From: Quality of pilot trial abstracts in heart failure is suboptimal: a systematic survey
 | Item | Criteria | Count | Percent (95% CI) |
---|---|---|---|---|
Title | Identifier | Title identifies the study is a randomized controlled pilot trial | 65 | 71 (60; 79) |
Description | Trial design | Description of pilot trial design (e.g., parallel or cluster) | 30 | 33 (23; 44) |
Method | Eligibility | Eligibility criteria for each participant | 81 | 88 (78; 94) |
Settings | Setting where pilot was conducted | 29 | 32 (22; 47) | |
Interventions | Interventions intended for each group | 91 | 99 (91; 99) | |
Objectives | Specific objectives of the pilot trial | 89 | 94 (89; 99) | |
Outcomes | Pre-specified assessment or measurement to address the pilot trial objectives | 89 | 97 (90; 98) | |
Randomization sequence generation | Describe how participants were allocated to the interventions | 12 | 13 (8; 19) | |
Blinding (masking) | Whether or not participants, caregivers, and those assessing the outcomes were blinded to group assignment | 20 | 22 (15; 31) | |
Results | Number randomized | Number of participants screened | 15 | 16 (9; 26) |
Number randomized to each group for the pilot objectives | 41 | 45 (36; 53) | ||
 | Recruitment | Trial status (for conference abstracts) | 2 | 2 (5; 8) |
 | Numbers analyzed | Number of participants analyzed in each group of pilot objectives | 15 | 16 (11; 24) |
 | Harm | Important adverse events or side effects | 28 | 30 (23; 39) |
Conclusion | Result interpretation | General interpretation of results of pilot trial | 80 | 87(76; 93) |
Plans | Any implication for future trial | 20 | 22 (15; 30) | |
Registration | Trial registration | Registration number of trial | 12 | 13 (7; 21) |
 | Funding | Source of funding | 1 | 1 (0.16; 6.9) |