Table 4.
Study characteristics associated with whether consent documents state “pilot” or “feasibility” in their titles (n = 184)
| Estimated category | Reference category (odds ratio = 1) | Originally submitted informed consent forms | Final approved informed consent forms |
|---|---|---|---|
| Odds ratio (95% confidence interval) | Odds ratio (95% confidence interval) | ||
| 2017 or more recent | 2016 or prior | 0.81 (0.33, 1.99) | 1.11 (0.41, 2.98) |
| Studies labelled as feasibility studies | Studies labelled as pilot studies | 1.72 (0.54, 5.43) | 1.31 (0.41, 4.20) |
| Randomized studies | Non-randomized interventional studies | 0.73 (0.26, 2.03) | 0.64 (0.21, 1.90) |
| Observational studies | Non-randomized interventional studies | 1.79 (0.63, 5.15) | 1.64 (0.53, 5.12) |
| Quantitative studies | Studies collecting both quantitative and qualitative data | 0.73 (0.26, 2.00) | 0.65 (0.21, 2.01) |
| Qualitative studies | Studies collecting both quantitative and qualitative data | 0.19 (0.04, 0.82) | 0.13 (0.03, 0.61) |
| Industry sponsored | Non-industry sponsored studies | 0.73 (0.17, 3.18) | 0.66 (0.15, 2.89) |
| Progression criteria stated in protocol | No progression criteria stated in protocol | 1.74 (0.71, 4.28) | 1.53 (0.59, 3.96) |