| 1. |
- Crippa, Alessio, et al.
(författare)
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The ProBio trial : molecular biomarkers for advancing personalized treatment decision in patients with metastatic castration-resistant prostate cancer
- 2020
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Ingår i: Trials. - : BioMed Central. - 1745-6215. ; 21:1
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Tidskriftsartikel (refereegranskat)abstract
- Background: Multiple therapies exist for patients with metastatic castration-resistant prostate cancer (mCRPC). However, their improvement on progression-free survival (PFS) remains modest, potentially explained by tumor molecular heterogeneity. Several prognostic molecular biomarkers have been identified for mCRPC that may have predictive potential to guide treatment selection and prolong PFS. We designed a platform trial to test this hypothesis.Methods: The Prostate-Biomarker (ProBio) study is a multi-center, outcome-adaptive, multi-arm, biomarker-driven platform trial for tailoring treatment decisions for men with mCRPC. Treatment decisions in the experimental arms are based on biomarker signatures defined as mutations in certain genes/pathways suggested in the scientific literature to be important for treatment response in mCRPC. The biomarker signatures are determined by targeted sequencing of circulating tumor and germline DNA using a panel specifically designed for mCRPC.Discussion: Patients are stratified based on the sequencing results and randomized to either current clinical practice (control), where the treating physician decides treatment, or to molecularly driven treatment selection based on the biomarker profile. Outcome-adaptive randomization is implemented to early identify promising treatments for a biomarker signature. Biomarker signature-treatment combinations graduate from the platform when they demonstrate 85% probability of improving PFS compared to the control arm. Graduated combinations are further evaluated in a seamless confirmatory trial with fixed randomization. The platform design allows for new drugs and biomarkers to be introduced in the study.Conclusions: The ProBio design allows promising treatment-biomarker combinations to quickly graduate from the platform and be confirmed for rapid implementation in clinical care.
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| 2. |
- Lundborg, Louise, et al.
(författare)
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First stage progression in women with spontaneous onset of labor : A large population-based cohort study
- 2020
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Ingår i: PLOS ONE. - : Public Library Science. - 1932-6203. ; 15:9
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Tidskriftsartikel (refereegranskat)abstract
- Objective: To describe the duration, progression and patterns of first stage of labor among Swedish women.Design: Population-based cohort study.Population: Data from Stockholm-Gotland Obstetric Cohort 2008–2014 including ¼ of all births in Sweden, the final sample involved a total of 85,408 women with term, singleton, vertex, live fetuses experiencing spontaneous labor onset and vaginal delivery with normal neonatal outcomes.Main outcome measures: Time to progress during first stage of labor using three approaches: 1) Traverse time in hours to progress centimeter to centimeter, 5th, 50th (and 95th percentile); 2) Dilation curves for different percentiles, and; 3) Cumulative duration for the 95th percentile by parity and dilation at admission.Results: Variation in both the total duration and the trajectory of cervical change over time is large. Similar to the general held view, the rate of cervical dilation accelerates at 5–6 centimeters. Among nulliparous women, the median time found in our population was faster than their counterparts in studies conducted on American and African cohorts. Among nulliparous and multiparous women our data suggest that the median cervical change over time is faster than 1 cm per hour during the first stage of labor. However, traverse time of cervical change at and beyond the 95th percentile is longer than 1 cm per hour.Conclusions: Labor progression varies widely and labors experiencing a prolonged first stage can still result in normal outcomes. The assumption of 1 cm per hour cervical dilation rate for the first stage of labor may not be universally meaningful. There are differences in progression for women during first stage of labor in different populations. For prolonged labor progression to be more clinically meaningful, the association with adverse birth outcomes needs to be further investigated in specific populations.
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| 3. |
- Mohammadi, Hanieh, et al.
(författare)
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Abdominal obesity and the risk of recurrent atherosclerotic cardiovascular disease after myocardial infarction
- 2020
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Ingår i: European Journal of Preventive Cardiology. - : Oxford University Press (OUP). - 2047-4873 .- 2047-4881. ; 27:18, s. 1944-1952
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: The association between abdominal obesity and recurrent atherosclerotic cardiovascular disease after myocardial infarction remains unknown.OBJECTIVE: The purpose of this study was to investigate the prevalence of abdominal obesity and its association with recurrent atherosclerotic cardiovascular disease in patients after a first myocardial infarction.DESIGN AND METHODS: In this register-based observational cohort, 22,882 patients were identified from the national Swedish Web-system for Enhancement and Development of Evidence-based Care in Heart Disease Evaluated According to Recommended Therapies (SWEDEHEART) registry at a clinical revisit 4-10 weeks after their first myocardial infarction 2005-2014. Patients were followed for recurrent atherosclerotic cardiovascular disease defined as non-fatal myocardial infarction, coronary heart disease death, non-fatal or fatal ischaemic stroke. Univariate and multivariable-adjusted Cox regression models were used to calculate hazard ratios and 95% confidence intervals in quintiles of waist circumference as well as three categories of body mass index including normal weight, overweight and obesity.RESULTS: The majority of patients had abdominal obesity. During a median follow-up time of 3.8 years, 1232 men (7.3%) and 469 women (7.9%) experienced a recurrent atherosclerotic cardiovascular disease event. In the univariate analysis, risk was elevated in the fifth quintile (hazard ratio 1.22, 95% confidence interval 1.07-1.39) compared with the first. In the multivariable-adjusted analysis, risk was elevated in the fourth and fifth quintiles (hazard ratio 1.21, confidence interval 1.03-1.43 and hazard ratio 1.25, confidence interval 1.04-1.50), respectively. Gender-stratified analyses showed similar associations in men, while U-shaped associations were observed in women and the body mass index analyses.CONCLUSIONS: Abdominal obesity was common in post-myocardial infarction patients and larger waist circumference was independently associated with recurrent atherosclerotic cardiovascular disease, particularly in men. We recommend utilising waist circumference to identify patients at increased risk of recurrent atherosclerotic cardiovascular disease after myocardial infarction.
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| 4. |
- Olausson, Nina, et al.
(författare)
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Incidence of pulmonary and venous thromboembolism in pregnancies after in vitro fertilization with fresh respectively frozen-thawed embryo transfer : Nationwide cohort study
- 2020
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Ingår i: Journal of Thrombosis and Haemostasis. - : WILEY. - 1538-7933 .- 1538-7836. ; 18:8, s. 1965-1973
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Tidskriftsartikel (refereegranskat)abstract
- Background The assisted reproductive technique in vitro fertilization (IVF) is associated with an increased risk of venous thromboembolism (VTE) and pulmonary embolism (PE) during the first trimester. Objectives To compare the incidence of VTE and PE during the first trimester of IVF pregnancies using fresh or frozen-thawed embryo transfer to that during natural pregnancies. Patient/Methods Nationwide Swedish registry-based cohort study of women who gave birth (n = 902 891) at the age of 15-50 years to their first child from the 1st of January 1992 until the 31st of December 2012. Exposure groups were IVF with fresh respectively frozen-thawed embryo transfer. Incidences of VTE and PE were calculated, and time-varying hazard ratios estimated for all trimesters after fresh respectively frozen-thawed embryo transfer IVF and compared to natural conception. Results and Conclusion Women giving birth after fresh embryo transfer IVF had a more than eightfold increased incidence of venous thromboembolism (hazard ratio [HR] 8.96, 95% CI 6.33 to 12.67) and pulmonary embolism during the first trimester, (HR 8.69, 95% CI 3.83 to 19.71) compared to women giving birth after natural conception. The incidence of VTE in women giving birth after frozen-thawed embryo transfer was not increased during the first trimester. To conclude, fresh embryo transfer IVF was associated with a significantly increased incidence of VTE and PE during the first trimester. These results suggest that frozen-thawed embryo transfer could be a preferred method of IVF with a minimised maternal risk.
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| 5. |
- Oskarsson, Viktor, et al.
(författare)
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Rising incidence of acute pancreatitis in Sweden : National estimates and trends between 1990 and 2013
- 2020
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Ingår i: United European Gastroenterology journal. - : Sage Publications. - 2050-6406 .- 2050-6414. ; 8:4, s. 472-480
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Tidskriftsartikel (refereegranskat)abstract
- Background: Recent reports from western countries have indicated an increased incidence and a decreased mortality in acute pancreatitis. However, the incidence assessment has often been hampered by the inclusion of both first-time and recurrent episodes of acute pancreatitis.Methods: In this retrospective cohort study, all Swedish residents hospitalized with a first-time episode of acute pancreatitis between 1990 and 2013 were identified using national registers. Sex- and age-standardized incidence rates per 100,000 individuals and year were calculated, as were annual percent changes (APC) from joinpoint regression models.Results: Overall, between 1990 and 2013, 66,131 individuals had a first-time episode of acute pancreatitis in Sweden. Comparing the first five years (1990-1994) to the last four years (2010-2013) of the study period, the overall incidence of acute pancreatitis increased from 25.2 (95% confidence interval (CI): 24.1, 26.3) to 38.3 (95% CI: 37.0, 39.5) cases per 100,000 individuals and year. An increase in incidence was observed irrespective of the subtypes of acute pancreatitis as well as the sex and age of the patients. Although the incidence of complicated acute pancreatitis declined in both men and women between 1990 and 2004, it started to increase in both sexes (APC 3.0; 95% CI: 0.5, 5.5 in men; APC 5.4; 95% CI: 2.6, 8.2 in women) from 2005 onwards.Conclusion: Based on nationwide data, the incidence of first-time acute pancreatitis has increased in Sweden over a period of 24 years. The incidence of disease-related complications has also been on the rise during the past few years, after declining for more than 15 years before that.
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