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 Reduces power and validity of the study Increases the cost of achieving the sample Increases the cost of achieving the sample Reduces funds available to other studies Reduces funds available to other studies

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

4. Patient barriers included: Patient barriers included: additional demands of the trialadditional demands of the trial patient preferencespatient preferences worry caused by uncertaintyworry caused by uncertainty concerns about information and consent.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 describing methods of seeking informed consent improving knowledge about the INIS trial. 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

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

11. 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).

12.  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.

13.  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

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

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

16.  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 % 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 Difference in absolute numbers of patients recruited per month

17. 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.

18. Table 1: Staff opinion about discussing RCTs and obtaining consent. Consultant (%) n = 4 Other doctors (%) n = 21 Nurses (%) n = 28 All (%) n = 53 Confident in discussing trials 100%71%48%62% Confident in discussing INIS 100%48%58%57% Motivated to recruit to trials 100%57%54%59% Find it difficult to get consent for trials 0%20%12%14% Find it difficult to get consent for INIS 0%16%15%14%

19. Consultant (%) n = 4 Other doctors (%) n = 21 Nurses (%) n = 28 All (%) n = 53 Further training needed for consent to trials 25%62%68%62% Read Booklet Read Booklet50%48%32%40% DVD taught useful strategies for consent to trials DVD taught useful strategies for consent to trials75%81%68%74% Information easy and clear to understand Information easy and clear to understand75%81%65%73% Understanding of consenting improved Understanding of consenting improved0%48%54%47%

20. Consultant (%) n = 4 Other doctors (%) n = 21 Nurses (%) n = 28 All (%) n = 53 More confident about clinical trials after DVD 50%65%64%63% Look at video/ booklet again? Look at video/ booklet again?0%50%63%53% Recommend DVD/booklet to other staff Recommend DVD/booklet to other staff75%86%74%79%

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

22. Group of NICUs n Recruits in 6 months pre DVD/video Recruits in 6 months post DVD/video p control128867NS Video/ booklet 129088NS

23. 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 1. Relative increase in eligible patients per month = 20%= 20% Incidence density ratio 1.2 [95% CI 0.86 – 1.66]Incidence density ratio 1.2 [95% CI 0.86 – 1.66] 2. Relative increase in absolute numbers per month 2. Relative increase in absolute numbers per month = 3% [95% CI -3, 9]= 3% [95% CI -3, 9] 0.5 patient per month0.5 patient per month [95% CI - 0.5, 1.5][95% CI - 0.5, 1.5]

24. 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