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Table 4 Study characteristics associated with whether consent documents state “pilot” or “feasibility” in their titles (n = 184)

From: Transparency of informed consent in pilot and feasibility studies is inadequate: a single-center quality assurance study

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)
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