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Randomised controlled trials2

Randomised Controlled Trials

Unless there is good reason to do otherwise, randomised controlled trials (RCTs) should include the headings set out in the revised CONSORT checklist and flowchartLink open in a new window. 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
  • Abstract
  • Plain English 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)
  • Conclusions (implications for healthcare, recommendations for research)
  • Acknowledgements
  • References
  • Appendices

Detailed guidance about what to include under each heading is available in the CONSORT statementLink open in a new window. For instance, the report should comply with the CONSORT extension for abstractsLink open in a new window 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) checklistLink open in a new window 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.