Conectar
Some people with HIV (PWH) experience brain changes that affect neurocognition, but little is known about how HIV impacts social cognition or related brain regions. Social cognition, the ability to perceive, understand and respond to social information, is important for maintaining relationships and quality of life. This article provides the protocol for the first comprehensive study examining social brain function in PWH and people without HIV (PWoH). With three aims, this study will: (1) examine neural circuits related to social cognition; (2) examine social cognitive performance across two social cognitive domains and (3) examine the role of social cognition in everyday social functioning.
Referred to as Social Brain Health Study in HIV Study, this cross-sectional study will enrol 105 PWH and 105 demographically matched PWoH aged 18–65 years. The study administers a comprehensive assessment battery across two visits within a 2-week period. Visit 1 includes behavioural measures of social cognition (Perceiving Social Cues and Understanding Others), neurocognition and social functioning (social network size and loneliness). Visit 2 involves functional MRI procedures with three social cognitive tasks designed to activate key brain regions (ie, fusiform face area, superior temporal gyrus, temporo-parietal junction, dorsal medial prefrontal cortex).
This study was funded by the National Institute of Mental Health (MH139613) and approved by the Institutional Review Board of the University of Alabama at Birmingham (IRB-300013394). Data collection is ongoing. The first results are expected to be submitted for publication in 2030. Findings of this study will be published in peer-reviewed journals and presented at local, national and international conferences as well as patient organisations such as AIDS service organisations and community talks.
Nigeria has the highest number of maternal deaths globally, and maternal peripartum sepsis is one of the leading causes of maternal mortality. A single oral dose of azithromycin (AZM; 2 g) is safe and effectively reduces 33%–60% of maternal sepsis during planned vaginal birth in low- and middle-income countries (LMICs). However, the clinical and cost-effectiveness of oral AZM during vaginal birth in Nigeria remains unknown in the context of poor antimicrobial stewardship practices, significant antimicrobial resistance and healthcare financing. Evidence is also lacking on the standard care for the prevention of maternal sepsis among pregnant women undergoing vaginal births in Nigeria. The AZIN-V trial is a hybrid type 2 effectiveness-implementation trial to determine the safety, clinical and cost-effectiveness of intrapartum oral AZM versus usual care in the prevention of peripartum maternal sepsis. The trial will also examine the impact of implementation strategies in enhancing adherence to the oral AZM protocol during planned vaginal births and identify effective strategies to improve adherence (fidelity) to the protocol in real-world LMIC settings.
This is a multicentre hybrid type 2 trial conducted in six Nigerian states: Ebonyi, Edo, Gombe, Kano, Kwara and Lagos. The study aims to simultaneously test the clinical and cost-effectiveness of AZM (clinical trial) and the impact of implementation strategies (implementation research) in Nigeria’s unique healthcare context. The clinical trial is a two-arm, cluster-randomised controlled trial conducted across 48 health facilities, randomly assigned (1:1) to either intrapartum administration of oral AZM (intervention group) or usual care—the current routine practice (control group). A total of 5040 study participants (2520 in each group) will be enrolled in the clinical trial. The implementation trial is a two-arm cluster non-randomised controlled trial conducted in 12 health facilities (1:1) allocated to either a bottom-up approach using the Plan-Do-Study-Act cycle or a usual top-down approach with a one-time training workshop and distribution of clinical guidelines, with both arms administering oral AZM during vaginal birth while assessing fidelity (primary outcome).
For the clinical trial, data will be analysed using intention-to-treat statistical methods. The cost-effectiveness outcome will be analysed using the Incremental Cost-Effectiveness Ratio. Implementation outcomes will be analysed using descriptive statistics and a thematic approach.
This study has been approved by the National Health Research Ethics Committee, Nigeria (NHREC/01/01/2007-30/09/2024), the ethics committees of the participating health institutions (Lagos University Teaching Hospital Research Ethics Committee: ADM/DSCST/HREC/APP/6325; University of Ilorin Teaching Hospital Health Research Ethics Committee: ERC/PAN/2025/03/0581; University of Benin Teaching Hospital Health Research Ethics Committee: ADM/E22/A/VOL. VII/483117141; Aminu Kano Teaching Hospital Research Ethics Committee: AKTH/MAC/SUB/12 A/P-3/VI/2509 and Irrua Specialist Teaching Hospital Research Ethics Committee: ISTH/HREC/20241507/605), the Ministries of Health of the six states and the National Agency for Food and Drug Administration and Control. Written informed consent will be obtained from all eligible study participants before enrolment. Results will be shared with communities and policy stakeholders and through peer-reviewed journals and will be presented at conferences.
Treatment advancements in chronic myeloid leukaemia (CML) have made the disease manageable but carry significant risk of side effects. Bridging information gaps between patients and physicians through shared decision-making (SDM) is increasingly favoured, yet understanding treatment complexities remains a challenge. This study sought to identify decisional and informational needs of both patients and physicians in CML care.
A qualitative study using semi-structured interviews was conducted to investigate the opinions, attitudes and preferences of both patients with chronic myeloid leukaemia and physicians.
Patients and physicians were recruited through the Dutch CMyLife platform, an initiative of haematologists, patients and patient organisations. They were provided with the participant information and invited to participate if interested.
A total of 15 interviews (n=10 patients, n=5 physicians) were conducted between April and October 2023.
A pre-defined interview guide was developed based on the Decisional Needs Assessment questionnaire. Interview transcripts were thematically analysed.
Eight themes and 28 sub-themes were observed, highlighting patient needs, treatment choices and informational preferences. Patients emphasised the importance of understanding medication options and side effects, while physicians stressed the necessity of delivering up-to-date and comprehensible information. Almost all participants had experienced professionals making the treatment decision, without patient involvement, especially when initiating treatment. Some patients expressed too little information and missed partnership with professionals at treatment onset. Peer support, decision-making dynamics and the role of caregivers were also significant considerations.
Both shared and distinct perspectives on CML treatment decision-making between patients and physicians were revealed, underscoring the complexity of decisional needs in CML management. The findings emphasise the importance of patient-centred care, SDM and tailored communication strategies to optimise patient outcomes and satisfaction. Improved communication and evidence-based decision-making tools can significantly impact patient well-being. Further research and interventions are necessary to address the challenges in decision-making processes in CML care.
This study describes the prototype testing and clinical validation of the Fit-Frailty App, a fully guided, interactive mobile health (mHealth) app to assess frailty and sarcopenia. This multi-dimensional tool is freely available on the App Store and considers medical history, physical performance, cognition, nutrition, daily function and psychosocial domains. To guide management, a total frailty score and clinical summary of underlying "risk flags" are provided. Our objectives were to examine usability, feasibility, criterion and construct validity.
Cross-sectional
Outpatient geriatric medicine clinic
Community-dwelling older adults, age 65 years or older
The primary outcome of the clinical validation study was criterion validity. A research nurse administered the Fit-Frailty App during a routine clinic appointment. Clinicians simultaneously completed a paper-based frailty index (FI) tool with similar items from a comprehensive geriatric assessment (FI-CGA). Total scores for both assessments were computed using the cumulative deficits frailty index scoring method. Intraclass and Pearson correlation coefficients and 95% CIs were calculated to examine criterion validity. Secondary outcomes were construct validity, feasibility (eg, completion rates, safety occurrences, resources) and usability (eg, ratings on ease of use, time to complete the app).
In the clinical validation study (n=75, mean age 79.2, SD=7.0, 53% female), the mean total Fit-Frailty App score was 0.33 (SD=0.13) with 73% of our sample considered frail or severely frail. The app presented comparable results to FI-CGA (moderate to good validity; ICC=0.65, 95%CI=0.50–0.76) with a strong association between the measures (r=0.74, 95%CI=0.62–0.83). In our prototype and clinical cohorts, the app had a 100% completion rate with no safety occurrences and had high usability ratings.
The Fit-Frailty App is a feasible and valid tool that can be used in research and clinical settings to comprehensively assess frailty and sarcopenia by non-geriatricians and could assist with developing targeted interventions.
The use of economic evidence to prioritise vaccines and delivery strategies to optimally use in immunisation systems is becoming a global priority, especially in low- and middle-income countries (LMICs), in view of challenges in funding and the need to make more efficient use of available resources. We undertook a scoping review to identify and synthesise available evidence on strategies that have been used to enhance the use of economic evidence in policy and decision-making in the immunisation ecosystem in LMICs. The review was also used to identify the facilitators and constraints to the use of economic evidence for vaccination policy and decision making in LMICs and the sustainability of the identified strategies.
A scoping literature review was undertaken to generate the evidence. The review adhered to the first five steps of Arksey and O’Malley’s methodological framework (identifying and refining the research questions, identifying relevant articles, selection of studies, data extraction and charting and data synthesis) and Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for scoping reviews.
Full-text articles were searched on PUBMED, HINARI and DOAJ using different combinations of search words as of 16 December 2024
We included articles from LMICs, including Africa, and global experiences, including those from LMICs. Papers must be written in English or have an English language translation available and published between 1 January 2004 and 16 December 2024.
Two independent reviewers used standardised methods to search, extract, and screen included studies. The findings from the review were summarized in themes that were synthesized qualitatively.
18 eligible articles met the inclusion criteria and were included in the synthesis. It was found that economic evidence was systematically requested and demonstrably influencing vaccine introduction or prioritisation decisions in only eight out of 32 LMIC settings with functional National Immunization Technical Advisory Groups (NITAGs) and in fewer than 20% of documented new vaccine introduction processes since 2015. In the majority of cases, decisions were reported as being driven primarily by disease burden, political priority, donor recommendations or historical precedent, with economic analyses either absent, produced post hoc or acknowledged but not used as a decisive factor.
There is minimal use of evidence from economics in decision-making within the immunisation ecosystem. Expert advisory committees in LMICS can, however, enhance the use of economic evidence in vaccination policy and decision-making. Hence, in order to use economic evidence for decision making, national advisory committees such as NITAGs need enhanced capacity, independence and close collaboration with researchers. LMIC NITAGs could also benefit from tailored adaptations, such as simplified cost-effectiveness tools and regional economic data hubs, to bridge this gap in decision-making and bring economic evidence to the fore of their decisions.
Interstitial lung diseases (ILD) associated with an underlying connective tissue disease (CTD), also known as a systemic autoimmune rheumatic disease or SARD, are chronic conditions with a tendency to progress. CTD-ILDs are increasingly diagnosed and pose an important global health challenge. This systematic review aims to provide an overarching evaluation of their epidemiology and disease burden in Asia. In this review, the term CTD-ILD will be used to denote all major forms of ILD arising in the context of a SARD.
This systematic review will adhere to the standards of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, including a flow diagram to depict the process by four independent reviewers that will assess titles and abstracts against the following predetermined criteria. A systematic review of the literature search published from 2000 to 2024 will be conducted using five electronic databases including PubMed/MEDLINE, Scopus, EMBASE, Cochrane Library and Web of Science. Publications that meet the inclusion criteria of this review will be subjected to a full-text review to extract relevant data. Collated data will be analysed and organised into categories based on the expected outcome and objectives. The quality of published evidence, including heterogeneity across studies, will be checked against PRISMA checklists and assessed by Newcastle-Ottawa Scale.
Ethics approval is not applicable for this study since no original data will be collected. The findings of this review will be disseminated through a peer-reviewed publication in a scientific journal and conference communications, with the aim of contributing insights to the field by identifying research gaps and informing clinical practice.
The protocol of this systematic review is registered with the National Medical & Research Register (ID-24–03600-GUB) and International Prospective Register of Systematic Reviews PROSPERO (CRD420251037095).
To describe the outcomes and associations of pericardial disease, with a particular focus on the outcomes of patients admitted with primary or secondary pericardial disease.
Retrospective observational study.
All public and private hospitals in New South Wales, Australia.
Hospitalised patients with pericardial disease admitted from 2004 to 2021 that was (a) a primary diagnosis or (b) a secondary diagnosis.
Mortality both in-hospital and during several years of available follow-up.
Out of 45 446 patients diagnosed with pericardial disease, under half (46.8%) had pericardial disease as the primary reason for hospitalisation. Patients in whom pericardial disease was the primary compared with the secondary diagnosis were more commonly male (68.2% vs 59.1%), younger (median 51.2 years vs 66.0 years) and less comorbid (age-adjusted median Charlson Comorbidity Index 1 vs 4). In patients with pericardial disease, adjusted in-hospital mortality was fivefold lower if this was the primary diagnosis (OR 0.21, p
Patients with pericardial disease have a low in-hospital mortality of about 1% if this was the primary diagnosis. However, patients in whom it was a secondary diagnosis, especially in the presence of comorbidities such as malignancy, had a much worse prognosis.
Advance care planning (ACP) can support individuals to express their autonomy in the decision-making process for future care. Traditional ACP training for healthcare providers faces significant challenges related to interactivity, accessibility, scalability and sustainability. Cutting-edge generative artificial intelligence (AI) holds promise in enabling intelligent and interactive chatbots for ACP. The present protocol outlines the development and evaluation of a large language model (LLM)-based ACP chatbot for healthcare providers.
The development of the LLM-based ACP chatbot will follow four stages: construction of dialogue data sets, fine-tuning, multi-LLM orchestration and ablation studies. A randomised controlled trial will then evaluate the LLM-based ACP chatbot’s effectiveness in enhancing ACP competence among healthcare providers. A total of 66 healthcare providers will be recruited from China and randomly assigned (1:1) to either: (1) The LLM-based ACP chatbot intervention or (2) An ACP knowledge manual. The primary outcome will be ACP competence, while secondary outcomes will include (1) ACP knowledge, (2) Attitudes/beliefs, (3) Practice willingness, (4) Readiness, (5) Self-efficacy, (6) Processes of change, and (7) Decisional balance. Both primary and secondary outcomes will be assessed to evaluate the immediate impact (postintervention) and short-term impact (3-month follow-up and 6-month follow-up) of the chatbot on ACP.
The research was approved by the Ethical Review Board, Xiangya School of Nursing, Central South University (E202442). Study modifications will be discussed among the research team members until a consensus is reached. Amendments reflecting study modifications will be submitted for institutional review board approval at all sites, updated on the clinical trial registry, and fully detailed and explained in the manuscript reporting the results of the study. All participants will provide written informed consent. The study will be conducted according to the principles outlined in the Declaration of Helsinki. The results of this study will be submitted for publication in peer-reviewed journals and presented at (inter)national conferences.
ChiCTR2400091022
Photobiomodulation (PBM) has shown promising effects in managing postoperative pain following conventional periapical surgery, although current evidence remains limited. This study aims to assess the effect of PBM on postoperative pain 24 hours after periapical surgery.
A randomised, controlled, double-blind trial will include 34 patients undergoing periapical surgery in the maxillary region, randomly assigned to an experimental group (n=17) or control group (n=17). The experimental group will receive PBM (GaAlAs diode laser, 808 nm, 100 mW, 4 J/cm², applied at five vestibular points) and placebo ibuprofen immediately and 24 hours postoperatively. The control group will receive simulated PBM and active ibuprofen. The primary outcome is postoperative pain assessed by the visual analogue scale at 24 hours. Secondary outcomes include pain at the seventh day, paracetamol intake, oedema, ecchymosis, soft tissue status and temperature at 24 hours and 7 days. Radiographic evaluation of healing will be performed at 1 and 3 months. Statistical analysis will be conducted based on data distribution, using repeated measures ANOVA (Analysis of Variance) or non-parametric equivalents for longitudinal outcomes, and appropriate tests for categorical variables. Significance will be set at p
The study was approved by the Human Research Ethics Committee of Universidad Católica del Uruguay (process no. 220914). Results will be disseminated to participants, healthcare professionals, the public and scientific communities.
There is an urgent need to better understand how information from circulating tumour DNA (ctDNA) can be integrated into routine care for patients with advanced solid cancer.
The implementation of liquid biopsies in routine care of patients with advanced solid cancer trial (LIQPLAT) is a single-centre, single-arm trial investigating the implementation of ctDNA in the routine care of patients with advanced solid cancer. We present a mixed-methods process evaluation embedded in the LIQPLAT trial, following Medical Research Council guidance and the Reach, Effectiveness, Adoption, Implementation, Maintenance framework. We show a logic model, which details the causal chain and related assumptions from recruiting patients into the trial to the goal of improving quality of life and survival. Data collection is longitudinal and includes: semistructured interviews with healthcare professionals (pathologists, biologists, oncologists; planned n=20) and patients (planned n=15) to identify implementation barriers and facilitators; recordings of molecular tumour board meetings to analyse clinical decision-making; the 23-item Normalisation MeAsure Development survey for healthcare professionals (planned n=20) at four time points. Quantitative data from hospital records will be used to assess implementation outcomes like patient acceptance rates and ctDNA workflow success. Qualitative data will undergo thematic and content analysis, and quantitative data will be analysed using a Bayesian framework.
The LIQPLAT trial was approved by the regional ethics committee of Northwestern and Central Switzerland (BASEC 2024-00358). The qualitative aspects of the process evaluation were exempted from ethics review according to the Swiss Human Research Act. We follow guidelines for data security, confidentiality and information governance. Results will be submitted for publication in peer-reviewed journals and discussed at conferences.
NCT06367751, SNCTP000005844.
Frequent haemodialysis creates close-knit communities within treatment units, where high patient mortality contributes to significant grief among patients and staff. Despite the emotional toll, support for grief and bereavement in these settings remains limited, and recent data are lacking. This scoping review aims to explore how patients and nursing staff within haemodialysis units experience and cope with bereavement, and to identify support strategies currently used or desired to inform future, culturally sensitive approaches, particularly in Australia.
Scoping review conducted in accordance with the Joanna Briggs Institute methodology.
A comprehensive search was conducted using the Clinical Information Access Portal, supplemented by grey literature and the Elicit AI Research Assistant tool.
We included literature exploring patient and nurse perspectives on grief and bereavement in haemodialysis units. Studies outside the haemodialysis setting and non-English studies were excluded. There were no geographical or publication year limitations.
Two reviewers independently screened titles, abstracts and full texts, with discrepancies resolved by consensus. A data extraction table was used to collect study characteristics and key findings. Thematic analysis was applied to synthesise data across studies.
17 publications from 1998 to 2021 were identified across five countries. Grief and bereavement following patient death profoundly shape haemodialysis unit dynamics. Patients form familial bonds and experience deep grief when peers die, while nurses face emotional stress and burnout. Reported support strategies include memorial services, peer and staff support, counselling and debriefing and spiritual care.
This study describes grief experiences, support strategies and cultural implications in haemodialysis units, which serve a culturally diverse group of people. By consolidating available knowledge, this review provides a critical platform for future empirical work and calls for culturally sensitive support and larger, diverse samples in future research.
Most patients receive behavioural healthcare (BH) in a primary care setting, yet much of the BH research was not developed to account for eventual implementation. Areas of research and intervention that are considered priorities to patients may be absent from our existing knowledge base. Engaging the community in the research process can facilitate translation and uptake. A key strategy for community engagement is to employ a Community Advisory Board (CAB). CABs can assist in a number of research processes, including guiding research questions to fit the priorities of the community and creating research materials that are tailored to the patient population and healthcare setting. There is variability in practices and reporting standards for CABs. The field would benefit from a summary of the state of the current literature on CAB utilisation for BH research in primary care. To fill this gap, we will conduct a scoping review to answer the question, ‘What is known about the use of CABs in behavioural health studies in primary care?’.
We will use the guidelines for scoping reviews outlined by Arksey and O’Malley: (1) identifying the research question; (2) identifying relevant studies; (3) study selection; (4) charting the data and (5) collating, summarising and reporting the results. Our reporting of the results will be guided by the Arnos and colleagues Toolkit for Project-Based Community Advisory Boards, a set of practical guidelines for employing a CAB. To this end, we will report on how well CABs currently employed in BH primary care research match existing guidelines and what gaps need to be filled by future research.
This review does not require ethics board approval, as no patient data will be collected. We will disseminate findings primarily through journal publications and conference presentations.
This scoping review protocol was registered on the Open Science Framework (https://osf.io/pa3rz/?view_only=31c558eb395a4a9482ee9c5b57ca1c4c)
This review aims to map oral health plans, programmes and policies worldwide in countries with universal health coverage.
This protocol describes a scoping review that will follow the Joanna Briggs Institute methodology and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses-Scoping Review checklist, guided by the PCC framework: Population—countries with universal health coverage (78 globally recognised); Concept—oral health plans, programmes and policies; Context—integration into health systems. Searches will be conducted in MEDLINE (PubMed), Scopus, Web of Science, Embase, Health System Evidence and Epistemonikos, with no restrictions on date, language or study type. Grey literature will be accessed through Google Scholar, OpenThesis and the Brazilian Digital Library of Theses and Dissertations. Official documents from ministries of health and international bodies, including the WHO and the International Monetary Fund, will also be reviewed. Two independent reviewers will screen titles and abstracts; a third will resolve disagreements. Eligible records will undergo full-text review. Data will be extracted into predefined categories reflecting health system components: population, structure, services, governance and oral health indicators. Results will be presented using tables, charts and figures to illustrate strategies and innovations.
This review does not involve primary data collection and does not require ethical approval. Results will be disseminated through a peer-reviewed publication and presentations at academic conferences and scientific events.
Open Science Framework (DOI 10.17605/OSF.IO/RCP8N).
SARS-CoV-2 is now endemic and expected to remain a health threat, with new variants continuing to emerge and the potential for vaccines to become less effective. While effective vaccines and natural immunity have significantly reduced hospitalisations and the need for critical care, outpatient treatment options remain limited, and real-world evidence on their clinical and cost-effectiveness is lacking. In this paper, we present the design of the Canadian Adaptive Platform Trial of Treatments for COVID in Community Settings (CanTreatCOVID). By evaluating multiple treatment options in a pragmatic adaptive platform trial, this study will generate high-quality, generalisable evidence to inform clinical guidelines and healthcare decision-making.
CanTreatCOVID is an open-label, individually randomised, multicentre, national adaptive platform trial designed to evaluate the clinical and cost-effectiveness of therapeutics for non-hospitalised SARS-CoV-2 patients across Canada. Eligible participants must present with symptomatic SARS-CoV-2 infection, confirmed by PCR or rapid antigen testing (RAT), within 5 days of symptom onset. The trial targets two groups that are expected to be at higher risk of more severe disease: (1) individuals aged 50 years and older and (2) those aged 18–49 years with one or more comorbidities. CanTreatCOVID uses numerous approaches to recruit participants to the study, including a multifaceted public communication strategy and outreach through primary care, outpatient clinics and emergency departments. Participants are randomised to receive either usual care, including supportive and symptom-based management, or an investigational therapeutic selected by the Canadian COVID-19 Outpatient Therapeutics Committee. The first therapeutic arm evaluates nirmatrelvir/ritonavir (Paxlovid), administered two times per day for 5 days. The second therapeutic arm investigates a combination antioxidant therapy (selenium 300 µg, zinc 40 mg, lycopene 45 mg and vitamin C 1.5 g), administered for 10 days. The primary outcome is all-cause hospitalisation or death within 28 days of randomisation.
The CanTreatCOVID master protocol and subprotocols have been approved by Health Canada and local research ethics boards in the participating provinces across Canada. The results of the study will be disseminated to policy-makers, presented at conferences and published in peer-reviewed journals to ensure that findings are accessible to the broader scientific and medical communities. This study was approved by the Unity Health Toronto Research Ethics Board (#22-179) and Clinical Trials Ontario (Project ID 4133).
Distal radius fractures account for one-fifth of all fractures in the active elderly population and may cause chronic pain, loss of hand function and reduced work productivity, imposing a significant socioeconomic burden. Most are initially treated with closed reduction and casting, but 30% subsequently require surgery due to insufficient realignment. The current approaches for analgesia for closed reduction are suboptimal. A brachial plexus nerve block provides complete pain relief and muscle relaxation distal to the elbow, potentially creating better conditions for realignment of the fractured bone ends. This may ultimately translate into reduced need for surgery and result in better functional outcomes and fewer complications compared to a haematoma block, which is the current standard care in Denmark.
The BLOCK Trial is an investigator-initiated, parallel-group, allocation-concealed, outcome assessor and analyst-blinded, superiority, randomised, controlled, clinical multicentre trial performed at 11 Danish emergency departments. Eligible adult patients with a distal radius fracture who need closed reduction will be included and allocated 1:1 to either an ultrasound-guided brachial plexus nerve block or a haematoma block. The primary outcome is the proportion of patients with distal radius fracture surgery 90 days after closed reduction. We will include 1716 participants to detect or discard a relative risk reduction of surgery of 20%. Secondary outcomes include treatment-related complications, patient-reported wrist function, pain during closed reduction and proportion of patients with unacceptable radiographic fracture position immediately after closed reduction.
The trial is approved by the Danish Medicines Agency and the Danish Research Ethics Committees (EU CT number: 2024-512191-35-00). All results will be summarised on www.theblocktrial.com, clinicaltrials.gov and euclinicaltrials.eu after publication. Primary and secondary outcome results from 0 to 90 days will be presented in the main article and submitted to a peer-reviewed journal. Results from outcomes on the 12-month follow-up will be presented separately.
Vaccination against SARS-CoV-2 was a crucial public health measure during the COVID-19 pandemic. Among the multiple strategies developed to increase vaccine uptake, governments often employed vaccine mandates. However, little evidence exists globally about the impact of these mandates and their subsequent removal on vaccine uptake, including in Australia, France, Italy and the USA. The aim of this study is to provide a protocol to evaluate and quantify the impact of COVID-19 vaccine mandates and removals on vaccine uptake in these countries, with a specific focus on comparing Australian policies with those from Europe and the USA. Actualising the work outlined in this protocol will help to provide policy and technical guidance for future pandemic preparedness and routine immunisation programmes.
This protocol outlines a retrospective study using existing data sources including Australian Immunisation Register-Person Level Integrated Data Asset for Australia and publicly available data for France, Italy and California (USA). Causal inference methods such as interrupted time series, regression discontinuity design, difference-in-differences, matching and synthetic control will be employed to assess the estimated effects of vaccine mandates and removals on vaccine uptake.
The University of Newcastle’s human research ethics committee has approved the study (reference number: H-2024-0160). Peer-reviewed papers will be submitted, and results will be presented at public health, immunisation and health economic conferences nationally and internationally. A lay summary will be published on the MandEval website.
Commentary on: Rooney, C, Pyer, M, & Campbell, J. Leaving it at the gate: A phenomenological exploration of resilience in mental health nursing staff in a high-secure personality disorder unit. J Adv Nurs, 00, 1–13. (2023) https://doi.org/10.1111/jan.15947
Implications for practice and research Organisational structures and systems of support such as clinical supervision can support resilience in mental health nursing staff who work in high-secure forensic settings. Future studies in different high-secure forensic settings and different countries are required to enhance the generalisability of the findings.
High-secure mental health hospitals, also known as high-secure forensic hospitals, are a specialism within mental healthcare.
FreshRSS 