Remini-Sing: A Feasibility Study of Therapeutic Group Singing to Support Relationship Quality and Wellbeing for Community-Dwelling People Living With Dementia and Their Family Caregivers

Background: Living at home following a diagnosis of dementia can be difficult for both the person living with dementia (PwD) and their family caregivers (FCG). Active group music participation may provide an avenue for emotional release, offer psychosocial support to caregivers and stimulate meaningful interaction between caregivers and loved ones with dementia. Therapeutic music interventions also have the capacity to facilitate reminiscence and social engagement and can help to manage challenging symptoms associated with dementia, such as anxiety, apathy, and agitation.Method: This feasibility study examined the acceptability of a 20-week therapeutic group singing intervention (Remini-Sing) and quantitative research assessments for PwD/FCG dyads living in the community. Quantitative measures for the following outcomes were tested for sensitivity and acceptability: relationship quality (PwD and FCG); life satisfaction, caregiver satisfaction, flourishing, and depression for FCGs; and anxiety, apathy, agitation, and quality of life for PwD. Quantitative assessments were conducted before, during (midway) and after 20 weeks of participation in a therapeutic singing group attended by the PwD and FCG together. The Remini-Sing intervention incorporated vocal warm ups, singing familiar songs, learning new songs, and opportunities for social interaction. Qualitative interviews were conducted with all dyads that completed the intervention.Results: Twelve PWD/FCG dyads were recruited and enrolled in the study. High participation and retention rates indicated that the intervention was received favorably by participants. There were no statistically significant changes on measures from pre to post intervention. However, favorable baseline scores on relationship quality and wellbeing measures were sustained over the 20-week intervention. The testing of these measures for feasibility also revealed that some were too difficult for PwD and thus yielded questionable results, some were potentially less relevant, and there were likely floor and ceiling effects on several of the measures utilized.Conclusions: This study demonstrated good feasibility for a research protocol and therapeutic group singing intervention for community-dwelling PwD and their FCGs. Participant reflections and researcher observations yielded useful information guiding the selection of quantitative outcome measures for future research in this area

Multiorgan MRI findings after hospitalisation with COVID-19 in the UK (C-MORE): a prospective, multicentre, observational cohort study

Introduction: The multiorgan impact of moderate to severe coronavirus infections in the post-acute phase is still poorly understood. We aimed to evaluate the excess burden of multiorgan abnormalities after hospitalisation with COVID-19, evaluate their determinants, and explore associations with patient-related outcome measures. Methods: In a prospective, UK-wide, multicentre MRI follow-up study (C-MORE), adults (aged ≥18 years) discharged from hospital following COVID-19 who were included in Tier 2 of the Post-hospitalisation COVID-19 study (PHOSP-COVID) and contemporary controls with no evidence of previous COVID-19 (SARS-CoV-2 nucleocapsid antibody negative) underwent multiorgan MRI (lungs, heart, brain, liver, and kidneys) with quantitative and qualitative assessment of images and clinical adjudication when relevant. Individuals with end-stage renal failure or contraindications to MRI were excluded. Participants also underwent detailed recording of symptoms, and physiological and biochemical tests. The primary outcome was the excess burden of multiorgan abnormalities (two or more organs) relative to controls, with further adjustments for potential confounders. The C-MORE study is ongoing and is registered with ClinicalTrials.gov, NCT04510025. Findings: Of 2710 participants in Tier 2 of PHOSP-COVID, 531 were recruited across 13 UK-wide C-MORE sites. After exclusions, 259 C-MORE patients (mean age 57 years [SD 12]; 158 [61%] male and 101 [39%] female) who were discharged from hospital with PCR-confirmed or clinically diagnosed COVID-19 between March 1, 2020, and Nov 1, 2021, and 52 non-COVID-19 controls from the community (mean age 49 years [SD 14]; 30 [58%] male and 22 [42%] female) were included in the analysis. Patients were assessed at a median of 5·0 months (IQR 4·2–6·3) after hospital discharge. Compared with non-COVID-19 controls, patients were older, living with more obesity, and had more comorbidities. Multiorgan abnormalities on MRI were more frequent in patients than in controls (157 [61%] of 259 vs 14 [27%] of 52; p<0·0001) and independently associated with COVID-19 status (odds ratio [OR] 2·9 [95% CI 1·5–5·8]; padjusted=0·0023) after adjusting for relevant confounders. Compared with controls, patients were more likely to have MRI evidence of lung abnormalities (p=0·0001; parenchymal abnormalities), brain abnormalities (p<0·0001; more white matter hyperintensities and regional brain volume reduction), and kidney abnormalities (p=0·014; lower medullary T1 and loss of corticomedullary differentiation), whereas cardiac and liver MRI abnormalities were similar between patients and controls. Patients with multiorgan abnormalities were older (difference in mean age 7 years [95% CI 4–10]; mean age of 59·8 years [SD 11·7] with multiorgan abnormalities vs mean age of 52·8 years [11·9] without multiorgan abnormalities; p<0·0001), more likely to have three or more comorbidities (OR 2·47 [1·32–4·82]; padjusted=0·0059), and more likely to have a more severe acute infection (acute CRP >5mg/L, OR 3·55 [1·23–11·88]; padjusted=0·025) than those without multiorgan abnormalities. Presence of lung MRI abnormalities was associated with a two-fold higher risk of chest tightness, and multiorgan MRI abnormalities were associated with severe and very severe persistent physical and mental health impairment (PHOSP-COVID symptom clusters) after hospitalisation. Interpretation: After hospitalisation for COVID-19, people are at risk of multiorgan abnormalities in the medium term. Our findings emphasise the need for proactive multidisciplinary care pathways, with the potential for imaging to guide surveillance frequency and therapeutic stratification

Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK.

BACKGROUND: A safe and efficacious vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), if deployed with high coverage, could contribute to the control of the COVID-19 pandemic. We evaluated the safety and efficacy of the ChAdOx1 nCoV-19 vaccine in a pooled interim analysis of four trials. METHODS: This analysis includes data from four ongoing blinded, randomised, controlled trials done across the UK, Brazil, and South Africa. Participants aged 18 years and older were randomly assigned (1:1) to ChAdOx1 nCoV-19 vaccine or control (meningococcal group A, C, W, and Y conjugate vaccine or saline). Participants in the ChAdOx1 nCoV-19 group received two doses containing 5 × 1010 viral particles (standard dose; SD/SD cohort); a subset in the UK trial received a half dose as their first dose (low dose) and a standard dose as their second dose (LD/SD cohort). The primary efficacy analysis included symptomatic COVID-19 in seronegative participants with a nucleic acid amplification test-positive swab more than 14 days after a second dose of vaccine. Participants were analysed according to treatment received, with data cutoff on Nov 4, 2020. Vaccine efficacy was calculated as 1 - relative risk derived from a robust Poisson regression model adjusted for age. Studies are registered at ISRCTN89951424 and ClinicalTrials.gov, NCT04324606, NCT04400838, and NCT04444674. FINDINGS: Between April 23 and Nov 4, 2020, 23 848 participants were enrolled and 11 636 participants (7548 in the UK, 4088 in Brazil) were included in the interim primary efficacy analysis. In participants who received two standard doses, vaccine efficacy was 62·1% (95% CI 41·0-75·7; 27 [0·6%] of 4440 in the ChAdOx1 nCoV-19 group vs71 [1·6%] of 4455 in the control group) and in participants who received a low dose followed by a standard dose, efficacy was 90·0% (67·4-97·0; three [0·2%] of 1367 vs 30 [2·2%] of 1374; pinteraction=0·010). Overall vaccine efficacy across both groups was 70·4% (95·8% CI 54·8-80·6; 30 [0·5%] of 5807 vs 101 [1·7%] of 5829). From 21 days after the first dose, there were ten cases hospitalised for COVID-19, all in the control arm; two were classified as severe COVID-19, including one death. There were 74 341 person-months of safety follow-up (median 3·4 months, IQR 1·3-4·8): 175 severe adverse events occurred in 168 participants, 84 events in the ChAdOx1 nCoV-19 group and 91 in the control group. Three events were classified as possibly related to a vaccine: one in the ChAdOx1 nCoV-19 group, one in the control group, and one in a participant who remains masked to group allocation. INTERPRETATION: ChAdOx1 nCoV-19 has an acceptable safety profile and has been found to be efficacious against symptomatic COVID-19 in this interim analysis of ongoing clinical trials. FUNDING: UK Research and Innovation, National Institutes for Health Research (NIHR), Coalition for Epidemic Preparedness Innovations, Bill & Melinda Gates Foundation, Lemann Foundation, Rede D'Or, Brava and Telles Foundation, NIHR Oxford Biomedical Research Centre, Thames Valley and South Midland's NIHR Clinical Research Network, and AstraZeneca

Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK

Background A safe and efficacious vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), if deployed with high coverage, could contribute to the control of the COVID-19 pandemic. We evaluated the safety and efficacy of the ChAdOx1 nCoV-19 vaccine in a pooled interim analysis of four trials. Methods This analysis includes data from four ongoing blinded, randomised, controlled trials done across the UK, Brazil, and South Africa. Participants aged 18 years and older were randomly assigned (1:1) to ChAdOx1 nCoV-19 vaccine or control (meningococcal group A, C, W, and Y conjugate vaccine or saline). Participants in the ChAdOx1 nCoV-19 group received two doses containing 5 × 1010 viral particles (standard dose; SD/SD cohort); a subset in the UK trial received a half dose as their first dose (low dose) and a standard dose as their second dose (LD/SD cohort). The primary efficacy analysis included symptomatic COVID-19 in seronegative participants with a nucleic acid amplification test-positive swab more than 14 days after a second dose of vaccine. Participants were analysed according to treatment received, with data cutoff on Nov 4, 2020. Vaccine efficacy was calculated as 1 - relative risk derived from a robust Poisson regression model adjusted for age. Studies are registered at ISRCTN89951424 and ClinicalTrials.gov, NCT04324606, NCT04400838, and NCT04444674. Findings Between April 23 and Nov 4, 2020, 23 848 participants were enrolled and 11 636 participants (7548 in the UK, 4088 in Brazil) were included in the interim primary efficacy analysis. In participants who received two standard doses, vaccine efficacy was 62·1% (95% CI 41·0–75·7; 27 [0·6%] of 4440 in the ChAdOx1 nCoV-19 group vs71 [1·6%] of 4455 in the control group) and in participants who received a low dose followed by a standard dose, efficacy was 90·0% (67·4–97·0; three [0·2%] of 1367 vs 30 [2·2%] of 1374; pinteraction=0·010). Overall vaccine efficacy across both groups was 70·4% (95·8% CI 54·8–80·6; 30 [0·5%] of 5807 vs 101 [1·7%] of 5829). From 21 days after the first dose, there were ten cases hospitalised for COVID-19, all in the control arm; two were classified as severe COVID-19, including one death. There were 74 341 person-months of safety follow-up (median 3·4 months, IQR 1·3–4·8): 175 severe adverse events occurred in 168 participants, 84 events in the ChAdOx1 nCoV-19 group and 91 in the control group. Three events were classified as possibly related to a vaccine: one in the ChAdOx1 nCoV-19 group, one in the control group, and one in a participant who remains masked to group allocation. Interpretation ChAdOx1 nCoV-19 has an acceptable safety profile and has been found to be efficacious against symptomatic COVID-19 in this interim analysis of ongoing clinical trials

Effects of antiplatelet therapy after stroke due to intracerebral haemorrhage (RESTART): a randomised, open-label trial

BACKGROUND: Antiplatelet therapy reduces the risk of major vascular events for people with occlusive vascular disease, although it might increase the risk of intracranial haemorrhage. Patients surviving the commonest subtype of intracranial haemorrhage, intracerebral haemorrhage, are at risk of both haemorrhagic and occlusive vascular events, but whether antiplatelet therapy can be used safely is unclear. We aimed to estimate the relative and absolute effects of antiplatelet therapy on recurrent intracerebral haemorrhage and whether this risk might exceed any reduction of occlusive vascular events. METHODS: The REstart or STop Antithrombotics Randomised Trial (RESTART) was a prospective, randomised, open-label, blinded endpoint, parallel-group trial at 122 hospitals in the UK. We recruited adults (≥18 years) who were taking antithrombotic (antiplatelet or anticoagulant) therapy for the prevention of occlusive vascular disease when they developed intracerebral haemorrhage, discontinued antithrombotic therapy, and survived for 24 h. Computerised randomisation incorporating minimisation allocated participants (1:1) to start or avoid antiplatelet therapy. We followed participants for the primary outcome (recurrent symptomatic intracerebral haemorrhage) for up to 5 years. We analysed data from all randomised participants using Cox proportional hazards regression, adjusted for minimisation covariates. This trial is registered with ISRCTN (number ISRCTN71907627). FINDINGS: Between May 22, 2013, and May 31, 2018, 537 participants were recruited a median of 76 days (IQR 29-146) after intracerebral haemorrhage onset: 268 were assigned to start and 269 (one withdrew) to avoid antiplatelet therapy. Participants were followed for a median of 2·0 years (IQR [1·0- 3·0]; completeness 99·3%). 12 (4%) of 268 participants allocated to antiplatelet therapy had recurrence of intracerebral haemorrhage compared with 23 (9%) of 268 participants allocated to avoid antiplatelet therapy (adjusted hazard ratio 0·51 [95% CI 0·25-1·03]; p=0·060). 18 (7%) participants allocated to antiplatelet therapy experienced major haemorrhagic events compared with 25 (9%) participants allocated to avoid antiplatelet therapy (0·71 [0·39-1·30]; p=0·27), and 39 [15%] participants allocated to antiplatelet therapy had major occlusive vascular events compared with 38 [14%] allocated to avoid antiplatelet therapy (1·02 [0·65-1·60]; p=0·92). INTERPRETATION: These results exclude all but a very modest increase in the risk of recurrent intracerebral haemorrhage with antiplatelet therapy for patients on antithrombotic therapy for the prevention of occlusive vascular disease when they developed intracerebral haemorrhage. The risk of recurrent intracerebral haemorrhage is probably too small to exceed the established benefits of antiplatelet therapy for secondary prevention. FUNDING: British Heart Foundation

Positive Psychology in Therapeutic Songwriting for People Living with Late-Life Depression—An Intervention Protocol

(1) Background: An increasing number of people are living with late-life depression, yet non-pharmacological treatments to help manage symptoms are limited. Two interventions, positive psychology and music therapeutic songwriting, have independently led to decreased depressive symptoms and an improved wellbeing in older people over 65 years old. (2) Methods: This article describes the development of a therapeutic songwriting program for people living with late-life depression. Knowledge from positive psychology and therapeutic songwriting was combined to maximize the potential benefits. (3) Results: The intervention program has ten weekly 45 min sessions that incorporate elements from positive psychology into therapeutic songwriting. Using a three-song approach encompassing ongoing musical practices, different positive psychology interventions were incorporated to support the experiences associated with a flourishing life. The intervention protocol for older people presented here is distinct from previous deficit-orientated approaches in that it shifts the focus to positive experiences, resources, and the individual’s ability to decrease their own depressive symptoms and improve their wellbeing. (4) Discussion: This protocol presenting a therapeutic songwriting program meets the need to develop new non-pharmacological treatment options. However, further studies are needed to examine the feasibility and impact of the intervention program on late-life depression and wellbeing in older people

The effects of live patterned sensory enhancement on group exercise participation and mood in older adults in rehabilitation

Background: Older adults in rehabilitation often experience barriers to exercise, which may impede recovery. Patterned sensory enhancement (PSE) is a neurologic music therapy intervention for sensorimotor rehabilitation. The use of live music during patterned sensory enhancement (live-PSE) may be particularly beneficial in meeting patient needs and improving older adults' exercise participation and mood during therapy. Objective: To examine the effects of live-PSE on exercise output, exercise adherence, ratings of perceived exertion, and mood for 24 older adult inpatients in a rehabilitation facility attending a group exercise program. Methods: Using a within-subjects design, results from sessions involving exercise instruction and live-PSE (experimental condition) were compared with sessions of exercise instruction alone (control condition). A logbook documenting participant comments and behaviors was also maintained. Results: There were no significant between condition differences for the exercise outcome measures. Between condition session outcome measures for mood were non-significant for all profiles except confusion, which suggested that some participants might have become more confused during sessions with live-PSE. Unsolicited participant comments and behaviors recorded in the logbook indicated that 21 participants perceived experimental sessions positively, 2 reacted negatively, and 1 did not express any preferences. Conclusions: Live-PSE did not significantly improve exercise outcomes and there were indications of increased confusion during experimental sessions for some participants. However, participant comments and behaviors also suggested positive experiences during sessions with live-PSE. Further research to investigate these discrepant results is warranted, and might best be explored using a mixed methods approach

Music interventions and physical activity in older adults: A systematic literature review and meta-analysis

Objective: To determine the effectiveness of music interventions in increasing physical activity in older adults. Methods: Searches until March 2011 were conducted through CINAHL, MEDLINE, EMBASE, PubMED, AMED, PsychINFO, AUSPORT, PEDro, OTseeker, Expanded Academic ASAP, SPORTDiscus, and The Cochrane Library. Selection criteria included older adults, music interventions, physical activity outcomes, and quantitative designs. Two reviewers independently screened records. Study details included objectives, designs, participants, music interventions, physical activity outcomes, and results. Risk of bias was assessed using the PEDro scale. Results: The review included 12 low to moderate quality studies with 309 participants. Three meta-analyses conducted for the review (4 trials and 99 participants) did not demonstrate any within-session differences in comparisons between music and no-music interventions. Two individual trials of moderate quality demonstrated increased capacity to perform physical activity following exercise programs with music over 4 and 8 weeks compared with no-music. There was no evidence that any particular music intervention was superior to another. Conclusion: Evidence from a small number of low to moderate quality trials did not demonstrate within-session improvements for older adults who listen to music during exercise. However, there may be cumulative benefits following programs with music over several weeks

How Singing Can Help People With Dementia and Their Family Care-partners: aAMixed Studies Systematic Review With Narrative Synthesis, Thematic Synthesis, and Meta-integration

Background: Recent research on the efficacy of music-based interventions for people with dementia have focused on specific outcomes and methods, and singing has been noted as a particularly beneficial activity. However, due to heterogeneity of research methods, there is a need to synthesise the findings of both quantitative and qualitative research in order to better understand both the impact and potential mechanisms of singing for people in this population. Method: This systematic review included quantitative, qualitative and mixed-methods studies, and analysed these using a systematic mixed-studies synthesis (with a results-based convergent approach). Quantitative and qualitative data were initially synthesised using a narrative synthesis and thematic synthesis method, respectively, before a final meta-integration method was used to synthesise common themes across the two data forms. Results: Electronic and hand search strategies revealed 1,815 relevant studies, 40 of which met the full eligibility criteria. Narrative synthesis of quantitative data revealed six key outcome areas (quality of life; psychological well-being; cognition; engagement; activities of daily living; care-partner well-being), and thematic synthesis of qualitative data generated seven themes relating to the impact and mechanisms of singing (pragmatic elements; social benefits; mood; identity; memory; flow-on effects; and relationships). Meta-integration identified four key areas relating to the impact and mechanisms of singing for people with dementia and care-partners: psychological well-being, quality of life, cognition, and care-partner well-being. Conclusion: Results from the syntheses suggest that singing can positively impact the lives of people with dementia and their care-partners, although due to heterogeneity of study design and outcome measures, it is difficult to draw conclusions based on quantitative data alone. Qualitative data provides further context and insights from participant perspectives, and when integrated with quantitative data, contextual factors that may influence the benefits that participants experience from singing are revealed. (PsycInfo Database Record (c) 2022 APA, all rights reserved