Checklist for trial participants
This checklist has been contributed 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 2005.
- Draft patient eligibility criteria that match your trial question.
- Make sure they exclude patients who cannot help you answer your
trial question.
- Make sure they are objective and unambiguous by achieving “almost
perfect” agreement when they are applied by different clinicians to the
same patients.
- Anticipate sample size requirements and begin to consider
strategies for achieving them.
- Generate clinician eligibility criteria for potential
collaborators
- Create your patient-entry forms.
- Decide how to handle “eligible but not randomized” patients
- Decide how to handle patients whose ineligibility is not
discovered until after they are randomized
- Decide whether and how to carry out a ‘dry-run’ of your forms and
systems
- See whether what you have done so far is consistent with your
trial question
- Set up the “patient-flow” diagram.
Back to Inclusion
and exclusion criteria
This document was last updated on 19th October 2004.