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Introduction Patients’ beliefs and attitudes about medications play a role in whether they adhere to their medications or not. Knowledge on how beliefs and attitudes about medications can be influenced is therefore important. Objectives The current study aimed to assess whether patients’ perceived support from their therapists regarding use of medications was associated with their beliefs and attitudes about medications. Because non-adherence in patients with psychosis frequently results in relapses and emergencies, this knowledge may be very useful for therapists and patients. Methods This cross-sectional study included 310 patients diagnosed with psychosis from 31 clinical units in Norwegian mental health specialist care. We assessed beliefs about medications using the Beliefs about Medicines Questionnaire (BMQ). BMQ-specific consists of two subscales, BMQ-necessity and BMQ-concerns. Higher score on the necessity subscale indicates stronger beliefs in the necessity of taking the medicine. Higher score on the concern subscale indicates stronger concerns about taking the medicine. We used a newly developed self-report questionnaire, MedSupport, to assess the patients’ perceived support from therapists in dealing with their medications. Higher score on the MedSupport means that the patient experienced more support with decisions related to medications. Linear mixed effect models were used to investigate possible associations of sociodemographic factors, clinical factors and patients’ perceptions of medication support with BMQ. Results Patients’ perceptions of medication support from therapists were positively associated with positive beliefs towards medications, β = 0.20, 95% CI [0.04 to 0.35], p=0.012, and negatively associated with concerns about taking the medications, β = -0.31, 95% CI [-0.44 to -0.17], p < 0.001, when other relevant variables were taken into consideration. Conclusions The present study shows that therapists may affect patients’ beliefs and concerns about medications. Consequently, medication support may lead to improved adherence to medications prescribed. Disclosure of Interest None Declared

ObjectivesThere is an increasing awareness of the spectrum of phenotypes in giant cell arteritis (GCA). However, there is sparse evidence concerning the phenotypic distribution which may be influenced by both genetic background and the environment. We established a cohort of all GCA-patients in the Bergen Health Area (Western Norway), to describe the phenotypic distribution and whether phenotypes differ with regards to incidence and clinical features.MethodsThis is a retrospective cohort study including all GCA-patients in the Bergen Health Area from 2013–2020. Data were collected by reviewing patient records, and patients considered clinically likely GCA were included if they fulfilled at least one set of classification criteria. Temporal artery biopsy (TAB) and imaging results were used to classify the patients according to phenotype. The phenotype “cranial GCA” was used for patients with a positive TAB or halo sign on temporal artery ultrasound. “Non-cranial GCA” was used for patients with positive findings on FDG-PET/CT, MRI-, or CT angiography, or wall thickening indicative of vasculitis on ultrasound of axillary arteries. Patients with features of both these phenotypes were labeled “mixed.” Patients that could not be classified due to negative or absent examination results were labeled “unclassifiable”.Results257 patients were included. The overall incidence of GCA was 20.7 per 100,000 persons aged 50 years or older. Overall, the cranial phenotype was dominant, although more than half of the patients under 60 years of age had the non-cranial phenotype. The diagnostic delay was twice as long for patients of non-cranial and mixed phenotype compared to those of cranial phenotype. Headache was the most common clinical feature (78% of patients). Characteristic clinic features occurred less frequently in patients of non-cranial phenotype compared to cranial phenotype.ConclusionThe overall incidence for GCA was comparable to earlier reports from this region. The cranial phenotype dominated although the non-cranial phenotype was more common in patients under 60 years of age. The diagnostic delay was longer in patients with the non-cranial versus cranial phenotype, indicating a need for examination of non-cranial arteries when suspecting GCA.

Abstract Background Implementation science comprises a large set of theories suggesting interacting factors at different organisational levels. Development of literature syntheses and frameworks for implementation have contributed to comprehensive descriptions of implementation. However, corresponding instruments for measuring these comprehensive descriptions are currently lacking. The present study aimed to develop an instrument measuring care providers’ perceptions of an implementation effort, and to explore the instrument’s psychometric properties. Methods Based on existing implementation literature, a questionnaire was designed with items on individual and team factors and on stages of change in an implementation process. The instrument was tested in a Norwegian study on implementation of evidence based practices for psychosis. Item analysis, factor structure, and internal consistency at baseline were examined. Results The 27-item Implementation Process Assessment Tool (IPAT) revealed large variation between mean score of the items. The total scale scores were widely dispersed across respondents. Internal consistency for the total scale was high (Cronbach’s alpha: .962), and all but one item contributed positively to the construct. The results indicated four underlying constructs: individual stages for behavioural change, individual activities and perceived support, collective readiness and support, and individual perceptions of the intervention. Conclusions The IPAT appears to be a feasible instrument for investigating the implementation process from the perspective of those making the change. It can enable examination of the relative importance of factors thought to be essential for implementation outcomes. It may also provide ongoing feedback for leaders tailoring support for teams to improve implementation. However, further research is needed to detect the instrument’s properties later in the implementation process and in different contexts. Trial registration ClinicalTrials.gov code NCT03271242 (retrospective registered September 5, 2017).

Abstract Background Our objective was to determine the survival and causes of death in a large and well-characterized cohort of patients with giant cell arteritis (GCA). Methods This is a hospital-based, retrospective, observational cohort study including patients diagnosed with GCA in Western Norway during 1972–2012. Patients were identified through computerized hospital records using the International Classification of Diseases (ICD)-coding system. Medical records were reviewed. Patients were randomly assigned population controls matched on age, sex, and geography from the Central Population Registry of Norway (CPRN). Date and cause of death were obtained from the Norwegian Cause of Death Registry (NCoDR). The survival was analyzed using Kaplan-Meier methods with the Gehan-Breslow test and the causes of death using cumulative incidence and Cox models for competing risks. Results We identified 881 cases with a clinical diagnosis of GCA of which 792 fulfilled the American College of Rheumatology (ACR) 1990 classification criteria. Among those fulfilling the ACR criteria, 528 were also biopsy-verified. Cases were matched with 2577 population controls. A total of 490 (56%) GCA patients and 1517 (59%) controls died during the study period. We found no difference in the overall survival of GCA patients compared to controls, p = 0.413. The most frequent underlying causes of death in both groups were diseases of the circulatory system followed by cancer. GCA patients had increased risk of dying of circulatory disease (HR 1.31, 95% CI 1.13–1.51, p

Background: Laparoscopic appendectomy is a common procedure and introduced early in general surgical training. How internal (i.e. surgeon's experience) or external (i.e. disease severity) may affect procedure performance is not well-studied. The aim of this study was to evaluate factors that may have an influence on the performance scores for surgical trainees., Methods: A prospective, observational cohort study of laparoscopic appendectomies performed by surgical trainees (experience < 4 years) operating under supervision. Trainers evaluated trainees' overall performance on a 6-point scale for proficiency. Perioperative data were recorded, including appendicitis severity, operating time and the overall difficulty of the procedure as assessed by the trainer. A "Challenging" procedure was defined as a combination of either/or "perforation" and "difficult". Trainees who had performed > 30 appendectomies were defined as "experienced". The trainees were asked if they had used simulation or web-based tools the week prior to surgery., Results: 142 procedure evaluation forms were included of which 19 (13%) were "perforated", 14 (10%) "difficult" and 24 (17%) "Challenging". Perforated appendicitis was strongly associated with procedure difficulty (OR 21.2, 95% CI 6.0-75.6). Experienced trainees performed "proficient" more often than non-experienced (OR 34.5, 95% CI 6.8-176.5). "Difficult" procedures were inversely associated with proficiency (OR 0.1, 95% CI 0.0-0.9). In "Challenging" procedures, identifying the appendix had lowest proficiency (OR 0.4, 95% CI 0.1-0.9). The procedures assessed as "difficult" had significantly longer operating time with a median (IQR) of 90 (75-100) min compared to 59 (25-120) min for the non-difficult (p < 0.001)., Conclusion: Both internal and external factors contribute to the performance score. Perforated appendicitis, technical difficult procedures and trainee experience all play a role, but a "difficult" procedure had most overall impact on proficiency evaluation., (© 2024. The Author(s).)

Objective: Previous studies indicate a possible bidirectional stimulatory relationship between parathyroid hormone (PTH) and adrenocortical hormones, but the pattern of adrenocortical secretion in hypoparathyroidism is unknown. We aimed to characterize the adrenocortical secretion in patients with postsurgical hypoparathyroidism, and whether continuous subcutaneous PTH (1-34) infusion alters secretion patterns., Design: Crossover interventional study., Methods: We recruited 10 patients with postsurgical hypoparathyroidism with very low PTH levels on stable treatment with active vitamin D and calcium. Cortisol, cortisone, and aldosterone levels were measured in microdialysate from subcutaneous tissue over 24 h, before and during continuous subcutaneous PTH (1-34) infusion. Cortisol was also assayed in serum, saliva, and urine, and aldosterone and ACTH in serum and plasma, respectively. Ten patients with primary hyperparathyroidism and 10 healthy volunteers matched for sex and age served as controls., Results: Hypoparathyroid patients displayed both ultradian and circadian rhythmicity for tissue cortisol, cortisone, and aldosterone. Tissue aldosterone and cortisone levels were significantly lower in hypoparathyroid patients than in healthy controls, with no difference in tissue cortisol, but a higher cortisol to cortisone ratio. Treatment with PTH (1-34) increased tissue levels of aldosterone, cortisol, and cortisone and reduced the ratio of cortisol to cortisone., Conclusion: Adrenocortical hormone levels are reduced in postsurgical hypoparathyroidism, and partly restored by short-term continuous subcutaneous PTH (1-34) therapy., Clinical Trial Registration Number: NCT02986607., Competing Interests: Conflict of interest: None declared., (© The Author(s) 2024. Published by Oxford University Press on behalf of European Society of Endocrinology.)

Objective: To examine patients' use of primary healthcare (PHC) before and after specialized rehabilitation and its relation with self-reported health and functioning., Design: Longitudinal cohort study., Participants: 451 rehabilitation patients., Methods: Register data were used to measure the frequency of visits to the general practitioner (GP) and physiotherapist (PT) in PHC 3 years before and after rehabilitation. Patients reported health (EQ-VAS) and functioning (SF-36) before rehabilitation and at 1 and 3 years after. Data are described for the total study cohort and subgroups with musculoskeletal disease (MSD) and cardiovascular disease (CVD)., Results: There was an increase in GP and PT visits preceding rehabilitation and a gradual decrease thereafter. An exception was GP visits among patients with CVD, with few diagnosis-specific visits before but an increase after. Lower levels of health and functioning tended to be related to more frequent GP and PT visits. An indication of clinically important improvement was found among those with frequent GP visits in the MSD subgroup, and among those with 1-2 GP visits in the CVD subgroup., Conclusions: The diverse relationship between health and functioning, and the use of PHC services at follow-up, may imply that additional factors besides healthcare use explain long-term improvement following rehabilitation.

Molecular blood biomarkers are lacking for high-grade (HG) gastroenteropancreatic (GEP) neuroendocrine neoplasms (NEN). To histologically distinguish between neuroendocrine carcinoma (NEC), neuroendocrine tumors G3 (NET G3), adenocarcinoma and MINEN is often challenging. The mRNA-based NETest has diagnostic, prognostic and predictive value in neuroendocrine tumors G1-2 but has not been studied in HG GEP-NEN. Patients with advanced HG GEP-NEN were prospectively included in an observational study. A blood sample was collected before the start of chemotherapy and pseudonymised before NETest was performed. NETest results are expressed as an activity index (NETest score) from 0 to 100. The normal score cut-off is 20. Histological sections were pseudonymised before centralized pathological re-evaluation. Samples from 60 patients were evaluable with the NETest. Main primary tumor sites were colon (14), rectum (12), pancreas (11) and esophagus (7). Re-classification: 30 NEC, 12 NET G3, 3 HG-NEN ambiguous morphology, 8 MiNEN, 3 adenocarcinomas with neuroendocrine differentiation (ADNE), 3 adenocarcinomas and 1 NET G2. Elevated NETest (>20) was seen in 38/45 (84%) HG GEP-NEN, all 17 large-cell NEC (100%), 11/13 (85%) small-cell NEC, all ambiguous cases and 7/12 (64%) NET G3. NETest was elevated in 5/8 (63%) MiNEN, 2/3 ADNE, however not in 3 adenocarcinomas. Median survival was 10.2 months (9.6-10.8 95%CI) for evaluable HG GEP-NEN treated with palliative chemotherapy (n = 39), and survival was significantly shorter in patients with NETest >60 with an OS of only 6.5 months. This is the first study to evaluate use of the NETest in advanced HG GEP-NEN. The NETest was almost always elevated in GEP-NEC and in all large-cell NEC. The NETest was also frequently elevated in NET G3 and MiNEN, however cases were limited. Baseline NETest was not predictive for benefit of chemotherapy, however a NETest >60 was prognostic with a shorter survival for patients receiving chemotherapy., (© 2024 The Author(s). Journal of Neuroendocrinology published by John Wiley & Sons Ltd on behalf of British Society for Neuroendocrinology.)

Introduction: Many patient safety practices are only partly established in routine clinical care, despite extensive quality improvement efforts. Implementation science can offer insights into how patient safety practices can be successfully adopted., Objective: The objective was to examine the literature on implementation of three internationally used safety practices: medication reconciliation, antibiotic stewardship programmes and rapid response systems. We sought to identify the implementation activities, factors and outcomes reported; the combinations of factors and activities supporting successful implementation; and the implications of the current evidence base for future implementation and research., Methods: We searched Medline, Embase, Web of Science, Cumulative Index to Nursing and Allied Health Literature, PsycINFO and Education Resources Information Center from January 2011 to March 2023. We included original peer-reviewed research studies or quality improvement reports. We used an iterative, inductive approach to thematically categorise data. Descriptive statistics and hierarchical cluster analyses were performed., Results: From the 159 included studies, eight categories of implementation activities were identified: education; planning and preparation; method-based approach; audit and feedback; motivate and remind; resource allocation; simulation and training; and patient involvement . Most studies reported activities from multiple categories. Implementation factors included: c linical competence and collaboration; resources; readiness and engagement; external influence; organisational involvement; QI competence; and feasibility of innovation . Factors were often suggested post hoc and seldom used to guide the selection of implementation strategies. Implementation outcomes were reported as: fidelity or compliance; proxy indicator for fidelity; sustainability; acceptability; and spread . Most studies reported implementation improvement, hindering discrimination between more or less important factors and activities., Conclusions: The multiple activities employed to implement patient safety practices reflect mainly method-based improvement science, and to a lesser degree determinant frameworks from implementation science. There seems to be an unexploited potential for continuous adaptation of implementation activities to address changing contexts. Research-informed guidance on how to make such adaptations could advance implementation in practice., Competing Interests: Competing interests: All authors have completed the ICMJE form for disclosure of competing interests. JTO, ES, SH, HVW have been supported in their work on this paper by grants from the Research Council of Norway, the Western Norway Regional Health Authority, and the Bergen Hospital Trust. MH has been supported in her work on this paper by grants from the Research Council of Norway, and by employment as a researcher by the Fonna Hospital Trust. SH has headed the reference group for the Norwegian Patient Safety Campaign (2011–2014, honorary without payment), and is a paid member of the Regional Committee for Medical Ethics since 2021. PEA has coauthored this paper as part of his work at the Norwegian Centre for Antiobiotic Use in Hospitals, Haukeland University Hospital. He is also an editor of the national guidelines for antibiotic use in hospitals, member of the editorial board of the national guidelines for antibiotic use in primary care, and member of the national breakpoint committee, all without extra funding, as part of his ordinary work. NS has recieved consulting fees as director of London Safety and Training Solutions. RKL has coauthored this paper salaried as an academic librarian at the University of Bergen., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Importance: Preterm children are at risk for neurodevelopment impairments., Objective: To evaluate the effect of a music therapy (MT) intervention (parent-led, infant-directed singing) for premature children during the neonatal intensive care unit (NICU) stay and/or after hospital discharge on language development at 24 months' corrected age (CA)., Design, Setting, and Participants: This predefined secondary analysis followed participants in the LongSTEP (Longitudinal Study of Music Therapy's Effectiveness for Premature Infants and Their Caregivers) randomized clinical trial, which was conducted from August 2018 to April 2022 in 8 NICUs across 5 countries (Argentina, Colombia, Israel, Norway, and Poland) and included clinic follow-up visits and extended interventions after hospital discharge., Intervention: Participants were children born preterm (<35 weeks' gestation) and their parents. Participants were randomized at enrollment to MT with standard care (SC) or SC alone; they were randomized to MT or SC again at discharge. The MT was parent-led, infant-directed singing tailored to infant responses and supported by a music therapist and was provided 3 times weekly in the NICU and/or in 7 sessions across 6 months after discharge. The SC consisted of early intervention methods of medical, nursing, and social services, without MT., Main Outcome and Measures: Primary outcome was language development, as measured by the Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III) language composite score, with the remaining BSID-III composite and subscale scores as the secondary outcomes. Group differences in treatment effects were assessed using linear mixed-effects models using all available data., Results: Of 206 participants (103 female infants [50%]; mean [SD] GA, 30.5 [2.7] weeks), 51 were randomized to MT and 53 to SC at enrollment; at discharge, 52 were randomized to MT and 50 to SC. A total of 112 (54%) were retained at the 24 months' CA follow-up. Most participants (79 [70%] to 93 [83%]) had BSID-III scores in the normal range (≥85). Mean differences for the language composite score were -2.36 (95% CI, -12.60 to 7.88; P = .65) for the MT at NICU with postdischarge SC group, 2.65 (95% CI, -7.94 to 13.23; P = .62) for the SC at NICU and postdischarge MT group, and -3.77 (95% CI, -13.97 to 6.43; P = .47) for the MT group at both NICU and postdischarge. There were no significant effects for cognitive or motor development., Conclusions and Relevance: This secondary analysis did not confirm an effect of parent-led, infant-directed singing on neurodevelopment in preterm children at 24 months' CA; wide CIs suggest, however, that potential effects cannot be excluded. Future research should determine the MT approaches, implementation time, and duration that are effective in targeting children at risk for neurodevelopmental impairments and introducing broader measurements for changes in brain development., Trial Registration: ClinicalTrials.gov Identifier: NCT03564184.

Background: Use of a vapor barrier in the prehospital care of cold-stressed or hypothermic patients aims to reduce evaporative heat loss and accelerate rewarming. The application of a vapor barrier is recommended in various guidelines, along with both insulating and wind/waterproof layers and an active external rewarming device; however, evidence of its effect is limited. This study aimed to investigate the effect of using a vapor barrier as the inner layer in the recommended "burrito" model for wrapping hypothermic patients in the field., Methods: In this, randomized, crossover field study, 16 healthy volunteers wearing wet clothing were subjected to a 30-minute cooling period in a snow chamber before being wrapped in a model including an active heating source either with (intervention) or without (control) a vapor barrier. The mean skin temperature, core temperature, and humidity in the model were measured, and the shivering intensity and thermal comfort were assessed using a subjective questionnaire. The mean skin temperature was the primary outcome, whereas humidity and thermal comfort were the secondary outcomes. Primary outcome data were analyzed using analysis of covariance (ANCOVA)., Results: We found a higher mean skin temperature in the intervention group than in the control group after approximately 25 min (p < 0.05), and this difference persisted for the rest of the 60-minute study period. The largest difference in mean skin temperature was 0.93 °C after 60 min. Humidity levels outside the vapor barrier were significantly higher in the control group than in the intervention group after 5 min. There were no significant differences in subjective comfort. However, there was a consistent trend toward increased comfort in the intervention group compared with the control group., Conclusions: The use of a vapor barrier as the innermost layer in combination with an active external heat source leads to higher mean skin rewarming rates in patients wearing wet clothing who are at risk of accidental hypothermia., Trial Registration: ClinicalTrials.gov identifier: NCT05779722., (© 2024. The Author(s).)

Background: It is uncertain whether T2-weighted Dixon water images (DixonT2w) and short tau inversion recovery (STIR) are interchangeable when evaluating vertebral bone edema, or if one method is superior or visualizes the edema differently., Purpose: To compare image quality and Modic change (MC)-related edema between DixonT2w and STIR and estimate inter-observer reliability for MC edema on DixonT2w., Material and Methods: Consecutive patients (n = 120) considered for the Antibiotics in Modic changes (AIM) trial underwent lumbar 1.5-T magnetic resonance imaging with two-point DixonT2w and STIR. Two radiologists assessed MC-related high-signal lesions on DixonT2w and compared image quality and lesion extent with STIR. Cohen's kappa and mean of differences ± limits of agreement were calculated., Results: Fat suppression and artefacts were similar on DixonT2w and STIR in 116 of 120 (97%) patients. Lesion conspicuity was similar in 88, better on STIR in 10, and better on DixonT2w in 9 of 107 patients with MC-related high-signal lesions. Contrast-to-noise ratio for STIR versus DixonT2w was 19.1 versus 17.1 (mean of differences 2.0 ± 8.2). Of 228 lesions L4-S1, 215 (94%) had similar extent on DixonT2w and STIR, 11 were smaller/undetected on STIR, and two were smaller/undetected on DixonT2w. Lesions missed on STIR (n = 9) or DixonT2w (n = 1) had a weak signal increase on the other sequence (≤17%; 0% = vertebral body, 100% = cerebrospinal fluid). Inter-observer reliability (mean kappa L4-S1) was very good for presence (0.87), moderate for height (0.44), and good for volume (0.63) of lesions on DixonT2w., Conclusion: DixonT2w provided similar visualization of MC-related vertebral edema as STIR., Competing Interests: Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Background: There is a need for knowledge regarding the medical management of motor neuron disease/amyotrophic lateral sclerosis (MND/ALS) with and without cognitive decline. It has scarcely been studied whether cognitive decline will influence the course of disease or interfere with the use of life-prolonging aids for respiration and nutrition. Cognitive decline may impact the length of illness., Methods: Patients were prospectively recruited from an ALS outpatient clinic at Haukeland University Hospital. Participants underwent the standardized cognitive test Edinburgh Cognitive and Behavioral ALS Screen Norwegian version (ECAS-N), clinical examination, and were functionally assessed by the ALS Functioning Rating Scale-revised version (ALS-FRS-R). The time and indication for installation of a feeding tube [percutaneous endoscopic gastrostomy (PEG)] and/or respiratory aid [bilevel positive airway pressure device (BiPAP)] or invasive respirator were retrieved from the medical records. Kaplan-Meier tests were used to study the risk of death and the probability for implementing PEG and/or BiPAP in relation to time from diagnosis. The individual assessment was used for analyzing the establishment of aids in relation to point of death., Results: A total of 40 patients were evaluated for the study, 31 of whom were finally included. None of the included patients did not use an invasive respirator. The patients were divided into two subgroups (normal cognition or cognitive decline, cut-off 92 points) according to their performance in the ECAS-N. The course of the disease, shown as a risk of death, was higher among the ALS/MND patients with cognitive decline compared to those with cognitive intact function throughout the study period. The cognitive status did not influence the fitting of aids. Use of aids did not influence the survival in subgroups significantly., Conclusions: The study demonstrated shorter survival for the patients with ALS/MND with cognitive decline compared to those without cognitive decline. The practice and implementation of both BiPAP and PEG did not differ among the ALS/MND patients with and without cognitive decline in Norway.

Study Design: Secondary analyses of a randomized trial [Antibiotics In Modic changes (MCs) study]., Objective: To assess whether or not reduced MC edema over time is related to reduced disability and pain in patients with chronic low back pain (LBP)., Summary of Background Data: It is not clear whether or not reduced MC edema implies improved clinical outcomes., Patients and Methods: Linear regression was conducted separately in 2 subgroups with MC edema at baseline on short tau inversion recovery (STIR) or T1/T2-weighted magnetic resonance imaging, respectively. Independent variable: reduced edema (yes/no) at 1 year on STIR or T1/T2-series, respectively. Dependent variable: 1-year score on the Roland-Morris Disability Questionnaire (RMDQ), Oswestry Disability Index (ODI), or 0 to 10 numeric rating scale for LBP intensity, adjusted for the baseline score, age, smoking, body mass index, physical workload, and baseline edema on STIR (STIR analysis only). Post hoc, we, in addition, adjusted all analyses for baseline edema on STIR, treatment group (amoxicillin/placebo), and prior disc surgery-or for disc degeneration., Results: Among patients with MC edema on STIR at baseline (n = 162), reduced edema on STIR was not significantly related to the RMDQ ( B : -1.0, 95% CI: -2.8, 0.8; P = 0.27), ODI ( B :-1.4, 95% CI: -5.4, 2.6; P = 0.50), or LBP intensity scores ( B : -0.05, 95% CI: -0.8, 0.7; P = 0.90) after 1 year. Among patients with MC edema on T1/T2-series at baseline (n = 116), reduced edema on T1/T2 ( i.e ., reduced volume of the type 1 part of MCs) was not significantly related to RMDQ ( B: -1.7, 95% CI: -3.8, 0.3; P = 0.10) or ODI score ( B : -2.3, 95% CI: -7.1, 2.5; P = 0.34) but was significantly related to LBP intensity at 1 year ( B : -0.9, 95% CI: -1.8, -0.04; P = 0.04; correlation coefficient: 0.24). The post hoc analyses supported these results., Conclusion: Reduced MC edema over 1 year was not significantly associated with pain-related disability but was (on T1/T2-series) significantly but weakly related to reduced LBP intensity., Level of Evidence: Level 3., Competing Interests: The authors report no conflicts of interest., (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc.)

This pilot study aimed to identify quantitative electroencephalographic (qEEG) biomarkers for children and adolescents with attention deficit hyperactivity disorder (ADHD). We examined whether qEEG power correlates with the behavioral symptoms. We included 89 children with ADHD and 77 healthy children as a control group. We conducted EEG spectral analysis in the eyes-closed and eyes-opened conditions and compared the findings with a normative database (Human Brain Index). We measured behavioral parameters by using scales proposed by Barkley. The findings revealed an age-dependent decrease in qEEG power in children with ADHD. We found significant discrimination between children with ADHD and healthy children in the theta/beta ratio and theta activity in the frontal area. We found a notable increasing trend in beta activity across two age groups (6-10 years and > 10 years). Correlation analysis showed an association between qEEG power and hyperactivity in younger children with ADHD, while theta activity in the frontal region correlated positively with hyperactivity. The qEEG power of children with ADHD decreased gradually as age increased, and these changes were related to their symptoms. This pilot study suggests that qEEG differences between children with ADHD and healthy children may serve as a sensitive diagnostic tool, depending on the child's age. Further research building upon these findings could deepen our understanding of ADHD and its neural correlates.

Objectives: There is an increasing awareness of the spectrum of phenotypes in giant cell arteritis (GCA). However, there is sparse evidence concerning the phenotypic distribution which may be influenced by both genetic background and the environment. We established a cohort of all GCA-patients in the Bergen Health Area (Western Norway), to describe the phenotypic distribution and whether phenotypes differ with regards to incidence and clinical features., Methods: This is a retrospective cohort study including all GCA-patients in the Bergen Health Area from 2013-2020. Data were collected by reviewing patient records, and patients considered clinically likely GCA were included if they fulfilled at least one set of classification criteria. Temporal artery biopsy (TAB) and imaging results were used to classify the patients according to phenotype. The phenotype "cranial GCA" was used for patients with a positive TAB or halo sign on temporal artery ultrasound. "Non-cranial GCA" was used for patients with positive findings on FDG-PET/CT, MRI-, or CT angiography, or wall thickening indicative of vasculitis on ultrasound of axillary arteries. Patients with features of both these phenotypes were labeled "mixed." Patients that could not be classified due to negative or absent examination results were labeled "unclassifiable"., Results: 257 patients were included. The overall incidence of GCA was 20.7 per 100,000 persons aged 50 years or older. Overall, the cranial phenotype was dominant, although more than half of the patients under 60 years of age had the non-cranial phenotype. The diagnostic delay was twice as long for patients of non-cranial and mixed phenotype compared to those of cranial phenotype. Headache was the most common clinical feature (78% of patients). Characteristic clinic features occurred less frequently in patients of non-cranial phenotype compared to cranial phenotype., Conclusion: The overall incidence for GCA was comparable to earlier reports from this region. The cranial phenotype dominated although the non-cranial phenotype was more common in patients under 60 years of age. The diagnostic delay was longer in patients with the non-cranial versus cranial phenotype, indicating a need for examination of non-cranial arteries when suspecting GCA., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The author(s) declared that they were an editorial board member of Frontiers, at the time of submission. This had no impact on the peer review process and the final decision., (Copyright © 2023 Skaug, Fevang, Assmus, Diamantopoulos, Myklebust and Brekke.)

Background: The optimal treatment for metastatic high-grade gastroenteropancreatic (GEP) neuroendocrine neoplasms when Ki-67 ≤55% is unknown. A prospective multi-centre phase 2 study was performed to evaluate the efficacy and safety of everolimus and temozolomide as first-line treatment for these patients., Methods: Patients received everolimus 10 mg daily continuously and temozolomide 150 mg/m 2 for 7 days every 2 weeks. Endpoints included response, survival, safety and quality of life (QoL). Histopathological re-evaluation according to the 2019 WHO classification was performed., Results: For 37 eligible patients, the primary endpoint with 65% disease control rate (DCR) at 6 months (m) was reached. The response rate was 30%, the median progression-free survival (PFS) 10.2 months and the median overall survival (OS) 26.4 months. Considering 26 NET G3 patients, 6 months DCR was 77% vs. 22% among nine NEC patients (p = 0.006). PFS was superior for NET G3 vs. NEC (12.6 months vs. 3.4 months, Log-rank-test: p = 0.133, Breslow-test: p < 0.001). OS was significantly better for NET G3 (31.4 months vs. 7.8 months, p = 0.003). Grade 3 and 4 toxicities were reported in 43% and 38%. QoL remained stable during treatment., Conclusion: Everolimus and temozolomide may be a treatment option for selected GEP-NET G3 patients including careful monitoring. Toxicity did not compromise QoL., Clinical Trial Registration: ClinicalTrials.gov (NTC02248012)., (© 2023. The Author(s).)

Objective: To investigate the causal effect of sense of coherence on long-term work participation after rehabilitation, including stratification by age and diagnoses., Design: Longitudinal cohort study., Participants: Patients aged ≤ 60 years, employed and accepted for somatic interprofessional rehabilitation in 2015 (n = 192)., Methods: Patients reported sense of coherence before rehabilitation in 2015 and mental and physical functioning in 2016. Register data were used to measure work participation during 2018 and days working without social security benefits during 2016-18. Regression models were used to explore the total effect of sense of coherence and the possible mediation of functioning. Results are reported as odds ratios (95% confidence intervals)., Results: During 2018, 77% of the total study cohort participated in work activities. The subgroup with musculoskeletal diagnoses had the fewest days of working without social security benefits. A causal relationship was found between sense of coherence and long-term work participation. Some of the effect of sense of coherence was mediated by mental functioning. The total effect of sense of coherence was strongest for patients with musculo-skeletal diagnoses (work participation: 1.11 (1.05, 1.17), days working without social security benefits: 1.05 (0.01, 109))., Conclusion: Improving coping resources may be beneficial to facilitate long-term work participation after injury or illness, especially for individuals with musculoskeletal diagnoses.

Objectives: Evidence as to whether or not giant cell arteritis (GCA) confers added risk of cancer or death is conflicting. Our aim was to identify factors predicting death or cancer in a large Norwegian GCA-cohort., Methods: This is a retrospective observational cohort study including patients diagnosed with GCA in Western Norway during 1972-2012. Patients were identified through computerized hospital records using the International Classification of Diseases coding. Medical records were reviewed and data about registered deaths and cancer occurrences were extracted from the Norwegian Cause of Death Registry and the Cancer Registry of Norway. We investigated predicting factors using Cox proportional hazards regression., Results: We identified 881 cases with a validated diagnosis of GCA (60% biopsy-verified). 490 patients (56%) died during the study period. Among 767 patients with no registered cancer prior to GCA diagnosis, 120 (16%) were diagnosed with cancer during the study period. Traditional risk factors were the main predictors of death; age at time of GCA-diagnosis [hazard ratio (HR) 2.81], smoking (HR 1.61), hypertension (HR 1.48) and previous cardiovascular disease (HR 1.26). Hemoglobin (Hb) level was also associated with risk of death with increasing Hb-levels at time of GCA-diagnosis indicating decreased risk of death (HR 0.91). Other GCA-related factors were not predictive of death. We did not identify any predictors of cancer risk., Conclusion: In our cohort of GCA-patients, the risk of death was predominantly predicted by age and traditional risk factors. We found no significant associations with regards to the risk of incident cancer., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Brekke, Assmus and Fevang.)

Background and Objectives: Based on previous success using apheresis platelets, we wanted to investigate the in vitro quality and platelet function in continuously cold-stored and delayed cold-stored platelet concentrates (PCs) from interim platelet units (IPUs) produced by the Reveos system., Materials and Methods: We used a pool-and-split design to prepare 18 identical pairs of PCs. One unit was stored unagitated and refrigerated after production on day 1 (cold-stored). The other unit was stored agitated at room temperature until day 5 and then refrigerated (delayed cold-stored). Samples were taken after pool-and-split on day 1 and on days 5, 7, 14 and 21. Swirling was observed and haematology parameters, metabolism, blood gas, platelet activation and platelet aggregation were analysed for each sample point., Results: All PCs complied with European recommendations (EDQM 20th edition). Both groups had mean platelet content >200 × 10 9 /unit on day 21. The pH remained above 6.4 for all sample points. Glucose concentration was detectable in every cold-stored unit on day 21 and in every delayed cold-stored unit on day 14. The cold-stored group showed a higher activation level before stimulation as measured by flow cytometry. The activation levels were similar in the two groups after stimulation. Both groups had the ability to form aggregates after cold storage and until day 21., Conclusion: Our findings suggest that PCs from IPUs are suitable for cold storage from day 1 until day 21 and delayed cold storage from day 5 until day 14., (© 2023 International Society of Blood Transfusion.)

Background: Research collaboration highlight a need for validated tests in other languages than English. Translation and culture adjustments may threaten essential features of the original instrument., Objective: To assess the internal consistency, inter-rater and test-retest reliability, and construct validity of the Norwegian version of the Edinburgh Cognitive and Behavioural Amyotrophic Lateral Sclerosis (ALS) Screen (ECAS-N)., Methods: Performance of 71 subjects with ALS, 85 healthy controls (HC) and 6 controls with Alzheimer's disease (AD) were assessed with the ECAS-N. Test-retest interval was four months. Internal consistency was evaluated using Cronbach's alpha; reliability was assessed using intraclass correlation coefficient (ICC), Cohen's kappa, and Bland Altman plot. Five hypothesis, including the Montreal Cognitive Assessment (MoCA) screen, was evaluated for construct validity., Results: ECAS-N total score produced a Cronbach's alpha of 0.65, had excellent inter-rater reliability (ICC = 0.99) and acceptable test-retest reliability (ICC = 0.73). Construct validity analysis suggested valid use of the ECAS-N to distinguish people with ALS-specific cognitive impairment from HC (p = 0.001) and those with AD (p = 0.002). The MoCA and ECAS-N were moderately correlated (r = 0.53)., Conclusion: The ECAS-N has potential to be used by different testers in clinical practice and research to screen patients with ALS who speak Norwegian and for documenting cognitive impairment over time., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Taule et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Importance: Parent-infant bonding contributes to long-term infant health but may be disrupted by preterm birth., Objective: To determine if parent-led, infant-directed singing, supported by a music therapist and initiated in the neonatal intensive care unit (NICU), improves parent-infant bonding at 6 and 12 months., Design, Setting, and Participants: This randomized clinical trial was conducted in level III and IV NICUs in 5 countries between 2018 and 2022. Eligible participants were preterm infants (under 35 weeks' gestation) and their parents. Follow-up was conducted across 12 months (as part of the LongSTEP study) at home or in clinics. Final follow-up was conducted at 12 months' infant-corrected age. Data were analyzed from August 2022 to November 2022., Intervention: Participants randomized to music therapy (MT) plus standard care or standard care alone during NICU admission, or to MT plus standard care or standard care alone postdischarge, using computer-generated randomization (ratio 1:1, block sizes of 2 or 4 varying randomly), stratified by site (51 allocated to MT NICU, 53 to MT postdischarge, 52 to both, and 50 to neither). MT consisted of parent-led, infant-directed singing tailored to infant responses and supported by a music therapist 3 times per week throughout hospitalization or 7 sessions across 6 months' postdischarge., Main Outcome and Measure: Primary outcome was mother-infant bonding at 6 months' corrected age, measured by the Postpartum Bonding Questionnaire (PBQ), with follow-up at 12 months' corrected age, and analyzed intention-to-treat as group differences., Results: Of 206 enrolled infants with 206 mothers (mean [SD] age, 33 [6] years) and 194 fathers (mean [SD] age, 36 [6] years) randomized at discharge, 196 (95.1%) completed assessments at 6 months and were analyzed. Estimated group effects for PBQ at 6 months' corrected age were 0.55 (95% CI, -2.20 to 3.30; P = .70) for MT in the NICU, 1.02 (95% CI, -1.72 to 3.76; P = .47) for MT postdischarge, and -0.20 (95% CI, -4.03 to 3.63; P = .92) for the interaction (12 months: MT in NICU, 0.17; 95% CI, -2.71 to 3.05; P = .91; MT postdischarge, 1.78; 95% CI, -1.13 to 4.70; P = .24; interaction, -1.68; 95% CI, -5.77 to 2.41; P = .42). There were no clinically important between-group differences for secondary variables., Conclusions and Relevance: In this randomized clinical trial, parent-led, infant-directed singing did not have clinically important effects on mother-infant bonding, but was safe and well-accepted., Trial Registration: ClinicalTrials.gov Identifier: NCT03564184.

Background: Treatment fidelity (TF) refers to methodological strategies used to monitor and enhance the reliability and validity of interventions. We evaluated TF in a pragmatic RCT of music therapy (MT) for premature infants and their parents., Methods: Two hundred thirteen families from seven neonatal intensive care units (NICUs) were randomized to receive standard care, or standard care plus MT during hospitalization, and/or during a 6-month period post-discharge. Eleven music therapists delivered the intervention. Audio and video recordings from sessions representing approximately 10% of each therapists' participants were evaluated by two external raters and the corresponding therapist using TF questionnaires designed for the study (treatment delivery (TD)). Parents evaluated their experience with MT at the 6-month assessment with a corresponding questionnaire (treatment receipt (TR)). All items as well as composite scores (mean scores across items) were Likert scales from 0 (completely disagree) to 6 (completely agree). A threshold for satisfactory TF scores (≥4) was used in the additional analysis of dichotomized items., Results: Internal consistency evaluated with Cronbach's alpha was good for all TF questionnaires (α ≥ 0.70), except the external rater NICU questionnaire where it was slightly lower (α 0.66). Interrater reliability measured by intraclass correlation coefficient (ICC) was moderate (NICU 0.43 (CI 0.27, 0.58), post-discharge 0.57 (CI 0.39, 0.73)). Gwet's AC for the dichotomized items varied between 0.32 (CI 0.10, 0.54) and 0.72 (CI 0.55, 0.89). Seventy-two NICU and 40 follow-up sessions with 39 participants were evaluated. Therapists' mean (SD) TD composite score was 4.88 (0.92) in the NICU phase and 4.95 (1.05) in the post-discharge phase. TR was evaluated by 138 parents. The mean (SD) score across intervention conditions was 5.66 (0.50)., Conclusions: TF questionnaires developed to assess MT in neonatal care showed good internal consistency and moderate interrater reliability. TF scores indicated that therapists across countries successfully implemented MT in accordance with the protocol. The high treatment receipt scores indicate that parents received the intervention as intended. Future research in this area should aim to improve the interrater reliability of TF measures by additional training of raters and improved operational definitions of items., Trial Registration: Longitudinal Study of music Therapy's Effectiveness for Premature infants and their caregivers - "LongSTEP"., Clinicaltrials: gov Identifier: NCT03564184. Registered on June 20, 2018., (© 2023. The Author(s).)

Background and Aims: Per oral endoscopic myotomy (POEM) has become an established treatment for achalasia, but no Scandinavian studies with long-term follow-up exist. This study from a tertiary referral center in Norway investigates the short-, mid-, and long-term feasibility, safety, efficacy, and complications of POEM., Methods: Prospective data from the first 84 patients who underwent POEM from 2014 to 2019 were analyzed. The median follow-up time was 44 months. Clinical success was defined as the Eckardt score (ES) ⩽3, and reflux as pathological if the acid exposure time (pH < 4) was more than 6%. ES was used for symptom evaluation before, and at 6, 12, and up to 64 months after POEM., Results: A total of 50 males and 34 females were included. A total of 43 (51%) were treatment naïve, 24 (28.6%) had been previously treated with botulinum toxin, pneumatic balloon dilatation, or both, and 17 (20.2%) were previously treated with Heller's myotomy. The median post-POEM ES at 12 months was 1 (0-9), compared to pre-POEM 7 (4-12) (p < 0.01). At 12 months after POEM, clinical success persisted in 74 patients (88.1%). Clinical success was the highest for patients who were naïve to treatment, 41/43 (95%), and lower for those previously treated with Heller's myotomy 12/17 (70.6%). Long-term follow-up at 5-6 years of 42 patients showed a clinical success rate of 94%. We experienced adverse events in five patients (6%). Post-POEM pathological reflux was found in 46% (28/61). After 3-4 years, the median ES was 1, and after 5-6 years, it was 2., Conclusion: POEM was safe and relieved the symptoms of achalasia significantly and persistently. The procedure had a better outcome in treatment naïve than previously treated patients. However, POEM is associated with significantly increased esophageal acid exposure., Twitter Summary: Norwegian single-center study: POEM had a clinical success rate of 94% after 5-6 years since its introduction at the center in 2014, providing a safe and effective treatment for achalasia.

Study Design: Exploratory subgroup analyses of a randomised trial [Antibiotics in Modic changes (AIM) study]., Objective: The aim was to assess the effect of amoxicillin versus placebo in reducing Modic change (MC) edema in patients with chronic low back pain., Summary of Background Data: The AIM study showed a small, clinically insignificant effect of amoxicillin on pain-related disability in patients with chronic low back pain and MC type 1 (edema type) on magnetic resonance imaging (MRI)., Materials and Methods: A total of 180 patients were randomised to receive 100 days of amoxicillin or placebo. MC edema was assessed on MRI at baseline and one-year follow-up. Per-protocol analyses were conducted in subgroups with MC edema on short tau inversion recovery (STIR) or T1/T2-weighted MRI at baseline. MC edema reductions (yes/no) in STIR and T1/T2 series were analyzed separately. The effect of amoxicillin in reducing MC edema was analyzed using logistic regression adjusted for prior disk surgery. To assess the effect of amoxicillin versus placebo within the group with the most abundant MC edema on STIR at baseline ("STIR3" group), we added age, STIR3 (yes/no), and STIR3×treatment group (interaction term) as independent variables and compared the marginal means (probabilities of edema reduction)., Results: Compared to placebo, amoxicillin did not reduce MC edema on STIR (volume/intensity) in the total sample with edema on STIR at baseline (odds ratio 1.0, 95% CI: 0.5, 2.0; n=141) or within the STIR3 group (probability of edema reduction 0.69, 95% CI: 0.47, 0.92 with amoxicillin and 0.61, 95% CI: 0.43, 0.80 with placebo; n=41). Compared with placebo, amoxicillin did not reduce MC edema in T1/T2 series (volume of the type 1 part of MCs) (odds ratio: 1.0, 95% CI: 0.5, 2.3, n=104). Edema declined in >50% of patients in both treatment groups., Conclusions: From baseline to one-year follow-up, amoxicillin did not reduce MC edema compared with placebo., Level of Evidence: 2., Competing Interests: The authors report no conflicts of interest., (Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc.)

Introduction: For individuals with substance use disorder (SUD), mild to borderline intellectual disability (MBID) goes undetected in treatment clinics. The Hayes Ability Screening Index (HASI) has been found to be a valid, time-saving screening instrument for MBID in SUD treatment. MBID can have significant implications for treatment planning and outcomes. Therefore, it is important to have methods for the early recognition of these comorbid conditions. Because of less sensitivity to recent or ongoing substance use, the HASI subtest background information may be particularly valuable as an early screening of MBID. The main aim was to investigate the convergent, predictive, and discriminant validity of the HASI subtest background information in identifying in-patients with SUD as MBID or non-MBID., Methods: Eighty-four in-patients with SUD aged 19-64 participated in this multicentre study. MBID was diagnosed according to the ICD-10 using WAIS-IV, Vineland II, and self-reported childhood learning difficulties., Results: The main finding was that, among the HASI subtests, background information was the strongest predictor. A HASI background information cut between 6 and 7 showed a sensitivity of 78% and a specificity of 72%., Conclusion: The HASI subtest background information has acceptable convergent, predictive, and discriminant validity as a screening for MBID among in-patients in SUD treatment., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Braatveit, Assmus and Hove.)

Background: Necrotizing soft tissue infections (NSTIs) are severe diseases with high morbidity and mortality. The diagnosis is challenging. Several guidelines recommend tissue biopsies as an adjunct diagnostic in routine management, but neither biopsy sampling nor classification is standardized or validated. We studied the quality of tissue biopsy examination as part of routine diagnostics in NSTIs., Methods: This was a retrospective cohort study of adult patients undergoing surgery due to suspected NSTIs in which tissue biopsy was taken as part of routine management. Clinical data were reviewed. The biopsies were evaluated according to a proposed histopathologic classification system and independently assessed by 2 pathologists. Interrater reliability and diagnostic accuracy were determined., Results: Tissue biopsies from 75 patients were examined, 55 NSTIs and 20 non-NSTIs cases. The cohorts were similar in clinical characteristics. Interrater reliability for histopathologic staging was moderate (0.53) and fair (0.37) for diagnosis. The sensitivity of histologic diagnosis was 75% and the specificity 80%. The positive predictive value was 91% and the negative predictive value 53%. Necrotizing Infection Clinical Composite Endpoint (NICCE) success was associated with a more severe histological stage, achieved by 42% and 71% of the cases in stage 1 and 2, respectively ( P = .046)., Conclusions: Our findings suggest that tissue biopsies have low clinical accuracy. The interrater reliability among experienced pathologists is only fair to moderate. A histopathologically more severe stage was associated with favorable outcome. These findings discourage the use of histopathologic evaluation as part of contemporary management of patients with suspected NSTI., Competing Interests: Potential conflicts of interest. All authors: No reported conflicts., (© The Author(s) 2022. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)

Purpose: To describe challenges of translating and culturally adapting the Edinburgh Cognitive and Behavioural Amyotrophic Lateral Sclerosis (ALS) Screen into Norwegian (ECAS-N), evaluate its content validity; provide age- and education-balanced norms for verbal fluency and cut-off values for abnormal performance., Materials and Methods: Translation to Norwegian and back-translation to English complied with standard methods. Patients and ALS experts evaluated the relevance, comprehensiveness and comprehensibility of the translated ECAS (ECAS-N). Content validity indexes at the item level (I-CVI), scale level (S-CVI) and inter-rater agreement were calculated. Performance of controls determined norms for written and spoken verbal fluency ( n  = 559) and cut-off scores for abnormal performance ( n  = 85)., Results: High levels of content validity was achieved for all items of the ECAS-N, I-CVI, S-CVI and inter-rater agreement was 87.5%. Age- and education-balanced norms for written and spoken verbal fluency were produced. Cut-off scores of abnormal performance were slightly lower than the original ECAS., Conclusions: The ECAS-N holds promise for detecting cognitive and behavioural impairment in Norwegian patients with ALS. Cut-off scores are situational and could slightly vary between different cultures. The ECAS-N can be used in international research, but researchers should be aware of the differences between the tests applied in the studies.Implications for rehabilitationThe ECAS-N, a Norwegian version of the English-language ECAS was produced for clinical use in Norway.Rigorous translation methods were used, and expert-judged modifications were made for Norwegian-specific culture and language nuances.Determination of ECAS-N cut-off scores for abnormal cognition was guided by a biostatistician, are slightly lower than the original ECAS, and are based on results from an objectively calculated number of healthy Norwegians.A nuanced picture of cognitive impairment in ALS drawn from a well-developed scale as the ECAS-N can contribute to a management process better tailored to patients'- and carers' individual needs.

Background: Modic Changes (MCs) in the vertebral bone marrow were related to back pain in some studies but have uncertain clinical relevance. Diffusion weighted MRI with apparent diffusion coefficient (ADC)-measurements can add information on bone marrow lesions. However, few have studied ADC measurements in MCs. Further studies require reproducible and valid measurements. We expect valid ADC values to be higher in MC type 1 (oedema type) vs type 3 (sclerotic type) vs type 2 (fatty type). Accordingly, the purpose of this study was to evaluate ADC values in MCs for interobserver reproducibility and relation to MC type., Methods: We used ADC maps (b 50, 400, 800 s/mm 2 ) from 1.5 T lumbar spine MRI of 90 chronic low back pain patients with MCs in the AIM (Antibiotics In Modic changes)-study. Two radiologists independently measured ADC in fixed-sized regions of interests. Variables were MC-ADC (ADC in MC), MC-ADC% (0% = vertebral body, 100% = cerebrospinal fluid) and MC-ADC-ratio (MC-ADC divided by vertebral body ADC). We calculated mean difference between observers ± limits of agreement (LoA) at separate endplates. The relation between ADC variables and MC type was assessed using linear mixed-effects models and by calculating the area under the receiver operating characteristic curve (AUC)., Results: The 90 patients (mean age 44 years; 54 women) had 224 MCs Th12-S1 comprising type 1 (n = 111), type 2 (n = 91) and type 3 MC groups (n = 22). All ADC variables had higher predicted mean for type 1 vs 3 vs 2 (p < 0.001 to 0.02): MC-ADC (10 - 6  mm 2 /s) 1201/796/576, MC-ADC% 36/21/14, and MC-ADC-ratio 5.9/4.2/3.1. MC-ADC and MC-ADC% had moderate to high ability to discriminate between the MC type groups (AUC 0.73-0.91). MC-ADC-ratio had low to moderate ability (AUC 0.67-0.85). At L4-S1, widest/narrowest LoA were for MC-ADC 20 ± 407/12 ± 254, MC-ADC% 1.6 ± 18.8/1.4 ± 10.4, and MC-ADC-ratio 0.3 ± 4.3/0.2 ± 3.9. Difference between observers > 50% of their mean value was less frequent for MC-ADC (9% of MCs) vs MC-ADC% and MC-ADC-ratio (17-20%)., Conclusions: The MC-ADC variable (highest mean ADC in the MC) had best interobserver reproducibility, discriminated between MC type groups, and may be used in further research. ADC values differed between MC types as expected from previously reported MC histology., (© 2022. The Author(s).)

Background: Investigations of implementation factors (e.g., collegial support and sense of coherence) are recommended to better understand and address inadequate implementation outcomes. Little is known about the relationship between implementation factors and outcomes, especially in later phases of an implementation effort. The aims of this study were to assess the association between implementation success (measured by programme fidelity) and care providers' perceptions of implementation factors during an implementation process and to investigate whether these perceptions are affected by systematic implementation support., Methods: Using a cluster-randomized design, mental health clinics were drawn to receive implementation support for one (intervention) and not for another (control) of four evidence-based practices. Programme fidelity and care providers' perceptions (Implementation Process Assessment Tool questionnaire) were scored for both intervention and control groups at baseline, 6-, 12- and 18-months. Associations and group differences were tested by means of descriptive statistics (mean, standard deviation and confidence interval) and linear mixed effect analysis., Results: Including 33 mental health centres or wards, we found care providers' perceptions of a set of implementation factors to be associated with fidelity but not at baseline. After 18 months of implementation effort, fidelity and care providers' perceptions were strongly correlated (B (95% CI) = .7 (.2, 1.1), p = .004). Care providers perceived implementation factors more positively when implementation support was provided than when it was not (t (140) = 2.22, p = .028)., Conclusions: Implementation support can facilitate positive perceptions among care providers, which is associated with higher programme fidelity. To improve implementation success, we should pay more attention to how care providers constantly perceive implementation factors during all phases of the implementation effort. Further research is needed to investigate the validity of our findings in other settings and to improve our understanding of ongoing decision-making among care providers, i.e., the mechanisms of sustaining the high fidelity of recommended practices., Trial Registration: ClinicalTrials.gov Identifier: NCT03271242 (registration date: 05.09.2017)., (© 2022. The Author(s).)

Background: Patients referred to specialised mental health care are usually triaged based on referral information provided by general practitioners. However, knowledge about this system's ability to ensure timely access to and equity in specialised mental health care is limited. We aimed to investigate to the degree to which patient triage, based on referral letter information, corresponds to triage based on a hospital specialist's consultation with the patient, and whether the degree of correspondence is affected by the quality of the referral letter., Methods: We gathered information from three specialised mental health centres in Norway regarding patients that were referred and offered health care (N = 264). Data consisted of triage decisions for each patient (i.e., the hospital specialist's assessment of maximum acceptable waiting time), which were determined on the basis of a) referral information and b) meeting the patient. Referral letter quality was evaluated using the Quality of Referral information-Mental Health checklist. The reliability of priority setting and the impact of referral letter quality on this measure were investigated using descriptive analyses, binary logistic regression and Nadaraya-Watson kernel regression., Results: In 143 (54%) cases, the triage decision based on referral information corresponded with the decision based on patient consultation. In 70 (27%) cases, the urgency of need for treatment was underestimated when based on referral information compared with that based on information from patient consultation. Referral letter quality could not explain the differences between the two triage decisions. However, when a cut-off value of 7 on the Quality of Referral information-Mental Health scale was used, low-quality letters were found more frequently among patients whose urgency of need was underestimated, compared with those whose need was overestimated., Conclusions: Deciding the urgency of patient need for specialised mental health care based on referral information is a reliable system in many situations. However, the possibility of under- and overestimation is present, implying risks to patient safety and inappropriate use of resources. Improving the content of referral letters does not appear to reduce this risk when the letters are of acceptable quality., Trial Registration: NCT01374035 ., (© 2022. The Author(s).)

Background: Gastroparesis is a severe diabetes complication characterized by delayed gastric emptying. We examined patients with symptoms of diabetic gastroparesis using gastric emptying scintigraphy and ultrasound drink test. The primary aim was to investigate how ultrasound could provide information about gastric motility features in diabetic gastroparesis., Material and Methods: We prospectively included 58 patients with diabetes (48 type 1) with symptoms of gastroparesis and 30 healthy controls. Patients were examined with ultrasound of the stomach in a seated position after drinking 500 ml low-caloric meat soup, at the same time recording dyspeptic symptoms. The following day, they were examined with gastric emptying scintigraphy, defining gastroparesis as >10% retention after 4 h., Key Results: We found motility disturbances in the proximal stomach measured by ultrasound in patients with diabetic gastroparesis. A linear mixed effects model including repeated ultrasound measurements revealed a slower decrease of the proximal stomach size in gastroparesis compared to healthy controls (p < 0.01), and the proximal diameter at 20 min was correlated to scintigraphy at 4 h (r = 0.510, p = 0.001). The antrum in patients with diabetic gastroparesis was twice as large compared to healthy controls (p = 0.009), and fasting antral size was correlated to gastric emptying scintigraphy (r = 0.329, p = 0.013). Both diabetes patients with and without gastroparesis had impaired accommodation (p = 0.011)., Conclusions and Inferences: On ultrasound, we found delayed reduction of proximal stomach size and impaired accommodation after a liquid meal in patients with gastroparesis, emphasizing the role of the proximal stomach. Furthermore, we found antral distention in gastroparesis patients., (© 2021 The Authors. Neurogastroenterology & Motility published by John Wiley & Sons Ltd.)

Background/objectives: There is limited long-term data comparing the outcomes of sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB) for severe obesity, both with respect to body weight, quality of life (QOL) and comorbidities. We aimed to determine 7-year trajectories of body mass index (BMI), QOL, obesity-related comorbidities, biomarkers of glucose and lipid metabolism, and early major complications after SG and RYGB., Subjects/methods: Patients scheduled for bariatric surgery at two Norwegian hospitals, preferentially performing either SG or RYGB, were included consecutively from September 2011 to February 2015. Data was collected prospectively before and up to 7 years after surgery. Obesity-specific, generic and overall QOL were measured by the Impact of Weight on Quality of Life-Lite, Short-Form 36 and Cantril's ladder, respectively. Comorbidities were assessed by clinical examination, registration of medication and analysis of glucose and lipid biomarkers. Outcomes were examined with linear mixed effect models and relative risk estimates., Results: Of 580 included patients, 543 (75% women, mean age 42.3 years, mean baseline BMI 43.0 kg/m 2 ) were operated (376 SG and 167 RYGB). With 84.2% of participants evaluable after 5-7 years, model-based percent total weight-loss (%TWL) at 7 years was 23.4 after SG versus 27.3 after RYGB (difference 3.9%, p = 0.001). All levels of QOL improved similarly after the two surgical procedures but remained below reference data from the general population at all timepoints. Remission rates for type 2 diabetes, dyslipidemia, obstructive sleep-apnea and gastroesophageal reflux disease (GERD) as well as the rate of de novo GERD significantly favored RYGB. SG had fewer major early complications, but more minor and major late complications combined over follow-up., Conclusion: In routine health care, both SG and RYGB are safe procedures with significant long-term weight-loss, improvement of QOL and amelioration of comorbidities. Long-term weight-loss and remission rates of main obesity-related comorbidities were higher after RYGB., (© 2021. The Author(s).)

Purpose: To present retinal and visual findings in a Norwegian west coast diabetic population and to elucidate the effect of dietary intake of marine polyunsaturated fatty acids (PUFAs) on the development of diabetic retinopathy (DR)., Methods: In an eye practice in an archipelago of 314 km², serving a population of about 40 000, we recorded the prevalence of visual impairment and DR in a referred diabetic population. 510 consecutive patients were included, 238 females and 272 males. 50 patients had type I and 460 had type II diabetes mellitus (DM). Self-reported medication, diet supplements, HbA1c and fish consumption were registered., Results: In the type I group, the median age was 44.5 and median DM duration 11.5 years [1-44]. 48% had photographic evidence of DR, 8 patients (16%) had proliferative retinopathy (PDR), and 6 patients (12%) had diabetic macular oedema (DME). All had best-corrected visual acuity (BCVA) of 0.5 (log MAR 0.3) or better in the best eye. In the type II group, the median DM duration was 8 years [1-53], and median age was 66. 98% had best eye BCVA at or better than 0.5 (log MAR 0.3) in the best eye., Conclusion: None of the 510 patients had BCVA worse than 0.3 (log MAR 0.48) due to diabetic retinopathy. Compared to similar studies, we found a very low visual impairment rate. A possible protective effect of PUFA on the prevalence and progression of diabetic microangiopathy including retinopathy is discussed., (© 2021 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.)