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Table 5 Study characteristics associated with whether consent documents state intent to assess feasibility (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

0.84 (0.38, 1.87)

0.80 (0.36, 1.78)

Studies labelled as feasibility studies

Studies labelled as pilot studies

8.09 (3.11, 21.03)

7.44 (2.85, 19.41)

Randomized studies

Non-randomized interventional studies

2.34 (0.91, 6.03)

2.49 (0.97, 6.35)

Observational studies

Non-randomized interventional studies

2.02 (0.84, 4.85)

1.83 (0.77, 4.35)

Quantitative studies

Studies collecting both quantitative and qualitative data

0.49 (0.22, 1.09)

0.47 (0.21, 1.04)

Qualitative studies

Studies collecting both quantitative and qualitative data

0.66 (0.16, 2.76)

0.63 (0.15, 2.61)

Industry sponsored

Non-industry sponsored studies

0.38 (0.09, 1.65)

0.34 (0.08, 1.46)

Progression criteria stated in protocol

No progression criteria stated in protocol

2.37 (1.14, 4.91)

2.59 (1.25, 5.36)