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First
Author's Name:
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Manuscript
Title:
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Subheading
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Description
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Was
it reported? Yes or No
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If
Yes, on what page number?
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TITLE
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1. Identify the study as a randomized trial. |
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ABSTRACT
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2.
Use a structured format. |
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INTRODUCTION
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- 3.
State prospectively defined hypothesis, clinical objectives,
and planned subgroup or covariate analyses.
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METHODS
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Protocol
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- Describe
- 4.
Planned study population, together with inclusion/exclusion
criteria.
- 5.
Planned interventions and their timing.
- 6.
Primary and secondary outcome measure(s) and the minimum
important difference(s), and how target sample size
was projected.
- 7.
Rationale and methods for statistical analyses, detailing
main comparative analyses and whether they were completed
on an intention-to-treat basis.
- 8.
Prospectively defined stopping rules (if warranted).
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Assignment
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- Describe
- 9.
Unit of randomization (e.g., individual, cluster, geographic).
- 10.
Method used to generate the allocation schedule.
- 11.
Method of allocation concealment and timing of assignment.
- 12.
Method to separate the generator from the executor of
assignment.
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Masking,
blinding
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- 13.
Describe mechanism (e.g., capsules tables); similarity
of treatment characteristics (e.g., appearance taste):
allocation schedule control (location of code during
trial and when broken) and evidence of successful: masking
(blinding) among participants, person doing intervention,
outcome accessors and data analysts.
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RESULTS
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Participant
Flow and follow-up
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- 14.
Provide a trial profile (see flow diagram - figure)
summarizing participant flow, numbers and timing of
randomization assignment, interventions, and measurements
for each randomized group.
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Analysis
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- 15.
State estimated effect of intervention on primary and
secondary outcome measures, including a point estimate
and measure of precision (confidence interval).
- 16.
State results in absolute numbers when feasible (e.g.,
10/20, not 50%)
- 17.
Present summary data and appropriate descriptive inferential
statistics in sufficient detail to permit alternative
analyses and replication.
- 18.
Describe prognostic variables by treatment group and
any attempt to adjust for them.
- 19.
Describe protocol deviations from the study as planned,
together with the reasons.
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COMMENT
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- 20.
State specific interpretation of study findings, including
sources of bias and imprecision (internal validity)
and discussion of external validity, including appropriate
quantitative measures when possible.
- 21.
State general interpretation of the data in light of
totality of the available evidence.
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*This
checklist of 21 items is intended to assist authors, editors,
and reviewers by ensuring that information pertinent to
the trial is included in the study report.
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