9.6 Patient monitoring

Patients should be assessed at baseline, then, regardless of the regimen prescribed, monitored throughout the course of treatment.

 

Monitoring includes:

• Assessment of treatment response
• Detection of adverse effects and adherence issues.

For the schedule of follow-up examinations, see Appendix 14. 

 

Baseline and follow-up findings should be noted in the patient file to enable the detection and interpretation of potential changes.

9.6.1 Clinical visits

Baseline assessment

Assessment includes:

• Symptoms of TB and their severity (cough, fever, night sweats, weight loss, shortness of breath, ability to perform daily activities).
• Vital signs and weight.
• Comorbidities and other risk factors for adverse effects requiring monitoring adaptation.
• Psychological assessment.

 

Other investigations may be needed depending on the drugs used in the regimen prescribed (Section 9.6.3).

Clinical assessment should be performed by a clinician. Psychological assessment should be performed whenever possible by personnel with appropriate training.

All patients starting treatment should be given the information they need to understand the disease and its treatment (Appendix 21).

Follow-up visits

Each follow-up visit, assessment includes:

• Clinical progress, vital signs and weight. Dosages should be adjusted to the weight if necessary.
• Occurrence of adverse effects.
• Adherence to treatment (Appendix 22).
• Psychological condition.

 

Frequency of visits depends on the patient’s clinical condition and evolution:

• A visit every other week for the first month, then once a month if there is no particular problem.
• Additional visits may be required in case of comorbidities, severe or multiple adverse effects, pregnancy, etc.

 

Visits should coincide with bacteriological examinations and other investigations when possible.

 

The clinician should take into account any information and concerns regarding treatment tolerance and adherence reported by the patient or the team responsible for the patient’s follow-up and support.

9.6.2 Bacteriological tests

To assess treatment response in patients with:

• PTB: bacteriological tests are essential.
• EPTB: evaluation is based on clinical evolution. However, bacteriological tests are required if patients also develop PTB.

Baseline tests

Baseline tests are those performed on specimens collected just prior to treatment initiation. They include:

• Rapid molecular tests (RMTs) for detection of M. tuberculosis and rifampicin and isoniazid resistance.
• Smear microscopy to monitor treatment progress.
• Culture and phenotypic DST (pDST) when indicated.

For more information, see Chapter 3.

Follow-up tests

• Smear microscopy

Microscopy should be performed every 2 months until treatment completion.

If treatment is effective, microscopy at Month 2, 4 and 6 should be negative.

Notes:

• Patients with high bacillary load at baseline may have dead bacilli in their sputum for several months.
• As microscopy cannot distinguish dead from live bacilli, a positive result does not necessarily indicate that the treatment has failed.

 

• Rapid molecular tests

RMTs cannot be used to monitor treatment progress. However, if microscopy or culture is positive at Month 2 or later, RMTs should be performed to detect the emergence of new drug resistance not present at baseline (Chapter 3).

 

• Culture and pDST

Culture and pDST should be performed:

• at Month 2 or later, if RMTs show a new resistance to rifampicin or isoniazid;
• at Month 4, if microscopy is positive.

Full pDST (for first- and second-line drugs) should be performed on any positive culture.

Note: bacteriological tests are performed at the end of the month (e.g. Month 2 means the end of the 2^nd month of treatment).

 

Regardless of the above schedule, RMTs, culture and pDST should be performed if the patient's clinical condition deteriorates. 

End-of-treatment test

Microscopy should be performed at end of treatment to confirm the end-of-treatment outcome (Chapter 17).

9.6.3 Other investigations

Radiography

• CXR: for children with presumptive PTB, patients with non-bacteriologically confirmed PTB, suspicion of other intra-thoracic TB at baseline, then if indicated (e.g. worsening respiratory symptoms, non-response to TB treatment).
• Bone x-ray: for patients with osteoarticular and spinal TB at baseline, then every 6 months.

Biological tests

Table 9.4 – Blood tests at baseline and during treatment

 

Tests	Indications
Full blood count (a) Citation a. Haemoglobin, red and white blood cells, platelets.	HIV-infected patients on rifabutin or zidovudine (AZT), at baseline, then once a month for the first 2 months, then if indicated.
Liver function tests (b) Citation b. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT). Bilirubin if elevated liver enzymes.	Patients with pre-existing hepatic disease, at baseline, then once a month.
Serum creatinine (c) Citation c. For estimation of creatinine clearance see Appendix 12.	Patients with renal insufficiency at baseline, then if indicated.
HbA1C and/or blood glucose level	All patients, at baseline, to detect diabetes. If diabetes is detected, monitor according to standard protocols.
HIV, hepatitis B and C	For patients with undocumented HIV, hepatitis B and C status; HIV test every 6 months in high HIV prevalence areas. Tests can be repeated in case of recent exposure.
CD4 count and viral load	HIV-infected patients: at baseline, then every 6 months.