Background
The NIHR strategy Best Research for Best Health (2021) highlights inclusion within the five key operating principles, from ensuring there is opportunity for everyone to participate in research through to providing opportunity for researchers from different disciplines, specialisms, geographies and backgrounds to develop and progress a career in research. Within this chapter we will demonstrate how the study team considered equality, diversity and inclusion within the PERMIT study team, PPIE participants and PERMIT study participants, both patients and parents.
PERMIT study team
The PERMIT study team was assembled to reflect expertise on the subject of rehabilitation and mobilisation and paediatric intensive care. The study team was composed of eight females, eight males. Ten of the study team were affiliated to eight NHS organisations, in a range of different geographical areas. These organisations had a wide variety of service users from a wide range of socioeconomic backgrounds. Early rehabilitation and mobilisation is an intervention which requires MDT involvement and the study team represented this with three paediatric intensivists (BS/KM/NP), two consultant paediatric neurologists (FK/RF), two physiotherapists (JT/MG), two registered nurses (JMan/JMen), an OT (JMc) and a psychologist (GC). From 2018 when the PERMIT study funding was awarded more junior members of the PERMIT team were supported with their career progression and development opportunities. JT was successfully appointed to a PhD, University of Birmingham (2020). JMc completed her PhD and was successfully appointed to Lecturer at the University of Salford. JMen was initially responsible for PPIE but went on to become second author on the national survey paper and was supported to lead the process evaluation within Phase 3.
Patient and public involvement and engagement
In Chapter 7 we report in full on our approach to PPIE. In total our PPIE participants included mothers (n = 6), fathers (n = 4), and one sibling of infants and children who had experienced an admission to PICU and young people naive to PICU (n = 2). The current age of the child admitted to PICU (n = 9) ranged from 1 month to <16 years of age and the reason for admission ranged from single organ failure (respiratory) in children who had been previously fit and well, through to children with multiple health conditions and rare diseases. All the families we engaged with could speak and read English and felt able to contribute to PPIE activities, although it was not the first language for at least three parents. Three participants identified as Asian and one parent as black, although parental ethnicity of PPIE participants was not fully reported. Parents of children admitted to two NHS organisations – Kings College Hospital, London, and Birmingham Women’s and Children’s NHS Foundation Trust – were approached about PPIE engagement. Both organisations have a local population, as well as families referred to the centre due to specialist services. Both perspectives were represented by participants with our PPIE work.
PERMIT study participants
Question 1: who should my trial results apply to?
Children and young people
Early rehabilitation and mobilisation is an intervention which is believed to be useful for all patients admitted to PICU. It was therefore important for the feasibility study to be as inclusive as possible, including infants and children of all ages 0–<16 years, admitted for PICU care either electively or as an emergency. The only exclusion criteria were if the parents/legal guardians chose to opt out (Phase 1) or declined consent (Phase 3) or if there was a local decision by the clinical team/principal investigator not to include the patient. CYP are recognised to be an under-served group with respect to research opportunities140 and recruitment of critically ill CYP to research is low.141 Fewer than 1 in 100 admissions to PICU globally are recruited to a clinical trial, compared to 1 in 10 adults in adult ICU,142 and a recent review identified that <1% of patients undergoing cardiac surgery are currently recruited to research.143 The PERMIT study therefore set out to be inclusive, opening the observational study in 50% of all UK PICUs (n = 15) to ensure participants from across the UK had the opportunity to participate. All CYP admitted to participating PICUs for over 48 hours were then eligible for inclusion. This ensured that some of the most vulnerable patients, for example CYP with cognitive impairments, learning and physical disabilities and multiple health conditions, were eligible for participation.
We recruited 169 participants in the Phase 1 observational study and 30 participants were recruited to the Phase 3 study. The ethnicities of CYP recruited across the two phases of the study were: white 116 (79%), Asian 20 (14%), black 15 (10%), mixed 4 (3%), other 2, not stated 20 (14%). When this is compared to the data collected by one study67 of patients admitted to PICU (2018–20) we can see that the ethnic diversity of the study participants’ is representative of the ethnicity of all UK/Republic of Ireland PICU admissions: white: 75%, Asian 12.5%, black 5.4%, mixed 3.6%, other 3.5%. Overall there were no differences in our planned trial population and those who successfully participated.
Parents
All parents of children admitted to PICU and approached for the feasibility study (Phase 3) were also offered the opportunity to be study participants and provide feedback about their child and family experience through questionnaires (21/30) and an additional optional interview (n = 14 participated). There were no exclusion criteria, although we were unable to provide translated versions of the validated questionnaires and we did not have the option to interview participants in any language other than English. In addition, we sought to hear the voice of parents who declined their child’s participation in the study. This perspective is seldom heard and the four families which this applied to were all offered the opportunity. Unfortunately, this was declined by all four families.
Are the groups identified in Question 1 likely to respond to the treatment in different ways?
A number of previous ERM studies have excluded patients <3 years of age,20,15 even though 60% of UK PICU admissions are <36 months.62 The PERMIT Phase 3 study team was therefore keen to ensure that families of infants were offered the opportunity of participation. This was successfully achieved across the three study sites with 9/30 (30%) participants under 12 months of age. We were also concerned to ensure that the study captured patients at risk of or experiencing multiple organ failure. Twenty-seven per cent (n = 8) of patients were admitted following surgery, including two patients who had undergone cardiac surgery. Other admission reasons included trauma (n = 2), infectious/inflammatory (n = 2) and neurosurgery (n = 1). In addition, 63% of recruited patients had an underlying disability (mild-severe) as indicated by a baseline POPC score. We therefore feel that opportunities to participate in PERMIT were offered equitably and ensured that under-served CYP and families had an opportunity to participate in research.
Will my trial intervention and/or comparator make it harder for any of the groups identified in Question 1 to engage with the intervention and/or comparator?
Evidence has shown that admission to PICU is extremely stressful for parents and many find it difficult to consider research during the initial few days.141 Our concern was that this would then serve as a barrier to families who were approached about the study for a full informed consent. Our PPIE work indicated that an opt-out consent approach would be appropriate in Phase 1 (observational only), which was confirmed by 100% (n = 169) of parents choosing for their child’s data to be included in the study. In Phase 3 an informed consent approach was required; however, steps were taken to help parents to understand each step of the study and reduce the stress associated with participation. Study participants endorsed this approach and, importantly, helped provide vital insight into the low perception of risk associated with a future trial. A future trial could therefore proceed with an opt-out consent, which helps facilitate research engagement for a wider range of patients and families.
Will the way I have planned and designed my trial make it harder for any of the groups identified in Question 1 to consider taking part?
We worked hard with our PPIE participants to design the trial and the patient-facing information as clearly as possible given the challenging situation eligible families were in. We also provided thorough training within the site initiation visit (SIV) with sites to discuss the importance of a sensitive approach to families and the value of the staged informed consent approach. We view the relatively low decline rate of 4/34 (12%) as testament to the clear participant information sheets and support of the research delivery teams. One aspect where we were mindful of ensuring choice was in the method of completing outcome measures. We did not want to digitally discriminate or disadvantage families so offered outcome measures in a number of different formats, including paper, online and completed with a researcher by phone.
Reflections and areas for improvement
One of the challenges for future research is about developing study information to help make research more accessible. Families suggested access to information leaflets on YouTube and opportunities to learn more about research in advance of a PICU admission when there is more time to consider what is involved. We also recognise that CYP want to be more involved with decision-making about research, but with the complications of assent while intubated and sedated we need to do more work to consider how we can better prepare those coming for an elective admission.
Upon reflection we realise that to demonstrate evidence about addressing equality, diversity and inclusion, we need to identify and measure relevant metrics. In our PPIE work we were cautious about collecting ‘unnecessary data’ and did not record or ask parents for information such as their ethnicity, age, employment status, number of other children and their own health status, all of which help to demonstrate that under-served communities are being included. In the future we will adopt a more standardised way of capturing these data so we can ensure a wider variety of perspectives are captured.