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- Burkill, Sarah, et al.
(author)
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The association between exposure to interferon-beta during pregnancy and birth measurements in offspring of women with multiple sclerosis
- 2019
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In: PLOS ONE. - : PLOS. - 1932-6203. ; 28:Suppl. 2, s. 371-372
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Journal article (peer-reviewed)abstract
- BACKGROUND: Interferon-beta (IFN-beta) is a commonly used treatment for multiple sclerosis (MS). Current guidelines recommend cessation of treatment during pregnancy, however the results of past studies on the safety of prenatal exposure to IFN-beta have been conflicting. A large scale study of a population of MS women is therefore warranted.OBJECTIVES: To assess whether, among those born to women with MS, infants prenatally exposed to IFN-beta show evidence of smaller size at birth relative to infants which were not prenatally exposed to any MS disease modifying drugs.METHODS: Swedish and Finnish register data was used. Births to women with MS in Sweden and Finland between 2005-2014 for which a birth measurement for weight, height, and head circumference was available were included. The exposure window was from 6 months prior to LMP to the end of pregnancy.RESULTS: In Sweden, 411 pregnancies were identified as exposed to IFN-beta during the exposure window, and 835 pregnancies were counted as unexposed to any MS DMD. The corresponding numbers for Finland were 232 and 331 respectively. Infants prenatally exposed to interferon-beta were on average 28 grams heavier (p = 0.17), 0.01 cm longer (p = 0.95), and had head circumferences 0.14 cm larger (p = 0.13) in Sweden. In Finland, infants were 50 grams lighter (p = 0.27), 0.02 cm shorter (p = 0.92) and had head circumferences 0.22 cm smaller (p = 0.15) relative to those unexposed.CONCLUSIONS: This study provides evidence that exposure to IFN-beta during pregnancy does not influence birth weight, length, or head circumference.
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- Hakkarainen, Katja Marja, et al.
(author)
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Pregnancy outcomes after exposure to interferon beta : a register-based cohort study among women with MS in Finland and Sweden
- 2020
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In: Therapeutic advances in neurological disorders. - : Sage Publications. - 1756-2856 .- 1756-2864. ; 13
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Journal article (peer-reviewed)abstract
- Background: Our aim was to estimate and compare the prevalence of adverse pregnancy outcomes among pregnant women with multiple sclerosis (MS) exposed to interferon beta (IFNB) and among women with MS unexposed to any MS disease-modifying drug (MSDMD).Methods: This cohort study used Finnish (1996-2014) and Swedish (2005-2014) national register data. Women with MS having IFNB dispensed 6 months before or during pregnancy as the only medication were considered as IFNB exposed (only IFNB-exposed), whereas women with MS unexposed to any MSDMD were considered unexposed (MSDMD-unexposed). Prevalence was described and compared using log-binomial or logistic regression and adjusted for potential confounders including maternal age and comorbidity.Results: Among 2831 pregnancies, 2.2% of the only IFNB-exposed and 4.0% of the MSDMD-unexposed women had serious adverse pregnancy outcomes [elective termination of pregnancy due to foetal anomaly (TOPFA), major congenital anomaly (MCA) in live, or stillbirth]. After adjustments, the prevalence of serious adverse pregnancy outcomes was lower among the only IFNB-exposed compared with the MSDMD-unexposed [relative risk 0.55, 95% confidence interval (CI) 0.31-0.96]. The prevalence of individual outcomes, including MCA, spontaneous abortions, and stillbirths was not increased with IFNB exposure. Women with MS exposed to IFNB appeared more likely to terminate their pregnancy for reasons other than foetal anomaly, compared with MSDMD-unexposed pregnant MS patients (odds ratio 1.71, 95% CI 1.06-2.78).Conclusion: In this large cohort study, no increase in the prevalence of adverse pregnancy outcomes was observed in women with MS exposed to IFNB compared with MS patients unexposed to any MSDMDs. This study together with other evidence led to a change in the labels of the IFNB products in September 2019 in the European Union, and IFNB use today may be considered during pregnancy, if clinically needed.
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- Maret-Ouda, John, et al.
(author)
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Aspiration pneumonia after antireflux surgery among neurologically impaired children with GERD
- 2020
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In: Journal of Pediatric Surgery. - : Elsevier BV. - 0022-3468 .- 1531-5037. ; 55:11, s. 2408-2412
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Journal article (peer-reviewed)abstract
- BACKGROUND AND OBJECTIVE: Aspiration pneumonia is a common and serious complication to gastroesophageal reflux disease (GERD) among neurologically impaired children. Medication of GERD does not effectively prevent aspiration pneumonia, and whether antireflux surgery with fundoplication is better in this respect is uncertain. The objective was to determine whether fundoplication prevents aspiration pneumonia among children with neurological impairment and GERD.METHODS: This was a population-based cohort study from Denmark, Finland, Norway and Sweden, consisting of neurologically impaired children with GERD who underwent fundoplication. The risk of aspiration pneumonia before fundoplication (preoperative person-time) was compared with the risk after surgery (postoperative person-time). Multivariable Cox regression provided hazard ratios (HRs) with 95% confidence intervals (CIs). Except for confounding adjusted for by means of the "crossover like" design, the HRs were adjusted for age, sex, year of entry and respiratory diseases.RESULTS: Among 578 patients (median age 3.5 years), the preoperative person-time was 956 years and the postoperative person-time was 3324 years. Fundoplication was associated with 56% decreased overall HR of aspiration pneumonia (HR 0.44, 95% CI 0.27-0.72), and the HRs decreased over time after surgery. The risk of other types of pneumonia than aspiration pneumonia was not clearly decreased after fundoplication (HR 0.79, 95% CI 0.59-1.08). The 30-day mortality rate was 0.7% and the complication rate was 3.6%.CONCLUSIONS: Antireflux surgery decreases, but does not eliminate, the risk of aspiration pneumonia among neurologically impaired children with GERD. Fundoplication may be a treatment option when aspiration pneumonia is a recurrent problem in these children.TYPE OF STUDY: Cohort study.LEVEL OF EVIDENCE: Prognosis study-level I.
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4. |
- Maret-Ouda, John, et al.
(author)
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Cohort profile : the Nordic antireflux surgery cohort (NordASCo)
- 2017
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In: BMJ Open. - Stockholm : Karolinska Institutet, Dept of Molecular Medicine and Surgery. - 2044-6055.
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Journal article (peer-reviewed)abstract
- PURPOSE: To describe a newly created all-Nordic cohort of patients with gastro-oesophageal reflux disease (GORD), entitled the Nordic Antireflux Surgery Cohort (NordASCo), which will be used to compare participants having undergone antireflux surgery with those who have not regarding risk of cancers, other diseases and mortality. PARTICIPANTS: Included were individuals with a GORD diagnosis recorded in any of the nationwide patient registries in the Nordic countries (Denmark, Finland, Iceland, Norway and Sweden) in 1964-2014 (with various start and end years in different countries). Data regarding cancer, other diseases and mortality were retrieved from the nationwide registries for cancer, patients and causes of death, respectively. FINDINGS TO DATE: The NordASCo includes 945 153 individuals with a diagnosis of GORD. Of these, 48 433 (5.1%) have undergone primary antireflux surgery. Median age at primary antireflux surgery ranged from 47 to 52 years in the different countries. The coding practices of GORD seem to have differed between the Nordic countries. FUTURE PLANS: The NordASCo will initially be used to analyse the risk of developing known or potential GORD-related cancers, that is, tumours of the oesophagus, stomach, larynx, pharynx and lung, and to evaluate the mortality in the short-term and long-term perspectives. Additionally, the cohort will be used to evaluate the risk of non-malignant respiratory conditions that might be caused by aspiration of gastric contents.
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5. |
- Markar, Sheraz, et al.
(author)
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Hospital Volume of Antireflux Surgery in Relation to Endoscopic and Surgical Re-interventions
- 2020
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In: Annals of Surgery. - : Wolters Kluwer. - 0003-4932 .- 1528-1140. ; 274:6, s. 1138-1143
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Journal article (peer-reviewed)abstract
- Objective: To test the hypothesis that higher hospital volume decreases endoscopic and surgical re-intervention rates after antireflux surgery.Background: Antireflux surgery for gastro-esophageal reflux disease is followed by varying rates of re-interventions. Whether hospital volume influences re-intervention rates is uncertain.Methods: This population-based cohort study used nationwide data from Denmark, Finland, and Sweden for patients having undergone primary antireflux surgery. Hospitals were divided into tertiles based upon annual volume, that is, 3 equal-sized groups. The outcomes were 30-day surgical re-intervention, endoscopic re-intervention, and secondary antireflux surgery. Multivariable Cox regression provided hazard ratios (HRs) with 95% confidence intervals (CIs) for risk of the first outcome occurrence. Incidence rate ratios were calculated to count all outcome occurrences. All risk estimates were adjusted for age, sex, comorbidity, type of antireflux surgery, year of surgery, and country.Results: Among 33,060 patients and a median follow-up of 12 years after antireflux surgery, the frequencies of 30-day re-intervention, endoscopic re-intervention, and secondary antireflux surgery were 1.2%, 4.6%, and 7.0%, respectively. When comparing the highest with the lowest tertiles, higher hospital volume did not decrease HRs of 30-day re-intervention (adjusted HR = 1.14, 95% CI 0.73-1.77), endoscopic re-intervention (HR = 1.21, 95% CI 0.96-1.51), or secondary antireflux surgery (HR = 1.28, 95% CI 1.05-1.54), but rather increased point estimates. The incidence rate ratios showed similar patterns.Conclusions: Higher hospital volume of primary antireflux surgery may not decrease risk of endoscopic or surgical re-intervention, suggesting that centralization will not decrease rates of postoperative complications or recurrence of gastro-esophageal reflux disease.
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