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☐ ☆ ✇ BMJ Open

The adaptive physical activity programme in stroke (TAPAS): protocol for a process evaluation in a sequential multiple assignment randomised trial

Por: Rocliffe · P. · Whiston · A. · O Mahony · A. · OReilly · S. M. · OConnor · M. · Cunningham · N. · Glynn · L. · Walsh · J. C. · Walsh · C. · Hennessy · E. · Murphy · E. · Hunter · A. · Butler · M. · Paul · L. · Fitzsimons · C. F. · Richardson · I. · Bradley · J. G. · Salsberg · J. · Hayes — Septiembre 15th 2025 at 05:56
Introduction

Participation in physical activity (PA) is a cornerstone of the secondary prevention of stroke. Given the heterogeneous nature of stroke, PA interventions that are adaptive to individual performance capability and associated co-morbidity levels are recommended. Mobile health (mHealth) has been identified as a potential approach to supporting PA post-stroke. To this end, we used a Sequential Multiple Assignment Randomised Trial design to develop an adaptive, mHealth intervention to improve PA post-stroke – The Adaptive Physical Activity programme in Stroke (TAPAS) (Clinicaltrials.Gov NCT05606770). As the first trial in stroke recovery literature to use this design, there is an opportunity to conduct a process evaluation for this type of adaptive intervention. The aim of this process evaluation is to examine the implementation process, mechanism of change and contextual influences of TAPAS among ambulatory people with stroke in the community.

Methods and analysis

Guided by the Medical Research Council Framework for process evaluations, qualitative and quantitative methods will be used to examine the (1) implementation process and the content of TAPAS (fidelity adaptation, dose and reach); (2) mechanisms of change (participants’ response to the intervention; mediators; unexpected pathways and consequences) and (3) influence of the context of the intervention. Quantitative data will be presented descriptively, for example, adherence to exercise sessions. Qualitative data will be collected among TAPAS participants and the interventionist using semi-structured one-to-one or focus group interviews. Transcribed interviews will be analysed using reflexive thematic analysis. Key themes and sub-themes will be developed.

Ethics and dissemination

Ethical approval has been granted by the Health Service Executive Mid-Western Ethics Committee (REC Ref: 026/2022) (25/03/2024). The findings will be submitted for publication and presented at relevant national and international academic conferences.

☐ ☆ ✇ BMJ Open

Developing and validating a risk prediction model for conversion to type 2 diabetes mellitus in women with a history of gestational diabetes mellitus: protocol for a population-based, data-linkage study

Por: Versace · V. · Boyle · D. · Janus · E. · Dunbar · J. · Feyissa · T. R. · Belsti · Y. · Trinder · P. · Enticott · J. · Sutton · B. · Speight · J. · Boyle · J. · Cooray · S. D. · Beks · H. · OReilly · S. · Mc Namara · K. · Rumbold · A. R. · Lim · S. · Ademi · Z. · Teede · H. J. — Septiembre 15th 2025 at 05:56
Introduction

Women with gestational diabetes mellitus (GDM) are at seven-fold to ten-fold increased risk of type 2 diabetes mellitus (T2DM) when compared with those who experience a normoglycaemic pregnancy, and the cumulative incidence increases with the time of follow-up post birth. This protocol outlines the development and validation of a risk prediction model assessing the 5-year and 10-year risk of T2DM in women with a prior GDM diagnosis.

Methods and analysis

Data from all birth mothers and registered births in Victoria and South Australia, retrospectively linked to national diabetes data and pathology laboratory data from 2008 to 2021, will be used for model development and validation of GDM to T2DM conversion. Candidate predictors will be selected considering existing literature, clinical significance and statistical association, including age, body mass index, parity, ethnicity, history of recurrent GDM, family history of T2DM and antenatal and postnatal glucose levels. Traditional statistical methods and machine learning algorithms will explore the best-performing and easily applicable prediction models. We will consider bootstrapping or K-fold cross-validation for internal model validation. If computationally difficult due to the expected large sample size, we will consider developing the model using 80% of available data and evaluating using a 20% random subset. We will consider external or temporal validation of the prediction model based on the availability of data. The prediction model’s performance will be assessed by using discrimination (area under the receiver operating characteristic curve, calibration (calibration slope, calibration intercept, calibration-in-the-large and observed-to-expected ratio), model overall fit (Brier score and Cox-Snell R2) and net benefit (decision curve analysis). To examine algorithm equity, the model’s predictive performance across ethnic groups and parity will be analysed. Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis-Artificial Intelligence (TRIPOD+AI) statements will be followed.

Ethics and dissemination

Ethics approvals have been received from Deakin University Human Research Ethics Committee (2021–179); Monash Health Human Research Ethics Committee (RES-22-0000-048A); the Australian Institute of Health and Welfare (EO2022/5/1369); the Aboriginal Health Research Ethics Committee of South Australia (SA) (04-23-1056); in addition to a Site-Specific Assessment to cover the involvement of the Preventative Health SA (formerly Wellbeing SA) (2023/SSA00065). Project findings will be disseminated in peer-reviewed journals and at scientific conferences and provided to relevant stakeholders to enable the translation of research findings into population health programmes and health policy.

☐ ☆ ✇ BMJ Open

Chronic health consequences of the COVID-19 pandemic on school workers: a cross-sectional post-pandemic analysis

Por: Watts · A. W. · Pitblado · M. · Li · S. · Irvine · M. A. · Golding · L. · Coombs · D. · OReilly · C. · OBrien · S. F. · Goldfarb · D. M. · Masse · L. C. · Lavoie · P. — Julio 29th 2025 at 06:15
Importance

The COVID-19 pandemic dramatically affected schools. However, there are insufficient data on the chronic physical and mental health consequences of the pandemic in school workers.

Objectives

To determine the prevalence and the functional and mental health impact of pandemic-related chronic health symptoms among school workers towards the end of the COVID-19 pandemic.

Design

Cross-sectional analysis of health questionnaires and serology testing data (nucleocapsid, N antibodies) collected between January and April 2023, within a cohort of school workers.

Setting

Three large school districts (Vancouver, Richmond, Delta) in the Vancouver metropolitan area, Canada (representing 186 elementary and secondary schools in total).

Participants

Active school staff employed in these three school districts.

Exposure

COVID-19 infection history by self-reported viral and/or nucleocapsid antibody testing.

Main outcomes

Self-reported, new-onset pandemic-related chronic health symptoms that started within the past year, lasting at least 3 months, after a positive viral test among those with a known infection.

Results

Of 1128 school staff enrolled from 185/186 (99.5%) schools, 1086 (96.3%) and 998 (88.5%) staff completed health questionnaires and serology testing, respectively. The N-seroprevalence adjusted for clustering by school and test sensitivity and specificity was 84.7% (95% Credible Interval (95% CrI): 79.2% to 91.8%) compared with 85.4% (95% CrI: 81.6% to 90.3%) in a community-matched sample of blood donors. Overall, 31.1% (95% CI: 28.4% to 34.0%) staff reported new-onset chronic symptoms. These symptoms were more frequently reported in staff with viral test-confirmed infections (38.0% (95% CI: 34.3% to 41.9%)) compared with those with positive serology who were unaware that they had COVID-19 (14.3% (95% CI: 7.6% to 23.6%); p

Conclusions

The pandemic had major health impacts on school workers. To our knowledge, this study is among the first to concurrently quantify a broad range of chronic physical and mental health impacts, highlighting the need for further research and targeted health programmes to address this significant burden.

☐ ☆ ✇ BMJ Open

Implementing best practice for peripheral intravenous cannula use in Australian emergency departments: a stepped-wedge cluster-controlled trial and health economic analysis protocol

Por: Egerton-Warburton · D. · Kuhn · L. · Enticott · J. · Yang · S. N.-Y. · Buntine · P. · Callander · E. · Cullen · L. · Fatovich · D. · Hullick · C. · Heiss · L. · Keijzers · G. · Le · L. K.-D. · Mihalopoulos · C. · Morphet · J. · OReilly · G. · Pokhrel · B. · Rickard · C. · Tran · V. · Camer — Junio 16th 2025 at 18:58
Introduction

Over one billion adults attend emergency departments (EDs) internationally every year, including 6.6 million in Australia. Up to half of these patients have a peripheral intravenous catheter (PIVC) inserted. Although healthcare workers believe that placing a cannula is helpful (‘just in case’), PIVCs often remain idle. PIVC insertion is painful for patients, takes clinicians’ attention away from other care, has adverse outcomes and causes major economic and environmental burden. Our aim is to codesign an implementation toolkit to reduce unnecessary PIVC insertions and improve other national quality indicators using an implementation science framework.

Methods and analysis

A stepped-wedge cluster-controlled trial will be conducted in nine ED sites (clusters) across Australia. The interventions will be codesigned with and adapted to sites based on local context. The interventions are evidence-based multimodal intervention (MMI) and aligned to the 2021 Australian Commission for Safety and Quality in Health Care National PIVC Clinical Care Standard. The Consolidated Framework for Implementation Research and Learning Health System will be used to guide implementation. Interventions will be phased across three steps (three sites per step), and each site will collect control and postintervention data using mainly routinely collected clinical data. Each site will be allocated to receive the intervention at one of three study steps. Implementation strategies will tailor broad clinician and consumer engagement, policy changes, education, audit and feedback and clinical champions, along with environment and equipment changes, to each site. The primary objective is to reduce the proportion of adult patients who have a PIVC inserted by 10%. We will evaluate the clinical, implementation and cost-effectiveness of the intervention.

Study findings will be used to conduct a health economic analysis, develop an implementation toolkit and inform a sustainable roadmap for national roll-out. This will meet the needs of a diverse range of EDs nationally and internationally.

Ethics and dissemination

The protocol was approved by the Monash Health Human Research Ethics Committee (HREC Reference Number: HREC/100808/MonH-2023-390692(v3)). The outcomes of this trial will be disseminated through peer-reviewed publications, conference presentations and communication with study partners and stakeholders including professional colleges and the Australian Commission for Safety and Quality in Health Care.

Trial registration number

Australian New Zealand Clinical Trials Registry registration number: ACTRN12623001248651. Date of registration: 1 December 2023. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=386256&showOriginal=true&isReview=true

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