Table 3 Extension of CONSORT for abstracts for reporting pilot trials
From: CONSORT 2010 statement: extension to randomised pilot and feasibility trials
Item | Standard checklist item | Extension for pilot trials |
|---|---|---|
Title | Identification of study as randomised | Identification of study as randomised pilot or feasibility trial |
Trial design | Description of the trial design (eg, parallel, cluster, non-inferiority) | Description of pilot trial design (eg, parallel, cluster) |
Methods: | ||
 Participants | Eligibility criteria for participants and the settings where the data were collected | Eligibility criteria for participants and the settings where the pilot trial was conducted |
 Interventions | Interventions intended for each group |  |
 Objective | Specific objective or hypothesis | Specific objectives of the pilot trial |
 Outcome | Clearly defined primary outcome for this report | Prespecified assessment or measurement to address the pilot trial objectives* |
 Randomisation | How participants were allocated to interventions |  |
 Blinding (masking) | Whether or not participants, caregivers, and those assessing the outcomes were blinded to group assignment |  |
Results: | ||
 Numbers randomised | Number of participants randomised to each group | Number of participants screened and randomised to each group for the pilot trial objectives* |
 Recruitment | Trial status†|  |
 Numbers analysed | Number of participants analysed in each group | Number of participants analysed in each group for the pilot objectives* |
 Outcome | For the primary outcome, a result for each group and the estimated effect size and its precision | Results for the pilot objectives, including any expressions of uncertainty* |
 Harms | Important adverse events or side effects |  |
 Conclusions | General interpretation of the results | General interpretation of the results of pilot trial and their implications for the future definitive trial |
 Trial registration | Registration number and name of trial register | Registration number for pilot trial and name of trial register |
 Funding | Source of funding | Source of funding for pilot trial |