Section of paper | Component to be reported | Details to be reported |
---|---|---|
Title | Randomization | Specify the use of randomization |
Abstract | Study design | Description of trial design |
Participants | Eligibility criteria and data collection setting | |
Interventions | Interventions given to each group within the trial | |
Objective | Objective or hypothesis of the trial | |
Primary outcome | Specification of the primary outcome, result for each intervention group, estimated effect size and precision | |
Randomization | Method used to allocate participants to intervention groups | |
Blinding | Who was blinded to group assignment | |
Numbers randomized and analyzed | Number of participants randomized to and analyzed in each intervention group | |
Recruitment | Specify whether study is ongoing, closed to recruitment, or closed to follow-up | |
Harms | Significant adverse events or side effects that occurred | |
Conclusions | Evaluation of the results | |
Trial registration | Trial register name and registration number | |
Funding | Funding source | |
Abstract (non-pharmacologic interventions) | Full description of the experimental treatment; comparator; care providers administering intervention; centres within which intervention administered; trial blinding status |