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Maximising recruitment to RCTs is important Slow recruitment

A CONSENT DVD/ VIDEO DESIGNED TO IMPROVE CONSENT UPTAKE TO RANDOMISED CONTROLLED TRIALS IN NEONATOLOGY: A PILOT STUDY IN THE INIS NETWORK [VINIS]. Priya Duggal-Beri, Phyllis Butow, Wendy Hague , Val Gebski, Lorraine O’Regan, William Tarnow-Mordi; on behalf of the

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Maximising recruitment to RCTs is important Slow recruitment

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  1. A CONSENT DVD/ VIDEO DESIGNED TO IMPROVE CONSENT UPTAKE TO RANDOMISED CONTROLLED TRIALS IN NEONATOLOGY:A PILOT STUDY IN THE INIS NETWORK [VINIS] Priya Duggal-Beri, Phyllis Butow, Wendy Hague , Val Gebski, Lorraine O’Regan, William Tarnow-Mordi; on behalf of the International Neonatal Immunotherapy Study (INIS) Collaborative Group.

  2. Maximising recruitment to RCTs is important • Slow recruitment • Reduces power and validity of the study • Increases the cost of achieving the sample • Reduces funds available to other studies

  3. Barriers to participation in randomised controlled trials: a systematic review.Ross et al 1999 • Clinician barriers included: • time constraints • lack of staff and training • worry about the impact on the doctor-patient relationship • concern for patients • loss of professional autonomy • difficulty with the consent procedure • lack of rewards and recognition • insufficiently interesting question.

  4. Patient barriers included: • additional demands of the trial • patient preferences • worry caused by uncertainty • concerns about information and consent.

  5. Published studies of interventions among staff to improve the quality of information they give and the consent process in multi-centre RCTs …

  6. We explored the effectiveness of a DVD/ video and accompanying booklet for staff involved or interested in gaining consent in • describing methods of seeking informed consent • improving knowledge about the INIS trial.

  7. International Neonatal Immunotherapy Study (INIS) • INIS is a simple, multi-centre, randomized, placebo-controlled study in 4,000 infants with suspected or proven infection. • It will test the hypothesis that non-specific intravenous immunoglobulin (IVIG), in addition to standard antibiotic therapy, reduces death and/ or disability at 2 years corrected gestation.

  8. single click to inis website [Google] inis ctc

  9. Centres and babies worldwide • ANZ             24ANZ babies = 1071UK               64 UK babies = 1120 Denmark       3Belgium         1Eire               2Serbia           1 Greece           1Argentina     21 Centres: 117Total babies: 2272

  10. Methods • A DVD containing trial-specific scenarios was devised based on feedback from clinical staff. Nurses, doctors and an actor playing the role of parents discussed common concerns of parents. • The intervention was randomly sent from the NHMRC Clinical Trials Centre in August 2005 to half the ANZ INIS sites (n=12), to staff who already obtained consent or were interested in obtaining consent to the INIS trial. • The other ANZ sites acted as controls (n=12).

  11. University of Sydney Central Ethics committee approved the NHMRC Clinical Trials Centre’s co-ordination of the VINIS study and the use of the DVD/ video and booklet among staff in Australia. • The Chair of the NZ Multi-centre Research Ethics considered that the project did not require ethics approval as it was not a clinical intervention. • Permission was sought from Clinical Directors of intervention NICUs for participation in the study.

  12. The DVD highlighted good and poor presentation of information, answering FAQs and obtaining informed consent from a parent. • A booklet outlined principles of gaining consent, including that the person should be: capable of giving consent, given all the information relevant to the decisions, understand the information, and consent should not be coerced

  13. Staff feedback was obtained by a questionnaire measuring responses using a Likert scale: • strongly agree (SA) • agree (A) • neutral (N) • disagree (D) • strongly disagree (SD) • “Positive responses” were identified if the staff member replied SA or A.

  14. Estimating the impact of the intervention on recruitment • All ANZ sites keep monthly logs, showing number of • Patients eligible for INIS • Patients approached for consent • Patients recruited

  15. We compared in the intervention vs control group • Difference in % eligible patients recruited per month (effect of intervention is underestimated in months when no patients are eligible) • Difference in absolute numbers of patients recruited per month

  16. Results • The DVD/ video was shown to staff in 11 of the 12 centres randomised to receive the initiative. One centre was unable to show the DVD due to staffing issues. • 53/ 70 staff from 7 of these 11 centres responded to the questionnaire. • Approximately half of the respondents had previously recruited to INIS.

  17. Table 1: Staff opinion about discussing RCTs and obtaining consent.

  18. Most staff respondents • Felt more training is needed in gaining consent to trials • Felt DVD taught useful strategies for gaining consent • Felt more confident in gaining consent after seeing DVD • Would recommend the DVD to other staff

  19. Patient recruitment to INIS Point estimates of difference in recruitment attributable to the intervention (1) with and (2) without accounting for numbers of eligible patients • 1. Relative increase in eligible patients per month • = 20% • Incidence density ratio 1.2 [95% CI 0.86 – 1.66] • 2. Relative increase in absolute numbers per month • = 3% [95% CI -3, 9] • 0.5 patient per month • [95% CI - 0.5, 1.5]

  20. Conclusions • A DVD/ video for staff may be a useful tool for improving knowledge and confidence in obtaining consent and randomised studies in larger networks are warranted. • The % recruitment of eligible patients may be a more sensitive comparison than the % of absolute numbers of patients recruited

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