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Unless there is good reason to do otherwise, randomised controlled trials (RCTs) should include the headings set out in the revised CONSORT checklist and flowchart. If your report is an RCT, please ensure that it is specifically stated in the title of the report.
A slightly adapted version of CONSORT headings is set out below:
- List of abbreviations/glossary
- Plain language summary
- Scientific Summary
- Introduction (including scientific background and explanation of rationale)
- Methods (including information about participants, interventions, objectives, outcomes, sample size, randomisation, blinding, statistical methods and a summary of any changes to the project protocol)
- Results (including participant flow, recruitment, baseline data, numbers analysed, outcomes and estimation, ancillary analyses, adverse events)
- Discussion (including interpretation, generalisability, overall evidence, recommendations for future research, implication for decision makers). You are encouraged to make some general observations about the wider field of research as well as specific recommendations, and there should be a balance between the two. Your discussion will be required to include separate headings to discuss ‘Equality, Diversity and Inclusion’ and ‘Patient and Public Involvement’, which will be mandatory from 1st April 2022.
- Conclusions (clear summary of the main findings of the research)
Detailed guidance about what to include under each heading is available in the CONSORT statement. For instance, the report should comply with the CONSORT extension for abstracts guidelines and contain the ISRCTN along with the corresponding author’s email address.
Particular attention should be paid to items 8 and 9 from the CONSORT checklist regarding randomisation and allocation. It is also important to ensure that missing data is properly reported (items 13a and 13b) and that interventions (item 5) are clearly stated.
In instances of reporting on more than one trial please ensure that it is clear throughout the report which trial you are referring to. It is advisable to use separate chapters or clearly marked headings to show which trial is being discussed.
If your trial reports on clinical effectiveness and cost-effectiveness, we advise that you produce the clinical effectiveness and cost-effectiveness in separate chapters, including if possible the methods, results and conclusions for each. The conclusions and recommendations should be clearly reported and should be described in the scientific summary.
You may find it useful to view an example of a randomised controlled trial.
The CONSORT site also contains guidance for reporting cluster RCTs and other designs. If you are reporting a study of diagnostic accuracy, please refer to and use the headings set out in the Standards for Reporting of Diagnostic Accuracy (STARD) checklist in your report.
When writing your report, if appropriate, we suggest you conduct a meta-analysis to demonstrate the additional impact of your study and as a sign of quality.