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Long-term recovery from post-traumatic neck pain: protocol for a prospective cohort study in the emergency department

Por: Lynaes · C. · Ravn · S. L. · Skou · S. T. · Mogensen · C. B. · Arvig · M. D. · Christensen · S. W. M. · Sterling · M. · Andersen · T. E.
Introduction

Post-traumatic neck pain is common, representing a substantial human and societal burden. About 15%–25% of individuals involved in an accident causing whiplash continue to experience moderate-to-severe symptoms and functional impairment 1 year post-trauma. Factors such as age, high pain intensity, hypersensitivity to pain and early post-traumatic hyperarousal are associated with persistent neck pain. However, multiple questions remain unanswered regarding how best to improve early care. As such, research on recovery patterns (including indicators for health economic burden) and their predictors is still needed, including biomarkers for pre-traumatic and peri-traumatic stress, and the value of early prediction tools.

Methods and analysis

This prospective cohort study will include 100 participants (18 years) suffering from post-traumatic neck pain sustained within 72 hours of an accident. At baseline (a combination of inclusion and 1 week assessment), eligible participants will undergo a thorough evaluation, including assessment of descriptive characteristics, self-reported variables (eg, pain, disability, sleep quality and post-traumatic stress), biomarkers (eg, heart rate variability (HRV) and hair cortisol) and clinical tests (eg, cervical range of motion). Follow-up will be conducted at 3, 6 and 12 months post-trauma. Further, register data (eg, data on labour market attachment) will be added for the period. Among other methods, a receiver operating characteristic (ROC) curve and multivariable regression analyses will be used to evaluate performance and associations of the prediction tools and their associations with measures of HRV.

The sample size calculation is based on previous studies, estimating that 15% of participants will develop moderate-to-severe ongoing symptoms. Using a conservative estimate, 64 participants are needed to achieve a statistical power of 90% with an expected area under the curve of 0.80. Accounting for a 25% loss to follow-up, 80 participants are required. For regression analysis, 100 participants will be included. The prediction tool will be validated using ROC analysis, sensitivity and specificity. Logistic regression models will be performed with and without biomarkers and pain sensitivity. Health economic costs will be compared across groups. Multivariable regression will examine the link between HRV and post-traumatic stress disorder, adjusting for confounders and a moderation analysis will assess hair cortisol as a potential moderator.

Ethics and dissemination

The study is approved by the Regional Committee on Health Research Ethics of Southern Denmark (S-20230037). Due to the acute nature of recruitment, the study design does not allow for a 24-hour reflection period; however, this approach has been approved by the Committee.

Study results will be published in peer-reviewed journals and disseminated through non-scientific outlets, including patient and professional publications, press releases and social media. If effective, workshops for clinicians will be organised. Results will be published regardless of outcome, with coauthorships following ICMJE guidelines.

Trial registration number

NCT06176209.

At the epicentre: a qualitative study of how parents of a child with de novo retinoblastoma experience the diagnostic process and primary treatment

Por: Lou · S. · Carstensen · K. · Mikkelsen · P. A. · Jensen · P. S. · Hogild · M. L. · Christensen · R. T. · Overgaard · J. · Urbak · S. F. · Staffieri · S. E. · Gregersen · P. A.
Objective

To explore how parents of children with de novo retinoblastoma (RB) experience the diagnostic process and acute treatment phase, and to identify factors that may support parental coping and adaptation.

Design

A qualitative interview study using reflexive thematic analysis.

Setting

National Retinoblastoma Unit at Aarhus University Hospital, Denmark.

Participants

Thirty-one parents (21 mothers, 10 fathers) of 21 children diagnosed with de novo RB were recruited via hospital follow-up clinics and a support group day.

Results

For most parents, the diagnostic process was short. In cases of diagnostic delay, parents described frustration and guilt due to missed symptoms. Receiving the RB diagnosis was described as a surreal experience, accompanied by feelings of shock, grief and loss of control. Parents faced challenges in adapting to rapid medical decisions and the unfamiliar demands of hospital protocols. However, meeting the clinical experts was a relief, as parents felt they were in capable hands, experiencing empathetic communication and a clearly framed treatment plan. Parents emphasised the importance of support systems, including family, healthcare professionals and the child’s resilience, as crucial for coping with and managing the diagnosis.

Conclusions

Parents faced a sudden and disruptive transition from symptom recognition to life-altering diagnosis and treatment. While professional care and communication were experienced as supportive, they did not eliminate the emotional impact. Clinical pathways should prioritise early validation of parental concerns and provide transparent communication, both prior to referral and throughout treatment. Future research should examine longer-term parental adjustment and identify interventions that support emotional resilience beyond the acute phase.

Impact of video service failure on triage outcomes in Danish out-of-hours primary care: a register-based study across four regions

Por: Nebsbjerg · M. A. · Bomholt · K. B. · Vestergaard · C. H. · Christensen · M. B. · Huibers · L.
Objectives

To evaluate the impact of video use in out-of-hours primary care (OOH-PC) telephone triage by examining how triage outcomes (ie, ended by telephone, clinic consultation or home visit) changed during a period with video service failure.

Design

Observational register-based study, using periods of video service failure as a randomisation mechanism for a controlled study.

Setting

OOH-PC in four of the five Danish regions.

Participants

All telephone triage contacts to the OOH-PC call centres between April 2020 and December 2021.

Interventions

Video service failures resulted in a subset of telephone triage contacts without the option of using video as a triage tool. Video service failures were identified algorithmically based on observed periods without video use.

Main outcome measures

Proportion of telephone triage contacts with clinic consultations or home visits as triage outcome during a period of video service failure compared with matched reference telephone triage contacts taking place during normal service (1:10), presented as risk ratios (RR) with 95% CI).

Results

The algorithm identified 6605 telephone triage contacts during video service failure. Compared with matched contacts during normal service, these had a 15% higher risk of resulting in a clinic consultation (RR: 1.15, 95% CI 1.09 to 1.20). This effect was primarily isolated to the year 2021 (RR: 1.23, 95% CI 1.16 to 1.31) compared with 2020 (RR: 1.05%, 95% CI 0.97 to 1.13). Video service failure did not significantly affect the risk of a home visit.

Conclusions

Results strongly suggest that the unavailability of the video service is likely to significantly increase the number of clinic consultations in OOH-PC as a triage outcome. Whether this effect is likely to persist in the long term remains unclear.

Outcomes following a behaviour change intervention within hospitals to improve birth registrations and hospital utilisation for Aboriginal and/or Torres Strait Islander infants: a quasi-experimental and cohort study

Por: McAuley · K. · Strobel · N. A. · Christensen · D. · Edmond · K. M. · Jacoby · P. · McAullay · D.
Objectives

The primary objective was to determine whether a behaviour change intervention delivered to hospital staff would (1) improve the proportion of Aboriginal and/or Torres Strait Islander (Aboriginal) babies being registered and (2) reduce hospital admissions and emergency presentations for babies

Design

Quasi-experimental design and cohort study.

Setting

Five tertiary birthing hospitals in WA.

Participants

The intervention was delivered to health service providers who were in the five tertiary birthing hospitals. Outcome data were collected on Aboriginal babies born between 1 January 2016 and 30 June 2018 who were delivered within these hospitals. Babies in the control group (n=226) were born 6 months before the intervention and intervention babies (n=232) were born 6 months following the intervention. For the secondary objective, there were 4573 babies included in the analysis.

Interventions

A behaviour change intervention delivered to hospital staff in five hospitals.

Primary and secondary outcome measures

The primary outcomes were the proportion of babies who were registered and whether a baby had been admitted to hospital or an emergency department by 3 and 6 months old. The secondary outcome was to determine factors that might influence the proportion of registered Aboriginal births in WA (cohort study).

Results

There was evidence of a 38% reduction in emergency presentations within 6 months for babies born to hospitals 6 months following the staff training (OR 0.62, 95% CI 0.42 to 0.91), and little evidence of improvements in birth registrations, hospital admissions within 3 or 6 months of birth or emergency department presentations within 3 months of birth. Of the 4573 babies included in the cohort study, 3769 (82.4%) babies had their births registered and 804 (17.6%) babies did not. Factors that were associated with not having a birth registered included low birth weight babies with a 34% decrease in odds of having a registered birth compared with those with a normal birth weight (adjusted OR (aOR) 0.66, 95% CI 0.51 to 0.86). Timing of first antenatal visit was associated with reduced odds of having a birth registered if this occurred in the second (aOR 0.77, 95% CI 0.64 to 0.93) or third trimester (aOR 0.59, 95% CI 0.45 to 0.77) compared with the first trimester.

Conclusions

Our study identifies the complexities surrounding birth registrations and improved hospital utilisation for Aboriginal babies, the importance of targeted interventions and ongoing efforts needed to address this issue comprehensively.

Trial registration number

ACTRN12615000976583.

Effect of no reduction versus closed reduction on distal radius fractures in adults aged 65 years and older: a protocol for the DISCLOSE randomised equivalence trial

Por: Kärnä · L. · Ponkilainen · V. · Reito · A. · Ostergaard · H. · Brorson · S. · Tootsi · K. · Paasikallio · K. · Senholt · T. · Li · Y. · Heikkinen · J. · Kukkonen · J. · Ryhänen · J. · Christensen · R. · Mattila · V. M. · Launonen · A. P.
Introduction

Distal radius fractures (DRFs) are common injuries, especially in older adults due to age-related frailty. Most DRFs in patients aged 60 and older are treated non-operatively since surgery offers no clinically important benefits. Although anatomical alignment has traditionally been the goal of the treatment, evidence suggests that in older populations, radiographic outcomes do not reliably correlate with functional outcomes. Current evidence, including one randomised trial, shows no functional benefit of closed reduction compared with casting alone, calling into question the routine use of the procedure in older patients. The primary objective is to evaluate whether no reduction is equivalent to closed reduction in patients aged 65 years or older with a displaced DRF, based on wrist-related pain and disability measured by the Patient-Rated Wrist Evaluation (PRWE) score at 12 months.

Methods and analysis

This is a multi-centre, randomised controlled, equivalence trial conducted in hospitals in Finland, Denmark, Sweden and Estonia. We aim to enrol 532 patients aged ≥65 years with a displaced DRF (AO/OTA 23A/23C). Participants will be randomised (1:1) to receive either a dorsal cast without reduction (experimental intervention) or closed reduction followed by casting (control comparator). The primary endpoint is the difference between groups assessed using the PRWE outcome score at 12 months. The equivalence margin will be set at 6 PRWE points. Key secondary endpoints will include the Numeric Rating Scale for pain, patient satisfaction, quality of life (EQ-5D-5L Index) and serious adverse events at 3 months and 12 months and cosmesis at 3 months. Our main analyses will follow an intention-to-treat principle, analysed using repeated measures mixed model.

Ethics and dissemination

Ethical approval has been granted by the Ethics Committee of Tampere University Hospital (R25001). Results of the trial will be disseminated through peer-reviewed journals.

Protocol version

6 July 2025, v1.0.

Trial registration number

NCT07042139.

Single-centre, prospective cohort to predict optimal individualised treatment response in multiple sclerosis (POINT-MS): a cohort profile

Por: Christensen · R. · Cruciani · A. · Al-Araji · S. · Bianchi · A. · Chard · D. · Fourali · S. · Hamed · W. · Hammam · A. · He · A. · Kanber · B. · Maccarrone · D. · Moccia · M. · Mohamud · S. · Nistri · R. · Passalis · A. · Pozzilli · V. · Prados Carrasco · F. · Samdanidou · E. · Song · J. · W
Purpose

Multiple sclerosis (MS) is a chronic neurological condition that affects approximately 150 000 people in the UK and presents a significant healthcare burden, including the high costs of disease-modifying treatments (DMTs). DMTs have substantially reduced the risk of relapse and moderately reduced disability progression. Patients exhibit a wide range of responses to available DMTs. The Predicting Optimal INdividualised Treatment response in MS (POINT-MS) cohort was established to predict the individual treatment response by integrating comprehensive clinical phenotyping with imaging, serum and genetic biomarkers of disease activity and progression. Here, we present the baseline characteristics of the cohort and provide an overview of the study design, laying the groundwork for future analyses.

Participants

POINT-MS is a prospective, observational research cohort and biobank of 781 adult participants with a diagnosis of MS who consented to study enrolment on initiation of a DMT at the Queen Square MS Centre (National Hospital of Neurology and Neurosurgery, University College London Hospital NHS Trust, London) between 01/07/2019 and 31/07/2024. All patients were invited for clinical assessments, including the expanded disability status scale (EDSS) score, brief international cognitive assessment for MS and various patient-reported outcome measures (PROMs). They additionally underwent MRI at 3T, optical coherence tomography and blood tests (for genotyping and serum biomarkers quantification), at baseline (i.e., within 3 months from commencing a DMT), and between 6–12 (re-baseline), 18–24, 30–36, 42–48 and 54–60 months after DMT initiation.

Findings to date

748 participants provided baseline data. They were mostly female (68%) and White (75%) participants, with relapsing–remitting MS (94.3%), and with an average age of 40.8 (±10.9) years and a mean disease duration of 7.9 (±7.4) years since symptom onset. Despite low disability (median EDSS 2.0), cognitive impairment was observed in 40% of participants. Most patients (98.4%) had at least one comorbidity. At study entry, 59.2% were treatment naïve, and 83.2% initiated a high-efficacy DMT. Most patients (76.4%) were in either full- or part-time employment. PROMs indicated heterogeneous impairments in physical and mental health, with a greater psychological than physical impact and with low levels of fatigue. When baseline MRI scans were compared with previous scans (available in 668 (89%) patients; mean time since last scan 9±8 months), 26% and 8.5% of patients had at least one new brain or spinal cord lesion at study entry, respectively. Patients showed a median volume of brain lesions of 6.14 cm3, with significant variability among patients (CI 1.1 to 34.1). When brain tissue volumes z-scores were obtained using healthy subjects (N=113, (mean age 42.3 (± 11.8) years, 61.9% female)) from a local MRI database, patients showed a slight reduction in the volumes of the whole grey matter (–0.16 (–0.22 to –0.09)), driven by the deep grey matter (–0.47 (–0.55 to –0.40)), and of the whole white matter (–0.18 (–0.28 to –0.09)), but normal cortical grey matter volumes (0.10 (0.05 to 0.15)). The mean upper cervical spinal cord cross-sectional area (CSA), as measured from volumetric brain scans, was 62.3 (SD 7.5) mm2. When CSA z-scores were obtained from the same healthy subjects used for brain measures, patients showed a slight reduction in CSA (–0.15 (–0.24 to –0.10)).

Future plans

Modelling with both standard statistics and machine learning approaches is currently planned to predict individualised treatment response by integrating all the demographic, socioeconomic, clinical data with imaging, genetic and serum biomarkers. The long-term output of this research is a stratification tool that will guide the selection of DMTs in clinical practice on the basis of the individual prognostic profile. We will complete long-term follow-up data in 4 years (January 2029). The biobank and MRI repository will be used for collaborative research on the mechanisms of disability in MS.

Association of non-standard working time arrangements with safety incidents: a systematic review

Por: Moen · L. V. · S Lie · J.-A. · Sterud · T. · Christensen · J. O. · Haugen · F. · Skogstad · M. · Nordby · K.-C. · Matre · D.
Objective

To systematically review the evidence on the association between non-standard working time arrangements (such as night work or shift work) and the occurrence of safety incidents.

Design

Systematic review conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and using a structured narrative approach and the Synthesis Without Meta-analysis framework to evaluate and summarise findings.

Data sources

MEDLINE, Embase, PsycINFO, Web of Science and ProQuest Health and Safety Science Abstracts were searched through February 2024.

Eligibility criteria for selecting studies

We included peer-reviewed English-language studies of paid workers (18–70 years) that examined the association between non-standard working time arrangements and safety incidents (accidents, near-accidents, safety incidents or injuries), excluding cross-sectional designs and studies on unpaid workers, athletes or military personnel.

Data extraction and synthesis

Two reviewers independently extracted data and assessed risk of bias using standardised forms, extracting study characteristics (author, year, country, sector and population), working time arrangements and exposure assessment, outcomes and their assessment, and reported risk estimates. We conducted a narrative synthesis, classifying studies into three exposure contrasts (shift worker versus non-shift worker, time-of-day and shift intensity), and summarised risk estimates using forest plots without calculating pooled effects.

Results

A total of 13 569 records were screened, and 24 studies met the inclusion criteria. The results indicated that shift workers generally had an elevated safety incident risk compared with non-shift workers (risk estimates ranged from 1.11 to 5.33). Most of the included studies found an increased risk of safety incidents during or after night shifts. Accumulated exposure to evening or night shifts increased the risk of safety incidents during the following 7 days. However, bias and heterogeneity across studies in design, populations and outcome measures resulted in an overall low to very low certainty of the evidence.

Conclusions

Non-standard working time arrangements, including night and evening shifts, appear to increase the risk of occupational safety incidents. Despite the low certainty of evidence, the findings highlight a potential area for preventive measures in work scheduling. Future longitudinal studies using individual data on daily working hours are needed.

Trends in educational inequality in healthy life expectancy in Denmark between 2010 and 2021: a population-based study

Por: Jensen · H. A. R. · Davidsen · M. · Bronnum-Hansen · H. · Eliasen · M. H. · Christensen · A. I.
Objectives

For several decades, mortality has decreased more rapidly among individuals with a higher socioeconomic position than among those with a lower position. This widening social inequality gap has increasingly been recognised as an important aspect of public health research and policies. The objective of this study was to examine trends in educational inequality in healthy life expectancy (HLE) in Denmark between 2010 and 2021 at the age of 30 years.

Design

The study is a population-based study based on register data on longest attained education, standard life tables and self-reported health information from nationwide health surveys.

Setting

The study is conducted among the general adult population in Denmark.

Participants

Participants include respondents from the Danish National Health Survey and the Danish Health and Morbidity Survey in 2010, 2013, 2017 and 2021 aged ≥30 years.

Primary and secondary outcome measures

Expected lifetime in good self-rated health, with no long-standing illness and with no activity limitations was estimated by Sullivan’s method, and educational inequality was expressed by the Slope Index of Inequality.

Results

Between 2010 and 2021, educational inequality in HLE increased among both men and women for long-standing illness (5-year trend: +1.1 and +1.2 years) and activity limitations (+2.4 and +2.6 years) but remained stable among men (+0.1 year) and decreased among women (–0.3 year) for self-rated health. For the latter two indicators, the inequality gap narrowed after 2017.

Conclusion

Trends in educational inequality in HLE in Denmark 2010–2021 vary by health indicator. Steadily widening gaps were demonstrated for long-standing illness, while narrowing gaps were seen after 2017 for activity limitations and self-rated health. Future studies are encouraged to explore potential health risk behaviours that may explain or modify these inequality trends.

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