Dummy tables

This section contains the following:


Introduction

It is important to consider what information you will need to collect before finalising the data collection tools, and generation of Dummy tables will inform this process.  Dummy tables outline how the results of the trial will be reported.  In practice, the structure of the ‘tables’ will often follow that suggested by the CONSORT statement:


The dummy tables should be appended to the end of the protocol and the form of any interim analyses or final analyses should adhere to them.  Successful completion of dummy tables allows cross-checking against questionnaires to ensure they are collecting all the correct data.  It also gets collaborators to agree on the important data items during the design stage, and it allows advance planning of interim and final analyses.

Back to top


Things to consider when writing a protocol


Scenarios where special considerations apply
Cluster trials
In patient randomised trials, all the data in the dummy tables relate to individual patients or participants.  In contrast, the reporting of cluster randomized trials often requires the reporting of both cluster level and patient level data.  The dummy tables should reflect this difference by reporting two baseline tables – one that reports the cluster level characteristics by randomized group and another that reports the patient level characteristics.  In addition, the flow diagram should represent the flow of clusters through each stage of the trial.  See further reading for more details.


Back to top

Illustrative examples - WHO pre-eclampsia trial

The protocol for the [WHO Multicentre Randomized Trial of Calcium Supplementation for the Prevention of Pre-eclamsia] contains dummy tables for the trial starting on page 29.  (WHO Multicentre Randomized Trial of Calcium Supplementation for the Prevention of Pre-eclamsia - go to protocol)


Back to top


Illustrative examples - KAT trial

The protocol for the [Knee Arthroplasty Trial] contains dummy tables for the trial in Appendix 8.  (KAT trial - go to protocol)


Back to top


Additional resources

Trial Protocol Tool resource icon Dummy tables checklist


Back to top


Trial Protocol Tool resource iconAnalysis and interpretation checklist

This checklist was developed by Dave Sackett, who prepared it for the forthcoming 3rd edition of Clinical Epidemiology; A Basic Science for Answering Questions about Health Care, to be published by Lippincott, Williams & Wilkins in 2004.

Back to top

Trial Protocol Tool resource iconThe CONSORT Statement

Web resource iconand the CONSORT website

The CONSORT statement is an important research tool that takes an evidence-based approach to improve the quality of reports of randomized trials. The statement is available in six languages and has been endorsed by prominent medical journals such as The Lancet, Annals of Internal Medicine, and the Journal of the American Medical Association. Its critical value to researchers, health care providers, peer reviewers, and journal editors, and health policy makers is the guarantee of integrity in the reported results of research.


Back to top


Further reading

Elbourne DR. Campbell MK. Extending the CONSORT statement to cluster randomized trials: for discussion. Statistics in Medicine 2001; 20: 489-96.

Back to top

This page was last updated 21st September 2005.