Sanmarti 1993

Methods	Randomized controlled trial; parallel group design. Duration: One year (1985 through 1987: recruitment and data collection)
Participants	Number enrolled: 318 Number analyzed: 264 Inclusion criteria: School children, both sexes in their first year of primary education with latent tuberculosis Method of screening: Mantoux test with 5 Tuberculin Units (TU) of Purified Protein Derivative (PPD) RT 23. A reaction of ≥ 6mm of induration was considered to be significant Exclusion criteria: Active tuberculosis; previous vaccination with BCG and; any contraindication to preventive therapy with isoniazid
Interventions	Education by nurse via telephone: Mothers were telephoned by specialized nursing personnel every three months, who informed them of the advantages of chemoprophylaxis for their child’s health and encouraged them to continue with this preventive measure. Education by nurse via home visit: Specialized nurse visited the participant's home every three months, providing health education to mother and child, encouraging them to continue with the preventive therapy, and re‐issuing informative leaflets given at the first visit. Also, the Eidus‐Hamilton reaction was performed to objectively verify compliance with the therapy. Possible adverse reactions were monitored. Education by doctor at clinic: The child was seen by the physician every three months at the Tuberculosis Prevention and Control Centre. At each visit, the doctor gave educational messages to both mother and child, provided the same informative leaflets given at the first visit, monitored possible drug adverse reactions, and performed the Eidus‐Hamilton reaction. Education messages were standardized through use of the same health education script by both the physician and the nurses, and participants were given the same pamphlets. Control group: No health education activity was performed. After the first visit, the mothers were informed that unless they considered it appropriate there was no need to come back until after they had followed the treatment for 12 months. At recruitment, all the groups received the following: Parents were told how their children had to take isoniazid and given informative leaflets regarding tuberculosis and its prevention. They were also informed what symptoms to look for and to see the doctor if they suspected the existence of any of these symptoms or if they considered it advisable. For all the groups, the final visit consisted of medical history and examination, a chest X‐ray and the performance of the Eidus‐Hamilton reaction.
Outcomes	Treatment adherence measured by: Attendance at the last visit scheduled one year after starting treatment. Presence of positive Eidus‐Hamilton reaction in the urine during follow‐up (Groups II & III), and at last visit.
Notes	Location: Spain. Setting: Public and private sector primary schools and referred to a Tuberculosis Prevention and Control Centre in the province of Barcelona.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	"Randomized", no further details provided.
Allocation concealment (selection bias)	Unclear risk	No information provided.
Blinding (performance bias and detection bias) All outcomes	High risk	It was not possible to blind the participants and personnel. Not stated if assessors were blind.
Incomplete outcome data (attrition bias) All outcomes	High risk	At the end of the study (12 months) 83% participants were included in the analysis.
Selective reporting (reporting bias)	Unclear risk	Protocol not available. Results for all the outcomes listed under methods section were reported.
Other bias	High risk	There were two additional interventions given to Groups I, II & III that were not provided to the control group:1) contacted or seen every three months (thus, additional attention); and 2) Eidus‐Hamilton reaction performed at every visit. There is therefore a risk of confounding by these additional interventions.