STANDARD 10.

All patients should be monitored for response to therapy, best judged in patients
with pulmonary tuberculosis by follow-up sputum smear microscopy (two specimens)
at least at the time of completion of the initial phase of treatment (two
months), at fi ve months, and at the end of treatment. Patients who have positive
smears during the fi fth month of treatment should be considered as
treatment failures and have therapy modifi ed appropriately. (See Standards
14 and 15.) In patients with extrapulmonary tuberculosis and in children,
the response to treatment is best assessed clinically. Follow-up radiographic
examinations are usually unnecessary and may be misleading.

Rationale and Evidence Summary

Patient monitoring and treatment supervision are two separate functions. Patient
monitoring is necessary to evaluate the response of the disease to treatment and
to identify adverse drug reactions. For the latter function, contact between the
patient and a provider is necessary. To judge response of pulmonary tuberculosis
to treatment, the most expeditious method is sputum smear microscopy. Ideally, where
quality-assured laboratories are available, sputum cultures, as well as smears, should be
performed for monitoring.

Having a positive sputum smear at completion of fi ve months of treatment defi nes treatment
failure, indicating the need for determination of drug susceptibility and initiation of a
retreatment regimen.23 Radiographic assessments, although used commonly, have been
shown to be unreliable for evaluating response to treatment.102 Similarly, clinical assessment
can be unreliable and misleading in the monitoring of patients with pulmonary tuberculosis.
102 In patients with extrapulmonary tuberculosis and in children, clinical evaluations
may be the only available means of assessing the response to treatment.

STANDARD 11.

A written record of all medications given, bacteriologic response, and adverse
reactions should be maintained for all patients.

Rationale and Evidence Summary

There is a sound rationale and clear benefi ts of a record keeping system.103 It is common
for individual physicians to believe sincerely that a majority of the patients in whom they
initiate antituberculosis therapy are cured. However, when systematically evaluated, it is
often seen that only a minority of patients have successfully completed the full treatment
regimen.103 The recording and reporting system enables targeted, individualized follow-up
to identify patients who are failing therapy.103 It also helps in facilitating continuity of care,
particularly in settings (e.g., large hospitals) where the same practitioner might not be seeing
the patient during every visit. A good record of medications given, results of investigations
(such as smears, cultures, and chest radiographs), and progress notes (on clinical
improvement, adverse events, and adherence) will provide for more uniform monitoring
and ensure a high standard of care.

Records are important to provide continuity when patients move from one care provider
to another and to enable tracing of patients who miss appointments. In patients who default and then return for treatment and patients who relapse after treatment completion,
it is critical to review previous records in order to assess the likelihood of drug resistance.
Lastly, management of complicated cases (e.g., multidrug-resistant tuberculosis) is not
possible without an adequate record of previous treatment, adverse events, and drug
susceptibility results. It should be noted that, wherever patient records are concerned,
care must be taken to insure confi dentiality of the information.