. 2018 Jun 12;11:89–94. doi: 10.1016/j.conctc.2018.05.003

Table 2.

Unadjusted relative risk levels on trial participation outcomes.

Outcome	Group 1 PICF v 1.4 Count/283 (%)	Group 2 PICF v 1.5 Count/425 (%)	RR 95% CI	P Value
Refusal % before BV1	66 (23.3%)	78 (18.4%)	0.78	0.107
Refusal % before BV1	66 (23.3%)	78 (18.4%)	0.58–1.05	0.107
Recruitment % (written informed consent completed at BV1)	217 (76.7%)	335* (78.8%)	1.02	0.505
Recruitment % (written informed consent completed at BV1)	217 (76.7%)	335* (78.8%)	0.94–1.11	0.505
Refusal % after BV1	40 (14.2%)	45 (10.6%)	0.74	0.156
Refusal % after BV1	40 (14.2%)	45 (10.6%)	0.50–1.11	0.156
Refusal % total before and after BV1	106 (37.5%)	123 (28.9%)	0.77	0.005
Refusal % total before and after BV1	106 (37.5%)	123 (28.9%)	0.62–0.95	0.005
Randomisation %**	152 (58.9%)	254 (65.3%)	1.10	0.110
Randomisation %**	152 (58.9%)	254 (65.3%)	0.97–1.25	0.110

Notes: Significant at probability alpha level 0.05; Reference group in statistical models is Group 1; PICF = Participant Information and Consent Form; BV1 = Baseline Visit 1; RR = Relative Risk or Risk Ratio; *12 participants are not included in this total as they did not attend their first baseline visit & were unable to be contacted for follow up, **Total randomised is adjusted by removing participants excluded due to pathology etc. after their first baseline visit (Group 1 n = 258, Group 2 n = 389).