Umeå University's logo

Objective: Antibiotic prophylaxis reduces infection risk following transrectal prostate biopsy. Studies in countries with high antibiotic resistance show that fosfomycin, given an hour or more before biopsy, has equal or better outcomes than ciprofloxacin. This study aimed to evaluate if fosfomycin, administered immediately before biopsy, is as effective as ciprofloxacin in Sweden, where antibiotic resistance is low.

Material and Methods: A randomised, non-inferiority study of different antibiotic prophylactic regimes, including men undergoing transrectal prostate biopsy, was conducted. A total of 3448 patients were planned to be included. Primary outcome was hospitalisation due to urinary tract infection (UTI) within 14 days. Men without risk factors for infection received either fosfomycin or ciprofloxacin immediately before biopsy. Patients with risk factors received additional doses post-biopsy.

Results: The study was stopped by the safety board after enrolment of 42 men. Four of 20 men (25%) in the fosfomycin group were hospitalised due to UTI, including two with positive blood cultures for Pseudomonas, whereas no hospitalisations (0%) occurred in the ciprofloxacin group. The main limitation was the small sample size.

Conclusion: Fosfomycin administered immediately before biopsy was not supported by this study. The results may be skewed by the high incidence of Pseudomonas infections.

Level of evidence: 2

Anorexia nervosa (AN) is an eating disorder that is mediated by psychological and metabolic factors, yet it is unclear how these factors interact. The NAMA trial objective is to clarify the metabo-psychiatric interaction and identify how it affects AN-patients' behavior. This randomized trial will recruit 36 treatment-naïve female AN patients, 13-18 years of age, and 36 matched healthy controls. Participants will undergo psychiatric assessments followed by 12-hour overnight fasting. In the next morning baseline assessments of outcomes will be performed. Patients will be randomly allocated 1:1 to receive a mixture with calories or receive a mixture without calories. Healthy controls will also be allocated to receive mixtures with/without calories. Mixtures will be standardized for taste and appearance and allocation will be masked. Primary outcome measure is resting-state functional magnetic resonance brain imaging 60 minutes post-consumption of the mixture. Secondary outcomes include: 1. Blood samples to study markers reflecting metabolic states, hunger/satiety, and stress responses, 2. psychometric evaluations of subjective experiences, and 3. In a second meal 3 hours later, effects of previous calorie intake on subsequent food consumption will be assessed. This article describes the study protocol, including analysis plan, for a randomized controlled trial to comprehensively evaluate the effects of calorie intake in AN. The trial will distinguish psychological and metabolic neuronal networks associated with food intake and uncover how their integration affects food intake and other hallmark symptoms in AN. The aim is to accelerate treatment development by identifying brain mechanisms that drive AN. Clinicaltrials.gov identifier: NCT06814002.

Background: Acute vestibular syndrome (AVS) causes sudden and continuous vertigo, dizziness, and postural instability and is a common reason for emergency department visits, most commonly due to vestibular neuritis and, in rare cases, stroke. Vestibular rehabilitation (VR) is an evidence-based exercise therapy that facilitates vestibular compensation and is effective in chronic vestibular disorders. However, evidence for VR in acute vertigo remains limited and, despite guideline support, it remains underused in practice. Internet-based VR has demonstrated benefit in chronic dizziness but has not been evaluated in acute vertigo. This study aimed to evaluate the efficacy of an internet-based VR tool compared with standard care (written instructions) in reducing vestibular symptoms after acute onset vertigo.

Methods and Findings: A multicentre, randomised, evaluator-blinded superiority trial was conducted across nine hospitals in Sweden. Adults with ongoing AVS were recruited within 1–7 days after symptom onset and randomised (1:1) to six weeks of internet-based VR with personalised, progressively adjusted home exercises or to written instructions for home-based VR exercises. The primary outcome was the between-group difference in vestibular symptoms at six weeks measured using the Vertigo Symptom Scale Short Form (VSS-SF; range 0–60), with a difference of ≥3 points prespecified as clinically significant. Secondary outcomes included dizziness-related disability, walking speed, and balance. Of 184 randomised participants, 183 were included in the analyses (94 online VR; 89 written instructions; median age 56 years). In the intention-to-treat analysis, both groups improved at six weeks, with no significant between-group difference (adjusted mean difference −2.0 points, 95% CI −4.9 to 0.9; p=0.18). Per-protocol analyses were consistent (−1.7 points, 95% CI −4.7 to 1.3; p=0.27). Over 12 weeks, both groups showed reduced vestibular symptoms and improved disability, balance, and walking speed, without significant between-group differences. No serious adverse events were attributed to the interventions, and compliance was high in both groups.

Conclusions: Internet-based VR was not superior to written instructions in reducing vestibular symptoms six weeks after acute onset vertigo. Both groups demonstrated improvement from baseline, with no statistically significant between-group differences. These findings suggest that ensuring access to vestibular rehabilitation exercises may be more important than the specific mode of delivery after acute onset vertigo, and internet-based tools represent viable alternatives for patients who prefer or may benefit from a digital format.

Background: Maternal diet during pregnancy is considered a potential modifiable risk factor for allergic diseases in offspring. The dietary inflammatory index (DII) is a tool to assess the inflammatory potential of the diet and has been suggested to be associated with offspring allergy development. Its association with food allergy and immunoglobulin E (IgE) sensitization in children remains understudied.

Methods: This study analyzed 4709 mother-partner-child triads from the NorthPop Birth Cohort in Sweden. Maternal DII scores were calculated from a food frequency questionnaire administered at gestational week 34. Allergy outcomes at 18 months included parent-reported physician-diagnosed food allergy, parent-reported eczema and atopic eczema according to UK Working Party criteria, parent-reported ever wheeze, parent-reported physician-diagnosed asthma, and IgE sensitization to food and airborne allergens. Associations between maternal DII scores (continuous and quartiles) and allergic outcomes were assessed using logistic regression, adjusting for maternal age, allergic heredity, farm living, region of birth, siblings, and education.

Results: At age 18 months, 4.9% of children had physician-diagnosed food allergy, 30.6% had eczema, 11.4% had atopic eczema, 15.9% reported ever wheeze, 4.1% had physician-diagnosed asthma, and 19% were IgE sensitized. No significant associations were found between maternal DII scores and the allergic outcomes of interest.

Conclusion: This large birth cohort study found no association between maternal DII during pregnancy and allergic diseases or IgE sensitization in 18-month-old children, suggesting that a proinflammatory diet during pregnancy does not influence early allergic outcomes. Further research is needed to clarify the role of maternal diet in offspring immune development.

Background: Mesh repair is recommended for umbilical hernias larger than 1 cm to reduce recurrence rates, yet current evidence remains limited for smaller umbilical hernias. Important questions concern optimal mesh positioning and wound complications/ surgical-site occurrences. The aim of this study was to report the preliminary results of a trial investigating surgical-site occurrences in suture versus mesh repair for umbilical hernias less than or equal to 2 cm.

Methods: A randomized, controlled, parallel-group, double-blind, multicentre trial across six Swedish surgical units is comparing 4 × 4 cm macroporous lightweight onlay mesh repair with conventional suture repair for primary elective umbilical hernias less than or equal to 2 cm. Intraoperative centralized web-based randomization ensured allocation concealment. The primary outcome of the trial is recurrence at 3 years, whereas secondary outcomes (the focus of this study) include surgical-site occurrences and pain intensity at 30 days post-surgery.

Results: From February 2020 to January 2024, 290 participants were randomly assigned to either suture or mesh repair. After exclusion and loss to follow-up, the remaining population for analysis was 144 participants for suture repair and 135 participants for mesh repair. Surgical-site occurrences (Clavien–Dindo grade greater than or equal to I) affected 32 mesh repair participants (23.7%) compared with 26 suture repair participants (18.1%), without any significant increase in surgical-site occurrences for mesh repair (OR 1.39 (95% c.i. 0.78 to 2.51)). Clinically relevant surgical-site occurrences (Clavien–Dindo grade greater than or equal to II) were less common in the mesh group (2 participants; 1.5%) compared with the suture group (4 participants; 2.8%). The median duration of surgery was 32 min for suture repair and 45 min for mesh repair (P < 0.001). Assessment of pain intensity revealed that 82.0% of suture repair participants and 73.0% of mesh repair participants reported no pain (P = 0.061).

Conclusion: This randomized clinical trial provides high-level evidence for mesh repair for umbilical hernias less than or equal to 2 cm. With regard to early postoperative outcomes, such as surgical-site occurrences, onlay mesh repair can be considered comparable to suture repair and is safe to use for smaller umbilical hernias.

Registration number: NCT04231071 (http://www.clinicaltrials.gov).

Background: Respiratory infections in early life are an identified risk factor for asthma. We hypothesized that infection-prevention measures during the coronavirus disease 2019 (COVID-19) pandemic influenced the risk of respiratory morbidity and aeroallergen sensitization in early childhood. Objective: We compared respiratory morbidity and aeroallergen sensitization in children born before and during the pandemic. Methods: We compared a COVID-19 category (exposed children; n = 1661) to a pre–COVID-19 category (nonexposed children; n = 1676) by using data from the prospective population-based NorthPop Birth Cohort study in Sweden. Data on respiratory morbidity and concomitant medication were retrieved from national registers. Prospectively collected data on respiratory morbidity using web-based questionnaires at 9 and 18 months of age were applied. At age 18 months, serum IgE levels to aeroallergens were determined (n = 1702). Results: The risk of developing any respiratory tract infection (adjusted odds ratio [aOR] = 0.33 [95% CI, 0.26-0.42]), bronchitis (aOR = 0.50 [95% CI, 0.27-0.95]) and croup (aOR = 0.59 [95% CI, 0.37-0.94]) were decreased in the COVID-19 category. The risk of wheeze in the first 9 months was lower in the COVID-19 category (aOR = 0.70 [95% CI, 0.55-0.89]). There were also fewer prescriptions of antibiotics in the COVID-19 category. The prevalence of aeroallergen sensitization was similar between categories. Conclusion: Children born during the COVID-19 pandemic demonstrated significantly decreased risks of respiratory infections and prescribed antibiotics until 18 months of age compared to children born before the COVID-19 pandemic. Whether this will affect the risk of developing asthma in childhood is being followed.

Background: The Vertigo Symptom Scale–short form (VSS–SF) is commonly used to measure dizziness and vertigo over the past month. This study aimed to (1) adapt the VSS–SF for the Swedish population and assess its psychometric properties, and (2) develop a modified version for measuring symptoms in the acute phase of acute vestibular syndrome (AVS).

Methods: The VSS–SF was translated into Swedish and adapted cross-culturally. Its psychometric properties were evaluated in 86 AVS patients, both in the acute stage (1–7 days from symptom onset) with a modified acute version, and after six weeks of vestibular rehabilitation using the standard VSS–SF. Factor structure, convergent and discriminant validity, and internal consistency were analyzed. Test-retest reliability was assessed at six weeks. Participants were also evaluated with the Dizziness Handicap Inventory (DHI) and balance tests. Controls included 54 healthy participants.

Results: Exploratory factor analysis revealed a two-factor structure for both versions, corresponding to vertigo-balance (VSS–V) and autonomic-anxiety (VSS–A) subscales. Both versions demonstrated strong factor structures with adequate loadings. Internal consistency was high for the standard version (Cronbach’s alpha 0.76 to 0.87) and for the total and VSS–V subscale of the acute version (0.82 and 0.85, respectively), but poor for the acute VSS–A subscale (0.50). Convergent validity was supported by Spearman’s rank correlations. The discriminative ability was excellent for the acute VSS–SF and VSS–V (AUC 0.98 and 0.99), and acceptable for VSS–A (AUC 0.77). After six weeks, discriminative ability decreased but remained above 0.5. Test-retest reliability at six weeks was excellent for all scales (ICC 0.94, 0.93, and 0.93 for VSS–SF, VSS–V, and VSS–A).

Conclusions: The VSS–SF was successfully adapted for the Swedish population, including an acute version for early dizziness assessment. Both versions confirmed a robust two-factor structure, with the acute version showing excellent early discriminative ability, particularly for the vertigo-balance dimension. However, the autonomic-anxiety subscale showed weaker psychometric properties, suggesting limited suitability for AVS patients. The adapted scales show promise for clinical use in diagnosing and evaluating dizziness and vertigo in the Swedish population.

Trial registration: Clinicaltrials.gov Identifier NCT05056324, September 24, 2021. https://clinicaltrials.gov/ct2/show/NCT05056324.

Rationale: Chronic obstructive pulmonary disease (COPD) includes respiratory symptoms and chronic airflow limitation (CAL). In some cases, emphysema and impaired diffusing capacity of the lung for carbon monoxide (DL_CO) are present, but characteristics and symptoms vary with smoking exposure.

Objective: To study the prevalence of CAL, emphysema, and impaired DL_CO in relation to smoking and respiratory symptoms in a middle-aged population.

Methods: We investigated 28,746 randomly invited individuals (52% women) aged 50-64 years across six Swedish sites. We performed spirometry, DL_CO testing, and high-resolution computed tomography and asked for smoking habits and respiratory symptoms. CAL was defined as post-bronchodilator forced expiratory volume in 1 second divided by forced vital capacity (FEV₁/FVC) < 0.7.

Results: The overall prevalence was 8.8% for CAL, 5.7% for impaired DL_CO (DL_CO < LLN), and 8.8% for emphysema, with a higher prevalence in current smokers than in ex-smokers and never-smokers. The proportion of never-smokers among those with CAL, emphysema, and impaired DL_CO was 32%, 19%, and 31%, respectively. Regardless of smoking habits, the prevalence of respiratory symptoms was higher among people with CAL and impaired DL_CO than those with normal lung function. Asthma prevalence in never-smokers with CAL was 14%. In this group, asthma was associated with lower FEV₁ and more respiratory symptoms.

Conclusions: In this large population-based study of middle-aged people, CAL and impaired DL_CO were associated with common respiratory symptoms. Self-reported asthma was not associated with CAL in never-smokers. Our findings suggest that CAL in never-smokers signifies a separate clinical phenotype that may be monitored and, possibly, treated differently from smoking-related COPD.

BACKGROUND: Vertigo and dizziness can be disabling symptoms that result in sick leave. Research regarding sickness absence due to dizziness has focused on specific vestibular diagnoses rather than the nonspecific vertigo/dizziness diagnoses. Strict sick leave regulations were introduced in Sweden in 2008. The aim of this study was to describe the vertigo/dizziness sick leave prevalence and duration considering both specific and nonspecific diagnoses according to International Classification of diseases 10th revision (ICD-10) on the 3-digit level, including the less specific "R" diagnoses.

METHODS: Through Swedish nationwide registers we identified individuals aged 16-64 years who during the years 2005-2018 were sickness absent > 14 consecutive days - minimum register threshold - due to vertigo/dizziness diagnoses according to ICD10 codes: specific diagnoses (H81.0, H81.1, H81.2, H81.3, H81.4, G11x) and nonspecific (R42, R26, R27, H81.9). We described the demographic characteristics, prevalence and duration of such sick-leave spells. Data were stratified according to diagnostic groups: ataxias, vestibular and nonspecific.

RESULTS: We identified 52,179 dizziness/vertigo sick leave episodes > 14 days in 45,353 unique individuals between 2005-2018, which constitutes 0.83% from all sick leave episodes in the given period.The nonspecific diagnoses represented 72% (n = 37741) of sick leave episodes and specific vestibular H-diagnoses 27% (n = 14083). The most common specific vestibular codes was Benign paroxysmal positional vertigo (BPPV) 9.4% (n = 4929). The median duration of sick leave was 31 days (IQR 21-61). Women on sick leave were younger than men (47 vs 51 years, p < 0.05) and had a higher proportion of nonspecific diagnoses compared with men (74% vs 70%, p < 0.05).

CONCLUSIONS: The vast majority of vertigo/dizziness sick leave episodes were coded as nonspecific diagnoses and occurred in women. BPPV, a curable vestibular condition, was the most common specific diagnosis. This suggests a potential for improved diagnostics. Women on sick leave due to dizziness/vertigo were younger and more often received nonspecific diagnostic codes. Future studies should determine the frequency of use of evidence based therapies and investigate further the gender differences.

Background: Randomized controlled trials have demonstrated that early introduction of allergenic foods, such as peanut and egg, can reduce food allergy in high-risk children. Many international guidelines recommend introduction of allergenic foods in the first year of life, and accordingly, the Swedish National Food agency released updated guidelines in June 2019.

Objective: Our aim was to examine whether the age at introduction and consumption frequency of allergenic foods have changed since release of the revised national guidelines on the introduction of solid foods in Sweden.

Methods: Children born between June 2016 and December 2018 (n = 1925) were compared with children born between June 2019 and April 2021 (n = 1761) by using data from the NorthPop Birth Cohort study. Data on food introduction, eczema, and food allergy were prospectively collected until age 18 months by using web-based questionnaires. IgE sensitization was assessed at 18 age months.

Results: The proportion of participants who had been introduced to egg, legume, soy products, peanut, almond, and cashew nut during the first year of life increased after implementation of the revised national guidelines. The most significant changes were seen for legume (from 55.2% to 69.8% [adjusted odds ratio = 1.90 (95% CI = 1.62-2.24)] and peanut (from 29.2% to 43.2% adjusted odds ratio = 1.87 (95% CI = 1.55-2.24)]); consumption frequency had also increased. No differences in the prevalence of eczema, food allergy, or sensitization to the foods of interest were found.

Conclusion: Since release of the revised guidelines, infants in the general population are introduced to and consume a variety of allergenic foods earlier and more frequently; however, early manifestations of allergic disease have remained unchanged.