This study is a longitudinal cohort study that will include all the patients diagnosed
with tuberculosis who visit the Tuberculous outpatient clinic at Kasr Alainy after
obtaining the approval of the ethical committee, and for about 6 months, to include at
least 400 patients as estimated from the sample size calculation result.
A detailed history will be taken including: full name, age, sex( maternity history will
be taken in case of female patients to report any current pregnancy or lactation) ,
mobile number, occupation, history of smoking( cigarette or shisha), type of TB, method
of TB diagnosis, history of any comorbidities, current drug(s), and the anti-tuberculous
therapy regimen ( including name and dose of each drug), in addition to a baseline liver
enzymes( ALT, AST) and a complete blood count (CBC) A written consent will be obtained
from the patients, however the study doesn't include any experimental intervention, as
it's a pure observational study and it possess no more risk than that encountered in
routine daily practice. Patients' confidentiality will be respected and protected.
Patients' identity will not be put on the data collection form, and will be replaced by a
serial number. This serial study number is linked to the patient identity in a document
that will be retained inside the department and will not be used outside the hospital.
Patients will be educated and provided with a sheet (titled drug monitoring diary) to
document any drugs that are taken/or will be prescribed concomitantly during the
anti-tuberculous therapy in the first month after the initial visit. This diary includes:
the drug name, date of start, dose (concentration and frequency), and duration of
therapy.
Patients will also be educated and provided with a check list sheet (titled adverse drug
events diary, as shown in table 3) to record in a day-by day process any possible adverse
drug events for one month, and to score the severity of these events from 1 to 3, as 1
means mild/self-limiting, 2 means moderate/required treatment, 3 severe/life-threatening
that needed a specialist consultation and management.
Patients will be educated to deal with expected minor adverse drug events, and will be
provided with the contact details of the corresponding researcher who will direct each
patient to the corresponding physician accordingly, in case of moderate to severe adverse
drug events.
A detailed history of the moderate or severe adverse drug event will be recorded by the
researchers, including the (date, symptom(s), and action(s) required to manage that
event) Patients are instructed routinely to come for a follow up visit after one month.
In this visit, laboratory tests (ALT, AST, CBC) are ordered. The research team will
record the laboratory results and the drug monitoring and adverse drug diaries notes. The
data will be revised for any missing or conflicting data then the sheets will be prepared
for analysis