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Table 2 Main investigation instruments and their components of ADACS-1

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

Instruments

Categories

Variables

Baseline questionnaire

Demographic characteristics

Age; Sex; Nationality; Education; Occupation; Marriage; Family income of last year; Health insurance, etc.

 

Family history

Liver, renal and other disease history of family members.

 

Medical history and concurrent disease

Previous hepatitis history; Previous hepatitis virus tests results. Diagnosis and duration of past renal, visional, auditive and other chronic disease history; Allergic history; Concurrent chronic diseases.

 

TB diagnosis and previous treatment

Definitive diagnosis of TB; Diagnosis time; Diagnosis agency; Anti-TB treatment history; Anti-tuberculosis induced ADEs occurrence history.

 

Current drug usage information

Product name; Production NO; Dose; Method and cost of anti-tuberculosis drugs and other concurrent using drugs.

Physical, laboratory examination

Physical examinations

Height; Weight.

 

Blood routine test

Erythrocyte count (1012/L); Leukocyte count (109/L); Hemoglobin concentration (g/L); Platelet count (109/L).

 

Urine routine test

PH value; Urine protein; Erythrocyte count; Leukocyte count; Urinary cylinder count.

 

Liver and renal function test

Alanine aminotransferase (ALT, U/L); Aspartate aminotransferase (AST, U/L); Total bilirubin (TBIL, μmol/L); Blood urea nitrogen (BUN, mmol/L).

 

Hepatitis B virus marker

HBsAg test.

Medication record

Anti-TB drugs

Name, commercial name, manufacturer, production number, usage, dosage, starting and ending time of anti-TB drugs, including RHZES and other supplementary anti-TB drugs.

 

Liver protective drugs

Name, commercial name, manufacturer, production number, usage, dosage, starting and ending time of drugs used for preventing ATLI.

 

Other drugs

Name, commercial name, manufacturer, production number, usage, dosage, starting and ending time of other drugs used during the anti-TB therapy, for example, antihypertensive drugs, hypoglycaemic drugs, etc.