Table 4.

Recommendations to optimise informed consent and recruitment in paediatric urgent care surgical trials

(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.