Summary of main findings
The literature review showed that although there is sufficient evidence to support the use of IACI injections in CYP with JIA, evidence for the use of other methods of administration of CSs and standardised dosing regimens is still lacking.
Although the qualitative study with CYP and their families did not identify one treatment as unsuitable overall, it showed the importance of taking account of CYP and parent treatment preferences in the design and conduct of any future RCT. Such a RCT would need to ensure that all of the treatments that are being investigated are suitable for all patients with JIA and, if this is not the case, eligibility criteria should be amended.
A future trial should be as accessible as possible to CYP and their families, for example by combining trial follow-up assessments with clinic appointments.
The national survey of clinical practice showed that there is no standard treatment for CYP with a new diagnosis of JIA or for those who are undergoing a flare.
Health-care professionals who took part in the national survey indicated that they would be willing to randomise CYP into a future trial.
A consensus process involving CYP, their families and HCPs chose the JADAS-71 as an appropriate primary outcome.
There were 95 CYP who were registered into the feasibility study. Missing data were highlighted as an issue for the JADAS-71, but the cJADAS-71 could be used in its place. Future trials should ensure that adequate monitoring is in place to ensure that any issues with regard to missing data are highlighted as early as possible.
Two trial protocols were considered by HCPs as the most appropriate to answer key questions regarding the most effective method of administrating CSs.
Overall conclusions
This mixed-methods study has confirmed the lack of a published evidence base for the CS regimen of choice for use in new or flaring JIA.
We have shown that this is an important question for CYP with JIA, their families and HCPs alike, as CSs are a long-established part of treatment in JIA, but decisions as to the CS route and dose are typically devolved to clinicians based on their opinion and experience, coupled with patient choice.
We have demonstrated excellent agreement and ‘buy-in’ to a multicentre study and have developed two different possible study protocols that have been worked up in a truly open and consensus-derived manner.
The unit-based screening log numbers, which revealed 250 patients screened by 12 centres over 6 weeks, coupled with double the anticipated recruitment to the feasibility study (with 95 patients recruited from 15 centres), show that there are enough CYP with JIA currently receiving courses of CSs.
The involvement of CYP, their families and HCPs led to a consensus in the choice of a composite primary outcome in the form of the cJADAS. Two trial protocols were developed and any future trial should consider the use of the treatment regimens and designs that have been discussed.
It is important that the results of this research are disseminated as widely as possible; the current outputs from this study are presented in Appendix 6.
