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The baseline assessments were conducted during four years 1995 to 1998; hospital admissions were collected by study nurses for each patient for a 2-year period from baseline (invitation to assessment) from hospital discharge letters in the patients' GP records.
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Counseling was given by study nurses and nutritionists specifically trained for their tasks.
Participation in the study implied being able to attend school (for adolescents) or to attend a consultation held by study nurses in a local community centre (for adults).
As part of the main IPT trial, without prior notification, urine samples were collected from 200 randomly selected participants in the 36-months and 50 participants in the placebo arm who continued to return to the clinic by study nurses and analyzed by non-study staff for isoniazid metabolites [12] on three occasions approximately one year apart.
Delirium was assessed daily by study nurses with the use of CAM-ICU.
Standardized instructions were provided by study nurses.
Active surveillance for pneumonia was performed by nurses at the six participating clinics, who referred birth cohort participants with respiratory symptoms to the research study nurses for assessment, or by directly contacting the study staff through a 24 h study cell phone.
However, test results varied by study nurse; positive test results for each of the three nurses were 16/22 (72.7%), 4/4(100%) and 66/72 (91.6%) respectively; the difference between nurse 1 and 3 of almost 20% was statistically significant (p value 0.01).
Subjects were then assessed clinically by a study nurse for presence of the 10 clinical signs of dehydration noted above.
Doses were administered in the child's home under direct observation by the study nurses who waited for at least 10 min after administering the drugs to ensure that they were not vomited.
The concordance between assessments performed by different study nurses will be established for an initial subsample of residents at one RACF.
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