Eligibility criteria Trials of adults with asthma randomised to maintenance treatments of at least 24 weeks duration and that reported on asthma exacerbations in full text.
Based on information from these reports and studies, we identify potential translational challenges of this approach and determine practical and ethical considerations for clinical trials, focusing on issues regarding selection criteria, trial design, and outcome evaluation.
Some criteria from the CONSORT Statement could be transferred to AHP studies: sample size, participants (eligibility criteria), trial designs, and statistical methods.
Details of inclusion and exclusion criteria, trial design and results can be obtained from the original publication of this trial 11.
Detailed descriptions of the recruitment, inclusion and exclusion criteria, trial treatment, adherence, follow-up and trial outcomes as well as the content of information leaflets and trial questionnaires have been published elsewhere [ 21- 24].
Detailed descriptions of recruitment, inclusion and exclusion criteria, trial treatment, adherence, follow-up and trial outcomes as well as the content of information leaflets and trial questionnaires have been published elsewhere [ 11- 17].
Most of these are relative contraindications in clinical practice but are standard exclusion criteria in trials.
We do this by introducing structured eligibility criteria, that enhance reuse of criteria across trials.
By original criterion, the trial point is acceptable if and only if (6) holds.
