Protective parents and permissive children: what qualitative interviews with parents and children can tell us about the feasibility of juvenile idiopathic arthritis trials

Abstract

BackgroundPatient recruitment can be very challenging in paediatric studies, especially in relatively uncommon conditions, such as juvenile idiopathic arthritis (JIA). However, involving children and young people (CYP) in the design of such trials could promise a more rapid trajectory towards making evidence-based treatments available. Studies involving CYP are advocated in the literature but we are not aware of any early stage feasibility studies that have qualitatively accessed the perspectives of parents and CYP with a long term condition to inform design and conduct of a trial. In the context of a feasibility study to inform the design of a proposed randomised controlled trial of corticosteroid induction regimen in JIA, we explored families’ perspectives on the proposed trial and on JIA trials generally.MethodsWe analysed interviews with 27 participants (8 CYP aged 8–16 years and 19 parents) from four UK paediatric rheumatology centres. CYP had recently received corticosteroids to treat JIA. Audio-recorded interviews were transcribed and analysed thematically, drawing on the Framework Method.ResultsBoth parents and CYP were capable of engaging with the logic of the proposed trial but pointed to challenges with its design. Treatment preferences influenced willingness to participate in the proposed trial. The preferences of older children and their parents often differed, with CYP being more willing to participate in the proposed trial than parents. Families’ current treatment preferences were largely informed by past positive and negative treatment experiences. Some participants also indicated that their treatment preferences were influenced by those of their clinicians.ConclusionPrevious research has typically focused on deficits in patients’ understandings of trials. We found that both parents and CYP understood trial concepts and were able to identify potential flaws in the proposed trial. We propose recommendations to optimise the design of a planned corticosteroid induction regimen trial in JIA. Accessing both parents’ and CYP’s perspectives helps to identify and address recruitment challenges, which will ultimately optimise informed consent and future recruitment.Electronic supplementary materialThe online version of this article (10.1186/s12969-018-0293-2) contains supplementary material, which is available to authorized users.

Conservative treatment for uncomplicated appendicitis in children: the CONTRACT feasibility study, including feasibility RCT

“…56 This multiperspective approach offers a comprehensive approach to identifying barriers to and facilitators of recruitment, to enhancing families' experience of the process and to informing future trial design. 59 In this section, we examine the effect of recruitment training (informed by the communication study findings) on health professionals' CONTRACT consultations with families and discuss the strengths and weaknesses of the communication study. We offer recommendations (see Appendix 2) to inform a future definitive trial to compare non-operative treatment with appendicectomy, and discuss the broader implications of the findings for the design and conduct of surgical versus non-surgical trials, paediatric trials and research conducted in an acute setting.…”

Different corticosteroid induction regimens in children and young people with juvenile idiopathic arthritis: the SIRJIA mixed-methods feasibility study

“…Hence, any clinical trial involving treatment requires careful and rigorous development with meaningful input from CYP and their families from the outset, to mitigate against challenges in the delivery of the clinical trial itself. 125 The survey that was conducted after the consensus meeting was completed by 45 HCPs and 16 CYP and their families. This allowed a wider group of individuals to provide their opinion in the choice of outcomes that should be used in any future trial.…”

“…The subsequent discussions were then useful in clarifying the 10 outcome measures that had previously been selected for potential inclusion in a feasibility study, helping to eliminate misunderstanding, particularly among non-HCPs. 119 To add additional context to the SIRJIA consensus meeting, participants were given a short presentation that highlighted the results from the preceding qualitative study that explored families' views on outcomes of importance to them in receiving CS treatment for JIA, 125 as part of the larger SIRJIA study. 36 Stage 4: group-based discussion (health-care professionals alongside children and young people with families) of the results of the first voting exercise and the inclusion/exclusion criteria for the prospective feasibility study…”

The importance of children and young person involvement in scoping the need for a paediatric glucocorticoid-associated patient reported outcome measure

“…Glucocorticoid medications offer potential for rapid clinical improvement, but frequently lead to side effects that adversely impact HRQOL. Many studies looking at the patient experience within paediatric rheumatic diseases, have found the burden of glucocorticoid treatment to be a recurring theme [ 14 – 17 ]. These range from short-term effects that may go unrecognised by clinicians (e.g., weight gain, anxiety, skin changes and poor sleep) to long-lasting adverse events (e.g., delayed growth and puberty, diabetes, loss of bone mass and fractures) [ 15 ].…”