyrazinamide (Z) plus Ethambutol (E) followed by 4 months of H and R (abbreviated 2HRZE/4RH), for category II, it is 2HRZES/1HRZE/5HRE, for category III, it is 2HRZ/4HR and for category IV, treatment is individualized for each patient.
Childhood TB care services
The district level public sector hospitals in Pakistan usually have 'pediatrician', i.e. child specialist or doctors and health personnel taking care of children. They were informed by NTP on how to manage childhood TB including suspect screening, use of scoring chart, diagnosis and managing records. Facilities that are available in these hospitals include sputum smear microscopy and CXR to support TB diagnosis. The administration of TST is delegated to a nurse or vaccinator. The recording and reporting (R&R) of routine TB cases is the responsibility of a DOTS facilitator, usually a paramedic from the existing set up and trained on NTP routine adult TB R&R system.
The term 'practice' in this study is the pediatrician's documented record of case management which should be based on NTP childhood TB policy guidelines. The absence of such records was termed as 'missing information'. The missing in terms of diagnosis includes missing information on the use of TST, chest X-ray or score charts. In the case of prescribing anti-TB treatment inadequacy was used to denote prescriptions that were wrong according to category and dose of any single drug.
Study sites
The NTP selected ten districts in all four provinces of Pakistan to pilot their childhood TB policy guidelines. The selection of districts was based primarily on evidence of functioning adult TB care in a district, geographic distribution and access, and willingness of districts to participate in a pilot. For our retrospective study, we selected all three districts from the province of Punjab for the study because of continued programme support including drugs and materials, which facilitated implementation under programme circumstances. All nine hospitals at district and sub-district level were included. The district level hospitals have more specialist persons and inpatient facilities available as compared to sub-district level hospitals. Otherwise they are almost similar in the context of routine TB care services including childhood TB case management. These three study districts represent southern, central and northern parts of the province. All childhood TB cases registered at these hospitals during the period under review were included in the study [11]. The pediatricians from these hospitals were oriented by NTP on the newly developed national policy guidelines. The tablet formulation of childhood anti-TB drugs was provided along with the supply of TST and required print materials. The X-ray service was available as a part of regular hospital arrangement.
Data collection and analysis
The documented case management practices in two cohorts of childhood TB cases were compared. The first cohort included patients registered during the two complete years 2004 and 2005, when NTP had no particular emphasis on childhood TB ('pre-intervention') and had recently expanded the DOTS strategy for adults. The second cohort consisted of patients registered during 2006 and 2007, when new NTP childhood TB policy guidelines were being implemented ('post-intervention'). The prime sources of data were the TB registers, TB treatment cards and quarterly reports. These were mainly available as outpatient records and were part of the standard NTP recording and reporting system. A specially designed form was provided in year 2006 to the pediatricians to document the scores of individual children using the scoring chart. The TB patient registration and quarterly reporting in the public sector had been decentralized in Pakistan to the level of diagnostic centers including all the public hospitals and the rural health centers in the district. These diagnostic centers (average 12-15 in public sector in a district) register the TB cases including children and send their quarterly case finding and treatment outcome reports to the district TB coordinator office. The district TB coordinator office then consolidates these quarterly reports and transmits a quarterly consolidated district case finding and treatment outcome report to the provincial TB control office. There are regular quarterly intra- and inter-district meetings to consolidate reports to avoid errors and to facilitate the progress. A researcher visited each hospital to review the patient records and extract relevant data, using a specially designed manual tool. The quality of data extraction was ensured by another researcher by cross-checking the extracted data for missing information and inconsistency.
Data were entered and analyzed using the SPSS version 15 software package. The comparisons of the two cohorts relate to diagnostic practices, to prescription of anti-TB drugs, allocation of treatment support and to treatment outcomes. For comparing group differences of categorical variables, Pearson Chi-square test was used and Student t-test was used for continuous variables. The level of significance was set at p < 0.05.