Co-creation of a student-implemented allied health service in a First Nations remote community of East Arnhem Land, Australia

Objectives: To co-create a culturally responsive student-implemented allied health service in a First Nations remote community and to determine the feasibility and acceptability of the service. Design: Co-creation involved a pragmatic iterative process, based on participatory action research approaches. Feasibility and acceptability were determined using a mixed-method pre/postdesign. Setting: The service was in Nhulunbuy, Yirrkala and surrounding remote First Nations communities of East Arnhem Land, Northern Territory, Australia. Participants: Co-creation of the service was facilitated by the Northern Australia Research Network, guided by Indigenous Allied Health Australia leadership, with East Arnhem local community organisations and community members. Co-creation of the day-to-day service model involved local cultural consultants, service users and their families, staff of community organisations, students, supervisors, placement coordinators and a site administrator. Findings: A reciprocal learning service model was co-created in which culturally responsive practice was embedded. The service was feasible and acceptable: it was delivered as intended; resources were adequate; the service management system was workable; and the service was acceptable. Health outcome measures, however, were not appropriate to demonstrate impact, particularly through the lens of the people of East Arnhem. Recommendations for the service included: continuing the reciprocal learning service model in the long term; expanding to include all age groups; and connecting with visiting and community-based services. Conclusion: The co-created service was feasible and acceptable. To demonstrate the impact of the service, measures of health service impact that are important to First Nations people living in remote communities of northern Australia are required

A good life for people living with disability: the story from Far North Queensland

Purpose: People with disability in regional, rural and remote Australia have poorer service access compared to people from metropolitan areas. There is urgent need for reform. This study’s aim was to explore the needs and aspirations of people with lived experience of disability in Far North Queensland (FNQ) to inform a new service framework. Materials and methods: Twenty-five individuals with diverse experience of disability were engaged in semi-structured interviews. Participants were recruited from four sites that differed geographically, culturally, and socioeconomically. Using an inductive then deductive thematic approach to data analysis, statements of needs and aspirations were compiled and aligned with three pre-determined vision statements. Results: Needs and aspirations aligned well with the vision statements which were to: feel “included, connected, safe and supported”; have “opportunities to choose one’s own life and follow one’s hopes and dreams”; and have “access to culturally safe services close to home.” To realise this vision in FNQ, support to navigate and coordinate services across sectors is essential. Conclusion: People of FNQ of all abilities, need and aspire to experience “a good life” like their fellow Australians. Any new service model must focus on providing service navigation and co-ordination amid the complexities of service delivery in FNQ

FNQ Connect: Connecting people, connecting care. A proposal for reform of disability, rehabilitation and lifestyle services for children, young people, adults and older people of FNQ

[Extract] FNQ Connect was created in response to a groundswell of interest and concern from FNQ people with lived experience of disability, their families and communities, together with stakeholders responsible for supporting them. They expressed an urgent need for service reform: current supply of services is outweighed by needs and is well below national standards; inaccuracies in national data conceal these inequities. Existing government, non-government and private services are largely fragmented; opportunities created by NDIS have added another layer of fragmentation. At the same time, demand for services is relentlessly increasing. To ensure quitable investment in services and continuity of care for the people of FNQ, accurate data and integration of services, were required

Alcohol management plans in Aboriginal and Torres Strait Islander (Indigenous) Australian communities in Queensland: community residents have experienced favourable impacts but also suffered unfavourable ones

Background: In Australia, 'Alcohol Management Plans' (AMPs) provide the policy infrastructure for State and Commonwealth Governments to address problematic alcohol use among Aboriginal and Torres Strait Islanders. We report community residents' experiences of AMPs in 10 of Queensland's 15 remote Indigenous communities.\ud \ud Methods: This cross-sectional study used a two-stage sampling strategy: N = 1211; 588 (48%) males, 623 (52%) females aged ≥18 years in 10 communities. Seven propositions about 'favourable' impacts and seven about 'unfavourable' impacts were developed from semi-structured interviews. For each proposition, one-sample tests of proportions examined participant agreement and multivariable binary logistic regressions assessed influences of gender, age (18–24, 25–44, 45–64, ≥65 years), residence (≥6 years), current drinking and Indigenous status. Confirmatory factor analyses estimated scale reliability (ρ), item loadings and covariances.\ud \ud Results: Slim majorities agreed that: AMPs reduced violence (53%, p = 0.024); community a better place to live (54%, 0.012); and children were safer (56%, p < 0.001). More agreed that: school attendance improved (66%, p < 0.001); and awareness of alcohol's harms increased (71%, p < 0.001). Participants were equivocal about improved personal safety (53%, p = 0.097) and reduced violence against women (49%, p = 0.362). The seven 'favourable' items reliably summarized participants' experiences of reduced violence and improved community amenity (ρ = 0.90).\ud \ud Stronger agreement was found for six 'unfavourable' items: alcohol availability not reduced (58%, p < 0.001); drinking not reduced (56%, p < 0.001)); cannabis use increased (69%, p < 0.001); more binge drinking (73%, p < 0.001); discrimination experienced (77%, p < 0.001); increased fines, convictions and criminal records for breaching restrictions (90%, p < 0.001). Participants were equivocal (51% agreed, p = 0.365) that police could enforce restrictions effectively. 'Unfavourable' items were not reliably reflected in one group (ρ = 0.48) but in: i) alcohol availability and consumption not reduced and ii) criminalization and discrimination.\ud \ud In logistic regressions, longer-term (≥ 6 years) residents more likely agreed that violence against women had reduced and that personal safety had improved but also that criminalization and binge drinking had increased. Younger people disagreed that their community was a better place to live and strongly agreed about discrimination. Current drinkers' views differed little from the sample overall.\ud \ud Conclusions: The present Government review provides an opportunity to reinforce 'favourable' outcomes while targeting: illicit alcohol, treatment and diversion services and reconciliation of criminalization and discrimination issues.\ud \u

Digital adaptation of the Standing up for Myself intervention in young people and adults with intellectual disabilities: the STORM feasibility study

Background: Stigma contributes to the negative social conditions persons with intellectual disabilities are exposed to, and it needs tackling at multiple levels. Standing Up for Myself is a psychosocial group intervention designed to enable individuals with intellectual disabilities to discuss stigmatising encounters in a safe and supportive setting and to increase their self-efficacy in managing and resisting stigma. // Objectives: To adapt Standing Up for Myself to make it suitable as a digital intervention; to evaluate the feasibility and acceptability of Digital Standing Up for Myself and online administration of outcome measures in a pilot; to describe usual practice in the context of the coronavirus disease 2019 pandemic to inform future evaluation. // Design: Adaptation work followed by a single-arm pilot of intervention delivery. // Setting and participants: Four third and education sector organisations. Individuals with mild-to-moderate intellectual disabilities, aged 16+, members of existing groups, with access to digital platforms. // Intervention: Digital Standing Up for Myself intervention. Adapted from face-to-face Standing Up for Myself intervention, delivered over four weekly sessions, plus a 1-month follow-up session. // Outcomes: Acceptability and feasibility of delivering Digital Standing Up for Myself and of collecting outcome and health economic measures at baseline and 3 months post baseline. Outcomes are mental well-being, self-esteem, self-efficacy in rejecting prejudice, reactions to discrimination and sense of social power. // Results: Adaptation to the intervention required changes to session duration, group size and number of videos; otherwise, the content remained largely the same. Guidance was aligned with digital delivery methods and a new group member booklet was produced. Twenty-two participants provided baseline data. The intervention was started by 21 participants (four groups), all of whom were retained at 3 months. Group facilitators reported delivering the intervention as feasible and suggested some refinements. Fidelity of the intervention was good, with over 90% of key components observed as implemented by facilitators. Both facilitators and group members reported the intervention to be acceptable. Group members reported subjective benefits, including increased confidence, pride and knowing how to deal with difficult situations. Digital collection of all outcome measures was feasible and acceptable, with data completeness ≥ 95% for all measures at both time points. Finally, a picture of usual practice has been developed as an intervention comparator for a future trial. // Limitations The pilot sample was small. It remains unclear whether participants would be willing to be randomised to a treatment as usual arm or whether they could be retained for 12 months follow-up. // Conclusions: The target number of groups and participants were recruited, and retention was good. It is feasible and acceptable for group facilitators with some training and supervision to deliver Digital Standing Up for Myself. Further optimisation of the intervention is warranted. // Future work: To maximise the acceptability and reach of the intervention, a future trial could offer the adapted Digital Standing Up for Myself, potentially alongside the original face-to-face version of the intervention. // Study registration: This study was registered as ISRCTN16056848. // Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme (NIHR award ref: 17/149/03) and is published in full in Public Health Research; Vol. 12, No. 1. See the NIHR Funding and Awards website for further award information

Alcohol management plans in Aboriginal and Torres Strait Islander (Indigenous) Australian communities in Queensland: Community residents have experienced favourable impacts but also suffered unfavourable ones

Background: In Australia, ‘Alcohol Management Plans’ (AMPs) provide the policy infrastructure for State and Commonwealth Governments to address problematic alcohol use among Aboriginal and Torres Strait Islanders. We report community residents’ experiences of AMPs in 10 of Queensland’s 15 remote Indigenous communities. Methods: This cross-sectional study used a two-stage sampling strategy: N = 1211; 588 (48%) males, 623 (52%) females aged ≥18 years in 10 communities. Seven propositions about ‘favourable’ impacts and seven about ‘unfavourable’ impacts were developed from semi-structured interviews. For each proposition, one-sample tests of proportions examined participant agreement and multivariable binary logistic regressions assessed influences of gender, age (18–24, 25–44, 45–64, ≥65 years), residence (≥6 years), current drinking and Indigenous status. Confirmatory factor analyses estimated scale reliability (ρ), item loadings and covariances. Results: Slim majorities agreed that: AMPs reduced violence (53%, p = 0.024); community a better place to live (54%, 0.012); and children were safer (56%, p < 0.001). More agreed that: school attendance improved (66%, p < 0. 001); and awareness of alcohol’s harms increased (71%, p < 0.001). Participants were equivocal about improved personal safety (53%, p = 0.097) and reduced violence against women (49%, p = 0.362). The seven ‘favourable’ items reliably summarized participants’ experiences of reduced violence and improved community amenity (ρ = 0.90). Stronger agreement was found for six ‘unfavourable’ items: alcohol availability not reduced (58%, p < 0.001); drinking not reduced (56%, p < 0.001)); cannabis use increased (69%, p < 0.001); more binge drinking (73%, p < 0.001); discrimination experienced (77%, p < 0.001); increased fines, convictions and criminal records for breaching restrictions (90%, p < 0.001). Participants were equivocal (51% agreed, p = 0.365) that police could enforce restrictions effectively. ‘Unfavourable’ items were not reliably reflected in one group (ρ = 0.48) but in: i) alcohol availability and consumption not reduced and ii) criminalization and discrimination. In logistic regressions, longer-term (≥ 6 years) residents more likely agreed that violence against women had reduced and that personal safety had improved but also that criminalization and binge drinking had increased. Younger people disagreed that their community was a better place to live and strongly agreed about discrimination. Current drinkers’ views differed little from the sample overall. Conclusions: The present Government review provides an opportunity to reinforce ‘favourable’ outcomes while targeting: illicit alcohol, treatment and diversion services and reconciliation of criminalization and discrimination issues. Keywords: Alcohol, Indigenous, Aboriginal and Torres Strait Islander, Australian, Legal intervention, EvaluationThe study was funded by the National Health and Medical Research Council of Australia (NHMRC, Project Grant #APP1042532) with additional support from the Australian Primary Health Care Research Institute-funded Centre for Research Excellence for the Prevention of Chronic Conditions in Rural and Remote High Risk Populations at James Cook University & University Adelaide. Associate Professor Caryn West is a National Health and Medical Research Council of Australia Early Career Research Fellow (#APP1070931). Professor Clough holds a NHMRC Career Development Award (#APP1046773)

COVAC1 phase 2a expanded safety and immunogenicity study of a self-amplifying RNA vaccine against SARS-CoV-2

BACKGROUND: Lipid nanoparticle (LNP) encapsulated self-amplifying RNA (saRNA) is well tolerated and immunogenic in SARS-CoV-2 seronegative and seropositive individuals aged 18-75. METHODS: A phase 2a expanded safety and immunogenicity study of a saRNA SARS-CoV-2 vaccine candidate LNP-nCoVsaRNA, was conducted at participating centres in the UK between 10th August 2020 and 30th July 2021. Participants received 1 μg then 10 μg of LNP-nCoVsaRNA, ∼14 weeks apart. Solicited adverse events (AEs) were collected for one week post-each vaccine, and unsolicited AEs throughout. Binding and neutralisating anti-SARS-CoV-2 antibody raised in participant sera was measured by means of an anti-Spike (S) IgG ELISA, and SARS-CoV-2 pseudoneutralisation assay. (The trial is registered: ISRCTN17072692, EudraCT 2020-001646-20). FINDINGS: 216 healthy individuals (median age 51 years) received 1.0 μg followed by 10.0 μg of the vaccine. 28/216 participants were either known to have previous SARS-CoV2 infection and/or were positive for anti-Spike (S) IgG at baseline. Reactogenicity was as expected based on the reactions following licensed COVID-19 vaccines, and there were no serious AEs related to vaccination. 80% of baseline SARS-CoV-2 naïve individuals (147/183) seroconverted two weeks post second immunization, irrespective of age (18-75); 56% (102/183) had detectable neutralising antibodies. Almost all (28/31) SARS-CoV-2 positive individuals had increased S IgG binding antibodies following their first 1.0 μg dose with a ≥0.5log10 increase in 71% (22/31). INTERPRETATION: Encapsulated saRNA was well tolerated and immunogenic in adults aged 18-75 years. Seroconversion rates in antigen naïve were higher than those reported in our dose-ranging study. Further work is required to determine if this difference is related to a longer dosing interval (14 vs. 4 weeks) or dosing with 1.0 μg followed by 10.0 μg. Boosting of S IgG antibodies was observed with a single 1.0 μg injection in those with pre-existing immune responses. FUNDING: Grants and gifts from the Medical Research Council UKRI (MC_PC_19076), the National Institute for Health Research/Vaccine Task Force, Partners of Citadel and Citadel Securities, Sir Joseph Hotung Charitable Settlement, Jon Moulton Charity Trust, Pierre Andurand, and Restore the Earth

Digital adaptation of the Standing up for Myself intervention in young people and adults with intellectual disabilities: the STORM feasibility study

Background Stigma contributes to the negative social conditions persons with intellectual disabilities are exposed to, and it needs tackling at multiple levels. Standing Up for Myself is a psychosocial group intervention designed to enable individuals with intellectual disabilities to discuss stigmatising encounters in a safe and supportive setting and to increase their self-efficacy in managing and resisting stigma. Objectives To adapt Standing Up for Myself to make it suitable as a digital intervention; to evaluate the feasibility and acceptability of Digital Standing Up for Myself and online administration of outcome measures in a pilot; to describe usual practice in the context of the coronavirus disease 2019 pandemic to inform future evaluation. Design Adaptation work followed by a single-arm pilot of intervention delivery. Setting and participants Four third and education sector organisations. Individuals with mild-to-moderate intellectual disabilities, aged 16+, members of existing groups, with access to digital platforms. Intervention Digital Standing Up for Myself intervention. Adapted from face-to-face Standing Up for Myself intervention, delivered over four weekly sessions, plus a 1-month follow-up session. Outcomes Acceptability and feasibility of delivering Digital Standing Up for Myself and of collecting outcome and health economic measures at baseline and 3 months post baseline. Outcomes are mental well-being, self-esteem, self-efficacy in rejecting prejudice, reactions to discrimination and sense of social power. Results Adaptation to the intervention required changes to session duration, group size and number of videos; otherwise, the content remained largely the same. Guidance was aligned with digital delivery methods and a new group member booklet was produced. Twenty-two participants provided baseline data. The intervention was started by 21 participants (four groups), all of whom were retained at 3 months. Group facilitators reported delivering the intervention as feasible and suggested some refinements. Fidelity of the intervention was good, with over 90% of key components observed as implemented by facilitators. Both facilitators and group members reported the intervention to be acceptable. Group members reported subjective benefits, including increased confidence, pride and knowing how to deal with difficult situations. Digital collection of all outcome measures was feasible and acceptable, with data completeness ≥ 95% for all measures at both time points. Finally, a picture of usual practice has been developed as an intervention comparator for a future trial. Limitations The pilot sample was small. It remains unclear whether participants would be willing to be randomised to a treatment as usual arm or whether they could be retained for 12 months follow-up. Conclusions The target number of groups and participants were recruited, and retention was good. It is feasible and acceptable for group facilitators with some training and supervision to deliver Digital Standing Up for Myself. Further optimisation of the intervention is warranted. Future work To maximise the acceptability and reach of the intervention, a future trial could offer the adapted Digital Standing Up for Myself, potentially alongside the original face-to-face version of the intervention

Point-of-care testing in paediatric settings in the UK and Ireland: A cross-sectional study

Background: Point-of-care testing (POCT) is diagnostic testing performed at or near to the site of the patient. Understanding the current capacity, and scope, of POCT in this setting is essential in order to respond to new research evidence which may lead to wide implementation. Methods: A cross-sectional online survey study of POCT use was conducted between 6th January and 2nd February 2020 on behalf of two United Kingdom (UK) and Ireland-based paediatric research networks (Paediatric Emergency Research UK and Ireland, and General and Adolescent Paediatric Research UK and Ireland). Results: In total 91/109 (83.5%) sites responded, with some respondents providing details for multiple units on their site based on network membership (139 units in total). The most commonly performed POCT were blood sugar (137/139; 98.6%), urinalysis (134/139; 96.4%) and blood gas analysis (132/139; 95%). The use of POCT for Influenza/Respiratory Syncytial Virus (RSV) (45/139; 32.4%, 41/139; 29.5%), C-Reactive Protein (CRP) (13/139; 9.4%), Procalcitonin (PCT) (2/139; 1.4%) and Group A Streptococcus (5/139; 3.6%) and was relatively low. Obstacles to the introduction of new POCT included resources and infrastructure to support test performance and quality assurance. Conclusion: This survey demonstrates significant consensus in POCT practice in the UK and Ireland but highlights specific inequity in newer biomarkers, some which do not have support from national guidance. A clear strategy to overcome the key obstacles of funding, evidence base, and standardising variation will be essential if there is a drive toward increasing implementation of POCT

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