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Familial risks of hospital treated osteoporosis and fractures in first-, second- and third-degree relatives - A Swedish nationwide real-world family study

by Christian Anker-Hansen, MirNabi Pirouzifard, Jan Sundquist, Kristina Sundquist, Bengt Zöller

Objective

Osteoporosis (OP) is a common degenerative disorder. This is the first real-world nationwide study aimed to determine the familial risks of hospital treated OP and fractures in first-, second- and third-degree relatives.

Design

The Swedish Multigeneration register was linked to the National Patient Register to investigate the familial risks of OP between 1997 and 2018. Offspring born to Swedish parents were included. The adjusted familial hazard ratios (afHRs) with 95% confidence interval (CI) were determined for hospital treated OP and fractures at common osteoporotic fracture sites among twins, full-siblings, half-siblings, and cousins. There was no information about zygosity of the twins. Adjustments were made for birth year, sex, educational level, and comorbidities.

Results

6,548,562 individuals (48.77% women) were included with a mean age of 41 years (range 0−87 years) at the end of follow-up. 57,869 (0.88%) individuals were affected with hospital treated OP, and 403,660 (6.16%) individuals with fractures. The afHRs were increased for both OP and fractures in twins, full-siblings, half-siblings, and cousins. The afHR for OP were for twins 2.92 (95%CI 2.32–3.67), full-siblings 2.22 (95%CI 2.14–2.31), half-siblings 1.74 (95%CI 1.55–1.94), cousins 1.81 (95%CI 1.55–2.11). Age-stratified analysis showed age-dependent familial associations with highest afHR in young individuals (<20 years): among full-siblings afHR was 125.70 (95%CI 59.44–265.84) for OP and 2.34 (95%CI 2.28–2.39) for fractures.

Conclusions

Heredity is associated with risk of hospital treated OP and fractures in the Swedish population. The familial risk of hospital treated OP or fractures is related to the genetic closeness of the affected relative(s).

RISE for recovery after acute whiplash injury: protocol for a randomised feasibility trial of a clinician-supported SMS-based behavioural intervention

Por: Elphinston · R. A. · Formosa · J. · Armfield · N. · van der Vegt · A. H. · Ashton-James · C. E. · Brain · K. · Buckley · L. · Papic · C. · Khan · A. · Eather · C.-E. · Liimatainen · J. · Hobbins King · A. · Hansen · K. · Staib · A. · Smith · G. M. · Chen · T. · Wright · K. · Garrad · E.
Introduction

Whiplash-associated disorders (WADs) are the most common and costly consequence of road traffic injury (RTI). Providing early and effective treatment is a healthcare priority; however, current guideline-based care which focuses on education and physiotherapy-led exercise does not routinely address the psychosocial effects of trauma, and access to early integrated treatment is limited. This study aims to evaluate the feasibility of delivering and evaluating recovery, information, support and empowerment (RISE), a co-designed short message service-based intervention integrating psychosocial and exercise/activity support for individuals with acute whiplash injury who are at risk of poor recovery in a randomised feasibility trial. Secondary aims are to explore preliminary changes in candidate clinical outcomes and opportunities for intervention personalisation and future implementation.

Methods and analysis

This mixed-methods randomised controlled feasibility trial with a nested process evaluation will recruit 50 participants (>18 years) with WAD grade II/III who are identified at medium to high risk of poor recovery and within 12 weeks of RTI from Queensland emergency departments and the community. Participants will be randomised in a 1:1 ratio to receive either the RISE intervention (tailored, daily messaging+optional brief clinician support session/s) or an active control (general health-related text messages plus access to an online resource, My Whiplash Navigator). Feasibility outcomes, including recruitment and retention rates, data collection (including wearable-derived and economic data) and intervention uptake will be descriptively summarised and evaluated against pre-defined traffic light progression criteria. Acceptability will be examined using validated questionnaires and purpose-built items, qualitative interviews with intervention participants and focus groups with patients, clinicians and funders. Secondary aims will be addressed through preliminary estimates of between-group differences in patient-reported outcomes with 95% CIs and exploratory analysis of multimodal data (eg, wearable-derived physiological data, intervention engagement metrics) using a large language model where possible to inform future personalisation and implementation planning.

Ethics and dissemination

This trial is approved by the Townsville Hospital Human Research Ethics Committee (HREC/QTHS/121395) and ratified by the Human Research Ethics Committee at The University of Queensland, which is the study sponsor (2025/HE002491). Results will be published in peer-reviewed journals and presented at conferences and professional meetings.

Trial registration

ACTRN12626000506392; date registered: 23 April 2026; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=390706&isReview=true

Education and Training Programmes for Health Professionals' Competence in Virtual Consultations: A Scoping Review

ABSTRACT

Aims

To map and synthesize which education and training programmes are available for current and future health professionals' competence in virtual consultations, with a special focus on training elements and structure.

Design

Scoping review following the PRISMA-ScR framework.

Methods

Studies describing structured education or training in synchronous virtual consultations were included. Data were charted and synthesised to map training modes, educational elements, and terminology.

Data Sources

MEDLINE, CINAHL and Scopus (September 2024; updated September 2025). Grey literature was also screened.

Results

Twenty-one studies were included. Five training modes were identified: simulation with standardised participants, avatar simulation, peer simulation, in situ training and Objective Structured Clinical Examination. A 5-stage curriculum framework emerged: pre-assess, prepare, conduct, follow-up and post-assess, followed by a catalogue of 34 diverse educational elements. Sixteen different terms were used to describe virtual consultations.

Conclusion

Evidence demonstrates an increasing focus on virtual consultation training, and a descriptive framework for organising training emerged, however, no consensus exists regarding specific elements, curriculum structure, terminology, or outcome evaluation.

Implications for the Profession and/or the Patient Care

The identified framework may guide curriculum development and support competence building across health professions.

Impact

This review addresses the lack of an overview of how virtual consultation training is structured. It identifies 34 core educational elements and a 5-stage framework. The findings support educators and clinicians implementing training in digital care.

Reporting Method

Reported in accordance with PRISMA-ScR and EQUATOR guidelines.

Patient or Public Contribution

No patient or public contribution.

Beyond Knowledge Transfer: Caregivers’ Evolving Medication Information Needs Across Paediatric Oncology Treatment

ABSTRACT

Aim

To identify and describe the medication information needs and preferences of caregivers of children with cancer, and the factors that support or impede those needs being met.

Design

Qualitative descriptive study guided by reflexive thematic analysis.

Methods

Between November 2024 and July 2025, semi-structured interviews were conducted with 13 caregivers purposively recruited from a tertiary paediatric oncology centre in Australia. Data collection and analysis proceeded concurrently using reflexive thematic analysis.

Results

Caregivers described receiving supportive medication information, yet their information needs persisted as responsibility for medication management shifted to families. Needs reflected the practical, emotional, and cognitive demands of translating clinical instructions into safe home-based care. Caregivers relied on visual tools, written schedules, and trusted clinicians to support medication management. High satisfaction with medication information coexisted with vigilance and uncertainty, highlighting a gap between information provision and the realities of home-based medication management.

Conclusion

Medication information needs in paediatric oncology are dynamic and linked to the transfer of responsibility to families. Phased, system-integrated approaches that support caregivers during care transitions and treatment are required.

Implications for the Profession and Patient Care

Reconceptualising medication information as an iterative process rather than a discrete event is recommended. Transition support, decision aids, and standardised visual medication tools may reduce cognitive burden and enhance medication safety.

Impact

This study addresses the gap between providing medication information and how caregivers manage complex home-based regimens. Unmet needs stem from the demands of medication administration during care transitions and when managing ‘as required’ medicines. Findings offer practical insights for paediatric oncology nurses, pharmacists, and policymakers designing transition processes and medication safety strategies in family-managed cancer care.

Reporting Method

Consolidated Criteria for Reporting Qualitative Research 32-item checklist.

Public Contribution

Caregivers reviewed the interview guide prior to interviews and were invited to provide feedback; no changes were required.

Measuring Barriers to Reporting Adverse Safety and Behavioural Events: Development and Psychometric Evaluation of the REPORT Scale

ABSTRACT

Aim

To develop and psychometrically validate the Reasons Employees Perceive Obstacles to Reporting (REPORT) Scale, a self-report instrument designed to identify barriers to incident reporting.

Design

Guided by the Theory of Planned Behaviour, this study used a descriptive, multiphase psychometric design.

Methods

Phase one used literature review and expert input to create an initial pool of items. Nursing staff (n = 1288) completed the preliminary scale and exploratory factor analysis (EFA) results identified conceptual gaps to address in subsequent rounds of item development. Phase two used focus groups and content validity index testing to refine and generate items for the next iteration of the scale. Phase three recruited a new nursing sample from the same institution (n = 1105) to complete the revised scale. This sample was randomly divided into three independent subsets for EFA, confirmatory factor analysis (CFA) and validity testing (convergent, discriminant, predictive).

Results

EFA factor loadings, together with theoretical and conceptual considerations, informed the development of six distinct factor groups representing the key barriers to reporting: reporting burden, leadership influence, personal and relational risks, reporting cynicism, knowledge and skill deficits, and normalization of events. The final 24-item scale (four items per factor group) demonstrated good model fit and strong validity. Findings were confirmed using the CFA sample subset and further validated with the remaining subset through convergent, discriminant and predictive validity testing.

Conclusion

The REPORT Scale is a rigourously developed and validated instrument for identifying staff barriers to reporting adverse workplace events. Its sound psychometric properties support its use in research and practice settings to advance understanding of reporting behaviours.

Implications for the Profession

This study helps to address the persistent problem of underreporting in healthcare by enabling leaders to measure and interpret the reasons why their employees do not report.

Impact

By applying the REPORT Scale, organisations can target interventions to reduce barriers to reporting and strengthen safety cultures across healthcare settings.

Reporting Method

STROBE Checklist for Cross-Sectional Studies.

Patient or Public Contribution

No patient or public involvement.

Contribution to Wider Global Clinical Community

The underreporting of adverse workplace events is a global challenge and the REPORT Scale is a rigourously developed and validated instrument for identifying barriers to workplace incident reporting. The REPORT Scale is a practical resource for healthcare leaders across different care settings to identify attitudinal, organisational, cultural and procedural barriers to reporting, supporting targeted safety interventions.

Who complains? A nationwide register-based cross-sectional study of socioeconomic differences in patient complaints and complaint case outcomes in Denmark

Por: Bogh · S. B. · Hansen · S. M.-B. · Morso · L. · Gillespie · A. · Reader · T. · Birkeland · S. F.
Objective

To examine socioeconomic and demographic differences in who complains about healthcare and whether these factors are associated with the outcomes of complaint cases.

Design

Nationwide cross-sectional study in Denmark using linked national health, complaint and administrative registers.

Setting

The Danish healthcare system provides universal coverage and has a centralised system for handling complaints with linked patient-level data to sociodemographic variables.

Participants

All healthcare contacts in 2022 in general practice (GP), non-psychiatric hospitals and psychiatric hospitals were included.

Primary and secondary outcome measures

We examined two outcomes: (1) submission of a complaint and (2) whether the authorities upheld the complaint. We then assessed how these outcomes varied by socioeconomic position (SEP), focusing on the contrast between patients with the lowest and highest SEP profiles. Relative risks (RRs) were estimated using modified Poisson regression with cluster-robust variance estimation at the patient level.

Results

There were 31.9 million GP contacts, 4.8 million non-psychiatric hospital contacts and 345 000 psychiatric contacts, with 1381, 3545 and 439 complaints, respectively (0.43–12.7 per 10 000 contacts). Clear socioeconomic disparities emerged. Low-income patients were more likely to complain about GP and non-psychiatric hospitals, while higher education was associated with fewer complaints in these settings but more complaints about psychiatry. Patients outside the workforce were more likely to complain, whereas elderly patients were consistently underrepresented in the complaints.

Low-SEP profiles had notably higher complaint probabilities than high-SEP profiles in GP (RR 2.60, 95% CI 2.22 to 3.70) and non-psychiatric hospitals (RR 1.69, 95% CI 1.40 to 1.98), but not in psychiatric hospitals (RR 0.93, 95% CI 0.47 to 1.38). Although individual SEP indicators showed no consistent differences in complaint outcomes, the combined SEP profiles revealed lower probabilities for complaints being upheld in lower SEP patients in GP (RR 0.58, 95% CI 0.22 to 0.94) and non-psychiatric hospitals (RR 0.70, 95% CI 0.43 to 0.96), while the estimate for psychiatric hospitals was inconclusive (RR 0.71, 95% CI 0.24 to 1.66).

Conclusions

In this nationwide study, socioeconomic and demographic factors were linked to clear differences in both complaint submission and complaint outcomes. Except for psychiatric hospital services, patients with fewer socioeconomic resources were more likely to file a complaint yet had a lower probability of having it upheld. These findings point to disparities in who complains and in how complaints are assessed, and they underline the need to consider all complaints, regardless of outcome, when using complaint data to inform quality improvement efforts.

Format and core components of effective preventive parenting interventions for childrens emotion regulation: a protocol for an umbrella review of systematic reviews

Por: Rohder · K. · Egmose · I. · Stuart · A. · Stevelt · H.-C. · Hansen · J. E. · Pollmann · J. B. · Smith-Nielsen · J. · Lassen · N. M. · Vaever · M. S.
Introduction

Preventive parenting interventions are a cornerstone of child mental health promotion and prevention efforts, with growing evidence supporting their overall effectiveness. However, less is known about which specific intervention formats and core components are essential and most strongly associated with improved outcomes for children and parents. This protocol describes an umbrella review aimed at identifying core components of existing preventive parenting interventions that meet rigorous criteria for methodological quality and demonstrate effectiveness.

Methods and analysis

We will conduct an umbrella review of systematic reviews of preventive parenting interventions. Searches will be performed in MEDLINE, PsycINFO, PubMed, Scopus, Web of Science and the Cochrane Database of Systematic Reviews using a predefined search strategy. Eligible reviews must: (1) be systematic reviews of randomised controlled, cluster randomised or quasi randomised trials; (2) examine preventive parenting interventions for parents of children aged 0–5 years; and (3) target child emotion regulation and/or emergent mental health problems (eg, internalising and externalising behaviour problems). Studies from all contexts will be included. Eligible studies are peer-reviewed, published in English and have been published from 2020 onwards.

Study selection and data extraction will be conducted in duplicate, with disagreements resolved by a third reviewer. The methodological quality of eligible reviews will be assessed using A MeaSurement Tool to Assess systematic Reviews (AMSTAR-2), retaining only those rated as moderate to high quality. A codebook of programme content and techniques will be employed to distill practice components from effective interventions and to map these components to specific target groups (eg, universal, selective and indicated interventions, child age, internalising vs externalising problems). Intervention formats will be coded according to delivery mode (group vs individual, online vs physical, duration and number of sessions).

Ethics and dissemination

This review will provide new insights into which intervention formats and core components are consistently present across effective preventive parenting interventions, applying stricter criteria for identifying effectiveness than in previous research. Findings will inform researchers, clinicians and policymakers in the evidence-based development, selection, adaptation and implementation of preventive parenting interventions in diverse real-world contexts, contributing to more ethically responsible and evidence-based practices for families. Results will be submitted for publication to international peer-reviewed journals.

PROSPERO registration number

CRD420251087217.

Help-seeking and barriers to emergency care during out-of-hospital cardiac arrests in public housing areas: a qualitative study

Por: Juul Grabmayr · A. · Kragh · A. M. R. · Kjaerholm · S. · Sheikh · A. P. · Ostergaard · D. · Hassager · C. · Folke · F. · Tjornhoj-Thomsen · T. · Malta Hansen · C.
Introduction

Understanding whether socioeconomic and ethnic backgrounds influence help-seeking and communication with emergency medical services (EMS) is essential to mitigate disparities.

Objective

We explored how public housing residents seek help and communicate with EMS, focusing on barriers and enablers to out-of-hospital cardiac arrest (OHCA) recognition and swift EMS responses.

Design

Explorative qualitative analysis of audio recordings of emergency service calls regarding non-EMS witnessed OHCAs. Audio recordings were screened and selected to ensure call variety—then transcribed and analysed using thematic analysis inspired by the concepts of social wrongs and social orders. We also analysed the dispatch protocol, a tool for managing emergency service calls.

Setting

Four public housing areas with >50% ethnic minority residents in Copenhagen, Denmark.

Participants

Non-EMS witnessed OHCAs from 2017 to 2022.

Results

We included 17 calls regarding 13 OHCAs and defined two themes. The effective call aligned with the dispatch protocol, leading to swift OHCA recognition and dispatcher-assisted cardiopulmonary resuscitation (CPR). In contrast, the challenging call, which did not match the framework of the dispatch protocol, entailed one or more of the following characteristics, leading to delayed or missed OHCA recognition: (1) multiple people involved (multiple callers, third-party caller or bystanders communicating with caller), (2) language barriers, (3) emotionally unstable callers and (4) lack of emergency medical competencies. Across themes, witnesses contacted someone in their network instead of calling emergency services immediately. This was a barrier to OHCA recognition in the challenging calls, which some dispatchers managed using calm intonation and simple inquiries.

Conclusions

We identified two themes concerning communication in emergency service calls from public housing areas: the effective call and the challenging call, resulting in swift or delayed/missed OHCA recognition, respectively. The dispatch protocol enabled swift recognition in the effective calls but was a barrier in the challenging calls. Across themes, witnesses used network-based help-seeking before calling emergency services, delaying EMS responses and dispatcher-assisted CPR.

Persistent symptoms, cognitive impairment, and clinical predictors of long COVID one year after Omicron infection: A clinical case–control study from the Faroe Islands

by Gunnhild Helmsdal, Marnar Fríðheim Kristiansen, Eyðbjørg Klemmentsen Gaard, Barbara Joensen Eysturoy, Pál Weihe, Eina Hansen Eliasen, Maria Skaalum Petersen

Background

Six years since the emergence of SARS-CoV-2, the newer variants of the virus continue to have long-term health effects.

Objectives

The aim of the study was to investigate persistent symptoms, cognitive impairment, and clinical and paraclinical predictors of long COVID in individuals infected during the Omicron wave.

Methods

We conducted a clinical case-control study including participants with persistent symptoms up to 13 months after confirmed SARS-CoV-2 Omicron infection (long COVID or LC group) and antibody-verified never-infected controls (NI group).

Results

A total symptom score based on a 24-item questionnaire was strongly associated with increased odds of long COVID (adjusted odds ratio (aOR) 1.21, 95% CI 1.13–1.30, p  Conclusions

One year after Omicron infection, a subset of people continue to experience a substantial symptom burden, particularly fatigue, cognitive impairment, and mental well-being, and a higher frequency of intercurrent infections.

Effect of supplemental hydrocortisone during stress in prednisolone-induced adrenal insufficiency: a study protocol for a multicentre, randomised, double-blinded, placebo-controlled clinical trial on health-related quality of life in patients with polymya

Por: Borresen · S. W. · Hansen · S. B. · Al-Jorani · H. · Tei · R. · Dreyer · A. F. · Boesen · V. B. · Bislev · L. S. · Jorgensen · N. T. · Jensen · R. C. · Bjergstrom · M. L. L. · Christensen · L. L. · Frederiksen · J. S. S. · Glintborg · D. · Bjorner · J. B. · Feldt-Rasmussen · U. · Jor
Introduction

Patients on low-dose prednisolone may develop adrenal insufficiency causing reduced health-related quality of life (HRQoL) and increased risk of adrenal crisis. This study examines whether supplemental hydrocortisone during mild to moderate stress improves HRQoL in patients with polymyalgia rheumatica/giant cell arteritis (PMR/GCA) with adrenal insufficiency on low-dose prednisolone.

Methods and analysis

A multicentre, randomised, double-blinded, placebo-controlled, clinical trial including patients with PMR/GCA receiving ongoing prednisolone ≤5 mg/day. Eligible patients undergo an adrenocorticotropic hormone (ACTH) test, and 250 patients with a stimulated cortisol

Ethics and dissemination

The study is approved by the Ethics Committee of the Capital Region of Denmark and the Danish Medicines Agency. Recruitment began June 2022. The last patient’s last visit is expected in 2026. Results will be disseminated via peer-reviewed publication and conference presentations.

Trial registration numbers

EudraCT:2021-002528-18, CTIS:2024-518272-30-00, NCT05435781.

Area-based measures of socioeconomic status in studies assessing health outcomes among people living with HIV in Canada and the USA: a scoping review

Por: Naidu · N. · Golzar · N. · Emerson · S. D. · Budu · M. O. · Hansen · S. · Branion-Calles · M. · McLinden · T. · Hogg · R. S. · Kooij · K. W.
Objective

Area-based measures of socioeconomic status (SES) are increasingly used to study health disparities among people living with HIV (PLWH), with wide variation in how they are defined and applied across studies and settings. This study synthesises the types of area-based measures of SES used in Canada and the USA, the domains captured and their associations with health outcomes among PLWH.

Methods

A scoping review of studies published in English between 2012 and 2025 was conducted using PubMed and Web of Science. The search combined ‘HIV’ with terms related to area-based SES measures. Eligible studies included PLWH, were based in Canada or the USA, used area-based SES measures and assessed health outcomes.

Results

We screened 3470 studies: 56 met inclusion criteria. Most were US-based (n=53) and focused solely on PLWH (n=46). Area-based SES was measured using composite (n=34), single (n=16) or both types of indicators (n=6), all drawn from census data. The most common SES domain was income/poverty (n=56), the most common geographic unit was census tract (n=19) and the most common health outcome assessed was viral load/suppression (n=29). Most studies linked lower area-based SES with poorer health outcomes among PLWH (n=46).

Conclusions

Our findings highlight the utility of area-based SES as an individual-level SES proxy and tool for capturing broader social determinants of health when assessing a range of health outcomes across studies including PLWH. This review contributes to strengthening methodological approaches and supports future work focused on addressing social determinants and advancing health equity for PLWH.

Navigating Concurrent Diagnoses With Cancer and Mental Health Disorder: Patients' Perspectives on Personalised Treatment and Care

ABSTRACT

Background

People living with concurrent cancer and mental health disorders face heightened vulnerability within healthcare systems that are predominantly organised around biomedical treatment pathways. Although cancer care has advanced substantially, less is known about how these patients experience recognition of their psychological vulnerability, continuity of care, communication and opportunities to participate meaningfully in decisions about treatment.

Aim

To explore patients' experiences of living with concurrent cancer and mental health disorders, with particular focus on how they experience being met in their individual needs within oncology care.

Methods

This qualitative study used individual semi-structured interviews with 11 adult patients receiving current or recent cancer treatment and living with an existing mental health or neurodevelopmental condition. Participants were recruited purposively from oncology and haematology departments at two Danish hospitals between September 2024 and December 2025. Data were analysed using interpretive qualitative content analysis.

Results

Six interrelated themes were identified: (1) being treated for cancer while mental illness was left outside the room; (2) the hidden work of self-coordination in a fragmented system; (3) communication as care: the need for predictability and adaptation; (4) cancer treatment as a trigger for mental health deterioration; (5) stigma, legitimacy and self-silencing; and (6) relational continuity and being remembered as protective factors. Across themes, participants described a persistent tension between technically competent somatic treatment and insufficient recognition of psychological vulnerability, support needs and relational needs.

Conclusion

Patient-centred oncology care for people living with co-morbidity depends not only on clinical expertise, but on recognition, adapted communication, shared responsibility and relational continuity. The findings suggest that vulnerability is shaped not only by illness itself, but also by how care systems and professional practices are organised.

Relevance to Clinical Practice

Small but meaningful changes in everyday oncology practice including psychologically informed communication, continuity of contact persons, explicit recognition of mental health needs and shared coordination of care—may substantially improve safety, participation and patient experience for this population.

Patient or Public Contribution

Patients living with concurrent cancer and mental health disorders contributed to this study through individual qualitative interviews. Their lived experiences formed the empirical foundation of the study and informed the analysis and interpretation of findings. Patients were not involved in the design of the study or the preparation of the manuscript.

Medication concentrations in human milk and potential adverse effects in breastfed infants (MedMilk): a protocol for an observational clinical study

Por: Resendal Gotfredsen · D. · Heerfordt · I. M. · Kähler Byskov · P. · Horwitz · H. · Gade · C. · Loekkegaard · E. · Friis-Hansen · L. · Bach Nielsen Fruekilde · P. · Cvetanovska · E. · Joergensen · N. R. · Pedersen · L. H. · Andersen · J. T.
Introduction

Data on medication concentrations in human milk and their potential effects on the breastfed infant remain limited, leaving clinicians with insufficient evidence to guide women who require medication while breastfeeding. The MedMilk study aims to systematically measure medication concentrations in human milk, calculate the relative infant dose (RID) and evaluate infant outcomes.

Methods and analysis

This observational clinical study will recruit breastfeeding women using prescription and over-the-counter medications. Women will provide milk and urine samples along with self-reported maternal and infant health data. The primary outcome is quantification of medication concentrations in human milk. Secondary outcomes include estimation of the RID based on measured milk concentrations, maternally reported infant symptoms and adverse events potentially related to medication exposure, and pharmacokinetically simulated infant plasma exposure. Analytical methods include solid-phase extraction liquid chromatography-tandem mass spectrometry for quantification combined with descriptive statistics and pharmacokinetic modelling. The study aims to recruit approximately 250 women across medication groups. For the most frequently used medications, we aim to include 20 participants per medication, with each participant contributing four milk samples and a urine sample. Biological samples will be stored in a biobank, and data in a secure database.

Ethics and dissemination

The study has been approved by the Regional Research Ethics Committee of the Capital Region of Denmark (Journal no. H-23062687) and the Danish Data Protection Agency (Ref. P-2023-14627). All participants will provide written informed consent before enrolment. Findings will be disseminated through peer-reviewed journal publications and presentations at relevant national and international scientific conferences.

Trial registration number

NCT07346716.

Multicentre randomised controlled trial of the Norwegian health in work service for patients with common mental disorders or musculoskeletal disorders: the Norwegian Sickness Absence Clinic (NSAC) Efficacy Study

Por: Aars · N. A. P. · Bardal · I. · Terjesen · C. · Hansen · B. O. · Jerven · A. · Kaspersen · K. I. · Lyngedal · O. · Hüttepohl · F. · Johnsen · I. · Uglebakken · T. O. · Brinchmann · B. · Mykletun · A.
Introduction

In many countries, a high or increasing rate of sickness absence is challenging the sustainability of present sickness absence benefit schemes. Most sickness absence is certified on the grounds of common mental disorders or musculoskeletal disorders, and substantial effort has been invested in developing interventions promoting return to work for these patients. In Norway, the Health in Work ((HelseIArbeid), HIA) clinics were established as outpatients’ services within the specialised healthcare system, with the aim of improving health and supporting return to work. The HIA service admits patients with low-to-moderate anxiety/depression and/or musculoskeletal disorders. In this protocol, we describe the naturalistic multicentre randomised controlled trial Norwegian Sickness Absence Clinic Efficacy study, which aims to determine the effect of HIA on work participation and health.

Methods and analyses

The HIA outpatient service is staffed by clinical psychologists, physiotherapists, medical specialists in physical medicine and rehabilitation and employment support supervisors from the Norwegian Labour and Welfare Administration. Patients admitted to HIA have access to multidisciplinary assessment and treatment. The trial recruits’ patients from five HIA outpatient clinics in Northern Norway. Patients are randomised in equal proportions to either (1) rapid HIA (assessment within 4 weeks), (2) delayed HIA (assessment within 10–14 weeks) or (3) active control, which consists of a monodisciplinary examination at HIA close to diagnosis-specific deadline for examination as suggested by guidelines (8–26 weeks). The trial commenced recruitment on 16 January 2023 and will recruit 2500 patients. The aim is to assess the effect of the HIA service, with the hypothesis that the HIA concept is superior to what resembles treatment as usual, in improving employment and preventing long-term welfare dependency. Secondary outcomes include self-reported symptoms of health problems. We also examine the effect the service has on other healthcare utilisation. To date, no research has been conducted to assess the efficacy of the HIA service. If proven efficacious, and if there is an economic case for this investment in tailored healthcare delivery, the policy implication may be implementation of the service at scale. If not, adaptations or investments into other viable paths of treatment may be considered.

Ethics and dissemination

The study is approved by the Regional Committee for Medical Research Ethics (REC North, #122770). Results from the study will be disseminated at national and international scientific conferences, to funders and participating outpatient clinics in seminars and in peer-reviewed scientific journals.

Trial registration number

NCT05310695.

Video-supported telephone triage in emergency primary healthcare: an observational study from Norway

Por: Sandal · N. · Johansen · I. H. · Hjortdahl · M. · Baste · V. · Ness · S. · Zakariassen · E.
Objectives

To describe how video support is used in telephone triage at Norwegian Local Emergency Medical Communication Centres (LEMCs), including frequency, call duration, patterns of video use and associations with urgency and response assessments.

Design

An observational study using national-level operational data and prospectively collected triage data from the Watchtower Project.

Setting

Norwegian LEMCs, which provide 24/7 nurse-managed telephone triage within the municipal emergency primary healthcare system, handling a broad range of medical inquiries.

Participants

79 LEMCs using the Norwegian Air Ambulance video solution in 2024 and six LEMCs participating in the Watchtower Project in 2022–2023.

Main outcome measures

Frequency of video use and call duration with and without video support. Video use across caller and patient characteristics and reasons for contact. Changes in urgency level and intended response following video use.

Results

The national-level dataset included 2 242 522 calls and the Watchtower dataset included 109 281 calls. Nationally, video was used in 4.9% of answered calls. Median call duration was 7:13 min (IQR: 5:09–10:02) with video and 3:58 min (IQR: 2:18–6:16) without video (p

Conclusion

Video-supported calls were longer than non-video calls. Video is used selectively and is associated with bidirectional adjustments in urgency and response assessments in a substantial share of calls.

HealthyPregnancy: development and feasibility of a digital care guide to promote recommended gestational weight gain in pregnant women living with overweight in Denmark

Por: Hansen · M. K. · Bendix · J. M. · Lokkegaard · E. C. L. · Schiotz · M. L. · Broberg · L.
Objectives

Excessive gestational weight gain increases the risk of complications in pregnancy, childbirth and later in life among pregnant women living with overweight and their offspring. Therefore, this study aimed to develop and examine the feasibility of a digital intervention supporting recommended gestational weight gain and the recommended level of physical activity, targeting pregnant women with a body mass index (BMI) of 27 or above.

Design

Intervention development was guided by the Medical Research Council guideline on the development and evaluation of complex interventions, and subsequent feasibility testing was conducted in a non-randomised design.

Setting

The obstetric department at Copenhagen University Hospital—North Zealand, Denmark.

Participants

98 pregnant women living with overweight participated in feasibility testing.

Interventions

The intervention developed in this study was a mobile phone application with a digital care guide containing text and video information supporting recommended gestational weight gain and physical activity levels. The video material featured multiple healthcare professionals and a pregnant woman from the target group.

Main outcome measures

The main feasibility measures were participant recruitment and engagement with the digital care guide throughout pregnancy.

Results

Recruitment rates were satisfactory, with 69% of eligible pregnant women consenting to participation. The participants used the application and engaged with the digital care guide; however, use of the care guide diminished as pregnancy progressed.

Conclusions

We developed a digital care guide supporting recommended gestational weight gain and physical activity levels for pregnant women with a BMI of 27 or higher. Feasibility testing indicated that there is sufficient interest in participating in a study promoting recommended weight gain and physical activity to warrant a larger effectiveness trial.

Socioeconomic disparities and mortality among acute patients with sepsis: a retrospective Danish cohort study

Por: Schade Skov · C. · Brabrand · M. · de Groot · B. · Rosenvinge · F. S. · Skjot-Arkil · H. · Mogensen · C. B. · Johansen · I. S. · Lassen · A. T.
Objectives

Socioeconomic inequalities exist in infectious diseases and sepsis in high-income countries. We investigated the association between income and mortality among patients with sepsis, overall and among those treated in the intensive care unit (ICU) versus general wards.

Design

A retrospective register-based cohort study.

Setting

The Region of Southern Denmark (RSD).

Participants

All adult patients with an unplanned contact with a hospital in the RSD from 1 January 2016 to 20 March 2018. Patients with sepsis were identified based on the following criteria: (1) blood culture(s) performed within 48 hours of arrival, (2) antibiotic(s) administered within 48 hours of arrival, (3) a discharge diagnosis of infection and (4) a SOFA (Sequential Organ Failure Assessment) score of ≥2. The cohort was divided into quartiles according to household income.

Primary and secondary outcome measures

Cox proportional hazards models were used to estimate the association between income groups and mortality. The primary outcome was 90-day mortality with 7-day and 365-day mortality as secondary outcomes. All outcomes were calculated overall and stratified by general ward treatment only and ICU admission.

Results

We identified 7813 first-time visits with community-acquired sepsis, including 886 ICU admissions (11.3%). Among patients in the lowest income group, sepsis was associated with a HR of 1.16 (95% CI 1.01 to 1.34) for 90-day mortality compared with the highest income group. This association was particularly pronounced at 365-day follow-up: HR=1.24 (95% CI 1.10 to 1.39). No difference was observed in 7-day all-cause mortality, HR=1.13 (95% CI 0.89 to 1.45). The association was not observed among patients admitted to the ICU.

Conclusion

Low income was associated with increased mortality in patients with sepsis, particularly during long-term follow-up. The impact of income disparities was not observed among patient admitted to the ICU.

Co-developing a vocational rehabilitation intervention for individuals with chronic low back pain across a regional spine centre and three municipalities in Denmark: a three-stage intervention development study guided by the Medical Research Council frame

Por: Frydenlund · G. · Mortensen · O. S. · ONeill · S. · Sondergaard · J. · Hansen · A.
Objectives

To co-develop the Stay-At-Work (SAW) intervention, a person-centred, interdisciplinary, cross-sectoral vocational rehabilitation (VR) programme for individuals on, or at risk of, sick leave due to chronic low back pain (CLBP) and to advance methodological understanding of how evidence, qualitative insights, stakeholder input and programme theory can be systematically integrated and operationalised into concrete intervention components.

Design

A three-stage intervention development study, guided by the Medical Research Council framework for complex interventions, involving evidence review and stakeholder consultation (previously reported); multistakeholder co-design; and prototyping in clinical settings.

Setting

The intervention was developed within a Danish public healthcare and welfare context, involving a secondary care spinal service, municipal employment services (n=3), municipal rehabilitation services (n=3) and general practice.

Participants

Stage 1: 17 individuals on long-term sick leave due to CLBP participated in interviews and focus groups. Stages 2 and 3: The co-design group included individuals living with CLBP (n=2); clinicians from a secondary care spine service (n=2) and municipal rehabilitation services (n=6); general practitioners (n=2); municipal employment service professionals (n=3) and local managers (n=3); and employer and employee representatives (n=2). Participants were purposively recruited based on their roles and experience in VR and return-to-work processes and contributed across different stages of intervention development.

Results

The SAW intervention consists of eight structured activities, developed through multistakeholder co-design and underpinned by a programme theory with four core mechanisms: (1) strengthened interprofessional and cross-sectoral understanding and collaboration; (2) stronger alignment around functional capacity and work ability; (3) addressing psychological vulnerability through systematic screening and support; and (4) enhanced coordination of care and rehabilitation efforts across services.

Stakeholder input from the co-design group informed the intervention’s content and procedures, thereby improving alignment with local contexts and strengthening cross-sector collaboration. Some proposals were excluded due to inconsistency with clinical guidelines.

Conclusion

This study demonstrates how a structured, theory-informed co-development process can be used to integrate evidence, stakeholder input and programme theory into a coherent, cross-sectoral VR intervention. The approach enhanced transparency, supported alignment with real-world practice, and provides methodological insight to strengthen the reproducibility and transferability of complex interventions.

Registration number: The Region of Southern Denmark’s Research Registry (journal no. 23/44927).

The Power of a Ricoeur‐Inspired Phenomenological‐Hermeneutic Approach to Focus Group Interviews

ABSTRACT

Aim

To justify the use of focus group interviews with patients and healthcare professionals within a phenomenological-hermeneutic approach inspired by the theory of the French philosopher Paul Gustave Ricoeur.

Design and Methods

Methodological guidance and discussion grounded in Ricoeur's theory on narrative, dialogue, threefold mimesis and interpretation.

Results

This phenomenological-hermeneutical approach to focus group interviews yields significant, in-depth understandings of lived experiences from both patients and healthcare professionals.

Conclusions

Ricoeur-inspired phenomenological-hermeneutical focus group interviews with patients and healthcare professionals offer a promising approach for exploring and generating new, valuable insights into the complexities of clinical nursing practice. Thus, this paper argues for an integration of focus group interviews and a phenomenological-hermeneutical approach within nursing science.

Implications for the Profession

The approach has significant implications for nursing practice. By incorporating Ricoeur-inspired dialogue-based collective voices of patients and healthcare professionals in focus group interviews, nursing practices can be refined, leading to improved patient care and more effective clinical interventions. Thus, this approach advocates for a broader adoption of Ricoeur-inspired focus group interviews in nursing research and in health research in general to enhance the understanding and development of clinical models.

Reporting Method

No available EQUATOR guidelines were applicable to this methodological paper, as no new data were created or analysed.

Patient or Public Contribution

As this is a methodological paper, no new patient or public contributions are included.

Public Health Nurses' Experiences of Child Maltreatment Preventive Work in Primary Healthcare: A Qualitative Metasynthesis

ABSTRACT

Aim

To explore public health nurses' experiences of child maltreatment preventive work in primary healthcare.

Design

The metasynthesis approach was based on the guidelines by Sandelowski and Barroso for synthesising qualitative research.

Methods

The quality of the included studies was appraised using Joanna Briggs Institute Checklist for Qualitative Research. The analysis followed Braun and Clarke's reflexive thematic analysis.

Data Sources

Searches were conducted in five electronic databases: Cinahl, Medline, PsychINFO, Web of Science and SocINDEX in May and July 2024, and updated in April and December 2025.

Results

Thirteen qualitative studies were included, and five themes were developed: Insufficient knowledge about when and how to act, building a therapeutic relationship with parents, keeping the child's best interest in focus, in need of better interdisciplinary support and ambivalence in addressing child maltreatment.

Conclusion

Public health nurses face challenges in child maltreatment preventive work, including insufficient knowledge and limited interdisciplinary support. Even so, public health nurses demonstrate a strong commitment to children's safety and well-being and to building relations with families.

Implications for the Profession

The findings suggest an increased focus on strengthening public health nurses' knowledge of child maltreatment and improved interdisciplinary collaboration.

Impact

The findings are of interest to healthcare professionals and health authorities to improve child maltreatment preventive work in primary healthcare.

Reporting Method

This review adhered to relevant EQUATOR guidelines.

Patient or Public Contribution

This study did not include patient or public involvement in its design, conduct or reporting.

Trial and Protocol Registration

PROSPERO registration number: CRD42025637855.

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