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Towards the development of a framework for monitoring and evaluating the multidimensional sustainability of healthcare organisations: a scoping review protocol

Por: Pain · G. C. F. · Chaves · R. L. P. · Zhao · W. · Haren · M. T. · Gartner · J.-B. · Bergeron · F. · Cote · A.
Introduction

The literature on sustainability performance frameworks for healthcare organisations varies in its applicability to different types of organisations and settings, functions and activities, and definitions and dimensions of sustainability. This fragmentation creates implementation barriers which may be overcome by consolidating existing evidence in a format that can be linked directly to organisations’ business models. This protocol proposes a scoping review to assess the extent of the literature on frameworks for monitoring and evaluating the multidimensional sustainability performance of healthcare organisations and to assemble a consolidated framework in an operationally relevant format to support progress towards sustainable healthcare organisations.

Methods and analysis

The search strategy will be applied across Semantic Scholar, Google Scholar, Web of Science, MEDLINE, Embase, Academic Search Premier, CINAHL and Business Source Premier databases. Search results from 2009, coinciding with the publication of the WHO’s ‘Healthy Hospitals, Healthy Planet, Healthy People’ report, will be considered. The scoping review will include studies reporting on multidimensional sustainability monitoring or evaluation frameworks applied or developed for use at the level of healthcare delivery organisations. Studies relating to operational units within organisations or to healthcare systems will be excluded. The review’s context will be restricted to operational sustainability and will not consider the literature on sustainable design planning and construction of new facilities. No specific exclusion criteria will be applied to the types of healthcare delivery organisations nor participants implicated in the frameworks. Title and abstract screening against the inclusion and exclusion criteria, followed by full-text assessment of remaining articles, will be performed by two reviewers. Data from included studies will be extracted using a custom-designed extraction tool, analysed using topic or thematic analysis to consolidate themes and presented within the triple-layered business model canvas.

Ethics and dissemination

Only publicly available sources will be used; research ethics approval is not required. Findings will be submitted to a peer-reviewed journal and presented at scientific meetings.

Seroprevalence of COVID-19 among healthcare workers in Hong Kong during the first 2 years of the COVID-19 pandemic (2020-2021): a longitudinal cohort study

Por: Lim · W. W. · Mak · L. · Ho · F. · Ng · T. W. Y. · Yau · E. M. · Ko · R. L. W. · Chen · D. · Xiao · J. · Seto · W. H. · Cheng · S. M. S. · Perera · R. A. P. M. · Ip · D. K. M. · Peiris · M. · Cowling · B. J.
Background

In the first 2 years of the COVID-19 pandemic, Hong Kong adopted strict public health and social measures to stop community transmission of SARS-CoV-2. These include border screening and control, isolation of cases and quarantine of their contacts and universal masking. During this period, attack rates in Hong Kong were among the lowest globally.

Objectives

To estimate the seroprevalence of COVID-19 among healthcare workers (HCWs) in Hong Kong in 2020 and 2021.

Methods

We reviewed contact tracing data from the Hong Kong Department of Health to identify COVID-19 cases reported among HCWs. Between June 2020 and December 2021, we conducted a longitudinal cohort study to estimate the seroprevalence of COVID-19 among HCWs working in hospitals and clinics in Hong Kong during the first 2 years of the COVID-19 pandemic.

Results

Overall seropositivity of COVID-19 by plaque reduction neutralisation test during the first (May–October 2020) and second round (November 2020–April 2021) of the study was 0% (95% CI 0.00% to 0.49%) and 0.52% (95% CI 0.14% to 1.33%). After COVID-19 vaccines were offered to HCWs in February 2021, seroprevalence by surrogate virus neutralisation assay among cohort participants who provided biannual blood samples rose to 68.7% (95% CI 65.9%, 71.3%) and 80.2% (95% CI 76.8%, 83.2%) in round 3 (May–October 2021) and the first 2 months of round 4 (November–December 2021).

Conclusions

Seroprevalence in Hong Kong HCWs in our study was low despite considerable exposure to confirmed COVID-19 cases in some study participants. However, the low rate of community transmission may have also contributed to the observed low seroprevalence among HCWs in our cohort.

Pre-diagnostic route reported by patients with sarcoma from the Netherlands, the UK, Australia and New Zealand: early detection challenges for general practitioners - an international observational cohort study

Por: Holthuis · E. I. · Soomers · V. L. M. N. · Rafiq · M. · Jones · R. L. · Hayes · A. · Van De Wal · D. · Drabbe · C. · Been · L. B. · Bonenkamp · H. · van der Hage · J. H. · Lee · A. T. J. · Verhoef · C. · van Houdt · W. J. · Young · R. J. · Bae · S. · Andelkovic · V. · Hong · A. M. · Conn
Objective

To investigate how patients with sarcoma present prior to diagnosis—through a general practitioner (GP) or another healthcare professional (HCP)—and describe presenting symptoms.

Design

International observational cohort study.

Setting

Data were obtained from the longitudinal ‘QUality of life and Experiences of Sarcoma Trajectories’ (QUEST) cohort study, conducted across the Netherlands, the United Kingdom (UK), Australia and New Zealand.

Results

Among 572 patients, 487 (85.1%) started their diagnostic trajectory at the GP (subcohort 1) and 85 (14.9%) with another HCP (subcohort 2)—mainly medical specialists treating unrelated conditions (36/85; 42.4%). Soft tissue sarcoma patients most often reported swelling, whereas bone sarcoma patients reported unexplained pain. Notably, 31/85 (36.5%) of subcohort 2 were asymptomatic. Reasons for delaying GP visits included assuming symptoms were minor and expecting them to resolve. Patients sought care when, among others, symptoms persisted and worsened.

Conclusions

Most patients first consulted a GP, underlining the role of primary care in sarcoma diagnosis internationally. Due to rarity and nonspecific symptoms, faster diagnosis remains challenging, requiring improvements in both primary and specialist care.

Trial registration number

NCT03441906; Results.

Engagement with behaviour change in people with mild cognitive impairment and mild frailty: a qualitative study

Por: Rookes · T. A. · Frost · R. · Barrado-Martin · Y. · Catchpole · J. · Armstrong · M. · Gardner · B. · Gould · R. L. · Cooper · C. · Hammond · C. · Marston · L. · Walters · K. R.
Background

Many older people experience Mild Cognitive Impairment (MCI), which may compromise the effectiveness of health promotion programmes.

Objectives

We explored engagement with behaviour change among participants scoring 18-25 on the Montreal Cognitive Assessment receiving HomeHealth, a health promotion intervention supporting older adults with mild frailty to maintain independence in England ().

Methods

Of the 46 semistructured process evaluation interviews, 29 participants scored in the MCI range, purposively selected for demographic characteristics and degrees of cognitive impairment and the seven support workers.

Results

Thematic analysis resulted in three themes: Navigating the impact of MCI; Addressing memory as a goal in the intervention; and Adapting Behaviour Change Interventions for MCI. Participants had varied opinions about whether their memory was problematic and whether anything could be done to help. Many reported not discussing memory concerns with support workers. Barriers to engagement in behaviour change included limited social support and not acknowledging memory problems. Facilitators included setting goals which increased or were linked to existing health behaviours, using reminders/prompts and actively involving family members.

Conclusions

Implementing these facilitators into existing and new health promotion interventions delivered to older adults, with suspected but unacknowledged MCI, could overcome the current barriers people with MCI face when trying to engage and benefit from interventions.

Trial registration number

ISRCTN54268283

Cost-benefit analysis of a 24/7 text-based online emotional support platform for at-risk youth in Hong Kong

Por: Yip · P. S. F. · Chen · J. · Tang · R. L. M. · Chau · C. L. I. · Cheng · W. M. K. · Lui · E. N. C.
Objectives

This study was to estimate the potential social value and net benefit of OpenUp, a 24/7 text-based online counselling service for youth in Hong Kong, and draw policy-relevant conclusions for service provision.

Design

A retrospective, model-based cost–benefit analysis using social return on investment (SROI) methods. Adopting a societal perspective, service, health and social outcomes were valued over a 1-year period, and productivity gains associated with avoided suicide deaths were valued over a 10-year period. Costs are reported in 2022 HK dollars (HK$; US$1=HK$7.8). Reporting was guided by Consolidated Health Economic Evaluation Reporting Standards 2022 (CHEERS 2022) Statement.

Setting

A text-based, synchronous online emotional support counselling platform in Hong Kong was accessible through WhatsApp, Facebook, SMS and the official web portal.

Participants

A total of 19 543 users aged 11–35 years accessed OpenUp services during the study period (1 December 2020 to 31 May 2022).

Primary and secondary outcome measures

These included total social value (HK$), net social benefit (social value minus investment) and the SROI ratio. The secondary outcomes included monetised savings in medical and social services and productivity gains from avoiding suicide attempts and death.

Results

The total social value was estimated to be HK$226 119 729 against an investment of HK$47 655 000 (SROI=4.74). Suicide risk reduction (productivity gains from avoided attempts and deaths) accounted for 75.4% of the social value. Deterministic one-way sensitivity analyses yielded SROI values ranging from 3.62 to 6.99 aggregated across the three groups, with results being most sensitive to assumptions about the duration of productivity impacts for avoided attempts and avoidable mortality.

Conclusions

Based on conservative assumptions, OpenUp can generate potential social value by providing an online emotional support service. Given the study’s reliance on modelling and proxy monetisation, these estimates should be interpreted with caution. Further integration of offline services with online intervention strategies requires continuous investment and evaluation.

Determinants of untimely receipt and non-receipt of routine childhood immunisation in Ebonyi state based on the Adapted Omale INDEPT FORCIS Framework and recommendations for policy and practice: a qualitative study

Por: Omale · U. I. · Iwegbulam · C. C. · Ekwuazi · L. C. · Amuzie · C. I. · Ikegwuonu · C. O. · Nkwo · G. E. · Ewah · R. L.
Objectives

The significant morbidity and mortalities from, and the recurrent outbreaks of, the vaccine-preventable infectious diseases (VPDs) of childhood could be due not only to non-receipt of recommended vaccinations but also to untimely receipt, which impairs the validity of immunisation coverage and protection against VPDs. This study explored the determinants of untimely receipt and non-receipt of routine childhood immunisation and made recommendations for policy and practice.

Design

This qualitative study was based on the Adapted Omale INDEPT FORCIS Framework – Determinants of Routine Childhood Vaccination Receipt Conceptual Framework.

Study setting and participants

From 22 August 2022 to 9 September 2022, 15 semi-structured, face-to-face focus group discussions were conducted in English, pidgin English and the local language with 127 purposively selected consenting parents of infants aged 0–2 months (with other key community members) and primary healthcare workers involved in the provision of routine childhood immunisation in Ebonyi state, Nigeria.

Analysis

Data analysis involved deductive (and some inductive) thematic analysis.

Results

There were many underlying determinants of untimely receipt and non-receipt of routine childhood immunisation, which included individual-related factors (mothers’ unfavourable experiences and perceptions and lack of knowledge about childhood diseases, vaccines/vaccinations and the vaccination system, relocation/travel from place of residence, children and/or mothers being ill); childhood disease-related, vaccination-related and the vaccination system-related factors (diseases not always severe/fatal, vaccinations causing side-effects, vaccination system constraints in availability, accessibility, affordability and acceptability); family and other individual-related factors; and broader context-related sociopolitical, cultural, economic, infrastructural, historic and health system factors.

Conclusion

The evidence demonstrates many specific and fundamental complex and interrelated determinants of untimely receipt and non-receipt of routine childhood immunisation and emphasises the need for multifaceted and innovative actions in dealing with the determinants in the drive to address the high morbidity and mortalities and recurring outbreaks of VPDs in Ebonyi state, Nigeria, and similar settings.

Examining social camouflaging and its cognitive, mental health and neurophysiological correlates in autistic adolescents through triangulation-based assessment using self, parent and daily diary reports: a study protocol

Por: Klein · J. · Krahn · R. L. · Howe · S. J. · Cormier · A. · Rush · J. · Ames · M. · McMorris · C. A. · Macoun · S.
Introduction

Social camouflaging (SC; ie, the concealing of autistic traits to socially assimilate) is associated with poor mental health, self-identity and quality of life outcomes, yet its typology, consequences and contextual triggers remain unexplored in autistic adolescents. Further study is necessary to identify protective factors against the potentially negative outcomes associated with SC to promote long-term well-being.

Methods

The current project will investigate SC in youth and its mental health, cognitive and neurophysiological correlates. Camouflaging will be captured by triangulating self-reported and caregiver-reported SC behaviours, as well as SC behaviours in day-to-day contexts using intensive longitudinal methods (ie, daily diaries). Non-autistic, self-identifying autistic and formally diagnosed autistic adolescents aged 15–18 years (N=150) will be recruited. Adolescents and caregivers will complete rating scales to assess mental health, and adolescents will complete in-lab cognitive assessments of attention, executive function, intellectual ability and theory of mind. Brain neurophysiological function and cortisol concentration over time will be measured during the same visit using electroencephalography and hair samples, respectively. Over the following 7 days, adolescents will complete daily diaries using their smartphones. The daily diaries pose survey questions about the type and degree of SC behaviour used within their daily environment, including the social context, individuals who are present and current well-being. Adolescents will also complete brief performance-based cognitive assessments of attention and executive function integrated within the daily diary surveys. Finally, adolescents and their parents will complete a follow-up of SC behaviours and mental health at 3 months. Correlations and regression analyses will be conducted to explore the associations between SC and mental health/cognitive outcomes and how baseline measures of cognition, mental health and SC predict patterns seen on the daily diaries. Multilevel modelling will be used, nesting daily data to capture within-person and between-group differences in contextual predictors of camouflaging behaviour. Results will contribute to current understanding of the typology of camouflaging, as well as inform intervention to mitigate mental health challenges for autistic youth.

Ethics and dissemination

This project is approved by the University of Victoria Human Research Ethics Board (#23–0013) and the University of Calgary Conjoint Faculties Research Ethics Board (#23–0641). Informed consent will be obtained from caregivers and adolescent participants, and safety procedures will be put in place to support the adolescent should mental health concerns arise. Results will be disseminated through academic publications and conferences, as well as summarised and communicated to interested participants and relevant stakeholders.

Identifying innovative models of urgent care in rural coastal areas in England: the Elevate study - a mixed-methods protocol

Por: Lampard · P. · Adamson · J. · Anderson · H. · Ballantine · L. · Bell · F. · Benger · J. R. · Blakey · R. L. · Dickinson · P. · Dykes · S. · Gaughan · J. · Maitland-Knibb · S. · Mensah · D. · Ransome · Z. A. · Richardson · G. · Santos · R. · Sheridan · R. · Sivey · P. · Smith · E. · Song · W
Introduction

Urgent and emergency care (UEC) systems in England face unprecedented pressures, with record accident and emergency attendances, persistent breaches of ambulance response targets and poorer outcomes for time-sensitive conditions. National UEC recovery plans have introduced multiple innovations—such as same-day emergency care, virtual wards and specialty hubs—to manage these pressures and improve patient flow. Rural coastal areas are particularly vulnerable to excessive demand due to higher levels of deprivation, older populations with complex health needs, seasonal surges that generate unpredictable demand and challenges in attracting and retaining staff. Following the Chief Medical Officer’s 2021 Annual Report, funding research and developing bespoke solutions to manage UEC demand and address geographical disparities has been recognised as a national priority. The Elevate study responds to this priority by identifying and evaluating innovative models of UEC in rural coastal communities in England.

Methods and analysis

The Elevate study is a 30-month, mixed-methods evaluation that comprises three interlinked work packages: (1) National service mapping—outlining provision of innovative models of UEC in rural coastal areas of England. This will be developed through document review and interviews with regional and national service leaders. (2) Quantitative analysis—quasiexperimental and longitudinal approaches will use National Health Service (NHS) England’s Emergency Care Data Set and linked routine NHS datasets to evaluate the impact of UEC models on health and process outcomes. Standard and bespoke metrics will be developed and used to assess performance. (3) Qualitative case studies—up to 12 case studies of UEC models in rural coastal communities. Interviews with patients and staff and non-participant observation will explore how and why different UEC models influence patient experience, clinical outcomes, resource use and the workforce. Findings will be integrated using the Consolidated Framework for Implementation Research to identify components of UEC models that are effective, scalable and sensitive to local context,

Ethics and dissemination

Ethical approval for qualitative components was granted by the North of Scotland Research Ethics Committee (25/NS/0099). Dissemination will include peer-reviewed publications, policy briefs, creative media and community engagement activities to ensure findings are communicated inclusively and effectively to policymakers, health and social care practitioners and the public.

Trial registration number

Research Registry (researchregistry11126).

Epidemiological investigation of perinatal depression among pregnant and postpartum women: findings from a cross-sectional survey in the Philippines

Por: Filoteo · J. A. · Maravilla · J. C. · Mamaat · J. E. · Flores · A. D. · Jumamil · A. N. · Cardenas · R. L. · Quijencio · W. · Bayani · M. A. · Santos · N. · Acena · J. L. · Alfonso · A. L. · Rivera · M. · Guarino · R. · Sarmiento · R. · Flenady · V. · Boyle · F. M. · Loughnan · S. A. · T
Objective

This study investigated perinatal depressive symptoms among pregnant and postpartum Filipino women.

Design

Cross-sectional survey.

Setting

The Philippines.

Participants

Participants were recruited online and face-to-face from maternal care facilities.

Primary outcome measure

Perinatal depressive symptoms were assessed using the Edinburgh Postnatal Depression Scale (EPDS) score, with prevalence calculated based on ≥13 cut-off, indicating clinically significant symptoms of depression. Patterns of depressive symptoms were examined by demographics, perinatal time period and other obstetric information using adjusted regression coefficients (ab) and risk ratios (aRR).

Results

A total of 856 women participated in the study, comprising 356 pregnant and 500 postpartum women. EPDS scores were, on average, similar between pregnant (14.4) and postpartum women (14.1). Using the locally validated cut-off of ≥13 revealed that 69.1% of pregnant and 62.0% of postpartum women reported clinically significant depressive symptoms. Consistent EPDS scores and prevalence were observed across pregnancy trimesters and within 12 months postpartum and beyond. Women who received adequate prenatal care were less likely to experience antenatal (ab=–1.59, 95% CI –3.13 to –0.05) and postpartum (ab=–1.30, 95% CI –2.48 to –0.12) depressive symptoms. Postpartum EPDS scores and depressive symptom prevalence (EPDS score ≥13) were higher among 18–24-year olds (ab=1.96, 95% CI 0.30 to 3.61; aRR=1.23, 95% CI 1.03 to 1.47) and single mothers (ab=3.46, 95% CI 0.22 to 6.71; aRR=1.42, 95% CI 1.07 to 1.90), compared with older and married mothers, respectively.

Conclusions

At least 60% Filipino mothers experienced clinically significant perinatal depressive symptoms, which exceeds the established global average of 25%. Younger and single postpartum women were at greater risk, while pregnant and postpartum women who attended adequate prenatal visits were less likely to report depressive symptoms. Our study underscores the need for further research to uncover the true burden of poor perinatal mental health and calls for targeted early interventions and integrative public health strategies to support at-risk mothers, particularly those from socially disadvantaged backgrounds.

Implementing a bundle of interventions to support older adults transitioning from hospital to residential aged care: a protocol for the process evaluation of the OPTIMAL stepped wedge cluster randomised controlled trial

Por: Fernando · R. L. · Crotty · M. · Inacio · M. C. · Batta · I. · Bourke · A. · Forward · J. · Furst · C. · Whitehead · C. · Shaw · S. · Shepperd · L. · Harvey · G.
Introduction

The Optimising older People’s Transition from acute care Into residential aged care through Multidisciplinary Assessment and Liaison (OPTIMAL) trial is a multisite hybrid type II stepped wedge randomised controlled trial with an embedded process evaluation that aims to evaluate the effectiveness of implementing a bundle of evidence-based interventions to provide systematic support to older adults being discharged from hospital to residential aged care (RAC) homes for the first time. The trial is based on evidence from models of care used internationally to improve the quality of care transitions and addresses a need to provide evidence of transferability and effectiveness of these models in the Australian context. The embedded process evaluation will assess the acceptability, appropriateness, feasibility, adoption and fidelity of the OPTIMAL intervention, as well as the mechanisms of impact.

Methods and analysis

The OPTIMAL trial will be implemented across the three metropolitan local health networks (LHNs) in South Australia. The process evaluation will be conducted in parallel with the main trial and is theoretically informed by the integrated Promoting Action on Research Implementation in Health Services (i-PARIHS) implementation framework, which theorises that the implementation success of OPTIMAL is determined by the facilitation of the intervention with the intended recipients in their inner and outer contextual setting. The process evaluation will employ a mixed methods approach. Qualitative and quantitative data will be collected through baseline context mapping of LHNs, interviews with key LHN and RAC stakeholders, online survey of clinical teams, fortnightly check-in forms, and activity logs and field notes maintained by the nurse facilitator in each LHN. Data will be mapped and reported based on the i-PARIHS framework.

Ethics and dissemination

Ethical approval for the OPTIMAL trial was obtained from the Southern Adelaide Clinical Human Research Ethics Committee (approval 2023/HRE00111), and the relevant governance approvals were obtained for each participating LHN. Ethical approval includes a waiver of the requirement for consent for routinely collected patient data. Study findings will be disseminated via journal publications, presentations at conferences, stakeholder discussions, consumer forums and advocacy to key decision makers to support knowledge translation.

Trial registration number

Australia New Zealand Clinical Trial Registry, ACTRN12624001008516, registered 20 August 2024.

Country-level and global burden of diseases caused by group A Streptococcus: protocol for a multicountry epidemiological study

Por: Taye · B. W. · Cannon · J. · Van Beneden · C. · Bowen · A. C. · Engel · M. · Baker · M. G. · Guy · R. L. · Lamagni · T. · Carapetis · J. · Moore · H. C. · on behalf of Strep A Vaccine Global Consortium (SAVAC) 2.0
Introduction

Group A Streptococcus (Strep A) causes a wide spectrum of diseases, ranging from pharyngitis and impetigo to severe invasive infections and immune-mediated conditions such as acute rheumatic fever, rheumatic heart disease and acute post-streptococcal glomerulonephritis. Contemporary data on the global burden of Strep A diseases are lacking. The proposed study aims to use administrative data from numerous jurisdictions to estimate age-specific incidence or prevalence of Strep A diseases, with an emphasis on severe clinical endpoints. Depending on the availability of data, a secondary objective will be to estimate the economic burden of Strep A diseases.

Methods and analysis

This population-based descriptive study will use routine health data obtained from different low-income and middle-income and high-income countries through international research collaborations to estimate the country-level and global burden of Strep A diseases. Data will be primarily obtained and collated from hospital or national health laboratory databases for individuals across all age groups, along with emergency department, primary care and microbiological datasets where available. Strep A disease endpoints will be identified using International Classification of Diseases 10th Revision or other relevant coding systems and microbiological diagnosis. Age-specific incidence and prevalence rates will be computed using population denominators, and country-level age-adjusted rates will be applied to standard global reference populations to estimate the number of cases globally.

Ethics and dissemination

Ethical approval to conduct this study was obtained from the Human Research Ethics Committee at the University of Western Australia (reference: #2024/ET000401) and governance approval was obtained from The Kids Research Institute Australia. The findings from this study will be published in peer-reviewed journals and presented at Strep A Vaccine Global Consortium collaborative meetings.

Efficacy of YOga in people with chronic non-specific low BACK pain and poor PROgnosis (YOBACK-PRO): protocol for a randomised clinical trial

Por: Nunes · S. M. · Rizzo · R. R. · Franco · M. R. · Ferreira · F. R. · Barros · L. J. G. · Maciel · I. T. · Santos · R. L. · Nascimento · R. R. · Couto · A. J. · Quaresma · L. S. · Fontes · R. M. · Ferreira · E. M. R. · Maher · C. G. · McAuley · J. H. · Pinto · R. Z.
Introduction

Yoga has been shown to improve pain and function compared with no exercise in people with chronic low back pain (LBP), but treatment effects are small. Given that yoga is a mind–body intervention that addresses physical as well as psychological factors, it may be more effective for patients with chronic LBP who are at high risk of poor prognosis. The study aims to investigate the efficacy of a 12-week yoga programme combined with education in reducing pain and disability for individuals with chronic LBP at high risk of poor prognosis at short (12 weeks) and intermediate (24 weeks) terms, compared with a control group receiving education only.

Methods and analysis

A randomised controlled trial will include 110 adults with chronic non-specific LBP reporting an average pain intensity of 3 points or more on a 0–10 scale over the past week and classified as high risk of poor prognosis (ie, scoring 50 points or above) on the Orebro Musculoskeletal Pain Questionnaire short-form. Participants in the control group will receive an educational booklet and attend three face-to-face lectures over a 3-month period. In the intervention group, in addition to the booklet and lectures, participants will attend group yoga sessions twice a week for 12 weeks, totalling 24 yoga sessions. The primary outcome is disability assessed at 12 weeks, measured using the Roland-Morris Disability Questionnaire.

Ethics and dissemination

The study was approved by the Human Research Ethics Committee of Universidade Federal de Minas Gerais (Protocol number CAAE: 57028022.0.0000.5149). Findings will be disseminated to trial participants, clinicians and the broader public and scientific community.

Trial registration number

NCT05953155.

Specialist PrE-hospital rEDirection for ischaemic stroke thrombectomY (SPEEDY): study protocol for a cluster randomised controlled trial with included health economic and process evaluations

Por: Shaw · L. · Allen · M. · Day · J. · Ford · G. A. · James · M. · McClelland · G. · McMeekin · P. · Mossop · H. · Pope · C. J. · Simmonds · R. L. · White · P. · Wilson · N. · Price · C. I.
Background

Outcome from large vessel occlusion stroke can be significantly improved by time-critical thrombectomy but treatment is only available in regional comprehensive stroke centres (CSCs). Many patients are first admitted to a local primary stroke centre (PSC) and require transfer to a CSC, which delays treatment and decreases the chance of a good outcome. Access to thrombectomy might be improved if eligible patients could be identified in the prehospital setting and selectively redirected to a CSC. This study is evaluating a new specialist prehospital redirection pathway intended to facilitate access to thrombectomy.

Methods and analysis

This study is a multicentre cluster randomised controlled trial with included health economic and process evaluations. Clusters are ambulance stations (or teams) which are work bases for ambulance practitioners. Intervention allocated ambulance practitioners use the Specialist PrE-hospital rEDirection for ischaemic stroke thrombectomY (‘SPEEDY’) pathway which comprises initiation according to specific criteria followed by contact with CSC staff who undertake a remote assessment to select patients for direct CSC admission. Control allocated ambulance practitioners continue to provide standard care which comprises admission to a local PSC and transfer to a CSC for thrombectomy if required. A co-primary outcome of thrombectomy treatment rate and time from stroke symptom onset to thrombectomy treatment will evaluate the impact of the pathway. Secondary outcomes include key aspects of emergency care including prehospital/hospital time intervals, receipt of other treatments including thrombolysis, and performance characteristics of the pathway. A broad population of all ambulance practitioner suspected and confirmed stroke patients across participating regions is being enrolled with a consent waiver. Data about SPEEDY pathway delivery are captured onto a study case record form, but all other data are obtained from routine healthcare records. Powered on a ‘primary analysis population’ (ischaemic stroke patients with pathway initiation criteria), 894 participants will detect an 8.4% difference in rate and data from 564 thrombectomy procedures will detect a 30 minute difference in time to treatment. The full study population is estimated to be approximately 80 000. Regression modelling will be used to examine primary and secondary outcomes in several analysis populations. The economic analyses will include cost-effectiveness and cost–utility analyses, and calculation of willingness to pay at a range of accepted threshold values. The process evaluation involves semi-structured interviews with professionals and patient/family members to explore views and experiences about the SPEEDY pathway.

Ethics and dissemination

This study has ethical, Health Research Authority and participating NHS Trust approvals.

Dissemination of study results will include presentations at national and international conferences and events, publication in peer-reviewed journals, and plain English summaries for patient/public engagement activities.

Trial registration number

ISRCTN77453332.

Implementation strategies for the WHO Safe Childbirth Checklist: a scoping review

Por: Gama · Z. A. d. S. · Semrau · K. E. A. · Rosendo · T. M. S. d. S. · Freitas · M. R. d. · Saraiva · C. O. P. d. O. · Westgard · C. M. · Mita · C. · Tuller · D. E. · Freitas · K. d. M. S. · Molina · R. L.
Background

The WHO Safe Childbirth Checklist (SCC) has been implemented in diverse settings to improve the quality and safety of intrapartum care, but implementation strategies and their relationship with adoption and fidelity remain heterogeneous and incompletely described.

Objectives

To describe the landscape of SCC implementation, map the implementation strategies used and explore how these strategies were reported in relation to adoption and fidelity.

Eligibility criteria

We included primary studies reporting SCC implementation in healthcare settings that described at least one implementation strategy, with no restrictions on country or language. Studies that did not report implementation strategies or did not involve SCC use in real-world care settings were excluded.

Sources of evidence

We searched PubMed, Embase, CINAHL, Global Health and Global Index Medicus (June 2024), screened reference lists and consulted grey literature for the period 2009–2024.

Charting methods

This scoping review followed JBI methodology (Peters et al) and was reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews. We extracted study characteristics and implementation findings, coded strategies using the Expert Recommendations for Implementing Change (ERIC) taxonomy and grouped them by clusters. Adoption (initial uptake) and fidelity (adherence to core components) were categorised following Proctor’s implementation outcomes. We created a descriptive implementation intensity score and conducted exploratory analyses (tertiles, boxplot).

Results

34 studies described 19 SCC implementation projects across 16 countries. We identified 24 distinct ERIC strategies, with most projects using 5–11 strategies. Frequently reported strategies included educational meetings, audit and feedback, supervision, contextual adaptation and leadership or champions. Exploratory analyses did not show consistent associations between implementation intensity and adoption or fidelity. ‘Change infrastructure’ strategies (such as record system or equipment changes) were variably defined and warrant cautious interpretation. Adaptations (eg, translation and alignment with national guidelines) were common and aimed at improving local fit, but heterogeneous reporting limited cross-study comparability.

Conclusions

SCC implementation has relied on diverse, multicomponent strategies, yet reporting—especially of strategy content and adaptations—remains insufficient, constraining comparison and synthesis across settings. As a pragmatic bundle, implementers may prioritise brief team training, unit-level champions and leadership signals, point-of-care audit and feedback, light-touch SCC adaptation that preserves core content and structured supervision or peer coaching, combined with systematic inclusion of women and families through codesign and companion-mediated prompting. Using theory-informed frameworks (such as Exploration, Preparation, Implementation, and Sustainment and Consolidated Framework for Implementation Research [CFIR]) and standardised reporting tools (eg, Proctor’s outcomes; Template for Intervention Description and Replication / Standards for Reporting Implementation Studies [TIDieR/StaRI]) can make SCC implementation strategies more transparent, comparable and scalable.

Registration

Open Science Framework: https://doi.org/10.17605/OSF.IO/RWY27.

Leveraging COVID-19 to modernise depression care for VA primary care populations: protocol for a sequential explanatory mixed method evaluation

Por: Leung · L. B. · Brayton · C. E. · Shepardson · R. L. · Gray · C. P. · Lee · M. L. · Funderburk · J. S. · Fortney · J. C.
Background

The Veterans Health Administration (VA) integrated mental and physical health services to better detect and treat depression. Primary care nurses conduct screening annually. Clinicians, including Primary Care Mental Health Integration (PCMHI) specialists, follow-up as needed for treatment. Depression detection and management processes are complex, involve multilevel stakeholders, and are subject to significant disruption from COVID-19 and from the resulting expansion of telehealth, aiming to preserve care access. This study aimed to examine whether the COVID-19 pandemic worsened depression-related care quality and/or patient outcomes (eg, suicide).

Methods

Given hypothesised care disruption (lowered care quality) during COVID-19, we will first assess the VA population’s trajectory from a new positive depression (and suicide risk) screen to appropriate treatment (ie, medication, therapy) in the Fiscal Year 2019–2323. We will also examine the changing mix of virtual and in-person depression care delivered. Second, we will use interrupted time series analyses to explore the extent to which psychiatric emergency visits and hospitalisations may be mitigated by clinician detection of depression. As well as compare mental health-related mortality rates between patients detected and not detected to have depression. Subanalyses will reveal where (eg, clinics with low PCMHI access) and for whom (eg, minorities) detection does not systematically occur, and downstream negative sequelae, to guide future intervention. Finally, we will interview 40 veterans, half of whom were detected and half not detected to have depression and 40 VA primary care and PCMHI providers about changes brought on by the pandemic and the expansion of virtual care across three VA facilities. In addition to contextualising disrupted care findings, qualitative data will help identify best practices on patient-to-provider and provider-to-provider interactions in hybrid in-person/telehealth depression care models.

Ethics and dissemination

Ethics approval was granted by the VA Greater Los Angeles Healthcare System Institutional Review Board. Alongside journal publications, dissemination activities include briefings to our policy and operational partners, and presentations to clinical, research and policy-oriented audiences.

Assessing the feasibility of a platform trial for Gram negative bloodstream infections: results from the vanguard phase of BALANCE+

Por: Daneman · N. · Johnstone · J. · Lee · T. C. · MacFadden · D. R. · McDonald · E. G. · Morpeth · S. C. · Ong · S. W. X. · Paterson · D. L. · Pinto · R. L. · Rishu · A. · Rogers · B. A. · Yahav · D. · Coburn · B. · Daley · P. · Das · P. · Fiest · K. · Findlater · A. · Fralick · M. · George · M
Objectives

Gram negative bloodstream infections (GN BSI) are a leading cause of mortality worldwide, and antibiotic treatment approaches remain understudied. BALANCE+ is a perpetual Bayesian adaptive platform trial to test multiple treatment questions for hospitalised patients with GN BSI. The vanguard phase objective was to test the feasibility of the main trial.

Design

Adaptive platform trial with five initial domains of investigation, each with open label 1:1 randomisation.

Setting

Ten hospitals across four Canadian provinces.

Participants

Individuals admitted to hospital with blood cultures yielding Gram negative bacteria.

Interventions

The five initial domains of investigation included: antibiotic de-escalation versus no de-escalation; oral transition to beta-lactam versus non-beta-lactam treatment; routine versus no routine follow-up blood cultures (FUBCs); central vascular catheter replacement versus retention; and, ceftriaxone versus carbapenem treatment for low risk AmpC organisms.

Primary outcome measures

Domain-specific recruitment rates and protocol adherence.

Results

During the vanguard phase, 719 patients were screened, of whom 563 (78.3%) were eligible, with 179 (31.8%) enrolled into the platform. The platform recruitment rate was 1.37 patients/site-week. Recruitment varied by domain: routine versus no FUBC domain 1.23 patients/site-week; oral beta-lactam versus non-beta-lactam domain 0.48; de-escalation versus no de-escalation domain 0.28; low risk AmpC domain 0.02; catheter replacement versus retention domain 0.01. Domain specific protocol adherence rates were 145/158 (91.8%) for routine versus no routine FUBC, 53/60 (88.3%) for oral beta-lactam versus non-beta-lactam, 26/33 (78.8%) for de-escalation versus no de-escalation, 3/3 (100%) for low risk AmpC, and 0/1 (0%) for line replacement versus retention. There was complete ascertainment of all study outcomes in hospital 170/170 (100%) and near complete ascertainment at 90 days 162/170 (95.3%).

Conclusions

The vanguard phase demonstrated overall trial feasibility by recruitment rate and protocol adherence, with differences across interventions, leading to a transition to the main BALANCE+ platform trial with minimal protocol modifications.

Trial registration number

NCT05893147.

Testing psychosocial work adversities as a necessary condition for work-related emotional exhaustion in young workers: a cross-sectional necessary condition analysis on a national general working population-based survey

Por: Schelvis · R. M. C. · van Veen · M. · Tamminga · S. J. · Oude Hengel · K. M. · Nieuwenhuijsen · K. · Boot · C. R. L. · Dul · J.
Objectives

Being exposed to adverse psychosocial working conditions contributes to poor mental health in young workers. This study explores whether psychosocial work adversities are a necessary condition for work-related emotional exhaustion in young workers.

Design

Data from the ‘Netherlands Working Condition Survey 2021’ was used. By applying a novel method called Necessary Condition Analysis, we tested two psychosocial work adversities as necessary conditions for high work-related emotional exhaustion in young workers: (1) a composite score of high job demands and low job resources and (2) a composite score of high job demands. Additionally, we tested whether the threshold for job demands as a necessary condition for high work-related emotional exhaustion differed for young workers with low versus high resources.

Setting

Secondary data analysis on a national working population-based survey.

Participants

The sample included 5791 young workers in the Netherlands (aged

Primary outcome measure

Work-related emotional exhaustion.

Results

A high level of the composite on job demands and job resources is necessary for a high level of work-related emotional exhaustion in young workers (effect size=0.11, p

Conclusions

Both psychosocial work adversities were necessary conditions for high work-related emotional exhaustion in young workers. The necessity threshold for job demands was higher for young workers with high job resources, compared with the group with low resources. This indicates that removing psychosocial work adversities and ensuring the presence of job resources might contribute to the prevention of high work-related emotional exhaustion in young workers.

PharmacoGENEtics in Youth Depression (GENE-YD) Study protocol: a pilot triple-blinded randomised controlled trial using pharmacogenetics to tailor antidepressant treatment in young Australians

Por: Roberts · B. · Cooper · Z. · Miljevic · A. · Stanley · S. H. · Majda · B. T. · Collins · K. R. L. · Baltic · S. · Lindsey-Temple · S. E. · Akkari · P. A. · Hood · S. D. · Rodger · J.
Background

The prevalence of depression and mood disorders has been steadily rising in Australian youth, with a concomitant increase in antidepressant pharmacotherapy prescription rates. Yet, the tolerability and efficacy of antidepressant drugs in youth remain poor. Pharmacogenetic (PGx) testing, or the personalised and guided treatment of medication based on genetic data, has been suggested to improve the effectiveness and tolerability of antidepressants. However, limited studies have evaluated the utility of antidepressant PGx-guided treatment in adolescent and young adult populations. Thus, this pilot randomised controlled trial (RCT), the GENE-YD Study, will evaluate the feasibility for a large-scale RCT assessing the effect of PGx-guided antidepressant prescription vs treatment as usual in youth with major depressive disorder (MDD).

Methods and analysis

Eighty young people between 16 and 24 years of age and in the early stages of pharmacotherapy treatment for MDD will be recruited. Following initial screening, participants will be randomised on a 1:1 ratio to either the intervention or control study group. Participants in the intervention condition will have their treatment tailored based on their PGx profile. Participants randomised into the control group will have their prescription based on current best practice recommendations, or treatment as usual. Individuals will be assessed at drug prescription baseline and again 6 and 12 weeks following drug prescription. The primary outcome of the study will be to evaluate the feasibility and acceptability of the GENE-YD protocol. Specifically, this study will explore participation recruitment strategies and attrition to the study protocols to guide the recruitment processes of a large-scale RCT, along with participating satisfaction in overall study protocols. Secondary outcomes will inform the utility and variability of specific measures (eg, depression rating scales, quality of life measures and medication adherence scales) that may be scaled up for use in a future full-scale trial.

Ethics and dissemination

Ethics approval was granted by the Department of Health, Western Australia’s Human Research Ethics Committee (RGS0000006822) and recognised by the University of Western Australia’s Human Research Ethics Committee (2024/ET000685). All participants will be required to provide written informed consent. Results will be published in international peer-reviewed journals.

Trial registration number

ACTRN12624000760572.

Optimising regional care delivery systems targeting adults with heart failure and mental health interconnected conditions: a participatory action research study protocol

Por: Philip · S. · Dahrouge · S. · Valade · R. L. · Hammond · E. · Aomreore · A. · Hosseini · M. · Archibald · D. · Bandk · K. · Antunes · P. · Assaoure · J. · Benoit · P. · Plourde · D. · Sabbagh · R. · Skaff · E. · Seguin · J. · Tanguay · E. · Welch · V. · Liu · P. · Kehoe MacLeod · K.
Introduction

Brain and heart conditions are among the leading causes of illness and mortality in Canada. Heart failure is one of the fastest-growing cardiovascular conditions globally, with more than 100 000 Canadians diagnosed each year. Individuals with heart failure are at significantly increased risk of mental health challenges such as depression, anxiety and stress. However, healthcare services often remain siloed, treating physical and mental health separately. This complicates care for individuals with multiple chronic conditions. This multiyear study will adapt, test and accelerate changes to regional care delivery models in Eastern Ontario to optimise brain-heart health and generate knowledge to support the spread and scale of effective interventions that address community needs and priorities. We aim to: (1) identify resource gaps by mapping available services; (2) document strengths and challenges in care delivery; and (3) co-design, pilot test and evaluate an intervention developed based on the priority gap area(s) identified through objectives (1) and (2).

Methods and analysis

This community-based participatory action research study is led by a research coalition of patient and caregiver partners, care providers and leadership staff from two Ontario Health Teams. In Year 1, we will conduct asset mapping and community consultations with individuals living with heart failure, caregivers, care providers and service organisations to identify care gaps, strengths and opportunities for improvement around modifiable behavioural risk factors and brain-heart health. A scoping review will identify evidence-based strategies to address care gaps and inform the co-design of an intervention focused on supporting individuals with brain-heart interconnected conditions. In Year 2, we will co-design an intervention with community partners for implementation with clinical test sites. Year 3 will involve pilot testing the intervention and conducting outcome and process evaluations. This will inform future spread and scale of the intervention to other brain-heart conditions and new jurisdictions.

Ethics and dissemination

The study is approved by the Bruyère Health Research Ethics Board (M16-24-016). Findings will be disseminated through peer-reviewed publications, conference presentations and knowledge mobilisation activities such as social media, community events and local media outreach, as well as through dedicated engagement with Ontario Health partners and the Brain-Heart Interconnectome Network via retreats and collaborative forums.

High-flow nasal Oxygen with or without alternating helmet Non-invasive ventilation for Oxygenation sUpport in acute Respiratory failure (HONOUR): a protocol for a pilot randomised controlled trial

Por: Angriman · F. · Ferreyro · B. L. · Rochwerg · B. · Sklar · M. · Adhikari · N. · Bagshaw · S. M. · Brochard · L. · Cuthbertson · B. · Del Sorbo · L. · Fowler · R. · Geagea · A. · Granton · J. T. · Mehta · S. · Munshi · L. · Muscedere · J. · Nardi · J. · Parhar · K. · Pinto · R. L. · Piquett
Introduction

Acute hypoxaemic respiratory failure is a common reason for intensive care unit (ICU) admission. Non-invasive respiratory support strategies such as high-flow nasal oxygen (HFNO) and helmet non-invasive ventilation may reduce the need for invasive mechanical ventilation and death. The High-flow nasal Oxygen with or without alternating helmet Non-invasive ventilation for Oxygenation sUpport in acute Respiratory failure pilot trial is designed to compare helmet non-invasive ventilation combined with HFNO vs HFNO alone in patients with acute hypoxaemic respiratory failure and to determine the feasibility of a larger randomised controlled trial.

Methods and analysis

This is a pragmatic, open-label, multicentre randomised controlled pilot trial enrolling 200 critically ill adults with acute hypoxaemic respiratory failure across 12 Canadian ICUs. Participants are randomised 1 to 1 to receive either helmet non-invasive ventilation plus HFNO or HFNO alone for at least 48 hours. The primary aim is to assess feasibility metrics including recruitment rate, protocol adherence and fidelity to pre-specified intubation criteria. Secondary outcomes include rates of intubation, all-cause mortality, ventilator-free days, ICU length of stay and quality of life at 6 months. Primary and secondary outcomes will be analysed using Bayesian methods.

Ethics and dissemination

Ethics approval has been obtained at all participating centres. Findings will inform the feasibility and design of a future full-scale trial and be disseminated through peer review publications and conference presentations.

Trial registration number

ClinicalTrials.gov Identifier: NCT05078034.

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