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

BACKGROUND: For many children and young people (CYP) with paediatric rheumatic conditions, glucocorticoid medications and their associated side-effects have a substantial impact on disease experience. Whilst there are physician-rated measures of glucocorticoid toxicity, no parallel patient reported measure has been developed to date for CYP with rheumatic disease. This manuscript describes a series of public patient involvement (PPI) events to inform the development of a future paediatric glucocorticoid-associated patient reported outcome measure (PROM). METHODS: One large group PPI event was advertised to CYP with experience of glucocorticoid medication use and their parents through clinicians, charities and existing PPI groups. This featured education on the team's research into glucocorticoid medication and interactive polls/structured discussion to help participants share their experiences. Further engagement was sought for PPI group work to co-develop future glucocorticoid studies, including development of a glucocorticoid associated PROM. Quantitative and qualitative feedback was collected from online questionnaires. The initiative was held virtually due to the Covid-19 pandemic. RESULTS: Nine families (n = 15) including 6 CYP joined the large group PPI event. Online pre-attendance and post-attendance questionnaires showed improvement in mean self-reported confidence [1 = not at all confident, 5 = very confident] in the following: what steroid medications are (pre = 3.9, post = 4.8), steroid side effects (pre = 3.8, post = 4.6), patient-reported outcome measures (pre = 2.0, post = 4.5), available research on steroids (pre = 2.2, post = 3.5). Five families (n = 7) were involved in a monthly PPI group who worked alongside the research team to identify priorities in glucocorticoid research, produce age-appropriate study materials, identify barriers to study participation (e.g. accessibility & convenience) and recommend appropriate modalities for dissemination. The participants found discussing shared experiences and learning about research to be the most enjoyable aspects of the initiative. CONCLUSIONS: This PPI initiative provided a valuable forum for families, including young children, to share their perspectives. Here, the authors explore the effective use of PPI in a virtual setting and provide a unique case study for the involvement of CYP in PROM development. The monthly PPI group also identified a need for the development of a new PROM related to glucocorticoid medication use and provided unique insights into how such a study could be structured.

Reviewing fair subject selection considerations for the unique case of post sequelae COVID-19 translational studies.

Fair inclusion of research subjects is necessary to ensure that post-acute sequelae COVID-19 (PASC) research results benefit all members of society. Scientists should conduct research on a broad sample of individuals who represent clinically relevant factors influencing a disease. Without demographic diversity and sociological and environmental variability, research outputs are less likely to apply to different populations and would thus increase health disparities. The goal of this narrative literature review and ethical analysis is to apply fair selection criteria to PASC research studies. We briefly highlight the importance of fair subject selection in translational research and then identify features of PASC, as well as PASC research, that hinder fair inclusion of research participants. We will demonstrate that determining an adequate and representative sample is not simply a matter of ensuring greater diversity; rather, fairness requires a broader evaluation of risks, burdens, and benefits specific to underrepresented populations. We provide recommendations to ensure fair subject selection in PASC research and promote translation toward positive health outcomes for all individuals, including the most vulnerable.

What can families and researchers learn from each other about glucocorticoid medication - Lessons from a virtual patient public involvement event?

Introduction: Patients and public involvement (PPI) events allow families to use their own experience to contribute meaningfully to health research, as well as learn more about research processes and findings. Glucocorticoid medications, or steroids, and their side effects remain a central part of the patient experience across a range of paediatric rheumatic diseases. The research team hosted a virtual PPI event around the use of glucocorticoid medication in children and young people (CYP). Objectives: The aims of the virtual event were to share experiences of glucocorticoid treatment, provide education about the research team's work, and to identify future key CYP/parents that would continue to be involved in a smaller that PPI group to co-develop glucocorticoid associated clinical studies. Methods: The event was advertised to CYP with experience of glucocorticoid medication use and their parents through clinicians (n=4), charities (n=9) and patient groups (n=2), including their associated social media channels. The event was held virtually on Zoom due to Covid-19 restrictions. During the session, the research team shared findings from four on-going studies involving glucocorticoid medications. Interactive polls and structured discussion were used to help participants share their experiences of steroids. Pre- and post-attendance online questionnaires were used to collect quantitative and qualitative feedback about the event. Results: 11 families with a range of conditions necessitating glucocorticoid medication (JIA, Behcet's, Lupus, Nephrotic Syndrome, Allergic Bronchopulmonary Aspergillosis) participated from across the UK. The ages of CYP ranged from 2-26. Participants had used glucocorticoid medication through a variety of administration routes (oral, intravenous, intra-articular, topical, inhaled). The duration of use varied from <1 year to >10 years. Online pre-attendance and post-attendance questionnaires showed an improvement in mean self-reported confidence [1 = not at all confident, 5 = very confident] in the following: what steroid medications are (pre = 3.9, post = 4.8), steroid side effects (pre = 3.8, post = 4.6), patient-reported outcome measures (pre = 2.0, post = 4.5), available research on steroids (pre = 2.2, post = 3.5). Most participants (86%) reported that they were likely or very likely to attend future PPI events. Diversity was seen in the experiences and views of CYP in relation to glucocorticoid medication. Many reported several benefits including rapid improvement in their disease, reduced pain and improved mobility. However, there were a greater number of negative effects reported, impacting upon health-related quality of life, including effects on body image, school, mood and relationships with others. A number of participants reported the most enjoyable part of the event was hearing other participants' experiences. This suggests that PPI events offer avenues for insight and therapeutic benefit through sharing common experiences. Conclusion: PPI initiatives provide a valuable forum for both researchers and families to share their perspectives. They can be a useful educational tool to disseminate research findings that are relevant to patients and improve health research knowledge. Families found the experience to be beneficial and enjoyed the opportunity to share experiences on the effect of glucocorticoid medication on health-related quality of life. Five families opted into further PPI group work to engage in the co-development of future glucocorticoid studies.

COVID-19 and Post-intensive Care Syndrome: Community-Based Care for ICU Survivors

Survivors of critical illness, including those with COVID-19, are likely to experience post-intensive care syndrome (PICS). PICS involves a constellation of physical, cognitive, and mental health problems that can occur following hospitalization in an intensive care unit (ICU). This focused review describes the impact of PICS on an individual’s function, societal participation, and family. Specific evidence-based screening tools for in-home identification of the deficits associated with PICS are recommended. Recognition of PICS through early screening by home health care providers is crucial in order to assemble the physical rehabilitation, mental health, and community resources needed to mitigate the long-term effects of COVID-19 and other critical illnesses. This review concludes with further PICS resources for community-based providers to enhance their knowledge and expertise and to prepare them for caring for COVID-19 and other critical illness survivors. © The Author(s) 2020.