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Introduction Many people with Parkinson’s (PwP) are not given the opportunity or do not have adequate access to participate in clinical research. To address this, we have codeveloped with users an online platform that connects PwP to clinical studies in their local area. It enables site staff to communicate with potential participants and aims to increase the participation of the Parkinson’s community in research. This protocol outlines the mixed methods study protocol for the usability testing of the platform.Methods and analysis We will seek user input to finalise the platform’s design, which will then be deployed in a limited launch for beta testing. The beta version will be used as a recruitment tool for up to three studies with multiple UK sites. Usability data will be collected from the three intended user groups: PwP, care partners acting on their behalf and site study coordinators. Usability questionnaires and website analytics will be used to capture user experience quantitatively, and a purposive sample of users will be invited to provide further feedback via semistructured interviews. Quantitative data will be analysed using descriptive statistics, and a thematic analysis undertaken for interview data. Data from this study will inform future platform iterations.Ethics and dissemination Ethical approval was obtained from the University of Plymouth (3291; 3 May 2022). We will share our findings via a ‘Latest News’ section within the platform, presentations, conference meetings and national PwP networks.

Introduction Metformin is a medication likely to improve measures of cardiometabolic disturbance in young people with mental illness. Evidence also suggests metformin may improve depressive symptoms. This 52-week double-blind randomised control trial (RCT) aims to investigate the efficacy of metformin pharmacotherapy as an adjunct to a healthy lifestyle behavioural intervention in improving cardiometabolic outcomes, and depressive, anxiety and psychotic symptoms in youth with clinically diagnosed major mood syndromes.Methods and analysis At least 266 young people aged 16–25 presenting for mental healthcare for major mood syndromes who are also at risk for poor cardiometabolic outcomes will be invited to participate in this study. All participants will engage in a 12-week sleep–wake, activity and metabolically focused behavioural intervention programme. As an adjunctive intervention, participants will receive either metformin (500–1000 mg) or placebo pharmacotherapy for 52 weeks.Participants will undergo a series of assessments including: (1) self-report and clinician-administered assessments; (2) blood tests; (3) anthropometric assessments (height, weight, waist circumference and blood pressure); and (4) actigraphy. Univariate and multivariate tests (generalised mixed-effects models) will be used to examine changes in primary and secondary outcomes (and associations with predetermined predictor variables).Ethics and dissemination This study has been approved by the Sydney Local Health District Research Ethics and Governance Office (X22-0017). The results of this double-blind RCT will be disseminated into the scientific and broader community through peer-reviewed journals, conference presentations, social media and university websites.Trial registration number Australian New Zealand Clinical Trials Registry (ANZCTR) Number: ACTRN12619001559101p, 12 November 2019.

Objectives Nosocomial transmission of SARS-CoV-2 has been a significant cause of mortality in National Health Service (NHS) hospitals during the COVID-19 pandemic. The COG-UK Consortium Hospital-Onset COVID-19 Infections (COG-UK HOCI) study aims to evaluate whether the use of rapid whole-genome sequencing of SARS-CoV-2, supported by a novel probabilistic reporting methodology, can inform infection prevention and control (IPC) practice within NHS hospital settings.Design Multicentre, prospective, interventional, superiority study.Setting 14 participating NHS hospitals over winter–spring 2020/2021 in the UK.Participants Eligible patients must be admitted to hospital with first-confirmed SARS-CoV-2 PCR-positive test result >48 hour from time of admission, where COVID-19 diagnosis not suspected on admission. The projected sample size is 2380 patients.Intervention The intervention is the return of a sequence report, within 48 hours in one phase (rapid local lab processing) and within 5–10 days in a second phase (mimicking central lab), comparing the viral genome from an eligible study participant with others within and outside the hospital site.Primary and secondary outcome measures The primary outcomes are incidence of Public Health England (PHE)/IPC-defined SARS-CoV-2 hospital-acquired infection during the baseline and two interventional phases, and proportion of hospital-onset cases with genomic evidence of transmission linkage following implementation of the intervention where such linkage was not suspected by initial IPC investigation. Secondary outcomes include incidence of hospital outbreaks, with and without sequencing data; actual and desirable changes to IPC actions; periods of healthcare worker (HCW) absence. Health economic analysis will be conducted to determine cost benefit of the intervention. A process evaluation using qualitative interviews with HCWs will be conducted alongside the study.Trial registration number ISRCTN50212645. Pre-results stage. This manuscript is based on protocol V.6.0. 2 September 2021.

Introduction The assistant in medicine is a new and paid role for final-year medical students that has been established in New South Wales, Australia, as part of the surge workforce management response to the COVID-19 pandemic. Eligibility requires the applicant to be a final-year medical student in an Australian Medical Council-accredited university and registered with the Australian Health Practitioner Regulation Agency. While there are roles with some similarities to the assistant in medicine role, such as assistantships (the UK) and physician assistants adopted internationally, this is completely new in Australia. Little is known about the functionality and success factors of this role within the health practitioner landscape, particularly within the context of the COVID-19 pandemic. Given the complexity of this role, a realist approach to evaluation has been undertaken as described in this protocol, which sets out a study design spanning from August 2020 to June 2021.Methods and analysis The intention of conducting a realist review is to identify the circumstances and mechanisms that determine the outcomes of the assistant in medicine intervention. We will start by developing an initial programme theory to explore the potential function of the assistant in medicine role through realist syntheses of critically appraised summaries of existing literature using relevant databases and journals. Other data sources such as interviews and surveys with key stakeholders will contribute to the refinements of the programme theory. Using this method, we will develop a set of hypotheses on how and why the Australian assistants in medicine intervention might ‘work’ to achieve a variety of outcomes based on examples of related international interventions. These hypotheses will be tested against the qualitative and quantitative evidence gathered from all relevant stakeholders.Ethics and dissemination Ethics approval for the larger study was obtained from the Western Sydney Local Health District (2020/ETH01745). The findings of this review will provide useful information for hospital managers, academics and policymakers, who can apply the findings in their context when deciding how to implement and support the introduction of assistants in medicine into the health system. We will publish our findings in reports to policymakers, peer-reviewed journals and international conferences.

Introduction Worsened cardiometabolic profiles in youth with mental ill health have been associated with a number of modifiable lifestyle risk factors. It is becoming increasingly evident that clinical interventions need to be multimodal in focus to improve mental health symptoms and the physical health symptoms in this already at-risk cohort.Methods and analysis This 12-week pilot clinical trial examines the efficacy, feasibility and acceptability of an adjunctive online psychoeducation programme for improving cardiometabolic risk parameters and affective symptoms in a transdiagnostic sample of at least 44 young people aged 16–25 years presenting for mental healthcare for mood and/or psychotic syndromes (including anxiety, depression, bipolar disorder and psychosis). Individuals will be invited to participate in a pilot clinical trial for a structured online psychoeducation programme incorporating nutritional, physical activity, sleep–wake and healthy lifestyle information, delivered fortnightly over six online modules. Participants will undergo a series of assessments including: (1) self-report and clinician administered assessments determining mental health symptomatology; (2) fasting blood tests to assess cardiometabolic markers (fasting insulin, fasting glucose and blood lipids); (3) anthropometric assessments (height, weight, waist circumference and blood pressure); and (4) sleep–wake behaviours and circadian rhythm assessments. Changes in scores for all cardiometabolic and affective measures will be assessed via paired samples t-tests, and correlations between change scores will be assessed via Pearson’s or Spearman’s correlations. Feasibility will be assessed via completion rates, and the acceptability of the programme will be assessed via programme satisfaction measures.Ethics and dissemination This pilot clinical trial has been approved by the Sydney Local Health District Research Ethics and Governance Office (X20-0228 & 2020/ETH01201). The results of this pilot clinical trial will be disseminated into the scientific and broader community through peer-reviewed journals, conference presentations, social media and university websites.Trial registration number Australian New Zealand Clinical Trials Registry (ANZCTR) Number: ACTRN12620000772943, Date 28 August 2020.

Introduction: Many people with Parkinson's (PwP) are not given the opportunity or do not have adequate access to participate in clinical research. To address this, we have codeveloped with users an online platform that connects PwP to clinical studies in their local area. It enables site staff to communicate with potential participants and aims to increase the participation of the Parkinson's community in research. This protocol outlines the mixed methods study protocol for the usability testing of the platform., Methods and Analysis: We will seek user input to finalise the platform's design, which will then be deployed in a limited launch for beta testing. The beta version will be used as a recruitment tool for up to three studies with multiple UK sites. Usability data will be collected from the three intended user groups: PwP, care partners acting on their behalf and site study coordinators. Usability questionnaires and website analytics will be used to capture user experience quantitatively, and a purposive sample of users will be invited to provide further feedback via semistructured interviews. Quantitative data will be analysed using descriptive statistics, and a thematic analysis undertaken for interview data. Data from this study will inform future platform iterations., Ethics and Dissemination: Ethical approval was obtained from the University of Plymouth (3291; 3 May 2022). We will share our findings via a 'Latest News' section within the platform, presentations, conference meetings and national PwP networks., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: The assistant in medicine is a new and paid role for final-year medical students that has been established in New South Wales, Australia, as part of the surge workforce management response to the COVID-19 pandemic. Eligibility requires the applicant to be a final-year medical student in an Australian Medical Council-accredited university and registered with the Australian Health Practitioner Regulation Agency. While there are roles with some similarities to the assistant in medicine role, such as assistantships (the UK) and physician assistants adopted internationally, this is completely new in Australia. Little is known about the functionality and success factors of this role within the health practitioner landscape, particularly within the context of the COVID-19 pandemic. Given the complexity of this role, a realist approach to evaluation has been undertaken as described in this protocol, which sets out a study design spanning from August 2020 to June 2021., Methods and Analysis: The intention of conducting a realist review is to identify the circumstances and mechanisms that determine the outcomes of the assistant in medicine intervention. We will start by developing an initial programme theory to explore the potential function of the assistant in medicine role through realist syntheses of critically appraised summaries of existing literature using relevant databases and journals. Other data sources such as interviews and surveys with key stakeholders will contribute to the refinements of the programme theory. Using this method, we will develop a set of hypotheses on how and why the Australian assistants in medicine intervention might 'work' to achieve a variety of outcomes based on examples of related international interventions. These hypotheses will be tested against the qualitative and quantitative evidence gathered from all relevant stakeholders., Ethics and Dissemination: Ethics approval for the larger study was obtained from the Western Sydney Local Health District (2020/ETH01745). The findings of this review will provide useful information for hospital managers, academics and policymakers, who can apply the findings in their context when deciding how to implement and support the introduction of assistants in medicine into the health system. We will publish our findings in reports to policymakers, peer-reviewed journals and international conferences., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)