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Granåsen, Gabriel, PhD
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Publications (10 of 39) Show all publications
Österlund, J., Granåsen, G., Bodén, S., Silfverdal, S.-A., Domellöf, M., Winberg, A. & West, C. E. (2024). Revised Swedish infant feeding guidelines are associated with earlier introduction of allergenic foods. Journal of Allergy and Clinical Immunology, 153(2), 461-470
Open this publication in new window or tab >>Revised Swedish infant feeding guidelines are associated with earlier introduction of allergenic foods
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2024 (English)In: Journal of Allergy and Clinical Immunology, ISSN 0091-6749, E-ISSN 1097-6825, Vol. 153, no 2, p. 461-470Article in journal (Refereed) Published
Abstract [en]

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.

Place, publisher, year, edition, pages
Elsevier, 2024
Keywords
complementary feeding, food allergy, Food introduction, guidelines, infants, NorthPop, solid foods, weaning
National Category
Respiratory Medicine and Allergy Immunology in the medical area
Identifiers
urn:nbn:se:umu:diva-216206 (URN)10.1016/j.jaci.2023.08.037 (DOI)37813287 (PubMedID)2-s2.0-85175313844 (Scopus ID)
Funder
Swedish Research Council, 2018-02642Swedish Heart Lung Foundation, 20180641Ekhaga Foundation, 2018-40Region Västerbotten, RV 832 441Region Västerbotten, RV 840 681Umeå University
Available from: 2023-11-06 Created: 2023-11-06 Last updated: 2024-05-07Bibliographically approved
Ekbäck, E., Rådmark, L., Granåsen, G., Svärling, R., Sörlin, M., Schönbeck, C. & Henje Blom, E. (2023). Clinical effectiveness of training for awareness, resilience, and action for adolescents and young adults with depression: the pilot phase of a multicenter randomized controlled trial. Frontiers in Psychiatry, 14, Article ID 1130035.
Open this publication in new window or tab >>Clinical effectiveness of training for awareness, resilience, and action for adolescents and young adults with depression: the pilot phase of a multicenter randomized controlled trial
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2023 (English)In: Frontiers in Psychiatry, E-ISSN 1664-0640, Vol. 14, article id 1130035Article in journal (Refereed) Published
Abstract [en]

Background: Depression is a top-ranking global health concern increasing in magnitude. Available treatments for adolescents and young adults are not convincingly effective and relapse rates remain high. Training for Awareness, Resilience and Action (TARA) is a group treatment program targeting specific pathophysiological mechanisms of depression in young people. TARA is feasible, acceptable, preliminarily efficacious in depressed American adolescents, and it affects postulated brain-circuitry.

Methods: As an initial step of a multicenter randomized controlled trial (RCT) we performed a single-arm multicenter pilot-study on TARA. Thirty-five depressed individuals (15–21 years old, 28 females) received TARA for 12 weeks face-to-face or online. Data was collected before (T0), during, and after the intervention (T1). The trial was pre-registered at clinicaltrials.gov, NCT Registration: identifier [NCT04747340]. Feasibility outcomes included recruitment, attendance rates, and session ratings. Adverse events were recorded weekly and extracted from medical records at the end of the trial. Primary effectiveness outcome was self-rated depression severity on Reynolds Adolescent Depression scale 2nd ed. at T1. Secondary outcomes were Children’s Depression Rating Scale-revised (CDRS-R) and Multidimensional Anxiety Scale for Children (MASC) at T1.

Results: TARA was feasible and safe in the present trial. No significant RADS-2-change was seen (adjusted mean difference –3.26, 95 % CI –8.35 to 1.83; p= 0.20), however a significant decrease in CDRS-R scores is reported (adjusted mean difference –9.99, 95% CI –14.76 to –5.22; p < 0.001). MASC-scores did not change significantly (adjusted mean difference 1.98, 95% CI –0.96 to 4.91; p=0.18). Additional feasibility aspects are presented and discussed.

Discussion: Limitations include substantial loss-to-follow-up, no randomization to control, and that some participants received concomitant treatment(s). The Coronavirus pandemic complicated both implementation and interpretation of the trial. In conclusion TARA was feasible and safe in depressed adolescents and young adults. Preliminary signs of effectiveness were seen. The initiated RCT will be important and worthwhile to conduct, and several improvements to the design are suggested based on the present results.

Place, publisher, year, edition, pages
Frontiers Media S.A., 2023
Keywords
adolescents, clinical trial, depression, feasibility studies, mindfulness, online intervention, yoga, young adults
National Category
Psychiatry
Identifiers
urn:nbn:se:umu:diva-208087 (URN)10.3389/fpsyt.2023.1130035 (DOI)000970913600001 ()2-s2.0-85153392594 (Scopus ID)
Funder
Swedish Research Council, 2021- 02257Umeå University, 970831Region Västerbotten, RV-939199Region Västerbotten, RV-967045Region Västerbotten, RV-969368Region Västerbotten, RV-941585Region Västerbotten, RV-932919Region VästernorrlandThe Kempe Foundations, LVNFOU933598Swedish Society of Medicine, SLS-935854
Available from: 2023-05-09 Created: 2023-05-09 Last updated: 2024-03-27Bibliographically approved
Surano, S., Grip, H., Öhberg, F., Karlsson, M., Faergemann, E., Bjurman, M., . . . Salzer, J. (2022). Internet-based vestibular rehabilitation versus standard care after acute onset vertigo: a study protocol for a randomized controlled trial. Trials, 23(1), Article ID 496.
Open this publication in new window or tab >>Internet-based vestibular rehabilitation versus standard care after acute onset vertigo: a study protocol for a randomized controlled trial
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2022 (English)In: Trials, E-ISSN 1745-6215, Vol. 23, no 1, article id 496Article in journal (Refereed) Published
Abstract [en]

Background: Dizziness and vertigo affect around 15% of adults annually and represent common reasons for contacting health services, accounting for around 3% of all emergency department visits worldwide. Vertigo is also associated with excessive use of diagnostic imaging and emergency care and decreased productivity, primarily because of work absenteeism. Vestibular rehabilitation is an evidence-based treatment for chronic dizziness and supervised group exercise therapy has recently been shown to be effective after vestibular neuritis, a common cause of acute onset vertigo. However, such interventions are not readily available and there is a need for more easily accessible tools. The purpose of this study is to investigate the effects on vestibular symptoms of a 6-week online vestibular rehabilitation tool after acute onset vertigo, with the aim of aiding vestibular rehabilitation by presenting a more accessible tool that can help to reduce recovery time. Methods: Three hundred twenty individuals diagnosed with acute vestibular syndrome (AVS) will be recruited from multiple hospitals in Sweden and the effects of an online vestibular rehabilitation tool, YrselTräning, on vestibular symptoms after acute onset vertigo will be compared to standard care (written instructions leaflet) in a two-armed, evaluator-blinded, multicenter randomized controlled trial. The primary outcome will be the Vertigo Symptom Scale Short Form (VSS-SF) score at 6 weeks after symptom onset. Secondary outcomes include effects of the intervention on activities of daily living, mood and anxiety, vestibular function recovery, mobility measures, health economic effects, and the reliability of the Swedish VSS-SF translation. Discussion: Participants using the online vestibular rehabilitation tool are expected to recover earlier and to a greater extent from their symptoms as compared to standard care. Since up to 50% of people with AVS without treatment develop persistent symptoms, effective treatment of AVS will likely lead to a higher quality of life and help reduce the societal costs associated with dizziness and vertigo. Trial registration: Clinicaltrials.gov NCT05056324. Registered on September 24, 2021.

Place, publisher, year, edition, pages
Springer Nature, 2022
Keywords
Acute onset vertigo, AVS, Gait function, Internet-based rehabilitation, Multicenter, Online tool, Portable motion sensors, Randomized controlled trial, RCT, Vestibular rehabilitation
National Category
Otorhinolaryngology
Identifiers
urn:nbn:se:umu:diva-203605 (URN)10.1186/s13063-022-06460-0 (DOI)000812260200013 ()35710448 (PubMedID)2-s2.0-85132078781 (Scopus ID)
Available from: 2023-01-19 Created: 2023-01-19 Last updated: 2024-01-17Bibliographically approved
Nüssler, E., Granåsen, G., Bixo, M. & Löfgren, M. (2022). Long-term outcome after routine surgery for pelvic organ prolapse: a national register-based cohort study. International Urogynecology Journal, 33(7), 1863-1873
Open this publication in new window or tab >>Long-term outcome after routine surgery for pelvic organ prolapse: a national register-based cohort study
2022 (English)In: International Urogynecology Journal, ISSN 0937-3462, E-ISSN 1433-3023, Vol. 33, no 7, p. 1863-1873Article in journal (Refereed) Published
Abstract [en]

Introduction and hypothesis: Pelvic organ prolapse (POP) is common, and women have an estimated 12–19% lifetime risk for needing POP surgery. Aims were to measure re-operation rates up to 10 years after POP surgery and patient-reported outcomes (PROMs) 5 years after a first-time operation for POP.

Methods: This is a cohort study using the Swedish National Quality Register for Gynaecological Surgery (GynOp). We retrieved information from 32,086 POP-operated women up to 10 years later. After validation, a web-based PROM questionnaire was sent to 4380 women who 5 years previously had standard POP surgery. Main outcome measures were reoperations due to a relapse of prolapse and PROMs 5 years after the primary operation.

Results: Among women operated for all types of POP, 11% had re-operations 5 years later and an additional 4% 10 years later, with similar frequencies for various compartments/types of surgery. PROMs yielded a 75% response rate after 5 years. Cure rate was 68% for anterior, 70% for posterior, and 74% for combined anterior-posterior native repairs. Patient satisfaction exceeded 70%, and symptom reduction was still significant after 5 years (p < 0.0001).

Conclusions: Following primary prolapse surgery, re-operation rates are low, even after 10 years. A web-based survey for follow-up of PROMs after POP surgery is feasible and yields a high response rate after 5 years. The subjective cure rate after primary POP operations is high, with reduced symptoms and satisfied patients regardless of compartment. Standard prolapse surgery with native tissue repair produces satisfactory long-term results.

Place, publisher, year, edition, pages
Springer, 2022
Keywords
Follow-up studies, Kaplan-Meier estimates, Pelvic organ prolapse, Population register, Surveys and questionnaires
National Category
Obstetrics, Gynecology and Reproductive Medicine Surgery
Research subject
Obstetrics and Gynaecology
Identifiers
urn:nbn:se:umu:diva-193595 (URN)10.1007/s00192-022-05156-y (DOI)000771388500002 ()35312802 (PubMedID)2-s2.0-85126814359 (Scopus ID)
Funder
Swedish Association of Local Authorities and Regions
Available from: 2022-04-13 Created: 2022-04-13 Last updated: 2022-12-19Bibliographically approved
Bäckström, D. C., Granåsen, G., Jakobson Mo, S., Riklund, K., Trupp, M., Zetterberg, H., . . . Eriksson Domellöf, M. (2022). Prediction and early biomarkers of cognitive decline in Parkinson disease and atypical parkinsonism: a population-based study. Brain Communications, 4(2)
Open this publication in new window or tab >>Prediction and early biomarkers of cognitive decline in Parkinson disease and atypical parkinsonism: a population-based study
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2022 (English)In: Brain Communications, E-ISSN 2632-1297, Vol. 4, no 2Article in journal (Refereed) Published
Abstract [en]

The progression of cognitive decline is heterogeneous in the three most common idiopathic parkinsonian diseases: Parkinson disease, multiple system atrophy and progressive supranuclear palsy. The causes for this heterogeneity are not fully understood, and there are no validated biomarkers that can accurately identify patients who will develop dementia and when. In this population-based, prospective study, comprehensive neuropsychological testing was performed repeatedly in new-onset, idiopathic parkinsonism. Dementia was diagnosed until 10 years and participants (N = 210) were deeply phenotyped by multimodal clinical, biochemical, genetic and brain imaging measures. At baseline, before the start of dopaminergic treatment, mild cognitive impairment was prevalent in 43.4% of the patients with Parkinson disease, 23.1% of the patients with multiple system atrophy and 77.8% of the patients with progressive supranuclear palsy. Longitudinally, all three diseases had a higher incidence of cognitive decline compared with healthy controls, but the types and severity of cognitive dysfunctions differed. In Parkinson disease, psychomotor speed and attention showed signs of improvement after dopaminergic treatment, while no such improvement was seen in other diseases. The 10-year cumulative probability of dementia was 54% in Parkinson disease and 71% in progressive supranuclear palsy, while there were no cases of dementia in multiple system atrophy. An easy-to-use, multivariable model that predicts the risk of dementia in Parkinson disease within 10 years with high accuracy (area under the curve: 0.86, P < 0.001) was developed. The optimized model adds CSF biomarkers to four easily measurable clinical features at baseline (mild cognitive impairment, olfactory function, motor disease severity and age). The model demonstrates a highly variable but predictable risk of dementia in Parkinson disease, e.g. a 9% risk within 10 years in a patient with normal cognition and CSF amyloid-β42 in the highest tertile, compared with an 85% risk in a patient with mild cognitive impairment and CSF amyloid-β42 in the lowest tertile. Only small or no associations with cognitive decline were found for factors that could be easily modifiable (such as thyroid dysfunction). Risk factors for cognitive decline in multiple system atrophy and progressive supranuclear palsy included signs of systemic inflammation and eye movement abnormalities. The predictive model has high accuracy in Parkinson disease and might be used for the selection of patients into clinical trials or as an aid to improve the prevention of dementia. 

Place, publisher, year, edition, pages
Oxford University Press, 2022
Keywords
cognitive decline, dementia, Parkinson disease, multiple system atrophy, progressive supranuclear palsy
National Category
Neurology
Research subject
Neurology
Identifiers
urn:nbn:se:umu:diva-196241 (URN)10.1093/braincomms/fcac040 (DOI)000773021800001 ()35350553 (PubMedID)2-s2.0-85137588604 (Scopus ID)
Funder
Umeå UniversityRegion VästerbottenKnut and Alice Wallenberg FoundationSwedish Research Council, 2018-02532Familjen Erling-Perssons Stiftelse, FO2019-0228Familjen Erling-Perssons Stiftelse, 860197
Available from: 2022-06-10 Created: 2022-06-10 Last updated: 2022-09-26Bibliographically approved
Do, L., Granåsen, G., Hellman, U., Lejon, K., Geijer, M., Baraliakos, X., . . . Forsblad-d'Elia, H. (2021). Anti-CD74 IgA autoantibodies in radiographic axial spondyloarthritis: a longitudinal Swedish study. Rheumatology, 60(9), 4085-4093
Open this publication in new window or tab >>Anti-CD74 IgA autoantibodies in radiographic axial spondyloarthritis: a longitudinal Swedish study
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2021 (English)In: Rheumatology, ISSN 1462-0324, E-ISSN 1462-0332, Vol. 60, no 9, p. 4085-4093Article in journal (Refereed) Published
Abstract [en]

OBJECTIVES: Antibodies against anti-CD74 are related to axial spondyloarthritis (axSpA). The objectives were (i) to study IgA anti-CD74 in radiographic (r)-axSpA patients in the Backbone cohort and to calculate the sensitivity and specificity of anti-CD74, (ii) to study the fluctuation of IgA anti-CD74 levels in prospectively collected samples, and (iii) to explore the relation between IgA anti-CD74 and radiographic spinal changes.

METHODS: IgA anti-CD74 was analysed by ELISA in 155 patients with r-axSpA and age- and sex-matched controls. BASDAI, ASDAS, BASFI and BASMI were assessed and spinal radiographs were scored for r-axSpA-related changes with mSASSS. Previously donated samples, before inclusion in the Backbone study, were identified in the Medical Biobank of Northern Sweden.

RESULTS: A total of 155 patients comprising 69% men and 31% women, age [mean (s.d.)] 55.5 (11.4) years and 152 (98.1%) HLA-B27 positive, were included. The plasma level of IgA anti-CD74 was significantly higher in the patients [median (interquartile range), 12.9 (7.9-17.9) U/ml] compared with controls [10.9 (7.2-14.6) U/ml, P = 0.003]. IgA anti-CD74 was above the cut-off level of 20 U/ml in 36/155 (23.2%) patients and in 15/151 (9.9%) controls (P = 0.002). Multivariable logistic regression analyses revealed ≥1 syndesmophyte associated with IgA anti-CD74 (odds ratio 5.64; 95% CI: 1.02, 35.58; P = 0.048) adjusted for hsCRP, smoking, BMI, sex and age. No distinct pattern of IgA anti-CD74 over time was revealed.

CONCLUSION: Plasma levels of IgA anti-CD74 were increased in r-axSpA and independently associated with radiographic spinal changes, which suggests that IgA anti-CD74 could play a role in the pathogenies of r-axSpA.

Place, publisher, year, edition, pages
Oxford University Press, 2021
Keywords
IgA anti-CD74, outcomes research, radiographic axial spondyloarthritis ankylosing spondylitis
National Category
Rheumatology and Autoimmunity
Identifiers
urn:nbn:se:umu:diva-191231 (URN)10.1093/rheumatology/keaa882 (DOI)000710982100036 ()33369649 (PubMedID)2-s2.0-85114422689 (Scopus ID)
Funder
Swedish Research Council, 2016-02035Region Västerbotten, ALFVLL-640251Stiftelsen Konung Gustaf V:s 80-årsfond, FAI-2017-0454
Available from: 2022-01-17 Created: 2022-01-17 Last updated: 2023-03-23Bibliographically approved
Ekbäck, E., Granåsen, G., Svärling, R., Blomqvist, I. & Henje Blom, E. (2021). Clinical Effectiveness of Training for Awareness Resilience and Action Online Compared to Standard Treatment for Adolescents and Young Adults With Depression: Study Protocol and Analysis Plan for a Pragmatic, Multi-Center Randomized Controlled Superiority Trial. Frontiers in Psychiatry, 12, Article ID 674583.
Open this publication in new window or tab >>Clinical Effectiveness of Training for Awareness Resilience and Action Online Compared to Standard Treatment for Adolescents and Young Adults With Depression: Study Protocol and Analysis Plan for a Pragmatic, Multi-Center Randomized Controlled Superiority Trial
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2021 (English)In: Frontiers in Psychiatry, E-ISSN 1664-0640, Vol. 12, article id 674583Article in journal (Refereed) Published
Abstract [en]

Depression in adolescents and young adults is an increasing global health concern. Available treatments are not sufficiently effective and relapse rates remain high. The novel group-treatment program “Training for Awareness, Resilience and Action” (TARA) targets specific mechanisms based on neuroscientific findings in adolescent depression. TARA is framed within the National Institute of Mental Health's Research Domain Criteria and has documented feasibility and preliminary efficacy in the treatment of adolescent depression. Since neurodevelopment continues well into the mid-twenties, age-adapted treatments are warranted also for young adults. Patients 15–22 years old, with either major depressive disorder (MDD) or persistent depressive disorder (PDD) according to the DSM-IV/5 or a rating >40 on the clinician rating scale Children's Depression Rating Scale—Revised (CDRS-R), will be recruited from specialized Child and Adolescent Psychiatry and local Youth-Clinics and randomized to either TARA or standard treatment, including but not limited to antidepressant medication and/or psychotherapy. Outcome measures will be obtained before randomization (T0), after 3 months of treatment (T1) and at 6-months- (T2) and 24-months- (T3) follow-up. Additionally, dose-response measures will be obtained weekly in the TARA-arm and measures for mediation-analysis will be obtained halfway through treatment (T0.5). Primary outcome measure is Reynolds Adolescent Depression Scale (RADS-2) score at T1. Secondary outcome measures include RADS-2 score at T2, Multidimensional Anxiety Scale for Children at T1 and T2, and CDRS-R at T1. Additional outcome measures include self-report measures of depression-associated symptoms, systemic bio-indicators of depression from blood and hair, heartrate variability, brain magnetic resonance imaging, as well as three-axial accelerometry for sleep-objectivization. Qualitative data will be gathered to reach a more comprehensive understanding of the factors affecting adolescents and young adults with depression and the extent to which the different treatments address these factors. In summary, this article describes the design, methods and statistical analysis plan for pragmatically evaluating the clinical effectiveness of TARA. This will be the first RCT to examine the effects of TARA compared to standard treatment for adolescents and young adults with MDD or PDD. We argue that this study will extend the current knowledgebase regarding the treatment of depression.

Place, publisher, year, edition, pages
Frontiers Media S.A., 2021
Keywords
adolescent depression, antidepressant drugs, biomarkers, psychotherapy, randomization, yoga, young adults
National Category
Psychiatry
Research subject
Psychiatry
Identifiers
urn:nbn:se:umu:diva-189121 (URN)10.3389/fpsyt.2021.674583 (DOI)000713179300001 ()34707516 (PubMedID)2-s2.0-85117953482 (Scopus ID)
Funder
The Kempe Foundations, LVNFOU933598Swedish Medical Products Agency, SLS-935854
Available from: 2021-11-12 Created: 2021-11-12 Last updated: 2024-03-27Bibliographically approved
Biström, M., Jons, D., Engdahl, E., Gustafsson, R., Huang, J., Brenner, N., . . . Sundström, P. (2021). Epstein-Barr virus infection after adolescence and Human herpesvirus 6A as risk factors for multiple sclerosis. European Journal of Neurology, 28(2), 579-586
Open this publication in new window or tab >>Epstein-Barr virus infection after adolescence and Human herpesvirus 6A as risk factors for multiple sclerosis
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2021 (English)In: European Journal of Neurology, ISSN 1351-5101, E-ISSN 1468-1331, Vol. 28, no 2, p. 579-586Article in journal (Refereed) Published
Abstract [en]

Background and purpose: Infections with human herpesvirus 6A (HHV‐6A) and Epstein–Barr virus (EBV) have been linked to multiple sclerosis (MS) development. For EBV, late infection has been proposed as a risk factor, but serological support is lacking. The objective of this study was to investigate how age affects the EBV and HHV‐6A associated risks of developing MS.

Methods:  In this nested case–control study, Swedish biobanks were accessed to find pre‐symptomatically collected blood samples from 670 individuals who later developed relapsing MS and 670 matched controls. A bead‐based multiplex assay was used to determine serological response against EBV and HHV‐6A. Conditional logistic regression was used to calculate odds ratios and 95% confidence intervals.

Results: Seropositivity against EBV exhibited a pattern where associations switched from a decreased risk of developing MS in the group below 20 years of age to an increased risk amongst individuals aged 20–29 and 30–39 years (p for trend 0.020). The age of transition was estimated to be 18.8 years. In contrast, HHV‐6A was associated with increased MS risk in all age groups (total cohort odds ratio 2.1, 95% confidence interval 1.6–2.7).

Conclusions: This study suggests EBV infection after adolescence and age independent HHV‐6A infection as risk factors for MS.

Place, publisher, year, edition, pages
John Wiley & Sons, 2021
Keywords
case–control studies, Epstein–Barr virus, human herpesvirus 6A, multiple sclerosis, serology
National Category
Neurology
Identifiers
urn:nbn:se:umu:diva-169075 (URN)10.1111/ene.14597 (DOI)000591137900001 ()33065762 (PubMedID)2-s2.0-85096633448 (Scopus ID)
Funder
Swedish Research Council, 2015-02419The Swedish Brain FoundationKnut and Alice Wallenberg FoundationEU, Horizon 2020, 733161
Available from: 2020-03-19 Created: 2020-03-19 Last updated: 2023-03-24Bibliographically approved
Melkemichel, M., Bringman, S., Granåsen, G. & Widhe, B. (2021). SUMMER Trial: mesh versus suture repair in small umbilical hernias in adults - a study protocol for a prospective randomized double-blind multicenter clinical trial. Trials, 22(1), Article ID 411.
Open this publication in new window or tab >>SUMMER Trial: mesh versus suture repair in small umbilical hernias in adults - a study protocol for a prospective randomized double-blind multicenter clinical trial
2021 (English)In: Trials, E-ISSN 1745-6215, Vol. 22, no 1, article id 411Article in journal (Refereed) Published
Abstract [en]

BACKGROUND: Small umbilical hernia repair is one of the most common surgical performances in general surgery. Yet, a gold standard procedure for the repair is still lacking today. There is an increasing evidence that mesh could be advantageous compared to suture repair in lowering recurrence rates. An additional important question remains with regard to the optimal anatomical positioning of the mesh. We hypothesize that the use of an onlay mesh in small umbilical hernia defects can reduce recurrence rates without increasing the complications compared to a simple suture repair.

METHODS: A prospective, national, multicenter, randomized, double-blind clinical trial comparing a standardized 4 × 4 cm onlay mesh to a conventional suture repair will be conducted. A total of 288 patients with a primary elective umbilical hernia ≤ 2 cm from 7 participating Swedish surgical centers will be enrolled. Intraoperative randomization will take place using a centralized web-based system resulting in total allocation concealment. Stratification will be done by surgical site and by defect size. Trial participants and follow-up clinical surgeons will be blinded to the assigned allocation. The primary outcome assessed will be postoperative recurrence at 1 and 3 years. Secondary outcomes assessed will be postoperative complications at 30 days and pain 1 year after surgery.

DISCUSSION: Currently, there has been no randomized clinical trial comparing the recurrence rates between an onlay mesh repair and a simple suture repair for small umbilical hernia defects. How to best repair a small umbilical hernia continues to be debated. This trial design should allow for a good assessment of the differences in recurrence rate due to the large sample size and the adequate follow-up. Surgeons' concerns surrounding optimal anatomical positioning and fear for larger required dissections are understandable. A small onlay mesh may become an easy and safe method of choice to reduce recurrence rates. Guidelines for small umbilical hernia repairs have stressed the need for reliable data to improve treatment recommendations. We can expect that this trial will have a direct implication on small umbilical hernia repair standards. TRIAL REGISTRATION: ClinicalTrials.gov NCT04231071. Registered on 31 January 2020. SUMMER Trial underwent external peer review as part of the funding process.

Place, publisher, year, edition, pages
BioMed Central, 2021
Keywords
Mesh repair, Randomized clinical trial, Recurrence, Small umbilical hernia, Suture repair
National Category
Surgery
Identifiers
urn:nbn:se:umu:diva-185903 (URN)10.1186/s13063-021-05366-7 (DOI)000665824700001 ()34158088 (PubMedID)2-s2.0-85109123101 (Scopus ID)
Funder
Region Stockholm
Available from: 2021-07-12 Created: 2021-07-12 Last updated: 2024-01-17Bibliographically approved
Granåsen, G. (2020). Patient stratification and treatment effects in diseases with disturbed cardiac function. (Doctoral dissertation). Umeå: Umeå universitet
Open this publication in new window or tab >>Patient stratification and treatment effects in diseases with disturbed cardiac function
2020 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

Background: Cardiovascular disease characteristics are often measured using a combination of different measurement modalities. By combining information from these modalities using statistical modelling we can gain additional knowledge about these diseases. 

Patients with hereditary transthyretin amyloidosis (ATTRv amyloidosis) often present with heart rate disturbances and ventricular hypertrophy. Although ATTRv amyloidosis can lead to a thick ventricular myocardium and heart failure this can also be due to other pathologies e.g. hypertrophic cardiomyopathy (HCM), which may lead to misdiagnosis. Children with hereditary long QT syndrome (LQTS) carry the risk of lethal cardiac events linked to increased sympathetic activity. If the regulatory pattern, measured by heart rate variability (HRV), could differentiate between LQTS genotypes and healthy children during childhood, it may then establish a role for HRV in evaluating such patients. Statins is the most common pharmaceutical treatment for atherosclerosis. However, the effect of statins on coronary calcification has shown mixed results between studies.

Aim: The overall aim of this thesis was to use statistically rigorous methodology to explore stratification of subgroups of patients and estimate treatment effects in diseases with cardiac involvement. The specific aims were: to evaluate discriminating features between ATTRv amyloidosis and HCM patients in different clinical examinations of their hearts; to evaluate the longitudinal growth pattern in HRV in children with LQTS; and, to estimate the short- and long-term treatment effects of statin treatment on coronary calcification in patients with coronary arteriosclerosis. 

Methods: In Study I we used classification and regression trees in order to create a clinical interpretable decision tree in order to differentiate between 35 ATTRv amyloidosis patients and 37 HCM patients based on features derived from echocardiography and ECG. In Study II a retrospective sample of 38 ATTRv amyloidosis patients, 41 HCM patients and 62 healthy controls were analyzed using k-means clustering and Random forest models in order to investigate similarities and differences in echocardiographic features and HRV. In Study III we calculated gender and treatment dependent age trends for spectral HRV features from longitudinal measurements from 70 children with LQTS (58 LQT1, 12 LQT2) and 65 healthy controls, using generalized additive mixed effects models. In Study IV data from two large clinical trials, in total 1585 patients with mild cardiac symptoms, was used to estimate the short- and long-term treatment effects of statin treatment on coronary calcification.

Results: In study I we found that a decision tree using both ECG and echocardiographic measurements provided the best separation between HCM and ATTRv amyloidosis. In study II we found that HRV could be used for discriminating between these diseases and that abnormalities in HRV are related on ATTRv fibril type but uncommon in HCM. In study III we found that the age trend in HRV in LQTS-patients showed no clear differences between controls and patients different LQTS genotypes. In study IV we found that high dose statin treatment resulted in a dose dependent increase in calcium score at both short- and long-term follow up. At the long-term follow up, we found no evidence to suggest that the increased calcium score had resulted in increased cardiac events.

Conclusions: The results from our studies could be used for differentiating HCM and ATTRv amyloidosis patients. The heterogeneity within these patient groups could further be characterized using features from echocardiography and HRV. Our data do not support evidence for a different age trend in HRV parameters in children with LQTS compared to controls of similar age. We also found that statin treatment increased calcium score on both short-and long-term follow up. Taken together the results and methods from this thesis may be used for future support in clinical decisions regarding patient stratification and knowledge of treatment effects.

Place, publisher, year, edition, pages
Umeå: Umeå universitet, 2020. p. 82
Series
Umeå University medical dissertations, ISSN 0346-6612 ; 2089
Keywords
Biostatistics, Heart rate variability, Cardiac amyloidosis, hypertrophic cardiomyopathy, cluster analysis, Echocardiography, Long QT syndrome, Pediatric, Statins, Coronary artery calcium, Computer tomography, Machine learning, Predictive modeling
National Category
Medical Engineering
Identifiers
urn:nbn:se:umu:diva-173971 (URN)978-91-7855-311-2 (ISBN)978-91-7855-310-5 (ISBN)
Public defence
2020-09-04, Sal 933, Unod B9, 9tr. Norrlands Universitetssjukhus, Norrlands Universitetssjukhus, Daniel Naezéns väg, 907 37 Umeå, Umeå, 13:00 (Swedish)
Opponent
Supervisors
Available from: 2020-08-17 Created: 2020-08-11 Last updated: 2020-08-12Bibliographically approved
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