Table 3 Relative inclusion of criteria for transparency based on each study characteristic for informed consent documents before and after research ethics board review
Study characteristic | Studies that use the term “pilot” or “feasibility” in the title of the consent forms (%) | Studies that define the term pilot/ feasibility in consent forms (%) | Studies that state objective to assess feasibility in consent forms (%) | Studies that state specific feasibility objectives in consent forms (%) | ||||
|---|---|---|---|---|---|---|---|---|
Before | After | Before | After | Before | After | Before | After | |
Term used in title of the study | ||||||||
“Pilot” (n = 147) | 78.9 | 82.3 | 9.5 | 12.9 | 32.0 | 34.0 | 16.3 | 16.3 |
“Feasibility” (n = 32) | 87.5 | 87.5 | 6.3 | 6.3 | 75.0 | 75.0 | 28.1 | 28.1 |
Both (n = 5) | 80.0 | 80.0 | 20.0 | 20.0 | 80.0 | 80.0 | 60.0 | 60.0 |
Study design | ||||||||
Randomized (n = 63) | 74.6 | 77.8 | 15.9 | 22.2 | 44.4 | 47.6 | 20.6 | 20.6 |
Non-randomized interventional (n = 54) | 74.1 | 74.1 | 0.0 | 0 | 31.5 | 33.3 | 9.3 | 9.3 |
Observational (n = 67) | 91.0 | 95.5 | 10.4 | 11.9 | 44.8 | 44.8 | 26.9 | 26.9 |
Data collected | ||||||||
Quantitative (n = 121) | 80.2 | 82.6 | 10.7 | 14.9 | 38.8 | 40.5 | 19.8 | 20.7 |
Qualitative (n = 12) | 58.3 | 58.3 | 0.0 | 0 | 33.3 | 33.3 | 16.7 | 8.3 |
Both (n = 51) | 86.3 | 90.2 | 7.8 | 7.8 | 47.1 | 49.0 | 19.6 | 19.6 |
Source of funding | ||||||||
Industry funded (n = 13) | 76.9 | 76.9 | 0.0 | 0.0 | 30.8 | 30.8 | 23.1 | 23.1 |
Non-industry funded (n = 171) | 80.7 | 83.6 | 9.9 | 12.9 | 41.5 | 43.3 | 19.3 | 19.3 |
Year of submission | ||||||||
2016 or prior (n = 135) | 81.5 | 83.0 | 8.9 | 10.4 | 40.0 | 41.5 | 21.5 | 21.5 |
2017 onward (n = 49) | 77.6 | 83.7 | 10.2 | 16.3 | 42.9 | 44.9 | 14.3 | 14.3 |
Objectives from protocol state intent to assess feasibility (n = 136) | 80.1 | 82.4 | 11.8 | 15.4 | 54.4 | 56.6 | 26.5 | 26.5 |
Objectives from protocol do not state intent to assess feasibility (n = 48) | 81.3 | 85.4 | 2.1 | 2.1 | 2.1 | 2.1 | 0.0 | 0.0 |
Specific feasibility objectives stated in protocol (n = 131) | 79.4 | 82.4 | 11.5 | 15.3 | 54.2 | 56.5 | 27.5 | 27.5 |
No specific feasibility objectives stated in protocol (n = 53) | 83.0 | 84.9 | 3.8 | 3.8 | 7.5 | 7.5 | 0.0 | 0.0 |
Progression criteria stated in protocol (n = 62) | 85.5 | 87.1 | 17.7 | 22.6 | 53.2 | 56.5 | 27.4 | 27.4 |
No progression criteria stated in protocol (n = 122) | 77.9 | 81.1 | 4.9 | 6.6 | 34.4 | 35.2 | 15.6 | 15.6 |