A realist evaluation of the feasibility of a randomised controlled trial of a digital music and movement intervention for older people living in care homes.

BACKGROUND: Low physical activity in care home residents brings about negative mental health consequences, such as higher levels of depression and loneliness. With advancements in communication technology, particularly during the COVID-19 pandemic, the feasibility and effectiveness of a randomised controlled trial (RCT) of a digital Physical Activity (PA) resource in care homes deserve more research attention. A realist evaluation was used to uncover influencing factors of a feasibility study implementation to inform how a digital music and movement programme would work and under what circumstances this would be most effective. METHODS: Participants were 49 older adults (aged 65 years +) recruited across ten care homes in Scotland. Surveys were administered at baseline and post-intervention comprising psychometric questionnaires on multidimensional health markers validated in older adults with possible cognitive impairment. The intervention comprised 12 weeks of four prescribed digitally delivered movement (n = 3) and music-only (n = 1) sessions per week. An activity coordinator delivered these online resources in the care home. Post-intervention focus groups with staff and interviews with a sub-sample of participants were conducted to gain qualitative data on the acceptability of the intervention. RESULTS: Thirty three care home residents started the intervention, but only 18 residents (84% female) completed both pre- and post-intervention assessments. Activity coordinators (AC) offered 57% of the prescribed sessions, with an average residents' adherence of 60%. Delivery of the intervention did not go as planned due to Covid restrictions in care homes and delivery challenges, including (1) motivation and engagement, (2) changes in cognitive impairment and disabilities of the participants, (3) death or hospitalisation of the participants and (4) limited staffing and technology resources to deliver the programme as intended. Despite this, group participation and encouragement of residents supported the delivery and acceptance of the intervention, with ACs and residents reporting improved mood, physical health, job satisfaction and social support. Improvements with large effect sizes were found for anxiety, depression, loneliness, perceived stress and sleep satisfaction, but no changes in fear of falling, domains of general health or appetite. CONCLUSION: This realist evaluation suggested that this digitally delivered movement and music intervention is feasible. From the findings, the initial programme theory was refined for future implementation of an RCT in other care homes but future research exploring how to tailor the intervention to those with cognitive impairment and/or lacking capacity to consent is needed. TRIAL REGISTRATION: Retrospectively registered at ClinicalTrials.gov NCT05559203.

Incidence of Early Revaccination After Pediatric Allogeneic Hematopoietic Stem Cell Transplant

Background: Infections are a common cause of morbidity and mortality after allogeneic hematopoietic stem cell transplantation (HSCT). Prolonged immune recovery post-HSCT increases the risk of infection and raises concern for poor response to vaccinations. Reimmunization is recommended for all pediatric HSCT patients by transplant and infectious disease organizations1,2, and individual institutions often develop revaccination guidelines. Objective: At Vanderbilt Children's Hospital (VCH), the clinical practice guideline (CPG) instituted in June 2015 recommends early initiation (6 months) of reimmunization in immunologically appropriate patients, starting with Haemophilus influenzae type B (Hib) and pneumococcal conjugate (PCV13) vaccinations. Therefore, we examined the feasibility of early vaccination for allogeneic HSCT patients and determined the causes of delayed or lack of vaccination. Methods:A retrospective chart review of the electronic medical record was conducted under an IRB-approved protocol. Data was gathered and entered in a REDCap database, including dates of vaccination, immune reconstitution studies (IgG concentration, T/B cell subsets) and clinical outcomes [e.g., intravenous immunoglobulin (IVIg) administration, graft versus host disease (GvHD), relapse] through 6-month (+/- 30 days) post-HSCT. Early revaccination was defined as Hib and PCV13 administration within 210 days post-HSCT. Patients not meeting this definition were further examined for factors that led to delay or lack of vaccinations. Patients were included if they were alive without underlying disease progression or graft failure 6-months post-HSCT. Results: Between June 15, 2015 and June 30, 2021, 66 patients met inclusion criteria. Early revaccination occurred in 21/66 patients (32%). Of the 45/66 (68%) that did not receive 6-month vaccinations, the most common reason was concern for impaired immune reconsti- tution (n = 33/45, 73%). Indicators of poor immune recovery included recent IVIg administration (n = 15), ongoing immunosuppression (n = 24), and poor B cell recovery (n = 4);many patients had multiple indications. Other reasons for delay included patient or parent refusal (n = 4), prioritization of COVID vaccinations (n = 3), scheduling conflicts (n = 4), and other (n = 1). Conclusions: Early vaccination occurred in 32% of patients. At 6 months post-HSCT, 50% of patients had poor immune reconstitution resulting in appropriate vaccination delays. However, scheduling conflicts and vaccine hesitancy despite eligibility were small but significant contributors, accounting for 17% of delays. This is a small, single center study but highlights significant challenges with delivery of best practice guidelines. Future directions could include engagement with other institutions regarding best practices to address vaccine hesitancy and to further explore if early revaccination reduces risk of infectious complications post-HSCT.

Identification of Early Features to Differentiate Hospitalized Children Admitted for Suspected MIS-C from Alternative Diagnoses

Background. Multi-system inflammatory syndrome in children (MIS-C) is a rare consequence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). MIS-C shares features with common infectious and inflammatory syndromes and differentiation early in the course is difficult. Identification of early features specific to MIS-C may lead to faster diagnosis and treatment. We aimed to determine clinical, laboratory, and cardiac features distinguishing MIS-C patients within the first 24 hours of admission to the hospital from those who present with similar features but ultimately diagnosed with an alternative etiology. Methods. We performed retrospective chart reviews of children (0-20 years) who were admitted to Vanderbilt Children's Hospital and evaluated under our institutional MIS-C algorithm between June 10, 2020-April 8, 2021. Subjects were identified by review of infectious disease (ID) consults during the study period as all children with possible MIS-C require an ID consult per our institutional algorithm. Clinical, lab, and cardiac characteristics were compared between children with and without MIS-C. The diagnosis of MIS-C was determined by the treating team and available consultants. P-values were calculated using two-sample t-tests allowing unequal variances for continuous and Pearson's chi-squared test for categorical variables, alpha set at < 0.05. Results. There were 128 children admitted with concern for MIS-C. Of these, 45 (35.2%) were diagnosed with MIS-C and 83 (64.8%) were not. Patients with MIS-C had significantly higher rates of SARS-CoV-2 exposure, hypotension, conjunctival injection, abdominal pain, and abnormal cardiac exam (Table 1). Laboratory evaluation showed that patients with MIS-C had lower platelet count, lymphocyte count and sodium level, with higher c-reactive protein, fibrinogen, B-type natriuretic peptide, and neutrophil percentage (Table 2). Patients with MIS-C also had lower ejection fraction and were more likely to have abnormal electrocardiogram. Conclusion. We identified early features that differed between patients with MIS-C from those without. Development of a diagnostic prediction model based on these early distinguishing features is currently in progress.