Effectiveness and cost-effectiveness of a personalised self-management intervention for living with long COVID: protocol for the LISTEN randomised controlled trial.

BACKGROUND: Individuals living with long COVID experience multiple, interacting and fluctuating symptoms which can have a dramatic impact on daily living. The aim of the Long Covid Personalised Self-managemenT support EvaluatioN (LISTEN) trial is to evaluate effects of the LISTEN co-designed self-management support intervention for non-hospitalised people living with long COVID on participation in routine activities, social participation, emotional well-being, quality of life, fatigue, and self-efficacy. Cost-effectiveness will also be evaluated, and a detailed process evaluation carried out to understand how LISTEN is implemented. METHODS: The study is a pragmatic randomised effectiveness and cost-effectiveness trial in which a total of 558 non-hospitalised people with long COVID will be randomised to either the LISTEN intervention or usual care. Recruitment strategies have been developed with input from the LISTEN Patient and Public Involvement and Engagement (PPIE) advisory group and a social enterprise, Diversity and Ability, to ensure inclusivity. Eligible participants can self-refer into the trial via a website or be referred by long COVID services. All participants complete a range of self-reported outcome measures, online, at baseline, 6 weeks, and 3 months post randomisation (the trial primary end point). Those randomised to the LISTEN intervention are offered up to six one-to-one sessions with LISTEN-trained intervention practitioners and given a co-designed digital resource and paper-based book. A detailed process evaluation will be conducted alongside the trial to inform implementation approaches should the LISTEN intervention be found effective and cost-effective. DISCUSSION: The LISTEN trial is evaluating a co-designed, personalised self-management support intervention (the LISTEN intervention) for non-hospitalised people living with long COVID. The design has incorporated extensive strategies to minimise participant burden and maximise access. Whilst the duration of follow-up is limited, all participants are approached to consent for long-term follow-up (subject to additional funding being secured). TRIAL REGISTRATION: LISTEN ISRCTN36407216. Registered on 27/01/2022.

Sjögren's syndrome and pregnancy: a Portuguese case-control study.

Introduction: Pregnancy in patients with autoimmune disorders is associated with an increased risk of adverse outcomes. Sjögren's syndrome (SS) is one of the most common among autoimmune diseases. Presently data regarding the impact of SS on obstetric outcomes are scarce and inconclusive. This study aims to evaluate the impact of SS on maternal-fetal and neonatal outcomes compared with pregnancy outcomes in the general population. Material and methods: A retrospective case-control study included 26 pregnancies in SS patients and a healthy control group (CG), followed in a Portuguese tertiary center, between 2015 and 2020. Baseline maternal data were collected, and maternal-fetal and neonatal outcomes were evaluated. Statistical analysis used SPSS 25.0, and a p-value of 0.05 was considered statistically significant. Results: All pregnancies occurred after the diagnosis of SS, with a mean exposure time between diagnosis and pregnancy of 4.92 ±2.78 years. In the SS group, the incidence of ANA, anti-Ro/SSA, and anti-La/SSB antibodies positivity was 80.8%, 61.5%, and 46.2%, respectively. Hydroxychloroquine (HCQ) was used in 57.7%.Miscarriage was significantly higher in the SS group (19.2% vs. 1.8%, p < 0.01). There was a higher prevalence of fetal growth restriction (OR 11.16, 95% CI: 0.96-129.26). Preterm delivery (9.5% vs. 5.6%, p = 0.503) and mean birth weight (2998.16 g vs. 3155.79 g, p = 0.178) did not differ significantly between the groups. In the SS group, admission to the neonatal intensive care unit (NICU) rate was increased (OR 71.67, 95% CI: 3.78-1357.16). Three pregnancies were complicated by congenital heart block (CHB) (14.3% vs. 0%, p = 0.015). In all cases, the diagnosis was performed during second trimester of pregnancy, and betamethasone was administered. Conclusions: Women with SS had a significantly higher incidence of miscarriage, admission to NICU, and CHB than controls. Congenital heart block was the most critical condition that affects the offspring of mothers with SS. Successful pregnancy in the study group was possible with prenatal monitoring and a multidisciplinary approach.

Supporting self-management after traumatic brain injury: Codesign and evaluation of a new intervention across a trauma pathway.

BACKGROUND: Supported self-management (SSM) is a recognized approach for people with long-term conditions but, despite the prevalence of unmet needs, little is known about its role for people with traumatic brain injury (TBI). OBJECTIVES: To codesign an SSM intervention with people with TBI and evaluate feasibility of implementation through multidisciplinary staff across a trauma pathway. SETTING AND PARTICIPANTS: People who had previously been admitted to a Major Trauma Centre following TBI and family members participated in a series of codesign activities. Staff attended SSM workshops and used the intervention with patients in acute and rehabilitation settings. METHODS: We used Normalization Process Theory constructs to guide and interpret implementation. Knowledge, beliefs and confidence of staff in SSM were assessed through pre- and post-training questionnaires, and staff, patients' and families' experiences were explored through semi-structured interviews. Qualitative data were analysed thematically, and clinical measures were mapped against a matched sample. RESULTS: Codesigned resources were created and used within an SSM approach for which 110 staff participated in training. Evaluation demonstrated significant differences in staff SSM confidence and skills, following training. Qualitative evaluation revealed adoption by staff, and patients' and families' experiences of using the resources. Challenges included reaching staff across complex pathways to achieve collective implementation. CONCLUSION: This is the first project to demonstrate feasibility of SSM for people after TBI starting in an acute trauma setting. Through an open approach to codesign with a marginalized group, the SSM resources were valued by them and held meaning and relevance for staff.