Conectar
To identify predictors of treatment changes and to evaluate the effectiveness and patient-reported outcomes (PROs) in patients with rheumatoid arthritis (RA) initiating tofacitinib in a real-world setting.
The non-interventional study ESCALATE-RA included 1518 patients with RA from Germany. RA treatment, including all changes in therapy, was documented for 24 months starting from the initial intake of tofacitinib.
All patients started with tofacitinib therapy, either as monotherapy or in combination with methotrexate (MTX).
The impact of several factors of interest on the number and timing of treatment changes was assessed as primary outcome using Cox proportional hazards models. Further outcomes were tofacitinib drug survival and the use of follow-up disease-modifying antirheumatic drugs after first treatment change. We also assessed the effectiveness, concomitant glucocorticoid (GC) use, PROs (such as functional ability, patient satisfaction, pain and quality of life) and safety. Analyses were based on observed data.
‘Lack of efficacy’ (HR 3.30) and ‘intolerance’ (HR 4.43) leading to termination of tofacitinib were key factors favouring therapy changes. Higher patient satisfaction was significantly associated with a reduced likelihood of treatment changes (HR 0.82). Increasing GC doses were associated with a higher probability of step-up/switch changes (HR 1.21). The estimated tofacitinib drug survival was 48% at the end of study. Proportions of patients achieving low disease activity (both Simplified Disease Activity Index (SDAI) and Clinical Disease Activity Index (CDAI) 62%) and remission (SDAI 25%, CDAI 28%) increased from baseline under tofacitinib and were comparable between monotherapy and combination therapy with MTX. Mean concomitant GC dose decreased (2 mg/day). PROs indicated reduced pain and fatigue, while functional ability and quality of life improved. 63.9% of the patients experienced a treatment-emergent adverse event (AE), 8.8% a treatment-emergent AE of special interest and deaths occurred in 0.5%.
Key factors for therapy changes in patients with RA treated with tofacitinib were lack of efficacy and intolerance. Higher patient satisfaction was associated with a reduced probability of treatment changes, while increased GC doses led to a higher likelihood of step-ups/switches. Patients demonstrated a marked reduction in disease activity for up to 24 months, along with improvements in functional ability, pain and quality of life. Observed AEs were consistent with the known safety profile of tofacitinib.
To develop and psychometrically test a comprehensive Cancer Nurse Self-Assessment Tool (CaN-SAT).
Modified Delphi to assess content validity and cross-sectional survey to assess reliability and validity.
Phase 1: An expert group developed the tool structure and item content. Phase 2: Through a modified Delphi, cancer nursing experts rated the importance of each element of practice and assessed the relevance and clarity of each item. Content Validation Indexes (CVI) were calculated, and a CVI of ≥ 0.78 was required for items to be included. Phase 3: Cancer nurses participated in a survey to test internal consistency (using Cronbach's alpha coefficients) and known-group validity (through Mann–Whitney U tests). This study was reported using the Guidelines for Reporting Reliability and Agreement Studies (GRRAS) checklist.
The CaN-SAT underwent two rounds of Delphi with 24 then 15 cancer nursing experts. All elements of practice were rated as important. Only three items achieved a CVI < 0.78 after round one; however, based on open-ended comments, 26 items were revised and one new item added. After round two, all items received a CVI above 0.78. The final tool consisted of 93 items across 15 elements of practice. Cronbach's alpha coefficients were between 0.92 and 0.98 indicating good reliability. Mann–Whitney U tests demonstrated significant differences between clinical nurses and advanced practice nurses across 13 out of 15 elements of practice.
The CaN-SAT is a comprehensive, valid and reliable tool that can be used for cancer nurses to self-assess current skill levels, identify their learning needs and inform decisions about educational opportunities to optimise cancer care provision.
The research team included three patient advocates from Cancer Voices NSW, who were actively involved in all aspects of the study and are listed as authors.
Mothers’ mental health and life satisfaction may have been negatively affected due to challenges during the COVID-19 pandemic. Given the risk of future crises, knowledge of possible mitigating factors in this population is essential. This study aims to examine whether the pandemic affected the level of protective factors such as social support, physical activity and employment situation, and how these factors are associated with mental distress and life satisfaction.
Longitudinal cohort study.
Primary outcomes were mental distress (measured by the eight-item version of the Hopkins Symptom Checklist) and life satisfaction (measured by the Satisfaction With Life Scale). As the first step, we investigated changes in the levels of social support (defined by the number and frequency of social contact), physical activity (average hours of physical activity during a week), employment situation (actively working vs sick leave or unemployed), alcohol consumption (measured by the Alcohol Use Disorders Identification Test-Consumption) and relationship satisfaction (measured by the five-item version of the Relationship Satisfaction Scale).
We analysed data from two waves of the Norwegian Mother, Father and Child Cohort Study (n=~18 000 mothers); one pre-pandemic wave and one wave where half of the sample responded after the onset of the pandemic, with pandemic exposure being defined by questionnaire response timing rather than cohort recruitment. To assess changes in protective factors over time and pandemic exposure, we used difference-in-differences analyses and regression discontinuity design. Associations between protective factors with mental distress and life satisfaction, and possible moderation by pandemic exposure, were investigated using multiple regression models with interaction terms adjusted for potential confounders.
Apart from physical activity, which declined less across time in the pandemic group (B=0.09, 99% CI 0.05 to 0.12), protective factors did not change during the pandemic. Social support, employment situation and relationship satisfaction were associated with mental distress and life satisfaction, whereas physical activity showed a unique relationship with mental distress. Most associations were similar across pandemic exposure groups, except employment situation which appeared to have a stronger protective effect in the pandemic group (β=–0.12, 99% CI –0.24 to –0.00).
Changes over time in self-reported levels of protective factors were generally consistent among mothers independent of the pandemic. These factors appear to play an equally important role for mental distress and life satisfaction both under ordinary circumstances and during public health crises. Our findings enhance the understanding of how potential protective factors among mothers are associated with mental distress and life satisfaction in the context of a global stressor. Future studies should investigate additional mitigating factors that may be particularly relevant during global crises and explore the causal relationship between protective factors, mental health and life satisfaction.
To explore the perceptions and experiences of managers in residential aged care settings regarding personal care workers' intention to stay and build a career. Specifically, this study sought to identify enablers and challenges influencing personal care workers' retention and to explore strategies that could improve workforce sustainability.
A qualitative study utilising semi-structured interviews underpinned by the Theory of Planned Behaviour.
The study was conducted in Australia from July 2023 to March 2024. Eleven managers participated in this study. Data were analysed using inductive thematic analysis.
Four themes emerged from the analysis and were conceptualised to illustrate the intricate relationship between recruitment practices, work environment, organisational culture and leadership in influencing personal care workers' intentions to stay in residential aged care. A botanical metaphor was used for each theme. The ‘Diverse Seeds of Varied Potential’ theme highlighted how ad-hoc recruitment processes were a primary driver of workforce instability. Challenging work conditions and differing expectations from personal care workers and management led to ‘Wilting in Adverse Environments’, which also contributed to a broader misalignment between facility culture and values, encapsulated within ‘Mismatched Habitats’. Participants emphasised the need for ‘Building a Greenhouse’, a metaphor for cultivating sustainable leadership and workforce development to address these issues.
This study's findings underscore the critical need for a cohesive approach to workforce development strategies in residential aged care. Transitioning from reactive, ad-hoc recruitment to strategic workforce planning, fostering a supportive organisational culture that aligns with personal care workers' expectations, and prioritising sustainable leadership practices are essential steps. Addressing these interconnected challenges can help build a more stable, committed and skilled workforce, ultimately enhancing the quality and continuity of care for residents.
Strategic workforce planning and sustainable leadership development are essential for building a stable workforce, which directly impacts the quality and continuity of resident care.
This study addressed the critical issue of high turnover among personal care workers in residential aged care facilities, specifically examining managers' perspectives on retention challenges: an underexplored area that is crucial for developing sustainable workforce strategies. The findings revealed that current ad hoc recruitment practices, misalignment between diverse personal care worker profiles and established organisational cultures, have great impact on long-term engagement and retention. These insights are particularly valuable for residential aged care facilities struggling with staffing stability, industry bodies focused on workforce development and educational institutions preparing future aged care workers. Furthermore, the findings can inform policy development aimed at strengthening the aged care workforce, ultimately benefiting the quality of care received by residents.
The Consolidated Criteria for Reporting Qualitative Research (COREQ).
There was no patient or public contribution.
Atrial fibrillation (AF) is a growing public health concern associated with significant morbidity, mortality and impaired quality of life. Despite evidence supporting cardiac rehabilitation (CR) as part of secondary prevention in AF care, referral rates remain low, and the extent of CR needs in this population is unknown. This protocol outlines a nationwide survey-based and registry-based study aiming to: i) describe CR needs among individuals with AF and ii) assess eligibility and acceptance of referral to specific CR components based on individual patient preferences and their overlap with identified needs.
This cross-sectional study includes three phases: 1) identification of the study population using Danish national registries; 2) electronic survey distribution to individuals with a first-time AF diagnosis in 2023–2024 and 3) registry data enrichment of the entire population. The survey includes validated patient-reported outcome measures aligned with a newly developed Needs Assessment Model, supplemented by items on patient preferences for CR components. Data are analysed descriptively and using correlation analysis.
Participants are informed of the study purpose, data protection and their rights before providing informed consent through survey participation. The study follows the Declaration of Helsinki and Danish ethical standards. Findings are disseminated via scientific journals, conferences, a cross-sectoral stakeholder workshop and public outreach activities.
To describe the organisation of nurse-led clinics and the factors facilitating or hindering their implementation based on experiences in five countries.
Descriptive multimethod study.
We analysed policy documents, nursing competency profiles and scientific literature and conducted 27 semi-structured interviews with stakeholders from the Netherlands, Ontario, Ireland, France and Finland between April and June 2023. We summarised relevant information on nurse-led clinic organisation in categories and mapped contextual factors following the Context and Implementation of Complex Interventions framework.
In the Netherlands, Ontario and France, nurse-led clinics are implemented in all care settings. In all regions, clinics are led by nurses with varied educational backgrounds, but master-trained advanced practice nurses have more autonomy than bachelor-trained nurses. In France and Ireland, expanded scope of nursing practice is expected to be formally documented in a practice agreement or protocol. In all regions, nurses can prescribe medication under specific conditions. Interviewees stressed the relevance of continuous education for nurses and clear role delineation to facilitate the implementation of nurse-led clinics and collaboration with physicians. Organisational readiness, practical support and research to demonstrate quality, safety and cost-effectiveness of nurses' expanded roles were drivers of successful nurse-led clinic integration.
Nurse-led clinics operate across various care settings and are staffed with nurses from diverse educational backgrounds, requiring adequate training and experience for autonomous practice. Successful implementation depends on clear role delineation, close collaboration with healthcare professionals, and supportive educational, legal and financial frameworks to ensure sustainable integration.
Our comprehensive description of the organisation of nurse-led clinics—including legal, financial, educational and practical aspects— along with our analysis of contextual factors supporting their implementation, provides guidance to policymakers and healthcare organisations considering the successful and sustainable adoption of this model of care within their healthcare system.
No Patient or Public Contribution.
Monitoring systems exist for clinical research transparency in high-income countries, but systematic assessment of these practices in global health (GH) research (GHR) is limited. We evaluated methods for monitoring GHR transparency and engagement.
Cross-sectional study.
Three sources were used: (a) ClinicalTrials.gov, (b) publications from 20 journals with ‘international’ or ‘global’ in the title and (c) outputs from selected GH funder websites.
From ClinicalTrials.gov, we selected 200 interventional trials on maternal health and tuberculosis (2008–2019), ensuring two-thirds were from low- and middle-income countries (LMIC). From journals, we included 200 trial publications (2011–2023). From funder websites, we included outputs with sufficient metadata to track trial registration and reporting.
Trials were extracted independently by two reviewers for result publications; journal articles were screened to confirm whether they reported trial results. Across all sources, we assessed registration timing, result reporting, open access and stakeholder engagement.
For 200 trials, 37% were prospectively registered, 65% published results in journals and 15% reported summary results in ClinicalTrials.gov. Only 34% reported results in any format within 24 months of completion. Of 200 publications, 72% were freely accessible, and 23% of the 100-article subsample included stakeholder engagement statements. The funder website sample yielded insufficient metadata for analysis.
Monitoring GHR is feasible using registries and journals, though funder websites provide limited tracking. While open-access rates are encouraging, timely reporting and engagement documentation remain weak. These results highlight opportunities for developing GHR-specific monitoring approaches through collaborative efforts among global stakeholders.
by Robin A. Pollini, Catherine E. Paquette, Brandon Irvin, Jennifer L. Syvertsen, Christa L. Lilly
Drug use is a highly stigmatized behavior, and drug-related stigma is a key driver of behavioral risk, lower health care utilization, and associated adverse health outcomes among people who inject drugs (PWID). While instruments exist for measuring drug-related stigma, their applicability to community-based PWID across multiple stigma types (enacted, anticipated, internalized) and settings (health care, society, family) is limited, as most were developed using treatment-based samples and all were developed in urban populations. This study sought to develop a Drug Use Stigma Scale (DUSS) that addresses these limitations. We developed an initial list of 39 items based on literature review and qualitative interviews (N = 27) and three focus groups (N = 28) with PWID recruited from syringe services programs and via peer referral in two predominantly rural West Virginia counties. The scale items were administered in a survey to 336 PWID recruited from the same two counties divided into development and validation samples. Responses to the 39-item scale went through a multidimensional refinement process, including examination of internal consistency, Confirmatory Factor Analysis (CFA), and a three-factor CFA based on stigma setting. Next, a set of final measurement CFAs were conducted. Finally, the resulting scale was examined for criterion-related concurrent validation. The final DUSS consisted of 16 items with excellent fit statistics for the development sample: SRMR: 0.03, RMSEA: 0.09, GFI: 0.92, CFI: 0.96, NFI: 0.94. Fit attenuated but remained satisfactory for the validation sample. DUSS scores were significantly associated with increased odds of not seeking healthcare when needed (OR: 1.47, p = 0.001; OR: 1.61, pHealth literacy (HL) is essential for making informed health-related decisions, for example enabling parents to reduce their child’s allergy risk. Health literacy does not, however, rely solely on an individual’s capacities, but is strongly influenced by external factors. Midwives provide important health advice to families, particularly since their relationship is close during a time of significant transition. This offers them a unique opportunity to positively influence the HL of parents, which in turn may support the health and well-being of the whole family. The aim of this study is to develop and evaluate an intervention that can support midwives in providing allergy prevention advice in a way that is in line with the concept of HL.
In accordance with the recommendations of the Medical Research Council framework in the first phase of this study, we will survey midwives (target sample size=379) in Germany regarding their practices, the potential barriers they face and enabling factors in providing advice on early childhood allergy prevention in an HL-responsive way. The data will be subjected to descriptive statistical analysis. Two co-design workshops will then be conducted with various stakeholders in two regions (Rhineland-Palatinate and Saxony) of Germany. Following the protocol proposed by the Stanford Design Thinking School, we will use design thinking to collect ideas for the intervention. Based on these ideas and our previous qualitative and quantitative study, we will develop an intervention in collaboration with didactic experts. The intervention will be piloted in three groups (midwives=10–15, midwives working as practice supervisors=5–10, students of midwifery=10–20). For the process evaluation, we will use observation protocols of the intervention conduct and qualitative interviews. For the outcome evaluation, we will use a questionnaire and observations in simulation laboratories with students of midwifery.
This study protocol was approved by the Ethics Committee of the University of Regensburg (ID 23-3441-101) and is in compliance with the Declaration of Helsinki. Participation in the study will only be possible after informed consent has been given. Our results will be presented at national and international conferences and published in scientific journals. Additionally, once it has been finalised, we will make the intervention available to educational institutions for (future) midwives.
Since 2018, WHO has endorsed the use of whole-genome sequencing (WGS) of Mycobacterium tuberculosis complex isolates to detect drug-resistant tuberculosis (DR-TB). This endorsement was based on the assumption that a faster and more detailed description of the resistance profile would improve treatment prescription for DR-TB by healthcare providers, and hence the treatment outcomes of patients. Nonetheless, this assumption has not been tested in routine clinical practice and different scenarios. In Brazil, WGS is not routinely used for the diagnosis of DR-TB, having been carried out in only a few centres for research purposes. With this trial, we will evaluate whether a WGS-based drug-resistance report improves treatment adequacy in patients with pulmonary DR-TB, compared with the current standard-of-care diagnostic methods used in the state of São Paulo, Brazil.
We will conduct a non-randomised controlled clinical trial with two arms to compare the intervention group (ie, individuals receiving a WGS-based report) with a historical control group (i.e., individuals who received resistance diagnostics based on the standard of care of conventional genotyping and phenotyping techniques). The primary outcome will be the proportion of patients whose treatment scheme was adequate based on complete resistance profile determined by WGS and/or phenotypic drug-susceptibility testing (pDST). Other secondary outcomes will also be considered. The target sample size is 88 eligible patients per group. The intervention group will be prospectively recruited over 18 months and the control group will be composed of patients diagnosed with pulmonary DR-TB up to 2 years before the start of the trial. To ensure comparability, isolates from the control group will undergo WGS retrospectively, and pDST will be performed retrospectively in both groups. This clinical trial will take place in six medical centres for the treatment of DR-TB in the state of São Paulo. This study is intended to support the implementation of the WGS in the routine diagnosis of DR-TB in the state of São Paulo.
Ethical approval was obtained from the Human Research Committee of the Institute of Biomedical Sciences, University of São Paulo, Brazil (CAAE: 79497924.1.1001.5467). Study results will be published in peer-reviewed journals and disseminated to policymakers and stakeholders.
U1111-1308-4669.
To explore Australian and New Zealand nursing and midwifery educators' planetary health knowledge, views, confidence and teaching practices.
A cross-sectional survey design.
An online survey was sent to Australian and New Zealand nursing and midwifery educators across the 45 Schools of Nursing and Midwifery between July and September 2023. The online survey consisted of 29 open- and closed-ended questions about nursing and midwifery educators' planetary health knowledge, views, confidence and teaching practices.
There was a total of 127 responses to the first open-ended question. A total of 97 nursing and midwifery educators then completed the remaining questions. While educators had mostly positive views about integrating planetary health into their teaching, they lacked the knowledge and/or confidence to do so effectively.
Australian and New Zealand nursing and midwifery educators acknowledge that planetary health should be included in nursing and midwifery curricula, but most reported a deficit in knowledge and/or confidence to integrate these complex concepts into their teaching. When considering planetary health, most educators focussed on climate change, which demonstrates their limited understanding of the concept of planetary health.
All nurses and midwives need to understand how the health of the planet and human civilization are interconnected and be prepared to address complex global health challenges now and in the future. Across the world, key healthcare organizations have called upon nursing and midwifery educators to prepare the healthcare workforce to practice in a more sustainable way, including supporting decarbonization of healthcare. However, our study has demonstrated that nursing and midwifery educators do not feel ready to respond due to a lack of required knowledge and/or confidence.
We used the Consensus-Based Checklist for Reporting of Survey Studies (CROSS).
No patient or public contribution.
To co-develop storyboards and scripts for multimedia resources to support the information needs of informal carers (carers) of older adults from Greek, Italian and Chinese (Cantonese- and Mandarin-speaking) Australian backgrounds during hospital-to-home transitions.
A modified experience-based co-design methodology was used to co-develop four storyboards and scripts with Greek, Italian and Chinese Australian carers and advocates from multicultural community-aged care organisations. To promote relevance, a Carer Advisory Group guided the research. The Carer Advisory Group, comprising 10 people, included carers and advocates from participating multicultural community-aged care organisations, a social worker from a large public health service, and policy representatives. Twenty-nine participants took part from June 2023 to April 2024. Data collection involved two rounds of co-development including 2 workshops, 9 small group interviews and 11 individual interviews. Round 1 focused on understanding participants' experiences of older adult care transitions, information needs and advice for other carers. This information was used to develop categories and example quotes to draft four storyboards reflecting participants' descriptions of the carer and patient journey during care transitions. Round 2 involved draft storyboards being presented to the same participants who advised on their acceptability. Certified interpreters and translators were used throughout data collection.
The co-developed categories, four storyboards and scripts are presented. Participants and the Carer Advisory Group agreed that the findings would be used to develop multimedia resources to support the information needs of carers and older adults from Greek, Italian and Chinese Australian backgrounds in care transitions.
The storyboards and scripts for multimedia resources are expected to improve access to information and services for carers and older adults from culturally and linguistically diverse backgrounds. The storyboards and scripts are examples to guide policymakers and leaders in improving transitional care in Australia and internationally.
The reporting of the study has adhered to the COREQ guidelines.
Informal carers were involved in the Carer Advisory Group which provided guidance and consultation to each phase of the project. Their contributions included reviewing the ethics application prior to submission for ethical review, and reviewing storyboards and scripts to optimise the relevance for informal carers and older adults.
To describe how the potential presence of cognitive biases in emergency nurses may influence the triage process in people experiencing homelessness compared to those who were not.
Qualitative descriptive design using observations and interviews.
Twelve emergency department nurses participated in interviews after being observed for over 128 triage patient interactions. Qualitative content analysis was used for observation data and thematic analysis was used for interview data. Findings were compared to identify differences and similarities between the observed presence of bias and nurses' described experiences.
Observation findings included two themes: (1) Emergency medical services (EMS) presentation: Words matter and (2) Nurse response: Taking action. Interview findings identified four themes: (1) Objective interpretation, (2) Subjective interpretation, (3) Resulting disparities, and (4) Busy environment. Differences included nurses' observed actions of often disregarding people experiencing homelessness compared to perceptions of remaining impartial. Similarities included the presence of bias in observation and interviews and reflected how personal labels and assumptions can influence nurse response.
Findings provide evidence about how cognitive biases can influence the type of nurse response when triaging people experiencing homelessness and suggest an opportunity for future research to investigate strategies to mitigate bias during triage.
Emergency nurses may require additional bias awareness education specific to vulnerable populations.
Evidence from this research added knowledge about how bias in emergency nurses may influence nurse response when triaging people experiencing homelessness.
COREG.
Patient contribution included presence and behaviour within the observed nurse/patient interactions, providing data for the descriptive statistics. Patients were not actively involved in data collection or analysis in a participatory sense.
To describe telephone-triage nurses' perceptions of their well-being and the system factors that influenced their well-being while conducting telephone-triage for COVID-19 during the pandemic.
This descriptive, qualitative study applied both inductive and deductive analysis to generate themes.
We interviewed a convenience sample of 27 nurses from two health systems about their perceptions of well-being when triaging patient calls about COVID-19 and reasons for those perceptions. Data collection occurred between November 2020 and June 2021. Themes were organised using the National Academies of Science, Engineering and Medicine framework.
Telephone-triage nurses' well-being was significantly impacted by COVID-19. Uncertainty regarding evolving COVID-19 guidance, increased call volumes and difficult patient responses were some of the key work system challenges that impacted nurses' well-being.
Our findings suggest the need to revisit work system factors that impact the well-being of telephone-triage nurses and develop organisational interventions to support nurses to provide optimal care during crisis situations.
Organisational information infrastructure should be bolstered for future pandemic responses to minimise impacts on nurses' well-being. Additionally, leaders need to realign tasks, workflows and workload of telephone triage during pandemic surges to prevent excessive demands on nurses.
This work contributes to understanding telephone-triage nurses' well-being during COVID-19. The increased demands they faced and impact on their well-being point to opportunities for organisational well-being interventions and development of crisis standards for tele-triaging to support nurses during high-stress, crisis situations.
The authors have adhered to COREQ guidelines for reporting.
No patient or public contribution.
Heightened rates of mental illness among children, young people and forcibly displaced adults are well-documented. Despite this, access to care in host countries is often low. Problem-management plus (PM+) is an intervention developed by the WHO that can be delivered through task-shifting by lay counsellors and has been shown to be effective in numerous studies. At the same time, it has been shown that PM+ has a limited effect on traumatic stress symptoms, a common problem among forcibly displaced individuals. In turn, to further these benefits, a novel emotional processing (EP) module has been developed to be adjunctively delivered alongside PM+(PM+EP).
The current study is a randomised controlled feasibility and acceptability study. 60 participants aged 16–25 will be randomly allocated to either PM+, PM+EP or care as usual. The primary outcome of this study will be the feasibility and acceptability of the delivery of PM+EP in forcibly displaced youth. Secondary outcomes are self-rated measures of distress, depression and anxiety, post-traumatic stress disorder, personally identified problems, hope, use of services and medications, general well-being and social support.
Following ethical approval in February 2024, recruitment commenced in October 2024. Study completion is anticipated by December 2025. Findings will be disseminated via peer-reviewed publications, conference presentations and communication with relevant stakeholders.
A substantial number of patients with major depressive disorder experience non-remission despite treatment with psychotherapy and several antidepressant drugs. This has increased the interest in new treatment strategies, including non-invasive brain stimulation methods. This randomised controlled trial examines a new treatment method using transcranial-pulsed electromagnetic fields (T-PEMF) delivered via a MoodHeadBand (MHB). The main study objective is to examine the antidepressant effect of T-PEMF on moderate to severe depression.
A double-blinded, randomised (1:1), sham-controlled trial with 96 participants diagnosed with moderate to severe depression without psychotic symptoms, recruited from Psychiatric Center Copenhagen. Participants receive daily 30 min at-home T-PEMF or sham treatment for 8 weeks with the MHB. Depressive symptomatology is examined using the Inventory of Depressive Symptomatology (Self-Report) (primary outcome) and Hamilton-D-17 Items Rating Scale at baseline and treatment completion. Cognitive functions are examined using a battery of emotion-laden and non-emotion-laden tests at baseline, after 1 week and at treatment completion. The participants fill out the Quick Inventory of Depressive Symptomatology (Self-Report) and sleep logs weekly. Summary statistics, generalised linear models, proc mixed models, mixed model repeated measures and Kaplan-Meier analysis will be applied as appropriate to analyse data on depressive symptoms, cognition and sleep.
The Danish Medicines Agency (CIV-23-01-041987) and the Medical Research Ethics Committee (2215332) have approved the trial. The project concurs with the EU directive for medical devices 2017/745 of 5 April 2017 and the ISO 14155 standard. Participants give written informed consent before any trial-related activities. Results will be published in peer-reviewed journals and presented at relevant conferences.
To systematically review and synthesise qualitative research on nurses' experiences of speaking up in various contexts and to identify factors facilitating or impeding such a behaviour.
This review was conducted as a qualitative metasynthesis, utilising the qualitative meta-ethnography approach.
A total of 6250 articles were screened. Two reviewers screened titles, abstracts and full texts. A total of 15 studies were included in this review. Researchers conducted a quality appraisal using the JBI critical appraisal checklist for qualitative research. An a priori protocol was created and registered on the Open Science Framework.
Literature searches were conducted in five international bibliographic databases (MEDLINE, Embase, PsycINFO, CINAHL and ProQuest Dissertations and Theses Global) and five Korean databases (RISS, KISS, DBpia, KCI and NDSL).
Three main themes were identified from the 15 studies used in the metasynthesis: (1) decisional complexity of speaking up, (2) motivators for speaking up and (3) barriers to speaking up. Nurses experienced challenges in speaking up. They were, and continue to be, concerned about negative responses. Hierarchy structure and poor work environment were identified as barriers to speaking up; professional responsibility and a supportive atmosphere were identified as facilitators for speaking up.
This review synthesised nurses' experiences of speaking up and influencing factors. Speaking up is crucial for nurses to improve patient safety, as frontline nurses are ideally positioned to observe early indicators of unsafe conditions in healthcare delivery.
Identified motivators and barriers of nurses' speaking-up behaviour offer considerations and opportunities for healthcare leaders and managers. This could lead to improvement in patient safety through the establishment of a safety culture that facilitates nurses' speaking-up behaviour.
The review adhered to the ENTREQ guideline.
No patient or public contribution has been made in this review.
Opioid use disorder (OUD) is a chronic and severe psychiatric condition defined by a level of opioid use which significantly impairs interpersonal and social functioning. In the biopsychosocial model of addiction, research has shown that psychiatric, sociological and neurobiological factors individually affect OUD severity. However, how these factors interact in the determination of OUD severity remains poorly understood.
The Epigenetic Bonds of Opioid Use Profiles are a multidisciplinary project whose primary objective is to characterise psychiatric and social factors of OUD in a large cohort of patients. The secondary objectives are, first, to correlate psychosocial severity with blood-derived epigenetic biomarkers to provide a deeper understanding of determinants of OUD and, second, to examine over a 2 year follow-up the correlation between the evolution of OUD and psychosocial severity with epigenetic biomarkers at inclusion. An additional objective is to analyse the impact of drug consumption rooms on access to care for most severely affected patients with OUD. In total, 300 opioid users will be recruited at supervised injection sites in Strasbourg and Paris and at addiction care centres in Strasbourg and Lyon to explore four psychiatric (substance use disorders beyond opioids, depression, anxiety, post-traumatic stress disorder) and five social (social support and status, traumatic experiences, housing, imprisonment, access to care) factors. Opioid users will be followed for 24 months and reassessed for psychosocial factors at 3, 6, 12, 18 and 24 months. Opioid consumption will be measured in all subjects using questionnaires, complemented by toxicological screenings (mass spectrometry). Finally, DNA methylation and gene expression will be characterised in capillary blood using next-generation sequencing. Mixed models will be used to model the primary and secondary outcomes.
This ongoing study was approved by the French Ethics Committee ‘Sud Méditerranée III’ of University Hospital of Nîmes (approval 2023–2024, protocol IDRCB number 2022-A02477-36) and authorised by the French Data Protection Authority (authorisation decision DR-2023–277 in December 2023). Results will be presented in international and national conferences and published in peer-reviewed international journals.
To generate an in-depth understanding of the perceptions and experiences of individuals with youth-onset type 2 diabetes (T2D) to inform knowledge translation initiatives and clinical care.
Interpretive descriptive qualitative study.
Individuals were eligible to participate if they received a T2D diagnosis on or before 18 years of age, resided in Manitoba, and were between 10 and 25 years of age at the time of data collection. Twenty-two individuals (13 females, 7 males, 2 prefer not to indicate gender; mean age = 19.3 years) participated in 22 semi-structured interviews (mean length: 29:01 min) remotely using Zoom video conferencing software or by telephone. Data were analysed using inductive thematic analysis.
Four themes were generated: (1) Low public knowledge, misconceptions, and stigma impact youth experiences including those of diagnosis, disclosure, treatment, and supports; (2) shared familial experiences impacts perception of the future; (3) mental and emotional wellness is critically important but requires more attention; and (4) T2D carries unanticipated positive and negative impacts for youth.
Findings illustrate the complex interrelationships between public and personal conceptions of T2D, stigma, and T2D navigation, emphasising the centrality of emotional and mental well-being to participants' T2D experiences and management. This representation of experiences and perceptions of youth onset T2D offers direction for holistic and youth-centred research and care and highlights areas where further mental health and educational resources would be beneficial.
The knowledge translation resource being developed from this study involves input from patient and public partners.
Although as many as 92% of survivors of physical intimate partner violence (IPV) report impacts to the head and/or non-fatal strangulation (NFS) that raise clinical suspicion of brain injury (BI), there are no evidence-based methods to document and characterise BI in this vulnerable population, limited clinical practice guidelines and insufficient understanding about long-term risks for conditions including Alzheimer’s Disease and Related Dementias (ADRD). This leaves most survivors of IPV-caused BI (IPV-BI), overwhelmingly women, without adequate access to medical care and support, safe housing, back-to-school/work accommodations or follow-up care for long-term neurocognitive health. Although traumatic brain injury (TBI) is an established ADRD risk factor, little is known about the attributable risk of ADRD due to IPV-BI, particularly in women.
Our overarching objectives are to (1) use plasma biomarkers as novel tools to assist clinicians to improve diagnosis of IPV-BI at the acute, subacute and chronic stages in a manner sensitive to the needs of this vulnerable population and (2) raise awareness of the importance of considering IPV-BI as a potential ADRD risk factor. A prospective observational study funded by the US Department of Defense (HT9425-24-1-0462), Brain Canada (6200) and the Canadian Institutes of Health Research (523320-NWT-CAAA-37499) leverages collaborative research at multiple clinical sites in British Columbia to maximise equity, diversity and inclusion among participants, with a target enrolment of n=600 participants.
The Advocates, Academics, Survivors and Clinicians to END Intimate Partner Violence Biomarkers study, which is predicated on pre-specified research questions, represents one of the most significant community-based studies on plasma biomarkers affected by an IPV-BI incident. Of particular significance is the fact our study uses robust biomarker approaches being applied in the TBI and ADRD fields to determine how the biomarker profile after IPV-BI compares to typical TBI and the early stage of neurodegenerative disorders.
This study was approved by the University of British Columbia Clinical Research Ethics Board (H24-01990, H22-02241 and H16-02792) and the Island Health Research Ethics Board (H22-03510). Upon publication of primary papers, de-identified data and biospecimens will be made widely available, including the US Federal Interagency Traumatic Brain Injury Research (FITBIR) federated database. Our data and integrated knowledge translation activities with persons with lived experience of IPV-BI and those working in the healthcare sector will be synthesised into co-designed and implemented knowledge tools to improve outcomes for survivors of IPV-BI.
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