Table 2.

Summary of the components of each CRF used for paediatric patients in the China NFATP

	Initial assessment	Follow-upa	Treatment termination	Medicationb	Transfer of clinical care
Patient name and ID	X	X	X	X	X
Current treatment ID	X	X	X	X	X
Treatment site location code	X	X	X	X	X
Patient demographics
Date of birth	X
Gender	X
Examination
Pre-treatment symptoms and diseasesc	X
Current symptoms and diseases	X	X
Current height, weight and head circumference	X
Height, weight and head circumference at birth	X
Laboratory test resultsd	X	X
HIV status
Date of HIV diagnosis	X
Route of HIV infection	X
PMTCT therapy	X
WHO clinical stage	X
Treatment status
Duration of follow-up		X	X
ART payment source	X
ART regimens at initiation				X
Use of TMP-SMZ	X	X		X
Current ART regimen				X
Current regimen initiation date	X			X
ART drug and SMZ specificse				X
Self-reported adherence		X
Reason for regimen changef		X
Concurrent use of other drugsg	X	X
ART adverse side effects		X
Termination
Type of terminationh			X
Cause of termination			X
Date of termination event			X
Cause of death			X
Adverse side effects caused by termination			X

^aFollow-up is performed at 0.5, 1, 2 and 3 months after ART initiation, once every 3 months thereafter.

^bCompleted at treatment initiation, change of regimen dosage/medication type, and change of regimen.

^cClassified into WHO HIV disease stages.

^dLaboratory tests include: CD4 count, viral load, hematology, immunology, liver function, PPD, HBsAg, anti-HCV.

^eDrug code, dosage form, amount per dose and frequency.

^fContinuing initial regimen with same dosage, continuing initial regimen with change in dosage/medication type, or regimen change.

^gAnti-TB drugs, Traditional Chinese Medicine, TMP-SMZ, others.

^hMortality, medication discontinuation, lost to follow-up and transfer of clinical care.

PMTCT = Prevention of mother-to-child transmission; TMP-SMZ = trimethoprim-sulfamethoxazole.