Approaches to consent in children’s emergency care: CONNECT study guidance development

1. @CONNECTStudy Approaches to consent in children’s emergency care: CONNECT study guidance development

2. CONNECT • Wellcome Trust postdoctoral fellowship in bioethics 2012-2015 • First UK study to explore parent and practitioner perceptions and experiences of deferred consent in children’s clinical trials • Aim: to provide new evidence to inform how consent should be sought for children’s emergency care trials • CONNECT Advisory group members: Prof Bridget Young, Prof Carrol Gamble, Dr Lucy Frith, Prof Angus Dawson, Prof Michael Parker, Dr Rachel Breen, Ms Helen Hickey, Dr Claire Snowdon, Ms Hazel Grieg Midlane and Ms Julia Harris

5. Research questions Key empirical research questions: • What types of consent methods are used in UK EC paediatric trials? • What are patient, family and practitioner experiences and attitudes to different consent methods? • What are the barriers and facilitators to obtaining informed consent in UK EC trials?

6. Research questions Key normative questions: • What is informed consent and is it possible, particularly in an EC situation? • Is enrolment on to a clinical trial in the best interests of the child? • What influences a parent’s decision to provide proxy consent? • Is it appropriate for practitioners to use deferred consent, waived consent and child assent? • What extra considerations are important if a child dies during or after a trial?

7. CONNECT Phase A: Survey of consent methods used in UK paediatric and neonatal emergency care trials. Sample: 45 emergency care practitioners. 16 (36%) consultant grade doctors and 29 (64%) research nurses. Method: Semi-structured 20 item questionnaire. Review of literature Review of literature Phase B: Consent in the CATCH trial: parent and practitioner perspectives Sample: 275 parents and 17 practitioners. Methods: trial survey (275), interviews (23 parents) and focus groups (17 practitioners). CONNECT guidance Phase C: Parental views and experiences of consent methods in diverse patient groups. Sample: 17 parents from 8 UK support groups, including 6 bereaved families. Methods: Interviews and focus group.

8. Phase A: Survey of consent methods used in UK paediatric and neonatal emergency care trials

9. Methods and sample • 20 item questionnaire. • Mapping of approaches to consent. Practitioner views and experiences of deferred consent. • 45 emergency care practitioners. 16 (36%) consultant grade doctors and 29 (64%) research nurses.

10. Key findings • 1 out of 13 trials used deferred consent. Over half the sample (n = 27/45, 60%) of practitioners had experience of using deferred consent. • Practitioners who had no experience of deferred consent reported negative perceptions of this consent method. - Concerns about the impact that deferred consent would have upon the parent-practitioner relationship. • Practitioners experienced in deferred consent described how families had been receptive to the consent method, if conducted sensitively and in a time appropriate manner. - Described how deferred consent had improved recruitment, parental decision-making capacity and parent-practitioner relationships in the emergency care setting. “Nearly all families were openly receptive and wanted their child to be involved” (P1, experienced in deferred consent)

11. Phase A conclusions • The views of practitioners with first-hand experience of deferred consent should be considered in the design and ethical review of future children’s EC trials and not solely informed by the beliefs of those without experience of deferred consent.

12. Phase B: Consent in the CATCH trial

13. CATheter Infections in CHildren (CATCH) A randomised controlled trial comparing the effectiveness of heparin bonded or antibiotic impregnated central venous catheters (CVC) with standard CVCs for preventing hospital acquired blood stream infection. 14 UK Paediatric Intensive Care Units (PICUs) between March 2010 and November 2012. Prospective consent/assent (for elective surgery admissions) and deferred consent/assent (for emergency admissions).

14. Method and sample • Mixed method. • Focus groups (17 practitioners from 6 trial sites). • 275 parents completed a questionnaire; approximately half (142, 52%) completed the questionnaire at home. 57% were emergency admissions. 8 were bereaved (3%), 24 were decliners (8.7%, 8 in the emergency group, 14 in the elective group) 173 mothers (62.9%),101 fathers (36.7%) and 1 guardian (0.4%). • 23 parents, 20 interviews (3 face to face and 17 telephone) with parents. 18 mothers and 5 fathers. 2 bereaved, approached before death. 1 family declined to participate in CATCH.

15. Practitioners’ initial concerns • Deferred consent was new • Parents’ response • Deferred consent for additional blood samples “The first time I did approach a parent I remember feeling really nervous about their reaction”(P7, female nurse, focus group 2). “We’ll frequently tell people afterwards what we’ve done to their child so that sort of telling them afterwards is, wasn’t particularly of concern to me… so the concept is quite… It’s not alien” (P13, female doctor, focus group 4).

16. Parents’ initial surprise • Many were unfamiliar with the approach “Um I didn’t know it existed to be honest”(Mother, emergency group). • Initially shocked or surprised (7/13) that their child had been randomised into a trial without their prior consent. “I thought that was a bit strange. I thought you ought to sort of agree to a trial before something was done”(Mother, emergency group).

17. Explanations are important “I haven’t got a problem with things like that because, you know, it was, it was explained”(Father, emergency group).

18. Did you provide consent for your child to participate in CATCH? (n=275) Figures are n (%)

19. Table 2. Satisfaction with consent No parents in either setting expressed any dissatisfaction with the consent process in their questionnaire responses. “Very receptive” (Focus group 1) “The majority of the time they were very, very happy”(Focus group 2).

20. Parents’ views on deferred consent • Parents supported the use of deferred consent in paediatrics emergency care trials. “In that situation obviously it's better that they ask me later” (Mother, Emergency, Bereaved) • Seeking prospective consent in the emergency setting was described as inappropriate. • Deferring consent provided parents with an opportunity to participate in research, which they valued. • Parents supported deferred consent, regardless of whether they had first-hand experience of the approach, or whether they were in the elective group. “You are worried; your child is potentially going to die..I may well have agreed to do the trial, but I wouldn’t have concentrated on it as much as I did later on. So I think deferred is probably the better option if you are in rushed circumstances or situations like that.” (Mother, Emergency)

21. Timing of an explanation “Once it had um, everything had calmed down and he’d… they’d got him stable, they then explained a lot more what they’d had to do.” (Mother, emergency group).

22. The impact of trial type All three catheters were in commonly used in hospitals across the UK. Administering a central venous catheter is a routine part of emergency care treatment; therefore a child’s care would not have changed as a result of being randomized to the trial. Some parents referred to the decision as insignificant: “Just like what? Okay whatever, kind of thing.”(Father, elective group); “It was one of the easiest ones I made in those forty-eight hours”. (Mother, emergency group) “But then when I realised that, you know, it wouldn’t have changed the way that the patient was treated in any way, then it didn’t really matter” (mother, emergency group).

23. Phase B: Key findings & conclusions • Prospective informed consent in the emergency care setting is inappropriate. • Experience makes a difference to the views of practitioners. • Verbal information and appropriate timing are important to assist parental decision making, understanding and acceptability of deferred consent. • Parents’ supported deferred consent in CATCH as well as for future trials conducted in the emergency care setting, regardless of their experience. • Practitioners’ refusal to defer consent may invalidate trial results, introduce bias or result in missing.

24. Phase C: Views and experiences of consent methods in diverse patient groups

25. Phase C: methods and sample • Qualitative interview and focus group study • 17 Parents of children with a range of acute and chronic health conditions including 6 bereaved parents- recruited via Facebook • Explored approaches to consent using two trial examples 1) CATCH and 2) EcLiPSE (Emergency use of Levetiracetam vs Phenytoin in Status Epilepticus), for the termination of acute, prolonged tonic–clonic seizures, including CSE in children aged 6 months to 18 years.

26. Parents views on deferred consent “uneasy”(P2, focus group, not bereaved) “It's the right direction to go, really, because quite often, um, you just don't have the time or the situation, and the data is valuable” (P17, mother, telephone interview, bereaved). “But then in that situation you are kind of a bit fuzzy anyway, and you think well they know what they are doing, so you know we sort of trust them to do their job” (P 9, mother, telephone interview, bereaved). “How it’s actually explained to parents at that point will have a huge impact” (P10, mother, telephone interview, not bereaved).

27. Risk to child safety Facilitator: “What would your initial thoughts be about this trial?” P 14: (mother, not bereaved): “I think I’d be a bit scared...”. Facilitator:“…So your child would have received phenytoin routinely if the seizures had not stopped. This can cause very unpleasant and serious side-effects. Studies of levetiracetam in adult emergency situations suggest that it may be an alternative rescue medicine to phenytoin. There have been no major side effects reported with the use of levetiracetam. So that’s sort of why they’re doing the trial. It’s to see if this drug, which some hospitals are using, might be better than phenytoin, which everybody’s using and they know can have nasty side effects. Would that help if they explained that to you a bit more?” P 14: “Yeah, so from that point of view, that sounds a lot better... That, that would be the pretty much perfect explanation to make a mum turn around and go, it’s so they’re doing everything they can to make sure my child is safe and to try and stop any side-effects”.

28. Deferred consent when a child has died “I don’t even know if there is a right way, because even, you know, how someone would talk to me, and how someone would talk to my husband, we would both react completely different”(P9, mother, telephone interview, bereaved).

29. Phase C: Key findings & conclusions • The majority of parents in our sample were unfamiliar with deferred consent, yet responded positively to a general description of the method. • Views and responses were similar to Phase B CATCH findings • Parents viewed observational studies as safer than trials of medicinal products and therefore a more acceptable study type to use deferred consent • Findings helped to inform the design of EcLiPSE, the PIS and the consent-seeking process and demonstrate the value of using qualitative methods at the pre-trial stage.

30. CONNECT study limitations • Those with experience of deferred consent were all from CATCH. • Parents were supportive of medical research – this sample may be more easily reassured than wider populations. • More mums than dads • Children were not involved in our study.

31. Group work Usefulness: • Is the recommendation clear? • Any suggestions for changes to the recommendation? Feasibility: • Are there any potential problems in implementing this recommendation? If yes, How could such problems be addressed? • How might these recommendations build on or change current approaches to recruitment and consent in the emergency care setting? • What are the implications of this (if any)? • What further resources, training or support might be needed to implement the recommendation? • To which other professional groups might they apply? (Refer to the list of groups above each recommendation) Impact and dissemination questionnaires