In projects: A Project Infrastructure for Researchers

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library(here)
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Abstract

1a Identification as a randomised trial in the title 1b Structured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for abstracts)

Introduction

Background/rationale

Scientific background and explanation of rationale

Objectives

Specific objectives or hypotheses

Methods

Trial design

Description of trial design (such as parallel, factorial) including allocation ratio Important changes to methods after trial commencement (such as eligibility criteria), with reasons

Participants

Eligibility criteria for participants Settings and locations where the data were collected

Interventions

The interventions for each group with sufficient details to allow replication, including how and when they were actually administered

Outcomes

Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed Any changes to trial outcomes after the trial commenced, with reasons

Sample size

How sample size was determined When applicable, explanation of any interim analyses and stopping guidelines

Randomisation:

Sequence generation

Method used to generate the random allocation sequence Type of randomisation; details of any restriction (such as blocking and block size)

Allocation concealment mechanism

Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned

Implementation

Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions

Blinding

If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how If relevant, description of the similarity of interventions

Statistical methods

Statistical methods used to compare groups for primary and secondary outcomes Methods for additional analyses, such as subgroup analyses and adjusted analyses

Results

Participant flow (a diagram is strongly recommended)

For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome For each group, losses and exclusions after randomisation, together with reasons

Recruitment

Dates defining the periods of recruitment and follow-up Why the trial ended or was stopped

Baseline data

A table showing baseline demographic and clinical characteristics for each group

Numbers analysed

For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups

Outcomes and estimation

For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) For binary outcomes, presentation of both absolute and relative effect sizes is recommended

Ancillary analyses

Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory

Harms

All important harms or unintended effects in each group (for specific guidance see CONSORT for harms)

Discussion

Limitations

Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses

Generalisability

Generalisability (external validity, applicability) of the trial findings

Interpretation

Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence

Other information

Registration

Registration number and name of trial registry

Protocol

Where the full trial protocol can be accessed, if available

Funding

Sources of funding and other support (such as supply of drugs), role of funders

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References

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projects documentation built on April 24, 2021, 5:06 p.m.