Table 6

The CONSORT statement for randomised controlled trials,93 with proposed adaptations in italics.

Item numberDescriptor
Title and abstract1How participants were allocated to interventions (for example, ‘random allocation’, ‘randomised’, or ‘randomly assigned’).
Introduction
Background2Scientific background and explanation of rationale.
Methods
Participants3Eligibility criteria for participants and the settings and locations where the data were collected, specifying the information provided to participants.
Interventions4Precise details of the interventions intended for each group and how and when they were actually administered, who provided the intervention, and what information caregivers received.
Control groupClear description of the care in the control group, details about the information provided and instructions given to control caregivers, including the rationale for blinding or not blinding caregivers to allocation status, details about the information provided, and instructions given to control patients, including the rationale for blinding or not blinding patients to allocation status.
Objectives5Specific objectives and hypotheses.
Outcomes6Clearly defined primary and secondary outcome measures and, when applicable, any methods used to enhance the quality of measurements (for example, multiple observations, training of assessors).
Sample size7How sample size was determined and, when applicable, explanation of any interim analyses and stopping rules.
Randomisation
Sequence generation8Method used to generate the random allocation sequence, including details of any restriction (for example, blocking, stratification).
Allocation concealment9Method used to implement the random allocation sequence (for example, numbered containers or central telephone), clarifying whether the sequence was concealed until interventions were assigned.
Implementation10Who generated the allocation sequence, who enrolled participants, and who assigned participants to their groups.
Blinding (masking)11Whether participants, those administering the interventions, those providing care in the control group, and those assessing the outcomes were blinded to group assignment. If done, how the success of blinding was evaluated.
Statistical methods12Statistical methods used to compare groups for primary outcome(s); methods for additional analyses, such as subgroup analyses and adjusted analyses.
Results
Participants' flow13Flow of individual participants through each stage (a diagram is strongly recommended). Specifically, for each group report the numbers of participants randomly assigned, receiving intended treatment, completing the study protocol, and analysed for the primary outcome. Describe protocol deviations from study as planned, together with reasons.
Recruitment14Dates defining the periods of recruitment and follow-up.
Baseline data15Baseline information for each group.
Numbers analysed16Number of participants (denominator) in each group included in each analysis and whether the analysis was by intention to treat. State the results in absolute numbers when feasible (for example, 10/20 not 50%).
Outcomes and estimation17For each primary and secondary outcome, a summary of results for each group, and the estimated effect size and its precision (for example, 95% confidence interval).
Ancillary analyses18Address multiplicity by reporting any other analyses performed, including subgroup analyses and adjusted analyses, indicating those pre-specified and those exploratory.
Adverse events19All important adverse events or side effects in each intervention group.
Discussion
Interpretation20Interpretation of the results, taking into account study hypotheses, sources of potential bias or imprecision, and the dangers associated with multiplicity of analyses and outcomes.
Generalisability21Generalisability (external validity) of the trial findings.
Overall evidence22General interpretation of the results in the context of current evidence.