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Unbound cloxacillin plasma concentrations in relation to toxicity and renal function: protocol for a prospective, observational clinical trial in a real-world Staphylococcus aureus bacteraemia population

Por: Damgaard · T. · Hellborg · T. · Larsson · A. · Eliasson · E. · Bonnedahl · J. · Nielsen · E. I. · Schön · T. · Hällgren · A.
Introduction

Staphylococcus aureus bacteraemia (SAB) is a common and severe infection, with a 90-day mortality of 24%–32%. Cloxacillin is regarded as a first-line antibiotic treatment in SAB in Sweden. However, exposure to cloxacillin in real-world hospitalised patients with SAB, most of whom are elderly patients treated outside the intensive care unit, is not well described. There are also limited data on the role of unbound cloxacillin exposure in relation to renal function or drug-induced toxicity.

Methods and analysis

This multicentre, prospective, observational clinical trial will include 95 adult patients with methicillin-susceptible S. aureus bacteraemia, treated with cloxacillin. Patients with endocarditis, polymicrobial bacteraemia or those considered unsuitable for cloxacillin treatment are excluded. Trough and peak total and unbound cloxacillin concentrations will be measured at steady state at days 2 and 7. Blood cultures will be obtained at days 2, 3, 4 and 7 to assess time to negative culture. Renal function will be assessed daily for plasma creatinine and at days 1 and 6 for cystatin C and for 12-hour urine creatinine clearance. In a novel approach to detecting nephrotoxicity, renal tubular damage biomarkers will be measured at days 1 and 6 (KIM-1, N-acetyl-β-D-glucosaminidase, neutrophil gelatinase-associated lipocalin, urine cystatin C, alpha-1-microglobulin). Detection of neurologic symptoms such as confusion, tremor, hallucinations and convulsions, as well as consciousness, will be monitored daily using a structured evaluation form.

We aim to investigate to which extent target attainment (100% of the dosing interval during which the free (unbound) drug concentration exceeds the minimum inhibitory concentration) is achieved with standard dosing of cloxacillin in a real-world cohort of hospitalised patients with SAB, and whether initial renal function can predict who is at risk for underdosing or overdosing. We will also explore whether neurological or renal damage is prevalent and associated with cloxacillin levels.

Ethics and dissemination

Ethics approval has been granted by the Swedish Ethical Review Authority (EUCT 2023-505148-20-00) as part of a low-intervention clinical trial approval according to EU regulation 536/2014. Results will be disseminated in a peer-reviewed journal and at academic conferences.

Trial registration number

EUCT 2023-505148-20-00.

Priorities for the development of a new rapid diagnostic test for patients with fever: a cross-sectional online survey among hospital physicians across Europe

Por: Bonnet · G. · Nielsen · M. J. · Foss · A. M. · Lewin · A. · Nijman · R. G. · Fitchett · E. · Carrol · E. · Yeung · S. · the DIAMONDS consortium · Bonnet · Nielsen · Foss · Lewin · Nijman · Fitchett · Carrol · Yeung
Objective

This study aimed to understand hospital doctors’ priorities (target use cases and aetiologies) for the development of a new rapid diagnostic test for patients with fever.

Design

A cross-sectional online survey.

Setting

Europe-wide.

Participants

Secondary and tertiary care doctors involved in patient assessment and diagnosis across Europe.

Intervention

Online survey from April to September 2024.

Main outcome measures

Importance of developing a new test on a scale of 1–10 for up to 19 ‘use cases’ (types of febrile presentations in specific demographic groups): use case scores and ranks and differences across subgroups of respondents, with free text to capture additional suggestions; respondents’ preferences (multiple choice) regarding which aetiologies should be included in a new test.

Results

265 respondents from 30 European countries (out of 270 starting the survey) were included in the analysis. Top priorities included febrile immunocompromised patients and fever without a focus for both paediatric and adult use cases, and 1–3 months old febrile infants. Rankings were similar across clinician subgroups despite some differences in average scores. 92% (243/263), 95% CI 89% to 95%, of respondents would find a ‘generic’ test for bacterial aetiology useful, even if it does not differentiate between Gram-positive and Gram-negative aetiologies. 54% (63/116), 95% CI 45% to 63%, of respondents would find a ‘generic’ test for inflammatory aetiology useful when seeking to diagnose children for whom Kawasaki’s disease (KD) is on the differential, even in the absence of any KD-specific test, 83% (96/116), 95% CI 75% to 89%, would find such a ‘generic’ test useful if they could use it alongside a KD test when desired.

Conclusion

Clinicians prioritise the most vulnerable patients (because of age or comorbidities) and unclear presentations (fever without a focus) for the development of a new fever diagnostic test. Even relatively simple (eg, bacterial, inflammatory) tests could provide added value to most clinicians.

Workshops as a Research Method in Health Science: Epistemological and Methodological Perspectives

ABSTRACT

Aim

The aim of this paper is twofold: (1) to introduce a phenomenological-hermeneutic approach and discuss its application within the context of WSs in the field of health science, (2) To present a method and a practical guide when conducting WSs in the field of health science.

Design and Methods

Epistemological and methodological discussions based on workshops as a self-standing research method.

Results

The epistemological and methodological discussions show that workshops conducted in health science are a self-standing research methods and align with a phenomenological-hermeneutical approach. Examples of research studies within this framework are provided to illustrate how workshops can be conducted in health science within this epistemological approach.

Conclusion

The phenomenological-hermeneutical approach embraces workshops as a research method as it includes individual experiences through self-reflection and shared contributions through interpretation. Furthermore, a systematic approach with regard to planning, conduction, data collection, and data analysis leads to reliable findings, enhancing the transparency of the research method and thus creating scientific knowledge. This paper argues that the systematic approach of “the how” to conduct workshops with “the why” enhances the transparency and trustworthiness of the research.

Implications for the Profession

Workshops are a way to involve and engage users in co-design processes that aim to develop solutions in clinical practice. User involvement has become an important part in academia and is essential in all aspects of the research process. However, we need solid systematic methods to create valid knowledge. Workshops are a self-standing research method, and a phenomenological-hermeneutical approach allows for an understanding of the phenomena as they unfold, emphasising subjective perceptions and meanings, which will finally lead to the development of a suitable solution for clinical practice.

Impact

This paper contributes theoretical knowledge about the use of workshops as a research method. It combines “the how” to conduct a workshop with “the why” and highlights the relevance of a phenomenological-hermeneutical approach. The main argument is that workshops are a self-standing research method; hence, this paper adds value in the academic field as it provides a scientific framework. The paper presents a method and a practical guide for researchers who plan to conduct workshops in the field of health science.

Reporting Method

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

Patient or Public Contribution

This is a methodological paper, and thus, there was no direct patient or public involvement.

Caring beyond the procedure: a qualitative study on thoracic surgery nurses perspectives on chronic illness experiences of individuals with myasthenia gravis undergoing thymectomy

Por: Missel · M. · Donsel · P. O. · Nielsen · T. F. · Secher · E. L. · Medeiros · E. B. Z. · Rude · K. · Hojgaard · J. L. S. · Viby · N.-E. · Birnbaum · S. · Andersen · L. K. · Petersen · R. H. · Witting · N.
Objectives

To explore how thoracic surgical nurses perceive and respond to the chronic illness needs of individuals with myasthenia gravis undergoing thymectomy.

Methods

Data were collected through four focus group interviews using a semi-structured interview guide. The analysis followed a hermeneutic approach, identifying recurring themes through iterative interpretation and critical reflection. Nineteen thoracic surgical nurses from ward and postanaesthesia care unit settings participated, representing a diverse range of clinical experience. The study followed the Consolidated Criteria for Reporting Qualitative Research (COREQ) checklist for reporting the findings of this study.

Results

The analysis identified three overarching themes reflecting nurses’ experiences of caring for individuals with myasthenia gravis undergoing thymectomy. First, nurses described how the chronic aspects of the illness often ‘disappeared’ within the surgical care process, with attention focused mainly on procedural recovery, leaving patients’ broader illness needs unaddressed. Second, nurses experienced a dilemma between providing acute surgical care and responding to patients’ chronic illness understanding, highlighting uncertainty due to limited knowledge and lack of clear guidelines. Third, nurses emphasised the difficulty of managing the invisible and unpredictable symptoms of myasthenia gravis, which created a heightened need for vigilance but also uncertainty in symptom assessment and support. Across all themes, the findings suggest that surgical care practices may insufficiently recognise patients’ ongoing illness experiences, emphasising the need for greater knowledge, interdisciplinary collaboration and chronic illness-sensitive care approaches.

Conclusions

The study highlights the need for increased attention to chronic illness needs in surgical care, supporting interdisciplinary collaboration and tailored nursing practices that address the lived experiences of patients with chronic conditions.

Mechanisms of SGLT inhibitor action and physiological mediators: systematic review and protocol for the MOSAIC collaborative meta-analysis

Por: Kugathasan · L. · Nardone · M. · Muskiet · M. · Diaz Martinez · J. P. · Lovblom · L. E. · Orchanian-Cheff · A. · Nielsen · S. · Rotbain · V. · Kazup · A. · Cersosimo · E. · Gullaksen · S. · Vernstrom · L. · van Baar · M. J. B. · van Bommel · E. · Kannenkeril · D. · Scholtes · R. · Hesp
Introduction

Sodium-glucose cotransporter (SGLT) inhibitors have shown substantial benefit in reducing cardiovascular and kidney events across diverse clinical populations, but the underlying physiological mechanisms remain unclear. However, existing mechanistic studies on renal and cardiovascular haemodynamics show variability in design, have limited statistical power and yield inconsistent outcomes, thus limiting the ability to draw generalisable conclusions. To address this gap, we conducted a systematic review and proposed the first meta-analysis to aggregate individual participant-level data from mechanistic studies to identify consistent physiological patterns and enhance understanding of the therapeutic effects of SGLT inhibition.

Methods and analysis

Gold-standard measured glomerular filtration rate (mGFR) was selected as the primary outcome for this systematic review, which aimed to identify all completed mechanistic studies investigating the effects of SGLT inhibition. Electronic databases including Ovid MEDLINE; Ovid Embase; Cochrane Database of Systematic Reviews; and Cochrane Central Register of Controlled Trials were searched using a detailed search strategy. In total, 24 studies (n=1296) were identified. This systematic review was reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Key variables including demographics, medical history, concomitant medications, vital signs, mGFR, renal haemodynamics, urine and plasma biochemistry, tubular sodium handling, echocardiography, cardiac output monitoring, arterial stiffness and fluid volume will be extracted. A one-stage individual participant data meta-analysis under a Bayesian framework will be conducted, using hierarchical models to simultaneously analyse data from all eligible studies. The risk of bias due to missing results will be assessed. Sensitivity analyses and subgroup evaluations will be incorporated to explore sources of heterogeneity and assess robustness of findings.

Ethics and dissemination

Ethics approval was obtained from University Health Network, Toronto, Canada. Findings from the Mechanisms of SGLT Inhibitor Action and Physiological Mediators (MOSAIC) meta-analysis will be published in peer-reviewed journals and results will be disseminated at scientific conferences.

PROSPERO registration number

CRD420251001413.

Treatment of bulbar urethral strictures with Optilume drug-coated balloons in a previously untreated population (FIRST-CARE): protocol for a single-blind multicentre randomised controlled trial

Por: Mahdi · M. B. · Haase · R. N. · Sander · L. · Tuckus · G. · Liltorp · D. L. · Jorgensen · L. · Graugaard-Jensen · C. H. · Weinreich · H. · Pennisi · C. P. · Nielsen · T. K.
Introduction

Minimally invasive endoscopic procedures constitute the cornerstone of first-line treatment for bulbar urethral strictures, although their long-term effectiveness is limited by high recurrence rates. The Optilume drug-coated balloon (DCB) is a novel intervention combining mechanical dilation with localised delivery of paclitaxel to reduce recurrence by inhibiting scar tissue formation. While its efficacy has been demonstrated in patients with recurrent strictures, its potential as a first-line option in treatment-naïve patients remains unexplored. The FIRST-CARE trial aims to assess the efficacy and safety of Optilume DCB compared with standard endoscopic treatment in treatment-naïve patients with bulbar urethral strictures.

Methods and analysis

Design: Two-arm, randomised, single-blind (participant), investigator-initiated, parallel-group, multicentre clinical trial. Patients: The study will enrol 140 adult male patients with treatment-naïve, single bulbar urethral strictures ≤3 cm in length. Interventions: All patients will undergo the assigned procedure under general anaesthesia with 1.5 g intravenous cefuroxime. Optilume group patients will receive ≥5 min balloon dilation with localised paclitaxel delivery. The control group will receive standard endoscopic treatment (eg, direct visual internal urethrotomy, laser or dilatation). In both groups, a 12–14 French Foley catheter will be left in place for 3–5 days. Primary outcome: Freedom from repeat intervention within 12 months of follow-up. Primary analysis: Time-to-event will be defined from the date of intervention to the date a repeat intervention is decided (indicated and planned) due to confirmed recurrence, with censoring at 12 months. Groups will be compared using Kaplan-Meier survival analysis and the log-rank test. Cox regression and modified Poisson regression will be used to estimate HRs and relative risks.

Ethics and dissemination

The trial is approved by the Danish National Committee on Health Research Ethics (2401370) and will be conducted in accordance with the Declaration of Helsinki and principles of Good Clinical Practice. In line with national guidelines, all eligible patients are counselled regarding available treatment options prior to enrolment. Results will be disseminated via peer-reviewed publications and scientific presentations.

Trial registration number

NCT06827210.

Psychometric validation of the Internalised Stigma Scale for Gestational Diabetes Mellitus (ISS-GDM): a cross-sectional study

Por: Davidsen · E. · Maindal · H. T. · Christensen · K. B. · Damm · P. · Byrne · M. · Dahl-Petersen · I. K. · Mathiesen · E. R. · Jensen · D. M. · Vinter · C. · Kampmann · U. · Ovesen · P. G. · Kragelund Nielsen · K.
Objectives

To develop and validate the Internalised Stigma Scale for Gestational Diabetes Mellitus (ISS-GDM), a questionnaire measuring self-reported internalised stigma among women with prior gestational diabetes mellitus (GDM). We hypothesised that internalised GDM stigma could be reliably and validly assessed through a short psychometric instrument.

Design

Cross-sectional validation study.

Setting

Follow-up data from the Danish, multicentre Face-it trial for women with prior GDM and their families.

Participants

In total, 248 women completed the ISS-GDM approximately 1 year after their GDM affected pregnancy.

Primary and secondary outcome measures

The primary outcome was psychometric properties of the ISS-GDM, assessed using Cronbach’s alpha, confirmatory factor analysis (CFA) and Rasch analysis (RA). Secondary outcomes included identification of item anomalies (local response dependence, differential item functioning).

Results

A large proportion of respondents endorsed statements reflecting self-disappointment, self-blame and an altered self-perception. Less endorsed statements included feeling inferior to other mothers or guilt towards family members due to GDM. The ISS-GDM demonstrated satisfactory psychometric properties. CFA indicated that item 2 assessing self-perceived capabilities as a mother did not load onto the main factor, while CFA and RA identified local response dependence and differential item functioning by body mass index. After adjustments, a two-factor solution supported calculating a sum score of items 1 and 3–11, with item 2 retained as a stand-alone indicator of perceived parenting capabilities. The 10-item scale demonstrated acceptable reliability (Cronbach’s alpha=0.78).

Conclusions

The ISS-GDM is a reliable and valid tool for assessing internalised stigma among women with prior GDM. Our findings further suggest that a substantial proportion of women with prior GDM experience self-blame and an altered self-perception due to their diagnosis. The ISS-GDM scale enables research into its prevalence, severity and consequences.

Simulation-based training intervention using artificial intelligence to improve clinical bronchoscopy performance: a pre-postintervention study

Por: Cold · K. M. · Arshad · A. · Kildegaard · C. · Laursen · C. B. · Konge · L. · Nielsen · A. B.
Objectives

Does a simulation-based training intervention with an artificial intelligence (AI) navigation system improve their clinical bronchoscopy performance? And can the AIs outcome measures be used to evaluate clinical performance?

Design

Pre–postintervention study.

Setting

Odense University Hospital of Southern Denmark, pulmonary endoscopy suite.

Participants

Nine bronchoscopists (4 experienced, >500 bronchoscopies and 5 intermediates, 10–500 bronchoscopies).

Primary outcome measures

Diagnostic completeness (DC), structured progress (SP), procedure time (PT) and procedure efficiency (DC/PT).

Results

The primary outcome measures showed no statistically significant difference between the pre- and postintervention bronchoscopies DC: 53% versus 59%, p=0.16, SP: 29% versus 32%, p=0.35 and PT: 219 s versus 181 s, p=0.22. The experienced outperformed the intermediates regarding DC: 73% versus 43%, p

Conclusions

DC, SP and PT showed no statistically significant difference after a simulation-based training intervention. DC, SP and procedure efficiency differentiated between experienced and intermediate bronchoscopists and can be used to evaluate clinical bronchoscopy performance.

Feasibility of micro-costing for hospital-at-home in Danish municipalities: a prospective pilot study

Por: Tayyari · N. · Duvald · I. · Galle Madsen · M. · Engelbrecht Sjol · S. · Nielsen · C. P. · Risor · B. W.
Objectives

To test the feasibility of identifying and quantifying resource use for a Hospital-at-Home (HaH) model in Danish municipalities, we used a micro-costing approach. Additionally, we aimed to generate a transparent activity and time dataset. This dataset will support subsequent tariff development with time-driven activity-based costing and feed into the economic evaluation of an ongoing randomised controlled trial (RCT).

Design

Prospective pilot feasibility study.

Setting

Three municipalities in the Central Denmark Region in collaboration with emergency department specialists and general practitioners.

Participants

56 elderly acute patients treated in HaH during the pilot phase.

Outcome measures

Feasibility of micro-costing data collection (completeness, consistency and acceptability to staff) and descriptive resource-use quantities by activity and provider group. No price assignment or cost estimates are reported.

Results

Patients received a mean of 3.8 HaH treatment days with 7.8 acute team visits and 3.9 municipal-staff visits per treatment course. The acute team spent a mean of 742 min per patient across treatment activities, communication, documentation and transport, while municipal care staff recorded a mean of 213 min. Intravenous medicine administration and vital sign assessments were the most frequent activities. Data completeness and consistency improved over time through co-design and feedback.

Conclusions

Detailed resource-use measurement using provider logs was feasible in a municipal HaH model and produced an activity and time dataset suitable for tariff development. Findings are context-specific and not generalisable due to the small sample. The micro-costing log refined through the pilot will be applied in an RCT, where time and activity data will be used to construct a tariff using time-driven activity-based costing.

Advance Care Planning During Healthcare Transitions for Community‐Dwelling Older Adults in Their End of Life: A Scoping Review

ABSTRACT

Background

Older adults often experience unplanned hospital admissions at the end of life, which may conflict with their wish to remain at home. Advance care planning (ACP) can help align care with patient preferences, but timely discussions and documentation are often lacking. Effective communication across healthcare settings is therefore essential.

Aim

To explore how ACP is delivered for community-dwelling older adults, focusing on intervention components, communication during care transitions and related barriers and facilitators.

Design

A scoping review conducted according to Joanna Briggs Institute methodology and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) guidelines.

Methods

We systematically searched six databases (PubMed, Embase, CINAHL, PsycINFO, Scopus and Web of Science) on 7 April 2025 for peer-reviewed primary studies on ACP interventions for community-dwelling older adults during healthcare transitions. Data were extracted using a structured table.

Results

Sixteen studies from seven countries (2016–2024) were included, with most conducted in the United States. ACP interventions typically involved healthcare professional education, structured documentation and coordination across settings. Communication strategies included written records, discharge summaries, telephone calls, face-to-face meetings and electronic systems. Key facilitators were timely patient identification, GP involvement, clear role distribution and use of existing clinical structures. Barriers included time constraints, unclear responsibilities, fragmented communication, insufficient training and emotional reluctance. ACP was often deprioritised due to acute care episodes.

Conclusion

ACP for community-dwelling older adults is a complex intervention challenged by structural, organisational and relational barriers. Future research should explore sustainable, context-sensitive ACP models that emphasise long-term integration, patient experiences and diverse care settings.

Patient or Public Contribution

No patient or public contribution.

Patients' Experiences of Day Surgery: A Qualitative Systematic Review

ABSTRACT

Aim

To examine how patients experience day surgery.

Design

Systematic review using Thomas and Harden's framework for synthesis and analysed through Ricoeur's theory of interpretation.

Methods and Data Sources

Systematic searches in MEDLINE, CINAHL and EMBASE (September 2023) identified qualitative studies focusing on patients' lived experiences with day surgery (defined as < 24-h hospital stay). Studies were required to provide qualitative data on patient experiences and be published in English or Scandinavian languages. Forward and backward citation searches were also conducted in Scopus.

Results

Thirty-four studies met the inclusion criteria. The analysis revealed four key themes: (1) ‘Perceptions of the day surgery concept shape patient expectations’; (2) ‘Navigating expectation and reality: Surprises and challenges in day surgery’; (3) ‘Navigating through postoperative recovery: Feelings of responsibility and insecurity following day surgery’; and (4) ‘The vital role of support from both family and professionals during recovery after day surgery’.

Conclusion

Patients' expectations of day surgery strongly influence their overall experience, while the complex self-care demands of postoperative recovery underscore the need for robust support systems involving families and healthcare professionals.

Implications for Patient Care

This review highlights the importance of thorough preoperative counselling and ongoing support for patients' complex postoperative self-care. These findings suggest that improved patient-centred care and targeted support could enhance recovery outcomes in day surgery pathways.

Impact

Problem addressed: The study explores the often-overlooked challenges that patients face with postoperative self-care following day surgery. Main findings: Expectations of day surgery as ‘minor’ often conflict with patients' emotional and physical self-care needs, revealing a need for comprehensive support. Research impact: Insights from this review can inform patient-centred care practices in day surgery settings globally, underscoring the critical role of family and professional support.

Patient or Public Contribution

No patient or public contribution.

Trial Registration

Registered with PROSPERO: CRD42023414310

Exposome project for health and occupational research night shift cohort (EPHOR-NIGHT): a unique resource to advance research on night shift work and chronic disease

Por: Harding · B. N. · Castano-Vinyals · G. · Broberg · K. · Albin · M. · Laurell · C. · Garde · A. H. · Nabe-Nielsen · K. · Fiehn · A. E. S. · van der Grinten · T. · Peters · S. · Vermeulen · R. C. H. · Gosh · M. · Loh · M. · Pronk · A. · Kogevinas · M.
Purpose

The EPHOR-NIGHT cohort was established to investigate how night shift work influences biological pathways and chronic disease risk using a comprehensive working-life exposome approach, focusing on cardiometabolic, mental health, cognitive and biological ageing outcomes.

Participant

The cohort includes 937 workers aged 20–65 years (88% female), primarily from the healthcare sector (96%) in Spain, Sweden, Denmark and the Netherlands. Participants were categorised as permanent day (39%), permanent night (35%) or rotating/other shift workers (26%). Data collection included questionnaires, daily ecological momentary assessments, wearable sensors tracking light, physical activity, heart rate and environmental exposures and biological samples (blood collected once and saliva collected during five points across the day), with harmonised protocols across countries.

Findings to date

From the 937 participants contributing data to the cohort, 708 had complete information from questionnaires, sensors and blood and saliva, with subsets undergoing advanced biological analyses, including genomics, targeted and genome-wide DNA methylation, telomere length and mtDNA copy number, metabolomics, transcriptomics, proteomics, hormone profiling and inflammatory biomarkers and blood metals. Many reported prevalent chronic conditions, including anxiety (27%), depression (18%) and metabolic disturbances. Night shift and rotating shift workers had greater exposure to long shifts and more scheduled rest days compared with day workers. Sleep duration and quality were poorest among permanent night shift workers.

Future plans

A 2-year follow-up was completed in June 2025, including the collection of additional biomarker data, psychosocial work environment data and data related to female sexual and reproductive health. Findings from the EPHOR-NIGHT study aim to inform prevention strategies and occupational health policies. Data will be made available to support broader research efforts on shift work and health.

Development and validation of the musculoskeletal health climate questionnaire

Por: Nielsen · K. J. · Jensen · S. H. J. · Andersen · D. R. · Andersen · J. H. · Christiansen · D. H.
Objective

To develop, evaluate and validate the musculoskeletal health climate questionnaire (MHCQ), a multidimensional questionnaire for measuring musculoskeletal health climate.

Design

Cross-sectional test–retest study including systematic scale development and psychometric validation.

Setting and participants

The questionnaire was developed following the best practice recommendations for scale development outlined by Boateng et al (2017), including item development, scale development and scale evaluation with input from experts, stakeholders and the target population. Validation was conducted among employees in three physically demanding occupations in Denmark (care workers, slaughterhouse workers and residential painters), where a total of 1420 participants were recruited through labour unions. Of these, 796 completed the retest survey 30 days later. Exploratory and confirmatory factor analyses (EFA and CFA, respectively), internal consistency (Cronbach’s α), test–retest reliability (intraclass correlation coefficients (ICC)) and SEM were used to assess the psychometric properties. Criterion validity was examined via associations with pain points, pain medication use and sickness absence. Construct validity was assessed using correlations with the prevent for work questionnaire (P4Wq).

Results

EFA and CFA supported a four-factor model (supervisor’s practices, workplace practices, worker involvement practices and workers’ pain practices) with good to excellent fit (comparative fit index, 0.96–0.99; root mean square error of approximation, 0.04–0.06). All scales showed high internal consistency (α=0.80–0.88) and excellent test–retest reliability (ICC=0.86–0.92). Associations with musculoskeletal outcomes supported criterion validity. Weak to moderate correlations with the P4Wq subscales (rho

Conclusions

The MHCQ provides a validated, multidimensional tool to assess workplace climate related to musculoskeletal health. It can support workplace assessments and prevention efforts by capturing shared perceptions of leadership, support, involvement and pain-related norms. Further longitudinal research and the use of objective outcome data are needed to assess predictive validity and strengthen the instrument’s applicability across settings.

Identification of gestational diabetes mellitus in European electronic healthcare databases: insights from the ConcePTION project

Por: Molgaard-Nielsen · D. · Mitter · V. · Lupattelli · A. · Hoxhaj · V. · Andaur Navarro · C. L. · Hayati · S. · Lopez-Leon · S. · Morris · J. K. · Geldof · A. · Jordan · S. · Leinonen · M. K. · Martikainen · V. · Manfrini · M. · Cammarota · L. · Neville · A. · Barrachina-Bonet · L. · Cave
Objective

To develop and compare algorithms for identifying gestational diabetes mellitus (GDM) across European electronic healthcare databases and evaluate their impact on the estimated prevalence.

Design

Multi-national cohort study using routinely collected electronic healthcare data

Setting

National and regional databases in five European countries (Norway, Finland, Italy, Spain and France), in primary and/or secondary care.

Participants

Pregnancy cohorts resulting in stillbirths or live births between 2009 and 2020, comprising 602 897 pregnancies in Norway, 507 904 in Finland, 374 009 in Italy, 193 495 in Spain and 116 762 in France.

Primary and secondary outcomes

The primary outcome was the prevalence of GDM identified using six algorithms: (1) Only diagnosis; (2) Diagnosis or prescription; (3) Two diagnoses or prescriptions (2DxRx); (4) Diagnosis including unspecified diabetes in pregnancy or prescription (DxRx broad); (5) Diagnosis excluding pre-existing diabetes in pregnancy or prescription; (6) Registration of GDM in a birth registry (BR).

Results

The strictest algorithm (2DxRx) resulted in the lowest GDM prevalence, while the broadest (DxRx broad) resulted in the highest, except in France where it was BR. In the Nordic countries, GDM prevalence varied only slightly by algorithm; greater variations were observed in other countries. The prevalence ranged from 3.5% (95% CI: 3.5% to 3.5%) to 4.6% (95% CI: 4.5% to 4.7%) in Norway; 12.1% (95% CI: 12.0% to 12.2%) to 15.8% (95% CI: 15.7% to 15.9%) in Finland, where prevalence was much higher than elsewhere. The prevalence ranged from 1.3% (95% CI: 1.3% to 1.3%) to 5.4% (95% CI: 5.3% to 5.5%) in Italy; 1.6% (95% CI: 1.5% to 1.7%) to 6.2% (95% CI: 6.1% to 6.3%) in Spain; and 1.7% (95% CI: 1.6% to 1.8%) to 5.8% (95% CI: 5.7% to 5.9%) in France.

Conclusions

In this multinational study, GDM prevalence ranged from 1.3% to 15.8% depending on the algorithm and database. Nordic countries showed smaller differences in prevalence between algorithms, while the other countries showed larger variations, likely due to differences in coding practices, healthcare systems and database coverage.

Association of nociceptive, neurocognitive, psychological and genetic profile on conditioned pain modulation in women with migraine: protocol for a case-control study

Introduction

Migraine is a primary headache showing a multifactorial component that includes altered pain processing, psychological/emotional problems, neurocognitive and executive function deficits, all with a possible genetic association. The aim of the current study will be to evaluate the association between sensitisation, psychological/emotional, neurocognitive and genetic profile on conditioned pain modulation (CPM) in women with migraine from a multidisciplinary perspective.

Methods and analysis

A cross-sectional observational case–control study including 90 women with chronic migraine, 90 women with episodic migraine and 90 women without migraine (as controls) will be conducted. Clinical variables (disability, pain), processing (sensitisation-associated, neuropathic-like symptoms), psychological/emotional (anxiety, depression, sleep quality, catastrophising), neurocognitive (attention), executive functions (memory, mental inhibition, speed processing) and genetics (Val158Met polymorphism rs4680 gene) will be assessed in all subjects by healthcare professionals. Subsequently, CPM will be evaluated with the cold-pressor test paradigm by assessing changes obtained in mechanical and thermal stimuli. The association of each group of variables on CPM will be analysed with multivariate analyses (OMNIBUS analysis of variance). A network model will also be created to identify those variables showing the greatest key measure of centrality with the rest of the severity indicators (strength, intermediation and closeness) to establish the potentially therapeutic targets in patients with migraine from a multidisciplinary point of view.

Ethics and dissemination

The protocol of the current study has been approved by the Ethics Committee of all involved institutions (Hospital Universitario Fundación Alcorcón 24–117, Universidad Rey Juan Carlos 010220240912024). All procedures will be conducted following the Declaration of Helsinki. Participants will be informed of the aims and procedures of the study and will receive the informed written consent which should be signed before their inclusion. Study results will be disseminated through peer-reviewed publications and presentations at scientific meetings.

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