This 11-item questionnaire is designed to collect data on eligibility criteria, random allocation, concealed allocation, similarity of baseline values, blinding of therapists and/or assessors, key outcomes, intention-to-treat analysis, between group differences, and point and variability measures.
Our rating system assessed studies on four potential sources of bias: unit of allocation, presence of baseline differences between groups potentially linked to study outcomes, objectiveness of outcome, and completeness of follow-up.
In addition to reducing source data uncertainties, reanalysis of historic changes in forest area can also facilitate sub-national allocation of deforestation baselines.
In this way concealment of allocation and blinding of baseline measures is ensured.
Parents will be notified of group allocation following completion of baseline questionnaires and the randomization process.
The quality criteria were the following: allocation concealment, comparison of baseline characteristics of the 2 study groups, conduct of a baseline test, protection against contamination, use of standardized outcome measurement tools, description of the analytic approach, and percentage of follow-up.
11 Therefore, the EPOC tool uses the same approach as the general Cochrane Risk of Bias Tool, but requires an assessment of bias in nine domains: sequence generation, allocation concealment, similarity of baseline measurements, similarity of baseline characteristics, incomplete data, blinding of outcome assessment, contamination, selective outcome reporting and others.
The distribution of participants with missing versus non-missing final blood pressure readings did not differ significantly by group allocation in terms of baseline systolic blood pressure (115 (15) v 114 (14) mm Hg, P=0.6) or diastolic blood pressure (74 (11) v 74 (11) mm Hg, P=0.5).
This was reached using standard GRADE criteria, including a high risk of selection bias (due to inadequate methods of generating the random sequence and concealing treatment allocation, and the lack of baseline data), and the statistical uncertainty given that the result did not reach standard levels of statistical significance (95%).
Participants were randomised and informed of their treatment allocation at the end of baseline interview.
