Haukeland University Hospital

Complex health and welfare organisations struggle to align resources and integrate services for mental health patients. In Western Norway, 16 leaders across four local public organisations participated in this action research study. Providing services for joint service users, they were mandated to make necessary changes towards resource alignment and service integration. The purpose of this study was to learn how these leader experienced the process and outcomes of participating in the four year action research project aiming at transforming practices by implementing a portfolio of social innovation initiatives. More than 300 people, including service users, frontline workers and leaders were involved in the social innovation initiatives, including two service design projects and a network for leaders for collective governance across organisations. Data for this study were co-created in reflexive dialogues in a focus group interview and a whole-day evaluation workshop for leaders in the network. Through reflexive thematic analysis this study found that participants experienced transformations in services, power relations, relational awareness of interdependency, organisational culture, and capability for self-steering in a `systemic whole`. We conclude that combining social innovation and action research enabled local contextualising of problems and solutions, contributing to co-creation of integrated, safer services and resource alignment in the Health Community.

Purpose Rheumatoid arthritis (RA) is a chronic inflammatory illness that mainly affects the joints. Untreated, it causes deformity, poor health-related quality of life (HRQoL) and increased morbidity and mortality. There have been tremendous strides in RA therapies globally but with sparse availability in resource-limited settings. We aimed to evaluate HRQoL among patients with RA and its related factors. Methods 132 patients with RA were enrolled and followed up for one year. The same number of healthy controls were recruited. HRQoL was assessed using the EuroQoL five-dimension five-level tool (EQ-5D). From the responses, utility and visual analog scale (VAS) scores were obtained. Analysis of variance and independent t tests were used to compare the utility and VAS scores for patient subgroups. Factors influencing HRQoL were investigated through multiple linear regression analysis. A p value of < 0.05 was considered significant. Results At baseline, mean patient utility score was 0.50 ± 0.06 and increased to 0.66 ± 0.10 at one year (p < 0.05). Compared to controls, whose mean utility score was 0.93 ± 0.02, patients with RA at one year had lower HRQoL (p < 0.001). Time to diagnosis of ≥ 1 year and higher disease activity were associated with poorer HRQoL. Patient VAS scores also improved from baseline to one year but were significantly lower than controls. Conclusion HRQoL of patients with RA was lower than in controls but improved at one year indicating the impact of treatment. Reducing delays in diagnosis and initiating early and aggressive treatment may help to improve the HRQoL.

Background Mandatory reporting is a common legislative preventative measure for several types of crimes, among them family violence and specifically intimate partner violence (IPV). Among the individuals who are mandated to report under the law are professionals working with IPV victims and perpetrators in their practice. However, little is known about which characteristics are associated with compliance with the mandatory reporting of IPV (MR-IPV) law, on the one hand, and choosing not to report IPV, on the other. Methods The current study sampled 357 professionals from 6 different agencies working with IPV victims and/or perpetrators. Six dichotomous outcome variables of compliance with MR-IPV and choosing not to report were analyzed by multiple logistic regression. The independent variables were professionals’ perceptions and knowledge of MR-IPV, context and workplace conditions, and experience with IPV cases and risk assessment. Results Findings showed that risk of compliance with MR-IPV varied between complying with and without consent. Perceived applicability of MR-IPV for an IPV victim was the only variable that had significantly positively odds ratio for both compliance with and without consent. For choosing not to report, significant variables varied between whether the incident had taken place sometime throughout participants’ careers or during the last year, and whether it concerned a victim or a perpetrator. However, knowledge of MR-IPV, experience with IPV cases, expectations of MR-IPV, perceived workplace time management, and perception of compliance were significant for choosing not to report. Conclusions Knowledge of the characteristics that are associated with professionals’ compliance with MR-IPV is essential to better understand the application of MR-IPV, to implement practice that is consistent with law, and ultimately to prevent IPV. Further research is needed to explore the context of compliance with MR-IPV.

This invited commentary refers to 'How is digital technology used to facilitate shared decision-making between healthcare professionals and patients in cardiovascular care? A scoping review', by D. Leysen et al. https://doi-org/ 10.1093/eurjcn/zvaf029.

Background Deep learning algorithms can aid medical decision-making by performing routine tasks without any human error. Reading of standardized radiographs lends itself well to a computerized approach. The posterior tibial slope is increasingly recognized as a factor in lower leg biomechanics. Slope readings should, therefore, be readily available when considering knee ligament or knee replacement surgery. Purpose/Hypothesis The purpose was to externally validate a deep learning model developed for posterior tibial slope readings by applying an independent data set, not included in initial development, for testing the reliability of the model, compared with human performance testing. It was hypothesized that a computerized approach would yield a reliability similar to that of human analyses. Study Design Descriptive laboratory study. Methods A consecutive series of lateral knee radiographs obtained in patients undergoing anterior cruciate ligament surgery were eligible for inclusion. Two independent experienced clinicians individually assessed the tibial slope measurement to establish the interreader reliability. Furthermore, all images were processed by the newly developed model for the automated readings. Intrarater and interrater reliability were thereafter established between readers and between manual and automated readings, measured by intraclass correlation coefficients (ICCs). Time consumption between methods was noted. Extreme differences between the 2 methods were analyzed for potential errors. Results A total of 289 radiographs were included in the study and therefore analyzed by both the manual and the automated method. A mean tibial slope of 9.7° (SD, 2.7°; range, 3.0°-19.1°) was found. The interrater and intrarater measurements between the independent measurers for the 2-circle method were 0.86 and 0.92. Furthermore, the intrarater agreement of the model was 1.00, while an ICC between 0.73 and 0.80 was found when comparing automated with manual measurement. The mean time consumption for manual readings was 52.5 seconds, while for automated readings it was 28.2 seconds. Conclusion In this external validation of a newly developed model for automated readings of tibial slope measures, a perfect intrarater reliability and a good interrater reliability were seen. Although the model needs further refinement in reporting the tibial slope as compared with a gold standard manual measurement, it clearly demonstrates the elimination of human variance with repeat readings and less time consumption than that with human effort.

Background Hip fractures are a significant public health concern due to increasing numbers, high mortality and negative impact on health-related quality of life (HRQoL). Socioeconomic position (SEP) affects various health outcomes, but the specific impact on HRQoL and satisfaction after hip fracture remains underexplored. This study assesses whether education and household income influence patient-reported outcome measures (PROMs) after hip fractures, measured by three visual analog scales: EQ-VAS, pain-VAS, and satisfaction-VAS. Methods This was a nationwide retrospective cohort study using linked data from the Norwegian Hip Fracture Register and Statistics Norway. PROMs assessed at 4, 12, and 36 months postoperatively in 35,206 hip fracture patients from 2015 to 2018 were included. The SEP data included household income and education levels. Covariance analyses were conducted to evaluate differences in mean VAS scores for general health (EQ-VAS), pain from the operated hip (Pain-VAS), and satisfaction with the result of the operation (Satisfaction-VAS). Analyses adjusted for age, sex, vital status, cognitive impairment, treatment type, and education or income when not used as independent variable. Results The study included 23,649 women (67.2%) and 11,557 men (32.8%) with median age 83 years. Lower education was linked to worse EQ-VAS and Pain-VAS scores at all follow-ups and to lower Satisfaction-VAS at 12 and 36 months in both unadjusted and adjusted analyses. Lowest level of income had significant lower EQ-VAS at all follow-ups, lower Pain-VAS at 12 months, and lower Satisfaction-VAS at 4 months. There were increasing differences in mean VAS-scores during follow-up. At 36 months the adjusted differences in mean EQ-VAS between highest and lowest level of income was − 2,51 (-4.04 -0.99). Differences across education levels were even stronger associated; -3.58 (-5.19 to -1.98). Mean differences in Pain-VAS between medium and low education compared to high were 4.30 (2.91 to 5.69) and 5.58 (4.08 to 7.08), respectively. Lower levels of education also had significant negative differences in Satisfaction-VAS at 36 months follow-up -4.06(-5.86 to -2.26). Conclusions Lower education and income were significantly associated with worse HRQoL and satisfaction after hip fracture. The clinical relevance of these findings warrants further investigation. Addressing SEP disparities should be integral to hip-fracture care strategies aiming to improve postoperative outcomes.

Background There is a lack of robust biological variation (BV) data for porphyria-related biomarkers. Our study aimed to estimate BV of erythrocyte total, metal-free, and zinc protoporphyrin IX in patients with erythropoietic protoporphyria (EPP) and healthy subjects and to explore the clinical implications of these data. Methods Fourteen patients with EPP and 15 healthy subjects were sampled quarterly for 2 years, and erythrocyte protoporphyrin analyses were performed in duplicate in all samples. A Bayesian method was used to estimate the within-subject (CVI) and personal (CVP(i)) BV. Results Based on clinical and laboratory assessments, EPP patients were stable during the study, with only 2 data points excluded. CVI in the EPP cohort was estimated as 9.8% (95% credible interval 8.5%–11.5%) for erythrocyte total protoporphyrin, 10.5% (9.0%–12.3%) for metal-free protoporphyrin, and 5.9% (4.3%–8.0%) for zinc protoporphyrin. Baseline metal-free protoporphyrin ranged from 6.9 to 139.8 µmol/L, but the CVP(i)s derived for each patient were similar (20th and 80th percentile of predicted distribution 9.5%–11.5%), and data were homogeneously distributed. Metal-free protoporphyrin was not measurable in the healthy cohort. Data for zinc protoporphyrin were heterogeneously distributed in both study cohorts. Conclusions The EPP patients had different set points for metal-free protoporphyrin, but the CVP(i) was similar, supporting the use of the same treatment goals when monitoring. This study is the first to use Bayesian analysis to demonstrate that personal BV is similar in patients with stable, chronic disease and different set points.

Objective It is generally assumed that graded sickness absence results in favourable health effects due to observed positive consequences of maintaining work participation. To date, however, the direct health benefits of graded sick leave have not been widely explored. Musculoskeletal disorders are among the most prominent health issues resulting in work incapacities. This study examined baseline characteristics and six-months pain-related disability and health-related life quality progression of working age adults who attended a neck and back pain outpatient clinic. Patients prescribed graded sick leave were compared to patients prescribed full sick leave and those working without sick leave. Methods Demographic, health, and treatment information of patients were assessed using clinician and patient self-report questionnaire data collected at neck and back pain outpatient clinics between 2016 and 2022. Data were obtained from the Norwegian Neck and Back Registry and the Norwegian Labour and Welfare Administration. Patient characteristics in the two weeks leading up to clinic intake were described. General linear models for repeated measures were employed to observe six-months changes in pain-related disability and health-related life quality. Results A total of 5143 (54% female, M = 44.70 years, SD = 11.50) patients were prescribed full (n = 1411, 27%), graded (n = 1164, 23%), and no (n = 2568, 50%) sickness absence. Patients prescribed graded sick leave reported lower baseline levels of pain-related disability compared to those on full sick leave but higher pain-related disability than patients without sick leave. There were significant main and interaction effects of time and sickness absence, whereby reductions in pain-related disability were greatest among patients prescribed full sick leave, however, this group reported the highest levels of pain-related disability and lowest life quality prior to their clinic intake and six months later. Conclusion Patients who were prescribed full, graded, or no sick leave exhibited significant, albeit not clinically meaningful, reductions in pain-related disability over a six-months period. Symptom reductions may be due to clinician support or remission trends in line with regression towards the mean. While no superior health effects of graded sick leave were noted, work participation did not appear to have detrimental health effects.

Introduction A recent study recommended 5.2 mmol/L as a cutoff for fetal blood sample (FBS) lactate in labor for the StatStrip Lactate®/Lactate Xpress® lactate meter. In the present study, we validated FBS lactate cutoffs in a larger population‐based setting, with different CTG guidelines, testing external validity. Material and Methods We conducted a prospective population‐based study at Oslo University Hospital, Ullevål, Norway, a tertiary referral obstetric department with 7000 annual deliveries. Women with a singleton fetus in cephalic presentation in gestational week ≥36 + 0 were included in the analyses. We used ROC curves to calculate the area under the curve (AUC) and estimate the optimal cutoff for the following adverse neonatal outcomes: Umbilical cord pH ≤7.10, umbilical cord pH ≤7.05, metabolic acidosis (pH <7.0 and Base deficitextracellular fluid > 12 mmol/L), 1‐minute Apgar score <4, 5‐min Apgar score <7, hypoxic ischemic encephalopathy, and transfer to the neonatal intensive care unit. Analyses were restricted to women with a FBS lactate within 25 min prior to delivery. The study is registered in clinicaltrials.gov (ClinicalTrials.gov Identifier: NCT04779294). Results Of 7816 included women, 1466 (19%) had a FBS lactate measurement within 25 min prior to delivery. The calculated optimal cutoff for FBS lactate varied by outcomes: 5‐min Apgar score <7: AUC 0.69 (0.57–0.80), cutoff 4.0 mmol/L; metabolic acidosis: AUC 0.92 (0.78–1.00), cutoff 7.0 mmol/L; hypoxic ischemic encephalopathy: AUC 0.95 (0.86–1.00), cutoff 4.7 mmol/L. Sensitivity increased for some of the outcomes with a decreasing cutoff. Specificity increased for all outcomes with an increasing cutoff. Conclusions We consider an FBS lactate cutoff of ≥5.2 mmol/L a good balance between high sensitivity for adverse neonatal outcomes and an acceptable number of needed interventions.

In acute myeloid leukemia, the burden of CD34+CD38- leukemia stem cells (LSC) has prognostic value at diagnosis and after induction chemotherapy. Since different methods of LSC quantification have been proposed, we determined the prognostic value on overall survival and incidence of relapse of these methods across ELN2017 risk groups, using data from the HOVON-SAKK132 trial. In addition, we have evaluated the optimal number of acquired white blood cells for accurate LSC detection and the prognostic value of individual LSC markers. Results show that acquiring 1 million white blood cells is essential for accurate LSC-negativity assessment. Among different LSC markers, CD44 overexpression on CD34+CD38- cells was the only insignificant marker in our panel. Testing the impact of several published variations on the analysis for LSC assessments on prognostic value for overall survival and cumulative incidence of relapse, showed marginal differences, demonstrating the robust prognostic value of LSC burden. For further clinical implementation, the optimal LSC assessment may differ among ELN risk groups. In conclusion, LSC burden is a robust prognostic factor and insight in the different methods of LSC definition can facilitate the clinical implementation.

Purpose Internationally, policies and legal changes seek to reduce the use of involuntary psychiatric admissions. Usually directed towards specialist services, these initiatives show little sustained progress. We tested whether an intervention at the level of primary mental health services has potential to reduce the use of involuntary admissions. Methods We conducted a two-arm cluster-RCT following Zelen’s design (ClinicalTrials.gov:NCT03989765). Each cluster included the primary mental health service and their local collaborators in mid-sized Norwegian municipalities with rates of involuntary admissions above the national average. Five clusters were randomised to co-create and implement a comprehensive intervention. These could not be blinded, but the five control clusters were. Our primary hypothesis was that rates of involuntary admissions would be lower in the intervention arm when comparing change over time between arms, and that this would sustain. Secondary hypotheses were that rates of referrals for involuntary admissions and rates of referrals confirmed for involuntary status after the second statutory assessment, would be lower in the intervention arm. Results Data obtained from the Norwegian Patient Registry included all events in the study period. The difference between trial arms in changes of rates of involuntary admissions from baseline to the intervention period was 6.8 (95% CI 1.8 to 11.7; effect size (EC) 2.7), and reduced to 3.0 (95% CI -3.8 to 9.7; ES 0.9) between baseline and the post-intervention period. The difference between arms regarding changes in referral rates between the baseline and intervention period was 1.7 (95% CI -4.6 to 8.1; ES 0.5), and for changes in the rate of referrals resulting in involuntary status it was 1.3 (95% CI -3.4 to 6.0; ES 0.8). Conclusion We found a clear difference between trial arms in our primary outcome of involuntary admissions during the intervention period, but not beyond that period, and not regarding referrals for involuntary admissions, although the consistent direction of change favoured the intervention. We interpret the results to constitute ‘proof of concept’ that adequately resourced primary mental health services might contribute to policy aims of reducing involuntary care. Further rigorous studies in heterogeneous contexts are required.

Innate differences in the female and male immune systems and subgroup results from clinical trials have led researchers to hypothesize there could be sex‐based disparities in the effectiveness of immune checkpoint inhibitors for anticancer treatment. This real‐world study evaluated potential sex‐based disparities in survival among non‐small cell lung cancer (NSCLC) patients treated with pembrolizumab as monotherapy or in combination with chemotherapy. The population‐based cohort included 1586 females and 1978 males diagnosed with advanced NSCLC in Norway, treated with first‐line pembrolizumab (2017–2021) or platinum‐based chemotherapy (2012–2016). Sex‐based survival differences among pembrolizumab users, and survival benefits relative to chemotherapy users, were evaluated using lung‐cancer specific survival adjusted for age, stage, histology, cardiovascular disease, education, and income. Results were presented for pembrolizumab mono‐ and combination therapy separately. We did not observe sex‐based differences in survival among pembrolizumab monotherapy users. Among combination therapy users, females had higher survival than males (7 percentage points higher 18 months after treatment initiation); this effect persisted until the end of follow‐up (36 months). When comparing the effect of pembrolizumab relative to chemotherapy, males derived a larger survival benefit from monotherapy than females. We did not observe any sex‐based disparities in the survival benefit of combination therapy. Sex‐based survival disparities in our study appeared to be associated with disparities in the effectiveness of chemotherapy, but could also indicate that pembrolizumab monotherapy is more effective for males. Framing the sex‐based effectiveness of pembrolizumab as a survival difference versus benefit relative to chemotherapy affected whether a disparity was observed.

Study Design Radiologic cross-sectional study based on a prospective cohort study (level III). Objective Investigate whether lumbar lordosis (LL) and sacral slope (SS) differ significantly on supine magnetic resonance imaging (MRI) versus standing radiographs in nondeformity lumbar spinal stenosis (LSS). Secondly, to quantify the amount of magnification on standing lumbar radiographs. Summary of Background Data Supine MRI is routinely performed when diagnosing LSS. Standing radiographs are often supplemented to measure spinopelvic angles. Little research has been done on whether LL and SS translate from standing radiographs to supine MRI. Previous studies have trended to significant changes in LL and SS; however, none have been performed exclusively in nondeformity LSS. Materials and Methods Review of preoperative standing lateral lumbar radiographs and midsagittal T2-weighted supine lumbar MRI in 211 patients with LSS without concomitant degenerative spondylolisthesis, measuring LL (L1–S1), segmental lumbar lordosis (sLL) (L4–S1) and SS, in addition to the anteroposterior diameter and height of the L3 vertebral body. We conducted a reliability study and performed a Pearson’s correlation analysis. Data was presented in Bland-Altman plots. Results Interobserver reliability was good to excellent, with ICC ranging from 0.77 to 0.94 for all parameters. Statistically significant differences were observed in LL and SS between image modalities. The mean radiographic measurements were as follows: LL 48.9 (SD: 12.8), sLL 32.3 (SD: 8.1), and SS 37.3 (SD: 8.7) degrees. The mean MRI measurements were as follows: LL 46.0 (SD: 10.5), sLL 32.3 (SD: 7.1), and SS 38.1 (SD: 7.1) degrees. Mean vertebral body magnification was between 21% and 23% for L3 anteroposterior diameter and height. Conclusions Our results suggest that supine lumbar MRI might be a viable alternative to standing lateral lumbar radiographs for measuring LL and SS in routine follow-up for patients with LSS without concomitant spinal deformity. Standing radiographs are recommended as part of the initial investigation for LSS. Standing lumbar radiographs may yield high grades of magnification.

Background While short-term occupational exposures to many agents are associated with increased risk of asthma, the long-term consequences of exposure have not been well understood. We investigated the effects of occupational exposures over two decades on the incidence of asthma. Methods This population-based, multicentre cohort was assessed at baseline (European Community Respiratory Health Survey (ECRHS)1) and followed up twice over 20 years (ECRHS2 and ECRHS3). This analysis included data for 5591 participants with complete work histories and free of asthma at baseline. Incident adult-onset asthma was defined as either an asthma attack, woken by an attack of shortness of breath and/or current asthma medication in the last 12 months before each timepoint, without asthma at a previous survey. An updated asthma-specific job exposure matrix was used to estimate exposures to asthmagens. Adjusted Poisson models were fitted with generalised estimating equations to estimate asthma incidence. Results Ever high exposure to high molecular weight sensitisers (rate ratio (RR)=1.31; 95% CI 1.15 to 1.63), irritants (RR=1.29; 1.09–1.54), biocides (RR=1.42; 1.12–1.79), only low exposure to low molecular weight sensitisers (RR=1.26; 1.08–1.47), mites (RR=1.48; 1.12–1.94) and reactive chemicals (RR=1.24; 1.06–1.45) were associated with increased incidence of asthma. Asthma incidence also increased with ever high or cumulative exposure to these exposures and for specific exposure to wood dust, cleaning agents and bleach. The population-attributable fraction for adult-onset asthma due to occupational exposures was 18% (16.9–19.4%). Conclusion This strengthens the evidence that occupational exposures to sensitisers and chemical irritants contribute substantial risk and a substantive attributable fraction of adult-onset asthma. Control of implicated hazardous exposures and periodic screening of exposed workers should be considered.

Objectives Tapering of tumor necrosis factor inhibitor (TNFi) treatment in rheumatoid arthritis (RA) remission is debated. We assessed the effect of tapering TNFi to withdrawal versus continued stable TNFi on flare‐free survival and joint damage progression over three years. Methods ARCTIC REWIND was a multicenter, open‐label, non‐inferiority trial including patients with RA in remission for ≥12 months on stable TNFi therapy. Patients were randomized 1:1 to taper TNFi to withdrawal or continue stable treatment. The primary endpoints of the current study were flare‐free survival and radiographic progression over three years. Flare‐free survival was analyzed by Kaplan‐Meier methods, flare rates by Cox regression, and radiographic progression by logistic mixed effects models. Results Of 99 randomized patients, 92 received the allocated therapy, 80 completed 3‐year follow‐up. Mean baseline DAS based on 44 joint count was 0.8, csDMARD co‐medication was used by 90%. After 3 years, 25% (95%CI: 13‐38%) remained flare‐free in the tapering TNFi group compared to 85% (70‐93%) in the stable group, corresponding hazard ratio for flare 9.4 (3.9‐22.8), p<0 . 0001. In the tapering group 6/41 (15%) experienced radiographic progression, compared with 3/38 (8%) in the stable group, risk difference 6.7% (‐7.1%‐20.5%, p=0.3). Adverse events occurred in 81% of the patients in the tapering group, and 89% of the patients in the stable group. Conclusion In contrast to those receiving stable TNFi treatment, a minority of RA patients in remission tapering TNFi to withdrawal remained flare‐free over three years. There was no statistically significant difference in radiographic progression between the groups.

Background Demand for whole blood (WB) transfusions can increase dramatically during a disaster, but it is difficult to predict the need for blood products in the early phase of an event. Generally, blood services have large stocks of blood component collection sets but lack bags for the collection of WB for transfusion. While the collection bag in conventional blood component sets often lacks transfusion ports and cannot be used for WB transfusion, the plasma bags in these same sets have transfusion ports and are without filters or additives. This study aimed to evaluate the feasibility of transfer to and storage of WB in plasma bags from blood component collection sets. Study Design and Methods Blood was collected in 10 Reveos (REV) and 10 Macopharma (MP) blood bag systems. Samples were taken from the units on days 1, 14, 21, 28, and 35 after donation. At each sample point, hematological, metabolic, and coagulation parameters were analyzed. Results All results from both groups were in accordance with European regulatory requirements until Day 28, where three and one bags from the REV and MP groups, respectively, exhibited hemolysis at or above the 0.8% threshold. By day 35, this rose to seven and three bags, respectively. Platelet count, coagulation function, and factor VIII levels decreased but remained detectable throughout storage. Discussion We conclude that storage of WB in the plasma bag of an ordinary blood component collection set as an emergency preparedness measure can maintain quality for a minimum of 21 days.

Background Widespread neuronal mitochondrial complex I (CI) deficiency was recently reported to be a characteristic in a subgroup of individuals with idiopathic Parkinson’s disease (PD). Here, we sought to determine whether a CI-deficient subgroup could be discerned using clinically accessible muscle biopsies. We further hypothesized that the inconsistency of previous findings of mitochondrial respiratory impairment in PD muscle may be due to interindividual variation, with respiratory deficiency only occurring in a subgroup of cases. Methods Using a cross-sectional design, vastus lateralis needle biopsies were collected from 83 individuals with PD and 29 neurologically healthy controls and analyzed by immunohistochemistry for CI and complex IV (CIV), cytochrome c oxidase/succinate dehydrogenase (COX/SDH) histochemistry, and spectrophotometric activity assays of complexes I–IV. Mitochondrial DNA (mtDNA) copy number, deletions, and point variation were analyzed in single muscle fibers and bulk biopsy samples. Results We show that PD muscle exhibits reduced CI activity at the group level, with 9% of cases falling below two standard deviations of the control group. In contrast, the activities of CII–CIV are not significantly different between the PD and control groups. No quantitative change of CI or CIV is detected, and the observed functional CI deficiency is not associated with mtDNA abnormalities. Conclusions Our findings support the existence of a PD subpopulation characterized by CI pathology in skeletal muscle and suggest that stratification by extra-neural mitochondrial dysfunction may be informative for selecting individuals for clinical trials.

Introduction Early and lifelong treatment is essential in patients with familial hypercholesterolaemia (FH) due to genetically elevated low-density lipoprotein cholesterol (LDL-C) from the first years of life. In women with FH, lipid-lowering treatment is interrupted during childbearing years due to contraindication of the medication during conception, pregnancy and breastfeeding. However, little is known about the impact of breastfeeding on lipid profile and other risk markers for atherosclerotic cardiovascular disease (ASCVD) in women with FH compared with women without hypercholesterolaemia, and to what extent statins transfer into breast milk. We aim to investigate (1) the association between breastfeeding and serum lipid profile in women with and without FH; (2) the association between breastfeeding and other ASCVD risk markers in women with and without FH and (3) the concentration of statins in breast milk of women with FH. Methods and analysis FH-FEMINA is a prospective study aiming to include 50 women with FH in Norway, the Netherlands and the Czech Republic. Additionally, 20 women without hypercholesterolaemia will be enrolled as a control group in Norway. Women will be included at the first study visit in gestational week 36, and follow-up visits will be scheduled at 2–4 weeks, and at 3, 6, 9 and 12 months postpartum. Information on lifestyle factors, treatment history and current and previous pregnancies will be collected. At each visit, a non-fasting blood sample, breast milk sample and information on diet, body mass index and blood pressure will be collected. Additional blood samples will be collected from the women with FH at 2, 4, 5, 7, 8, 10 and 11 months postpartum for as long as they are breastfeeding. At (re-)initiation of statin treatment, breast milk samples from women with FH will be collected for drug concentration measurements. Ethics and dissemination Ethical approval will be obtained prior to study start in all three countries. Participants will be informed about the study and receive ample time to ask questions before the informed consent form is signed. The findings from this study will be disseminated to healthcare professionals, researchers and patients via peer-reviewed scientific article(s), conferences, patient organisations and social media. Trial registration number NCT05367310.

Introduction/Aims The World Health Organization (WHO) recommends that all children, including those with disabilities, should be physically active for optimal health benefits. The primary aim of this study was to quantify and describe overall physical activity (PA) levels and sedentary behavior in Norwegian boys with Duchenne muscular dystrophy (DMD), in comparison with healthy controls. Methods Boys aged 5–18 years with DMD were enrolled in this cross‐sectional study. Sedentary time, light PA, and moderate‐to‐vigorous physical activity (MVPA) were measured with use of an accelerometer for seven consecutive days. Data on PA were obtained via self‐report questionnaires. Comparisons were drawn between ambulatory and non‐ambulatory boys with DMD, and between ambulatory boys with DMD and healthy controls, with data retrieved from a database. Results Twenty‐eight boys with DMD participated, with a mean age of 12.6 (standard deviation 3.6) years, of whom 24 had accelerometry data. Ambulatory boys had higher PA levels compared with non‐ambulatory boys ( p = 0.008), and 53% of ambulatory boys met the WHO's recommendation for daily MVPA, whereas none of their non‐ambulatory counterparts did. Boys with DMD were less physically active compared with healthy peers. Sedentary time was higher over weekends compared with weekdays, and increased with age both in the DMD group and in healthy controls. Discussion Further research is needed to improve participation in PA by exploring barriers and facilitators, with a particular focus on non‐ambulatory boys with DMD.