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Table 3 Main investigation instruments and their components of ADACS-2

From: Design of the Anti-tuberculosis Drugs induced Adverse Reactions in China National Tuberculosis Prevention and Control Scheme Study (ADACS)

Instruments

Categories

Variables

ADE assessment and investigation questionnaire

ADE occurring features

ADE affected organs; Signs and symptoms; Symptoms first appearing time and their duration; Suspected drugs and their sequencing; Assessment of ADE relationship with anti-TB drugs.

 

ADE treatment, prognosis

Clinical consultation, treatment, examination and hospitalization induced by ADE; Drugs used; Examinations taken; Days of hospitalization; ADE prognosis.

 

Direct and indirect costs of ADE

Drug, examination, hospitalization cost; Transport, nutrition, nursing fees; missing working time of patients and family; Impaction on anti-TB treatment such as drug change, drug withdrawal and costs induced; Percentage of health insurance payment for direct medication expenditure.

Nested case-control questionnaire

TB treatment surveillance

Patient's drug taken compliance in latest 1 month; Drug taken timing; Supervising doctor's visiting times; Health education given to patient.

 

Lifestyle risk factors

Smoking; drinking; Intake of milk, tea and other diet habits, etc.

 

Knowledge and faith

Patient's knowledge of TB curing, spreading, ADRs, etc; Patient's Faith in curing TB with current treatment.

Tuberculosis outcome record

Performance in the end of initial intensive phase of treatment

Whether patient's serum smear turns to be Mycobacterium negative. Whether a prolongation of initial intensive phase is needed.

 

Time and reason for ending anti-TB therapy

Reasons: curing, exceeding 6-9 months, death form TB, death from other reasons, treatment failure, lost, outmigration, refusing treatment, misdiagnosis, or others.

ADACS follow up calendar

Discomforts

Everyday record of discomforting such as nausea, vertigo, headache, diarrhea, arthralgia, paresthesia, visual and auditory abnormal feelings.

 

Anti-TB drug usage

Everyday record of usage of anti-TB drug.

Genotyping result

Candidate genes

N-acetyltransferase 2(NAT2); Cytochrome P450 2E1 (CYP2E1); Glutathione S-transferase (GST) enzyme(GSTM1, GSTT1), etc.