Background
Methods
Overview
Participants
Procedure
Consultations
Semi-structured interviews
Children and parent interviews | |
• Experience of illness | |
• Initial thoughts about CONTRACT | |
• Experience of being approached about CONTRACT | |
- Thoughts on how CONTRACT was explained | |
- How the health professional explained the treatment options | |
- Family preferences | |
- Recollection of key aspects of CONTRACT | |
• Decision-making about CONTRACT participation/non-participation | |
• Views and understanding of randomisation | |
• Experience of treatment | |
• Experience of recovery | |
• Reflections on CONTRACT since being approached | |
Health professional interviews | |
• Initial thoughts about CONTRACT | |
• Knowledge of CONTRACT and views on its aims | |
• Recruitment pathways | |
• Experiences of approaching families | |
• Health professional treatment preferences | |
• Experience of delivering the treatments | |
• Anticipated CONTRACT results |
Analysis
CONTRACT communication training
Results
Communication study dataset characteristics
Families who provided a consultation recording | N = 58 |
---|---|
Total consultations recorded | 85 |
Initial (median duration in minutes, range) | 58 (10, 1–24) |
Subsequent including second, third and/or fourth | 27 |
CONTRACT participation status | |
Consent (v decline) | 38 (v 20) |
Treatment allocation | |
Non-operative (v appendicectomy) | 19 (v 19) |
Patient characteristics | |
Median age (range) | 10 (4–15) |
Males (v females) | 39 (v 19) |
Families interviewed | N = 28 |
Interview median duration in minutes (range) | 59 (22–89) |
Format of interview | |
Face-to-face (v telephone) | 12 (v 16) |
Patient characteristics | |
Median age (range) | 11 (5–15) |
Males (v females) | 21 (v 7) |
Health professionals interviewed | N = 35 |
Total interviews recorded | 40 |
Initial (median duration in minutes, range) | 35 (48, 20–79) |
Subsequent (median duration in minutes, range) | 5 (51, 39–69) |
Health professional’s role | |
Surgeon | 25 |
Research nurse | 7 |
Ward nurses | 3 |
Format of interview | |
Face-to-face (v telephone) | 23 (v 17) |
Identifying opportunities to enhance informed consent and recruitment
Imbalanced content and presentation of trial arms
Surgeon 7: Do you want to know a bit more about it [CONTRACT]?Mother 6: Um, I don’t think... no, I’d just rather get…Surgeon 7: You’d just rather get on?Mother 6: Yeah, the normal way.Surgeon 7: Okay, that’s absolutely fine. Um, so in that case, what we’ll try to do is take his appendix out, okay.(Cons_Surgeon7_Family6_Declined)
It's difficult when you're just trying to get people into the study… if the situation arose again and there was some situation where they were… very pro … the non-operative arm, then that would have been an opportunity to, to go through that. But at that point, you know, it's a success, it's a tick in the success column, we just take it and run. (Int_Surgeon57)
What I didn’t want to do was to be the person who pushes it too much and they complain. (Int_Surgeon18)
Preference for appendicectomy | Preference for non-operative treatment |
---|---|
Surgery as standard care: “I’ve been doing surgery now for 15 years, so appendicitis equals an operation and it’s quite difficult to change your mindset.” (Int_Surgeon54) | Experience of antibiotics as effective: “You watch some patients get better with antibiotics and it’s really, really tempting to just not sort of bother with the trial and just offer patients antibiotics occasionally, which I haven’t done. But, you know, it’s quite hard to sort of, you know, keep your own personal views under control as you see it unfold.” (Int_Surgeon17) |
Patient perceived as more poorly leading to doubts about eligibility: “How they look and if they obviously look pretty sick, then I think you’ll be more reluctant to do something that doesn’t feel standard… He was definitely eligible, for sure. But… he looked like he had appendicitis which, which is not entirely well.” (Int_Surgeon37) | Patient perceived as less poorly leading to doubts about eligibility: “We do agree that for the selected group of patients [antibiotics] would work… The irony is that sometimes we have selected certain people that we think ‘oh, they definitely, it’s more the early appendicitis type and not the complicated appendicitis and would definitely do well’, but … sometimes you feel sad that someone that looked really well and would do really well with antibiotics alone, is then randomised to having an operation.” (Int_Surgeon11) |
Avoiding contributing towards antibiotic resistance: “You could argue that more [families] than not will go towards the antibiotics rather than surgery. Unless of course you have more scare stories about how antibiotic resistance is coming in… that may well influence how people decide in the longer term.” (Int_Surgeon12) | |
Fewer surgical training opportunities: “You take away these straightforward… training operations which can become useful … for people building basic skills... In the longer term you … have to become more inventive or find different ways … for people to gain their surgical experience and that could be a counter risk going forward.” (Int_Surgeon12) |
Time pressures in urgent care trials
Challenges involving children and young people in decision-making
Surgeon 8: Did the video make any sense to you [child] or are you feeling a bit too sore?Child 42: [Crying] … too sore.(Cons_Surgeon8_Child42_Age11_Declined)Child 33: It was hard for me to concentrate…Mother 33: The lady was asking him questions, wasn’t she? And you were just going, ‘Oh I just want it, I just want to stop it’.(Int_Family33_Age12_Declined)
When [the surgeon] went through all the complications… I even said to the doctor… “does he need to, does he really need to know this?” … when they’re in that much pain, and frightened anyway, I don’t think they need to know all of that… perhaps those conversations should be made outside the room, you know, away from the child. (Int_Mother44_App)
I use that [difference of opinion] as fuel to try and recruit them into the study… there's a disagreement here within the family, let's take it out of your hands as a family and, let the computer decide sort of thing. (Int_Surgeon10)
Post-randomisation factors that may influence retention
I was talking to a nurse… the consultant came round and said ‘no, sorry, she’s not got it’, I was like, ‘What? Not got what? What?’ So that was a bit of a blow. I think I’d rather have been told away from her [daughter]… that felt like it was thrown at me. (Int_Mother32_App)
So she’d had all the delay with the drip, it didn’t work... I have felt a bit guilty that maybe if I’d have gone with my initial instinct, which was to just get the operation over and done with… that she might not have had it perforate. (Int_Mother45_NOT)
Discussion
(1) Present the trial arms in a balanced way in recruitment consultations, using neutral terminology and emphasise clinical equipoise. (2) Elicit and acknowledge family treatment preferences. Where possible, explore the reasons underlying these preferences and provide information to balance preferences and address any misconceptions. (3) Involve children and young people in research discussions and decision-making as consistent with guidance from the UK Nuffield Council on Bioethics [5]. This recommends that where possible, decisions about research should be shared decisions by children and their parents. It adds that “children should be as involved in decisions as they wish, and are able to be. Where children and young people have sufficient maturity and understanding, but are not yet treated legally as adults, professionals should seek consent both from children and from their parents.” (4) Some parents may be anxious about what their child hears about treatment procedures and risks. It is important to be sensitive to these anxieties when discussing a trial. (5) Provide families with advance information about how a child’s treatment will be managed pre-randomisation and in both treatment arms. Where relevant, this should include the timing of trial treatments and the timeframe in which families should expect to see an improvement in their child’s conditions. Doing so may help to reduce families’ anxieties and enhance trial recruitment and retention. (6) Parents may link treatment delays to the additional procedures required for the trial and this could discourage them from participating, or remaining, in the trial. Where possible, health professionals should avoid delays in delivering treatments pre and post-randomisation. This may also help to reduce families’ anxieties and improve trial recruitment and retention. (7) In cases where families’ treatment preferences conflict, randomisation may offer a means to resolve this conflict. Sensitively convey treatment arm allocation to families. If a child is upset with treatment allocation, exploring their anxieties and concerns about treatment may help to allay their concerns. Indeed, exploring and balancing treatment preferences pre-allocation could help prevent such difficulties, especially if a child is subsequently allocated to their non-favoured treatment and this is not available outside of the trial. Such discussions may help to avoid families withdrawing from the trial because they do not want to continue with the allocated treatment. If the child remains upset about the prospect of continuing with the treatment they have been allocated to, the opportunity of withdrawal and treatment options outside of the trial should be discussed. (8) Develop a strategy to allow families to indicate when they have made a decision regarding participation, so minimising delays from the perspective of families. This will help to reduce families’ anxieties about the condition progressing, avoid compromising their trust in health professionals and enhance trial recruitment. Future work should explore how best to implement such a strategy in time urgent settings. (9) Consider staffing strategies to support health professionals in recruiting families outside of normal working hours. (10) Avoid making statements to families that convey retrospective judgements about the suitability of a participant for one or other treatment arm after randomisation. Be aware of this particularly when discussing surgical findings with a trial participant's family after surgery. Explaining that non-operative treatment may have been inappropriate may deter their trust, which is a cornerstone of recruitment and retention in trials. |