| 1. |
- Sundh, Josefin, 1972-, et al.
(author)
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Beta-blockeRs tO patieNts with CHronIc Obstructive puLmonary diseasE (BRONCHIOLE) - Study protocol from a randomized controlled trial
- 2020
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In: Trials. - : BioMed Central (BMC). - 1745-6215. ; 21:1
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Journal article (peer-reviewed)abstract
- Background: Observational studies indicate that beta-blockers are associated with a reduced risk of exacerbation and mortality in patients with chronic obstructive pulmonary disease (COPD) even without overt cardiovascular disease, but data from randomized controlled trials (RCT) are lacking. The aim of this RCT is to investigate whether beta-blocker therapy in patients with COPD without diagnosed cardiovascular disease is associated with a decreased 1-year risk of the composite endpoint of death, exacerbations, or cardiovascular events.Methods: The Beta-blockeRs tO patieNts with CHronIc Obstructive puLmonary diseasE (BRONCHIOLE) study is an open-label, multicentre, prospective RCT. A total of 1700 patients with COPD will be randomly assigned to either standard COPD care and metoprolol at a target dose of 100 mg per day or to standard COPD care only. The primary endpoint is a composite of death, COPD exacerbations, and cardiovascular events. Major exclusion criteria are ischemic heart disease, left-sided heart failure, cerebrovascular disease, critical limb ischemia, and atrial fibrillation/flutter. Study visits are an inclusion visit, a metoprolol titration visit at 1 month, follow-up by telephone at 6 months, and a final study visit after 1 year. Outcome data are obtained from medical history and record review during study visits, as well as from national registries.Discussion: BRONCHIOLE is a pragmatic randomized trial addressing the potential of beta-blockers in patients with COPD. The trial is expected to provide relevant clinical data on the efficacy of this treatment on patient-related outcomes in patients with COPD.
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| 2. |
- Jans, Anders, 1981-, et al.
(author)
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Reliability of the DSS-Swe Questionnaire
- 2023
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In: Obesity Surgery. - : Springer. - 0960-8923 .- 1708-0428. ; 33:11, s. 3487-3493
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Journal article (peer-reviewed)abstract
- BACKGROUND: Symptomatic postbariatric hypoglycemia (PBH) is a known complication that can occur a few years after Roux-en-Y gastric bypass (RYGB). There is currently no established rating scale for PBH-associated symptoms developed for use in Swedish populations. The aim of the study was to translate an already existing questionnaire into Swedish and to test its reliability.METHODS: The study included forward and backward translations of the original Dumping Severity Scale (DSS) questionnaire with 8 items regarding symptoms of early dumping and 6 items regarding hypoglycemia, with each item graded on a 4-point Likert scale. The reliability of the Swedish translated questionnaire (DSS-Swe) was estimated using internal consistency and test-retest methods.RESULTS: A total of 200 patients were included in the study. Good internal consistency was demonstrated regarding the items related to early dumping symptoms, with a Cronbach's alpha coefficient of 0.82, and very good agreement in terms of test-retest reliability, with an overall intraclass correlation coefficient (ICC) of 0.91 (95% CI 0.88-0.93). The items related to hypoglycemia yielded a good Cronbach's alpha coefficient of 0.76 and an ICC of 0.89 (95% CI 0.85-0.91).CONCLUSION: The DSS-Swe questionnaire shows good reliability regarding both internal consistency and test-retest performance for use in Swedish populations.
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| 3. |
- Stenberg, Erik, 1979-, et al.
(author)
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Long-term Safety and Efficacy of Closure of Mesenteric Defects in Laparoscopic Gastric Bypass Surgery : A Randomized Clinical Trial
- 2023
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In: JAMA Surgery. - : American Medical Association (AMA). - 2168-6254 .- 2168-6262. ; 158:7, s. 709-717
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Journal article (peer-reviewed)abstract
- IMPORTANCE: Short-term and midterm data suggest that mesenteric defects closure during laparoscopic Roux-en-Y gastric bypass (LRYGB) surgery reduces the risk of internal herniation with small bowel obstruction (SBO) but may increase risk of kinking of the jejunojejunostomy in the early postoperative period. However, to our knowledge, there are no clinical trials reporting long-term results from this intervention in terms of risk for SBO or opioid use.OBJECTIVE: To evaluate long-term safety and efficacy outcomes of closure of mesenteric defects during LRYGB.DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial with a 2-arm, parallel, open-label design included patients with severe obesity scheduled for LRYGB bariatric surgery at 12 centers in Sweden from May 1, 2010, through November 14, 2011, with 10 years of follow-up after the intervention. INTERVENTIONS: During the operation, patients were randomly assigned 1:1 to closure of mesenteric defects beneath the jejunojejunostomy and at the Petersen space using nonabsorbable running sutures during LRYGB or to nonclosure.MAIN OUTCOME AND MEASURES: The primary outcome was reoperation for SBO. New incident, chronic opioid use was a secondary end point as a measure of harm.RESULTS: A total of 2507 patients (mean [SD] age, 41.7 [10.7] years; 1863 female [74.3%]) were randomly assigned to closure of mesenteric defects (n = 1259) or nonclosure (n = 1248). After censoring for death and emigration, 1193 patients in the closure group (94.8%) and 1198 in the nonclosure group (96.0%) were followed up until the study closed. Over a median follow-up of 10 years (IQR, 10.0-10.0 years), a reoperation for SBO from day 31 to 10 years after surgery was performed in 185 patients with nonclosure (10-year cumulative incidence, 14.9%; 95% CI, 13.0%-16.9%) and in 98 patients with closure (10-year cumulative incidence, 7.8%; 95% CI, 6.4%-9.4%) (subhazard ratio [SHR], 0.42; 95% CI, 0.32-0.55). New incident chronic opioid use was seen among 175 of 863 opioid-naive patients with nonclosure (10-year cumulative incidence, 20.4%; 95% CI, 17.7%-23.0%) and 166 of 895 opioid-naive patients with closure (10-year cumulative incidence, 18.7%; 95% CI, 16.2%-21.3%) (SHR, 0.90; 95% CI, 0.73-1.11).CONCLUSIONS AND RELEVANCE: This randomized clinical trial found long-term reduced risk of SBO after mesenteric defects closure in LRYGB. The findings suggest that routine use of this procedure during LRYGB should be considered.TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01137201.
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| 4. |
- Abawi, Akram, et al.
(author)
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Five-Year Follow-Up After Transcatheter Aortic Valve Implantation in Patients with Severe Aortic Stenosis and Concomitant Coronary Artery Disease : A Single-Center Experience
- 2023
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In: Brazilian Journal of Cardiovascular Surgery. - : Sociedade Brasileira de Cirurgia Cardiovascular. - 0102-7638 .- 1678-9741. ; 39:1
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Journal article (peer-reviewed)abstract
- INTRODUCTION: There is no consensus on the impact of coronary artery disease in patients undergoing transcatheter aortic valve implantation. Therefore, the objective of this study was, in a single-center setting, to evaluate the five-year outcome of transcatheter aortic valve implantation patients with or without coronary artery disease.METHODS: All transcatheter aortic valve implantation patients between 2009 and 2019 were included and grouped according to the presence or absence of coronary artery disease. The primary endpoint, five-year all-cause mortality, was evaluated using Cox regression adjusted for age, sex, procedure years, and comorbidities. Comorbidities interacting with coronary artery disease were evaluated with interaction tests. In-hospital complications was the secondary endpoint.RESULTS: In total, 176 patients had aortic stenosis and concomitant coronary artery disease, while 170 patients had aortic stenosis only. Mean follow-up was 2.2±1.6 years. There was no difference in the adjusted five-year all-cause mortality between transcatheter aortic valve implantation patients with and without coronary artery disease (hazard ratio 1.00, 95% confidence interval 0.59-1.70, P=0.99). In coronary artery disease patients, impaired renal function, peripheral arterial disease, or ejection fraction < 50% showed a significant interaction effect with higher five-year all-cause mortality. No significant differences in complications between the groups were found.CONCLUSION: Five-year mortality did not differ between transcatheter aortic valve implantation patients with or without coronary artery disease. However, in patients with coronary artery disease and impaired renal function, peripheral arterial disease, or ejection fraction < 50%, we found significantly higher five-year all-cause mortality.
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| 5. |
- Ahmad, Irma, et al.
(author)
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High prevalence of persistent symptoms and reduced health-related quality of life 6 months after COVID-19
- 2023
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In: Frontiers In Public Health. - : Frontiers Media S.A.. - 2296-2565. ; 11
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Journal article (peer-reviewed)abstract
- BACKGROUND: The long-term sequelae after COVID-19 constitute a challenge to public health and increased knowledge is needed. We investigated the prevalence of self-reported persistent symptoms and reduced health-related quality of life (HRQoL) in relation to functional exercise capacity, 6 months after infection, and explored risk factors for COVID-19 sequalae.METHODS: This was a prospective, multicenter, cohort study including 434 patients. At 6 months, physical exercise capacity was assessed by a 1-minute sit-to-stand test (1MSTST) and persistent symptoms were reported and HRQoL was evaluated through the EuroQol 5-level 5-dimension (EQ-5D-5L) questionnaire. Patients with both persistent symptoms and reduced HRQoL were classified into a new definition of post-acute COVID syndrome, PACS+. Risk factors for developing persistent symptoms, reduced HRQoL and PACS+ were identified by multivariable Poisson regression.RESULTS: Persistent symptoms were experienced by 79% of hospitalized, and 59% of non-hospitalized patients at 6 months. Hospitalized patients had a higher prevalence of self-assessed reduced overall health (28 vs. 12%) and PACS+ (31 vs. 11%). PACS+ was associated with reduced exercise capacity but not with abnormal pulse/desaturation during 1MSTST. Hospitalization was the most important independent risk factor for developing persistent symptoms, reduced overall health and PACS+.CONCLUSION: Persistent symptoms and reduced HRQoL are common among COVID-19 survivors, but abnormal pulse and peripheral saturation during exercise could not distinguish patients with PACS+. Patients with severe infection requiring hospitalization were more likely to develop PACS+, hence these patients should be prioritized for clinical follow-up after COVID-19.
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| 6. |
- Athlin, Simon, 1971-, et al.
(author)
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Pneumococcal urinary antigen testing for antimicrobial guidance in community-acquired pneumonia : A register-based cohort study
- 2022
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In: Journal of Infection. - : Elsevier. - 0163-4453 .- 1532-2742. ; 85:2, s. 167-173
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Journal article (peer-reviewed)abstract
- OBJECTIVES: To evaluate the effect of pneumococcal urinary antigen test (UAT) usage on broad-spectrum antibiotic treatment in community-acquired pneumonia (CAP).METHODS: Patients admitted to 32 Swedish hospitals between 2011 and 2014 were retrospectively included from the Swedish National Quality Register of CAP. Using propensity score matched data, stratified by CRB-65 score, we studied the effect of performing UAT and of positive test results on treatment with broad-spectrum β-lactam monotherapy (BSBM) and antibiotics with coverage for atypical bacteria compared to narrow-spectrum β-lactam monotherapy (NSBM).RESULTS: UAT was performed for 4,995/14,590 (34.2%) patients, 603/4,995 (12.1%) of whom had positive test results. At day three, performing UAT was not associated with decreased use of BSBM (OR 1.07, 95% CI 0.94-1.23) but was associated with increased atypical coverage among patients with CRB-65 score 2 (OR 1.47, 95% CI 1.06-2.02). A positive UAT was associated with decreased BSBM use (OR 0.39, 95% CI 0.25-0.60) and decreased atypical coverage (OR 0.25, 95% CI 0.16-0.37), predominantly in non-severe CAP. At day one, performing UAT was associated with atypical coverage among patients with CRB-65 scores 2 (OR 2.60, 95% CI 1.69-3.98) and 3-4 (OR 3.69, 95% CI 1.55-8.79), and a positive test reduced the odds of BSBM treatment among CRB-65 score 3-4 patients (OR 3.49, 95% CI 1.02-12.0).CONCLUSIONS: Performing UAT had no overall effect on decreasing the use of BSBM treatment by day three of hospitalization, yet non-severely ill patients with positive UAT results were less likely to be treated with BSBM and antibiotics with atypical coverage.
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| 7. |
- Axelsson, Susanne, et al.
(author)
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A combination of the activation marker CD86 and the immune checkpoint marker B and T lymphocyte attenuator (BTLA) indicates a putative permissive activation state of B cell subtypes in healthy blood donors independent of age and sex
- 2020
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In: BMC Immunology. - : BioMed Central (BMC). - 1471-2172. ; 21:1
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Journal article (peer-reviewed)abstract
- BACKGROUND: The use of anti-B cell based therapies in immune-mediated diseases targeting general B cell markers or molecules important for B cell function has increased the clinical needs of monitoring B cell subpopulations.RESULTS: We analyzed the expression profile of cell surface markers CD86 and B and T lymphocyte attenuator (BTLA) in B cell subtypes using flow cytometry, including naïve, transitional, switched memory, non-switched memory and double-negative memory B cells and plasmablasts, and investigated the dependence of age and sex in a healthy adult blood donor population. The switched memory B cell subtype displayed a divergent expression of the markers, with increased CD86 and decreased BTLA as compared to non-switched and double negative memory cells, as well as compared to naïve B cells. Plasmablasts expressed highly increased CD86 compared to all other subtypes and a decreased expression of BTLA compared to naïve cells, but still higher compared to the memory cell populations. Transitional B cells had CD86 and BTLA expression similar to the other naïve cells.CONCLUSIONS: We show divergent expression of CD86 and BTLA in memory cells and plasmablasts compared to naïve B cells independent of age and sex. Furthermore, a similarly divergent difference of expression pattern was seen between the memory cell subtypes, altogether indicating that the combination of CD86 and BTLA might be markers for a permissive activation state. We suggest the combination of CD86 and BTLA expression on B cell subtypes as a potentially important tool in monitoring the status of B cell subtypes before and after treatments influencing the B cell compartment.
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| 8. |
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| 9. |
- Bazargani, Farhan, 1969-, et al.
(author)
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Skeletal and dentoalveolar effects using tooth-borne and tooth-bone-borne RME appliances : a randomized controlled trial with 1-year follow-up
- 2021
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In: European Journal of Orthodontics. - : Oxford University Press. - 0141-5387 .- 1460-2210. ; 43:3, s. 245-253
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Journal article (peer-reviewed)abstract
- OBJECTIVES: To evaluate and compare the skeletal and dentoalveolar effects of tooth-borne (TB) and tooth-bone-borne (TBB) rapid maxillary expansion (RME).MATERIALS AND METHODS: Fifty-two consecutive patients who met the eligibility criteria were recruited and allocated to either the TB group, mean age 9.3 years [standard deviation (SD) 1.3], or the TBB group, mean age 9.5 years (SD 1.2). Cone-beam computed tomography (CBCT) records and plaster models were taken before (T0), directly after (T1), and 1 year after expansion (T2). Dentoalveolar and skeletal measurements were made on the CBCT images. The dental expansion was also measured on the plaster models.RANDOMIZATION: Participants were randomly allocated in blocks of different sizes using the concealed allocation principle in a 1:1 ratio. The randomization list was also stratified by sex to ensure homogeneity between groups.BLINDING: Due to clinical limitations, only the outcomes assessors were blinded to the groups to which the patients were allocated.RESULTS: Skeletal expansion in the midpalatal suture and at the level of the nasal cavity was significantly higher in the TBB group. However, the magnitude of the expansion in the midpalatal suture was around 1 mm [95 per cent confidence interval (CI) 0.5-1.7, P = 0.001] more and perhaps not clinically significant. The magnitude of the expansion at the level of the nasal cavity was almost two times higher in the TBB group (95 per cent CI 0.7-2.6, P = 0.001). The dental expansion, alveolar bending, tipping of the molars, and stability 1 year post-expansion did not show any statistically significant differences between the groups. The actual direct cost of the treatment for the TBB group was approximately €300 higher than TB group.LIMITATIONS: Double blinding was not possible due to the clinical limitations.CONCLUSIONS: In young preadolescents with constricted maxilla and no signs of upper airway obstruction, it seems that conventional TB RME achieves the same clinical results with good stability 1 year post-expansion at lower cost.TRIAL REGISTRATION: The trial was not registered.
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| 10. |
- Bazargani, Farhan, 1969-, et al.
(author)
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Three-dimensional comparison of tooth-borne and tooth-bone-borne RME appliances : a randomized controlled trial with 5-year follow-up
- 2023
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In: European Journal of Orthodontics. - : Oxford University Press. - 0141-5387 .- 1460-2210. ; 45:6, s. 690-702
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Journal article (peer-reviewed)abstract
- Objectives: To compare the long-term skeletal effects of tooth-borne (TB) and tooth-bone-borne (TBB) rapid maxillary expansion in growing children, using 3D imaging.Materials and methods: In total, 52 consecutive patients who met the eligibility criteria were recruited and allocated to either the TB group, mean age 9.3 years (SD 1.3), or the TBB group, mean age 9.5 years (SD 1.2). Cone-beam computed tomography records and plaster models were taken before (T-0), directly after (T-1), 1 year after (T-2), and 5 years after expansion (T-3).Randomization: Participants were randomly allocated in blocks of different sizes, using the concealed allocation principle in a 1:1 ratio. The randomization list was also stratified by sex to ensure homogeneity between groups.Blinding: Due to clinical limitations, only the outcome assessors were blinded to the groups to which the patients were allocated.Results: At T-1, the midpalatal suture at its anterior part showed a statistically significant difference between the groups with a mean of 0.6 mm (CI 0.2-1.1) more expansion in the TBB group (P < 0.01). This difference was also more evident in boys at T-1 with a mean of 0.8 mm (CI 0.2-1.4) (P < 0.01). These differences, however, blotted out at T-2 and T-3. The nasal width also showed similar differences between the groups, with a significantly larger expansion in the TBB group by a mean of 0.7 mm (CI 0.1-1.4) (P = 0.03). This group difference in favour of the TBB group was maintained at T-2 (1.6 mm) and T-3 (2.1 mm) (P < 0.01 T-2 and T-3, respectively).Conclusions: Skeletal expansion in the midpalatal suture was significantly higher in the TBB group; however, the magnitude of this expansion was around 0.6 mm more and may not be clinically significant. Skeletal expansion at the level of the nasal cavity was significantly higher in the TBB group. There were no differences between boys and girls with regard to skeletal expansion.
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