Figure 1 shows the CONSORT/TREND diagram with the total number of enrolled patients per study stage (randomization and sequential enrolment stage), those assigned, allocated, exposed to the intervention, followed-up, and analyzed, both in the basic effectiveness (n = 151) and intent-to-treat analysis (n = 198).
The pre-publication history for this paper can be accessed here: http://www.biomedcentral.com/1471-2431/13/88/prepub The Sydney Children's Hospital Emergency Department provided assistance during the enrolment stage of the study.
2. Treatment allocation concealment Was the allocated treatment adequately concealed from study participants and clinicians and other healthcare or research staff at the enrolment stage? 3. Blinding Were the personnel assessing outcomes and analysing data sufficiently blinded to the intervention allocation throughout the trial?
Time to ART-initiation for different age groups was estimated using Cox regression, controlling for sex, place of residence, enrolment phase and WHO clinical stage upon presentation.
When controlling for sex, place of residence, enrolment phase and WHO clinical stage upon presentation, it was found that children in the age group 0 4 years waited longer to initiate ART (HR: 0.50, 95% CI: 0.25-0.97, P = 0.04).
Children aged 0 4 years were more likely to be lost to follow-up (40.0 vs. 21.8%, chi-square test, χ2 = 5.4, P = 0.02) and had a longer time to initiate ART Coxx regression analysis, HR: 0.50, 95% CI: 0.25-0.97, P = 0.04, controlling for sex, place of residence, enrolment phase and WHO clinical stage upon presentation).
All students enrolled during the study period were eligible to participate, regardless of their course, year of enrolment or stage of candidature.
Two of three patients with the longest survival (44.6 and +58 months) had radiological evidence of disease progression at the time of enrolment, BLCL stage C disease, as well as portal vein thrombosis, three predictors of short survival (Llovet et al, 2003).
These variables include date of HIV-testing, date of pre-ART enrolment, WHO clinical stage, total lymphocyte count (TLC), CD4 count, haemoglobin level (HGB), history of TB (as reported by patient or caregiver), current TB (diagnosed within one month before or after presentation), sex, age, place of residence (rural or urban), pre-ART outcome and date of ART-initiation (if initiated).
Using a data abstraction form as a guide, we recorded date of HIV testing, date of pre-ART enrolment, WHO clinical stage, CD4 count, total lymphocyte count (TLC), history of tuberculosis, pregnancy, age, sex, and place of residence for all patients directly into an SPSS data file.
User-involvement in this case represents an important element in the enrolment and mobilization stage: it helped to promote enrolment and foster ownership of the system.
