Responding to parents’ well-being needs throughout the COVID-19 pandemic – a critical reflection on the experiences of vulnerable parents and frontline service providers

In March 2020, a range of public health measures were introduced to curb the spread of COVID-19 in Ireland, including the closure of non-essential services and schools, and restricting the movements and social interactions of the majority of the population. The social and economic upheaval caused by these measures led to increased stress, strain and worry for parents, significantly heightening the risk for detrimental effects on well-being. Barnardos, Irelands leading children’s charity, responded quickly to the crisis by adapting its existing therapeutic services and creating a range of new services to support the needs of parents and families. This paper uses the lens of parental well-being to review the situation in Ireland experienced by vulnerable families during the COVID-19 pandemic as a result of the disruptions and the service response. We explore the research background to parental well-being and detail the specific challenges faced by parents as reported in organisational surveys during the pandemic and in feedback from our frontline services. We also outline the complexities for services in responding innovatively and urgently to evolving family needs, and demonstrate facilitators and barriers to engagement. The paper concludes with a summary of the current and anticipated future context for families, and some recommendations for key actions around promoting and sustaining parental well-being

To CAG or not to CAG? Difficulties in determining submission to the Confidentiality Advisory Group: A commentary

The Confidentiality Advisory Group (CAG) is a specialised body that advises the Health Research Authority (HRA) and the Secretary of State for Health on requests for access to confidential information, in the absence of informed consent from its owners. Its primary role is to oversee the safe use of such information and to counsel the governing bodies mentioned above as to whether such use is appropriate or inappropriate. Researchers who seek access to England or Wales-based confidential data, for medical purposes that are in the interest of the public, are typically required to submit an application to this body. However, it is not always clear to researchers whether requests for access to patient data fit within the remit of the CAG or a Trust’s local information governance team. This commentary will, therefore, explore the role of the CAG and reflect on how best to support researchers with this question

Navigating multisite research set-up and approvals: Helping researchers on the ground — a commentary

Confirming multisite studies presents an ongoing challenge for researchers based in England. Those wishing to set up a multisite study must undergo local Research & Development review, in addition to ethical review by a Research Ethics Committee. However, both the documentation required for multisite review and the length of time it takes to complete such a review can cause significant difficulty to researchers and add to research delays. This short article will examine the process of confirming multisite studies and the implications of current practice

Longitudinal Outcomes of Gender Identity in Children (LOGIC): protocol for a prospective longitudinal cohort study of children referred to the UK gender identity development service.

INTRODUCTION: Gender identity development services (GIDS) worldwide have seen a significant increase in referrals in recent years. Many of these referrals consist of children and young people (CYP) who experience gender-related distress. This study aims to improve understanding of outcomes of CYP referred to the UK GIDS, specifically regarding gender identity, mental health, physical health and quality of life. The impact of factors such as co-occurring autism and early social transition on outcomes over time will be explored. METHODS AND ANALYSIS: This is a prospective cohort study of CYP aged 3-14 years when referred to the UK GIDS. Eligible participants will be ≤14 years at the time their referral was accepted and will be on the waitlist for the service when baseline measures are completed. Children aged under 12 years will complete the measures in an interview format with a researcher, while young people aged 12 years and over and their parents/caregivers will complete online or paper-based questionnaires. Participants will complete follow-up measures 12 months and 24 months later. The final sample size is expected to be approximately 500. Logistic regression models will be used to explore associations between prespecified explanatory variables and gender dysphoria. Appropriate regression models will also be used to investigate explanatory variables for other outcomes. Subgroup analyses based on birth-assigned gender, age at referral and co-occurring autistic traits will be explored. ETHICS AND DISSEMINATION: The study has been approved by the Health Research Authority and London - Hampstead Research Ethics Committee (reference: 19/LO/0857). The study findings will be published in peer-reviewed journals and presented at both conferences and stakeholder events. Findings will be used to inform clinical practice

Longitudinal Outcomes of Gender Identity in Children (LOGIC): study protocol for a retrospective analysis of the characteristics and outcomes of children referred to specialist gender services in the UK and the Netherlands.

INTRODUCTION: Specialist gender services for children and young people (CYP) worldwide have experienced a significant increase in referrals in recent years. As rates of referrals increase, it is important to understand the characteristics and profile of CYP attending these services in order to inform treatment pathways and to ensure optimal outcomes. METHODS AND ANALYSIS: A retrospective observational study of clinical health records from specialist gender services for CYP in the UK and the Netherlands. The retrospective analysis will examine routinely collected clinical and outcome measures data including demographic, clinical, gender identity-related and healthcare resource use information. Data will be reported for each service and also compared between services. This study forms part of a wider programme of research investigating outcomes of gender identity in children (the Longitudinal Outcomes of Gender Identity in Children study). ETHICS AND DISSEMINATION: The proposed study has been approved by the Health Research Authority and London-Hampstead Research Ethics Committee as application 19/LO/0181. The study findings will be published in peer-reviewed journals and presented at both conferences and stakeholder events

Acute otitis externa: Consensus definition, diagnostic criteria and core outcome set development.

OBJECTIVE: Evidence for the management of acute otitis externa (AOE) is limited, with unclear diagnostic criteria and variably reported outcome measures that may not reflect key stakeholder priorities. We aimed to develop 1) a definition, 2) diagnostic criteria and 3) a core outcome set (COS) for AOE. STUDY DESIGN: COS development according to Core Outcome Measures in Effectiveness Trials (COMET) methodology and parallel consensus selection of diagnostic criteria/definition. SETTING: Stakeholders from the United Kingdom. SUBJECTS AND METHODS: Comprehensive literature review identified candidate items for the COS, definition and diagnostic criteria. Nine individuals with past AOE generated further patient-centred candidate items. Candidate items were rated for importance by patient and professional (ENT doctors, general practitioners, microbiologists, nurses, audiologists) stakeholders in a three-round online Delphi exercise. Consensus items were grouped to form the COS, diagnostic criteria, and definition. RESULTS: Candidate COS items from patients (n = 28) and literature (n = 25) were deduplicated and amalgamated to a final candidate list (n = 46). Patients emphasised quality-of-life and the impact on daily activities/work. Via the Delphi process, stakeholders agreed on 31 candidate items. The final COS covered six outcomes: pain; disease severity; impact on quality-of-life and daily activities; patient satisfaction; treatment-related outcome; and microbiology. 14 candidate diagnostic criteria were identified, 8 reaching inclusion consensus. The final definition for AOE was 'diffuse inflammation of the ear canal skin of less than 6 weeks duration'. CONCLUSION: The development and adoption of a consensus definition, diagnostic criteria and a COS will help to standardise future research in AOE, facilitating meta-analysis. Consulting former patients throughout development highlighted deficiencies in the outcomes adopted previously, in particular concerning the impact of AOE on daily life

Uncorking the bottleneck in gaining sponsorship for clinical research

Research is essential to advancing clinical treatment, improving treatment outcomes, and evolving healthcare services (NHS England, 2014; NHS England Innovation & Research Unit, 2018). This is recognized by the UK Department of Health, most notably by means of continued multibillion investment in the National Institute for Health Research (NIHR), to ensure the proliferation of applied and clinical research (Department of Health Research and Development Directorate, 2006; National Institute of Health Research, 2017). The focal aim of such investment is to support researchers to succeed in completing world-class research that benefits the public and those using the NHS, thus informing practice and policy. Nevertheless, long-standing issues in transforming research into practice persist, with an estimated lag of 17 years between publication and the introduction of an intervention (Morris et al., 2011). Partly in response to this lag, in November 2017, NHS England and the National Institute for Health Research released ‘Twelve actions to Support and Apply Research in the NHS’ (NHS England in partnership with The National Institute for Health Research, 2017). The goal of this joint statement was to highlight how both the NHS and the NIHR, in addition to other NHS-related bodies, could help tackle systemic and local inefficiencies that obstruct the timely production of research (NHS England in partnership with The National Institute for Health Research, 2017)